tag:blogger.com,1999:blog-367627112024-03-14T03:10:32.613-04:00Drug and Device Lawhttp://www.druganddevicelaw.blogspot.comRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger2981125tag:blogger.com,1999:blog-36762711.post-35074304275564652442016-05-20T12:00:00.000-04:002016-05-20T12:00:41.328-04:00SPECIAL ANNOUNCEMENT – WE’RE MOVING THE BLOG THIS WEEKEND
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As you’ve probably gathered from our posts this
week, the Drug and Device Law blog is going on a brief hiatus as we move to an
upgraded platform. <span style="mso-spacerun: yes;"> </span>We have well over
3000 posts, and it takes our technical people time to move them all and check
all the various links.<span style="mso-spacerun: yes;"> </span>That requires us
to go dark on this coming Monday and Tuesday, but we look forward to bringing
you our usual updates and analysis on drug and device product liability cases
at our new site starting on Wednesday.</div>
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At that point, you’ll be able to visit us at <a href="http://www.druganddevicelawblog.com/">DrugAndDeviceLawBlog.com</a>
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Have a great weekend, everyone, and keep those
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Wednesday.</div>
Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com2tag:blogger.com,1999:blog-36762711.post-60349651251172071852016-05-20T06:00:00.000-04:002016-05-20T14:01:26.534-04:00Guest Post - The Connecticut Supreme Court Modifies The State’s Consumer Expectation Test By Adopting The Modified Test<br />
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Today’s guest post is by <a href="http://www.shipmangoodwin.com/amasin">Adam M. Masin</a>, a partner at <a href="http://www.shipmangoodwin.com/amasin">Shipman & Goodwin LLP</a>.<span style="mso-spacerun: yes;"> </span>It’s about the most significant general
Connecticut product liability decision in almost 20 years.<span style="mso-spacerun: yes;"> </span>It’s not a drug/device case, though.<span style="mso-spacerun: yes;"> </span>Instead it involves tobacco.<span style="mso-spacerun: yes;"> </span>But make no mistake about it, this case could
affect our sandbox – particular design defect cases involving medical devices.</div>
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As always our guest posters deserve
all the credit, and any blame, for the contents of their posts.</div>
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Finally – be sure to read the
repeated <b style="mso-bidi-font-weight: normal;"><u>IMPORTANT ANNOUNCEMENT</u></b>
at the end of this post.<span style="mso-spacerun: yes;"> </span>DDLaw blog is
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<span style="mso-tab-count: 1;"> </span>The
Connecticut Supreme Court this month clarified how Connecticut distinguishes
between the use of the “ordinary consumer expectation test” and the “modified
consumer expectation test” in strict product liability design defect cases.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;"><span style="color: #212121; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Izzarelli v. R.J. Reynolds Tobacco Co</span></i><span style="color: #212121; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">., ___ A.3d ___, 321 Conn. 172 (2016).<span style="mso-spacerun: yes;"> </span></span>Not to confuse things from the start, but
Court’s key holding was that the “modified consumer expectation test” is now
the “primary strict liability test.”<span style="mso-spacerun: yes;"> </span>In
other words, the prior ordinary test in Connecticut is no longer the ordinary
test, and the primary test is the modified test.<span style="mso-spacerun: yes;"> </span>Just so we are clear.<span style="mso-spacerun: yes;"> </span>Wordplay aside, this is an unfortunate
through probably unsurprising development in a state that still has a ways to
go to firm up its product liability law (more on that below).</div>
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<span style="mso-tab-count: 1;"> </span>Some
background helps to clarify how a “modified” test supplanted an “ordinary”
test.<span style="mso-spacerun: yes;"> </span>As the Court noted, Connecticut
was one of the first states to adopt § 402 of the Restatement (Second) of
Torts.<span style="mso-spacerun: yes;"> </span>(Connecticut was also the first
state to adopt a speed limit restriction for cars − a blazing 12 MPH).<span style="mso-spacerun: yes;"> </span>[Editor’s note, both make about the same
amount of sense these days.]<span style="mso-spacerun: yes;"> </span>Connecticut
interpreted § 402 to require a plaintiff alleging a strict liability claim to
prove, amongst other things, “the product was in a defective condition unreasonably
dangerous to the consumer or user.” <span style="mso-bidi-font-family: "Times New Roman";"><span style="mso-spacerun: yes;"> </span></span><i style="mso-bidi-font-style: normal;">Giglio
v. Connecticut Light & Power Co.</i>, 180 Conn. 230, 234 (1980).<span style="mso-spacerun: yes;"> </span>Connecticut interpreted that element to mean,
based on comment (i) to § 402, that “the article sold must be dangerous to an
extent beyond that which would be contemplated by the ordinary consumer who
purchases it, with the ordinary knowledge common to the community as to its
characteristics.”<span style="mso-spacerun: yes;"> </span>That became known as
the “ordinary consumer expectation test.”</div>
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<span style="mso-tab-count: 1;"> </span>In 1997,
the Connecticut Supreme Court in <i style="mso-bidi-font-style: normal;">Potter
v. Chicago Pneumatic Tool Co.</i>, 241 Conn. 199 (1997), finally noticed that
the “ordinary consumer expectation test” did not adequately address “the
problem of complex products for which a consumer might not have informed safety
expectations.”<span style="mso-spacerun: yes;"> </span>It of course doesn’t make
a whole lot of sense to apply a consumer expectations test to a product about
which a consumer would not have reasonable expectations.<span style="mso-spacerun: yes;"> </span></div>
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<span style="mso-tab-count: 1;"> </span>So the <i style="mso-bidi-font-style: normal;">Potter</i> Court’s solution was to create a
“modified consumer expectation test” whereby the jury would be asked to “weigh
the product's risks and utility and then inquire, in light of those factors,
whether a ‘reasonable consumer would consider the product design unreasonably
dangerous.’”<span style="color: #212121; font-family: "arial" , "sans-serif"; font-size: 10.5pt;"><span style="mso-spacerun: yes;"> </span></span>The <i style="mso-bidi-font-style: normal;">Potter</i> court decided that the “ordinary
consumer expectation test” would “when the everyday experience of the
particular product's users permits the inference that the product did not meet
minimum safety expectations.”<span style="mso-spacerun: yes;"> </span>That
required proof of an incident “so bizarre or unusual” that expert testimony
would not be required to conclude that the product failed to meet the
consumer’s expectations.<span style="mso-spacerun: yes;"> </span>One might
imagine what qualified as “so bizarre or unusual.”<span style="mso-spacerun: yes;"> </span>For the most part, one had to imagine because
so few Connecticut state courts were faced with deciding that issue in the
subsequent years.<span style="mso-spacerun: yes;"> </span></div>
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<span style="mso-tab-count: 1;"> </span>As the <i style="mso-bidi-font-style: normal;">Izzarelli</i> Court noted, Connecticut state
courts had limited opportunities to determine what test would be appropriate
under what circumstances because actions under Connecticut’s product liability
act were typically brought in federal court.<span style="mso-spacerun: yes;">
</span>Those decisions − including a recent federal court case involving
combination hormone replacement therapy, <i style="mso-bidi-font-style: normal;">Moss
v. Wyeth</i>, Inc., 872 F. Supp.2d 162, 166 (D. Conn. 2012) − were all over the
map.<span style="mso-spacerun: yes;"> </span>The <i style="mso-bidi-font-style: normal;">Moss</i> decision, for example, predicted that that <i style="mso-bidi-font-style: normal;">both</i> tests applied somehow before
launching into a discussion of the learned intermediary doctrine.<span style="mso-spacerun: yes;"> </span>In fact, the reason <i style="mso-bidi-font-style: normal;">Izzarelli</i> finally addressed this issue was because it answered a
certified question from the Second Circuit, but the Connecticut Supreme Court
actually had to expand on<span style="mso-spacerun: yes;"> </span>Second
Circuit’s question in order to clear up the confusion.</div>
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<span style="mso-tab-count: 1;"> </span>Fortunately
for good lawyering, the <i style="mso-bidi-font-style: normal;">Izzarelli </i>Court
now makes it clear that the modified consumer expectation test is the primary or
“default” test in Connecticut in a strict product liability action based on
defective design.<span style="mso-spacerun: yes;"> </span>The “ordinary consumer
expectation test” is reserved for “res ipsa type cases” when the product failed
to meet “the ordinary consumer’s <i style="mso-bidi-font-style: normal;">minimum</i>
safety expectations.” (the Court’s italics, not ours).<span style="mso-spacerun: yes;"> </span>The Court did not define “minimum” and it
later referred to “legitimate, commonly accepted minimum safety expectations,”
without much indication of what those words meant either.<span style="mso-spacerun: yes;"> </span>But the Court’s italics and the result of the
case indicate that the safety bar is set really, really low for purposes of
clearing the ordinary consumer expectation test − so low that the Court held
that a cigarette that exposes a user to the risk of cancer cannot be said to
fail to meet minimum safety expectations. </div>
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<span style="mso-tab-count: 1;"> </span>Don’t be
tempted to view that as a defense-friendly result.<span style="mso-spacerun: yes;"> </span>It isn’t.<span style="mso-spacerun: yes;">
</span>It actually means, as the Court stressed at length, that Connecticut
will allow strict liability design defect claims to proceed under a
“risk-utility” analysis even when the consumer knows about the danger.<span style="mso-spacerun: yes;"> </span>As the Court put it, a “product might meet
the consumer’s minimum safety expectations because the product’s dangers are
known or obvious but nonetheless be defective because it could have been
designed to be less dangerous without unreasonably compromising cost or
utility.”<span style="mso-spacerun: yes;"> </span>The Court also held that
expert testimony on product design is not needed to prove the product’s
defect.<span style="mso-spacerun: yes;"> </span>So at least we in Connecticut don’t
need to argue about “bizarre and unusual” incidents anymore to handle these
cases.<span style="mso-spacerun: yes;"> </span>The bizarre and unusual in our
cases will still likely come up, only now only in the context of plaintiffs’
expert opinions.<span style="mso-spacerun: yes;"> </span>Despite the fact that
Connecticut does not require experts in this context, as a practical matter we
don’t expect too many situations in our area of the law when a plaintiff’s
lawyer won’t trot out a bunch of experts.</div>
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<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">Izzarelli </i>goes a long way to clarify
what needs to be shown in a strict product liability case in Connecticut, so
its at least helpful in that regard.<span style="mso-spacerun: yes;"> </span>It’s
worth noting, however, that <i style="mso-bidi-font-style: normal;">Izzarelli</i>
does not clarify many of the pharmaceutical product-specific issues discussed
in <i style="mso-bidi-font-style: normal;">Moss</i>, so the Connecticut Supreme
Court has ample room to develop that law.<span style="mso-spacerun: yes;">
</span>In addition, as the <i style="mso-bidi-font-style: normal;">Izzarelli</i> Court
noted, the Connecticut Supreme Court is in the middle of writing a decision
that will likely clarify how these principles apply to a product liability
claim for negligence and will also clarify Connecticut’s law on punitive
damages.<span style="mso-spacerun: yes;"> </span>Stay tuned.</div>
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<b style="mso-bidi-font-weight: normal;"><u>IMPORTANT ANNOUNCEMENT</u></b> – When we created the Drug and Device
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<br />Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-13930491493940552102016-05-19T16:33:00.000-04:002016-05-19T16:33:08.759-04:00Trimming Some Fat From Statin Litigation With Daubert and Preemption
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<span style="mso-tab-count: 1;"> </span>One of the
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</span>The Blog will have its own migration shortly, which we hope will be a one-time
event without dangerous river crossings or, well, loads of crap for either us
or our readers.<span style="mso-spacerun: yes;"> </span>Next week, the Drug and
Device Law Blog will be moving to an upgraded platform via LexBlog.<span style="mso-spacerun: yes;"> </span>All the old posts will be available and going
to the old site should redirect you to the new site.<span style="mso-spacerun: yes;"> </span>That’s the easy part.<span style="mso-spacerun: yes;"> </span>The comparatively difficult part should take
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will not be posting on May 23 or May 24.<span style="mso-spacerun: yes;">
</span>If your DDL addiction is too strong for that much of a break, then feel
free to peruse old posts.<span style="mso-spacerun: yes;"> </span>Checklists and
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a stronger fix, then try searching for obscure or inflammatory words used in
past posts.<span style="mso-spacerun: yes;"> </span>Hours of fun.</div>
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<span style="mso-tab-count: 1;"> </span>In the
mythical days of product liability yore, a big drug litigation was spurred by a
notable event—like a study describing a new risk appearing in a major journal,
a significant labeling change because of new or greater risk, or the withdrawal
of the drug—and was built on identifiable and otherwise uncommon injuries in
patients who took the drug.<span style="mso-spacerun: yes;"> </span>Because
there was a notable event and there were identifiable injuries, the
manufacturer could generally expect when lawsuits about those injuries would
need to be filed and that it could figure out if a plaintiff was suing over an
injury that fit the larger liability issues.<span style="mso-spacerun: yes;">
</span>In the purportedly distinct modern era of drug litigation, the only
notable events sometimes are the start of plaintiff lawyer conferences and
advertising on the drug and the injuries claimed may not be particularly
identifiable or otherwise uncommon.<span style="mso-spacerun: yes;"> </span>The
cases brought probably include non-product liability claims for economic harm
and product liability claims loosely tied to the risk of the injury actually
sustained by the individual plaintiffs.<span style="mso-spacerun: yes;"> </span>Even
if there is no good science backing up the plaintiffs’ claims, it can take
quite a bit of time and effort for the manufacturer to get the rulings needed
to show the claims and evidence offered in support of them to be bogus.</div>
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<span style="mso-tab-count: 1;"> </span>This seems
to be what is going on in litigation involving the drug Lipitor, which has been
one of the most widely prescribed drugs over the last twenty years (although
generic entry had an effect a few years ago).<span style="mso-spacerun: yes;">
</span>Along the way, the manufacturer has faced litigation over liver injuries
and rhabdomyolysis (like the other statins), antitrust claims, and some other
issues.<span style="mso-spacerun: yes;"> </span>Meanwhile, the drug continued to
be recommended as first line therapy for an expanding range of indications
related to improving lipids and reducing cardiovascular risk.<span style="mso-spacerun: yes;"> </span>From what we can tell, without anything terribly
dramatic, the drug was also one of several in the class associated with a
possible small increase in the risk of developing Type 2 diabetes.<span style="mso-spacerun: yes;"> </span>If you have been paying attention over the
last few decades, then you probably know that the rates of Type 2 diabetes have
climbed dramatically, basically hand-in-hand with increases in the rates of obesity,
hypertension, unhealthy eating, inactivity, and some other bad habits that call
to mind the scooter-bound humans of the future in “WALL-E.”<span style="mso-spacerun: yes;"> </span>You might also know that the risks of heart
attacks and strokes go up when you add a bad lipid profile to the mix and go
down when the lipid profile improves.<span style="mso-spacerun: yes;">
</span>That is why doctors and patients care about LDL, HDL, and triglycerides
in trying to prevent first or second heart attacks, for instance, just as they
try to monitor and control obesity, hypertension, diabetes, sleep apnea,
etc.<span style="mso-spacerun: yes;"> </span>In this context, it makes sense
that doctors might continue to prescribe Lipitor or any of the other statins
pretty much as they did before the labels warned of a possible increase in
blood sugar levels and the rate of diabetes.<span style="mso-spacerun: yes;">
</span>That might make you think plaintiffs suing over a risk of diabetes might
have hard time establishing either medical causation or proximate cause for
failure to warn of diabetes.<span style="mso-spacerun: yes;"> </span>But the
plaintiff lawyers filed enough cases that an MDL was established, so they must
have mustered some good theories and evidence to support their claims, right?</div>
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<span style="mso-tab-count: 1;"> </span>Starting
about six months ago, we reported on a series of <i style="mso-bidi-font-style: normal;">Daubert</i> decisions from the MDL<span style="mso-spacerun: yes;"> (<a href="http://druganddevicelaw.blogspot.com/2015/12/bookends-prof-jewells-opinions-also.html" target="_blank">here</a>, <a href="http://druganddevicelaw.blogspot.com/2015/12/lipitor-mdl-judge-dissects-plaintiffs.html" target="_blank">here</a> and <a href="http://druganddevicelaw.blogspot.com/2016/04/gutsy-gatekeeping-plaintiffs-experts.html" target="_blank">here</a>) </span>
that generally excluded plaintiffs’ experts on general and specific causation
for plaintiffs’ injuries.<span style="mso-spacerun: yes;"> </span>We recently
also saw that the Second Circuit affirmed the dismissal of a separate False
Claims Act case about the purported off-label use and promotion of Lipitor
based on a nonsensical interpretation of the drug’s label, which happened to have
been one of our <a href="http://druganddevicelaw.blogspot.com/2012/12/fca-fda-whats-difference.html" target="_blank">first posts</a>.<span style="mso-spacerun: yes;"> </span>We now get two more orders from
Lipitor MDL, which we read as being more of the delayed inevitable response to
a questionable litigation.<span style="mso-spacerun: yes;"> </span>The second in
time, <i style="mso-bidi-font-style: normal;">In re: Lipitor (Atorvastatin
Calcium) Mkt’g Sales Practs. & Prods. Lib. Litig.</i>, MDL no. 2:14-mn-02502-RMG,
-- F. Supp. 3d --, 2016 WL 2851445 (D.S.C. May 11, 2016), is similar to the
prior <i style="mso-bidi-font-style: normal;">Daubert</i> decisions, particularly
the<a href="http://druganddevicelaw.blogspot.com/2015/12/lipitor-mdl-judge-dissects-plaintiffs.html" target="_blank"> one</a> on the other expert in the same two cases. <span style="mso-spacerun: yes;"> </span>In this
decision, Dr. Handshoe, whose pulmonology background seems ill-suited to weigh
in on whether a lipid drug causes diabetes, could not offer a reliable
causation opinion for either plaintiff.<span style="mso-spacerun: yes;">
</span>The court started by saying that the relative risk of 1.25 that Dr.
Handshoe thinks applies to Lipitor and diabetes means that “20% of the people
who take Lipitor and develop diabetes did so only because they took
Lipitor.”<span style="mso-spacerun: yes;"> </span>We can quibble with this
discussion of attributable risk exposed calculations—it presupposes general
causation, for one—but it does show the uphill battle of connecting diabetes to
the drug for a specific plaintiff.<span style="mso-spacerun: yes;"> </span>The
case-specific facts for the first plaintiff made it even harder, as she had a
strong family history of Type 2 diabetes, was overweight and had “pre-diabetes”
when she started Lipitor and was obese when she was diagnosed as diabetic six
years later.<span style="mso-spacerun: yes;"> </span>(This case, as one might expect
with a litigation like this, was brought more than ten years after her
diagnosis and without regard to the massive improvement in her lipid while on
the drug whose manufacturer she sued.)<span style="mso-spacerun: yes;">
</span>She also had hypertension and hyperlipidemia (duh), which he considered
risk factors for diabetes, and was a smoker, which he did not think was a risk
factor even through some studies and governmental publications say
otherwise.<span style="mso-spacerun: yes;"> </span>He also could not interpret
relative risk data and relied heavily on the timing of plaintiff’s progression
from pre-diabetes to diabetes occurring while she was on the drug.<span style="mso-spacerun: yes;"> </span>Without belaboring it too much, this shoddy
case-specific causation opinion failed just about every criterion for
reliability.<span style="mso-spacerun: yes;"> </span>The analysis for the second
plaintiff was not quite as egregious, but was also excluded.<span style="mso-spacerun: yes;"> </span>While this plaintiff had a weaker family
history of diabetes and no recorded history of abnormal blood sugar readings
when she started a lower dose of Lipitor (taken irregularly), she had risk
factors from her weight (overweight and continuing to gain weight), age, ethnic
background, hyperlipidemia, and hypertension, which Dr. Handshoe could not rule
out or reliably place into context.<span style="mso-spacerun: yes;"> </span>If
you consider that these plaintiffs took a dose<span style="mso-spacerun: yes;">
</span>of Lipitor as to which one of the plaintiffs’ epidemiologists could not
offer a <a href="http://druganddevicelaw.blogspot.com/2016/04/gutsy-gatekeeping-plaintiffs-experts.html" target="_blank">general causation opinion</a>, then the inability of an expert to offer a reliable case-specific causation
opinion for plaintiffs with multiple risk factors other than the drug should
not be surprising.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>The second
decision, <i style="mso-bidi-font-style: normal;">In re: Lipitor (Atorvastatin
Calcium) Mkt’g Sales Practs. & Prods. Lib. Litig.</i>, -- F. Supp.3d <span style="mso-spacerun: yes;"> </span>--, MDL No. 2:14-mn-02502-RMG, 2016 WL 2840215
(D.S.C. May 6, 2016), is somewhat more interesting and more controversial to us
for a few reasons.<span style="mso-spacerun: yes;"> </span>First, it spells out
that the plaintiffs—it applies to all of them—have asserted warnings and design
claims predicated on the lack of efficacy in preventing coronary heart disease
in women who have not had a coronary event.<span style="mso-spacerun: yes;">
</span>We think those claims are highly suspect even if true—although there
might be other claims associated with false affirmative representations about
efficacy for a subgroup.<span style="mso-spacerun: yes;"> </span>Second, it
evaluated the impact of <i style="mso-bidi-font-style: normal;">Bartlett</i> and <i style="mso-bidi-font-style: normal;">Mensing</i> on preemption of these “lack of
efficacy claims” for a branded prescription drug.<span style="mso-spacerun: yes;"> </span>Third, it used both <i style="mso-bidi-font-style: normal;">Daubert</i> and preemption in excluding most of the challenged expert
testimony supporting these claims.<span style="mso-spacerun: yes;">
</span>Although the results here are pretty good, we think the court could have
gone a little farther.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>A little
more background is needed to understand these issues.<span style="mso-spacerun: yes;"> </span>Among the various approved indications for
Lipitor was one for “primary prevention of cardiovascular disease” for men and
women based on the ASCOT study, as to which the label remarked “due to the
small number of events, the results for women were inconclusive.”<span style="mso-spacerun: yes;"> </span>Following the <i style="mso-bidi-font-style: normal;">Levine</i> game plan, the plaintiffs claimed that a CBE could have been
used to change the label to essentially re-frame the approved primary
prevention indication as being for men only.<span style="mso-spacerun: yes;">
</span>Noting that “any claim that a drug label should be changed based on
information previously submitted to the FDA is preempted because the CBE
regulation cannot be used to make a label change based on such information,”
the court held that plaintiffs could not use a for-litigation reevaluation of
the ASCOT study as basis for their claims.<span style="mso-spacerun: yes;">
</span>The plaintiffs also could not use new risk information as a basis for
requiring a labeling change as to efficacy through a CBE, given that the CBE
regulations themselves require a link between the new data and the aspect of the
label to be changed.<span style="mso-spacerun: yes;"> </span>The court also
recognized that claims other types of labeling provided to healthcare
professionals should have been changed are just as preempted as claims that the
label itself should have been changed.<span style="mso-spacerun: yes;">
</span>And it recognized that plaintiffs cannot get around any of this
preemption by claiming that the manufacturer could have just stopped selling
the drug for primary prevention in women.<span style="mso-spacerun: yes;">
</span>All of that is good and part of the progression of branded drug
preemption that we have urged for some time.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Where we
think the court could have gone farther is on some issues that would have
required more analysis.<span style="mso-spacerun: yes;"> </span>The court
elected not to analyze if the law of any of 52 jurisdictions actually imposed
duties on the manufacturer to take the steps plaintiffs claimed related to lack
of efficacy and left open that the defendant could re-raise the arguments that
specific requirements for liability based on advertising to the general public
were preempted.<span style="mso-spacerun: yes;"> </span>It also did not dig
deeply behind plaintiffs’ allegations that a study called CASHMERE could have
been used as the basis for a CBE to change the approved primary prevention
indication.<span style="mso-spacerun: yes;"> </span>While the “Defendant argues
that ‘the results of CASHMERE have no bearing on the primary prevention
indications’ [and] such arguments concern the sufficiency of evidence to
survive summary judgment, not preemption,” there is the issue of whether
CASHMERE was ever evaluated by FDA and what FDA thought about it.<span style="mso-spacerun: yes;"> </span>A temporary labeling change that would have
been reversed by FDA because it still thought its approval of the primary
prevention indication for both sexes was still correct has little impact on the
claims of most plaintiffs.<span style="mso-spacerun: yes;"> </span>Thus, the
conclusion that “[t]o the extent that Plaintiffs claim that a state law duty
required Defendant to include different statements on Lipitor’s label regarding
Lipitor’s efficacy for prevention in women, based on CASHMERE or other newly
acquired information, the claims are not preempted” seems incomplete.<span style="mso-spacerun: yes;"> </span>We also think—without having tried to re-do
the regulatory arguments—that there is a fairly direct conflict between the
requirement for advertisements directed to the general public must truthfully
summarize the efficacy of the drug and a contention that the advertisements
should have said primary prevention indication was wrong in not excluding
women.<span style="mso-spacerun: yes;"> </span>With a little more digging, it
should be fairly obvious that all the “lack of efficacy claims” involve second
guessing the FDA’s repeated decisions about efficacy, which should lead to broad
preemption if any such claims actually exist under state law.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>The <i style="mso-bidi-font-style: normal;">Daubert</i> portion of the ruling also
seemed somewhat inconsistent, although the defendant got almost all of what it
wanted on the five experts challenged.<span style="mso-spacerun: yes;"> </span>First,
it did not look like any of the experts opined that CASHMERE—as opposed to just
reinterpreting ASCOT—should have led to a revision of the drug’s indication,
which undercuts the preemption ruling above.<span style="mso-spacerun: yes;">
</span>Second, while one expert was allowed to offer his own for-litigation
re-analysis of ASCOT (which was also a peer-review publication) because “I
think I was the only one to ever check the proportional hazards assumption”
underlying the statistical test used in the original analysis to determine
whether the results could properly be applied to men and women.<span style="mso-spacerun: yes;"> </span>We are not sure how this is relevant to any
non-preempted claim in the case or the basis of the expert’s belief that nobody
else checked the assumptions.<span style="mso-spacerun: yes;"> </span>We would
wager that FDA only approved the primary prevention indication based on the
ASCOT study after getting its data and checking it thoroughly, which would
raise the issue of how plaintiffs’ claims are predicated on FDA making informed
but incorrect decisions.<span style="mso-spacerun: yes;"> </span>When another
expert opined that “the ASCOT data did not establish efficacy of Lipitor in
women for primary prevention, and the label was misleading on this point,” his
opinions were excluded as irrelevant based on the preemption decision.<span style="mso-spacerun: yes;"> </span>They were also confusing and misleading under
Fed. R. Evid. 402 and 403 given that “such allegations cannot be the basis of
Plaintiffs’ claims.”<span style="mso-spacerun: yes;"> </span>It seems like that
same analysis could have been applied to the first expert’s opinions.<span style="mso-spacerun: yes;"> </span>Likewise, these rules provided the basis for
precluding a third expert from offering his opinion that “I don’t think FDA
should have approved Lipitor for primary prevention in women.”<span style="mso-spacerun: yes;"> </span>The court was consistent, however, in
excluding opinions from multiple experts—phrased in slightly different
ways—that there was no evidence that Lipitor (or other drugs of its class) was
effective in women for primary prevention.<span style="mso-spacerun: yes;">
</span>In doing so, the experts had no reasoned basis for disregarding multiple
large published studies and meta-analyses that found efficacy in women.<span style="mso-spacerun: yes;"> </span>As such, we will not dwell on how the
different experts failed in trying to offer their lack of efficacy opinions.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>We see
this all as related to the problem we identified up front:<span style="mso-spacerun: yes;"> </span>a drug litigation that is not driven by
science suggesting a significant risk of an identifiable and otherwise uncommon
injury will struggle to fit into the existing legal framework.<span style="mso-spacerun: yes;"> </span>Proving that overweight hypertensive patients
developed diabetes because of a drug that might increase the risk by 25%--far
less than the patient’s weight or blood pressure does—is difficult.<span style="mso-spacerun: yes;"> </span>It is also hard to prove that a warning about
such a risk would have changed any physician’s decision to prescribe a lipid
medication to try to avoid heart attacks and strokes.<span style="mso-spacerun: yes;"> </span>That is why the plaintiffs make up “lack of
efficacy claims” that should not be cognizable in most states, walk right into
conflict preemption, and set up experts to offer unsustainable opinions.<span style="mso-spacerun: yes;"> </span>We suspect that it will take several more
decisions from this court before the plaintiffs pack it in, though.</div>
<div style="margin: 0in 0in 12pt;">
<br /></div>
Eric Alexanderhttp://www.blogger.com/profile/01766054899255569417noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-32232875125200777152016-05-18T07:30:00.000-04:002016-05-18T07:30:02.921-04:00Mass Appeal of Off Label Use<div style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: 'Times New Roman'; line-height: normal; margin-bottom: 12px;">
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<span style="font-size: large;"><br /></span></div>
<div style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: 'Times New Roman'; line-height: normal; margin-bottom: 12px;">
<span style="font-size: large;">Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a case from preemption. And hardly a week goes by without plaintiff lawyers attempting to inject off label issues into our cases, as though mere mention of the possibility conjured up liability, punitive damages, and settlement-grids. As we have discussed many times before, the demonization of off label use is wrongheaded and counterproductive, given how off label use can be the only thing standing between patients and pain. Today’s case, <i>Tangney v. Burwell, Secy of HHS</i>, 2016 U.S. Dist. LEXIS 61724 (D. Mass. May 10, 2016), reminds us of that fact yet again. </span></div>
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<span style="font-size: large;">The plaintiff in <i>Tangney</i> suffered from severe nausea and abdominal pain emanating from gastrointestinal issues, not cancer - facts that, as you will see, possibly become pertinent. It was undisputed that off label use of Dronabinol alleviated these symptoms. The issue was whether Medicare Part D covered the cost of the medicine. Such coverage is available if the drug’s use is approved by the FDA (not the case here) or is “supported by one or more citations included or approved for inclusion in any of the [listed] compendia.” 42 U.S.C. Section 1396r-8(k)(6). The particular compendium at issue in <i>Tangney</i> was Drugdex, which cited the successful use of Dronabinol to treat nausea resulting ... in a case involving cancer.</span></div>
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<span style="font-size: large;"><br /></span></div>
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<span style="font-size: large;">Medicare rejected coverage because the plaintiff’s nausea was unconnected to cancer. Then a hearing officer reversed that decision and concluded there was coverage, because (1) the title of the Drugdex citation was not limited to cancer, even if the underlying case study was, and (2) the plaintiff’s real-world history showed that without coverage of the off-label use of the medicine, the plaintiff would “either have to remain in the hospital indefinitely or possibly die.” The Appeals Council then reversed the hearing officer”s decision and concluded there was no coverage, because the underlying case study involved a cancer patient, and there was insufficient evidence to show that efficacy would extend to non-cancer patients. The Appeals Council decision is considered a decision by the Secretary of the U.S. Department of Health and Human Services, Sylvia Burwell, and that is why she is listed as the defendant in the case that subsequently went before a federal judge.</span></div>
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<span style="font-size: large;"><br /></span></div>
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<span style="font-size: large;">The first decision for that federal judge was whether or how much to defer to the HHS Appeals Council. On this blog, we talk about product liability, not administrative law, so we will not linger on the niceties of <i>Chevron</i> or <i>Skidmore</i> deference to agency decisions. Leave it at this: the court held that the denial of Medicare Part D coverage of this particular off label use was not the sort of precedential, legislative ruling by an agency that required full-blown (and usually dispositive) <i>Chevron</i> deference. Rather, a lower level of deference, called <i>Skidmore</i> deference, came into play. <i>Skidmore</i> deference focuses on consistency and persuasiveness. Even with this lower level deference, the government usually wins. </span></div>
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<span style="font-size: large;"><br /></span></div>
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<span style="font-size: large;">But it did not win this time. The court held that the hearing officer got it right, and that it made more sense to frame the degree of generality in terms of effective treatment of nausea as opposed to effective treatment of nausea associated with cancer. Palliative care is palliative care. Our favorite part of the D. Mass. opinion is a footnote where the court observes how “Kafkaesque” it was to force the plaintiff to prove that the underlying case study supporting the Drugdex citation to off label use should apply to her, when she herself offered the most compelling case study, “with her having taken Dronabinol to near miraculous effect for three years before switching to Part D and being denied coverage.” The plaintiff herself presented a strong instance of challenge, rechallenge, etc. She suffered from severe nausea, the off label drug alleviated the pain, and then the pain returned when she had to go off the drug after coverage was denied. </span></div>
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<span style="font-size: large;">Try telling this plaintiff, or millions of other patients in this country, that there is something nefarious with off label use of medicines. Try telling doctors. Or try telling judges who pay more attention to reality than rhetoric. </span></div>
Steve McConnellhttp://www.blogger.com/profile/14959081465420761870noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-88529605052771245862016-05-17T06:30:00.000-04:002016-05-19T22:32:33.227-04:00Guest Post − Implied Certification: An Eradicated Pest or Here to Stay?<br />
<div style="margin: 0in 0in 12pt;">
Today’s guest post is courtesy of Reed Smith’s <a href="https://www.reedsmith.com/lindsey_harteis/">Lindsey Harteis</a>.<span style="mso-spacerun: yes;"> </span>She’s been following the big-deal <u>UHS v.
