Wednesday, September 02, 2015

Plaintiffs’ Daubert Challenge Rejected

            This post is from the non-Reed Smith side of the blog.

            If you skim through our Daubert posts, they are usually celebrating successful defense challenges to plaintiffs’ experts.  We have posts on repeat offenders like Blume and Parisian.  We have posts on unqualified experts – those with no educational or professional experience on the topics they wish to opine.  We have lots of posts on unsupported opinions, insufficient data and unreliable methodology.  And there are posts on experts who seek to invade the province of the jury (those who want to interpret corporate documents) or the court (those whose vocabulary include things like negligent and reckless). 

            It is less common for plaintiffs to file Daubert motions seeking to exclude defense experts.  But that is just what happened in In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., 2015 WL 5050214 (N.D. Ill. Aug. 25, 2015).  Which means today we get to celebrate the denial of a Daubert motion – a Daubert win from a slightly different angle.

            On of the issues in the Zimmer Nexgen litigation is whether defendant’s high-flex knee implants have an artificially higher failure rate than their equivalent counterparts.  Id. at *1.  To dispute such a conclusion, defendant proffered testimony from an expert epidemiologist, Dr. Vitale, who conducted a literature review from which he concluded that the studies relied on by plaintiffs were outliers.  Id.  Plaintiffs challenged both the qualifications and methodology of defendant’s expert.

            On qualification, plaintiffs focused on the fact that defendant’s expert is a pediatric spine surgeon; that he does not specialize in knee replacements.  Plaintiffs, however, overlooked that Dr. Vitale also has a master’s degree in public health with an emphasis on clinical outcomes research, an area in which he has also published.  Id. at *4.  His testimony and conclusions were not based on his experience as a pediatric spine surgeon, but rather his “epidemiological and general clinical research expertise.”  Id. at *5. 

            The analysis of Dr. Vitale’s research methodology is more complex and multi-faceted.  We’ll walk through the important aspects, but the overall conclusion of the court is that his methodology was reliable and admissible.  Those aspects of his research and conclusions plaintiffs take issue with do not warrant exclusion, but rather can be tested through cross-examination.

            What was his research?  Dr. Vitale conducted a “formal systematic review of the literature.”  (He reviewed other data as well that plaintiffs did not challenge).  In the simplest terms, Dr. Vitale used search terms to find relevant literature on the topic at issue or to create a “neutral snapshot of the existing research on a particular question.”  Id. at *3.  Irrelevant studies – those that don’t address the research topic – are omitted, as are studies that have other flaws.  Id. at *4.  The remaining literature is reviewed and scored and the research usually concludes with summary statistics and qualitative findings.  Id. at *3.  Plaintiffs did not challenge that a formal systematic literature review is an invalid methodology, but rather that the way Dr. Vitale conducted his review made it unreliable.

            Plaintiffs’ first argument was that Dr. Vitale failed to comply with internationally recognized guidelines for systematic reviews known as PRISMA.  Id. at *6.  The court was skeptical of plaintiffs’ argument from the outset considering plaintiffs’ own expert neglected to cite PRISMA, “which casts some doubt on Plaintiff’s claim of widespread acceptance.”  Id  at *7.  More importantly, the court noted that PRISMA is really about the “reporting” of systematic reviews, not their “conduct.”  Id. While reporting is important for publication, it isn’t really the cornerstone of a Daubert analysis.  So, failing to report his results graphically, for example, isn’t something that calls into question the reliability of Dr. Vitale’s research.  Id. at *8.  Nor was it fatal that Dr. Vitale’s report did not include an explicit statement of his research question.  Again, this is important for publication so that subsequent researchers can determine if the analysis is applicable to their interests.  In the context of litigation, Dr. Vitale’s research objective was clear – both from his deposition testimony and the totality of his report.  Id. at *7.  Would Dr. Vitale’s research and conclusions have to be reported differently to pass peer review for publication?  Maybe.  But that’s not Daubert. 

            Plaintiffs next challenged Dr. Vitale’s opinion on the ground that he commingled heterogeneous studies – studies of varying lengths, size, follow-up, etc.  Id. at *9.  While heterogeneity can be problematic, Dr. Vitale’s report acknowledged that “the variability among study cohorts precludes aggregate analysis.”  Id.  It is up to the plaintiffs to cross-examine Dr. Vitale regarding this inclusion and exclusion of certain studies, it is not the court’s role “to determine whether Dr. Vitale’s ultimate conclusion is the right one.”  Id.  That’s for the jury.

            Plaintiffs also alleged that Dr. Vitale “cherry-picked” the studies he included in his review.  Maybe a little pot calling the kettle on this one.  There is no shortage of instances where defendants have challenged plaintiffs’ experts on this basis.  Here, however, the court did not find evidence of inappropriate selection or exclusion by Dr. Vitale.  First, Dr. Vitale did not ignore the studies as plaintiffs contend.  All were cited and discussed in the report, including the reasons why they were excluded.  The court took note of Dr. Vitale’s even-handed exclusion, for objective scientific reasons, of studies that were both favorable and unfavorable to the defense position.  Id. at *10-11.  While there may have been oversights, those should be the topic of cross-examination.  There was no basis to conclude that Dr. Vitale attempted to distort the data such that his results should be excluded as unreliable.  Id.

