Thursday, February 28, 2013

Making The Desert Bloom

We’ve followed, albeit fitfully, the saga of the learned intermediary rule in New Mexico.  Our first post on the subject, available here, protested an adventurous (and Erie-improper) decision by a New Mexico federal district court that ignored no fewer than five decisions by the New Mexico Court of Appeals (Serna v. Roche Laboratories, 684 P.2d 1187, 1189 (N.M. App. 1984); Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 748 (N.M. App. 1983); Perfetti v. McGahn Medical, 662 P.2d 646, 650 (N.M. App. 1983); Richards v. Upjohn Co., 625 P.2d 1192, 1195 (N.M. App. 1980); and Hines v. St. Joseph’s Hospital, 527 P.2d 1075, 1077 (N.M. App. 1974)) and refused to apply the learned intermediary rule in a prescription drug case brought over a ghastly murder-suicide.  See Rimbert v. Eli Lilly & Co., 577 F. Supp.2d 1174 (D.N.M. 2008).  The defendant in Rimbert eventually obtained a favorable result, though.  The judge who wrote this monstrosity eventually recused himself, and the replacement judge eventually pitched the case on Daubert grounds.  See Rimbert v. Eli Lilly & Co., 2009 WL 2208570 (D.N.M. July 21, 2009).

But even that favorable result still left intact Rimbert’s erroneous conclusions about the learned intermediary rule on the books.  So we were pleased when, several years after Rimbert, a federal MDL judge rejected that conclusion and opined that New Mexico did indeed follow the learned intermediary rule along with all but one other United States jurisdiction.  See In re Trasylol Products Liability Litigation, 2011 WL 2586218 (S.D. Fla. June 23, 2011).  The Trasylol court dismissed Rimbert with an unadorned “but see” footnote citation and followed the prior Court of Appeals precedent.  Id. at *11 n.4.

But now we have even better news.  The New Mexico Court of Appeals continues to follow the learned intermediary rule.  We had been a little nervous that the most recent of the prior five state court opinions had been in 1984.  But no longer.  In Silva v. SmithKlineBeecham Corp., 2013 WL 4516160, slip op. (N.M. App. Feb. 7, 2013), in yet another suicide case, the Court of Appeals reiterated that the learned intermediary rule applies:

To satisfy the burden of proving causation in the present case, Plaintiffs must show that adequate warnings would have altered [the prescriber’s] decision to treat Patient with [the drug].  [Long citation to Richards].  As such, if it is factually established that [the prescriber] would have prescribed [the drug] to patient even if [the manufacturer] had provided a more adequate warning about the risk . . ., then Plaintiffs cannot prove the causation element of its claims of inadequate warning.

Silva, slip op. at 7.  See also Id. at 6 (quoting Richards, 527 P.2d at 1077, for the proposition that “[o]rdinarily the manufacturer’s duty to warn of the dangers of prescription drugs is to the attending physician, not the patient”).

Thus the Rimbert aberration is now even further on the way to extinction.  Please make a note if this, if you might be litigating under New Mexico law, because one peculiarity of Silva is that the phrase “learned intermediary” doesn’t appear anywhere in the opinion, so it’s possible that the usual search (instead of shepardizing Richards) might miss it.

Wednesday, February 27, 2013

Fifth Circuit Affirms Constitutionality of Non-Economic Damage Caps

We've just learned, thanks to a head's up from Skadden's Elliott Davis, that the Fifth Circuit today affirmed the constitutionality of Mississippi's $1 million statutory non-economic damages cap.  In Learmouth v. Sears, Roebuck & Co., No. 09-60651, slip op. (5th Cir. Feb. 27, 2013), the court rejected challenges based on: 

(1)  The "inviolate" right to jury trial under the Mississippi constitution.  The statute does not invade the jurys's fact finding - indeed the jury isn't even told about the statute.  The judge simply reduces the award in accordance with the "legal effect" of the cap.  Slip op. at 13-14. 

(2) There is no derivative constitutional right to a dollar-for-dollar conversion of a verdict into an enforceable judgment, as the legislature may revise legal remedies.  Id. at 14-20.

(3) Separation of powers under the Mississippi constitution.  Since the statute sets a non-discretionary limit on legal remedies, it is not an invalid legislatively-enacted procedural rule.  Slip op. at 20-22.  Nor does it invade a "core" function of the judicial branch.  Id. at 22-25.  The legislature has a right to make changes to substantive law.  Id. at 23.

We also note the 2009 docket number.  Lest anyone question the Fifth Circuit's diligence, we suspect that a lot of the time passed while the court waited, in vain, for the Mississippi Supreme Court to accept certification of the issue.  See Slip op. at 1, 5.  Given our views on the role of federal courts sitting in diversity, see slip op. at 10, we believe that the certification attempt was precisely the right move.

The Gray View on Device Preemption

As we trudge through these gray days of Winter, we cannot help but think we have made a mistake.   Our calendar and geography are askew.  February in Philly is joyless.  We line up grimly on I-95 or I-76, forming a vast concatenation of complaint.  Expect no kind words from us today.  We see error all around us. 

It does not help that the prior two posts this week have virtually dared today’s writer to join debate on the merits of the recent Academy Awards.  On Monday, Sullivan’s heart ached for the injustices done to Django Unchained.  Yesterday, Yeary heaped praise on the musical numbers.  We have no witty riposte, since we were in midair headed for a hearing whilst the statuettes were doled out (apparently all of the technical sound awards were distributed to the villains from the Die Hard movies).  A viewer of Sunday night’s festivities would be pardoned for thinking that he or she had turned on a time machine, as several of the musical numbers came from Chicago, a Best Picture winner (ha!) from ten years ago.  Naturally, the producers for the Oscars broadcast had been the producers of Chicago.  You see, there are all sorts of ways to attain artistic immortality.  By the way, we despise musicals.  We’d rather fill our ears with tartar sauce than hear someone dream a dream, or refuse to go, or bloviate through an autotuner about the circle of life.  There is a phrase that the Drug and Device Law heirs use that fits pretty well with how we take in musicals:  if we watch them at all, we "hate-watch" them. 

Anyway, it is not as if anybody expects the Academy to get things right.  These are, after all, the folks who chose Dances with Wolves over Goodfellas.  And while we are mentioning a Scorsese masterpiece, let’s consider his career as a little window into Academy ineptitude.  The Academy ignored Mean Streets and Taxi Driver, chose Ordinary People over Raging Bull, and belatedly recognized Scorsese for one of his weaker films (The Departed).  The Hollywood gerontocracy also used another rare Scorsese clunker, The Color of Money, as a vehicle for slinging a Best Actor award to Paul Newman that was only about 20 years overdue.  That’s a pretty terrible batting average.  We even think Jersey courts get expert witness issues right more often than that. 