Escobar</u> False Claims Act that the Supreme Court could decide any day now
(or could wait until the end of June), which involves the existence and
(perhaps) extent of the so-called “implied certification” theory of FCA
liability.</div>
<br />
<div style="margin: 0in 0in 12pt;">
As always our guest posters deserve all the credit, and any
blame, for the contents of their posts.</div>
<br />
<div style="margin: 0in 0in 12pt;">
Finally – be sure to read the <b style="mso-bidi-font-weight: normal;"><u>IMPORTANT ANNOUNCEMENT</u></b> at the end of this post.<span style="mso-spacerun: yes;"> </span>DDLaw blog is getting ready to move, and that
means you’ll have to resubscribe to continue getting our posts.<span style="mso-spacerun: yes;"> </span>But don’t worry, it’s easy.</div>
<br />
<div style="margin: 0in 0in 12pt;">
******************</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>We spent
this past weekend chasing our ten-week old Samoyed puppy around the backyard,
where he ventured “down in the weeds” more than a few times.<span style="mso-spacerun: yes;"> </span>This caused the OCD in us to go over him
multiple times with a fine-toothed comb:<span style="mso-spacerun: yes;">
</span>We reasoned that he was bound to pick up some ticks.<span style="mso-spacerun: yes;"> </span>Lucky for us, he didn’t.<span style="mso-spacerun: yes;"> </span>But it got us thinking that when courts go
down in the weeds like our dog did, they are bound to pick up a few nasty
buggers themselves.<span style="mso-spacerun: yes;"> </span>In the oral argument
for the appeal in <i style="mso-bidi-font-style: normal;">United Health Services
v. Escobar</i>, 780 F. 3d 504 (1<sup>st</sup> Cir. 2015), the Court definitely
took a run through the weeds.<span style="mso-spacerun: yes;"> </span>(We
blogged briefly on the case <a href="http://druganddevicelaw.blogspot.com/2015/12/supreme-court-to-rule-on-implied.html" target="_blank">here</a>).<span style="mso-spacerun: yes;"> </span>We’re taking our fine tooth comb through the
oral argument to look for ticks, and we fear we’re bound to find in this ruling
another “corpus juris festooned with various duties.”<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>That’s a
quote from a Justice we missed dearly while listening to the oral argument in
this case.<span style="mso-spacerun: yes;"> </span>Justice Scalia used it in his
concurring opinion in <i style="mso-bidi-font-style: normal;">Skilling v. United
States</i>, 561 U.S. 358 (2010), which limited a fraud statute in the criminal
context due to vagueness and via the 5<sup>th</sup> Amendment Due Process
route.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">Skilling</i> reminds us of <i style="mso-bidi-font-style: normal;">United Health Services</i> for a couple of
reasons: (1) It dealt with defining the contours of a sort of fraud – honest
services fraud – for which the lower courts took an expansive view that wasn’t
foreseeable based on the plain language in the statute; (2) Scalia was accusing
the Courts of Appeals of invention of law rather than interpretation in their
rulings on what constituted honest services fraud; and (3) the case involved a
fusion of Restatement and black letter law in an unrelated area (Agency and
Trusteeship) but was a criminal case.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>There are
definite parallels.<span style="mso-spacerun: yes;"> </span>Again, <i style="mso-bidi-font-style: normal;">United Health Services</i> presents an
opportunity for the high court to define the contours of an actionable sort of
fraud, this time fraud in submitting claims for payment to the government.<span style="mso-spacerun: yes;"> </span>Here, the punitive lever is the False Claims
Act (“FCA”).<span style="mso-spacerun: yes;"> </span>This case also features a
situation where Courts of Appeals, beginning with <i style="mso-bidi-font-style: normal;">Ab-Tech</i> in 1994 (discussed below) seem to have wielded legislative
power instead of judicial restraint.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">United Health Services</i> also involved, at
least in oral argument, the suggestion by more than one justice that the proper
standard might invoke principles from an entirely different area of law – and
invoked Hornbook contract law when trying to grasp at a standard for liability.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Before we
take you much deeper in the weeds, here’s how <i style="mso-bidi-font-style: normal;">United Health Services</i> came to be before the eight justice
court.<span style="mso-spacerun: yes;"> </span>Beginning with <i style="mso-bidi-font-style: normal;">Ab-Tech Cons., Inc. v. United States</i>, 31
Fed. Cl. 429 (1994), federal courts birthed a new theory that expanded FCA
liability.<span style="mso-spacerun: yes;"> </span>The theory is called “implied
certification."<span style="mso-spacerun: yes;"> </span>This theory
expanded the scope of FCA liability to allow a claim where a company submitted
a claim for payment to the government after making an “implied certification”
that it was in compliance with the conditions to participating in a SBA
program, namely using third party contractors that are minority owned, to
further the interests of the program.<span style="mso-spacerun: yes;"> </span>In
fact, the company did not use any third party contractors that met the criteria
for its participation in the program.<span style="mso-spacerun: yes;">
</span>So, the Federal Circuit held, this was a false claim for payment that
violated the FCA. </div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Over the
last twenty years, some federal courts have run amok with this theory,
expanding it in every direction.<span style="mso-spacerun: yes;"> </span>They
have created a significant problem of identifying types of regulatory
noncompliance which are relevant enough to trigger a finding of a “false or
fraudulent claim,” whether the certification of regulatory compliance should be
explicit (or if a mere failure to disclose noncompliance triggers liability),
and even what sense the courts use the word “material,” to sort the actionable
FCA claims due to a regulatory violation from inactionable ones.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>On the <i style="mso-bidi-font-style: normal;">United Health Services</i> appeal, the First
Circuit had no problem stepping into the shoes of not only the Massachusetts
Legislature and Congress, but also those of executive agencies by invoking
multiple regulations (some of which contradicted one another about the
qualifications a provider should have in order to bill for services), and
interpreting the regulations based on a statement by a non-promulgating entity
in favor of a finding of fraud.<span style="mso-spacerun: yes;"> </span>What’s
more – the First Circuit seemingly usurped the role of counsel and cited a
regulation not cited in the Complaint, in any appellate brief and not even in
the state government’s amicus brief – to make the finding of fraud.<span style="mso-spacerun: yes;"> </span>To us, this looks like anything but calling
balls and strikes.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Here the
regs used as the basis of liability not only lacked an explicit indication
that, when read together, they created preconditions of payment, but the court
had to layer three separate regulations (not all of which clearly
cross-referenced one another)<span style="mso-spacerun: yes;"> </span>on top of
each other to conclude this “precondition of payment” was violated.<span style="mso-spacerun: yes;"> </span>Further, this isn’t something either the
Massachusetts Government or Federal Government thought they did.<span style="mso-spacerun: yes;"> </span>They both declined to intervene in the suit
altogether.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>The regulatory
agencies at issue all reviewed the facts in this case, and two of them entered
into agreements with the provider to restore compliance.<span style="mso-spacerun: yes;"> </span>Just one individual was issued a $1,000 civil
penalty for holding herself out as a therapist without the appropriate
license.<span style="mso-spacerun: yes;"> </span>It seems to us that if the
Government doesn’t think a provider has submitted a false claim due to some
“implied certification” by the claimant, then a relator shouldn’t be able to
replace the Government or contracting party and offer a different
interpretation of how material the alleged regulatory breach was, or even if
there was a breach at all.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Seemingly,
the First Circuit believed as long as some court is willing to divine material
noncompliance, it doesn’t matter if the Government thinks there was
noncompliance or if the Government thinks it was material – or even if the
Government is willing to pay the claim at all.<span style="mso-spacerun: yes;">
</span>Indeed, the First Circuit says, even if the Government doesn’t lift a
finger and intervene in the suit, the relator can play a plaintiff’s lawyer
game of after-the-fact “gotcha!” and that’s precisely what Defense counsel
argued before the Supreme Court.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>To get a
sense of where the Supreme Court is on all this, we listened to the oral
argument, which occurred on April 19, 2016.<span style="mso-spacerun: yes;">
</span>Justice Breyer described the problem as how to distinguish the
regulations for which a breach is fraudulent and contains an implicit promise
not to breach versus those in a sea of “millions of regulations” – and for
which a breach is less than fraudulent.<span style="mso-spacerun: yes;">
</span>Breyer was grabbing at contract principles of materiality – and
suggested that perhaps violations and nondisclosure of violations that would be
“material” to the government’s decision to pay a claim would be actionable.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>The chief
problem with such reasoning is that is that FCA cases often don’t involve
contracts.<span style="mso-spacerun: yes;"> </span>But that didn’t stop the
justices from trying to invoke contract law.<span style="mso-spacerun: yes;">
</span>Chief Justice Roberts approached the idea of phrasing liability in terms
of whether the Government might “repudiate” or deny payment of the claim on the
basis of the regulatory infraction.<span style="mso-spacerun: yes;"> </span>A
second problem is how anybody could get in the Government’s head in a case like
this where the Government didn’t see fit to intervene.<span style="mso-spacerun: yes;"> </span>A third and perhaps more significant problem,
as counsel for the provider argued, is that materiality is a <i style="mso-bidi-font-style: normal;">separate</i> FCA requirement apart from any
contract law understanding of that term.<span style="mso-spacerun: yes;">
</span>It makes no sense that contract-variety materiality is an appropriate
substitute for the falsity or <i style="mso-bidi-font-style: normal;">mens rea</i>
elements of a FCA claim.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Justices
Sotomayor and Kagan seemed downright annoyed that the First Circuit ventured
into the regulatory weeds in the first place.<span style="mso-spacerun: yes;">
</span>To them, this case was as simple as the reason the FCA was enacted.<span style="mso-spacerun: yes;"> </span>Back then, the “Lincoln law” was enacted
because government contractors provided cardboard boots, dead mules and guns
that didn’t shoot for the Civil War.<span style="mso-spacerun: yes;">
</span>Kagan likened the provision of services by someone who is not a doctor,
when the state was charged for a doctor’s services, to providing a gun that
doesn’t shoot and then claiming payment for a gun.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>To us,
DOJ’s primer on what constitutes a FCA violation is instructive:<span style="mso-spacerun: yes;"> </span>“A person does not violate the False Claims
Act by submitting a false claim to the government; to violate the FCA a person
must have submitted, or caused the submission of, the false claim (or made a
false statement or record) with knowledge of the falsity, knowledge of false
information is defined as being (1) actual knowledge, (2) deliberate ignorance
of the truth or falsity of the information, or (3) reckless disregard of the
truth or falsity of the information.”<span style="mso-spacerun: yes;"> </span>If
the United States via DOJ doesn’t think a regulatory infraction is a false
claim, it seems that should be good enough for the Court.<span style="mso-spacerun: yes;"> </span>The fact of a regulatory violation shouldn’t
be confused with <i style="mso-bidi-font-style: normal;">the submission of false</i>
<i style="mso-bidi-font-style: normal;">information</i>.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>A
regulatory infraction might have happened here.<span style="mso-spacerun: yes;">
</span>Maybe, although the Government isn’t convinced.<span style="mso-spacerun: yes;"> </span>But that’s a different thing from submitting
an explicitly false claim to the Government and a thing that has separate
regulatory and other remedies.<span style="mso-spacerun: yes;"> </span>As
defense counsel argued, the Government holds all the keys in how it can address
regulatory infractions, but the FCA is not one of them.<span style="mso-spacerun: yes;"> </span>We didn’t do the math, but are willing to bet
that the majority of implied certification theory-founded FCA claims are
products of relators and their counsel and not the United States Government.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>At least
three and maybe even all the justices think fraud occurred on the facts
here.<span style="mso-spacerun: yes;"> </span>But it remains to be seen if they
agree about which of those facts made for the fraud, which of those regulations
they might be willing to invoke to make a finding of fraud, and whether they
need or can agree to invoke the implied certification theory to get there.<span style="mso-spacerun: yes;"> </span>We’re still hoping for a deus ex machina
here.<span style="mso-spacerun: yes;"> </span>The Court should avoid the
regulatory weeds – and the implied certification theory – whatever it decides.<span style="mso-spacerun: yes;"> </span>And on our next walk, we too will avoid the
weeds.<span style="mso-spacerun: yes;"> </span>Stay tuned and we’ll be sure to
announce the fate of the theory – and this case – as soon as it drops from the
high Court.</div>
<br />
<div style="margin: 0in 0in 12pt;">
***************</div>
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Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-11252524939124671462016-05-16T12:38:00.000-04:002016-05-16T12:38:56.864-04:00New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion
This post comes from the Cozen O'Connor side of the blog.<br />
<br />
<br />
Last week, the New York Appellate Division upheld a preemption
decision in a medical device case involving alleged off-label promotion.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Pitkow
v. Lautin</i>, <span style="color: black; font-family: "Georgia",serif; font-size: 10pt; mso-bidi-font-family: Georgia;">2016 WL 2746469 (N.Y. App. Div. May
12, 2016).<span style="mso-spacerun: yes;"> </span></span>While the Appellate Division’s
opinion was only three-paragraphs long, it affirmed the trial court’s ruling in
every respect, making the trial court’s lengthier opinion that much more
important.<span style="mso-spacerun: yes;"> </span>We obtained a copy, and <a href="https://www.cozen.com/cozendocs/public/SJ-Order-Pitkow-v-Lautin.pdf">here it is</a>.<span style="mso-spacerun: yes;"> </span><br />
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
The plaintiff’s claims were based on complications that
arose after her use of an injectable product, Sculptra, for cosmetic purposes, which
was an off-label use.<span style="mso-spacerun: yes;"> </span>Plaintiff sued the
doctors who injected her and the manufacturers of Sculptra.<span style="mso-spacerun: yes;"> </span>Among other things, she alleged that the manufacturers
had improperly promoted off-label use of Sculptra.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
After discovery, the manufacturers moved for summary
judgment, arguing that all of plaintiff’s claims were preempted.<span style="mso-spacerun: yes;"> </span>The trial court agreed and, quite
effectively, walked through the manner in which both <i style="mso-bidi-font-style: normal;">Riegel</i> and <i style="mso-bidi-font-style: normal;">Buckman </i>preempted
plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at
parallel violation claims.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
First up was <i style="mso-bidi-font-style: normal;">Riegel</i>
preemption, since Sculptra was approved under the FDA’s PMA process: </div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
Sculptra is a Class III medical
device that was undeniably approved through the PMA process.<span style="mso-spacerun: yes;"> </span>What is more, all of the plaintiff’s claims
against the [manufacturers] regard the safety and effectiveness of the device
or require a finding that Sculptra’s design, labeling, and/or manufacturing
process should have differed from that approved by the FDA via the PMA process
. . . .<span style="mso-spacerun: yes;"> </span>Thus, the claims are preempted
by the federal law.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
Slip. Op. at 8-9.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
The trial court had at least as much to say about
plaintiff’s parallel violation claims.<span style="mso-spacerun: yes;">
</span>Plaintiff alleged “that the defendants promoted an off-label use of
Sculptra that was contrary to the representations of the [manufacturers] made
to the FDA during the PMA process.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 9. <span style="mso-spacerun: yes;"> </span>The court, however, found that plaintiff pointed
to no violation of an FDA requirement or state law that paralleled that
requirement: “plaintiff has failed to cite a specific federal regulation that
was violated, or an obligation existing under state law that was ‘identical’ or
‘generally equivalent’ to a specific obligation imposed by federal law.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
The trial court went further in taking out plaintiff’s
parallel violations claims.<span style="mso-spacerun: yes;"> </span>The court
held that <i style="mso-bidi-font-style: normal;">Buckman</i> prohibits the broad
use of state law to enforce FDA requirements, in particular for fraud on the
FDA, and made the important point that the <i style="mso-bidi-font-style: normal;">Riegel</i>
case itself involved allegations of off-label claim promotion:</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
What is more, any claims based on
alleged off-label promotion and/or misrepresentations to the FDA during the PMA
process are barred by <i style="mso-bidi-font-style: normal;">Buckman Co. v.
Plaintiffs’ Legal Comm.</i>, 531 U.S. 341 (2001).<span style="mso-spacerun: yes;"> </span>The Supreme Court there indicated that only
the FDA, and not private litigants, may sue based on alleged noncompliance with
the Medical Device Amendments, stating (at 347) that the FDA is “amply empower[ed]
to police fraud against the Administration, and policing the fraud is not a
field the States have traditionally occupied.”<span style="mso-spacerun: yes;">
</span>The Court explained that while the doctrine may be read to allow for
some state-law claims that are parallel to the requirements under the MDA, “it
does not and cannot stand for the proposition that any violation of the FDCA
will support a state law claim.” <i style="mso-bidi-font-style: normal;">Id.</i>
at 353.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
The Court rejects plaintiff’s
claim here (at ¶42) that <i style="mso-bidi-font-style: normal;">Buckman </i>should
not be applied because the fraud on the FDA allegedly committed by the Sculptra
Defendants was of greater magnitude than usual.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Buckman</i> makes no such
distinction.<span style="mso-spacerun: yes;"> </span>What is more, the plaintiff
in <i style="mso-bidi-font-style: normal;">Riegel </i>had alleged that the
medical device was used in an off-label and contra-indicated manner, similar to
plaintiff’s claims here, but those claims did not escape preemption.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at 9-10. <span style="mso-spacerun: yes;"> </span>Given plaintiff’s arguments, the trial court also
had to explain, very quickly, why <i style="mso-bidi-font-style: normal;">Wyeth v.
Levine</i> (prescription drugs, no Medical Device Amendments’ preemption clause)
and <i style="mso-bidi-font-style: normal;">Medtronic v. Lohr</i> (§510k process,
not PMA process) did not apply. <span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
With that, the trial court, now with a stamp of approval from
the Appellate Division, made it much more difficult for New York plaintiffs to state
parallel violation claims based on off-label promotion. <span style="mso-spacerun: yes;"> </span>New York plaintiffs face a significant challenge
in identifying an FDA requirement that would be violated by such off-label promotion
and, more important, a parallel New York law that also prohibits it. <span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
John J. Sullivanhttp://www.blogger.com/profile/01479637903241019239noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-33887307623082448962016-05-13T13:03:00.002-04:002016-05-13T13:10:57.013-04:00Yet Another Failure-To-Update Claim Bites the Dust<br />
<div style="margin: 0in 0in 0pt;">
In terms of the legal gyrations plaintiffs try to
avoid preemption, we’ve already <a href="file:///H:/NRPortbl/US_ACTIVE/JMBECK/motion%20to%20dismiss%20granted%20against%20all%20claims%20in%20case%20involving">expressed</a>
our <a href="http://druganddevicelaw.blogspot.com/2014/11/short-subjects.html">opinion</a>
that so-called “failure to update” claims take the booby prize.<span style="mso-spacerun: yes;"> </span>There are good reasons, discussed in these
prior posts, why plaintiffs not faced with preemption never bring claims for
failure to update a warning – they’re simply lousy claims.<span style="mso-spacerun: yes;"> </span>The latest example of this fact is <u>Woods
v. Wyeth, LLC</u>, 2016 WL 1719550 (N.D. Ala. April 29, 2016).</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Woods</u> is yet another metoclopramide case –
that’s the generic drug that produced <u>PLIVA v. Mensing</u>, 131 S. Ct. 2567
(2011).<span style="mso-spacerun: yes;"> </span>Stuck between a rock and a hard
place, the plaintiff:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
Argue[d] that her claims are not preempted because they
are based on the generic defendants’ “failure to update” their labels to be
consistent with the brand name labeling.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Woods</u>, 2016 WL 1719550, at *1.<span style="mso-spacerun: yes;"> </span><u>Woods</u>, after examining various
non-binding precedents, concluded that plaintiff “has set out a narrow claim
that falls outside the scope of federal preemption” – the failure to update
claim involving no more than the FDA-approved labeling.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *8.</div>
<br />
<div style="margin: 0in 0in 0pt;">
OK, so take generic preemption out of the mix entirely
– what happens with <u>Woods</u>?</div>
<br />
<div style="margin: 0in 0in 0pt;">
Same ultimate result as if the claim had been
preempted; that is to say, judgment on the pleadings for the generic
defendants.</div>
<br />
<div style="margin: 0in 0in 0pt;">
For a few months, in 2004-05, plaintiffs alleged
that the generic defendants did not include the latest of a number of
FDA-approved labeling revisions.<span style="mso-spacerun: yes;"> </span><u>Id.</u>
at *3.<span style="mso-spacerun: yes;"> </span>This period overlapped briefly
with the allegedly injured plaintiff’s 2005-09 use of the drug.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *4.<span style="mso-spacerun: yes;"> </span>So there is a short period where it is
temporally possible that a prescribing physician could have acted on the basis
of un-updated labels.</div>
<br />
<div style="margin: 0in 0in 0pt;">
Temporality of use is not enough to establish
causation, particularly in a case that turns on information, and that’s exactly
what happened.<span style="mso-spacerun: yes;"> </span>Plaintiff’s own
allegations were incompatible with causation, because the doctor in question
didn’t even prescribe generic metoclopramide.<span style="mso-spacerun: yes;">
</span>Instead, the doctor’s prescription was for the branded drug, and generic
substitution came later.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at
*9.</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
In the instant case, [plaintiff’s] doctors prescribed
her the brand name drug . . . – not the generic drug metoclopramide –
from 2005 to 2009. <span style="mso-spacerun: yes;"> </span>The labels for [the
branded product] <b style="mso-bidi-font-weight: normal;"><u>already contained</u></b>
the 2004 warnings at the time that [plaintiff’s] doctors
prescribed. . . . <span style="mso-spacerun: yes;"> </span>Thus, [plaintiff’s]
doctors had already gleaned “substantially the same” knowledge about the
effects of using [the drug] from the 2004 updates to the [branded] label that
they would have gained from an identical update to the labels of the generic
version of the drug.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Id.</u> (emphasis added).<span style="mso-spacerun: yes;"> </span>The opinion pointed out that exactly the same
result has been reached in other update-related cases.<span style="mso-spacerun: yes;"> </span><u>Id.</u> (citing <u>Fullington v. Pfizer,
Inc.</u>, 720 F.3d 739, 747 (8th Cir. 2013); <u>Bell v. Pfizer, Inc.</u>, 716 F.3d
1087, 1097 (8th Cir. 2013)).<span style="mso-spacerun: yes;"> </span>Why are we
not surprised?</div>
<br />
<div style="margin: 0in 0in 0pt;">
Allegations of failure to update imply that
something else needed updating, and that something was the branded label.<span style="mso-spacerun: yes;"> </span>Thus, the adequacy of the branded label, for
a doctor who prescribed the branded product, defeat causation.<span style="mso-spacerun: yes;"> </span>We’ve seen in other cases how plaintiffs
complain about pharmacies and generic substitution.<span style="mso-spacerun: yes;"> </span>Whether or not such complaints have merit in
other contexts, they certainly kill causation in failure-to-update cases. Where the prescriber never even prescribed the defendant's product, how could s/he have relied on the defendant's warnings?</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
[B]ecause [plaintiff’s] physicians prescribed her [the
branded drug], not generic metoclopramide, [she] has not shown that her
physicians relied on the labeling of generic metoclopramide.</div>
<br />
<div style="margin: 0in 0in 0pt; text-align: center;">
*<span style="mso-tab-count: 1;"> </span>*<span style="mso-tab-count: 1;"> </span>*<span style="mso-tab-count: 1;"> </span>*</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
[Plaintiff] does not allege that her physicians
prescribed [the branded drug] <b style="mso-bidi-font-weight: normal;"><u>because
of</u></b> any labeling or representations made <b style="mso-bidi-font-weight: normal;"><u>by the generic defendants</u></b>.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Woods</u>, 2016 WL 1719550, at *9-10 (emphasis
original).<span style="mso-spacerun: yes;"> </span>Of course plaintiff did not.<span style="mso-spacerun: yes;"> </span>That’s the opposite of what plaintiffs
normally allege, particularly in Alabama, where for a few months the courts
imposed innovator liability before the legislature <a href="http://druganddevicelaw.blogspot.com/2015/04/alabama-legislature-abolishes-weeks.html">put
a stop to it</a>.<span style="mso-spacerun: yes;"> </span>Indeed, “[plaintiff]
has not alleged that her physicians ever saw the package inserts or labeling
for the generic drug . . ., much less that they relied on those
labels.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *10.</div>
<br />
<div style="margin: 0in 0in 0pt;">
Oh, and for the sake of completeness, two
plaintiffs’ other claims – failure to add warnings and failure to send reminder
“Dear Doctor” letters (“consistent with” FDA-mandated labeling) – were
preempted.<span style="mso-spacerun: yes;"> </span><u>Woods</u>, 2016 WL 1719550,
at *4-6.<span style="mso-spacerun: yes;"> </span>The final claim, fraud, wasn’t
pleaded with specificity under Fed. R. Civ. P. 9(b), <u>id.</u> at *10-11, a
conclusion that was <i style="mso-bidi-font-style: normal;">a fortiori</i> from
the just-discussed analysis of how failure-to-warn lacked evidence of
causation.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Woods</u> is further confirmation that the
other side’s duty-to-update ruse to avoid preemption is hardly worth the
candle.<span style="mso-spacerun: yes;"> Even if they beat preemption, the claim itself is worthless. </span>Most doctors never see generic
labeling at all, particularly those who prescribe the branded product subject
to pharmacy substitution.<span style="mso-spacerun: yes;"> </span>As we’ve
discussed <a href="http://druganddevicelaw.blogspot.com/2013/10/dont-forget-about-prescribing.html">at
great length</a>, failure to read the allegedly inadequate label is fatal to
causation in a warning case.</div>
Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-5971592434861474602016-05-12T08:12:00.003-04:002016-05-12T10:06:00.347-04:00Guest Post – Highlights of FDA Draft Guidance on 3D Printing<br />
<div style="margin: 0in 0in 12pt;">
Another guest post today, this one by Reed Smith’s <a href="https://www.reedsmith.com/en-US/matt_jacobson/">Matt Jacobson</a> on the draft
guidance document released earlier this week by the FDA.<span style="mso-spacerun: yes;"> </span>With the 3D printing of medical devices at
the forefront of the burgeoning additive manufacturing revolution − and inevitably
to become the target, eventually, of product liability litigation – anything the
FDA does to move the ball forward (or not) is of great interest.</div>
<br />
<div style="margin: 0in 0in 12pt;">
As always, our guest blogger deserves all the credit (and
any blame) for what follows.<span style="mso-spacerun: yes;"> </span>Take it
away Matt.</div>
<br />
<div style="margin: 0in 0in 12pt;">
***********</div>
<br />
<div style="margin: 0in 0in 12pt;">
The blog is not a stranger to 3D printing, the cooler and slang
term for the additive manufacturing process.<span style="mso-spacerun: yes;">
</span>See <a href="http://druganddevicelaw.blogspot.com/2015/10/guest-post-first-contact-3d-printing.html">here</a>,
<a href="http://druganddevicelaw.blogspot.com/2015/09/shameless-plugs-more-support-from-your.html">here</a>,
<a href="http://druganddevicelaw.blogspot.com/2015/07/a-couple-of-law-review-articles-we.html">here</a>,
and <a href="http://druganddevicelaw.blogspot.com/2015/02/some-ideas-about-3d-printing.html">here</a>.