            Finally, plaintiffs challenged Dr. Vitale’s subsequent analysis on range of motion.  In response to Dr. Vitale’s initial report, plaintiffs claimed that he had failed to consider the range of motion achieved by the patients in the studies (plaintiffs contend that failure rates may be higher for those who achieve high flexion as opposed to those who do not).  So, Dr. Vitale went back to look at that issue.  Plaintiff then claimed that Dr. Vitale “is required to conduct a completely new systematic review with a search driven by this new question.”  Id. at *12.  If we understand correctly, plaintiffs’ position is that because the defense expert did a subsequent analysis to respond to plaintiffs’ criticism, he has to start from scratch and do his analysis based on plaintiffs’ stated objective.  The court understood that too:

Dr. Vitale simply revisited those studies to determine whether [plaintiffs’] attack had merit and updated his data accordingly.  The court does not agree with Plaintiffs that this subsequent analysis was invalid or unreliable.


            So, when the bellwether trials in the Zimmer NexGen litigation begin, the jury will be able to hear from Dr. Vitale that in his expert epidemiological opinion, the studies relied on by plaintiffs are outliers.  He’ll be allowed to present his methodology and his conclusions with a stamp of approval from the judge that he is both qualified to do so and that he used a reliable methodology.  Sure, plaintiffs can pick around the edges – but most of their arguments have been rejected.    It is slightly odd to be lauding the denial of a Daubert motion, but Zimmer’s expert report in this case seems to stand head and shoulders above what we often see from plaintiffs. While we may be the ones more often challenging things like cherry-picking and commingling, it’s nice to see that when plaintiffs tried to turn the table – the defendant still came out on top. 

Tuesday, September 01, 2015

New Jersey Federal Baked Goods Fraud Class Actions Are Toast

Almost on this date in 1901 (tomorrow actually), Teddy Roosevelt for the first time uttered in public the immortal phrase, "Speak softly and carry a big stick". It is hard to find people who do not admire that statement.  It is harder to find people who actually practice it. These days we are accustomed to wimpy parents and blowhard politicians who talk tough but do nothing.   As a result, you get teenagers gobbling up the cheese-of-the-month delivery and Russia gobbling up Crimea.  We also encounter some soft-hearted and -headed judges who speak loudly and wield no stick – at least when it comes to clamping down on bogus lawsuits.  Corporate defendants hauled/haled/but-definitely-not-hailed into court are held to ludicrously high standards, while plaintiffs dwell in a world of do-overs and feckless flexibility. 

A couple of weeks ago we discussed CD Cal Judge Wilson, who is as demanding as he is smart.  One could say (and we have said) the same about Judges Posner, Boggs, Kozinski, and Rakoff.  One could also say that about D NJ Judge Irenas who sits in the Camden federal courthouse, which we can see out our window if we crane our heads just so.  If you read the Robing Room evaluations of Judge Irenas (which you must necessarily take with a grain of salt, since they are peppered with the comments of sore losers) a picture emerges of intelligence and rigor.  

We can be an oath-helper on that fact.  After our first year of law school, we summered at McCarter & English in Newark, NJ. Irenas was a partner there, and was universally acknowledged to be the smartest lawyer in the building.  In our second or third week as a summer associate, we received an assignment from Irenas.  The other summer associates cackled with glee. That is because in addition to having a reputation for being smart, Irenas had a reputation for not suffering fools gladly.  And all of the summer associates were fools.  An Irenas assignment was an opportunity, but a frightening one. 

The assignment involved the inevitable research memo.  After we turned it in to him and were grilled to a nice medium-well, we got on a conference call.  At one point, the party on the phone voiced some trepidation and reservations, whereupon Irenas thundered a withering critique of said reservations. Loud dysphemisms filled the air.  He must have seen us shaking with terror, because he smiled and gestured to show us that his finger, which was resting on the microphone (back then speakerphones were separate from the actual telephone, and were connected by a wire) was also pushing down on something we did not know existed - a mute button.  He then released the button and rendered a much more temperate, but still piercing, dissection of the reservations.  What he said was about a hundred times more insightful and felicitously expressed than our pathetic research memo.  Lesson learned.  

Our encounter with Irenas was all too brief that long-ago summer.  In the decades since we have never encountered a smarter lawyer.  Eventually, he became a judge, and his reputation for intelligence followed him to the federal courthouse.  Of course, there are plenty of smart judges out there.  But not all are willing to apply that intelligence to winnow away weak litigation.  A delicious example of a brilliant judge taking a close look at a case and dismissing it for not passing muster is Mladenov v. Wegman's Food Markets, Inc., 2015 U.S. Dist. LEXIS 112740 (D.N.J. August 26, 2015). 


Mladenov was actually three cases – three purported diversity class actions in which the plaintiffs alleged that three different grocery stores misrepresented bread and bakery products as being baked fresh in the store, when they were actually frozen, processed, or baked in another location, supposedly in violation of New Jersey consumer fraud statutes as well as express warranties.  The class was defined as all individuals and entities within New Jersey who purchased bread and/or bakery products advertised and sold as “made in house” and/or “freshly baked” and /or "freshly boiled” and/or “fresh” in those three grocery stores located in New Jersey on or after December 14, 2008. 

Judge Irenas tested the ingredients of the lawsuits layer by layer.  The court initially asked the parties to address whether the classes would be ascertainable.  The proposed classes consisted of consumers who purchased individual allegedly-misrepresented products and the proposed method of identifying class members would rely on retail records.  The class definitions also required that the purchased products were specifically advertised at the time as based in store or baked fresh.  But here is a big problem:  the retail records, such as receipts, would not reflect such information.  Moreover, the plaintiffs did not dispute that cash purchasers of the bread and bakery products who did not use loyalty cards could not be identified in any reliable way.  So much for ascertainability.  The court also decided that certification under Fed. R. Civ. P. 23(b)2) – which applies to actions for injunctive or declaratory relief – was unavailable here because even though such claims were included in the prayer for relief, it was obvious that the lawsuits were primarily for money damages. 