This year, Error seemed to be the theme of the Academy Awards.  Several films indulged in various levels of bad history.  We all understand that Django Unchained, like Tarantino’s earlier mash-up, Inglorious Basterds, was a counter-historical romp.  It is not meant to be taken seriously.  Rather, it is an exercise in bloody wish fulfillment.  It is okay to get things wrong if you acknowledge that you are getting things wrong.  Ben Affleck was canny in the marketing of Argo, admitting that the dramatic chase scene at the airport never happened.  Reality had to be sacrificed at the altar of drama.  Stamping passports and waving people through would be a little short on suspense.  There shouldn’t have been much suspense in Lincoln.  We all know how it turned out.  (And MacFarlane’s joke about that wasn’t that bad.  Honestly, is 148 years really still ‘too soon’?)  Spielberg and that nutty actor/shoe cobbler pretended to be making the most historically faithful film of the lot, but then why are two nay votes on the 13th Amendment attributed  to representatives from Connecticut, when that never-ever happened?  Look – the writer of Lincoln was Tony Kushner, one of the country’s best.  But when he tries to explain the dramatic necessity of his historical error, it rings hollow.  The actual nay votes were from Illinois – Lincoln’s state!  Isn’t that more dramatic?  Gratuitous mistakes are the worst kind.  Finally, Zero Dark Thirty seems to have had its Oscar chances eliminated by the controversy over its depiction of the role of torture.  We have heard some people call the picture pro-torture and some have called it anti-torture.  Is it possible it is neither?  We get the sense that the people behind the picture were not trying to exploit the torture issue and were trying to report the facts as they understood them – even as the sources for such things are inherently unreliable.  To our mind, Zero Dark Thirty was the victim of character assassination.  But we’ll let it go.  As government screw-uppers have been known to say, mistakes were made. 

Today’s case is another mistake.  In Gray v. Stryker Corp., 2013 U.S. Dist. LEXIS 22848 (S.D. Ind. Feb. 20, 2013), the court rendered a perfectly horrible decision on both TwIqbal and the dreaded “parallel claim” exception to Riegel preemption.  Though the decision is a mistake, it is inevitable, as it is compelled by another mistake, the Seventh Circuit’s execrable decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).  We have wept over Bausch here and here and several other places.  Where’s a Tarantino counterfactual scenario when you most need one? 

In Gray, the plaintiff brought claims against Stryker for violations of the Indiana Products Liability Act related to the alleged failure of the Trident hip replacement prosthetic device.  So, yes, it is just like Bausch.  Following her hip replacement surgery, the plaintiff began experiencing hip pain and began hearing “squeaking” and “popping” noises while walking.  Ultimately, the Trident device failed, resulting in another hip replacement surgery.  The plaintiff alleged that the Trident device had a defective bearing that was caused by manufacturing problems and poor quality control.  Specifically, … well, there are no specifics.  More about that later.   

Defendants filed a motion to dismiss the Amended Complaint because the plaintiff’s claims were preempted by the Medical Device Amendments.  The district court denied that motion, and hardly seemed to break a sweat in so doing.  Bad law, like Bausch, can sometimes make things easy.  The Gray court applied the parallel claim exception because the causes of action in the Amended Complaint “reference violations of the requirements set forth by the FDA as the cause of the alleged defects, not that the device violated Indiana products liability laws despite compliance with federal regulations and requirements.”  2013 U.S. Dist. LEXIS 22848 at * 11.  Hence, the claim is parallel.  But what claim?  And parallel to what federal requirement?  Shhhhh.   “It is not necessary that Ms. Gray include the specific federal laws or regulations at issue in her Amended Complaint, only that she put the Defendants on notice that her claims are premised upon allegations that some federal law or regulation was violated.”  Id.   There it is.  That’s the Bausch we’ve all come to know and love to hate.  (It turns out that, as with musicals, we hate-watch Bausch and its progeny.)  The parallel claim exception ceases to be an exception; it is an incantation that swallows up the very notion of preemption. 

As in Bausch, the defendant in Gray had the temerity to inquire whether, under United States Supreme Court precedent, the plaintiff might politely be invited to supply some facts.  As in that crazily-wrong Best Picture winner Oliver!, there was a plaintive request:  “Please Sir, may I have some more?’  And as in the movie, the request was greeted with contempt:  “Defendants believe that Ms. Gray should have included in her Amended Complaint facts showing that the problems with her prosthetic device were the result of manufacturing defects and not physician error, how the FDA’s findings relate to the defect that she alleges, and state which specific device components were manufactured inappropriately.”  Id. at *12.  Seems fair, doesn’t it?  Er, no?  Oops.  Sorry.  The court informs us that “this level of specificity is not required to be included in the complaint under the “plausibility” standard applied in Iqbal and Twombly.”  Id.   Well, maybe not in the Seventh Circuit.  Not right now.  Posner and Easterbrook and Wood – why aren't you riding in with Jamie Foxx, doctrinal guns blazing?!  Surely, as in Argo, this is pure suspense conjured up for amusement, right? 

As in Bausch, the Gray court drearily justifies its evisceration of preemption and TwIqbal by recounting how difficult it is for plaintiffs to round up any facts before engaging in what the rules call formal discovery, but what some flinty-eyed folk call extortion:  “Plaintiffs in these medical device defect cases are not expected to plead violations of specific federal laws or product specific information, not only because it is not required under the notice pleading standard of Federal Rule of Civil Procedure 8 (a)(2) but also because plaintiffs often do not have access to product-specific information about the manufacturing of these devices, which are kept confidential by federal law, until they are able to obtain this information through discovery.”  Id. at *12-13.  Again following the dance-steps laid out on the floor by Bausch, the Gray court  rather bizarrely repeats the bromide that “[t]here are no special pleading requirements for product liability claims in general, or for Class III medical device claims in particular.”  Id.  at *13. Who is asking for special pleading requirements?  How about just following the regular, applies-to-all-federal-cases TwIqbal requirements? 

The Gray opinion, like the The Grey movie, offers the opposite of a happy ending.  But we are reminded of the ending of Argo, and that charming little phrase the Hollywood people used whenever they mentioned the title of the faux film. 

Tuesday, February 26, 2013

A Short and Sweet Preemption Decision (and Continued Oscar Coverage)