</div>
<br />
<div style="margin: 0in 0in 12pt;">
The U.S. Food and Drug Administration (FDA) is not a
stranger to 3D printing either.<span style="mso-spacerun: yes;"> </span>It has
already approved more than 80 medical devices and one prescription drug that are produced by
3D printing techniques.<span style="mso-spacerun: yes;"> </span>It also held a <a href="http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm">public
workshop</a> to obtain information and input about 3D printing issues on
October 8 and 9, 2014.<span style="mso-spacerun: yes;"> </span>FDA brought
together technical 3D printing expertise from various industries and sectors to
help the agency develop an evaluation process for future submissions of medical
devices resulting from additive manufacturing techniques.<span style="mso-spacerun: yes;"> </span>After the workshop, FDA was silent on 3D
printing, well that is, until last Tuesday, when it released a <a href="http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm499809.pdf">draft
guidance for Technical Considerations for Additive Manufactured Devices</a>.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
Although the FDA workshop was almost a year-and-a-half ago,
it was not for nothing, as the draft guidance is based on the feedback from the
workshop.<span style="mso-spacerun: yes;"> </span>According to FDA, the draft guidance
is a “leap-frog” guidance to share FDA’s “initial thoughts regarding
technologies that are likely to be of public health importance early in product
development.”<span style="mso-spacerun: yes;"> </span>While the draft guidance
is not meant to be a comprehensive document to address all regulatory
requirements, it highlights the technical considerations and recommendations
for design, manufacturing, and testing of medical devices that include at least
one fabrication step using additive manufacturing. <span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
FDA is careful to warn that the guidance does not apply to
any devices that use bioprinting − incorporating biological, cellular, or tissue-based products
into the additive manufacturing process.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
FDA also provides that point-of-care manufacturing (that is, on-site 3D printing of devices in hospitals and doctor's offices) “may”
raise additional technical considerations.<span style="mso-spacerun: yes;">
</span>Despite the mounting desire to migrate personalized, 3D device
manufacturing from central processing hubs to point-of-care manufacturing in a
health care setting, we understand why FDA avoided detailed discussion and
guidance regarding point-of-care manufacturing.<span style="mso-spacerun: yes;">
</span>Not only does point-of-care manufacturing involve additional technical
considerations, but it also raises not insignificant regulatory and legal
complications (such as whether each “point of care” is a “manufacturer” under
the statute) – all of which remain unresolved.</div>
<br />
<div style="margin: 0in 0in 12pt;">
The guidance is split up into two categories of
considerations: 1) design and manufacturing and 2) device testing.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Both
sections overlap in substance, and the device testing section in particular provides strong, detailed
recommendations for what a device manufacturer should include in a premarket
submission for a device that uses additive manufacturing. <span style="mso-spacerun: yes;"> </span>This will likely have an effect on how 3D
printing device companies design, manufacture, and test their devices,
especially those who manufacture patient-matched devices (devices that are
“customized” for a specific patient’s anatomy, usually based on medical imaging
data), to which the FDA draft guidance pays particular attention. </div>
<br />
<div style="margin: 0in 0in 12pt;">
FDA’s recommendations for design and manufacturing
considerations, are not as useful, as many of the sound platitudinous. These include:</div>
<br />
<ul style="direction: ltr; list-style-type: disc;">
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
That manufacturing and dimensional
specifications be carefully considered and documented.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
For patient-matched devices, understanding the
image quality and the role deformation may play.<span style="mso-spacerun: yes;"> </span>Also ensuring that the label expiration date account
“for time-dependent changes to the patient anatomy before the device is used.”</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Any software used to make patient-matched modifications
to a device’s design should include “internal checks to prevent the user from
exceeding the pre-established device specifications documented in the device
master record.” </div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
All software file conversation steps should be
tested in “worst-case scenarios.”</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Before a device is additively manufactured,
considerations should be made for<span style="mso-spacerun: yes;"> </span>build
volume placements, use of support material, layer thickness, build paths,
machine parameters, and environmental considerations. </div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Understanding the chemical properties of the
material being used and how the additive manufacturing process may affect those
properties. </div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Process validation and consistency of quality
are key.<span style="mso-spacerun: yes;"> </span>In other words, “knowledge of
how the variability of each input parameter and processing step affects the
final finished device or component is critical to ensuring party quality.”</div>
<div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: none; tab-stops: .5in;">
</div>
</li>
</ul>
<br />
<div style="margin: 0in 0in 12pt;">
For device testing considerations, FDA recommends that the
following (if applicable for the particular device) be included in a premarket
submission for a medical device using 3D printing:</div>
<br />
<ul style="direction: ltr; list-style-type: disc;">
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Range of dimensions for the device (small,
medium, large) and any dimensions that may be altered to match a patient’s
anatomy.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Performance testing results.<span style="mso-spacerun: yes;"> </span>While these are generally the same for any
device, whether 3D printed or traditionally manufactured, for 3D printed
devices build direction orientation should be considered when testing is
performed. </div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Dimensional tolerances and measurements should
be specified.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
All materials involved in the manufacturing of
the medical device should be clearly identified.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Material polymers may need to be tested to
ensure that they will not unintentionally form chemical properties through the
additive manufacturing process, which may pose a risk to patient health.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Interlayer bonding materials should be
characterized.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Any cleaning and sterilization process for a
final product should be validated and should consider the complex geometry of
the final product.<span style="mso-spacerun: yes;"> </span>Only additive
manufactured devices that were cleaned of manufacturing materials should be
provided to the end user. </div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
The biocompatibility of the final device should
be evaluated.</div>
</li>
<li style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal;"><div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: l0 level1 lfo1;">
Additional labeling considerations for
patient-matched devices is recommended to include the patient identifier,
identifying use, file design iteration, and that the patient be surveyed for
potential anatomical changes (between the time of imaging and surgery).</div>
<div style="color: black; font-family: "Times New Roman","serif"; font-size: 12pt; font-style: normal; font-weight: normal; margin-bottom: 0pt; margin-top: 0in; mso-list: none; tab-stops: .5in;">
</div>
</li>
</ul>
<br />
<div style="margin: 0in 0in 12pt;">
As stated in the guidance, FDA is aware that 3D printing “is a
rapidly growing technology,” which has numerous advantages for medical devices,
but at the same time “pose[s] challenges in determining optimal
characterization and assessment methods for the final finished device, as well
as optimal process validation and acceptance methods for these devices.”<span style="mso-spacerun: yes;"> </span>The FDA’s guidance is long overdue, but the
agency has evidently thought about the unique considerations involved in 3D
printing of medical devices.</div>
<div style="margin: 0in 0in 12pt;">
Interested parties should note that FDA is
accepting comments on the draft guidance now and hopefully the final guidance
will come soon (at least quicker than the draft guidance). To ensure FDA
considers your comments before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft guidance
within 90 days [<a href="https://www.regulations.gov/#!documentDetail;D=FDA-2016-D-1210-0001">Docket
No. FDA-2016-D-1210</a>]. <span style="mso-spacerun: yes;"> </span>Who knows
maybe by the time the final guidance comes out, we may be 3D printing a version
for our book shelf, or even of our book shelf.<span style="mso-spacerun: yes;"> </span></div>
Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com1tag:blogger.com,1999:blog-36762711.post-22187246000013082472016-05-11T07:30:00.000-04:002016-05-11T08:06:32.064-04:00Zofran MDL Jurisdictional Analysis Bounces Non-Missouri Plaintiffs<br />
<span style="font-size: large;"><span style="font-family: "helvetica";">Over the years we have completed many written evaluations of young associates, and the first category on the form has almost always been "Legal Analysis." That primacy makes sense. If a lawyer does not understand the legal issues, what good is oral or written expression, teamwork, or pretty much anything else? (That being said, it is amazing how business development can cure any perceived weakness of analytical ability). When we do what we usually do on this blog, scrutinizing judicial opinions, we are basically doing a legal analysis of a legal analysis. According to most dictionaries, to analyze something is to separate it into constituent parts. The word "analyze" comes from Greek words "ana" and "lupin" - to unloosen. Analysis picks things apart while synthesis puts things together.</span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">Today's case, <i>In re Zofran Products Liability Litigation</i>, 2016 U.S. Dist. LEXIS 59296 (D. Mass. May 4, 2016), is a nice piece of legal analysis. The court takes a messy case, separates the issues, sequences them logically, and then disposes of each part clearly and succinctly. The case was messy because the plaintiff lawyers made it so, by consolidating claims of four different plaintiffs from four different states: Missouri, Delaware, North Carolina, and Pennsylvania. The case was initially filed in Missouri state court. The defendant removed the case to Missouri federal court, and the case was then transferred to the MDL federal court in Massachusetts. The plaintiff moved to remand the case to state court and the defendant moved to dismiss the claims of the three non-Missouri plaintiffs.</span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">The plaintiffs' argument for remand was that complete diversity did not exist because there was a Delaware plaintiff and a Delaware defendant. The defense response to that was that the Delaware plaintiff was fraudulently joined. This was a debate over subject matter jurisdiction.</span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">Personal jurisdiction was also in play. A transferee court (here, the federal court in Massachusetts) had personal jurisdiction over the defendant only if the transferor court (Missouri) had personal jurisdiction. The defendant argued that there was no personal jurisdiction over it in Missouri, except with respect to the Missouri plaintiff.</span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">The first issue for the court was whether to consider subject matter or personal jurisdiction first. The plaintiffs wanted to begin with subject matter jurisdiction, while the defendant wanted to begin with personal jurisdiction. It turns out that there is no hard and fast rule on priority between the two jurisdictional analyses. Thus, the court did the sensible thing by electing to address the cleaner, simpler issue first. Fraudulent joinder, rightly or wrongly, has become a "rather complicated" issue. By contrast, the personal jurisdiction analysis, taken bit by bit, was straightforward and inevitable, and removed the need to fret over the fraudulent joinder problem.</span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">The Supreme Court's <i>Bauman</i> opinion strikes again. (The beneficence of <em>Bauman</em> is set forth comprehensively in our <em>Bauman</em> <a href="http://druganddevicelaw.blogspot.com/2016/04/bauman-personal-jurisdiction-in-house.html">checklist</a>.) Personal jurisdiction breaks down into General Jurisdiction (whether the court would have jurisdiction over the defendant for any case, because the defendant is essentially at home in that jurisdiction) and Specific Jurisdiction (whether the court has jurisdiction over the defendant in that specific case because the defendant's conduct touched that jurisdiction in significant, meaningful ways). Here, the defendant neither was incorporated in Missouri nor had its principal place of business there. Absent some extraordinary nexus with Missouri, that means no general personal jurisdiction. The plaintiffs argued that the defendant had consented to Missouri jurisdiction by registering to do business there. While there are some outlier opinions that buy into that view, more and more courts have concluded that such a consent theory would render <i>Bauman</i> a dead letter. The Zofran MDL court held that the consent theory "would distort the language and purpose of the Missouri registration statute" while also running afoul of the Supreme Court precedent. So much for General Jurisdiction.</span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">On Specific Jurisdiction, the "complaint falls far short of anything establishing any nexus between the non-Missouri plaintiffs' claims and GSK's Missouri-based activities." Unlike with the single Missouri plaintiff, "the non-Missouri plaintiffs do not allege that they were prescribed Zofran in Missouri, took Zofran in Missouri, or that their children suffered injuries in Missouri." That means that the claims by the non-Missouri plaintiffs were dismissed for want of personal jurisdiction. The litigation tourists must go home. (As we explained <a href="http://druganddevicelaw.blogspot.com/2016/03/mdl-decision-debunking-pendent.html">here</a>, recent case law makes clear that pendent jurisdiction cannot prolong the litigation tourists' vacation.) </span><br style="font-family: Helvetica;" /><br style="font-family: Helvetica;" /><span style="font-family: "helvetica";">What is left is the claim by a Missouri plaintiff versus a non-Missouri defendant. That is complete diversity and decides the subject matter jurisdiction issue in favor of the defendant. The case, therefore, was not remanded. Instead, it stayed in federal court in front of a judge who earned high marks for legal analysis.</span></span>Steve McConnellhttp://www.blogger.com/profile/14959081465420761870noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-68330124081685767832016-05-10T13:45:00.001-04:002016-05-10T13:45:34.480-04:00Failure to Train Preempted in California
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> This post is from the non-Reed Smith side of the blog. </span></div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"></span> </div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span><span lang="DE" style="mso-ansi-language: DE;">In <i style="mso-bidi-font-style: normal;">Glennen
v. Allergan, Inc.</i>, -- Cal. </span>Rptr.3d --, 2016 WL 1732243 (Cal. Ct.
App. Apr. 29, 2016), plaintiff brought one cause of action – negligent failure
to adequately train physicians in the use of a medical device.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *1.<span style="mso-spacerun: yes;"> </span>That’s it.<span style="mso-spacerun: yes;"> </span>Not that the product was defectively
designed.<span style="mso-spacerun: yes;"> </span>Not that the defendant erred
in the manufacturing process.<span style="mso-spacerun: yes;"> </span>Not that
the device came with inadequate warnings.<span style="mso-spacerun: yes;">
</span>The plaintiff made none of those allegations.<span style="mso-spacerun: yes;"> </span>Instead she asserted only that she was
injured as a result of implantation of the device done poorly by her
physician.<span style="mso-spacerun: yes;"> </span>But rather than lay that
blame at the foot of the physician, plaintiff sued the manufacturer claiming it
was the manufacturer’s fault for not properly training the physician.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>Quick
sidebar:<span style="mso-spacerun: yes;"> </span>Plaintiff’s pronounced focus on
the doctor’s alleged negligence made use stop and think.<span style="mso-spacerun: yes;"> </span>Plaintiff filed her lawsuit nine years after
her surgery and alleged injury.<span style="mso-spacerun: yes;">
</span>California has a 1-year statute of limitations for medical malpractice,
and while the products liability statute is only 2 years, plaintiff probably
saw more leeway in arguing when she “discovered” her claim against the
manufacturer then against her surgeon.<span style="mso-spacerun: yes;">
</span>Just a little supposition on how this essentially med-mal claim turned
into a products liability claim. <o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
We’ve talked a little about the “duty
to train” <a href="http://druganddevicelaw.blogspot.com/search/label/Duty%20To%20Train" target="_blank">here</a>. <span style="mso-spacerun: yes;"> </span>It’s not a theory that has generated much
traction for plaintiffs, especially in prescription medical device cases.<span style="mso-spacerun: yes;"> </span>It is after all just a failure to warn to claim
trying to disguise itself.<span style="mso-spacerun: yes;"> </span>In a Class
III, Pre-Market Approval medical device case, we understand why plaintiffs are
trying to put lipstick on a pig.<span style="mso-spacerun: yes;"> </span>In PMA
cases, it is practically unanimous that between express and implied preemption,
there remains only a “narrow gap” through which state law claims can fit to
survive preemption.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *5.<span style="mso-spacerun: yes;"> </span>Fortunately for
the defendant, the <i style="mso-bidi-font-style: normal;">Glennen</i> court did
not allow failure to train to slip through.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
The case is on appeal because the
trial court dismissed plaintiff’s lone failure to train claim with
prejudice.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *2.<span style="mso-spacerun: yes;"> </span>On <i style="mso-bidi-font-style: normal;">de novo</i> review, the appellate court
affirmed.<span style="mso-spacerun: yes;"> </span>The device at issue was a
Lap-Band, designed to be surgically implanted for weight loss.<span style="mso-spacerun: yes;"> </span>Plaintiff suffered complications from the
surgery which required removal surgery and resulted in significant injury.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>The
PMA for the Lap-Band included a requirement that the device’s labeling specify
the training procedures for surgeons who could use the device.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *1.<span style="mso-spacerun: yes;"> </span>The manufacturer prepared a
brochure outlining the training that was necessary for practitioners.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Plaintiff alleged that her failure
to train claim was a parallel claim that survived preemption.<span style="mso-spacerun: yes;"> </span>To support her contention, plaintiff cited to
some of our not so favorite cases – <i style="mso-bidi-font-style: normal;">Bausch
v. Stryker</i>, 630 F.3d 546 (7<sup>th</sup> Cir. 2010); <i style="mso-bidi-font-style: normal;">Hughes v. Boston Scientific Corp.</i>, 631 F.3d 762 (5<sup>th</sup>
Cir. 2011); <i style="mso-bidi-font-style: normal;">Bass v. Stryker Corp.</i>,
669 F.3d 501 (5<sup>th</sup> Cir. 2012); and <i style="mso-bidi-font-style: normal;">Stengel v. Medtronic, Inc.</i>, 704 F.3d 1224 (9<sup>th</sup> Cir.
2013).<span style="mso-spacerun: yes;"> </span>But as the court pointed out,
none of them had anything to do with failure to train.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *6.<span style="mso-spacerun: yes;"> </span>They dealt with manufacturing
defects and failure to warn the FDA.<span style="mso-spacerun: yes;"> </span>We
don’t agree with the results of any of those cases, but we do agree they are
inapplicable here.<span style="mso-spacerun: yes;"> </span>In fact, the court
couldn’t find any case cited by plaintiff in which a failure to train claim was
successfully maintained in a medical device case, “let alone a Class III device
that has undergone the PMA review process.”<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> <o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Putting aside irrelevant precedent
the court had to determine if plaintiff had alleged a violation of a PMA
regulation such that her claim was a non-preempted parallel claim.<span style="mso-spacerun: yes;"> </span>She had not.<span style="mso-spacerun: yes;">
</span>The court first looked at the actual allegations of the complaint.<span style="mso-spacerun: yes;"> </span>They focused exclusively on “what her surgeon
did incorrectly.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *7.<span style="mso-spacerun: yes;"> </span>“Physician error
is not enough to support a claim against a manufacturer for improper training
or marketing of an approved Class III device.”<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id</i>.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>There
were no allegations about the defendant’s brochure or training protocols – both
of which were approved by the FDA during PMA review.<span style="mso-spacerun: yes;"> </span>And no allegation that the training defendant
provided deviated from the approved FDA requirements.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.<span style="mso-spacerun: yes;"> </span></i>“The PMA process does not obligate [manufacturers]
to follow their products into the surgery room.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>Indeed,
the FDCA is set up to explicitly <i style="mso-bidi-font-style: normal;">not</i> interfere
in the practice of medicine.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;">
</span>So, the court’s analysis started with the conclusion that plaintiff had
not alleged a violation of a federal duty.<span style="mso-spacerun: yes;">
</span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Plaintiff was relying on the
Current Good Manufacturing Practice (“CGMPs”) requirements, specifically
provisions contained in the Quality System Regulation.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>As the court noted, there is a split in
authority regarding whether the CGMPs can be used as a basis for a parallel
violation claim due to their vague and non-specific nature.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *8.<span style="mso-spacerun: yes;"> </span>The court didn’t have to choose a
side in that debate because it found that the CGMPs do not apply to physician
training programs.<span style="mso-spacerun: yes;"> </span>It’s right there in the
title – manufacturing processes.<span style="mso-spacerun: yes;"> </span>The
CGMPs are about the manufacturing process, the quality of the manufacturing process,
the training of internal manufacturer employees in the manufacturing process.<span style="mso-spacerun: yes;"> </span>They have nothing to do with physician
training.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *8-9.<span style="mso-spacerun: yes;"> </span>Which isn’t
surprising based on the aforementioned FDA principle of not interfering in the practice
of medicine.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *10.<span style="mso-spacerun: yes;"> </span>The court
observed that<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<blockquote class="tr_bq">
Plaintiff effectively seeks to write in a new provision to
the FDCA, namely, that medical device companies who are required to provide
training to physicians as a condition of premarket approval must insure such
training is designed to satisfy the standard of care applicable to medical
malpractice actions. We do not pass judgment on whether this would be a wise
rule for the FDA to adopt. It is sufficient for our inquiry that it <b style="mso-bidi-font-weight: normal;">has not done so</b>. </blockquote>
<i style="mso-bidi-font-style: normal;">Id.</i> at *10
(emphasis added).<span style="mso-spacerun: yes;"> </span>And since it has not
done so, any such state law requirement (such as one imposed by a jury) would
be different from or in addition to federal requirements and therefore preempted.<span style="mso-spacerun: yes;"> </span><o:p></o:p><br />
<br />
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>The court
also found that the claim was impliedly preempted because it arose solely out
of the FDA’s mandate that the manufacturer provide physician training.<span style="mso-spacerun: yes;"> </span>Plaintiff tried to distance herself from <i style="mso-bidi-font-style: normal;">Buckman</i> by arguing that she wasn’t
making a fraud-on-the FDA claim, but the court was unwilling to adopt such a
narrow interpretation of <i style="mso-bidi-font-style: normal;">Buckman</i>.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>Instead, the court ruled that plaintiff could
not make out a negligent voluntary undertaking claim because the manufacturer
was not involved in a voluntary undertaking.<span style="mso-spacerun: yes;">
</span>The device’s PMA required physician training.<span style="mso-spacerun: yes;"> </span>Therefore, plaintiff’s failure to train claim
“exists solely by virtue of the FDCA requirements.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *11.<span style="mso-spacerun: yes;"> </span>Because the claim does not exist
independent of the FDCA, it is impliedly preempted.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>Moreover,
there were no allegations or evidence presented that the FDA had evaluated the
adequacy of the manufacturer’s training program during the PMA process.<span style="mso-spacerun: yes;"> </span>So any allegation that the training that was
provided was inadequate “goes beyond whatever the FDA did do, or chose not to
do, in approving the product.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *12.<span style="mso-spacerun: yes;"> </span>The plaintiff’s private cause of action
cannot be allowed to “displace” the FDA’s exclusive role in enforcing its regulations.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>Plaintiffs
cannot impose into federal PMA requirements state law medical malpractice
standards.<span style="mso-spacerun: yes;"> </span>Defendant had a federal
obligation to provide training and to specify that training in its
labeling.<span style="mso-spacerun: yes;"> </span>It complied with both
requirements.<span style="mso-spacerun: yes;"> </span>If the FDA was concerned
or dissatisfied with the way in which those obligations were being fulfilled,
that is a matter for the FDA to deal with.<span style="mso-spacerun: yes;">
</span>If a plaintiff is dissatisfied with the medical care she received, there
are appropriate avenues for addressing those grievances – a products liability lawsuit
against a device manufacturer is not one of them.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
</div>
Michelle Yearyhttp://www.blogger.com/profile/00994598841153573554noreply@blogger.com1tag:blogger.com,1999:blog-36762711.post-27394212612782938422016-05-09T16:00:00.001-04:002016-05-09T16:00:26.354-04:00When You’re In, You’re All In
<br />
<div>
This post comes from the Cozen O'Connor side of the blog.</div>
<br />
<br />
Drug and device lawsuits fling open the plaintiffs’
medicine cabinet and slide open the drawers to their doctors’ file cabinets.<span style="mso-spacerun: yes;"> </span>Everything is in play: the plaintiff’s
disease state, the alleged side effects, the revision surgery, all the pre-existing
conditions, the risk factors, the medication history, medical histories (pre-and-post
event), all the doctors, and more.<span style="mso-spacerun: yes;"> </span>In
almost every mass tort drug or device case we’ve handled, plaintiffs provide
records for all of this.<span style="mso-spacerun: yes;"> </span>In fact, one of
the first things that courts managing mass tort drug and device cases do is order
plaintiffs, as a matter of course, to provide a profile or data sheet laying
out this information.<span style="mso-spacerun: yes;"> </span><br />
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
The hip-replacement plaintiff in <i style="mso-bidi-font-style: normal;">Raab v. Smith & Nephew, Inc.</i> 2016 U.S. Dist. LEXIS 59185
(S.D.W.V. May 4, 2016), wanted to provide less.<span style="mso-spacerun: yes;">
</span>She objected to discovery of two medical providers and all her medical
insurance coverage, arguing that her gynecologist and plastic surgeon had no
information relevant to her hip issues and that her insurance coverage provided
only irrelevant collateral source information.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> at *3-7.<span style="mso-spacerun: yes;"> </span>She claimed to have otherwise produced enough
information about her doctors and medical treatment, using catch-phrases such
as “carte blanche” and “fishing expedition” to describe defendant’s efforts to
get more.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *5, 7.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
And she lost.<span style="mso-spacerun: yes;"> </span>While
the court acknowledged that these arguments might work to limit discovery under
FRCP 26 in certain cases, plaintiff’s medical device claim was not one of
them.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *8.<span style="mso-spacerun: yes;"> </span>The claim itself placed
her medical care and medical condition squarely at issue, which could easily
implicate every aspect of her medical treatment.<span style="mso-spacerun: yes;"> </span>But her claims of physical injury and
emotional and stress-related damages only further broadened the defendants’
need for already broad discovery into her medical history:</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
Plaintiffs have claimed a variety
of damages as a result of [Smith & Nephew’s] allegedly defective joint
replacement components, including physical injury, pain, suffering, mental
anguish, emotional distress, and damage to the marital relationship. Given the
broad nature of the damage claims asserted by Plaintiffs, S&N is entitled
to broad discovery of Ms. Raab’s medical and emotional history.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at *8.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
Plaintiff also argued that, after providing information on
seventeen of her doctors, she shouldn’t have to provide any more.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *5.<span style="mso-spacerun: yes;"> </span>That isn’t the test.<span style="mso-spacerun: yes;"> </span>The test is whether the information is
relevant to plaintiff’s claims and its discovery is proportional to the needs
of the case.<span style="mso-spacerun: yes;"> </span>Here, information from her
gynecologist and plastic surgeon could easily address her bone quality, health
status, and emotional state.<span style="mso-spacerun: yes;"> </span>Moreover, adding
only two doctors certainly seems proportional.<span style="mso-spacerun: yes;">
</span>Just as important, plaintiff provided no evidence to suggest that her
gynecological and plastic surgery history had no relevant evidence: </div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
Plaintiffs have not provided any
information regarding the nature of Ms. Raab’s plastic surgery or gynecologic
treatment that would clearly demonstrate the irrelevancy of that care.
Plaintiffs have not moved for a protective order, nor have they demonstrated
that providing the requested information would be disproportional to the needs
of the case.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at *9.<span style="mso-spacerun: yes;"> </span>The court therefore ordered plaintiff to
provide information as to all of her medical providers, not just those she had unilaterally
selected.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
Plaintiff’s effort to block her insurance coverage from
discovery fared no better.<span style="mso-spacerun: yes;"> </span>Collateral
source rule or not, the insurance records will provide information on plaintiff’s
medical care and her medical condition, including the need for disability
benefits.<span style="mso-spacerun: yes;"> </span>This information cuts across
all aspects of her claims.<span style="mso-spacerun: yes;"> </span>Even
information about collateral source payments could be relevant to damages and,
perhaps, credibility:</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
In this case, while some of the
information requested by S&N may be collateral source data, the remaining
information deals with other claims related to medical care, disability
benefits, and the like filed by Ms. Raab in the past ten years. Certainly, in
view of Plaintiff’s physical injury, emotional distress, and lost wages claims,
materials related to disability and unemployment benefits sought or received by
Plaintiffs are relevant, as is evidence of Ms. Raab’s medical claims and
treatment. To the extent materials reflect payments by collateral sources and
may not be admissible, those materials may still be relevant to issues of
credibility and damages and, thus, are discoverable barring other exceptions.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at
*10-11.<span style="mso-spacerun: yes;"> </span>The court ordered plaintiff to
produce this information as well.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
We see this as an easy call.<span style="mso-spacerun: yes;"> </span>Frankly, there are additional reasons to
produce these records.<span style="mso-spacerun: yes;"> </span>Each medical
provider records a medical history and history of medication, and experience
tells us that each doctor’s history is rarely complete or the same as that of other
doctors, making a full set of medical records necessary. <span style="mso-spacerun: yes;"> </span>Each doctor must also consider the plaintiff’s
disease states and ongoing treatment by other medical providers when determining
her or his own treatment.<span style="mso-spacerun: yes;"> </span>And, so, even
doctors not directly treating a plaintiff’s disease state or the claimed side
effect will have relevant information in their records. <span style="mso-spacerun: yes;"> </span>Our experience also tells us that plaintiffs’ own
recollections of their medical histories, even the identities of their own doctors,
are rarely complete, and getting medical and insurance records is necessary to fill
in those gaping holes. <span style="mso-spacerun: yes;"> </span>Moreover, all medical
providers are likely to have information on risk factors or pre-existing
injuries.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
There may be cases in which discovery of medical
information can be somewhat limited.<span style="mso-spacerun: yes;"> </span>But
those instances are few and far between in drug or medical device cases.<span style="mso-spacerun: yes;"> </span>And, like in <i style="mso-bidi-font-style: normal;">Raab</i>, a plaintiff who tries to limit that discovery will, and should,
almost always lose.<span style="mso-spacerun: yes;"> </span></div>
John J. Sullivanhttp://www.blogger.com/profile/01479637903241019239noreply@blogger.com1tag:blogger.com,1999:blog-36762711.post-25028020646983130322016-05-06T15:20:00.001-04:002016-05-11T17:39:14.568-04:00Don't Mess With Texas<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
This post is from the non-Reed Smith side of the blog.</div>
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
</div>
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
We found it strange that last month’s decision in <i style="mso-bidi-font-style: normal;">Jenkins v. Boston Scientific Corp.</i>, 2016
WL 1448867 (S.D.W. Va. April 12, 2016), held – almost as a throw-away point –
that Texas law wouldn’t apply Restatement (Second) of Torts §402A, comment k
(1965) to medical devices as it does to prescription drugs. That’s a notable,
indeed almost unprecedented, result.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Jenkins</i>
did recognize that Texas law has, for a long time, applied comment k
across-the-board to bar design defect claims against all prescription
drugs.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *5, <i style="mso-bidi-font-style: normal;">citing Carter v.