Getting beyond the class certification issue, the court went on to dismiss the substantive claims because the plaintiffs failed to plead unlawful conduct, ascertainable loss, or a causal relationship between the alleged unlawful conduct and loss.  The plaintiffs alleged that the defendants displayed in-store signs such as “STORE BAKED ROLLS.” But the complaints did not allege that the plaintiffs actually saw such signs, in which store that occurred, or when the plaintiffs saw it.  As the court observed, the defendants’ stores contain numerous bread and bakery products and the signs advertising such products change often.  It was simply not the case that all relevant items were stamped “freshly baked.” 

Further, nowhere in their complaints or anywhere else did the plaintiffs allege facts supporting an out-of-pocket loss, i.e., that the products they purchased were worthless.  Wherever the bread was baked, it was presumably edible.  The plaintiffs claimed to be particularly health conscious consumers, but they did not allege that the relevant products were somehow less nutritious due to their not being made from scratch in the store.  As the court saw it, the real allegation underlying the case was that the plaintiffs paid an unnecessary premium for what they believed to be store-made bread.  That would be a benefit-of-the-bargain theory of ascertainable loss.  But the plaintiffs “gave no basis for valuing the products they received as opposed to the products they were promised.”  Rather, the plaintiffs alleged only that they purchased various bread and bakery products at premium prices over the years and would not have done so “in absence of Defendant’s misleading advertisement.”  Easy to say.  The problem with this theory ties in with the class action ascertainability issue:  the plaintiffs did not specify any instance in which they even saw the defendant’s advertisements, either in the stores or on websites.  The plaintiffs also failed to allege which food products they purchased as a result of viewing the advertisements.  Thus, the court could not, without more, “infer from Plaintiffs’ pleadings a link between an affirmative misrepresentation and an ascertainable loss.” 

The court slices open the plaintiffs’ allegations and finds more puff than filling.  We then get to watch each legal theory fall, one by one.  Thus, the court tartly dispenses with the misrepresentation claims because the “conclusory allegations regarding numerous potential purchases of various products over a substantial period of time with the mere specter of supposedly misleading advertisements generally existing in Defendants’ stores and websites will not suffice under Rule 9(b)’s heightened pleading standard.”

The warranty claims disintegrated into mere crumbs.  An express warranty claim “requires a plaintiff to allege that she brought a product based on a particular promise regarding that product, which ultimately proved false.”  But, again, the plaintiffs cannot successfully plead such a claim without identifying in the complaints any specific sign or advertisement they saw and the products they purchased as a result.  Again, the plaintiffs simply did not satisfy the recipe.     

The claims for injunctive and declaratory relief also found their way to the waste bin.  There was no plausible claim of threat of immediate harm.  How could there be?  After all, the plaintiffs disclaimed any intention to continue to purchase the defendants’ bread and bakery products.  Instead, the plaintiffs argued that they were entitled to injunctive relief based on the threat of future harm to other consumers. How thoughtful.  How inadequate.   At this stage, when no class has been or ever will be certified, the court considered “Plaintiffs’ claims as they apply to Plaintiffs alone, not the putative class.”     

We will end with the icing on the cake, the aspect of the case that is most relevant to drug and device law.  The plaintiffs’ claims under the New Jersey consumer protection statute appeared to rely on regulations (specifically, 21 C.F.R. § 101.95) under the Food Drug and Cosmetic Act.  But it is “well settled … that the FDCA creates no private right of action.”  The plaintiffs in this bakery fraud case could not use the New Jersey statute “to bootstrap a FDCA claim they could not otherwise bring.”  That is a tasty result.  (We cannot resist wondering why California courts resist this sort of logic and rigor, and why they are willing to entertain so much silly food litigation premised on nothing more than a hunger for attorney fees.) 

Mladenov may not be a drug or device case, but what it says about no FDCA private right of action, or class ascertainability, or connecting specific representations to injury, are all pertinent to our field.  Plus there’s this:  all lawyers should know that one cannot walk into Judge Irenas's courtroom with legal arguments that are half-baked. 

Monday, August 31, 2015

Guest Post - Game of Thrones, the FDA Under Attack, An In-House View of Amarin

Today's guest post is a first for this blog in two ways, first, our guest poster is anonymous.  Second, our guest post is from an in-house source.  The two are, of course, related.  While it is important to us as lawyers that our clients not be charged with anything we say on our blog, that goes double (or triple) for someone actually working in-house.  So you won't know exactly who to credit, or blame, for what follows.

What follows is our in-house source's thoughts on the recent Amarin First Amendment victory over the FDA.


We are witnessing a strange chapter in the hegemony of FDA control over drug promotion.  For while the OIG and DOJ continue to make good use of their Swiss army knife of an Anti-Kickback Statute, the FDA has been taking body blows from First Amendment litigators.  First, the Supreme Court’s Sorrell decision, Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), protecting promotional communications as commercial speech; next, the Second Circuit in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), vacating a misbranding conviction on First Amendment grounds; and finally, the Southern District of New York in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015), declaring that a manufacturer may legally engage in off-label promotional communications.


Any doubts that this may indeed be a watershed event should be assuaged by the FDA’s public relations campaign to marginalize Caronia and the agency’s anxious efforts to moot the Amarin case or controversy before decision.


After all, the attack here is not a flanking maneuver.  It is aimed straight at the FDA’s weakened center and threatens to scatter the spoils of decades of doctrinal toil spent erecting the divide between on- and off-label communications, an article of faith in the industry.  And, to add insult to injury, and in marked contrast to the restraint shown in Caronia, the opinion in Amarin deliberately sabotages a key justification for FDA’s land grab on this subject −  that the FDA must be allowed to regulate truthful, non-misleading speech to protect the integrity of the drug approval process – by reasoning that the regulatory scheme “predates modern First Amendment law respecting commercial speech” and is thus vulnerable to “frontal assault” from manufacturers.  2015 WL 4720039, at *25.