            Yesterday we gave you our take on this year’s Best Picture winner, so today we thought we’d give you our opinion on the Oscars themselves (not sure that this represents the opinion of our collective group, but I have the floor today and I’m sure McConnell will fill in what I missed or got “wrong”). 
            Overall assessment – pretty good.  Let’s start with the obvious, the host.  Traditionally comedians have made for better Oscar hosts than actors.  We still can’t quite erase from our memory the James Franco/Anne Hathaway debacle of two years ago.  And it would be hard not to include Billy Crystal and Steve Martin on a short list of best hosts (we’ll also admit to being disappointed by Ellen DeGeneres and Chris Rock, so being a stand-up doesn’t automatically make you a good host).  That brings us to Seth MacFarlane who doesn’t get our vote for the best, but also wasn’t the worst.  He’s a quasi-performer who is more known for his funny voices and hilarious push-the-envelope writing.  So, we expected some good jokes and production pieces, which we got.  We are still chuckling over the fleeing Von Trapp Family Singers.  And the Captain Kirk opening number had some good moments, but was way too long.  We also expected some jokes that some people were going to find offensive.  He delivered on that one too.  The bottom line – he was mostly funny, definitely provocative, and attracted a younger audience.  We think that’s what the producers were going for and they got it.    
            We also have to give the producers kudos for featuring movie music throughout the show.  We didn’t just get to hear this year’s nominees, but some great classics too.  As if Shirely Bassey and Barbara Streisand weren’t enough – the only thing that could possibly have followed Jennifer Hudson’s re-creation of her Oscar winning performance was the entire cast of Les Miserables.  Great use of the Jaws theme music too.  If only that worked in real life.   
            As always, the attempt at witty banter between presenters was lackluster at best.  The worst of the evening was delivered by two strong comedic actors, Paul Rudd and Melissa McCarthy.  What was that?  Even the Avengers were funnier.  And, finally the highs and lows of acceptance speeches.  Our favorite goes to Daniel Day Lewis – and by now he should be pretty good at this.  He was funny and warm and sincere.  The worst – Anne Hathaway.  This was her big moment and it simply fell flat.  Her performance of “I Dreamed a Dream” is probably the most heart-breaking, gut-wrenching four minutes in film last year.  So, while we don’t need tears or jokes, some emotion as she achieved her dream would have been nice. 
            Now, all that has absolutely nothing to do with today’s case.  So, we’ll manufacture a segue much like those hackneyed bits of filler all the award shows are guilty of clinging to. The presenters can’t deliver them and so all they do is add length to shows that are always exceedingly too long.  We know this could be considered the pot calling the kettle.  After all, lawyers write documents called briefs that are more often than not anything but.  As a group we have been known to be occasionally long-winded, or at least never at a lack for words.  But even we can appreciate brevity.  That something shorter can have a greater impact due to simplicity and directness. 
            While succinctness didn’t appear to have been a main concern for the producers of the Oscars, we tend to like it when it is for the courts.  The decision in Anderson v. Boston Scientific Corporation, 2013 U.S. Dist LEXIS 22982 (S.D. Ohio Feb. 19, 2013) is just such a short, direct – and in our opinion – correct ruling.  So, we’ll keep our summary equally short and direct.
            Following implantation of a spinal cord stimulator, plaintiff suffered an infection that required additional surgery.  Id. at *1-2.  Plaintiff filed traditional product liability claims against the medical device manufacturer alleging that a flaw in the manufacture or design of the device was to blame for her injuries.  Id. at *2.  She also brought suit against one of the manufacturer’s employees who had direct contact with plaintiff following her surgery.  The allegation is that the employee provided misinformation which led to a delay in plaintiff seeking medical attention for her infection.  Id. 
            Defendants moved to dismiss on two grounds – failure to satisfy the federal pleading requirements, what we refer to as the Twiqbal pleading standard, and preemption.  First, Anderson sets out a few good Twiqbal sound bites:
A motion to dismiss is . . . a vehicle to screen out those cases that are impossible as well as those that are implausible.  Id. at *4.
The admonishment to construe the plaintiff's claim liberally when evaluating a motion to dismiss does not relieve a plaintiff of his obligation to satisfy federal notice pleading requirements and allege more than bare assertions of legal conclusions.  Id. at *5.
Then, as to the complaint at hand and the allegations against the company representative, the court determined that with a “very generous reading,” plaintiff may have alleged enough to pass the test on duty and breach of duty, but that the complaint completely lacked any facts supporting even a plausible inference of causation.  Id. at *6-7.  Plaintiffs argued that they need discovery to obtain such facts, but the court quickly closed down that argument.  Id. at *8 (“discovery cannot be used as a fishing expedition to uncover the facts necessary to support the causes of action presented in the complaint”). 
            The court moved on to dismiss the claims against the manufacturer just as quickly and efficiently.  The product at issue is a premarket approved (“PMA”) medical device and therefore plaintiff’s claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (state law claims that impose requirements “different from or in addition to” FDA’s PMA requirements are preempted).   Since plaintiff Anderson’s state law claims would require her “to show that the stimulator should have been manufactured, designed, inspected and/or maintained in a manner different from that approved by the FDA,” they are preempted.  Id. at *10. 
            Plaintiff’s two arguments to support her claims were that her “parallel violation claims” (claims premised on a violation of FDA regulations) aren’t preempted and that “Congress did not intend to foreclose all recourse to plaintiffs.”  Id. at *10-11.  However, plaintiff didn’t plead a parallel violation claim:
there is nothing in the complaint that even approximates an allegation, let alone anything providing factual support for that allegation, that the spinal cord stimulator deviated from FDA requirements.
Id. at *11.  And as to her second argument, yes they did.  Plaintiff’s “this isn’t what Congress intended” argument was raised by the Riegel dissent and dispensed with by the Riegel majority.  Id. at *12-13.  Enough said. 
            Plaintiffs are getting a second chance and we won’t be surprised if we see an attempt at more fulsome allegations against the device representative and a parallel violation claim. So, unlike the Oscars for which we need to wait a whole year for a new host and a new slate of one-liners, plaintiff Anderson has 30 days to fix what was broken and try it again.  

Monday, February 25, 2013

A Solid Decison Dismissing Third Party Payer Claims -- And a Mundane Oscar Decision

We’re a bit too tired from going late into the evening watching the Oscars to say much of anything pithy today.  We’ll just complain.  Argo was a very good movie.  But Best Picture good?  Maybe, but maybe not.  It’s certainly not as shaky as last year’s pick, The Artist.  Cute and different doesn’t mean best.  Does anyone remember Crash winning best picture for 2005?  How the heck did that happen?  That might not even have been a good movie, no less best.  And Shakespeare In Love?  How does its victory over Saving Private Ryan look in retrospect? 

Against these historic mistakes, the selection of Argo isn’t bad.  As we said, it really was a good movie.  A historically based movie is unquestionably good when it can get your teen-aged son to look at you with wide eyes during the last 20 minutes and say, “Man, this is intense.”  Its selection as Best Picture also created a second, “hey, can you believe Ben Affleck just won an Oscar” moment.  Those are always fun.  He’s gotten pretty good at making movies.  The Town was a good one too.  So we’re really not complaining about Argo. 

This is more about Django Unchained.  We knew it never had a chance to win.  Quentin Tarantino makes unusual movies.  They’re loaded with violence, cursing and one odd circumstance piled on top of or backed into another.  And Tarantino himself sometimes comes off as a know-it-all when it comes to cinema.  But, man, what a move that was.  It must have been incredibly difficult to craft a movie about such a painful part of our history and yet have it at once be action-packed, terrifying, funny, exhausting, exhilarating, realistic, cartoonish, unpredictable and wonderfully predictable – and then to wrap it all up in a spaghetti western.  Who would even think to do such a thing, no less accomplish it?  For those of you who saw it, wasn’t it great to cheer Django on as he whipped the heck out of his former slave master?  We bet you’d never thought you’d get that experience at a movie.  Or wasn’t it a surreal movie-going moment to laugh along with the entire crowd as the KKK members complained about the guy who improperly cut the eye holes into their hoods?  And then be thrilled when Django shoots the KKK leader, Big Daddy (Don Johnson), off his horse.  Tarantino doesn’t make the type of movie that gets selected as Best Picture.  The Academy seems more comfortable throwing him a Best Screenplay award from time to time instead.  But you’ll likely never see another movie like that one again.  And you’ll definitely see more Argos.  Maybe Django Unchained should have been picked. 