Tap Pharmaceuticals, Inc.</i>, 2004 WL 2550593, at *5 (W.D. Tex. Nov. 2, 2004)
(“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe
as a matter of law.”).<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Carter</i> is hardly the only Texas case for
applying comment k generally to bar design defect claims.<span style="mso-spacerun: yes;"> </span>We collected that law in our 2011 <a href="http://druganddevicelaw.blogspot.com/2011/04/comment-k-some-of-way.html" target="_blank">Comment K,Some of the Way</a> post:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Centocor, Inc. v. Hamilton</i>, 310 S.W.3d
476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect
claim”), <i style="mso-bidi-font-style: normal;">rev’d on other grounds</i>, 372
S.W.3d 140 (Tex. 2012); <i style="mso-bidi-font-style: normal;">Schwarz v. Block
Drug Co.</i>, 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the
Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in
damages only if it failed to warn of a defect of which it knew or should have
known.”) (unpublished, in table at 180 F.3d 261); <i style="mso-bidi-font-style: normal;">Reyes v. Wyeth Laboratories</i>, 498 F.2d 1264, 1273-74 (5th Cir. 1974)
(applying unavoidably unsafe standard without individualized assessment); <i style="mso-bidi-font-style: normal;">Holland v. Hoffman-La Roche, Inc.</i>, 2007
WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not
susceptible to a design defect claim where, as here, the drug is “accompanied
by proper directions and warning”); <i style="mso-bidi-font-style: normal;">Hackett
v. G.D. Searle & Co.</i>, 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he
Court thus holds that under Texas law and comment k of the Restatement,
Defendants can only be held strictly liable if the drug was not properly prepared
or marketed or accompanied by proper warnings”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
However, after recognizing Texas law with respect
to comment k and prescription drugs, <i style="mso-bidi-font-style: normal;">Jenkins</i>
declined to apply comment k in the same fashion to medical devices:<i style="mso-bidi-font-style: normal;"><o:p></o:p></i></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
I reject [defendant’s] contention that Texas’s absolute
bar for FDA-approved prescription drugs, applies here, given that the products
are neither FDA-approved nor prescription drugs. <span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See Lofton
v. McNeil Consumer & Specialty Pharm.</i>, 682 F. Supp.2d 662, 679 (N.D.
Tex. 2010) (refusing to “take a leap not taken by Texas courts” in applying
comment k categorically outside the prescription drug context).<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
2016 WL 1448867, at *5 (citation omitted).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
That’s it.<span style="mso-spacerun: yes;">
</span>The entire extent of the discussion of Texas law on this point is one
sentence and one citation.<span style="mso-spacerun: yes;"> </span>Absent is any
discussion of why the policy reasons that have led Texas courts to apply
comment k in every prescription medical product case over the last forty years
don’t apply to prescription medical devices.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
But what about <i style="mso-bidi-font-style: normal;">Lofton</i>?<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Of course we took a look.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Lofton</i>
involved an OTC product – not a prescription product of any sort.<span style="mso-spacerun: yes;"> </span>Here’s the full quote from <i style="mso-bidi-font-style: normal;">Lofton</i>:<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
Defendants have cited no cases applying comment k to an <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">over-the-counter
drug</i></b>; the cases cited all apply it only to prescription drugs. <span style="mso-spacerun: yes;"> </span>Comment k itself refers to drugs, “many of
which ... cannot be legally sold <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">except to physicians</i></b>, or <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><u>under
the prescription of a physician</u></i></b>.” Restatement (Second) of Torts §
402A cmt. k. The court will not take a leap not taken by Texas courts and apply
this exception <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">to an over-the-counter drug</i></b>, even if at one time ibuprofen was
a prescription drug. <span style="mso-spacerun: yes;"> </span>At the time
Decedent took the drug <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">it was not</i></b>.<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
682 F. Supp.2d at 679 (emphasis added).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Lofton</i>,
with its repeated emphasis on comment k’s “prescription” language, is hardly a
basis for the almost unique holding that, in a jurisdiction that has adopted
comment k (not all have, as we discuss in the “<a href="http://druganddevicelaw.blogspot.com/2011/04/comment-k-some-of-way.html" target="_blank">Some of the Way</a>” post) in
prescription drug cases, comment k does not apply in the same way to medical
devices that likewise require a doctor’s prescription before use.<span style="mso-spacerun: yes;"> The Texas rule applying comment k across the board has been applied, for example, in the case of prescription biologics. <span style="font-family: "Times New Roman","serif"; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;"><em>Massa v. Genentech Inc.</em></span><span style="font-family: "Times New Roman","serif"; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;">, 2012
WL 956192, at *5 (S.D. Tex. March 19, 2012). </span> Biologics - requiring a prescription - are a lot closer to prescription medical devices, than the non-prescription OTC drug in <em>Lofton</em>, as <em>Lofton</em>'s own analysis demonstrates. </span>In this respect, <i style="mso-bidi-font-style: normal;">Jenkins</i> is way out on a limb.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Exactly how far out is indicated by another federal
court recently asked to make the same prediction.<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">Anastasi
v. Wright Medical Technology, Inc.</i>, 16 F. Supp.3d 1032 (E.D. Mo. 2014), the
court was also asked to dismiss a design defect claim against a medical device
under comment k in a case that applied Texas law.<span style="mso-spacerun: yes;"> </span>The court recognized that Texas applied
comment k broadly.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 1041.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Anastasi</i> applied comment k to medical
devices but held that dismissal was “premature” at the motion to dismiss stage
due to a need to “weigh evidence”:<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
Only if the product is determined not “unreasonably
dangerous per se” does the analysis proceed to the “unreasonably dangerous as
marketed” inquiry, at which point Comment k becomes applicable. <span style="mso-spacerun: yes;"> </span>Because the prerequisite “unreasonable
dangerous” determination involves weighing of evidence, consideration of the
applicability of Comment k’s bar to Plaintiff's strict liability design defect
claim is not appropriate in a motion to dismiss.<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i>
(citations omitted).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Three other legal aspects also indicate to us that the
result in <i style="mso-bidi-font-style: normal;">Jenkins</i> is erroneous.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<i style="mso-bidi-font-style: normal;">First</i>,
that holding is contrary to the Restatement (Third) of Torts, which explicitly
applies the same liability standards to both prescription drugs and medical
devices:<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
§6 Liability of Commercial Seller or Distributor for
Harm Caused by Defective <b style="mso-bidi-font-weight: normal;"><u>Prescription
Drugs and Medical Devices</u></b><o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
(a) A manufacturer of a <b style="mso-bidi-font-weight: normal;"><u>prescription drug or medical device</u></b> who sells or otherwise
distributes a defective <b style="mso-bidi-font-weight: normal;"><u>drug or
medical device</u></b> is subject to liability for harm to persons caused by
the defect. A <b style="mso-bidi-font-weight: normal;"><u>prescription drug or
medical device</u></b> is one that may be legally sold or otherwise distributed
only pursuant to a health-care provider’s prescription.<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
Restatement (Third) of Torts, Products Liability §6(a)
(1998) (emphasis added).<span style="mso-spacerun: yes;"> </span>As we discussed
in our “<a href="http://druganddevicelaw.blogspot.com/2010/09/whats-up-with-third-restatement.html" target="_blank">What’s Up With the Third Restatement</a>” post, the Texas Supreme Court was
an early adopter of the Third Restatement generally.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See Hernandez
v. Tokai Corp.</i>, 2 S.W.3d 251, 257-58 (Tex. 1999); <i style="mso-bidi-font-style: normal;">General Motors Corp. v. Sanchez</i>, 997 S.W.2d 584, 592 (Tex. 1999); <i style="mso-bidi-font-style: normal;">Hyundai Motor Co. v. Rodriguez</i>, 995
S.W.2d 661, 666-67 (Tex. 1999); <i style="mso-bidi-font-style: normal;">Uniroyal
Goodrich Tire Co. v. Martinez</i>, 977 S.W.2d 328, 335 (Tex. 1998).<span style="mso-spacerun: yes;"> </span>Since that 2010 post, we can add a direct
citation to §6.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See Centocor, Inc. v. Hamilton</i>, 372 S.W.3d 140, 157, 159 (Tex.
2012) (citing §6; also citing comment b).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
We also note that a Texas appellate court has emphatically
rejected an analogous argument that the learned intermediary rule shouldn’t
apply to medical devices.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Bean v. Baxter Healthcare Corp.</i>, 965
S.W.2d 656, 662 (Tex. App. 1998).<span style="mso-spacerun: yes;"> </span>As
with <i style="mso-bidi-font-style: normal;">Lofton</i>, the prescription nature
of the device was dispositive:<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
Appellants also contend, correctly, that Texas courts
have applied the doctrine only to prescription drugs and not to medical
devices. <span style="mso-spacerun: yes;"> </span>Importantly, however, the
doctrine has not been rejected by a Texas court under these circumstances. <span style="mso-spacerun: yes;"> </span>Furthermore, other jurisdictions have applied
the doctrine in failure to warn cases involving [the same medical device]. <span style="mso-spacerun: yes;"> </span>In addition, other jurisdictions have approved
the doctrine’s application in cases involving other medical
devices. . . .<span style="mso-spacerun: yes;"> </span>Certainly,
in the context of [this device], there is a <b style="mso-bidi-font-weight: normal;"><u>patient-physician relationship</u></b>, as is necessary to apply the
doctrine. <span style="mso-spacerun: yes;"> </span>The evidence establishes the <b style="mso-bidi-font-weight: normal;"><u>implanting physicians were integrally
involved</u></b> in determining which implants to use, as appellants relied on
them to choose the appropriate implant and give them information regarding the
surgery and the product. <span style="mso-spacerun: yes;"> </span>Further, the
doctors were clearly in a better position than the patient to weigh the
benefits of the implant against the harm they posed, if any. <span style="mso-spacerun: yes;"> </span>In addition, we see no basis for
distinguishing [medical devices] from prescription drugs for purposes of
applying the doctrine; in both instances, the product is manufactured for <b style="mso-bidi-font-weight: normal;"><u>administration only by a physician</u></b>
or other authorized person.<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
<em>Id.</em> at 663 (many citations omitted) (emphasis
added).<span style="mso-spacerun: yes;"> </span>For other Texas (and other
states’) cases applying the learned intermediary rule to prescription medical
devices, see our post <a href="https://www.blogger.com/blogger.g?blogID=36762711#allposts/src=dashboard"><span style="color: blue;">here</span></a>.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Collectively, strike one.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Second, Texas’ rejection of design defect claims
involving prescription medical products is also reflected in that state’s
product liability statute.<span style="mso-spacerun: yes;"> </span>For all other
products, the design defect standard is set by Tex. Civ. Prac. & Rem. Code
Ann. §82.005.<span style="mso-spacerun: yes;"> </span>However, prescription
medical products are exempt:<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
This section does not apply to:<span style="mso-spacerun: yes;"> </span>. . .<span style="mso-spacerun: yes;"> </span>(2) a <b style="mso-bidi-font-weight: normal;"><u>drug
or device</u></b>, as those terms are defined in the federal Food, Drug, and
Cosmetic Act.<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
<em>Id.</em> §82.005(d)(2) (emphasis added).<span style="mso-spacerun: yes;"> </span>Rather, “with respect to any product which is
not subject to this section, the “common law,” as “develop[ed]” by the courts,
applies.<span style="mso-spacerun: yes;"> </span><u>Id.</u> §82.005(e).<span style="mso-spacerun: yes;"> </span>Thus, the Texas tort reform statute, like the
Third Restatement, expressly treats prescription drugs and medical devices <span style="mso-no-proof: no;">identically</span> with respect to design defect
claims.<span style="mso-spacerun: yes;"> </span>That the legislature chose to
treat prescription drugs and prescription medical products in the same fashion
is also a strong indication of what Texas law is.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Since we’re dealing with the common law, we should
point out that, with respect to design defects, the Third Restatement
approaches them differently from the Second Restatement’s comment k – barring
liability unless “the foreseeable risks of harm posed by the drug or medical
device are sufficiently great in relation to its foreseeable therapeutic
benefits” that no “reasonable” physician would “prescribe the drug or medical
device for any class of patients.”<span style="mso-spacerun: yes;">
</span>Restatement (Third) of Torts, Products Liability §6(c) (1998).<span style="mso-spacerun: yes;"> </span>The Texas Supreme Court has never expressly
adopted §6(c), and in <i style="mso-bidi-font-style: normal;">Hamilton</i> it
followed comment k instead:<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
[D]octors have a legal duty to pass prescription drug
warnings on to their patients.<span style="mso-spacerun: yes;"> </span>And as
the official comment to the Restatement (Second) of Torts notes, the learned
intermediary doctrine applies particularly to the medical field and unavoidably
unsafe products like prescription drugs, which, by law, cannot go from the
manufacturer to the end user except through a prescribing physician.<span style="mso-spacerun: yes;"> </span><u>See</u> Restatement (Second) of Torts §
402A cmt. k. <o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
372 S.W.3d 140, 165 (other citation omitted).<span style="mso-spacerun: yes;"> </span>Whatever might be the ultimate outcome of the
design defect debate in Texas (§6(c) or §402A, comment k), it looks to us that
– contrary to <i style="mso-bidi-font-style: normal;">Jenkins</i> – the same
standard will apply to all prescription products.<span style="mso-spacerun: yes;"> </span>There is simply no Texas law, from any Texas
court, to the contrary.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Strike two.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Third, we looked to see what courts in other states
have held when addressing the same question.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Jenkins</i> cited no other law on
this point, but Bexis has it in <a href="http://www.lawcatalog.com/productdetail/15056/affil/?productid=15056&cmp=affil-lc-2011-drug20and20medical" target="_blank"> his book</a>. <span style="mso-spacerun: yes;"> </span>“Almost all courts have extended the
unavoidably unsafe product doctrine to medical devices.”<span style="mso-spacerun: yes;"> </span>Beck & Vale, Drug & Medical Device
Product Liability Deskbook §2.02[2], at 2.02-12 (Supp. 2014).<span style="mso-spacerun: yes;"> </span>The accompanying footnote collects the cases
that support this statement − where courts across the country have applied
comment k to medical devices.<span style="mso-spacerun: yes;"> </span>There are
literally scores of such decisions.<span style="mso-spacerun: yes;">
</span>Rather than list them all, we’re including only the top couple from each
jurisdiction that has decided this question.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Alabama</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Emody
v. Medtronic, Inc</i>., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) (“prescription
medical devices are unavoidably unsafe products, and where inherent risks are
at issue, the only other permissible theory of liability is inadequate warning”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Arizona</u></b>:
<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Gebhardt
v. Mentor Corp.</i>, 191 F.R.D. 180, 185 (D. Ariz. 1999) (applying Restatement
Third §6(c) equally to medical devices), <i style="mso-bidi-font-style: normal;">aff’d
mem.</i>, 15 F. Appx. 540 (9th Cir. 2001); <i style="mso-bidi-font-style: normal;">Conklin
v. Banner Health</i>, 2015 WL 10688305, at *4 (Ariz. Super. Oct. 30, 2015)
(applying comment k equally to medical devices).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Arkansas</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Hill v.
Searle Laboratories</i>, 884 F.2d 1064, 1067-70 (8th Cir. 1989) (applying
comment k equally to intrauterine devices).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>California</u></b>:
<i style="mso-bidi-font-style: normal;">Garrett v. Howmedica Osteonics Corp.</i>,
153 Cal. Rptr.3d 693, 701 (Cal. App. 2013) (“The public interest in the
development, availability and affordability of implanted medical devices
justifies an exemption from design defect strict products liability for all
implanted medical devices that are available only through the services of a
physician.”); <i style="mso-bidi-font-style: normal;">Plenger v. Alza Corp.</i>, 13
Cal. Rptr.2d 811, 818 (Cal. App. 1992) (applying comment k equally to medical
devices; we “are unable to make any principled distinction in terms of policy
considerations between prescription drugs and prescription implanted medical
devices”); <i style="mso-bidi-font-style: normal;">Hufft v. Horowitz</i>, 5 Cal.
Rptr.2d 377, 3823 (Cal. App. 1992) (“the important considerations underlying [comment
k] apply with equal force to implanted medical devices, which like prescription
drugs, are available only through a physician”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Colorado</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Haffner
v. Stryker Corp.</i>, 2014 WL 4821107, at *3 (D. Colo. Sept. 29, 2014) (applying
comment k and Restatement Third §6(c) equally to medical devices; “[p]rescription
medical devices are not the same as ordinary consumer products”); <i style="mso-bidi-font-style: normal;">Wollam v. Wright Medical Group, Inc.</i>,
2012 WL 4510695, at *5 (D. Colo. Sept. 30, 2012) (applying comment k equally to
medical devices).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Connecticut</u></b>:
<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Hurley
v. The Heart Physicians, P.C.</i>, 898 A.2d 777, 784 (Conn. 2006) (“we can see
no principled reason to distinguish between a prescription implantable medical device
like a pacemaker and a prescription drug”); <i style="mso-bidi-font-style: normal;">Breen
v. Synthes-Stratec, Inc.</i>, 947 A.2d 383, 388 (Conn. App. 2008) (“comment (k)
is not limited to prescription drugs but also is applicable to medical devices
such as the plates implanted in the plaintiff’s body”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Florida</u></b>:
<i style="mso-bidi-font-style: normal;">Adams v. G.D. Searle & Co.</i>, 576
So.2d 728, 731-33 (Fla. App. 1991) (applying comment k equally to medical
devices); <i style="mso-bidi-font-style: normal;">Small v. Amgen, Inc.</i>, 134
F. Supp.3d 1358, 2015 WL 5687668, at *10 (M.D. Fla. 2015) (same).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Illinois</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Greenberg
v. Michael Reese Hospital</i>, 415 N.E.2d 390, 394-95 (Ill. 1980) (applying
“public policy” of comment k to a medical device); <i style="mso-bidi-font-style: normal;">Mele v. Howmedica, Inc.</i>, 808 N.E.2d 1026, 1041 (Ill. App. 2004)
(“Comment k . . . provides further support for use of risk-benefit
analysis for evaluating the danger of the medical device defendant made”)
(later overruled on other grounds).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Indiana</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Parks
v. Danek Medical, Inc.</i>, 1999 WL 1129706, at *6 (N.D. Ind. June 17, 1999) (“comment
k has been held to apply to prescription medical devices, as well as to
prescription drugs”).<span style="mso-spacerun: yes;"> </span><u>See also</u>
Ind. Code Ann. §34-20-4-4 (codifying comment k and applying it to all products)<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Kentucky</u></b>:
<i style="mso-bidi-font-style: normal;">Cales v. Medtronic, Inc.</i>, 2014 WL
6600018, at *15 (Ky. Cir. Nov. 21, 2014) (applying comment k equally to medical
devices), <i style="mso-bidi-font-style: normal;">reconsideration denied</i>,
2014 WL 6600018 (Ky. Cir. Nov. 21, 2014); <u>Prather v. Abbott Laboratories</u>,
960 F. Supp.2d 700, 707 (W.D. Ky. 2013) (“[t]he Court does not discern a
meaningful difference between this device and a prescription drug, and does not
believe the framers of comment k would exclude such a product”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Louisiana</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">McPheron
v. Searle Laboratories, Inc.</i>, 888 F.2d 31, 33 (5th Cir. 1989) (rejecting
argument against applying comment k to medical devices; finding “[t]he great
weight of the authority in other jurisdictions is to the contrary”) (later
vacated due to settlement, 904 F.2d 251).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Massachusetts</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Lareau
v. Page</i>, 840 F. Supp. 920, 933 (D. Mass. 1993) (applying comment k equally
to medical device).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Minnesota</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Johnson
v. Zimmer, Inc.</i>, 2004 WL 742038, at *8 n.5 (D. Minn. March 31, 2004)
(applying comment k equally to medical devices).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Missouri</u></b>:
<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Racer
v. Utterman</i>, 629 S.W.2d 387, 393 (Mo. App. 1981) (applying comment k
equally to medical devices); <i style="mso-bidi-font-style: normal;">Joyce v.
Davol, Inc.</i>, 2016 WL 775183, at *2-3 (E.D. Mo. Feb. 29, 2016) (same).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>New
Mexico</u></b>: <span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Perfetti v. McGahn Medical</i>, 662 P.2d 646, 649-50 (N.M. App. 1983)
(rejecting argument against extending comment k to medical devices).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>New York</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Bravman
v. Baxter Healthcare Corp.</i>, 984 F.2d 71, 75-76 (2d Cir. 1993) (district
court was “correct” in considering medical device to be a “unavoidably unsafe”
product under comment k).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Ohio</u></b>:
<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Burwell
v. American Edwards Laboratories</i>, 574 N.E.2d 1094, 1098 (Ohio App. 1989)
(applying “the standard to be applied in cases involving unavoidably unsafe
products” to a medical device).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Oklahoma</u></b>:
<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Edwards
v. Basel Pharmaceuticals</i>, 933 P.2d 298, 300 (Okla. 1997) (applying comment
k equally to medical devices under <i style="mso-bidi-font-style: normal;">Tansy</i>);
<i style="mso-bidi-font-style: normal;">Tansy v. Dacomed Corp.</i>, 890 P.2d 881,
885-86 (Okla. 1994) (rejecting argument against extending comment k to medical
devices; “[m]ost courts which have considered the question have found that
Comment k applies to medical devices”) (collecting cases).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Oregon</u></b>:
<i style="mso-bidi-font-style: normal;">Coursen v. A.H. Robins</i>, 764 F.2d
1329, 1337 (9th Cir. 1985) (applying comment k equally to medical devices), <i style="mso-bidi-font-style: normal;">corrected</i>, 773 F.2d 1049 (9th Cir.
1985); <i style="mso-bidi-font-style: normal;">Allen v. G.D. Searle & Co.</i>,
708 F. Supp. 1142, 1148-49 (D. Or. 1989) (same).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Pennsylvania</u></b>:
<i style="mso-bidi-font-style: normal;">Creazzo v. Medtronic, Inc.</i>, 903 A.2d
24, 30-31 (Pa. Super. 2006) (“We find no reason why the same [comment k] rationale
applicable to prescription drugs may not be applied to medical devices”); <i style="mso-bidi-font-style: normal;">Kee v. Zimmer, Inc.</i>, 871 F. Supp.2d 405,
409 (E.D. Pa. 2012) (“Numerous federal district courts, including this Court,
have predicted that the Pennsylvania Supreme Court would, if faced with the
issue, similarly extend comment k to prescription medical devices.”)
(collecting cases); <i style="mso-bidi-font-style: normal;">Soufflas v. Zimmer,
Inc.</i>, 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007) (same; rejecting attempt
to distinguish medical devices).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>South
Carolina</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Brooks v. Medtronic, Inc.</i>, 750 F.2d 1227, 1230 (4th Cir.
1984) (“Certain products, particularly . . . medical devices, often
cause unwanted side effects despite the fact that they have been carefully
designed and properly manufactured. <span style="mso-spacerun: yes;"> </span>In
section 402A terminology, such products are deemed “unavoidably unsafe”)
(citing comment k); <i style="mso-bidi-font-style: normal;">Correa v. Bon Secours
St. Francis Xavier Hospital, Inc.</i>, 2013 WL 5925733, at *3 (S.C.C.P. April
26, 2013) (courts “appl[y] the unavoidably unsafe doctrine in a variety of
medical contexts including prescription drugs, implantable medical devices,
surgical tools, hospital equipment, and hand-held medical devices”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Tennessee</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Rodriguez
v. Stryker Co.</i>, 680 F.3d 568, 575 (6th Cir. 2012) (affirming dismissal of
strict liability claims against medical device under comment k); <i style="mso-bidi-font-style: normal;">Harwell v. American Medical Systems, Inc.</i>,
803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (dismissing medical device strict
liability claims under comment k; collecting medical device cases).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Utah</u></b>:<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">In re
Wright Medical Technology Inc. Conserve Hip Implant Products Liability
Litigation</i>, 127 F. Supp.3d 1306, 1357 (N.D. Ga. 2015) (applying Utah law) (“The
Court concludes, notwithstanding <i style="mso-bidi-font-style: normal;">Creech</i>,
that Utah state courts would recognize that Comment K’s concern about ensuring
that the social need for medical products is satisfied and would follow other
jurisdictions and apply Comment K to prescribed medical devices that are implanted
in the human body”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<b style="mso-bidi-font-weight: normal;"><u>Washington</u></b>:
<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Terhune
v. A.H. Robins Co.</i>, 577 P.2d 975, 977-80 (Wash. 1978) (adopting comment k
in medical device case; “The principles stated in comment k do not rest upon a
finding or an assumption that all drugs, vaccines or other products obtainable
only through a physician have been tested by the Food and Drug Administration”);
<i style="mso-bidi-font-style: normal;">Payne v. Paugh</i>, 360 P.3d 39, 53
(Wash. App. 2015) (“an unavoidably unsafe product such as a medical device is
incapable of being made completely safe”); <i style="mso-bidi-font-style: normal;">Taylor
v. Intuitive Surgical, Inc.</i>, 355 P.3d 309, 317 (Wash. App. 2015) (“The
presence of the physician as learned intermediary places medical products in a
class of their own, and justifies the “blanket exemption” of comment k;
rejecting attempt to distinguish medical devices), <i style="mso-bidi-font-style: normal;">review granted</i> (Wash. Feb. 9, 2016); <i style="mso-bidi-font-style: normal;">Transue v. Aesthetech Corp.</i>, 341 F.3d 911, 914-15 (9th Cir. 2003)
(“comment k provides an exemption for medical products generally”).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Strike three.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
Only two cases we know of are to the contrary.<span style="mso-spacerun: yes;"> </span>One of them, <i style="mso-bidi-font-style: normal;">Creech v. Stryker Corp.</i>, 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6,
2011), mentioned the issue only in a footnote, and its reasoning was found
wanting in <i style="mso-bidi-font-style: normal;">Wright Medical</i>, cited
above.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See also In re Wright Medical Technology Inc. Conserve Hip Implant
Products Liability Litigation</i>, ___ F. Supp.3d ___, 2016 WL 1367747, at *18
n.17 (N.D. Ga. April 5, 2016) (reiterating rejection of <i style="mso-bidi-font-style: normal;">Creech</i> concerning comment k) (applying Utah law).<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
The second decision, <i style="mso-bidi-font-style: normal;">Larsen v. Pacesetter Systems., Inc.</i>, 837 P.2d 1273 (Haw. 1992),
amended, 843 P.2d 144 (Haw. 1992), held that “we do not believe this [device]
was sufficiently analogous to a new and experimental drug to warrant comment k
exemption from strict products liability.”<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> at 1286.<span style="mso-spacerun: yes;"> </span>While that can be read as a rejection of
comment k to medical devices, it can also be read as specific to the particular
device in question (most of the surrounding discussion involves pacemakers),
and thus as being no more than an oddly phrased application of the case-by-case
approach to comment k generally.<span style="mso-spacerun: yes;">
</span>Certainly, the Hawaii case we blogged about <a href="http://druganddevicelaw.blogspot.com/2016/05/some-case-by-case-comment-k-mixed-with.html" target="_blank">last week</a>, <i style="mso-bidi-font-style: normal;">Segovia v. Bristol-Myers Squibb Co.</i>,
2016 WL 1587220 (D. Haw. April 19, 2016), treated <i style="mso-bidi-font-style: normal;">Larsen</i> as an exemplar of a case-by-case approach to comment k and
applied the same rationale to a drug, <i style="mso-bidi-font-style: normal;">id.</i>
at *4 – which was our major complaint about <i style="mso-bidi-font-style: normal;">Segovia</i>.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *4.<span style="mso-spacerun: yes;"> </span>But even considering <i style="mso-bidi-font-style: normal;">Larsen</i> as an outright rejection of the
application of comment k to medical devices, it remains an extreme outlier.<o:p></o:p></div>
<br />
<div class="BodyText2Justified" style="margin: 0in 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Larsen</i>,
moreover, was a state supreme court.<span style="mso-spacerun: yes;">
</span>Whether we like it or not, a state supreme court has the inherent power
(barring legislation) to interpret that state’s common law in whatever fashion
it desires.<span style="mso-spacerun: yes;"> </span>Whether or not we agree with
the result, we have no doubt of such a court’s authority to reach it.<span style="mso-spacerun: yes;"> </span>The same is not true of a federal district
court.<span style="mso-spacerun: yes;"> </span>As we have pointed out many times
before, in the posts under our <a href="http://druganddevicelaw.blogspot.com/search/label/Erie%20Doctrine" target="_blank">Erie Doctrine</a> topic heading, a federal court
sitting in diversity is not supposed to make novel predictions of state law
that expand tort liability.<span style="mso-spacerun: yes;"> </span>That
violates the state sovereignty assured by our federal system.<span style="mso-spacerun: yes;"> </span>This principle is as true in the Fourth
Circuit as it is in any other federal circuit.<o:p></o:p></div>
<br />
<div class="BlockTextWide" style="margin: 0in 0.5in 12pt;">
[O]ur role in the exercise of our diversity jurisdiction
is limited. <span style="mso-spacerun: yes;"> </span>A federal court acting under
its diversity jurisdiction should respond conservatively when asked to discern
governing principles of state law. <span style="mso-spacerun: yes;"> </span>Therefore,
in a diversity case, a federal court should not interpret state law in a manner
that may appear desirable to the federal court, but has not been approved by
the state whose law is at issue. <span style="mso-spacerun: yes;"> </span>Mindful
of this principle, we decline the plaintiffs’ invitation to predict that the [relevant
state high court] would adopt the specific provisions of the Restatement
advanced by the plaintiffs.<o:p></o:p></div>
<br />
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Rhodes v. E.I.
du Pont de Nemours & Co.</i>, 636 F.3d 88, 96 (4th Cir. 2011) (citing <i style="mso-bidi-font-style: normal;">Day & Zimmermann, Inc. v. Challoner</i>,
423 U.S. 3, 4 (1975)).</div>
<div class="BodyTextUndent1" style="margin: 0in 0in 0pt;">
<o:p></o:p> </div>
<span style="font-family: "times new roman" , serif; font-size: 12pt;">For
all of these reasons, we respectfully dissent from the result in <i style="mso-bidi-font-style: normal;">Jenkins</i>.<span style="mso-spacerun: yes;">
</span>We know of no basis for predicting that the Texas Supreme Court would
apply Restatement §402A, comment k any differently to prescription medical
devices than Texas courts have routinely applied it to prescription drugs over
the past four decades.</span>Michelle Yearyhttp://www.blogger.com/profile/00994598841153573554noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-58865928032434709702016-05-05T17:26:00.001-04:002016-05-05T17:26:41.223-04:00Court Says Auf Wiedersehen To Plaintiffs Under Forum Non Conveniens
<br />
<div style="margin: 0in 0in 12pt;">
We generally file motions to dismiss for forum non
conveniens under one of two circumstances.<span style="mso-spacerun: yes;">
</span>Most often we are resisting blatant forum shopping—plaintiffs who try to
import their claims into a forum that they view as favorable, but with which
neither they nor their claims bear any arguable relationship.<span style="mso-spacerun: yes;"> </span>Plaintiffs’ lawyers often do this as part and
parcel of inventory litigation, where they combine multiple claimants into mass
complaints and file them in places like California or Illinois.<span style="mso-spacerun: yes;"> </span>Maybe there are one or two Californians or
Illinois residents among the masses, but everyone else is just tagging along.<span style="mso-spacerun: yes;"> </span>You would think that judges would react
poorly to this imposition on their courtrooms and state taxpayers, but it does
not always work that way.<span style="mso-spacerun: yes;"> </span>Some grant our
motions and send the carpetbaggers home, but others see no harm in presiding
over dozens or hundreds of claims involving similar products, even though the
claims themselves (usually personal injury claims) all require individual
adjudication.<span style="mso-spacerun: yes;"> </span>Post-<i style="mso-bidi-font-style: normal;">Bauman</i>, challenges to personal jurisdiction have packed more punch
in thinning out such “mass” complaints. </div>
<div style="margin: 0in 0in 12pt;">
The other circumstance under which we generally file forum
non conveniens motions is when the forum shopping is not so blatant, but there
is an alternate forum that is both more appropriate for the plaintiff’s claims
and more advantageous for our clients.<span style="mso-spacerun: yes;">
</span>An example is a foreign plaintiff suing a U.S. company in the company’s
home forum.<span style="mso-spacerun: yes;"> </span>In that case, the plaintiff
can certainly gain jurisdiction over the defendant in the defendant’s home
forum, but is that the best forum in which to conduct the case?<span style="mso-spacerun: yes;"> </span>The answer was “no” in a recent order from
the Northern District of California, <i style="mso-bidi-font-style: normal;">Kleiner
v. Spinal Kinetics, Inc.</i>, No 5:15-cv-02179, 2016 WL 1565544 (N.D. Cal. Apr.