Of course the victory is not conquest, and needs to be tempered by the acknowledgement that Caronia and Amarin reflect Second Circuit jurisprudence with limited precedential value outside of New York, Connecticut and Vermont.  The decision is also not a blanket license to promote off-label.  Different facts, and in particular different safety risks or less reliable scientific evidence, may result in a different balancing and warrant greater restrictions to protect the public health.  And there is the court’s admonition that the First Amendment protects speech, not conduct, 2015 WL 4720039, at *27, so promotional tactics designed to increase off-label use may still receive the full treatment from OIG and DOJ.  That being said, manufacturers are ahead of the FDA 3-0 in cases where the federal courts have applied Central Hudson’s commercial speech balancing test (see Central Hudson Gas & Electric Corp. v. Public Service Communication, 447 U.S. 557 (1980)). to drug promotion (4-0 if you include the venerable Washington Legal Foundation decision, WLF v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998)).


Given these caveats, the end game that will emerge from whatever chaos attends the demise of the FDA’s position is difficult to handicap at this point in time, which calls to mind Littlefinger’s apt observation, “Chaos is not a pit.  Chaos is a ladder.”  Interested observers, and forward thinking advisors, might be well-advised to climb that ladder and consider what this new world order would look like if this view from Manhattan were fully realized, at least for the sake of discussion.  For one thing, the heretofore binary world, divided between scientific exchange (unregulated) and promotion (heavily regulated), turns into a tripartite world, with a third category one could label “protected speech”:


So while the distinction in 21 C.F.R. § 312.7, cordoning off communications that are made outside of “a promotional context,” still applies to emancipate scientific exchange, promotional speech would now be separated into communications subject to traditional FDA controls and a new category of truthful and non-misleading promotion that is neither necessarily on-label nor based upon “substantial evidence.”  In effect, the dichotomy between on- and off-label communications disappears, since none of these three categories relies on the distinction as a criterion.


Most importantly, the authority for what is “truthful and not misleading” is not inevitably the FDA − which, if asked, is likely to take the position that the standard is coterminous with the existing substantial evidence requirements.  Put another way, the Second Circuit decisions stand for the proposition that “truthful and not misleading” data does not need to meet the FDA’s heightened standard, or require FDA approval, before it can be communicated to healthcare providers.


This change, should it take hold, would be significant, but probably not as momentous as the hysterics among us would have you think.  For one thing, one would expect that the drill for updating safety information would remain unchanged, since the interests of industry and the FDA are closely aligned on this issue.  There is every incentive for manufacturers to continue to work through the existing FDA processes to bring about label revisions to ensure that accurate and up-to-date contraindications, adverse reactions and interactions are reflected in the label (and failure to warn defenses in product liability cases preserved).  There is also much that remains on the FDA’s plate in terms of policing efficacy claims, even if the new standard is changed to truthful and not misleading.  If anything, the change should presage more, rather than less work for FDA staffers, now stripped of the thick armor provided by a blanket off-label prohibition.


Would this be a good thing for patient health?  It is hard to see how it would not be.  Manufacturers have always been the best source for detailed scientific information about their products and have clamored for many years against seemingly arbitrary restrictions on their ability to communicate this information.  Earlier efforts to fix the problem have fallen victim to what appeared to be kneejerk conservatism from the FDA – a condition that got the agency into this battle in the first place.

Ask But Don’t Tell: Kentucky Allows Defendant to Seek Ex Parte Interviews of Plaintiff’s Treating Physicians

We walked into the Drug and Device Law Rock Climber’s room last night to find her packing for her return to college while the ignored TV blared in the background.  Onscreen was a popular cable reality franchise involving wealthy denizens of a gated community in Southern California.  The heated argument du jour involved one resident’s decision to speak privately to another about a third, during which exchange B-to-C confidences may or may not have been disclosed to A.  The original confider was adamant that the information was hers alone to control, insisting that the private conversation should not have occurred.  Much perfectly-coiffed shrieking ensued.

We were reminded of this spectacle as we read the decision of the Kentucky Supreme Court in Caldwell v. Chauvin, -- S.W. 3d. --, 2015 WL 3653447 (Ky. June 11, 2015).  In Caldwell,  the underlying medical malpractice action involved plaintiff’s claim that her spinal surgery was unnecessary and negligently performed and caused her permanent injuries.  In the course of discovery, defendant moved for a qualified protective order permitting him to make ex parte contacts with plaintiff’s healthcare providers.   The court entered an order permitting such contacts but expressly declining to authorize disclosure of plaintiff’s health information. The order “also explicitly stated it was [not] requiring any physician to speak with [defendant] . . . , noting [that] the treating physicians [were] free to accept of decline counsel’s request as they [saw] fit.”  Id. at *2 (internal punctuation omitted).  Plaintiff sought a writ of prohibition from the Court of Appeals.  The Court of Appeals declined to issue the writ, holding: 1) no Kentucky law prohibits the trial court from authorizing ex parte communications with non-expert treating physicians; and 2) the order did not violate any privacy right plaintiff might have because it did not compel the disclosure of any information.  Id.