Who knows?  McConnell thinks a lot about these things and sees all the Best Picture nominees.  He’ll probably straighten this all out on Wednesday. 

Now for your entertainment . . . . a third-party-payer case called Employer Teamsters-Local Nos. 175/505 Health and Welfare Trust Fund v. Bristol Myers Squibb Co., No. 2013 U.S. Dist. LEXIS 21589 (S.D. W.Va. Jan. 29, 2013).  As cases go, if you like courts dismissing plaintiffs’ claims for all sorts of reasons, this one should keep your attention. 

The Teamsters locals and their benefits fund sued Bristol Myers Squibb and Sanofi-Aventis, claiming that they’d paid too much for the blood thinner Plavix because defendants had marketed it as superior to aspirin when it allegedly wasn’t.  They claimed unjust enrichment and breach of the implied warranty of merchantability and sought reimbursement of the cost difference between Plavix and aspirin.  When this picture opens, the plaintiffs are already on their second amended complaint.  But they’re gonna need another one.  Because in the end the court grants defendants’ motion to dismiss. 

Plaintiffs’ breach of implied warranty of merchantability claim was based on the allegation that the “intended purpose” of Plavix was to serve as a superior alternative blood thinner to aspirin.  Id. at *14.  Superior performance to another product, however, seems strained as a definition of ordinary purpose.  Performance as indicated and labeled is more like it.  In fact, that’s how the plaintiffs themselves had framed it in their earlier complaint.  And ultimately that’s what the court found to be proper.  The FDA had approved Plavix to treat certain (principally heart related) conditions, and that’s how it was labeled.  Id. at *15-16.  It wasn’t approved as “superior” to aspirin.  There is also significant precedent, cited by the court, holding that implied warranty of merchantability claims must be based on the product’s ordinary purpose, not its superiority to other products:

Under the U.C.C., claims about a product's superiority over another product are not part of the implied warranty of merchantability.  Richard A. Lord, 18 Williston on Contracts § 52:76 (4th ed. 2012) (footnotes omitted) (“As a general principle . . . the implied warranty of merchantability requires only that the goods be fit for their ordinary purpose, not that they be perfect or in perfect condition, or be outstanding or superior, or of the best or highest quality.”); see also Sessa v. Riegle, 427 F. Supp. 760, 769 (E.D. Pa. 1977), aff'd, 568 F.2d 770 (3d Cir. 1978) (“The standard established [by U.C.C. § 2-314] does not require that goods be outstanding or superior.”); Miller v. Badgley, 51 Wn. App. 285, 753 P.2d 530, 535 (Wash. Ct. App. 1988) (“In order to be merchantable, goods need not be outstanding or superior . . . .”).  Furthermore, “a product that performs its ordinary functions adequately does not breach the warranty merely because it does not function as well as the buyer would like . . . .”  18 Williston on Contracts § 52:76 (footnote omitted).

Id. at 17. 

Plaintiffs’ unjust enrichment claim had similar problems.  Plaintiffs asserted, essentially, that defendants convinced doctors to prescribe allegedly overpriced Plavix instead of cheaper aspirin and the defendants were thereby unjustly enriched.  Id. at *20.  But plaintiffs can’t just say that.  They have to satisfy Twombly and Iqbal by alleging facts that make this claim plausible.  They also have to explain how payment for a product that performs as intended can constitute unjust enrichment.  They did neither:

[T]he SAC does not allege, let alone plausibly, whether any prescriptions were written based on a misunderstanding of Plavix's efficacy. Nor does it allege how Defendants' retention of payments for a product that was effective in its ordinary purpose--though perhaps not as effective compared to other drugs as claimed--rises to the level of constituting unjust enrichment.

Id. at *20-21.  On this basis, the court dismissed the unjust enrichment claim.

Potentially more helpful, though, is the court’s discussion of the complaint’s deficient proximate causation allegations, which all by itself served as a basis to dismiss all plaintiffs’ claims.  The court traced its definition of proximate causation to the Supreme Court’s 1992 opinion in Holmes v. Securities Investor Protection Corp., 503 U.S. 258 (1992).  Even though Holmes was a RICO case, the court believed that its “discussion of proximate causation . . . . provide[d] a general formula, not just applicable to RICO claims.”  Id. at *23 n.9 (citing Holmes, 503 U.S. at 268-69).  Under Holmes, proximate causation required “some direct relation between the injury asserted and the injurious conduct alleged.”  Id. at *23 (quoting Holmes, 503 U.S. at 268). 
Even with that broad definition, plaintiffs’ claims were doomed. 

As the defendants put it, “the causation between the alleged marketing activities and the reimbursement of Plavix prescriptions is riddled with too many intervening events for the Court to impose liability on Defendants.”  Id. at *21.  The most obvious and significant intervening event was the decision-making of the prescribing doctors:

[P]hysicians use their independent medical judgment to decide whether [a drug] is the best treatment for a given patient, and independent judgment can be influenced by a number of things, only one of which may be representation by a manufacturer as to a particular drug's relative safety and efficacy.

Id. at *23 (quoting Pennsylvania Employees Benefit Trust Fund v. AstraZeneca Pharma., 2009 U.S. Dist. LEXIS 76555 (M.D. Fla. July 18, 2009) (in turn applying Holmes).  The court was also influenced by a West Virginia Supreme Court decision that disallowed claims under West Virginia’s consumer protection act against a pharmaceutical manufacturer because doctors, rather than consumers, are the ones who select the drugs to prescribe to patients.  Id. at 30 (citing White v. Wyeth, 227 W.Va. 131 (W.Va. 2010). 

The prescribing doctors independent judgments and decision-making processes were just too significant as intervening events to allow plaintiffs’ claims to survive as alleged: 

Holmes and the other cases above suggest that the proximate causation analysis is about carefully drawing a line so as to distinguish the direct consequences in a close causal chain from more attenuated effects influenced by too many intervening causes. . . . .  The Court finds that Plaintiffs' claims do not satisfy the “direct relation” test found in Holmes . . .  and also finds that the policies announced in Holmes weigh in favor of dismissal here.  Between Defendants' alleged misleading marketing and Plaintiffs' prescription reimbursements lies a vast array of intervening events, including the “independent medical judgment” of doctors.  Without any specific allegations as to who received these misrepresentations, how the misrepresentations influenced doctors, and why certain patients received Plavix instead of alternative medications, this Court is left without sufficient allegations from which to properly infer that proximate causation is satisfied. Therefore, both of Plaintiffs' claims should be dismissed for lack of causation.