19, 2016).<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">Kleiner</i>, the German plaintiffs alleged injuries that they
attributed to spinal implants that were designed and manufactured in
California.<span style="mso-spacerun: yes;"> </span>However, the devices were sold
by the defendant’s German subsidiary; the devices were implanted in Germany;
the plaintiffs suffered their alleged injuries in Germany; and they were treated
for their alleged injuries in Germany by German doctors.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *1.<span style="mso-spacerun: yes;"> </span>They sued in California, and it
is no mystery why:<span style="mso-spacerun: yes;"> </span>Their attorneys
perceived it as a more favorable forum, including through the potential recovery
of punitive damages.<span style="mso-spacerun: yes;"> </span>German law, by
contrast, does not permit punitive damages.<span style="mso-spacerun: yes;">
</span></div>
<div style="margin: 0in 0in 12pt;">
The defendant moved to dismiss the case on the basis or
forum non conveniens.<span style="mso-spacerun: yes;"> </span>It might seem odd
that a defendant would assert that its home state is an inconvenient forum, but
it depends on the facts of the case, and there are a number of prominent authorities
supporting such a motion.<span style="mso-spacerun: yes;"> </span>The case we
always cite in California is <i style="mso-bidi-font-style: normal;">Stangvik v.
Shiley</i>, 54 Cal. 3d 744 (1991), where Swedish and Norwegian plaintiffs sued
a California-based medical device manufacturer in California, and the
California Supreme Court sent them back to Scandinavia.<span style="mso-spacerun: yes;"> </span>At the federal level, the case you will want
to review is <i style="mso-bidi-font-style: normal;">Piper Aircraft Co. v. Reyno</i>,
454 U.S. 235 (1981), where the U.S. Supreme Court held that Scottish plaintiffs
could not proceed with their lawsuit against a plane manufacturer in
Pennsylvania, even though the plane was manufactured there.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
Because of precedents like these, the defendant’s motion in
<i style="mso-bidi-font-style: normal;">Kleiner</i> was a strong motion, and the
district court agreed.<span style="mso-spacerun: yes;"> </span>The court
determined first that there was a suitable alternative forum—Germany.<span style="mso-spacerun: yes;"> </span>Sure, the German courts are not the same as
federal court in California, and they may not even be as good.<span style="mso-spacerun: yes;"> </span>Some would say the German courts are
better.<span style="mso-spacerun: yes;"> </span>It really doesn’t matter,
because an alternate forum is adequate if the forum’s laws do not “completely
deprive” the plaintiff of a remedy.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at **2-3.<span style="mso-spacerun: yes;"> </span>Whether imperfect or superior or something in
between, the German forum cleared this low bar. </div>
<div style="margin: 0in 0in 12pt;">
The more interesting part is the district court’s treatment
of the private and public interest factors that courts weigh in determining which
forum is more suitable.<span style="mso-spacerun: yes;"> </span>On the private
interest factors, we appreciate how the district court focused on the locale of
the plaintiffs’ treatment and its impact on the evidence.<span style="mso-spacerun: yes;"> </span>As the court observed, “The surgeons, by
virtue of their role in implanting and subsequently removing Defendant’s
products from Plaintiffs, possess substantial material information regarding
the cause and extent of the Plaintiffs’ injuries.<span style="mso-spacerun: yes;"> </span>Likewise the treating physicians possess
material information regarding the extent of Plaintiffs’ injuries and the
effect of their treatment.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *4.<span style="mso-spacerun: yes;"> </span>This is exactly the right place for the
analysis to start.<span style="mso-spacerun: yes;"> </span>These are critical
witnesses, and their presence outside the subpoena power of the California-based
court was a significant problem.<span style="mso-spacerun: yes;"> </span>The
court also noted that the plaintiff’s claims arose in Germany and that the
plaintiff’s choice of forum was “entitled to less deference” because they
resided outside their chosen forum.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *5.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
The private interest factors thus weighed in favor of
Germany, and so did the public interest factors.<span style="mso-spacerun: yes;"> </span>Germany had a significant local interest in
the controversy because the plaintiffs “are residents of Germany, underwent
their respective implantation operations in Germany, and suffered similar
injuries there.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *6.<span style="mso-spacerun: yes;"> </span>California’s
interest?<span style="mso-spacerun: yes;"> </span>It was “identifiable, albeit
tenuous.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>Similarly, Germany’s
interest in applying its laws (including the lack of punitive damages) “far
outweighs the interest of California,” because while the product was designed
and manufactured in California, that fact alone was insufficient to apply
California law. <span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *7.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
The order came with conditions, which they always do.<span style="mso-spacerun: yes;"> </span>The defendant has to submit to the
jurisdiction of the German courts and satisfy any judgment obtained in Germany,
and it has to produce employee witnesses for discovery and trial.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at **7-8.<span style="mso-spacerun: yes;"> </span>We are sure the defendant can
live with that, and although we have not read its motion, we are equally sure
that the defendant suggested those conditions to help the court reach the
desired and correct result.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
We will reiterate that the district court’s focus on the
plaintiff-specific evidence, and particularly on evidence regarding the
plaintiffs’ surgery and other medical treatment, is the story of this
case.<span style="mso-spacerun: yes;"> </span>The plaintiffs surely emphasized
the evidence in California regarding the design, manufacture, and sale of the
produce, but in the final analysis the balance tipped to Germany.<span style="mso-spacerun: yes;"> </span>We commend the order to our readers, who
likely will handle similar disputes.<span style="mso-spacerun: yes;"> </span></div>
Anonymousnoreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-87659619168796609862016-05-04T12:26:00.000-04:002016-05-05T06:33:38.566-04:00Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>In Hawaii,
from whence today’s case comes, tourists are encouraged to try poi, mashed up
taro root, which looks like purple wallpaper paste and tastes like, well,
purple wallpaper paste.<span style="mso-spacerun: yes;"> </span>The term is also
used as a friendly descriptor of ethnically ambiguous looking people, whose
roots have been mashed together to form something not readily identifiable by
traditional visual stereotypes.<span style="mso-spacerun: yes;"> </span>(At
least it seemed friendly when we heard it applied to our own offspring.)<span style="mso-spacerun: yes;"> </span>Personally, we think it is a nice concept and
the less that categorizing people to determine their rights, opportunities, and
expectations happens, the better.<span style="mso-spacerun: yes;"> </span>For a
number of aspects of product liability law, however, the decision on whether to
proceed categorically or case-by-case is still hotly contested.<span style="mso-spacerun: yes;"> </span>This is particularly true for comment k to
the Restatement (Second) of Torts, <span style="mso-bidi-font-family: "Times New Roman";">§</span>
402A, which forms the meat of the decision in <i style="mso-bidi-font-style: normal;">Segovia v. Bristol-Myers Squibb Co.</i>, CV. No. 15-00519 DKW-RLP, 2016
U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016).</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">Segovia </i>involves a fatal hemorrhagic
stroke with an anticoagulant prescribed and used for atrial fibrillation.<span style="mso-spacerun: yes;"> </span>We are not sure what was different from the
first complaint, but the second try made vague allegations about
misrepresentations to FDA and others that it was “tested and found to be safe
and effective for its indicated uses” and that FDA and others had not been told
of the drug’s “defects” in support of allegations of strict liability and
negligent failure to warn and design defect theories.<span style="mso-spacerun: yes;"> </span>While it seems like this complaint asserted
claims based on non-existent duties and clearly preempted claims, the only
issues addressed by the court on the motion to dismiss were whether Hawaii law
took comment k to preclude design defect claims for all prescription drugs
categorically and whether any fraud-based claims had been pleaded with
sufficient particularity.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>As to the
first question, the court did not look to our relatively <a href="http://druganddevicelaw.blogspot.com/2016/04/comment-k-case-by-case-falling-out-of.html" target="_blank">recent discussions</a> on
<a href="http://druganddevicelaw.blogspot.com/2011/04/comment-k-some-of-way.html" target="_blank">this issue</a>, but generally looked to older cases to find the public policy rationale for
taking a case-by-case approach for prescription drugs—which was essentially
determinative on a motion to dismiss.<span style="mso-spacerun: yes;">
</span>But we are getting ahead of ourselves.<span style="mso-spacerun: yes;">
</span>The first step was determining what Hawaii case law already said about
comment k and only two cases were discussed.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Larsen v. Pacesetter Sys., Inc.</i>,
837 P.2d 1273, 1286 (Haw. 1992), involved a pacemaker—not a drug—and concluded
that summary judgment based on comment k was inappropriate where there was
evidence that the “pacemaker was demonstrably capable of being made safe for
its intended use.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Forsyth v. Eli Lilly & Co.</i>, 1998 WL 35152135, **3-4 (D. Haw.
Jan. 5, 1998), involved a prescription drug, but did not decide the issue of
categorical or case-by-case because a genuine issue as to the adequacy of
warnings was sufficient to preclude summary judgment.<span style="mso-spacerun: yes;"> </span>Rather than view these cases are leaving the
issue open, the <i style="mso-bidi-font-style: normal;">Segovia</i> court found
“neither <i style="mso-bidi-font-style: normal;">Larsen</i> nor <i style="mso-bidi-font-style: normal;">Forsythe</i> create a blanket rule of design
defect immunity for pharmaceutical manufacturers, and the Court declines to
extend comment k in a fashion that the Hawaii courts themselves have thus far
declined to do.”<span style="mso-spacerun: yes;"> </span>2016 U.S. Dist. LEXIS
52405, *11.<span style="mso-spacerun: yes;"> </span>We think this misconstrues
comment k, which does not provide “immunity,” and what it means to conclude
that all prescription drugs are “unavoidably unsafe.”</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Comment k
is a comment to the formulation of what a plaintiff needs to prove to establish
design defect liability for a claim of injury with a product because it
explains how those requirements would work for certain types of products.<span style="mso-spacerun: yes;"> </span>It is not set up as an immunity.<span style="mso-spacerun: yes;"> </span>It is not really set up as an affirmative
defense, although <i style="mso-bidi-font-style: normal;">Segovia</i> and some of
the cases it cites take it as such.<span style="mso-spacerun: yes;"> </span>Take
<i style="mso-bidi-font-style: normal;">Segovia</i>’s description of the general
Hawaii strict liability law and its only mention of burden:</div>
<br />
<div style="margin: 6pt 0.5in 0pt; text-align: justify;">
<span style="mso-bidi-font-family: Courier; mso-fareast-font-family: Courier;">Under
Hawaii law, a plaintiff's burden with respect to a claim of strict product
liability “is to prove (1) a defect in the product which rendered it
unreasonably dangerous for its intended or reasonably foreseeable use; and (2)
a causal connection between the defect and the plaintiff's injuries.”<span style="mso-spacerun: yes;"> </span>A product may be defective because it was
defectively designed or carried an insufficient warning.</span></div>
<br />
<div style="margin: 6pt 0in 0pt; tab-stops: 6.5in;">
<i style="mso-bidi-font-style: normal;">Id.</i> at *5 (citations omitted).<span style="mso-spacerun: yes;"> </span>If the dangers of a product cannot be avoided
by adjusting its design—“incapable of being made safe for their intended and
ordinary use,” per comment k—then the design cannot be said to make the product
“unreasonably dangerous for its intended or reasonably foreseeable use.”<span style="mso-spacerun: yes;"> </span>The only way the manufacturer can make the
product less dangerous is by providing warnings.<span style="mso-spacerun: yes;"> </span>In this way, it makes sense to say the
plaintiff must prove that the warnings were inadequate as to the danger that
allegedly befell that her to establish liability (absent a manufacturing
defect).<span style="mso-spacerun: yes;"> </span>It does not make sense to
impose liability for injuries that result from adequately warned of risks that
the “present state of human knowledge” cannot avoid by altering the design of
the product.<span style="mso-spacerun: yes;"> </span>For prescription drugs, we
have said many times, like <a href="http://druganddevicelaw.blogspot.com/2016/01/the-saga-of-preempting-prescription.html" target="_blank">here</a>, that liability for prescription drug manufacturers should turn on the
adequacy of the warnings, or the plaintiff’s proof that they were
inadequate.<span style="mso-spacerun: yes;"> </span>Viewing comment k as a route
to “blanket immunity” loses sight of what the plaintiff has to prove.</div>
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</div>
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<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">Segovia</i> reinforced its view that it was
best to take a case-by-case approach with prescription drugs based on its interpretation
of the word “many” in comment k’s language after the example of why a rabies
vaccine is unavoidably unsafe:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The same is true of <i style="mso-bidi-font-style: normal;">many</i>
other drugs, vaccines, and the like, many of which for this very reason cannot
legally be sold except to physicians, or under the prescription of a physician.
<span style="mso-spacerun: yes;"> </span>It is also true in particular of <i style="mso-bidi-font-style: normal;">many</i> new or experimental drugs as to
which, because of lack of time and opportunity for sufficient medical
experience, there can be no assurance of safety, or perhaps even of purity of
ingredients, but such experience as there is justifies the marketing and use of
the drug notwithstanding a medically recognizable risk.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at **6-7
(emphasis added).<span style="mso-spacerun: yes;"> </span>By using “many other
drugs” and “many new and experimental drugs” instead of “all prescription
drugs,” “the clear language of the comment indicates that it is to apply to
only some products.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *11.<span style="mso-spacerun: yes;"> </span>Drawing on the generally older cases
endorsing a case-by-case approach rather than the generally newer cases
endorsing a categorical application of comment k to prescription drugs, the
court found “[t]he better reasoned view is that courts should determine on a
case-by-case basis whether a product is within the scope of comment k -- that
is, examining cost, risk, safety and policy considerations, among others, to
determine whether it is an ‘unavoidably unsafe’ product.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *12.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>At this
point, the decision should have looked to see whether plaintiffs’ second
complaint included sufficient factual allegations to satisfy the standards for
design defect under Hawaii law.<span style="mso-spacerun: yes;"> </span>Instead,
it merely determined that it could not determine on the pleadings whether the
anticoagulant was an “unavoidably unsafe” product, hinting that this would be
more appropriate for summary judgment.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *13.<span style="mso-spacerun: yes;"> </span>Not having read the complaint or examined the
merits of the claims, we can still engage in some speculation about whether the
design defect claim surviving a motion to dismiss should have been a foregone
conclusion.<span style="mso-spacerun: yes;"> </span>After all, this was a “blood
thinner” with the intended use of inhibiting clotting—that is, “thinning the
blood”—to reduce the risk of ischemic strokes in patients with atrial
fibrillation.<span style="mso-spacerun: yes;"> </span>The plaintiffs claim the
decedent had a hemorrhagic stroke, which is a well-known risk of every blood
thinner.<span style="mso-spacerun: yes;"> </span>The risk of ischemic stroke
with untreated atrial fibrillation so greatly exceeds the risk of hemorrhagic
stroke on a blood thinner that anticoagulation has been the standard of care
non-surgical option in such patients for decades.<span style="mso-spacerun: yes;"> </span>We wonder what factual allegations could have
been made to make plausible that the drug’s risk of hemorrhagic stroke was
unreasonable and due to an aspect of its design that could have been changed
without compromising efficacy.<span style="mso-spacerun: yes;"> </span>Whatever
they were, they surely walk straight into a wall of preemption, but that will
be for another day.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See, e.g.,</i> <i style="mso-bidi-font-style: normal;">Mut. Pharm. Co. v.
Bartlett</i>, 133 S. Ct. 2466, 2475 (2013) (“[T]he altered chemical would be a
new drug that would require its own NDA to be marketed in interstate commerce.”)</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>By
contrast, the court stood firm in applying the heightened pleading requirements
for fraud under Fed. R. Civ. P 9(b).<span style="mso-spacerun: yes;"> </span>It
is not clear how any of these allegations fit into the plaintiffs’ failure to
warn claims or if they were just thrown in as a way of getting to punitive
damages, but plaintiffs included a typically liberally sprinkling of
allegations of fraud by representation or omission on the decedent, the public,
physicians, FDA, and unspecified others.<span style="mso-spacerun: yes;">
</span>“Plaintiffs do not sufficiently plead the date(s) or location(s) of each
instance of the alleged fraudulent conduct, or the person(s) making the alleged
misrepresentation.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *15.<span style="mso-spacerun: yes;"> </span>Although the
court gave plaintiffs a chance at a third strike on these allegations, it did
give warning that they had to specify “which statements are alleged to have
been made fraudulently, and which negligently,” without being allowed to make
these assertions in the alternative. <span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> <span style="mso-spacerun: yes;"> </span>Until they complied, their claim for punitive
damages, which was predicated on allegations of fraud, would be out—categorically.</div>
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Eric Alexanderhttp://www.blogger.com/profile/01766054899255569417noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-80726323404458535682016-05-03T07:30:00.000-04:002016-05-03T07:30:02.536-04:00Texas Federal Court Says Device Manufacturer is not a Health Care Provider, but also not a Seller<br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">Sometimes it takes us a while to catch on to things.
This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first
two albums, <strong>Greetings from Asbury Park</strong> and <strong>The Wild, The Innocent, and The E
Street Shuffle</strong>, we would not commit until after the release of <strong>Born to Run</strong>,
by which time Bruuuuuuuce had become a national phenomenon. For years
we saw shaved kale salad on menus and passed it by, thinking that we probably
did not like kale and definitely did not like shaving, so why bother? Now
it is our go-to appetizer for when we want to feel vaguely virtuous. We
were late adopters of on-line banking, Apple Pay, and Twitter. Our garage
will surely be the last in the neighborhood with a hybrid powered car, a
self-driving car, or a flying car. On the way back from visiting the Drug
And Device Law Son in Moscow, the British Airways entertainment offerings
included season 2 of <strong>Catastrophe</strong>, an Anglo-American miracle of fun and filthy
television comedy. Now we are queuing up season one on Amazon
Prime. We are complete-ists, even backwards, if nothing else.
Better late than never, right?</span></div>
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<span style="font-family: "calibri"; font-size: large;">Today we are taking a look at an old case (two and a
half-years old, but turning up in our topic searches just now). The case
is called <em>Meredith v. Nuvasive, Inc</em>., 2013 U.S. 190130 (W.D. Texas Dec. 9,
2013). The plaintiff in <em>Meredith</em> alleged injuries from malfunction of a
neuromonitoring device during spinal surgery. Her claims were for
manufacturing defect, breach of implied warranties, negligence, gross
negligence, and <em>res ipsa loquitur</em>. There is nothing especially unusual in
any of that. But here is the man-bites-dog aspect of the case: the
product liability plaintiff moved for summary judgment against two relatively
unusual defenses, the manufacturer defendant as a “health care provider” under
the Texas malpractice statute, and lack of any sale of a medical device
precluding warranty claims. </span></div>
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<span style="font-family: "calibri";"><span style="font-size: large;">For those of you in need of an executive summary, know
this: The plaintiff in <em>Meredith</em> went one for two. (1) The court held that a
device manufacturer was not a health care provider under the relevant medical
malpractice statute. (2) Because the device was simply used in the
hospital, and not sold to the plaintiff or anyone else, the defendant had a real
shot at picking off the warranty claims.</span> </span></div>
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</div>
<br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">Maybe it is because doctors have a powerful lobby, or
because they are so gosh-darned popular, but actions against doctors are
typically subject to restrictions that other defendants wish they could
enjoy. The Texas Medical Liability Act (TMLA) imposes a cap on damages,
and the defendant tried to invoke that cap here. The TMLA applies to
"health care liability claims" and “health care providers.”
In <em>Meredith</em>, the defendant argued that its employee, who was in the operating
room, was functioning as an independent contractor for the hospital. So
this is an unusual case where the sales rep's presence in the operating room
was possibly a good fact for the defense. In the alternative, the defendant
argued that it was an "Affiliate" of the hospital, which would bring
it within the sweet embrace of the TMLA. The court rejected both of those
arguments. The manufacturer's employee had no contractual relationship
with the hospital. It is not as if he had the sort of privileges that a
doctor has. The hospital's willingness to provide access to the employee
"subject to certain conditions does not fundamentally alter the
relationship of the parties." Nor did the hospital control the
manufacturer in the sense required to make it an affiliate. Thus, the
court held that the defendant could not avail itself of the TMLA. (Since
the <em>Meredith</em> case was decided, the issue has come up in other Texas
cases. Bexis discussed one of those cases, and hypothesized about what it
would take for a manufacturer defendant to benefit from the TMLA’s provisions,
<a href="http://druganddevicelaw.blogspot.com/2015/11/medical-device-manufacturers-as-health.html">here</a>. It is possible that Bexis was a wee bit optimistic.) </span></div>
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<span style="font-family: "calibri"; font-size: large;">The plaintiff’s summary judgment motion against the warranty
lack-of-sale defense was less successful. That is, it was unsuccessful.