On further appeal, the Supreme Court first considered whether HIPAA prohibits ex parte contacts with treating physicians.  The Court noted that HIPAA provides for mandatory disclosure of protected health information by a covered entity, such as a healthcare provider, only when: 1) an individual requests her own health information; or 2) the Secretary of HHS requests it to investigate HIPAA compliance.  Id. at *6 (citation to HIPAA omitted).   “Permissible disclosures” under HIPAA include the “litigation exception,”  which “permits disclosure of protected health information in the course of any judicial or administrative proceeding, either in response to an order of court or administrative tribunal or in response to a subpoena, discovery request or other lawful process, so long as additional safeguards are met” to protect the disclosed information.  Id. (internal punctuation and citation omitted). 

 “Noticeably absent from the sea of HIPAA privacy regulations,” the Court pointed out, “is any mention of ex parte communications between counsel and a covered entity.  In fact, the privacy rule does not purport explicitly to regulate the permissibility of ex parte communications or interviews as an informal discovery tool.” Id. at *7.  However, “[b]ecause HIPAA, by its terms, applies to the oral disclosure of health information, it has routinely been held that the disclosure of protected health information in ex parte interviews falls within the ambit of HIPAA. “  Id.  While plaintiff argued that that the so-called “judicial exception” is inapplicable to ex parte discovery because such discovery falls “outside the course of any judicial or administrative proceeding,” the Court agreed with defendant that HIPAA “does not prohibit ex parte interviews with treating physicians” but “merely superimposes procedural prerequisites to authorize disclosure of protected health information.”  Id.  The Court emphasized that protected health information may be disclosed in the course of such an interview only when ordered by a court or administrative tribunal.  Id.


The Court next considered the issue of HIPAA preemption, noting that “HIPAA contains a preemption clause whereby any ‘contrary’ provision of state law is preempted absent the application of any enumerated exception.”  Id. at *10.  But, “if a ‘contrary’ law requires a more stringent standard of privacy, HIPAA’s preemption provisions are inapplicable and state law controls.”  Id. at *10.  Thus, the Court analyzed Kentucky law to determine what law controlled the dispute.

First, the Court rejected plaintiff’s arguments that a patient- physician privilege protected her communications with her treating physicians, or, in the alternative, that the Court should treat those communications as privileged even if no privilege existed..  The Court commented that plaintiff’s argument was “disingenuous at best,” as, “[f]or better or worse, [Kentucky] jurisprudence has been unwavering in [its] rejection of the patient-physician privilege.”  Id. at *11.  The Court concluded, with evident impatience, “It is high time litigants abandon this tired argument.  Our disinclination to recognize a physician-patient privilege or to apply the faux privilege that [plaintiff] argues for in the alternative is well documented,” to be altered only by changes to the rules of evidence or by legislative enactment.  Id.

Next, the Court rejected plaintiff’s argument that the American Medical Association’s Code of Medical Ethics rendered ex parte contacts with treating physicians impermissible. The Court noted that, while the relevant provisions “created a professional duty that requires healthcare providers to maintain the confidentiality of patient information,” the Code lacked the force of law and did not “create an all-encompassing right to confidentiality by patients.”  Id. at *12.  The Court concluded,

A physician’s ethical duty of confidentiality, even if promulgated by a professional body under statutory authority, does not carry the weight of law to limit a litigant’s ability to engage in ex parte interviews with physicians.  Admittedly, the ethical duty may restraint he physician’s willingness to agree to such an interview, but it in no way prohibits a party to litigation from requesting one. 

Id. at *13.   

Finally, commenting that, “[a]s with her previous state-law arguments, [plaintiff] again overstates the scope of the law she cites,” the Court concluded that nothing in Kentucky case law “limits a litigant’s ability to conduct informal ex parte interviews when the fact witness interviewed is a treating physician.  They are like any other fact witness in the eyes of the law.”  Thus, Kentucky law contains neither prohibition against such interviews nor entitlement to them.  Id. at *14.  As such, “Kentucky law cannot be contrary to HIPAA as pertaining to ex parte interviews with treating physicians . . . ,” and preemption doesn’t come into play. 

The Court concluded  that, while the challenged trial court order was not HIPAA-compliant and could not operate to authorize the disclosure of the plaintiff’s protected health information, it did not seek to provide such authorization.  In fact, it expressly declined to compel disclosure of protected  information.  As such, the trial court’s order did “nothing more than maintain the status quo.   It . . .effectively, and correctly, stated the status of the law currently:  defense counsel may seek an ex parte interview with [plaintiff’s] treating physicians, but those physicians may not disclose her protected health information without facing HIPAA sanctions.”  Decision affirmed, no writ issued. 

We like this opinion.  We enjoy good writing and appreciate a prickly, impatient judge (when we are not the targets).  And if nothing really happened – if all of the holdings were already inevitable under Kentucky law and HIPAA – it was a good show.  Like our favorite reality screamfests.  Tune in tomorrow.   

Friday, August 28, 2015

Breaking News - Ohio Sets Class Actions Right.

One of the most basic prerequisites to having court rules is that the rules aren’t supposed to change substantive law.  With class action rules, like Fed. R. Civ. P. 23 and its state-law analogs, courts seem to have a hard time remembering that.  No substantive effect means that, if a plaintiff couldn’t bring the claim individually, that same claim can’t be brought on behalf of that same plaintiff via a class action.

One of the most basic attributes of almost any cause of action is injury.  That’s why we’re bringing you news of the recent Ohio Supreme Court decision in Felix v. Ganley Chevrolet, Inc., No. 2013-1746 slip op. (Ohio Aug. 27, 2015), even though it’s not a drug and device case.

It’s a consumer fraud statute case brought under the Ohio version of Rule 23, and we think all defense attorneys who confront this kind of thing ought to know about it.  It’s that good.  Some choice quotes:

Plaintiffs bringing OCSPA [the Ohio statute] class-action suits must allege and prove that actual damages were proximately caused by the defendant’s conduct.

Felix ¶31.