Id. at *31-32. 

So there’s your entertainment for today: claim-specific defenses to third-part-payer claims for unjust enrichment and breach of the implied warranty of merchantability, along with a broad proximate cause defense to boot.  It’s pretty good, just like Argo, but not very challenging or unusual.  But that’s what you get around Oscar time. 

Friday, February 22, 2013

When Did This Happen?

In most states, the most famous exception being Louisiana, there’s no such thing as a “direct action” against an insurance company by the allegedly injured person.  That means that X (or someone claiming through X), who was allegedly injured by Y, cannot sue Z, who is Y’s liability insurer.

Well, now it appears that there may be an exception – if the injured person also happens to be a Medicare beneficiary.  It’s another example of how the Medicare as Secondary Payer (“MSP”) statute is changing the law in unexpected ways.

We first got wind of this when the decision, Michigan Spine & Brain Surgeons, PLLC, , v. State Farm Mutual Automobile Insurance Co., 2013 U.S. Dist. Lexis 17721 (E.D. Mich. Feb. 11, 2013), showed up, more or less by accident, in one of the ongoing searches we use to stay abreast of drug/device developments,  Apparently, however, the more important decision was over a year ago in Bio-Medical Applications, Inc. v. Central States Health & Welfare Fund, 656 F.3d 277 (6th Cir. 2011).

Here’s what’s going on.

In both Bio-Medical and Michigan Spine, the plaintiffs were health care providers who provided medical services to persons who had health insurance provided by the defendants.  Well, one of the things we all know and love about health insurers is their endlessly creative ways of denying coverage.  In Bio-Medical, the defendant insurer had written its policy so that its benefits terminated the moment that the beneficiary also became eligible for Medicare.  656 F.3d at 280.  In Michigan Spine, the denial of coverage was due to “pre-existing condition.”  2013 U.S. Dist. Lexis 17721, at *2.

In both Bio-Medical (by design) and Michigan Spine (by happenstance) the results of the denials of coverage was that the health care costs in question were picked up by Medicare.  656 F.3d at 281; 2013 U.S. Dist. Lexis 17721, at *2.  In Bio-Medical, at least, the health care provider plaintiff also received a lower reimbursement from Medicare than had would have been the case had the private insurer not denied coverage.  656 F.3d at 281.

But turnabout, under MSP, is evidently fair play.  The health care providers who were stiffed by the insurer denials turned around and brought suit against those insurers as private plaintiffs under the MSP.  The question, particularly in Bio-Medical, is whether they had standing (the right) to do that under the Act.  First, the court in Bio-Medical held that the insurance provision in question – terminating benefits due to Medicare eligibility – was blatantly illegal:

[The insurer] would have us completely emasculate the Act.  If private plans could terminate coverage whenever a planholder became entitled to Medicare, then private plans often would do just that, thereby forcing Medicare to bear the full burden by itself. Medicare would not be the secondary payer; it would be the only payer. . . .  Applying the law to this case, [the insurer] violated the Act by terminating the patient's coverage.

656 F.3d at 283 (emphasis original).

The question then became, could the plaintiff – a health care provider that not only wasn’t paid but subjected to self-help (offsets) by the illegally operating insurer – do anything about it.

The Sixth Circuit held that health care providers who would otherwise have been reimbursed by the defendant insurer could bring MSP claims.  The private right of action was in the passive voice:

There is established a private cause of action for damages (which shall be in an amount double the amount otherwise provided) in the case of a primary plan which fails to provide for primary payment (or appropriate reimbursement). . . .

Id. at 284 (quoting 42 U.S.C. §1395y(b)(3)(A)).

There follows a lot of MSP-related mumbo jumbo providing the technical basis for the court’s decision, but the bottom line is that the insurer’s counterarguments proved too much, “if a primary plan’s [that is to say, the insurer in this instance] violation . . . is necessary for a party to prevail on the private cause of action, then the private cause of action is rendered inoperative.”  656 F.3d at 286.  The court refused to nullify the private action by accepting the defendant insurer’s reading.  Id.

There follows more mumbo-jumbo about the MSP’s “demonstrated responsibility” provision (which according to the opinion, has since been amended to solve the problem).  Suffice it to say that the court in Bio-Medical held that an MSP private plaintiff need not do so before ever bringing suit.  Thus, the stiffed medical services provider could sue the insurer who stiffed it under MSP – including for double damages:

The meaning of our holding and the regulation for the instant case is that the “demonstrated responsibility” provision does not bar [the provider’s] lawsuit against [the insurer].  [It]is a traditional insurer, not a tortfeasor. A nd the “demonstrated responsibility” provision places a condition precedent only on lawsuits against tortfeasors. . . .  A healthcare provider . . . need not first demonstrate the responsibility of a private insurer . . .  before bringing a lawsuit for double damages under the Act’s private cause of action.  It need not first sue and win, in order to sue again.

656 F.3d at 291.

Michigan Spine, decided by a federal district court bound by the Sixth Circuit’s prior decision, did basically the same thing, except that the health care provider more or less lucked into the lawsuit.  The denial of coverage was for reasons unrelated to Medicare, and due to the patient’s age, Medicare stepped in.  2013 U.S. Dist. Lexis 17721, at *6.  That didn’t make a difference:

[The defendant insurer] also contends that Bio-Medical is distinguishable because the patient/insured in that action assigned her rights under the insurance plan to . . . the medical care pro-vider. . . .  Nowhere in that case does it suggest that it was intended only to apply to medical service providers who are assigned rights under an insurance contract.

Id. at *15-16.

OK, back to our original point – direct actions.  We don’t see anything in the “there shall be” phrasing of the MSP statute that limits standing in suits of this nature to health care providers who are stiffed by insurers.  If the end result is that Medicare picks up the bill as a result of a coverage denial, then why couldn’t anybody sue?  And if the “demonstrated responsibility” provision doesn’t apply to “private insurers,” then why couldn’t X sue Z, provided that Medicare paid X’s bills after Z refused?  Possibly the “tortfeasor” language in Bio-Medical would cut that off, but Y would be the tortfeasor, not Z.

We can’t say whether Congress intended, in enacting and then amending the MSP, to create a direct action statute against traditional insurers, but under Bio-Medical, that seems to be the way things are headed.

NJLRA CLE on Daubert - March 1, 2013

Earlier today we posted yet another report on the application of Daubert in the Aredia-Zometa litigation. To say that expert witness issues come up often in our business would be a bit of an understatement. Take a look at our topic headings on the right side of this page. Junk science, with or without the mellifluous stylings of Dr. Parisian, is the kudzu of drug and device law.
Next Friday (March 1) the New Jersey Lawsuit Reform Alliance is offering a CLE program on “The Unfinished Daubert Revolution” at the Hilton Hotel in Short Hills, N.J. The panel is terrific, with one possible exception. Professor David Bernstein (George Mason Univ.), Michelle Bufano (Gibbons), John Kim (J&J), the Hon. Edwin Stern (retired, now at Gibbons), and mighty-brave plaintiff lawyer Kevin Roddy (Wilentz) will have interesting things to say about expert witnesses. The exception alluded to above is that, instead of the originally scheduled, mega-smart Paul Schmidt (Covington), who has been called away to some exotic destination on business, the panel is now saddled with mega-snarky McConnell of this blog as the new sixth wheel. McConnell will certainly complain loudly about New Jersey’s “flexible” standard for expert testimony and will likely draw inapt analogies to The Sopranos and Real Housewives of New Jersey.
It should be fun.