That is, the defendant was successful. The simple fact was that the
product that allegedly malfunctioned had not been sold or leased to the
hospital, surgeon, or the plaintiff. The plaintiff argued that
there was Texas authority loosening up the privity requirement. Maybe so,
but any such authority still involved a product that had been sold to someone,
even if not the plaintiff. Not so here. The defendant's defense
against the warranty claim would live to fight another day. </span></div>
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<span style="font-family: "calibri"; font-size: large;">Of course, because the rulings in <em>Meredith</em> were on a summary judgment
motion by a plaintiff, rather than a defendant, we do not have anything close
to a definitive ruling on whether the plaintiff's claims are truly viable. But
it is interesting to see what the court did with those defenses, and it is
interesting (and a bit unnerving) to see a plaintiff muster the energy and
creativity to file a motion for summary judgment. </span></div>
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Steve McConnellhttp://www.blogger.com/profile/14959081465420761870noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-4612477049996441382016-05-02T17:00:00.000-04:002016-05-02T17:00:04.025-04:00Not Hooked on a Feeling, the Eleventh Circuit Upholds Exclusion of Expert
In <i style="mso-bidi-font-style: normal;">Witt v. Stryker
Corp.</i>, 2016 WL 1583816 (11<sup>th</sup> Cir. Apr. 20, 2016), a Daubert
decision in a Stryker knee replacement case, even <i style="mso-bidi-font-style: normal;">ipse dixit</i> seemed a bit generous.<span style="mso-spacerun: yes;">
</span>Roughly translated, <i style="mso-bidi-font-style: normal;">ipse dixit </i>means
“he himself said it.”<span style="mso-spacerun: yes;"> </span>But it’s not clear
that the expert in <i style="mso-bidi-font-style: normal;">Witt </i>said “it.” <span style="mso-spacerun: yes;"> </span>His report didn’t seem to venture an opinion
at all, no less one that came from applying a scientific process to true
and accurate data.<span style="mso-spacerun: yes;"> </span>It offered a feeling,
seemingly a timid one hoping not to be noticed: “I <i style="mso-bidi-font-style: normal;">feel</i> that the mechanical failure of the EIUS [the knee replacement
system] Stryker components was the competent producing cause for the need for
surgery on 04/17/2009 and for a revision arthroplasty to a total knee
replacement.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *5 (emphasis added).<span style="mso-spacerun: yes;"> </span>In
case you thought this was just careless terminology, he did it again:<span style="mso-spacerun: yes;"> </span>“I <i style="mso-bidi-font-style: normal;">feel</i> that the mechanical failure of the EIUS System installed on
04/18/2008 was a competent cause for the need for subsequent surgeries on 03/30/2011
and on 01/17/2012.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> (emphasis added).<span style="mso-spacerun: yes;"> </span><br />
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
We haven’t studied the case law on feelings.<span style="mso-spacerun: yes;"> </span>But we are confident that, if it exists, it
won’t be favorable to this expert.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
Things grew more timid from there. At has deposition, it wasn’t even clear what the expert was
feeling:</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
Indeed, <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">he explicitly disclaimed having
any expert opinion about why</i></b> the EIUS design was defective. <span style="mso-spacerun: yes;"> </span>Besides broadly referencing the likelihood
that the device suffered some mechanical failure, Dr. Lubliner <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">offered
no explanation for why the defect was one of design and not of manufacture</i></b>.</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> (emphasis
added).<span style="mso-spacerun: yes;"> </span>Oof.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Daubert </i>didn’t ever
have to be written for us to know how the Eleventh Circuit was going to rule on
this one.<span style="mso-spacerun: yes;"> </span>Finding his opinion, to say
the least, undeveloped and unreliable, it upheld the trial court’s exclusion of
the expert:</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt 0.5in;">
Plainly, his sparse report and
subsequent deposition do not explain how the looseness of the device is related
to the failure of its mechanical operation, nor did the expert report so much
as consider any alternative explanation. <span style="mso-spacerun: yes;"> </span>Because Dr. Lubliner’s opinion regarding
Witt’s EIUS device could reasonably be termed undeveloped and unreliable, the
decision to exclude his testimony fell well within the district court’s
exercise of discretion as a gatekeeper.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
<i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>Seeing no viable causation expert, the
Eleventh Circuit then upheld the trial court’s grant of summary judgment to the
defendant.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *7</div>
<div class="MsoBodyText" style="margin: 12pt 0in 0pt;">
The Eleventh Circuit issued two other
rulings.<span style="mso-spacerun: yes;"> </span>It upheld the trial court’s refusal
to allow plaintiff to amend her complaint a third time to add a failure to warn
claim based on studies published two years after the device was implanted in
plaintiff.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *3.<span style="mso-spacerun: yes;"> We certainly understand that ruling. </span>The Court also upheld
the trial court’s decision not to further extend the discovery deadline to
allow more time for expert discovery.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *4. <span style="mso-spacerun: yes;"> </span>Given the expert opinion that we saw, we had a
feeling that would happen too.<span style="mso-spacerun: yes;"> </span></div>
John J. Sullivanhttp://www.blogger.com/profile/01479637903241019239noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-5796884990961450022016-04-29T11:56:00.000-04:002016-04-29T11:56:08.619-04:00Preemption: Oregon Has Not Gone Bananas
<br />
<div style="margin: 0in 0in 12pt;">
Can you get sued over a picture of a banana?<span style="mso-spacerun: yes;"> </span>It seems the answer might depend on where you
live and probably not in Oregon.<span style="mso-spacerun: yes;"> </span>That is
one takeaway from a good preemption case that came out of the District of
Oregon last week, <i style="mso-bidi-font-style: normal;">Henry v. Gerber
Products Co.</i>, No. 3:15-cv-02201, 2016 U.S. Dist. LEXIS (D. Or. Apr. 18,
2016).<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">Henry</i>, a concerned mother sued because the baby “Puffs” she
purchased depicted a banana on the label, but contained only “natural banana
flavor.”<span style="mso-spacerun: yes;"> </span>Not actual bananas.<span style="mso-spacerun: yes;"> </span>Never mind that label stated the product’s
ingredients truthfully and clearly in black and white.<span style="mso-spacerun: yes;"> </span>Never mind that if a parent wants his or her
toddler to snack on bananas, he or she could purchase, you know, bananas.<span style="mso-spacerun: yes;"> </span>For whatever reason, this parent preferred
banana puffs, with bright yellow bananas on the label.<span style="mso-spacerun: yes;"> </span>And it resulted in a federal lawsuit.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
How did we get here?<span style="mso-spacerun: yes;">
</span>Like most every other state, Oregon has an Unfair Trade Practices Act
that prohibits product sellers from representing that their products have
“particular characteristics, ingredients, benefits, or qualities that they do
not have.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See</i> Or. Rev. Stat. <span style="mso-bidi-font-family: "Times New Roman";">§</span>
646.608(1)(e).<span style="mso-spacerun: yes;"> </span>A right and just law when
applied properly, to be sure.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
It becomes interesting, however, when talking about food
because federal law is extraordinarily specific in regulating food labels.<span style="mso-spacerun: yes;"> </span>Surely you read our <a href="http://druganddevicelaw.blogspot.com/2015/09/guest-post-sweet-smell-of-preemption.html">guest post</a> on the FDA’s
regulation of non-functional slack-fill (whatever that is) and its impact on
product packaging.<span style="mso-spacerun: yes;"> </span>Or our <a href="http://druganddevicelaw.blogspot.com/2015/01/preemption-how-do-you-define-water.html">post</a> on food “standards of
identity” which dictate what food sellers can and cannot call their products.<span style="mso-spacerun: yes;"> </span>You probably also knew that a food label’s
Nutrition Facts have to appear in a certain place on the package, unless the
package has less than 40 square inches of surface area, except when the
packaging includes a cellophane window, which does not count as available surface
area, unless the window is itself used as a label (such as with a sticker), in
which case the window <i style="mso-bidi-font-style: normal;">does</i> count as
available surface area, and provided that the manufacturer has not applied for
special allowance to affix something to the packaging that might obscure the
Facts, such as a straw.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See</i> 21 C.F.R. <span style="mso-bidi-font-family: "Times New Roman";">§ </span>101.9.<span style="mso-spacerun: yes;"> </span>You
get the idea—the FDA has put a lot of thought into the uniform regulation of
food labels.</div>
<div style="margin: 0in 0in 12pt;">
The tie in to drugs and medical devices is <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">preemption</i></b>.<span style="mso-spacerun: yes;"> </span>The Nutrition Labeling and Education Act
gives the FDA authority to oversee food labeling, and the statute has an <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">express
preemption clause</i></b> that forbids states from establishing any requirement
that “<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">is not identical to</i></b>” the federal requirements in five areas of
food labeling, including labeling on ingredients and flavorings.<span style="mso-spacerun: yes;"> </span>21 U.S.C. <span style="mso-bidi-font-family: "Times New Roman";">§</span> 343-1(a)(2) & (3).<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">Henry</i>,
the plaintiff alleged that the banana puff manufacturer led customers to
believe that the puffs actually contained “the prominently depicted fruits,” <i style="mso-bidi-font-style: normal;">e.g</i>., bananas, which allegedly violated
Oregon’s UTPA.<span style="mso-spacerun: yes;"> </span>2016 U.S. Dist. Lexis
52638, at *18.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
But, as it turns out, the FDA’s regulations provide that it
is perfectly okay to represent a food’s flavor with a picture of a fruit, even
where the food contains only “natural flavor” and not the actual fruit.<span style="mso-spacerun: yes;"> </span>The manufacturer just has to say so on the
label in a mind-bogglingly particular way.<span style="mso-spacerun: yes;">
</span>(We won’t quote the regulation here; you’ll have to read the opinion to
get its flavor, but trust us, its detail is exceptional.)<span style="mso-spacerun: yes;"> </span>The banana puffs manufacturer complied to a
tee, which led it to argue justifiably that the plaintiff’s Oregon law claims
sought to impose requirements that were “<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">not identical to</i></b>” federal
requirements.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at **12-13.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
That means federal preemption, and the district court
agreed:<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The gravamen of Henry’s complaint is that “[the manufacturer’s]
marketing and labeling of Puffs lead consumer to believe that Puff’s <i style="mso-bidi-font-style: normal;">actually contain</i> the prominently
depicted fruits or vegetables for which each variety is named.”</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
. . . .</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
[However, the] law, as applied to the situation presented to
this Court, is clear:<span style="mso-spacerun: yes;"> </span>“FDA regulations
permit illustrations of fruit on product labels to indicate that product’s
‘characterizing flavor,’ even where the product contains no ingredients derived
from the depicted fruit.”<span style="mso-spacerun: yes;"> </span>[<span style="mso-bidi-font-family: "Times New Roman";">¶</span>]<span style="mso-spacerun: yes;"> </span>Henry’s state law claims under the UTPA are,
therefore preempted.<span style="mso-spacerun: yes;"> </span></div>
<br />
<div style="margin: 0in 0in 12pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at **18-19
(citations omitted).<span style="mso-spacerun: yes;"> </span>This is a pretty
straightforward application of express preemption, but there are two points
that we think make this order particularly interesting.<span style="mso-spacerun: yes;"> </span></div>
<div style="margin: 0in 0in 12pt;">
First, in its discussion of preemption law, the district
court invoked the “presumption against preemption,” under which it would “start
with the assumption that the historic police powers of the State were not to be
superseded by [federal law] unless that was the clear and manifest purpose of
Congress.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *13 (citing <i style="mso-bidi-font-style: normal;">Medtronic
v. Lohr</i>, 518 U.S. 470 (1996)).<span style="mso-spacerun: yes;"> </span>Don’t
get Bexis started on the presumption against preemption.<span style="mso-spacerun: yes;"> </span>(<i style="mso-bidi-font-style: normal;">See</i>,
for example, <a href="http://druganddevicelaw.blogspot.com/2015/04/is-presumption-against-preemption-dead.html">here</a>)<span style="mso-spacerun: yes;"> </span>The presumption (or assumption) is a
false concept, a makeweight invoked when consistent with a no-preemption
result.<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">Henry</i>, the express preemption was so clear that the “presumption”
did not matter.<span style="mso-spacerun: yes;"> </span>The district court found
preemption regardless.</div>
<div style="margin: 0in 0in 12pt;">
Second, the district court distinguished the case from
another from its neighbor to the south, the Golden State.<span style="mso-spacerun: yes;"> </span>You see, the Nutrition Labeling and Education
Act has a catch-all, which prohibits food labeling that is “false or misleading
in any particular.”<span style="mso-spacerun: yes;"> </span>21 U.S.C. <span style="mso-bidi-font-family: "Times New Roman";">§ 343(a).<span style="mso-spacerun: yes;"> </span>Because the preemption provision does not
expressly cover the catch-all, the plaintiff argued that any claim under the
catch-all was <i style="mso-bidi-font-style: normal;">not</i> preempted, citing
an order from the Central District of California, <i style="mso-bidi-font-style: normal;">Zupnik v. Tropicana Products Inc.</i>, No. 09-cv-6130 (C.D. Cal. Feb.
1, 2010).<span style="mso-spacerun: yes;"> </span></span></div>
<div style="margin: 0in 0in 12pt;">
<span style="mso-bidi-font-family: "Times New Roman";">The
district court rejected this argument as overly simplistic.<span style="mso-spacerun: yes;"> </span>Just because a label allegedly falls within a
catch-all for “false or misleading” labeling does not mean that it all of a
sudden falls outside the FDA’s more specific regulations, which permit exactly
that labeling.<span style="mso-spacerun: yes;"> </span>As the district court put
it, “[W]here the challenged conduct is expressly required or permitted by FDA
regulations, the claims fall within the core of the preemption provision
because they would ‘impose different requirements on precisely those aspects .
. . that the FDA had approved.’”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *20 (citations omitted).<span style="mso-spacerun: yes;"> </span>Moreover, where the FDA regulations permit
particular labeling, that labeling is not considered “false or misleading” under
federal law by definition.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;">
</span>According to the <i style="mso-bidi-font-style: normal;">Henry</i> judge,
the <i style="mso-bidi-font-style: normal;">Zupnik</i> order from California was
an outlier and “quite perfunctory” in an area of the law that was complex and
nuanced.<span style="mso-spacerun: yes;"> </span>As Californians, we say
“ouch.”<span style="mso-spacerun: yes;"> </span>But setting our native pride aside,
we have to say that we agree.<span style="mso-spacerun: yes;"> </span></span></div>
<div style="margin: 0in 0in 12pt;">
<span style="mso-bidi-font-family: "Times New Roman";">Food
litigation may continue in California, but manufacturers should continue to
push back with preemption and its lesser sibling, primary jurisdiction.<span style="mso-spacerun: yes;"> </span>Preemption carried the day in Oregon, and it
should continue to do so.<span style="mso-spacerun: yes;"> </span></span></div>
Anonymousnoreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-58559313305281803272016-04-28T14:00:00.000-04:002016-04-28T15:59:37.245-04:00Complete PMA Preemption Win in Texas<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>We talk a
lot about PMA preemption on this blog.<span style="mso-spacerun: yes;">
</span>And why shouldn’t we.<span style="mso-spacerun: yes;"> </span>It’s
probably been the most consistent source of defense wins in the last five plus
years.<span style="mso-spacerun: yes;"> </span>The body of preemption law that
has grown out of <i style="mso-bidi-font-style: normal;">Riegel v. Medtronic, Inc</i>.
is something we’ve watched with admiration.<span style="mso-spacerun: yes;">
</span>Likewise, we’ve watched plaintiffs’ counsel try to thwart, dodge, and
squeeze by or around PMA preemption for just as long.<span style="mso-spacerun: yes;"> </span>Plaintiffs have met with occasional limited
success, which while not our favorite topic, doesn’t usually give us
significant pause because even if a claim or two sneaks by – preemption usually
guts most of plaintiffs’ causes of action. <span style="mso-spacerun: yes;"> </span>But then every so often, we get the complete
win.<span style="mso-spacerun: yes;"> </span>Total victory, dismissal with
prejudice.<span style="mso-spacerun: yes;"> </span>And as routine as a PMA
preemption win might be – the complete win is still something blog-worthy.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>That brings
us to today’s case – <i style="mso-bidi-font-style: normal;">Yosowitz v. Covidien</i>,
Civil Action No. H-15-2902 (S.D. Tex. Apr. 25, 2016).<span style="mso-spacerun: yes;"> </span>Plaintiff underwent a surgical procedure to repair
intracranial aneurysms during which defendant’s embolization device was
implanted.<span style="mso-spacerun: yes;"> </span>Plaintiff alleges that a
defect in the device caused her to suffer a blocked blood vessel which led to
mini-strokes and resultant injuries.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Yosowitz</i>, <a href="https://drive.google.com/file/d/0B-lYJagi-p7vbXp2eUpBVGtBcmM/view?usp=sharing" target="_blank">slip op.</a> at 1-2.
The device was a Class III, Pre-Market Approved device.<span style="mso-spacerun: yes;"> </span>So, the court’s first stop in its decision
was a fairly thorough of PMA preemption law.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> at 7-13.<span style="mso-spacerun: yes;"> </span>Following that discussion, you’ll see this
section heading:<span style="mso-spacerun: yes;"> </span><u>Plaintiffs’ Claims
are All Preempted or Fail to Properly Allege a Claim</u> which was followed by <u>Plaintiffs
Have Not Pleaded Any Parallel Claim</u>. <i style="mso-bidi-font-style: normal;">Id.</i>
at 13.<span style="mso-spacerun: yes;"> </span>Pretty much guaranteed we were
going to like the rest of the opinion.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Applying
all that preemption law to the claims in <i style="mso-bidi-font-style: normal;">Yosowitz</i>,
the court started with the state law claims for negligence, strict liability,
breach of express warranty and breach of implied warranty.<span style="mso-spacerun: yes;"> </span>Since all four impose requirements on medical
devices, they must not be different from or in addition to the requirements
imposed by the FDCA.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id</i>. at 16-17.<span style="mso-spacerun: yes;"> </span>To establish that, plaintiff’s allegations
must identify the “specific PMA requirements that have been violated.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at 14.<span style="mso-spacerun: yes;"> </span>“[S]cattered allegations of
federal law violations” do not suffice.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 13.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
The court summed up plaintiff’s
negligence claims as failure to manufacture, market and label a product that was
(1) safe and/or (2) consistent with the original design and/or (3) consistent
with FDA regulations.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 18.<span style="mso-spacerun: yes;"> </span>As to point 1, the device received FDA PMA
approval – any state law that required defendant to manufacture or label its
device in a way other than the way the FDA approved it, is preempted.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at 18.<span style="mso-spacerun: yes;"> </span>Plaintiff tried to argue that
points 2 and 3 were parallel claims, but the court found the unsupported
allegations failed to provide any information on how the device’s design
differed or was inconsistent with federal regulations.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at 21.<span style="mso-spacerun: yes;"> </span>All the negligence claims were
dismissed.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Plaintiff’s strict liability claim
did not contain any allegations that defendant failed to comply with any
federal regulations – therefore, any requirement plaintiff sought to impose on
defendant would be different from or in addition to federal regulations.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at 22. <span style="mso-spacerun: yes;"> </span>All the strict liability claims
were dismissed.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
With breach of express warranty,
there again is no allegation of a violation of any federal regulation.<span style="mso-spacerun: yes;"> </span>So, any finding of breach of warranty would
necessarily involve a decision by a jury that the device was “unsafe and
ineffective.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 24.<span style="mso-spacerun: yes;"> </span>“The FDA
determined otherwise through the PMA process, so the state claim is based on
different or additional requirements and is expressly preempted.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
<span style="mso-spacerun: yes;"> </span>Moreover, plaintiff’s complaint failed
to allege the actual representations constituting the express warranty or when
and how the plaintiff received notice of them.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> at 24-25.<span style="mso-spacerun: yes;"> </span>Finally, if the alleged representations were
made in the label, warnings or instructions for use – they were FDA approved.<span style="mso-spacerun: yes;"> </span>Another basis for express preemption.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at 25.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Plaintiff’s breach of implied
warranty claim suffered from the same problems, because plaintiff only alleged
that she “believes” there was a violation that was a cause of her
injuries.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 26.<span style="mso-spacerun: yes;"> </span>Belief may be
strong enough for Santa Claus and the Tooth Fairy, but it’s not enough to
satisfy federal pleadings standards.<span style="mso-spacerun: yes;"> </span>All
the breach of warranty claims were dismissed.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
With the traditional state law
claims disposed of, plaintiff’s remaining claim was for failure to comply with
the FDCA and its implementing regulations.<span style="mso-spacerun: yes;">
</span>Had plaintiffs never heard of <i style="mso-bidi-font-style: normal;">Buckman</i>?<span style="mso-spacerun: yes;"> </span>Is this anything other than a private cause
of action to enforce FDCA regulations?<span style="mso-spacerun: yes;">
</span>This claim is impliedly preempted.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> at 27-28.<span style="mso-spacerun: yes;"> </span>Even if it weren’t preempted, it doesn’t
contain any allegations of how defendant failed to comply the regulations nor
any allegations of a causal connection between failure and the plaintiff’s
injuries.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 28.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
And with that, the case was dismissed
with prejudice.<span style="mso-spacerun: yes;"> </span>An excellent result for
which extend congratulations to our friends <a href="http://www.gtlaw.com/People/Lori-G-Cohen?wosView=quickContact" target="_blank">Lori Cohen</a> and <a href="http://www.gtlaw.com/People/DavisLockardVictoria?wosView=quickContact" target="_blank">Victoria Lockard</a> at <a href="http://www.gtlaw.com/" target="_blank">Greenberg Trauig</a> who passed
this along to us.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
Michelle Yearyhttp://www.blogger.com/profile/00994598841153573554noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-55429615658870104062016-04-27T07:30:00.000-04:002016-04-27T13:27:30.218-04:00C.D. Cal. Dismisses Infusion Pump Complaint<br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">The plaintiff in <em>Frere v. Medtronic, Inc</em>., 2016 WL 1533524
(C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump
implanted to treat her chronic low-back pain. According to the plaintiff,
the device never delivered the pain relief she had experienced during her
pre-implantation pump trial, and she ultimately suffered complications. The
device is a Class III medical device, requiring FDA premarket approval.
Product liability litigation involving Class III devices does not get very far
without bumping into federal preemption issues. Frere is no
exception. </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"> </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">The problem with the plaintiff’s complaint was that it was
either unclear or clearly preempted. The strict liability claims failed
because they consisted of conclusory allegations that the purported defects or
failure to warn caused her injuries. For example, in the manufacturing
defect claim, the plaintiff alleged: (1) that “the catheters at issue were occluded,
fractured, obstructed, and/or malfunctioning, which caused Plaintiff to suffer
severe injuries and which required multiple surgeries and medical procedures to
correct these defects”; and, (2) “as a direct result of the defects, Plaintiff
suffered crippling injuries which left Plaintiff with permanent and significant
disabilities compensable under the law.” There is no there there.
Similarly, in connection with her failure to warn claim, the plaintiff alleged
that “[a] foreseeable, direct and proximate result of [Defendants’] failure to
warn Plaintiff, Plaintiff’s medical providers, and the FDA . . . about the
defective condition of the [Device], Plaintiff suffered crippling injuries that
left Plaintiff with permanent and significant disabilities.” The court
refused to accept those mere “labels and conclusions.” The complaint was
bereft of any facts as to how the alleged manufacturing defect and failure to
warn caused her injuries. All we get is the conclusion of causation
itself. </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"> </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">That’s before we even get to preemption. The claims
run afoul of either implied, <em>Buckman</em> preemption by asking the court to
second-guess the FDA, or run afoul of express Medical Device Amendment
preemption by asking the court to impose a requirement different from or in
addition to federal law. The plaintiff argued that “[t]he sum and
substance of [her] claim is that the product in question was manufactured at a
time when Defendants were in violation of federal regulations dealing with
manufacturing processes.” That argument walks into <em>Buckman</em> and does not
identify “specific federal requirements” that parallel California law.
The plaintiff also alleged that the defendants “failed to inform or otherwise
warn the FDA, medical providers, and consumers such as Plaintiff of the high
failure rates” of “the catheters at issue.” But federal regulations
required the defendants to report adverse events to the FDA, not to doctors, so
the claim sought to impose additional requirements.</span></div>
<br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"> </span></div>
<br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">Other claims fared no better. The court was just as exacting
with respect to the inevitable warranty claims as with the defect and warning
claims. The plaintiff failed to plead facts that plausibly
indicated that the defendants breached a warranty made beyond any statements
approved by the FDA during the premarket approval process. The plaintiff
alluded to “articles in medical journals, advertising and/or other documents
and/or promotional materials,” but offered no reason to infer that such
statements became “part of the basis of the bargain” sufficient to state a
claim for breach of express warranty. Moreover, in basing an implied warranty
claim solely on conduct allegedly violating the FDCA, the plaintiff once again
walked off the <em>Buckman</em> cliff. </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"> </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">The fraud/misrepresentation claims walked off that same
cliff, because the allegedly offending marketing materials had all been
reviewed by the FDA as part of the PMA process. The plaintiff never
suggested that the statements exceeded the scope of any statements approved by
the FDA. Moreover, and predictably, the fraud claims flunked the Rule 9
particularity requirement. The complaint did not allege the when and
where of the misrepresentations, to whom they were made, and how they were
false. </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"> </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">The complaint also included an allegation that the defendants
had failed to train the plaintiff’s medical providers regarding how to
install the device. The court held that such a claim can survive “only to
the extent the manufacturer failed to provide the training required by the
premarket approval process.” Here, the plaintiff did not allege any facts
regarding how the defendants’ training procedure deviated from the training
procedure approved by the FDA in the premarket approval process. Nor did
the plaintiff assert any causal connection between the potential training
deviations and her injuries. Those failures derailed the training claim.</span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"> </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">Finally, the court dismissed the plaintiff’s claim under
California’s Unfair Competition Law. That claim sounded in fraud and was
therefore subject to the same particularity pleading requirement that knocked
out the fraud claims. Again, the complaint failed to state how the
alleged misrepresentations “immediatel[ly]” caused the plaintiff’s injuries.
</span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"> </span></div>
<span style="font-size: large;">
</span><br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;">These rulings resulted in a dismissal of the entire
<em>Frere</em> complaint. But the court saw a possibility that the plaintiff could
reallege her claims “to evade preemption,” so dismissal was with leave to
amend. In all likelihood, we will report again on this case in the
not-too-distant future. </span></div>
<br />
<div style="margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"> </span></div>
Steve McConnellhttp://www.blogger.com/profile/14959081465420761870noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-9160894214562323992016-04-26T15:18:00.002-04:002016-04-27T10:57:28.948-04:00Handy-Dandy Checklist for Admissibility of Electronic Evidence<br />
<div style="margin: 0in 0in 0pt;">
For years we’ve advocated about <a href="http://druganddevicelaw.blogspot.com/2011/11/e-discovery-for-defendants-cheat-sheet.html">ediscovery</a>
<a href="http://druganddevicelaw.blogspot.com/2015/01/a-day-in-real-life-of-facebooking.html">for</a>
<a href="http://druganddevicelaw.blogspot.com/2013/08/omg-i-have-to-produce-what-four-steps.html">defendants</a>
– consisting mostly of material gathered from a plaintiff’s social media
postings.<span style="mso-spacerun: yes;"> </span>OK, so let’s assume some
degree of success.<span style="mso-spacerun: yes;"> </span>Defense-side
ediscovery has generated some good stuff, and come trial, we want to get it
admitted into evidence.<span style="mso-spacerun: yes;"> </span>Now what?</div>
<br />
<div style="margin: 0in 0in 0pt;">
That’s the subject of today’s rather short
post.<span style="mso-spacerun: yes;"> </span>Since we’re hardly the source of
all useful information, we’d like to pass along a handy 4-page <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Electronic_Evidence_-_Admission_Guide_pdf.pdf">checklist
for the admissibility of electronic evidence</a>.<span style="mso-spacerun: yes;"> </span>It covers evidence in the form of:<span style="mso-spacerun: yes;"> </span>e-mail, internet website posts; text
messages/tweets; computer stored information; animations and simulations; and
digital photos.<span style="mso-spacerun: yes;"> </span>It has the following
headings:</div>
<br />
<div style="margin: 0in 0in 0pt;">
1. Preliminary Rulings on Admissibility</div>
<br />
<div style="margin: 0in 0in 0pt;">
2. Is the Evidence Relevant?</div>
<br />
<div style="margin: 0in 0in 0pt;">
3. If Relevant, Is It Authentic?</div>
<br />
<div style="margin: 0in 0in 0pt;">
4. Is Evidence Hearsay?</div>
<br />
<div style="margin: 0in 0in 0pt;">
5 Original Writing Rule</div>
<br />
<div style="margin: 0in 0in 0pt;">
6 Practice Tips</div>
<br />
<div style="margin: 0in 0in 0pt;">
It’s what it purports to be – a checklist – it doesn’t
provide case law, but it’s the kind of thing that lends itself to use in trial,
rather than pretrial, situations.</div>
<br />
<div style="margin: 0in 0in 0pt;">
This <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Electronic_Evidence_-_Admission_Guide_pdf.pdf">nifty
guide</a> was prepared jointly by Hon. Paul W. Grimm and <a href="http://www.redgravellp.com/our-people/profiles/kevin-f-brady">Kevin F.
Brady</a> of <a href="http://www.redgravellp.com/">Redgrave LLP</a>, so give
credit where credit is due.<span style="mso-spacerun: yes;"> </span>We’ve been
in touch with both of them, and they have graciously allowed us to disseminate <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Electronic_Evidence_-_Admission_Guide_pdf.pdf">their
work</a>.</div>
Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-44527061157769529322016-04-25T15:08:00.000-04:002016-05-05T13:51:16.978-04:00Discovery − Oppenheimer’s Half Life Has Long Been Exceeded<br />
<div style="margin: 0in 0in 0pt;">
As we’ve <a href="http://druganddevicelaw.blogspot.com/2016/01/the-shape-of-discovery-things-to-come.html">discussed
previously</a>, and as the legal profession is by now well aware, the discovery
provisions of the Federal Rules of Civil Procedure were significantly amended
effective December 1, 2015.<span style="mso-spacerun: yes;"> </span>One of the
foundational changes was to Rule 26(b)(1), and was intended to reduce the scope
of discovery generally. <span style="mso-spacerun: yes;"> </span>The old excuse
for ridiculous over-discovery – “reasonably calculated to lead to the discovery
of admissible evidence” – is no more.<span style="mso-spacerun: yes;">
</span>The new, more restrictive, language defining the scope of discovery is “any
nonprivileged matter that is relevant to any party’s claim or defense and proportional
to the needs of the case.”<span style="mso-spacerun: yes;"> </span>Fed. R. Civ.
P. 26(b)(1).<span style="mso-spacerun: yes;"> </span>As the committee notes to
this amendment explain, the old language was frequently misunderstood to permit
discovery into material that was itself irrelevant to litigation:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The former provision for discovery of relevant but
inadmissible information that appears “reasonably calculated to lead to the
discovery of admissible evidence” is also deleted.<span style="mso-spacerun: yes;"> </span>The phrase has been used by some,
incorrectly, to define the scope of discovery.<span style="mso-spacerun: yes;">
</span>As the Committee Note to the 2000 amendments observed, use of the
“reasonably calculated” phrase to define the scope of discovery “might swallow
any other limitation on the scope of discovery.”<span style="mso-spacerun: yes;"> </span>The 2000 amendments sought to prevent such
misuse by adding the word “Relevant” at the beginning of the sentence, making
clear that “‘relevant’ means within the scope of discovery as defined in this
subdivision ...”<span style="mso-spacerun: yes;"> </span>The “reasonably
calculated” phrase has continued to create problems, however, and is removed by
these amendments.<span style="mso-spacerun: yes;"> </span>It is replaced by the
direct statement that “Information within this scope of discovery need not be
admissible in evidence to be discoverable.”</div>
<br />
<div style="margin: 0in 0in 0pt;">
Committee Note to Rule 26, 2015 US Order 0017 (April
29, 2015).</div>
<br />
<div style="margin: 0in 0in 0pt;">
That’s all well and good, but since amended Rule 26
became effective, it has become evident that some courts continue to do the same
thing they’ve always done, giving lip service to the new rule, but
effectively applying the old standard.<span style="mso-spacerun: yes;">
</span>One recent example is <u>Hodges v. Pfizer, Inc.</u>, 2016 WL 1222229 (D.