Plaintiffs in class-action suits must demonstrate that they can prove, through common evidence, that all class members were in fact injured by the defendant’s actions.

Id. ¶33.  Note the word “all.”

The inquiry into whether there is damage-in-fact is distinct from the inquiry into actual damages:  fact of damage pertains to the existence of injury, as a predicate to liability.

Id. ¶34 (citation and quotation marks omitted).

If the class plaintiff fails to establish that all of the class members were damaged (notwithstanding questions regarding the individual damages calculations for each class members), there is no showing of predominance.

Id. ¶35.  Again, note the word “all.”

Perhaps the most basic requirement to bringing a lawsuit is that the plaintiff suffer some injury.  Apart from a showing of wrongful conduct and causation, proof of actual harm to the plaintiff has been an indispensable part of civil actions.  We agree, and we hold that all members of a class in class action litigation alleging violations of the OCSPA must have suffered injury as a result of the conduct challenged in the suit.

Id. ¶36 (emphasis added).

Here, here!  This is the only way that a class action rule can be read so that it does not improperly change the underlying substantive law, and plaintiffs get away with herding uninjured persons into class actions – indeed, bringing class actions where nobody at all has been injured − all the time.

Not in Ohio, anymore.  We thought you’d like to know.

Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

            A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted directed verdict at the end of plaintiffs’ case.  Our readers may have noticed that we (in both the singularly singular and common plural sense of the word) have a thing for proximate cause for failure to warn, which was why the defendant won in Hexum.  So, we decided to somewhat deeper dive on why the defendant drug manufacturer won and whether there are lessons to be learned.

            We start with two caveats and one somewhat rhetorical question.  First, plaintiffs rested their case on the second day of trial.  How much evidence they could have presented was no doubt limited by the Daubert rulings and other evidentiary rulings, but they seem to have taken a pretty narrow view of the evidence they needed to present for their four remaining claims—negligent failure to warn, strict liability failure to warn, negligent misrepresentation, and fraud—all grounded in failure to warn the learned intermediary.  For instance, they chose not to present evidence from the physician who directed plaintiff (the one on the drug) to taper down and stop the drug.  Second, from the testimony presented in the order—which we assume is the most relevant—it does not look like plaintiffs pushed hard to get the “magic words” that most plaintiffs try to get from prescribing physicians.  The result was testimony that was more “fuzzy” on some key issues than we normally see in prescription drug product liability cases, even though this testimony was from the trial.  Assuming plaintiffs did not do any better with the prescribing physician in deposition than they did at trial—and one would expect they would have impeached him with inconsistent deposition testimony—then why did this case get past summary judgment?
            But it did, so on to the directed verdict order.  The basic allegation was that the label was inadequate in how it warned about the risk of various (mostly transient central nervous system) symptoms upon discontinuation of the drug and the need to taper the drug down.  The plaintiff who took the drug—her husband also sued—experienced some of these a year after starting the drug when she moved away and talked to a new doctor about stopping the drug so that she could get pregnant.  The symptoms resolved without lasting effect, she had a successful pregnancy, and she managed the condition for which she had been prescribed the drug by switching to non-pharmaceutical therapies.  Id. at **13-15.  We suppose that we should mention that the drug was a selective serotonin and norepinephrine reuptake inhibitor and she was taking it for fibromyalgia, which was not an approved indication (and she knew it).  It apparently worked while she took it, so we have a hard time seeing why a suit was brought at all.  Plaintiffs also had no real theory that we can discern for what was allegedly lacking from the fairly thorough discussion in the label about discontinuation symptoms—at least after their expert case was gutted.  If the plaintiffs cannot articulate through admissible evidence some reason why the label’s actual warnings in the label about the very risk at issue were inadequate, then they should lose before they get to trial.  Such a shortcoming also makes the proximate cause analysis unduly abstract:  the question should be whether the “stronger warning” urged by plaintiffs would have changed the prescribing physician’s behavior and avoided the injury not whether an unspecified “stronger warning” would have done the same.

            While the lack of evidence of what the warnings should have been instead of what they were should have been another ground for directed verdict (or summary judgment), there is one basic fact pattern that gets to a defense win without even considering what the label did say or allegedly should have said—when the prescribing physician did not read the label.  That is what happened here and is the focus of the order.  We have posted many times about how warnings claims should fail unless the prescribing physician actually read the label that plaintiff contends should have provided additional warnings about whatever harm eventually (and allegedly) befell her.  What Hexum did was cut through less than clear testimony and hold plaintiffs to their burden.  The prescribing physician here did not recall reading the label before prescribing the drug to plaintiff, did not typically read labels “cover to cover,” and only recalled reviewing a third-party publication called Up To Date before prescribing the drug to plaintiff.  Id. at **8-9.  He acknowledged that labels came with the drug samples he received and that he would have reviewed the label if a sales representative asked him to do so, but plaintiffs did not close the loop on whether that happened with this drug before plaintiff’s prescription.  Id. at **9-11.  Some courts might have determined that all of this created a jury issue, but this court saw that “there is no proof beyond speculation that Wollaston read Cymbalta’s label before prescribing it to Hexum.”  Id. at *24.  Nor could it be inferred from the testimony about the doctor and patient’s discussion of discontinuation risk—yes, the patient admits that she was also warned, but more on that later—that the doctor had read the drug’s label before prescribing it to plaintiff.  Id. at **24-25.  Under the applicable and pretty good California law, this was a clear break in the causal chain for every claim that plaintiffs asserted.
             In so holding, the court distinguished cases using a heeding presumption—which California does not have—to allow failure to warn claims to survive even when the prescriber did not read the label.  Id. at *21 n.4.  In our compilation on this issue, we do discuss the role heeding presumptions have played in cases from around the country.  To us, in addition to the heeding presumption being inapplicable to all prescription drug cases except those with warnings that remove all judgment by urging something like “don’t use the drug in someone exactly like this plaintiff,” it does not make sense that a heeding presumption would link up the broken causal chain from a doctor not reading the label.  You can’t heed what you don’t read.  Maybe this really requires a reading presumption, but that presumption would be rebutted by the doctor’s actual practice of having not read the label.