Preemption in the Land of 10,000 Medical Devices

For some reason, just as pharmaceutical manufacturing is concentrated in New Jersey and Southeastern Pennsylvania, and just as there are an abnormal number of Class II implant manufacturers in Indiana, the epicenter of American pre-market approved medical device manufacturing seems to be in Minnesota.

Similarly, preemption is at the epicenter of medical device product liability litigation involving PMA devices.

Since plaintiffs are able to avoid federal court through the simple stratagem of suing defendants (all defendants, not just medical device manufacturers) in their “home” courts, we have been wondering how PMA preemption would fare in Minnesota state court.  Minnesota already has a relatively expansive consumer protection statute and (until recently) an extremely long (six-year) statute of limitations for personal injury cases.  If there were also an indication that Minnesota courts would view PMA preemption in a pro-plaintiff fashion, we could see Philadelphia-style influx of litigation tourism.

Fortunately that doesn’t appear to be in the offing.  A couple of years ago, Medtronic scored big with In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867 (Minn. Dist. Hennepin Co. Oct. 20, 2009), which as we discussedat the time, adopted just about all the pro-preemption holdings in In re Medtronic Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. Oct 15, 2010).  There were a lot of good holdings, which we gloated over here.

Still, Sprint Fidelis was just a county-level trial court.  The Sprint Fidelis plaintiffs chose not to take their chances on appeal.  One bad decision from the Court of Appeals of Minnesota could wipe everything out.

Or, conversely, one good appellate decision could cement everything in place and send the litigation tourists scurrying elsewhere.

Fortunately, the latter happened the other day.  See Lamere v. St. Jude Medical, Inc., ___ N.W.2d ___, 2013 WL 599178, slip op. (Minn. App. Feb 19, 2013).  Lamere involved a Class III PMA approved mechanical heart valve, and the court affirmed summary judgment on the basis of preemption.  Not even the Public Citizen Litigation Group (probably the other side’s biggest guns on preemption) could sway the result in Lamere.

The valve in Lamere was implanted in 1988.  Nearly 20 years later the recipient died, allegedly as a result of a valve failure.  The plaintiff – like the decedent a California resident – chose to bring suit in Minnesota state court.  Thus Lamere was a blatant example of litigation tourism.

The defendant manufacturer received summary judgment, on both preemption and (ironically) statute of limitations grounds, and the plaintiff appealed.  The Court of Appeals affirmed.  We won’t spend much time on the statute of limitations, which the court applied (to a wrongful death claim) in a manner similar to a statute of repose.  Based on what appears to us to be strong Minnesota precedent, the court concluded that the six-year statute runs from the time of the defendant’s “act or omission,” which in this instance was “either . . . the date the medical device was manufactured or the date it was implanted.”  2013 WL 599178, at *4.  Since the implant had lasted for over 19 years, the plaintiff was out of luck.  Id.  The court refused to expand a “latent disease” (read, asbestos) exception to include other products that simply lasted a long time before allegedly malfunctioning, id. at *4-5, and refused to apply the discovery rule to wrongful death cases.  Id. at *5.

Now on to why we’re posting about Lamere.  The court held, as an alternative, ground, that summary judgment could be affirmed on the basis of PMA preemption.  Who knows?  If it weren’t for all of Public Citizen’s caterwauling about preemption, the court may have left sleeping dogs lie with the statute of limitations.

As usual in PMA preemption cases, the argument came down to the court’s view of the vexing and ill-defined concept of “parallel” violation claims under (1) the throw-away dictum in Riegel concerning a waived claim and (2) vague claims that the Court took less-than-seriously in Lohr.  See Lamere, 2013 WL 599178, at *6 (dealing with these cases’ “parallel” violation language in a paragraph).

The plaintiff in Lamere took the manufacturing defect/good manufacturing practice (“GMP”) approach to preemption, id., arguing that, even though the valve operated properly for almost twenty years, it was nonetheless manufactured in violation of … something….  Plaintiff never was very clear; even the Public Citizen folks weren’t able to come up with a viable theory.

So they argued that they didn’t have to − any old GMP was enough.  The two GMPs that the plaintiff settled on were:

Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.  Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

21 C.F.R. § 820.70(a) (emphasis added).

Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.  The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.  The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.

21 C.F.R. § 820.90(a) (emphasis added) (both quoted at 2013 WL 599178, at *7).

As the emphasized language makes quite clear, these GMPs are of the “umbrella” variety.  They tell a manufacturer what topics to pay attention to, but provide absolutely no specifics about what the manufacturer is supposed to do in order to comply.  They are, in short, the classic vague regulations that leave it to the manufacturer to decide how to comply.  That's exactly the opposite of how state law ordinarily works, with violation claims replacing the "reasonable man" default standard only if the violated enactment provides a specific substitute (like "speed limit 55" instead of a "reasonably safe speed under the circumstances").
The Court of Appeals went through the “split” among the federal circuits about whether GMPs had to be “specific” in order to support a viable “parallel” claim.  Lamere, 2013 WL 599178, at *6.  Ultimately, the court came down on the side of specificity – at least that a GMP had to do more than tell a manufacturer that it needed to do something about this or that:

Without concluding that a GMP may never form the basis of a valid parallel claim, we hold that in this case [plaintiff] failed to sufficiently plead a parallel claim based on the specific GMPs she cites.  We observe that those circuit court cases approving of the use of GMPs as a basis for a parallel claim require that the plaintiff plead with greater specificity.

2013 WL 599178, at *7 (emphasis added).  For this proposition the court cited Bass v. Stryker Corp., 669 F.3d 501, 511-12 (5th Cir. 2012).  Bass isn’t exactly the greatest decision we’ve ever seen on specificity (the complaint survived), although Bass did involve a relatively detailed complaint, as we discussed here.  So Lamere had to be pretty poorly pleaded to fail that test.

Not only that, but these plaintiffs weren’t all that sympathetic, even with Public Citizen on the case.  Lamere was decided on summary judgment (remember, if you want to win a preemption motion, your odds are considerably better on summary judgment – it’s just a lot more expensive).  Thus, Lamere wasn’t a case where the plaintiffs were being shown the door without benefit of discovery.  Rather, they “had ample opportunity to discover whether any GMPs had been violated” and hadn’t been able to come up with anything (not surprising, given that the valve lasted for almost twenty years).  Plaintiffs have to do better than that:

[T]o survive a motion for summary judgment following discovery, [plaintiff] is required to do more than merely cite two GMPs without explaining how the violation of these GMPs occurred or how such a violation was causally related to the failure of the mechanical heart valve.