Minn. March 28, 2016) – yet another Stevens-Johnsons Syndrome case, this time
against Advil − in which the plaintiff sought, and obtained, excessive
discovery concerning:<span style="mso-spacerun: yes;"> </span>(1) dealings with
foreign regulators (“seven countries and three areas,” <u>id.</u> at *3) who do
not follow the same standards as the FDA; (2) “financial documents” concerning
Advil, including “profits (gross and net) . . . sales forecasts,
advertising budgets, business plans, marketing plans, and financial plans” for
a ten-year period, <u>id.</u> at *4; and (3) old “sales and marketing documents
. . . from before June 2005, when the FDA required manufacturers to
include new warnings about” this condition.<span style="mso-spacerun: yes;">
</span><u>Id.</u> at *4.<span style="mso-spacerun: yes;"> </span>While the
opinion doesn’t mention the date of injury, we thought it might be 2010 (five
years after the label change) and since we have a <a href="https://ecf.mnd.uscourts.gov/cgi-bin/show_multidocs.pl?caseid=144548&arr_de_seq_nums=5&magic_num=&pdf_header=&hdr=&pdf_toggle_possible=1">PACER
account</a> and know how to use it, we were able to confirm that date as correct.</div>
<br />
<div style="margin: 0in 0in 0pt;">
All three requests were granted despite their
obvious remoteness from a U.S. case involving a single injury in 2010. Indeed, in 2010, any Advil made in 2005 would have long since been expired.<span style="mso-spacerun: yes;"> </span>While the new rule was cited, it was
construed solely by reference to pre-amendments cases – in particular, one
holding that “relevance” in Rule 26 “is to be construed broadly and encompasses
‘any matter that bears on, or that reasonably could lead to other matter that
could bear on, any issue that is or may be in the case.’”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *2 (quoting a 1997 D. Minn. case
that in turn quotes <u>Oppenheimer Fund, Inc. v. Sanders</u>, 437 U.S. 340, 351
(1978)).</div>
<br />
<div style="margin: 0in 0in 0pt;">
That’s where at least part of the problem
lies.<span style="mso-spacerun: yes;"> </span><u>Oppenheimer</u> is obsolete – overtaken
by at least two sets of rules amendments.<span style="mso-spacerun: yes;">
</span>The case is almost 40 years old.<span style="mso-spacerun: yes;">
</span>To use it to perpetuate the same broad view of discovery scope that the
2015 “claims or defenses” amendment to Rule 26 expressly rejected is unsupportable.<span style="mso-spacerun: yes;"> </span>We discussed the intent of the 2015
amendments at length <a href="http://druganddevicelaw.blogspot.com/2016/01/the-shape-of-discovery-things-to-come.html">here</a>,
relying upon Chief Justice Roberts’ <a href="http://www.supremecourt.gov/publicinfo/year-end/2015year-endreport.pdf">contemporaneous
report</a> concerning them.</div>
<br />
<div style="margin: 0in 0in 0pt;">
So, what went down in <u>Oppenheimer</u>?<span style="mso-spacerun: yes;"> </span><u>Oppenheimer</u> was a securities class
action.<span style="mso-spacerun: yes;"> </span>Through discovery, the plaintiff
demanded that the defendant essentially do plaintiff’s work for him – to
provide the information that would identify who was, and was not, a member of
the putative class.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at
350.<span style="mso-spacerun: yes;"> </span>The Court was asked to determine
whether identification of class members was properly addressed by discovery, or
alternatively under Fed. R. Civ. P. 23.<span style="mso-spacerun: yes;">
</span>The Court held that Rule 23 controlled:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
Rule 23 . . . deals comprehensively with class
actions, and thus is the natural place to look for authority for orders
regulating the sending of notice. <span style="mso-spacerun: yes;"> </span>It is
clear that Rule 23(d) vests power in the district court to order one of the
parties to perform the tasks necessary to send
notice. . . .<span style="mso-spacerun: yes;"> </span>Since
identification simply is another task that must be performed in order to send
notice, we agree . . . that Rule 23(d) also authorizes a district
court in appropriate circumstances to require a defendant’s cooperation in
identifying the class members to whom notice must be sent.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Id.</u> at 354-55 (footnotes omitted).<span style="mso-spacerun: yes;"> </span>What about the discovery rules?<span style="mso-spacerun: yes;"> </span>“[W]e do not think that the discovery rules
are the right tool for this job.”<span style="mso-spacerun: yes;"> </span><u>Id.</u>
at 354.</div>
<br />
<div style="margin: 0in 0in 0pt;">
What that tells us is that what the Court had to
say about the discovery rules generally – as they stood in 1978 – is entirely <i style="mso-bidi-font-style: normal;">dictum</i>.<span style="mso-spacerun: yes;">
</span><u>Oppenheimer</u> did not make any precedential ruling about discovery, or about
Rule 26. To the contrary, it held that that discovery rules were inapplicable.</div>
<br />
<div style="margin: 0in 0in 0pt;">
Beyond that, the <i style="mso-bidi-font-style: normal;">dictum</i> in <u>Oppenheimer</u> is facially inapplicable to the new
language of Rule 26.<span style="mso-spacerun: yes;"> </span>The Court stated:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The <b style="mso-bidi-font-weight: normal;"><u>key phrase</u></b>
in this definition − “relevant to the subject matter involved in the pending
action” − has been construed broadly to encompass any matter that bears on, or
that reasonably could lead to other matter that could bear on, any issue that
is or may be in the case.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Id.</u> at 315 (citing <u>Hickman v. Taylor</u>,
329 U.S. 495, 501 (1947) – a case about work-product protection) (emphasis added).<span style="mso-spacerun: yes;"> </span>That “key phrase” no longer exists.<span style="mso-spacerun: yes;"> </span>The phrase was precisely what the 2015
amendments got rid of, and the committee that drafted those amendments did so equally
precisely (as quoted above – and there are more quotes to the same effect) to reduce
the scope of discovery.</div>
<br />
<div style="margin: 0in 0in 0pt;">
The phrase that <u>Oppenheimer</u> described in
1978 is simply no longer the test of discoverability.<span style="mso-spacerun: yes;"> </span>Rather, “[p]roportional discovery relevant to
any party’s claim or defense suffices, given a proper understanding of what is
relevant to a claim or defense” is.<span style="mso-spacerun: yes;"> </span>Committee
Note to Rule 26, 2015 US Order 0017 (April 29, 2015).<span style="mso-spacerun: yes;"> </span>Nor would <u>Oppenheimer</u> even support
discovery into old labeling used long before an accident.<span style="mso-spacerun: yes;"> </span>“[I]t is proper to deny discovery of matter
that is relevant only. . . to events that occurred before an
applicable limitations period, unless the information sought is otherwise
relevant to issues in the case.”<span style="mso-spacerun: yes;"> </span>437
U.S. at 352.</div>
<br />
<div style="margin: 0in 0in 0pt;">
Unfortunately, <u>Hodges</u> is not alone in
erroneously relying on the <u>Oppenheimer</u>’s obsolete observation as if it
were somehow applicable to the “claims or defenses” scope-of-discovery standard
in current Rule 26(b)(1).<span style="mso-spacerun: yes;"> </span>The “key
element” language is found in headnote six of <u>Oppenheimer</u>.<span style="mso-spacerun: yes;"> </span>According to Westlaw, <u>Oppenheimer</u> has
been cited in 73 cases since December 1, 2015.<span style="mso-spacerun: yes;">
</span>Of those 73 cases, obsolete headnote six has been cited in 53 of
them.<span style="mso-spacerun: yes;"> </span>Plainly, a concerted effort is
underway to misquote <u>Oppenheimer</u> – leaving out that the “key element” is
precisely the language amended out of the rule – in order to gut the 2015
amendment. </div>
<br />
<div style="margin: 0in 0in 0pt;">
A few examples should suffice.<span style="mso-spacerun: yes;"> </span>The most recent case of the lot, <u>Rhone v.
Schneider National Carriers, Inc.</u>, 2016 WL 1594453 (E.D. Mo. April 21,
2016), granted a motion to compel while citing the <u>Oppenheimer</u> language
– conveniently omitting the “key phrase” part and beginning its quotation with
“broadly construed.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at
*1.<span style="mso-spacerun: yes;"> </span>In <u>Lightsquared Inc. v. Deere
& Co.</u>, 2015 WL 8675377 (S.D.N.Y. Dec. 10, 2015), although conceding that
“discovery no longer extends to anything related to the ‘subject matter’ of the
litigation,” the opinion nevertheless cited to <u>Oppenheimer</u> to hold that
“relevance is still to be ‘construed broadly to encompass any matter that bears
on, or that reasonably could lead to other matter that could bear on’ any
party’s claim or defense.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at
*2.<span style="mso-spacerun: yes;"> </span><u>United States ex rel. Shamesh v.
CA, Inc.</u>, 2016 WL 74394 (D.D.C. 2016), is even worse – using the obsolete <u>Oppenheimer</u>
<i style="mso-bidi-font-style: normal;">dictum</i> to evade the 2015 amendments
altogether:<span style="mso-spacerun: yes;"> </span>“Like before, relevance is
still to be ‘construed broadly to encompass any matter that bears on, or that
reasonably could lead to other matter that could bear on’ any party's claim or
defense.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *7 (quoting <u>Oppenheimer</u>).</div>
<br />
<div style="margin: 0in 0in 0pt;">
These decisions are simply erroneous.<span style="mso-spacerun: yes;"> </span><u>Oppenheimer</u> expressly construed
language deleted by the 2015 amendments because it was being used to allow
excessively broad discovery.<span style="mso-spacerun: yes;"> </span>To the
extent <u>Oppenheimer</u> is relevant to anything anymore, we recommend its
holding that plaintiffs – the requesting party − be required to pay for
discovery that they sought of electronically stored information:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
Both opinions [below] suggest that the fact that part of
these records are kept on computer tapes justifies imposing a greater burden on
[defendants] than might be imposed on a party whose records are kept in another
form. . . .</div>
<br />
<div style="margin: 0in 0in 0pt; text-align: center;">
*<span style="mso-tab-count: 1;"> </span>*<span style="mso-tab-count: 1;"> </span>*<span style="mso-tab-count: 1;"> </span>*</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
We do not think these reasons justify the order in this
case.<span style="mso-spacerun: yes;"> </span>There is no indication or
contention that these petitioners have acted in bad faith to conceal
information from respondents.<span style="mso-spacerun: yes;"> </span>In
addition, although it may be expensive to retrieve information stored in
computers when no program yet exists for the particular job, there is no reason
to think that the same information could be extracted any less expensively if
the records were kept in less modern forms.<span style="mso-spacerun: yes;">
</span>Indeed, one might expect the reverse to be true, for otherwise computers
would not have gained such widespread use in the storing and handling of
information.<span style="mso-spacerun: yes;"> </span>Finally, the suggestion
that petitioners should have used “different systems” to keep their records
borders on the frivolous. . . .<span style="mso-spacerun: yes;">
</span>[W]e do not think a defendant should be penalized for not maintaining
his records in the form most convenient to some potential future litigants
whose identity and perceived needs could not have been anticipated.</div>
<br />
<div style="margin: 0in 0in 0pt;">
437 U.S. at 362-63</div>
<br />
<div style="margin: 0in 0in 0pt;">
In short, it is disingenuous in the extreme for
those pursuing discovery to justify their overreaching demands with obsolete <i style="mso-bidi-font-style: normal;">dictum</i> from <u>Oppenheimer</u>.<span style="mso-spacerun: yes;"> </span>To do so only undermines the years of efforts
that went into the reform of discovery represented by 2015 Amendments.</div>
Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-6478161623897002182016-04-22T14:02:00.000-04:002016-04-22T15:51:19.636-04:00Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”<br />
<div style="margin: 0in 0in 0pt;">
According to <u>Black’s Law Dictionary</u>, “<i style="mso-bidi-font-style: normal;">a fortiori</i>” is legal Latin meaning:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
By even greater force of logic; even more so it follows
<if 13-year-old="" 14-year-old="" a="" binding="" cannot="" child="" contract="" fortiori="" sign="" then="">.</if></div>
<br />
<div style="margin: 0in 0in 0pt;">
<a href="http://druganddevicelaw.blogspot.com/2015/09/in-case-of-good-judge-break-glass.html">We’ve</a>
<a href="http://druganddevicelaw.blogspot.com/2014/02/mensing-its-not-just-about-generics.html">been</a>
<a href="http://druganddevicelaw.blogspot.com/2013/07/major-drug-labeling-changes-that.html">arguing</a>
<a href="http://druganddevicelaw.blogspot.com/2012/10/interesting-mensing-application.html">for</a>
<a href="http://druganddevicelaw.blogspot.com/2013/07/ruminations-on-independence-and.html">some</a>
<a href="http://druganddevicelaw.blogspot.com/2011/07/implied-preemption-and-medical-devices.html">time</a>
– since <u>PLIVA v. Mensing</u>, 131 S. Ct. 2567 (2011), and <u>Mutual Pharmaceutical
Co. v. Bartlett</u>, 133 S. Ct. 2466 (2013), were first decided that − because they
apply implied impossibility preemption − the principles that these cases
enunciate are equally applicable to non-generic drug products, such as branded
drugs and §510k-cleared medical devices.<span style="mso-spacerun: yes;">
</span>Some cases have agreed with us.<span style="mso-spacerun: yes;">
</span>You can find those (at least as to innovator drugs) on our post-<u>Levine</u>
drug preemption <a href="http://druganddevicelaw.blogspot.com/2010/10/post-levine-drugvaccine-preemption.html" target="_blank">cheat sheet</a>.</div>
<br />
<div style="margin: 0in 0in 0pt;">
The contrary cases, and there are a number of them,
largely refuse to evaluate implied preemption on its merits.<span style="mso-spacerun: yes;"> </span>Instead, they state that innovator
drugs/§510k medical devices are “not generic drugs” and leave it at that.<span style="mso-spacerun: yes;"> </span><u>E.g.</u>, <u>Shipley v. Forest
Laboratories, Inc.</u>, 2015 WL 4199739, at *9 (D. Utah July 13, 2015); <u>In
re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation</u>,
2014 WL 3557392, at *10-11 (N.D. Tex. July 18, 2014); <u>In re Actos
(Pioglitazone) Products Liability Litigation</u>, 2014 WL 60298, at *8 (W.D.
La. Jan. 7, 2014).<span style="mso-spacerun: yes;"> </span>Occasionally a court
gets into more detail, and the result is really hard to follow.<span style="mso-spacerun: yes;"> </span>For example, <u>Mullins v. Ethicon, Inc.</u>,
___ F. Supp.3d ___, 2015 WL 7761033 (S.D.W. Va. Dec. 2, 2015), gets
off on the wrong track by holding the <b style="mso-bidi-font-weight: normal;"><u>express</u></b>
preemption analysis in <u><span style="-ms-layout-grid-mode: line;">Medtronic, Inc.
v. Lohr</span></u><span style="-ms-layout-grid-mode: line;">, 518 U.S. 470 (1996),
“directly applicable” to implied impossibility preemption.<span style="mso-spacerun: yes;"> </span><u>Mullins</u>, </span>2015 WL 7761033, at
*5.<span style="mso-spacerun: yes;"> </span><u>Cf.</u> <u>Buckman Co. v.
Plaintiffs Legal Committee</u>, 531 U.S. 341, 352 (2001) (“neither an express pre-emption
provision nor a saving clause bars the ordinary working of conflict pre-emption
principles”) (citation and quotation marks omitted).<span style="mso-spacerun: yes;"> </span>Then <u>Mullins</u> invoked the “uniqueness”
of generic drugs to reject preemption of design claims even though it was
undisputed that the FDA would have to approve a supplement before the design
change could be implemented:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The impossibility in <u>Mensing</u> arose from the
unique “duty of sameness” imposed on generic drugs, which has no corollary in
the medical device context. . . .<span style="mso-spacerun: yes;"> </span>The Supreme Court has cited Mensing in two
subsequent majority opinions, but has nowhere referred to “special permission
and assistance” in a preemption analysis. . . .<span style="mso-spacerun: yes;"> </span>In <u>Mensing</u>, there was no official
regulatory process by which a generic could change its label, so the generic
manufacturer was “barred” from taking the action state law required. <span style="mso-spacerun: yes;"> </span>This is completely different from the
defendants’ situation . . . [where] [t]he law simply requires that
manufacturers making a “significant change” submit another 510(k) notification,
which the FDA will clear if <span style="mso-spacerun: yes;"> </span>making a
“significant change” submit another 510(k) notification, which the FDA will
clear if it determines the device is substantially equivalent to a device
already on the market.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u><span style="-ms-layout-grid-mode: line;">Mullins</span></u><span style="-ms-layout-grid-mode: line;">, </span>2015 WL 7761033, at *5-6 (citations
omitted).</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Mullins</u> and similar cases, however, do not
accurately describe either <u>Mensing</u> or <u>Bartlett</u>.</div>
<br />
<div style="margin: 0in 0in 0pt;">
What <u>Mensing</u> really held was this:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
If the Manufacturers had independently changed their
labels to satisfy their state-law duty, they would have violated federal law. .
. .<span style="mso-spacerun: yes;"> </span>Thus, it was impossible for the
Manufacturers to comply with both their state-law duty to change the label and
their federal law duty to keep the label the same.</div>
<br />
<div style="margin: 0in 0in 0pt; text-align: center;">
*<span style="mso-tab-count: 1;"> </span>*<span style="mso-tab-count: 1;"> </span>*<span style="mso-tab-count: 1;"> </span>*</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The question for “impossibility” is whether the private
party could independently do under federal law what state law requires of it.</div>
<br />
<div style="margin: 0in 0in 0pt;">
131 S. Ct. at 2578-79.</div>
<br />
<div style="margin: 0in 0in 0pt;">
What <u>Bartlett</u> really stated was that it was equally
“impossible” to comply with an immediate state-law duty to change a design where
FDA pre-approval was required, because “[o]nce a drug − whether generic or
brand-name − is approved, the manufacturer is prohibited from making any major
changes.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 2471.<span style="mso-spacerun: yes;"> </span>The manufacturer could not “independently
chang[e]” its product, “[t]hus, federal law prohibited [defendant] from taking
the remedial action required to avoid liability under [state] law.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 2476.<span style="mso-spacerun: yes;"> </span>“When federal law forbids an action that
state law requires, the state law without effect.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 2477 (citation and quotation
marks omitted).</div>
<br />
<div style="margin: 0in 0in 0pt;">
However, it’s getting harder for courts to stick
their fingers in their ears and chant “not generic, not generic, not generic”
in response to preemption arguments based on agency pre-approval arguments.<span style="mso-spacerun: yes;"> </span>As we’ve <a href="http://druganddevicelaw.blogspot.com/2015/12/breaking-news-sixth-circuit-affirms.html">already</a>
<a href="http://druganddevicelaw.blogspot.com/2015/02/breaking-news-first-circuit-extends.html">chronicled</a>,
two courts of appeals have previously made the easiest jump – the one mentioned in
<u>Bartlett</u> – and have applied <u>Mensing</u>/<u>Bartlett</u> impossibility
preemption to innovator drugs.<span style="mso-spacerun: yes;"> </span><u>See</u>
<u>Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.</u>, 808 F. 3d 281 (6th
Cir. 2015); <u>In re Celexa & Lexapro Marketing & Sales Practices
Litigation</u>, 779 F.3d 34 (1st Cir. 2015).</div>
<br />
<div style="margin: 0in 0in 0pt;">
Now there are three, and the latest is the most <i style="mso-bidi-font-style: normal;">a fortiori</i> of the lot.</div>
<br />
<div style="margin: 0in 0in 0pt;">
The Third Circuit has applied the <u>Mensing</u>/<u>Bartlett</u>
impossibility preemption rationale outside of the FDCA altogether, to preemption
of design defect claims involving airplanes.<span style="mso-spacerun: yes;">
</span><u>Sikkelee v. Precision Airmotive Corp.</u>, ___ F.3d ___, 2016 WL 1567236
(3d Cir. April 19, 2016).<span style="mso-spacerun: yes;"> </span>Since the <u>Mensing</u>/<u>Bartlett</u>
preemption rationale can apply to a completely different statutory scheme –<em> a
fortiori </em>it applies to other FDCA-governed and FDA-regulated products such as
innovator drugs and §510k medical devices.</div>
<br />
<div style="margin: 0in 0in 0pt;">
After rejecting a field preemption argument under
the Federal Aviation Act (something with no FDCA-related analogy), <u>Sikkelee</u>
turned to impossibility preemption:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
In addition to field preemption, federal law may
supersede state law through conflict preemption. <span style="mso-spacerun: yes;"> </span>This occurs when a state law conflicts with
federal law such that compliance with both state and federal regulations is
impossible[.] <span style="mso-spacerun: yes;"> </span><u>PLIVA, Inc. v. Mensing</u>,
131 S. Ct. 2567, 2577 (2011).</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Sikkelee</u>, 2016 WL 1567236, at *5.</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Skikelee</u> held that <u>Mensing</u>/<u>Bartlett</u>
impossibility preemption would preempt “analogous” design defect claims that
FAA regulations classified as “major” and thereby must be approved by the FAA
before being implemented:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
[W]hen confronting an analogous preapproval scheme for
pharmaceutical labeling, the Supreme Court has held that, where manufacturers
are unable to simultaneously comply with both federal and state requirements,
state law design defect claims are conflict preempted. . . .<span style="mso-spacerun: yes;"> </span>[citing <u>Mensing</u> and <u>Bartlett</u>].<span style="mso-spacerun: yes;"> </span>Before a new drug may legally be distributed
in the United States, both its contents and its labeling must be preapproved by
the FDA. . . .<span style="mso-spacerun: yes;"> </span>[C]laims
against generic drug manufacturers cannot survive a conflict preemption
analysis because the generic manufacturers are bound by federal law to directly
mimic their brand-name counterparts.<span style="mso-spacerun: yes;">
</span>[citing <u>Mensing</u> and <u>Bartlett</u>].<span style="mso-spacerun: yes;"> </span><b style="mso-bidi-font-weight: normal;"><u>Ultimately,
where a party cannot “independently do under federal law what state law
requires of it,” the state law is conflict preempted.</u></b><span style="mso-spacerun: yes;"> </span>[citing <u>Mensing</u>].</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Sikkelee</u>, 2016 WL 1567236, at *18 (emphasis
added) (various citations and footnote omitted).</div>
<br />
<div style="margin: 0in 0in 0pt;">
There’s that “independent” action implied preemption
principle again.</div>
<br />
<div style="margin: 0in 0in 0pt;">
That principle – that mandatory agency action prior
to approval equals impossibility preemption − applies equally to airplanes
subject to FAA pre-approval design requirements for “major” design changes:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
The <b style="mso-bidi-font-weight: normal;"><u>same
considerations apply</u></b> to the case before us. <span style="mso-spacerun: yes;"> </span>The FAA’s preapproval process for
specifications . . . precludes a manufacturer from making at least
“major changes” to a design aspect <b style="mso-bidi-font-weight: normal;"><u>without
further preapproval</u></b>, means a manufacturer may well find it impossible
to simultaneously comply with both [FAA] specifications and a separate − and
perhaps more stringent − state tort duty. <span style="mso-spacerun: yes;"> </span>Thus, there may be cases where a
manufacturer’s compliance with both the [FAA] and a state law standard of care
“is a physical impossibility”. . . .<span style="mso-spacerun: yes;"> </span>In such cases, <b style="mso-bidi-font-weight: normal;"><u>the state law claim would be conflict preempted</u></b>. <span style="mso-spacerun: yes;"> </span>For, even if an alternative design aspect
would improve safety, the mere “possibility” that the FAA would approve a
hypothetical application for an alteration does not make it possible to comply
with both federal and state requirements: As the Supreme Court observed in [<u>Mensing</u>],
if that were enough, conflict preemption would be “all but meaningless.”</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Sikkelee</u>, 2016 WL 1567236, at *19 (emphasis
added) (various citations and footnote omitted).</div>
<br />
<div style="margin: 0in 0in 0pt;">
<span style="line-height: 200%; mso-bidi-font-size: 10.0pt;">But what about <u>Lohr</u>?<span style="mso-spacerun: yes;"> </span><u>Sikkelee</u>
addressed the difference between express and implied preemption as well:</span></div>
<br />
<div style="margin: 0in 0.5in 12pt;">
Together these cases [<u>Lohr</u> and <u>Riegel</u>] reflect
a narrow, rather than sweeping, approach to analyzing the preemptive contours
of a federal premarket approval scheme. . . .<span style="mso-spacerun: yes;"> </span>Here, confronted with a similarly exhaustive
preapproval process governing aircraft manufacture and design and no express
preemption clause, we see no justification for going further than the Supreme
Court elected to go in <u>Riegel</u> or <u>Lohr</u>. . . .</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Sikkelee</u>, 2016 WL 1567236, at *19.<span style="mso-spacerun: yes;"> </span>Therefore, while there was no “field”
preemption of product liability claims under the FAA, there could be implied
preemption of particular design claims where prior FAA approval precluded
immediate adoption of a plaintiff’s supposedly safer design under state law.</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
We thus read Riegel not to bestow field preemptive
effect on [aircraft designs], but rather to counsel in favor of narrowly
construing the effect of federal regulations on state law − much like the
conflict preemption analysis undertaken in <u>Bartlett</u> and [<u>Mensing</u>].</div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Id.</u></div>
<br />
<div style="margin: 0in 0in 0pt;">
As a last gasp, the plaintiffs in <u>Sikkelee</u>
criticized the quality of FAA oversight, much as our opponents have criticized
the FDA.<span style="mso-spacerun: yes;"> </span>Once again, the Third Circuit
recognized that the two situations were analogous:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
This very same argument, however, was raised in <u>Bartlett</u>
and failed to carry the day. <span style="mso-spacerun: yes;"> </span>While the
dissenters decried that granting “manufacturers of products that require
preapproval . . . <i style="mso-bidi-font-style: normal;">de facto</i>
immunity from design-defect liability” would force the public “to rely
exclusively on imperfect federal agencies with limited resources,” the majority
held that because generic drug manufacturers are required to directly mirror
the preapproved labels of their brand-name counterparts and are thus
“prohibited from making any unilateral changes” to their labels, state law
design defect claims were foreclosed by “a straightforward application of
pre-emption law”. . . .<span style="mso-spacerun: yes;"> </span>Thus,
the reasoning of the <u>Bartlett</u> majority, and the consideration we must
give to the FAA’s views under separation of powers principles, lead us to
conclude that <b style="mso-bidi-font-weight: normal;"><u>the FAA’s preapproval
process for aircraft component part designs must be accorded due weight under a
conflict preemption analysis.</u></b></div>
<br />
<div style="margin: 0in 0in 0pt;">
<u>Sikkelee</u>, 2016 WL 1567236, at *23 (emphasis
added) (citations omitted).<span style="mso-spacerun: yes;"> </span>Thus, while
there is no field preemption of product liability claims under the FAA, like
there isn’t under the FDCA, design claims remain “subject to traditional
conflict preemption principles.”<span style="mso-spacerun: yes;"> </span><u>Id.</u></div>
<br />
<div style="margin: 0in 0in 0pt;">
While not accepting the defendants’ field
preemption arguments, <u>Sikkelee</u> is a resounding reaffirmance of the
universality of implied conflict preemption principles.<span style="mso-spacerun: yes;"> </span>Since <u>Mensing</u>/<u>Bartlett</u>
impossibility preemption applies to airplanes – governed by a totally separate
statutory scheme – “by even greater force of logic” those same principles must
apply to other FDA-regulated products, such as innovator drugs and §510k
medical devices, whenever plaintiffs contend that some state-law duty forces
these products’ manufacturers to make an immediate product alteration that,
under the FDCA, requires prior FDA approval.</div>
Bexishttp://www.blogger.com/profile/12984303395998821374noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-34985083790566693982016-04-21T14:48:00.000-04:002016-04-21T14:48:47.134-04:00Georgia MDL Court Muddles Utah Law
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>We aren’t
going to mince words today.<span style="mso-spacerun: yes;"> </span>We don’t
like <i style="mso-bidi-font-style: normal;">Christiansen v. Wright Medical
Technology Inc.</i>, MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5,
2016).<span style="mso-spacerun: yes;"> </span>It is an opinion on post-trial
motions in a case that went to trial in the <i style="mso-bidi-font-style: normal;">Conserve
Hip Implant Products Liability Litigation</i>.<span style="mso-spacerun: yes;">
</span>It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s
true where you are.<span style="mso-spacerun: yes;"> </span>If it is, and if
anything in this post makes you interested in the greater details and nuances
of the decision, we recommend taking it outside, sitting under a tree, and
enjoying some fresh air.<span style="mso-spacerun: yes;"> </span>You should at
least have pleasant surroundings while you try to get through it.<span style="mso-spacerun: yes;"> </span>It’s long, and tedious, and frankly,
muddled.<span style="mso-spacerun: yes;"> </span>So, we are going to try to
focus in on the key parts – so that we might also try to get out and enjoy some
of this fine weather.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">Christiansen</i> is a hip implant case.<span style="mso-spacerun: yes;"> </span>It went to trial on 5 theories of
liability:<span style="mso-spacerun: yes;"> </span>strict liability design
defect, negligent design defect, fraudulent misrepresentation, fraudulent
concealment, and negligent misrepresentation.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id</i>. at *2-3.<span style="mso-spacerun: yes;"> </span>Apparently the court had dismissed plaintiff’s
failure to warn claim on summary judgment.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id.</i> at *69 n.18.<span style="mso-spacerun: yes;"> </span>The jury ultimately returned a verdict
finding the hip implant was defectively designed and caused plaintiff’s
injuries and awarded $550,000 in compensatory damages.<span style="mso-spacerun: yes;"> </span>The jury also found in favor of the defendant
on the fraudulent misrepresentation and concealment claims, but awarded another
$450,000 to plaintiff on his negligent misrepresentation claim and $10 million
in punitives.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *18.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
But that wasn’t the jury’s first
verdict.<span style="mso-spacerun: yes;"> </span>It’s first verdict, delivered
days earlier, answered the first question on the Verdict Form – do you find the
hip implant was defectively designed – in the negative.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *6.<span style="mso-spacerun: yes;"> </span>While that should have been the
end of the inquiry, the jury didn’t understand the instruction to not go any
further and they kept answering the verdict form.<span style="mso-spacerun: yes;"> </span>So, they went on to find that defendant had
made negligent misrepresentations and awarded plaintiff $662,500 in
compensatory damages and $2.5 million in punitives.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *7.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Clearly the jury was confused.<span style="mso-spacerun: yes;"> </span>Clearly the responses on the verdict form
were inconsistent.<span style="mso-spacerun: yes;"> </span>But, just as clearly
– a unanimous jury found that the hip implant was <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">not</i></b> defective.<span style="mso-spacerun: yes;"> </span>We, like the defendant, believe that’s where
the case should have ended.<span style="mso-spacerun: yes;"> </span>Without a
defect, plaintiff had no right to recovery against defendant.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *5.<span style="mso-spacerun: yes;"> </span>That’s why the verdict form was
written the way it was.<span style="mso-spacerun: yes;"> </span>The jury may
have mistakenly gone on to respond to the question about misrepresentation –
but that shouldn’t have mattered.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Instead the court sent the jury
back with the form and told them to read it again.<span style="mso-spacerun: yes;"> </span>When they still didn’t understand, the court
decided it needed to be rewritten.<span style="mso-spacerun: yes;"> </span>You
read that right.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">After</i> the jury had deliberated to a verdict, the court decided to
rewrite the verdict form and send the jury back to deliberate a second
time.<span style="mso-spacerun: yes;"> </span>Maybe that’s been done before, but
we’ve never encountered it.<span style="mso-spacerun: yes;"> </span>It plainly
should have been a mistrial at worst, and a defense verdict at best.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Anyway, then the court re-charged
the jury and sent them back with modified – pro-plaintiff – instructions.<span style="mso-spacerun: yes;"> </span>At this point, a new wrinkle is added.<span style="mso-spacerun: yes;"> </span>With the new instructions – the jury is no
longer unanimous.<span style="mso-spacerun: yes;"> </span>One juror is no longer
on board.<span style="mso-spacerun: yes;"> </span>We, like the defendant, think
this juror likely understood the first verdict form and now disagreed with the
remaining jurors’ changing the answer to the defect question, as the sole
reason to change the answer to that question was to award the plaintiff
money.<span style="mso-spacerun: yes;"> </span>The facts hadn’t changed.<span style="mso-spacerun: yes;"> </span>The charge hadn’t changed.<span style="mso-spacerun: yes;"> </span>What had changed was the jury’s understanding
that they had to say yes to question 1.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Mistrial now?<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
No.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
Instead, the court purged the jury
of its evidently most pro-defense member, and with him so too disappeared those
parts of the verdict form that had previously favored defendant.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt; text-indent: 0.5in;">
The defendant challenged the verdict
on the original no-defect ruling being dispositive, juror confusion, and on the
dismissal of the juror.<span style="mso-spacerun: yes;"> </span>Not
surprisingly, given that the same judge had made these prior rulings, that challenge
was to no avail.<span style="mso-spacerun: yes;"> </span>We’ll leave the details
to your leisure time reading.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *22-55.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>The flubs
surrounding the verdict, however, were not the only problems with this
case.<span style="mso-spacerun: yes;"> </span>Defendant had ample substantive
challenges as well.<span style="mso-spacerun: yes;"> </span>The most significant
of which was the court blatantly ignoring Utah law on comment k and design
defect.<span style="mso-spacerun: yes;"> </span>While comment k is applied
differently state-to-state, make no mistake that Utah is one of the most solid
comment k states for prescription products:</div>
<br />
<blockquote class="tr_bq">
We agree with the principle comment k embodies, that
manufacturers of unavoidably dangerous products should not be liable for a
claim of design defect. We are persuaded that all prescription drugs
should be classified as unavoidably dangerous in design because of their unique
nature and value, the elaborate regulatory system overseen by the FDA, the
difficulties of relying on individual lawsuits as a forum in which to review a
prescription drug's design, and the significant public policy considerations. .