            After concluding that plaintiffs lost because they did not establish that the prescribing physician read the drug’s label, the court considered plaintiff’s failure of proof on two possible alternative methods to prove causation that we do not think would have worked under the law anyway.  Plaintiffs often try to backdoor proximate cause by suggesting that a doctor who would have prescribed the drug anyway would have discussed the risk with the plaintiff (in some unspecified way compared to the actual discussion of the risk that occurred) and the plaintiff, blessed with the power of hindsight and a secondary profit motive, would have declined to take the drug (or been a more responsible patient in avoiding or minimizing the risk).  The plaintiff here, who admitted she had actually read the label’s discussion of discontinuation risk before taking the drug, testified that “I can’t guess and speculate what I would have done” if told the risk of discontinuation symptoms were higher than 1-2%—a purported contrast to the standard discussion in the label of clinical trial events occurring at 1% or greater and at a significantly higher rate than in placebo patients.  Id. at *29.  She also offered a lukewarm “I imagine not” when posed with the leading and admittedly speculative question about what she would have done if her doctor had told her the risks were “more than 44 to 78 percent.”  Id. at **29-30.  On top of the lack of predicate evidence about what her doctor would have told her (and maybe if anybody ever said the label should have included such percentages), this was “too ambiguous and speculative to allow a jury to find that if given stronger warnings Hexum would never have taken Cymbalta.”  Id. at *30.  This is all pretty far afield when the prescriber did not read the label, but we have a hard time seeing this sort of chain ever being sufficient to satisfy proximate cause.  At a minimum, there would need to be clear testimony from the prescribing physician on how the discussion with the plaintiff would have differed if presented with the specific alternative label and the plaintiff would have to answer questions tied to that testimony, not to generalities about a “stronger warning.”  The court also slammed plaintiffs for failing to present testimony from “the tapering physician” as a way to make a failure to warn claim.  Id. at **32-33.  But the prescription drug manufacturer does not owe a duty to warn every physician in any specialty who may later treat a patient on its drug.  It owes a duty to the physicians who prescribe its drug.  A breach of a non-existent duty cannot create liability.
            Like we said, we have a thing when it comes to proximate cause for failure to warn.  Hexum was a nice win and may help some other court reject the sort of cobbled together speculation that some plaintiffs offer as proof of proximate cause for failure to warn with prescription medical products.  We would take that.