2013 WL 599178, at *7.

But Public Citizen was persistent, if not persuasive.  Plaintiff kicked “parallel” violations to the curb and attempted to make a virtue of their inability to find anything.  In a frontal assault on Riegel plaintiff argued that precisely because there wasn’t any federal regulation “specifically” on point, their claims couldn’t be preempted.  Id. at *7.  Talk about chutzpah – that’s precisely what Riegel was all about.

The Court of Appeals quite rightly rejected this claim as incompatible with Reigel’s holding that the PMA process, in and of itself, provides whatever “specificity” is necessary under the statute’s express preemption clause:

[Plaintiff] argues that a general state-law duty not to distribute products with manufacturing flaws does not impose any requirements on [defendant] that are different from or in addition to federal requirements that are specifically applicable.  But this argument ignores Riegel, which concluded that “[g]eneral tort duties of care ... ‘directly regulate’ the device itself, including its design.”  We conclude that imposing the state’s strict-liability rules on a PMA device would impose a general duty that would directly regulate the device itself, which would be a regulation that is different from the federal regulations applicable to the PMA device.

2013 WL 599178, at *8 (Riegel citation omitted) (emphasis added).  In other words, PMA preemption actually means something.  Getting hurt isn’t carte blanche to sue.  “PMA process does not guarantee that every device is safe.”  Id.

So much for medical device litigation tourism in Minnesota.

A One-Two Punch in the Aredia/Zometa Litigation

Here's another quasi-guest post from our quasi-regular blogger - Reed Smith's Melissa Wojtylak.  It's her post, I'm just the piano player.


Novartis scored a double victory in the Northern District of California last week, when the court granted a Daubert motion to preclude Plaintiff’s experts’ specific causation testimony, then granted summary judgment on the basis that without that testimony, Plaintiff couldn’t prove her case.  The Plaintiff in Messick had received therapy with the bisphosphonate drugs Aredia or Zometa for approximately two years, and alleged that she developed osteonecrosis of the jaw (“ONJ”) approximately a year and four months after stopping therapy. See Messick v. Novartis Pharmaceuticals Corp., No. 3:12-cv-00693-SI, slip. op. (N.D. Cal. Feb. 15, 2013).  (As an aside, during the time in which she was on Aredia and/or Zometa therapy, Plaintiff also had a litany of dental maladies – unrelated to her therapy - that would make even the most lax flosser repent of their ways.) 

The court first looked at Plaintiff’s oral and maxillofacial surgery expert, Dr. Jackson, who opined that Ms. Messick’s Aredia/Zometa use was the cause of her ONJ.  While the court found that that Dr. Jackson had pointed to reliable evidence to support general causation, it found that his evidence on specific causation was not reliable.  Dr. Jackson purported to rely on a pathology analysis of a fragment of bone that had been removed from Ms. Messick’s jaw in November 2008, claiming that this analysis demonstrated that her ONJ was caused by her Aredia and Zometa use.  Opinion, p. 7.  Here’s the problem:  the fragment was three years old when Dr. Jackson analyzed it, and in that three years, the fragment had merely been stored “in a plastic container,” and not preserved in any way.  Opinion, p. 6.  (As a certain teenage niece might say, “Um, ewww.”)   Not surprisingly, even Dr. Jackson had to admit that this sort of testing was not scientifically reliable.  Opinion, p. 7. 

 Dr. Jackson also purported to rely on a differential diagnosis to support his conclusion that Ms. Messick’s ONJ was caused by the drugs.  The Court was not persuaded, noting that while Dr. Jackson had been able to rule out three conditions that could have caused this patient to develop ONJ, he also identified five other risk factors that Plaintiff had for developing ONJ.  The support for the so-called differential diagnosis boiled down to Dr. Jackson’s assertion that “it just doesn’t happen” that someone with Ms. Messick’s risk factors would develop ONJ without also being exposed to bisphosphonates.  Opinion, p. 7.  As the court pointed out, Dr. Jackson never explained the scientific basis for his conclusion.  Opinion, p. 7.  After the “it just doesn’t happen” comment, it seems pretty clear to us that there wasn’t one – the doctor’s “differential diagnosis” was nothing more than a litigation-driven guess.   Ultimately, Dr. Jackson admitted that in a patient with multiple risk factors, there was no scientifically reliable way for him to determine which one had caused the injury.  Opinion, p. 7.  Because his specific causation opinion was not based on reliable methodology, it was out.  Opinion, pp. 7-8.   We liked the fact that at this point, the court cited to a 2012 opinion from the Eastern District of Washington, in which that court also excluded Dr. Jackson’s causation testimony.  Opinion, p. 8. 

But the court wasn’t finished with Dr. Jackson.  It next found that Dr. Jackson’s testimony also did not meet Rule 702’s relevance requirement, as under California law, Dr. Jackson’s testimony did not demonstrate that bisphosphonate therapy had more likely than not caused Ms. Messick’s injury.  Opinion, p. 8.  The best Dr. Jackson could do was to assert that a patient “like” Ms. Messick would not have gotten ONJ without bisphosphonate exposure – he never said that it had actually caused Ms. Messick’s ONJ.  Opinion, p. 8.  The court pointed out again that Dr. Jackson had specifically stated that he could not say this.  Id. 

After disposing of Dr. Jackson, the court moved on to the opinions of two of Plaintiff’s treaters, Drs. Silverman and Lam, and precluded them on the basis that neither of them had any reliable scientific basis for concluding that Aredia and Zometa had caused Ms. Messick’s ONJ.  Dr. Silverman performed no differential diagnosis (not even the lame-o Jackson variety), no research and no literature review; he merely testified that he “assumed” her ONJ was caused by the bisphosphonates, because “[t]here was a possibility of an association.”  Opinion, p. 9.  Dr. Lam brought even less to the table, testifying that it was his “impression” that the ONJ was bisphosphonate-related, but that he relied upon Dr. Silverman for a definitive diagnosis.  Opinion, p. 9.  The court rejected this Pete and Repeat act, holding

Dr. Silverman’s “assumption” and Dr. Lam’s “impression” are simply inadequate to satisfy the Ninth Circuit’s requirement under Rule 702, that where evidence of pre-litigation research or research subject to peer review is unavailable, the expert must point to an objective source, such as a treatise, policy statement of a professional association, or a published article in a reputable scientific journal.

Opinion, p. 9.   The court also noted that the doctors’ “impression” and “assumption” couldn’t get them past the Rule 702 relevance requirement either.  Opinion, p. 10.

After making short work of Drs. Jackson, Silverman and Lam, the court found that without their testimony, there was “a complete absence of affirmative evidence in the record that Aredia and Zometa more likely than not caused Ms. Messick’s ONJ.”  Opinion, p. 11.  Because this proof of specific causation was a required element on each of the Plaintiff’s claims, the court then entered summary judgment in Novartis’ favor. 

Congratulations to Frank Leone and Robert Johnson of Hollingsworth LLP and Jim Colopy of Farella Bruen. 