. .</blockquote>
<o:p></o:p><br />
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<u>Grundberg v. Upjohn Co.</u>, 813 P.2d 89, 95 (Utah
1991).<span style="mso-spacerun: yes;"> </span>Based on this, we don’t
understand how the design defect claims even made it to trial.<span style="mso-spacerun: yes;"> </span>But, since they did, and since Utah law is so
strong, the jury charge should have been clear.<span style="mso-spacerun: yes;">
</span>Nope.<span style="mso-spacerun: yes;"> </span>The Utah model jury
instruction on comment k says that to establish a product is unavoidably unsafe,
a defendant must prove that “(1) when the product was made, it could not be
made safe for its intended use even applying the best available testing and
research; and (2) the benefits of the product justified its risk.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Christiansen,</i>
at *61.<span style="mso-spacerun: yes;"> </span>Easy enough for a prescription-only
medical device.<span style="mso-spacerun: yes;"> </span>But the <i style="mso-bidi-font-style: normal;">Christiansen</i> court tacked on a third
requirement.<span style="mso-spacerun: yes;"> </span>Defendant also had to prove
that the device “was accompanied by proper directions or warnings.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *63.<span style="mso-spacerun: yes;"> </span>Not only is this not Utah law (the
citations in the opinion are to Georgia, not Utah law), but there was no
warning-related claim in this case.<span style="mso-spacerun: yes;">
</span>That’s right, after failure to warn was dismissed on summary judgment,
the court brought it back under the guise of (certainly not Utah) comment k. <span style="mso-spacerun: yes;"> </span>But more than that, the court effectively shifted
the burden at trial to defendant to prove its warning adequate.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>And when
the jury found the device was defective, guess which is the only element of the
court’s comment k charge it found defendant failed to prove – warnings.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *65.<span style="mso-spacerun: yes;"> </span>So, if the court had correctly
applied Utah law at the outset, the design defect claim would have been
dismissed.<span style="mso-spacerun: yes;"> </span>If the court had correctly
charged the jury on Utah law, the jury would have found in favor of
defendant.<span style="mso-spacerun: yes;"> </span>Two strikes.<span style="mso-spacerun: yes;"> </span>The third was finding no error.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *66-75.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>At this
juncture, we have to point that this process was entirely <i style="mso-bidi-font-style: normal;">ultra vires</i> under <i style="mso-bidi-font-style: normal;">Erie v.
Tompkins,</i> 304 U.S. 64 (1938).<i style="mso-bidi-font-style: normal;"> </i><span style="mso-spacerun: yes;"> </span>As we have pointed out many times in the<a href="http://druganddevicelaw.blogspot.com/search/label/Erie%20Doctrine" target="_blank"> past</a>
-- a federal court sitting in diversity is not supposed to create new expansive
forms of state-law liability, as this court did – twice – with comment k and
design defect.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>Finally, on
the misrepresentation and concealment claims, the jury found for the plaintiff
on negligent misrepresentation based on statements by a sales rep that went
beyond the package insert.<span style="mso-spacerun: yes;"> </span>The jury did
not find defendant’s actions rose to the level of fraudulent conduct.<span style="mso-spacerun: yes;"> </span>But the court went on to allow a punitive
damages claim anyway based on reckless indifference to a “substantial risk.”<span style="mso-spacerun: yes;"> </span>But the decision seems to ignore the
substantiality of the risk, and allows punitive damages solely on the basis
that the device had not been adequately tested and the risk wasn’t known, not that it was actually substantial. <i style="mso-bidi-font-style: normal;">Id.</i> at *95-97.<span style="mso-spacerun: yes;"> </span>That’s not proper either, as our <span class="MsoHyperlink"><a href="http://druganddevicelaw.blogspot.com/2015/11/punitive-damages-how-much-increased.html" target="_blank">post last year</a></span>
on substantiality and punitive damages points out, both Utah and Georgia
require a high likelihood of injury before punitive damages are allowed.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Action
Marine, Inc. v. Continental Carbon Inc.</i>, 481 F.3d 1302, 1313 (11th Cir.
2007) (punitive damages permissible “where the actor believes that the
consequences of his act are <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">substantially certain</i></b> to result from
[it]”) (applying Georgia law) (emphasis added); <i style="mso-bidi-font-style: normal;">Daniels v. Gamma W. Brachytherapy, LLC</i>, 221 P.3d 256, 269 (Utah
2009) (punitive damages permissible where the conduct involved a “<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">high
degree</i></b> of risk”) (following Restatement (Second) §500) (emphasis
added).<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>While the
court reduced the amount of the punitive award to $1.1 million, under the
evidence described in the opinion, punitive damages had no business going to
the jury in the first place.<o:p></o:p></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-tab-count: 1;"> </span>There is a
lot going on in this decision and most of it is bad.<span style="mso-spacerun: yes;"> </span>We hope the defendant has better luck with a
do-over on appeal than it did with the jury’s do-over verdict.<o:p></o:p></div>
Michelle Yearyhttp://www.blogger.com/profile/00994598841153573554noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-49806569211350991142016-04-20T07:30:00.000-04:002016-04-20T07:30:20.960-04:00TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>In third
party payor litigation over prescription medical products, we have often
marveled at the causation arguments that plaintiffs have offered and the
willingness of some courts to accept collective proof over what really should
involve individualized proof.<span style="mso-spacerun: yes;"> </span>Like <a href="http://druganddevicelaw.blogspot.com/2015/12/the-third-circuit-does-about-face-on.html" target="_blank">here</a>, <a href="http://druganddevicelaw.blogspot.com/2015/02/indigestion-inducing-treatment-of-class.html" target="_blank">here</a> and <a href="http://druganddevicelaw.blogspot.com/2014/08/assuming-what-you-are-trying-to-prove.html" target="_blank">here</a>.
<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>(This
same dynamic plays out when governmental entities seek reimbursement for such
products too.)<span style="mso-spacerun: yes;"> </span>Usually, though, the
plaintiffs allege that the manufacturer’s fraud—under whatever particular
statutes or headings it is pursued—was unknown to them during the time for
which they seek damages for amounts paid for the product and that the damages
stopped once they found out.<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">Teamsters Local 237 Welfare Fund v.
Astra-Zeneca Pharms. LP</i>, No. 415, 2015, 2016 Del. LEXIS 236 (Del. Apr. 12,
2016), the plaintiff payors were undone by their concession that they knew
about the alleged fraud and kept paying for the drug at issue anyway.<span style="mso-spacerun: yes;"> </span>Based on its self-described common sense
analysis, the Delaware Supreme Court affirmed the dismissal for lack of
causation without weighing in on the Superior Court’s rejection of causation
where individual physicians made individual decisions about what to
prescribe.<span style="mso-spacerun: yes;"> </span>This is a good result, but we
are concerned about the implications for the practices of payors who seem
increasingly interested in signing up with contingency fee lawyers to sue
medical product manufacturers.<span style="mso-spacerun: yes;"> </span>(In case
you were wondering, that was a teaser, designed to get you to read all the way
to the end of the post.)</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>The basic
facts are that the plaintiff filed a purported nationwide class action on
behalf of third-party payors in Delaware state court in 2004, alleging that the
defendant violated state consumer fraud laws by falsely marketing Nexium as
being more effective than Prilosec, an older product with allegedly one-half of
the same active ingredient per dose.<span style="mso-spacerun: yes;"> </span>Adding
some facts omitted in the opinion, the initial NDA for Prilosec had been
approved in 1989 (under the name Losec) and lost exclusivity in 2001, around which
time FDA approved the NDA for Nexium, which had an enantiomer (here, the left
hand chiral image) of the Prilosec’s active ingredient as its active ingredient.<span style="mso-spacerun: yes;"> </span>The indications for both drugs were expanded
through the years, with Prilosec going over-the-counter in 2015.<span style="mso-spacerun: yes;"> </span>These drugs together accounted for a large
chunk of the prescriptions written for heartburn, gastroesophageal reflux
disease, and related complaints.<span style="mso-spacerun: yes;">
</span>Plaintiffs claimed that the development of Nexium and the marketing
campaign after its introduction were designed to get the defendant paid a high
price for its newer branded product instead of money going to pay for cheaper
generic versions of the older product.<span style="mso-spacerun: yes;"> </span>They
claimed they had been harmed by paying for the Nexium prescribed by physicians
for the patients participating in their plans.<span style="mso-spacerun: yes;">
</span>The same group of lawyers apparently filed other “essentially identical
class actions” with different sets of named plaintiffs, including one in
Delaware federal court that resulted in the dismissal of a New York consumer
fraud claim.<span style="mso-spacerun: yes;"> </span>Ignoring some history and
details much like the plaintiffs ignored the marketing for Prilosec over the
last fifteen years and the difference between a racemic mixture and an
enantiomer, the Delaware state court action woke up from a long slumber in 2014
with its second amended complaint asserting the same claims the federal court
had disposed of a few years before.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>The
Superior Court first determined that the law of New York, where the named
plaintiffs were based, applied instead of the law of Delaware, where the
defendant was based, or the laws of thirteen other states.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *9.<span style="mso-spacerun: yes;"> </span>The court found that plaintiffs
had not alleged the causation required for a consumer fraud claim:<span style="mso-spacerun: yes;"> </span>the “purported chain of causation that runs
from the allegedly deceptive advertisements that may have influenced the decisions
of individual doctors to prescribe a drug to their patients to causally affect
the payer unions in this case is simply too attenuated,” as the doctors would
be “presumed to go beyond advertising medium and use their independent
knowledge in making medical decisions.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at **9-10.<span style="mso-spacerun: yes;"> </span>We certainly like this reasoning, which would
apply to a bunch of these cases.<span style="mso-spacerun: yes;"> </span>We also
like that the court did not give plaintiffs a fourth chance to frame a
complaint that stated a claim.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>On appeal,
the Delaware Supreme Court took a different tack.<span style="mso-spacerun: yes;"> </span>First, it decided that it did not have to
choose between New York and Delaware law, as each had a similar causation
requirement in its consumer fraud law.<span style="mso-spacerun: yes;">
</span>New York’s clearly required a showing of causation, because the statute
authorized suit by “any person who has been injured by reason of any violation
of this section.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *12.<span style="mso-spacerun: yes;"> </span>In Delaware, the
statute did not have an express causation requirement and allowed a violation
without a showing of reliance.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at **10-14.<span style="mso-spacerun: yes;"> </span>It did, however, only authorize private suits
by a “victim of a violation.”<span style="mso-spacerun: yes;"> </span>The
court’s common sense interpretation, informed by common law fraud, was that
“the violation must have ‘caused’ harm to the person bringing the action for
violation of the act, or the person would not be a ‘victim.’”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *13.<span style="mso-spacerun: yes;"> </span>That makes sense to us and
allowed the court to address the adequacy of pleading under both New York and
Delaware law.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>When it
did, it chose not to address the Superior Court’s reasoning or “the lively
debate about the scope of causation and its interplay with state consumer fraud
statutes” given the role of physicians as prescribers of the products at
issue.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *17.</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
Instead, we rely on the common sense notion that TPPs who
claim that false advertising injured them, but continue to cover the allegedly
falsely advertised drug on their formularies and reimburse members for
prescriptions cannot, as a matter of law, establish that they were “injured by
reason of” or were victims of the false advertising.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>Plaintiffs had conceded at oral argument
below that they continued to pay for Nexium even after discovering that it was
a “fraudulent product.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at n.33.<span style="mso-spacerun: yes;"> </span>The three complaints had presumably been
silent on this, but they had made clear that they were aware of the “full scope
of the alleged fraud,” which distinguished this from cases where plaintiffs got
past motions to dismiss based on selective pleading about what they knew while
paying for the product at issue.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at n.34.<span style="mso-spacerun: yes;"> </span>There is perverse incentive for plaintiffs in
these cases to omit facts that would foreclose causation, when they should have
to make factual allegations about what they knew and what their behavior was to
state a claim for consumer fraud.<span style="mso-spacerun: yes;"> </span>The <i style="mso-bidi-font-style: normal;">Teamsters</i> plaintiffs, in part because of
the questioning of the court below, admitted enough so that it was apparent
that “[t]hey were injured by their own conduct,” not the defendant’s.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *19.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Plaintiffs’
remaining arguments for why they were harmed even though they each decided to
keep paying for Nexium prescriptions were rejected.<span style="mso-spacerun: yes;"> </span>Plaintiffs first offered a fraud on the
market theory, claiming the “market” price of Nexium was inflated (kindof like we addressed <a href="http://druganddevicelaw.blogspot.com/2014/12/when-it-comes-to-class-objective-is.html" target="_blank">here</a>).<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>“No
‘market’ in the traditional economic sense exists to set a price for
prescription drugs—pharmaceutical companies set prices in a heavily regulated
environment with little interplay between the laws of supply and demand,”
making any claim that the “market” price has been depressed speculative.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i>
at *21.<span style="mso-spacerun: yes;"> </span>In addition, because “the TPPs
elected to continue covering Nexium fully aware of their false advertising
claims[, to] recognize fraud on the market theory in the present context would
ignore the TPPs culpability for their self-inflicted wound.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>Plaintiffs’ last argument was that the
defendant’s advertising somehow forced them to pay for Nexium.<span style="mso-spacerun: yes;"> </span>The court’s rejection of this is as contrary
to business realities is best read in full:</div>
<br />
<div style="margin: 0in 0.5in 12pt;">
Their argument is particularly unpersuasive given the role of
TPPs in the healthcare system, a large part of which is cost control. <span style="mso-spacerun: yes;"> </span>TPPs are structured to counter pharmaceutical
company pressure on physicians and patients to prescribe and to use more
expensive branded drugs where generics will do. <span style="mso-spacerun: yes;"> </span>TPPs can incent physician and patient behavior
by not listing a drug on their formularies, or by offering financial incentives
to use less expensive and equally effective generic medicines. <span style="mso-spacerun: yes;"> </span>The TPPs chose not to do so here while fully
aware of their false advertising claims. That was their business decision to
make. But they cannot then recover damages under either consumer fraud statute
for the harm they inflicted on themselves.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<i style="mso-bidi-font-style: normal;">Id.</i> at *23.<span style="mso-spacerun: yes;"> </span>So, the dismissal without leave to amend was
affirmed in a decision providing plenty of ammunition to fend off similar
suits.</div>
<br />
<div style="margin: 0in 0in 12pt;">
<span style="mso-tab-count: 1;"> </span>Aside from
the incentive to plead in a way that makes it looks like plaintiffs might be
able to prove causation even for dubious reimbursement claims, there is another
potential incentive here.<span style="mso-spacerun: yes;"> </span>As we have
noted, there has been a spate of third party payor litigation over the last
decade or so and the dynamic seems be that plaintiff firms identify target
defendants and then trawl for “injured” payers to represent.<span style="mso-spacerun: yes;"> </span>Often, the same sort of newsworthy developments
that spawn product liability litigation—like major labeling changes, recalls or
market withdrawals, or new studies on risk or efficacy—give rise to third party
payor suits claiming damages before the news.<span style="mso-spacerun: yes;">
</span>We cannot presume to know everything that affects what drugs are listed
on the TPP’s formularies, what they pay, when they encourage a branded drug
over another, or when they encourage generics over branded drugs, but it would
be a shame if decisions about prescription drug benefits were influenced by the
prospect of future litigation.<span style="mso-spacerun: yes;"> </span>If, at
the first sign of an issue with a marketed drug, the response of a
litigation-conscious TPP is to pull it from the formulary, then the benefits
and potentially health of participating patients whose doctors still prescribe
them the drug may suffer.<span style="mso-spacerun: yes;"> </span>That would be
bad for patients, but it could also give rise to suits against the
TPPs—particularly if a number seem to act in concert—for wrongfully limiting
their benefits.<span style="mso-spacerun: yes;"> </span>The same plaintiff firms
might even trawl for suits against the TPPs.</div>
<div style="margin: 0in 0in 12pt;">
<br /></div>
Eric Alexanderhttp://www.blogger.com/profile/01766054899255569417noreply@blogger.com0tag:blogger.com,1999:blog-36762711.post-67479524657800612792016-04-19T17:44:00.002-04:002016-04-19T17:44:30.511-04:00Gutsy Gatekeeping: Plaintiffs’ Experts Excluded in Lipitor MDL
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">This week, as Drug and Device Law Jews, we are
preparing for Passover, which, like most Jewish holidays, begins with a
multi-generational dinner at the home of the Drug and Device Law Bubbie (our
mother).<span style="mso-spacerun: yes;"> </span>Although we of the second
generation (there are now four) still fancy ourselves to be the “kids’ table”
at this dinner – giggling at the solemn points of the reading, singing endless
choruses of our favorite Passover song in defiance of the “just one time” edict,
and generally disrupting the proceedings as much as possible – the reality is
that we are all upper-middle-aged adults.<span style="mso-spacerun: yes;">
</span>And, as our matriarch ages (at least on paper), we assume more and more
of the food preparation for the Seder dinner.<span style="mso-spacerun: yes;">
</span>And there’s the rub.<span style="mso-spacerun: yes;"> </span>For, much as
we would enjoy the occasional stroke of rogue creativity, we know that nothing
unfamiliar will be allowed on the table and that each of the traditional dishes
must taste exactly as it has tasted for the past 50-plus (if not 2,000) years.<span style="mso-spacerun: yes;"> </span>Every ingredient and every step of
preparation is subject to scrutiny, and Bubbie is the gatekeeper.<span style="mso-spacerun: yes;"> </span>(You know where this is going).<span style="mso-spacerun: yes;"> </span></span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">As everyone knows, under SCOTUS’s <i style="mso-bidi-font-style: normal;">Daubert </i>decision, the trial court is the
gatekeeper when it comes to admitting or excluding the testimony of expert
witnesses.<span style="mso-spacerun: yes;"> </span>We who practice in the mass
tort space have gratefully experienced judges who take this responsibility
seriously and have endured those who “punt” these determinations, nearly always
to the benefit of plaintiffs whose dime-store experts – lacking qualifications,
methodologies, or both – are permitted to peddle their wares to unsuspecting
juries.<span style="mso-spacerun: yes;"> </span></span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">The Lipitor MDL judge falls resoundingly into the
former camp.<span style="mso-spacerun: yes;"> </span>In <i style="mso-bidi-font-style: normal;">In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices, and
Prods. Liab. Litig., </i>2016 WL 1251828 (D.S. C. Mar. 30, 2016), considered
the defendant’s <i style="mso-bidi-font-style: normal;">Daubert </i>motions
addressed to the plaintiffs’ four causation experts, and wholly or partially
excluded all four.<span style="mso-spacerun: yes;"> </span>But there is
backstory.<span style="mso-spacerun: yes;"> </span>Lipitor is prescribed in four
different doses – 10 mg, 20 mg, 40 mg, and 80 mg.<span style="mso-spacerun: yes;"> </span>This is an MDL, so our readers can guess
which doses most of these plaintiffs took.<span style="mso-spacerun: yes;">
</span>While several studies show a statistically significant association
between higher doses and new-onset diabetes, none shows such an association at
the lowest dose.<span style="mso-spacerun: yes;"> </span>After the plaintiffs’
experts submitted their initial reports, the court “was concerned as to whether
Plaintiffs’ experts had sufficient facts and data to support their causation
opinions at all doses . . . , and even whether the experts would be willing to
offer an opinion at low doses, given the available data.” <i style="mso-bidi-font-style: normal;">In re Lipitor, </i>2016 WL 1251828 at *3.<span style="mso-spacerun: yes;"> </span>Over the defendant’s objections, the court
allowed all four of the plaintiffs’ experts to submit supplemental reports
addressing whether the drug caused diabetes at particular doses.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at
*5.<span style="mso-spacerun: yes;"> </span>The defendant’s <i style="mso-bidi-font-style: normal;">Daubert</i> motions followed submission of the supplemental reports. </span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<u><span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Expert No. 1</span></u></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Plaintiff’s first expert was an epidemiologist.<span style="mso-spacerun: yes;"> </span>He used “standard epidemiological
methodology;” namely, he performed a systematic literature search, searched
relevant databases, reviewed studies, and conducted his own meta-analysis,
noting that “multiple studies found a statistically significant association
between statins and incident diabetes.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *6.<span style="mso-spacerun: yes;"> </span>Once he identified this association, the
expert applied the Bradford Hill factors (strength of the association,
replication of the findings, specificity of the association, temporal
relationship, dose-response relationship, biological plausibility, consistency
with other knowledge, consideration of alternative explanations, and cessation
of exposure) to determine whether the association reflected a causal
relationship.<span style="mso-spacerun: yes;"> </span>Though the defendant
attacked the expert’s methodology, the court rejected this argument, holding
that the expert had applied the Bradford Hill factors in an acceptable manner,
and that the defendant’s disagreement with the expert’s conclusions was a
matter for cross-examination, not exclusion of the expert’s testimony.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at
*7.</span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Reiterating that each expert was required provide
opinions with regard to specific doses, the court next considered whether the
expert had identified sufficient facts and data to support his causation
opinion at all of the various doses.<span style="mso-spacerun: yes;">
</span>With respect to all except the highest (80 mg) dose, the court held that
the expert had not.<span style="mso-spacerun: yes;"> </span>The court explained,
“The critical guide . . . in determining whether the evidence, taken as a
whole, is sufficient to support an opinion under Rule 702 is whether it would
be sufficient in the relevant field or is sufficient under the applied
methodology.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *9.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>With respect to the expert’s 10 mg opinion,
the court held, that the opinion “was not based on sufficient facts and data
and that [the expert] did not reliably apply the epidemiological/Bradford Hill
method, which requires at the outset a statistically significant association
before applying the Bradford Hill factors to make a judgment about whether the
observed association is causal.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *11.<span style="mso-spacerun: yes;"> </span>There was no such association, and the expert
had (improperly) skipped directly to application of the Bradford Hill
factors.<span style="mso-spacerun: yes;"> </span></span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">With respect to the 20 mg and 40 mg doses, the
expert had testified in deposition that he could identify no study that
produced a statistically significant finding that either dose increased the
risk of Type 2 diabetes.<span style="mso-spacerun: yes;"> </span>As such, by his
own testimony, the expert was unable to offer causation opinions about the 20
mg and 40 mg doses.<span style="mso-spacerun: yes;"> </span></span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<u><span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Expert No. 2</span></u></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">The plaintiff’s second expert was “not an expert in
epidemiology, and his deposition highlight[ed] the fact that he [was]
unfamiliar with basic principles of the field.<span style="mso-spacerun: yes;">
</span><i style="mso-bidi-font-style: normal;">Id. </i>at *12.<span style="mso-spacerun: yes;"> </span>The expert had not heard of common epidemiological
phrases, testified that, in clinical trials, the patient’s own baseline was “a
more important and better control” than a placebo group, <i style="mso-bidi-font-style: normal;">id., </i>and confused “association” with “causation.” </span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">With respect to the expert’s methodology, the court
commented, “Given that [he] is not an epidemiologist, it is unsurprising that
he does not use the epidemiological/Bradford Hill method” to determine
causation.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *13.<span style="mso-spacerun: yes;"> </span>However,
“neither of his reports state[d] what methodology he is using or attempting to
use to reach his conclusions, and the method [was] not obvious from the face of
his reports.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.<span style="mso-spacerun: yes;"> </span></i>Plaintiffs argued that
the expert used the method of a literature review; however, the court found
that he did not review the “totality of the literature.”<span style="mso-spacerun: yes;"> </span>Rather, he impermissibly cherry-picked data
to support his conclusions and failed to adequately account for contrary
evidence.<span style="mso-spacerun: yes;"> </span>As such, the court held that
the expert had not utilized a reliable methodology and had not employed
adequate intellectual rigor in reaching his conclusions.</span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<u><span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Expert No. 3</span></u></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">The plaintiffs’ third expert’s supplemental report
reached a single causation conclusion that swept across the four dosage levels,
thus failing to comply with the court’s order that the four dosages be
considered separately.<span style="mso-spacerun: yes;"> </span>In addition,
“[the expert’s] other methodological flaws only compound[ed] her reliability
problem.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i>at *17.<span style="mso-spacerun: yes;"> </span>Admitting that
she was not an expert in epidemiology, the expert “[did] not state what, if
any, methodology she used, [could not] identify the limitations of different
types of epidemiological studies and [was] not even able to give a basic
definition of some types of epidemiological studies . . . .”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>She “believe[d] that observational studies
provide better evidence than randomized control trials, . . . appear[ed] to
confuse association and causation. . . , and, in her deposition, “seemingly
forgot what methodology she employed to reach her opinions.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.<span style="mso-spacerun: yes;"> </span></i><span style="mso-spacerun: yes;"> </span>Asked to explain her methodology, the expert
stated, “I read the articles.<span style="mso-spacerun: yes;"> </span>And I
don’t really understand the question.<span style="mso-spacerun: yes;"> </span>I
don’t – I didn’t use any – I don’t know what you mean by what method did I use
to analyze them.”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.<span style="mso-spacerun: yes;"> </span></i>Finally, the court held
that, whether the expert used the Bradford Hill method or the literature review
method that the plaintiffs claim she used, the method was not reliably applied.
Deliciously nailing the coffin, the court held:</span></div>
<br />
<div style="margin: 0in 0.5in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Because [the expert] had no methodology for
determining which studies to consider and which to disregard, apparently just
choosing those that she remembered or found supportive of her opinion, because
she fails to adequately account for contrary evidence, because she confuses
association and causation, because she lacks the epidemiological expertise to
evaluate epidemiological studies in a Bradford Hill analysis, and because she
fails to provide any analysis at all as to whether particular dosages are capable
of causing diabetes, the Court excludes [the expert’s] opinions as unreliable
under Rule 702.</span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<i style="mso-bidi-font-style: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Id.
</span></i><span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">at
*18. </span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<u><span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">Expert No. 4</span></u></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">The plaintiffs’ fourth expert, a retired professor
of diabetic medicine, “discusse[d] several observational studies, clinical trials,
and meta-analyses,, and offer[ed] the opinion that ‘atorvastatin increases the
risk of diabetes in a sustained dose-dependent manner.’”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id. </i><span style="mso-spacerun: yes;"> </span>He did not conduct a systematic review of the
literature, but stated that he “put his reliance on meta-analyses using
powerful methodology. ”<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.<span style="mso-spacerun: yes;"> </span></i>Finally,
he did not submit the required supplemental report, but simply “ascribe[d] the
risk of [the drug] to all doses”. . . . The court held that the expert’s
opinion was unreliable and excluded it in its entirety.</span></div>
<br />
<div style="margin: 0in 0in 10pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; line-height: 115%;">And so, out of four experts’ reports, all was
excluded except for one expert’s opinion about the very highest dose of the
drug.<span style="mso-spacerun: yes;"> </span>As a practical matter, this left
most plaintiffs without causation experts and unable to meet their burdens of
proof.<span style="mso-spacerun: yes;"> </span>You can bet those claims were
poor, otherwise the MDL plaintiffs would have been able to offer better expert
opinions.<span style="mso-spacerun: yes;"> </span>We applaud this gutsy
judge.<span style="mso-spacerun: yes;"> </span>No doubt over Bubbie’s
objections, we will sing a final joyful chorus of our favorite Passover song in
his honor.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></span></div>
Rachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.com0