Thursday, August 27, 2015

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion.  Both of them raised the same suggestion:  “Does the logic of this opinion permit a generic manufacturer to include truthful warnings about the risks of a drug on its labeling when such truthful warnings do not appear on the labeling of the branded drug?”
Not much later, we saw the same point raised by a plaintiff-side lawyer in this story in 360:
“I think this decision has huge implications for the preemption doctrine,” Lou Bograd of the Center for Constitutional Litigation PC said.
“If it's the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn't on the label of the brand-name products,” he said.
Needless to say, we don’t think that’s true.  Moreover, if plaintiffs try for what amounts to an Amarin-based Hail Mary pass, it may even create a jurisdictional advantage for our side.
There may be others, but right now we see two reasons why the FDA’s speech-based prohibition on truthful off-label promotion is not the First Amendment equivalent of the FDA’s sameness-based requirement that generic drug manufacturers to receive prior Agency approval for all substantive label changes.
First reason:  The first FDA scheme (off-label promotion) is a flat ban – a prior restraint − backed by criminal penalties, fines, and the threat of False Claims Act civil actions.  That’s all discussed in the Amarin decision.  See Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039, at *5-6 (S.D.N.Y. Aug. 7, 2015).  The second FDA scheme (generic label changes) is a reasonable time, place, and manner restriction that simply requires the submission of all would-be warning changes to the FDA so that it can see that the statute’s non-speech-related sameness requirements are met.  The statutory sameness requirements have nothing to do with the substance of the warning changes, and everything to so with the basic bioequivalence requirement that is at the core of the Hatch-Waxman Act.  Unless they’re the “same,” generics simply aren’t generics.  Nor does the FDA ban label changes for generic products; it simply requires agency review before they happen, rather than afterwards (as is the case with its CBE process).
So we don’t think, in First Amendment terms, that the off-label promotion ban is in the slightest bit equivalent to how the Agency chooses to time review of generic label changes.  The demise of the first says nothing about the validity of the second.
Second reason:  Remember what procedure the manufacturer followed with respect to its proposed truthful off-label promotion in Amarin:
The FDA does, however, encourage manufacturers to request advisory comments . . . with respect to promotional materials aimed at healthcare professionals. . . .  The FDA’s Office of Prescription Drug Promotion (the “OPDP”) reviews such materials to ensure, inter alia, that they are not false or misleading; it provides written comments on proposed materials, reviews complaints of alleged violations, and initiates enforcement actions as to materials it finds false or misleading.
2015 WL 4720039, at *6 (footnotes omitted).  Amarin thus approached the FDA and asked it to bless its promotional materials, and the FDA refused:
The FDA also refused to approve Amarin’s request to include the ANCHOR results in the Vascepa label.  It “reserve[d] comment” until the application is otherwise adequate.  In the penultimate sentence of the [rejection letter], the FDA stated: “This product may be considered to be misbranded under the [FDCA] if it is marketed with this change before approval of this supplemental application.”
Id. at *12.
Thus, Amarin approached the FDA ahead of time and sought, if not approval, at least Agency acquiescence in its truthful off-label promotion.  That’s all well and good, but it’s not something that can defeat preemption.  Rather, it’s a variant of the less-than-formal-submission “take steps” approach that the FDA proposed, and the Supreme Court rejected, in PLIVA v. Mensing, 131 S.Ct. 2567 (2011), as a ground for defeating preemption:
[T]he agency asserts that a different avenue existed for changing generic drug labels.  According to the FDA, the Manufacturers could have proposed − indeed, were required to propose − stronger warning labels to the agency if they believed such warnings were needed.  If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturer to create a new label for both the brand-name and generic drug.
Id. at 2576 (citations omitted).  Going to the FDA (as Amarin did in the First Amendment context), and seeking its agreement to a label change doesn’t make simultaneous compliance with state and federal duties “possible” under Mensing:
The federal duty to ask the FDA for help in strengthening the corresponding brand-name label, assuming such a duty exists, does not change this analysis.  Although requesting FDA assistance would have satisfied the Manufacturers’ federal duty, it would not have satisfied their state tort-law duty to provide adequate labeling.  State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.
Id. at 2578.  What Amarin did is precisely what the Supreme Court held in Mensing does not ameliorate the “impossibility” of simultaneous compliance with both federal and state duties.
There may be more, but those are two reasons that come to mind why generic plaintiffs should get nowhere with a last gasp “truthful speech” argument (assuming truth, which may also be disputed) against Mensing/Bartlett preemption.
But there’s somewhere else that plaintiffs might get with such an argument – into federal court.
We’ve blogged before about the availability of federal question jurisdiction in certain types of prescription medical product liability litigation under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005).  Successful invocations of Grable-based federal question jurisdiction have been few and far between.  The Supreme Court’s latest iteration of the test for such jurisdiction is found in Gunn v. Minton, 133 S.Ct. 1059 (2013).
[F]ederal jurisdiction over a state law claim will lie if a federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.
Id. at 1065.
Most Grable-based attempts to remove cases to federal court have foundered on prong three – substantiality.  With few exceptions, device-specific claims of “parallel-claim” FDCA violations, tied causally to the timing of a particular plaintiff’s medical history haven’t been able to overcome the substantiality requirement.  A few other cases have, however.  Take, for example NASDAQ OMX Grooup, Inc. v. UBS Securities, LLC, 770 F.3d 1010 (2d Cir. 2014), where it wasn’t just the removing defendant claiming substantiality, but also the relevant government agency.  Specifically, the Securities & Exchange Commission made a statement about the federal interests involved in NASDAQ OMX that “strongly signal[ed] the substantial importance of the[] federal issues” at stake in the litigation.  Id. at 1025.
The same thing could be said about the FDA’s position on First Amendment protection for truthful off-label promotion.  In Amarin, for example, the Agency characterized the company’s position as “a frontal assault . . . on the framework for new drug approval that Congress created in 1962” with “the potential to eviscerate [the] FDA drug approval regime.”  2015 WL 4720039, at *25.  In a prior Amarin post we mentioned another statement by the Agency that:
In discharging its regulatory responsibilities, however, FDA has reviewed other alternatives − including all of those identified in Caronia, 703 F.3d at 168 − but has found them all inadequate to meet public health needs, and therefore not viable less restrictive alternatives to the regulatory approach adopted by FDA.
Quoting FDA brief at 38.
We don’t think that First Amendment protection of truthful promotional speech about drugs, on- or off label, means that the sky is falling, but the FDA certainly does.  Remember the Agency’s explosive rhetoric in the Solis case?  We blogged about it here.  The FDA claimed that recognizing free speech rights to off-label promotion would mean that “vast areas of federal and state law would be invalidated.”  Since one of the prongs of the commercial speech test in Central Hudson Gas & Electric Corp. v. Public Service Commission, is a “a substantial interest to be achieved by restrictions on commercial speech,” 447 U.S. 557, 564 (1980), we’re certain that mining the government’s briefs in prior First Amendment litigation such as United States v. Caronia, 703 F.3d 149 (2d Cir. 2012),  will yield numerous governmental statements at least as full-throated as the one that established the Gunn/Grable substantiality in NASDAQ OMX.
The final factor of the Gunn/Grable federal jurisdiction test, that the federal dispute be “capable of resolution in federal court without disrupting the federal-state balance approved by Congress,” would also seem easily satisfied in a generic preemption case where the plaintiffs are raising the First Amendment.  Given the broad scope of generic preemption, there’s unlikely to be many other, confounding arguments.  Amarin shows the ability of federal courts to address such First Amendment issues.  Finally, given the FDA’s prior position that the ban is necessary to protect the “substantial’ interest in encouraging submission of new uses for drugs to the Agency, it and any generic defendant are likely to find some common ground on what exactly does, or does not, “disrupt” the “federal-state balance.”
So if generic plaintiffs want to join us in driving a First Amendment stake through the heart of the FDA’s ban on truthful off-label promotion, be our guest.  We think that there’s a world of difference between that absolute prohibition and FDA regulations regarding how and when generic labels are updated, but we’ll happily pocket the other side’s signing on to the initial proposition found in Amarin - that pharmaceutical detailing is accorded free speech protection when truthful.  First Amendment-related arguments of this sort by plaintiff lawyers can only help innovator drug and medical device defendants in product liability litigation involving off-label promotion allegations. Nor do we think – for the reasons stated −  that such arguments will ultimately have much effect on generic preemption, except for ensuring that the venue in which they are heard is federal.