Wednesday, February 20, 2013

Accutane MDL Court Dismisses 40 Cases for Plaintiffs' Failure to Meet Expert Designation Deadline

Not to complain or anything, but these are rough days. We were stunned by the last episode of Downton Abbey. [SPOILER ALERT for you pathetic Nigel-Come-Latelies to Downton Abbey.  Skip to the third paragraph if you are still catching up via your Betamax machine.  By the way, you might also want to try listening to a hot new musical group called The Beatles.  Also, check out vanilla ice cream.  It's an acquired taste, but pretty darn good.]  When has a series killed off two main characters (and, arguably, the most important character, in terms of setting action in motion and being transformative) in the same season? The show is well written and splendidly acted, but it is, at bottom, cruel. The resumption of Breaking Bad will actually come as a relief; sure, there’s lots of drug dealing and murder in it, but it does not toy with our emotions nearly so much as those arch Brits. (For an interesting mash-up, see the “Breaking Abbey” skit here.)  From what we hear, the latest Downton death came about because the actor wanted to abandon the show for other acting opportunities. Mr. Stevens, we mutter a few curse words in your direction: "Daniel J. Travanti" and "David Caruso." Good day, sir!


The expiration of a charming fictional lawyer followed by only a few days the death of a real life, regal legal eminence, Ronald Dworkin. In our first year of law school the great Edward Levi taught a class called “Elements of the Law,” which addressed the Big Questions – certainly bigger than the Rule in Shelley’s Case or the distinction between larceny by trick and obtaining property by false pretenses. In "Elements" we read from the likes of Bentham, Rawls, and Dworkin. We struggled mightily to follow Dworkin's intricate analyses. How can a book with such a straightforward title, Taking Rights Seriously, be encumbered with such impenetrable prose? And yet Dworkin's insistence on law's moral dimension was undeniably refreshing. Dworkin was the second most cited legal scholar of the 20th Century, exceeded only by our favorite Seventh Circuit Judge, the one who launched our occasional postings on why “There’ll Always be Posner.” Dworkin ennobled our profession, even as he often puzzled it.


Meanwhile, the same issue of the Wall Street Journal with Dworkin’s obituary also informed us that fish exposed to certain anti-anxiety drugs (via industrial run-off or sewage) become less social but braver. Granted, we are not sure how to define ichthyo-courage, but the story had us hooked. It also made us feel somewhat anxious. As is all too often the case, we find ourselves wondering how bits of news and popular culture would affect judges and jurors. It might well be that a timid perch could benefit from a random dose of an antianxiety medication. The fish's consumption of the Mickey Fin might have been off-label, but we do not think an over-enthusiastic sales rep played any role in luring in that particular customer.  Still, we couldn’t help but think that some readers would take this fish-story (the one that did not get away) as further evidence of corporate perfidy and bad drug side effects. We are swimming through the waters of a double standard. The scales are weighted against corporations, which are held to a higher standard and suspected of the worst means and motives.


Speaking of side effects, we capped off the week by seeing a movie by that name. Side Effects is the new (and, by the director's account, last) Steven Soderbergh film. The coming attractions promised yet another ugly cinematic portrait of drug and device companies, as in The Constant Gardener and Love and Other Drugs. Nevertheless, while Side Effects has a couple of negative references to drug marketing, it says at least as many bad things about doctors and patients as about companies that sell products. ' Trust nobody' seems to be the message. Fine. Done.


When we surveyed the weekly docket, we were looking for a way to rinse off all this depression and anxiety. At a minimum, we were looking for a case where our side did not get burnt by the usual double standard. We found that case in the Accutane MDL - specifically, Aranda et al. v. Hoffman-Laroche, 2013 WL 562707 (M.D. Fla. Feb. 14, 2013), where the court ended up denying the plaintiffs' tardy effort to name a general causation expert witness and consequently granted summary judgment and dismissed 40 cases.


The Aranda plaintiffs filed their multi-plaintiff action in Illinois state court, alleging that they developed inflammatory bowel disease ("IBD") as a result of their use of Accutane.  The case was removed to federal court, and then was sent to the Accutane MDL. Here is the relevant chronology:


  • Earlier in the MDL, the court had struck the plaintiffs' IBD general causation expert.

  • The magistrate judge issued a scheduling order for all new cases in the MDL, requiring plaintiffs to name general causation experts four months after transfer to the MDL.  The order made clear that extensions “should not be anticipated.”

  • In July 2012 the magistrate judge held a status conference and set a November date for plaintiffs to disclose their experts. Plaintiffs' counsel attended telephonically. The magistrate judge issued a scheduling order, though the plaintiffs’ counsel later claimed they never received a hard copy of the order.

  • In September 2012, the court severed the Aranda cases and forced the filing of separate complaints. The severance order referenced the July scheduling order. 

  • November 2012 came and went without any designation by the plaintiffs of a general causation expert.

  • In December 2012, the defense counsel sent a letter to plaintiffs’ counsel asking why they had not yet disclosed their experts. There was no response.

  • The defendant filed a summary judgment motion in January 2013.  On that last day of that month, the court issued an order to show cause directing plaintiffs' counsel to file a response to the summary judgment motion. 

  • Only after that did plaintiffs seek an extension of time to name their expert.



The issue was whether plaintiffs' counsel had established "good cause" to modify the scheduling order pursuant to Fed. R. Civ. P. 16(b)(4).  The judge saw no such good cause, finding that the plaintiffs "do not present any legitimate excuse for failing to meet the Court's deadlines."  2013 WL 562707 at *2.  The plaintiffs' counsel's claim that it did not receive a hard copy of the July 2012 scheduling order was "disingenuous" in light of the plaintiffs’ telephonic presence at the conference.  Id.  The court noted that the plaintiffs' counsel's failure to sign up for electronic service notifications was not a valid excuse.  Id. at n. 1.  Further, the CM/ECF system showed service of a hard copy of the July 2012 scheduling order at two separate addresses.  Anyway, why wouldn't counsel have made some sort of inquiry after not receiving the order?  Moreover, plaintiffs' counsel clearly received the September 2012 severance order -- inasmuch as they complied with it -- and that order specifically referenced the earlier scheduling order. 


Perhaps the most damning evidence was the plaintiffs' counsel's failure to respond to the defense counsel inquiry in December. To make matters worse, though the Aranda cases had been lingering for 19 months, the plaintiffs' counsel admitted they had not begun looking for an expert until after receiving the inquiry from defense counsel. The court found that admission "inexplicable."  Id. at *3.  Here is the court's conclusion:  "Their failure to do anything with respect to locating an expert until December 14, 2012, already one month after the disclosure deadline, is inexcusable and demonstrates an utter lack of diligence to pursue their claims in this case.  Their delay of another month and a half after the letter before seeking an extension of time is similarly inexcusable.  Accordingly, their motion for an extension of the expert deadlines is denied."  Id


Without a causation expert, summary judgment was a foregone conclusion. Those 40 cases are gone.  It is as if they had crashed and are now overturned in a ditch by the side of the road.