Wednesday, December 29, 2010

Top Ten Best Prescription Drug/Medical Device Decisions Of 2010

We hope all our readers had excellent holidays, didn’t get stranded in the snow (here on the US East Coast), and received lots of desired presents due to what the economic stats we’ve seen are saying has been a better than expected retailing season.  That is, it’s better than expected if you’re a retailer or a recipient.  For those of us who have to pay the bills … well, we won’t go there and ruin the good cheer.

Good cheer it is, too, as today’s post is devoted to our favorite drug/medical device judicial decisions of 2010.  There've been a raft of good decisions, although none from the United States Supreme Court, for all us practitioners on the right (in more ways than one) side of the “v.” to be thankful for.  Indeed, we confess that depending on the day, any of the first three cases could have been ranked as number one.  We’ve changed the rankings ourselves since we first started thinking about this list a couple of weeks ago.

So here are our best of 2010 – the decisions that had us happily typing away on “breaking news” and other posts throughout the year.

1. UFCW Local 1776 & Participating Health & Welfare Fund v. Eli Lilly & Co., 620 F.3d 121 (2d Cir. 2010).  Stick a fork in economic loss class actions derivative of supposed product liability defects – they’re done.  That’s what we thought when we first read this widely anticipated decision, which reversed the #2 worst decision of 2008.  Third party payers cannot prove reliance on a classwide basis even under what plaintiffs considered their last, best hope of a theory, RICO.  Try as they might, purveyors of class actions can’t escape the intensely individualized medical decisionmaking process that underlies any prescription of drugs (and presumably medical devices).  Whether it’s called “reliance” or “causation,” allegedly inadequate information must affect a doctor’s prescription decision, and the gambit of using TPPs as proxies doesn’t obscure that fact.  We ultimately put this Zyprexa decision first because of its broad implications for all of our clients, particularly if the result had gone the other way.  Unless the Supreme Court were to change class action law adversely in the pending Dukes case (unlikely), we don’t think there’s much of a future for class actions (economic loss or otherwise) based upon supposed safety defects in drugs.  We discussed the decision as breaking news here and in more detail here.

2. Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010).  Here, we had to decide whether to go with an industry-specific, or a state-specific case.  Then last week the Seventh Circuit forced our hand by dropping Bausch on us like a humongous lump of coal into our stockings.  That moved Bryant up because, if not for Bryant, the entire post-Riegel preemption model we’ve been advocating for two years might have been knocked down by one adverse circuit decision (shades of Mason).  But with Bryant as the first appellate decision, we’ve got a direct circuit split, with perhaps an avenue to the Supreme Court (and the Medtronic folks must be tearing their hair out watching their competitors mess up the law).  Anyway, Bryant demonstrates the power of preemption, affirming our #7 best case of 2009 and defeating an entire MDL at a stroke.  The opinion is great on preemption principles, particularly the interplay between express and implied Buckman preemption in parallel violation claims – something we’ve consistently advocated on this blog.  Bryant is an absolute must read for any PMA medical device defendant thinking about a preemption motion.  For good measure the Eighth Circuit also trashed the “suspect motives” behind the plaintiffs’ attempt to recuse the judge.  And to think, but for a fortuitously delayed settlementBryant almost never saw the light of day.  We rather gleefully blogged about Bryant here.

3. White v. Wyeth, ___ S.E.2d ___, 2010 WL 5140048 (W.V. Dec. 17, 2010).  Hellhole?  What hellhole?  Our number three case is courtesy of the West Virginia Supreme Court of Appeals – which places two decisions in our top ten this year.  The court first held that any private action under the West Virginia consumer fraud statute required reliance as an element – at least in affirmative misrepresentation cases (the only theory at issue).  That alone would be hugely significant, because reliance is the D's chief bulwark against class actions in consumer fraud cases.  Not stopping there, the court went on to hold that:  (1) “because the consumer can not and does not decide what product to purchase” when a prescription is required, and (2) “the high degree of federal regulation,” by the FDA, prescription medical products are not subject to consumer protection claims at all.  That's right - never.  In addition to its considerable merits, White has a couple of other implications, first the emphasis on the role of the prescribing physician suggests an opportunity for reconsideration of the execrable Karl decision (cited only as “but see”) rejecting the learned intermediary rule.  Second, since White obliterated the legal theory underlying the class action/collateral estoppel case now pending (Smith v. Bayer, 09-1205) in the Supreme Court, might that case now be moot?  We previously discussed White here and here.

4. West Virginia v. Johnson & Johnson, ___ S.E.2d ___, 2010 WL 4709084 (W. Va. Nov. 18, 2010).  Reversing a really scary – and totally erroneous – multi-million dollar trial court verdict, the West Virginia Supreme Court of Appeals held that a company receiving an FDA warning letter is not collaterally estopped from disputing the FDA’s assertions in court.  At quite some length, the court agreed with the position taken by this blog that FDA warning letters, being tentative, preliminary, not final agency action, etc., can’t collaterally estop anybody from contesting anything.  Note the caption.  This was an attorney general action.  We’re frankly shocked that the coercive power of any state would be put behind such a flimsy theory.  That made the case doubly scary.  Thus, we’re doubly pleased to see this “egregious” (the court’s word) theory done away with.  We blogged about this case here.

5. Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010).  There wasn’t much good preemption news on the prescription drug side in 2010.  Robinson was a searchlight shining in the darkness, and from an unexpected quarter.  The court found – in an OTC drug case – that the FDA’s rejection of a petition to add a warning about the same risk that the plaintiff advocated was “clear evidence” of conflict with the FDA as required by Levine to preclude suit over the warning.  Given how poorly preemption has fared recently, that might not be enough to reach the top ten, but Robinson (yes, it’s Posner) contains a rich vein of other legal nuggets, on choice of law, contributory negligence, causation, overwarning, and warranty.  We discussed the preemption aspect of Robinson here, and mined the other nuggets here.

6. Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010).  Kilpatrick is our pick as the best Daubert decision of 2010.  Unlike many cases, this court did not let the plaintiff’s expert get away with anything.  On general causation, the expert cherry picked five articles from the medical literature.  The court examined each article individually and determined that none of them was reliable.  On specific causation, the court tore the expert’s purported “differential diagnosis” to shreds, holding that under Daubert an expert must take idiopathic (that is, unknown cause) occurrences of a disease into account and that a differential diagnosis based upon temporal relationship is unreliable.  We’d like to see more courts engage in Kilpatrick-level critical analysis of junk science.  We blogged acout Kilpatrick here.
7. Wyeth, Inc. v. Blue Cross & Blue Shield of Alabama, 42 So.3d 1216 (Ala. 2010).  This is another important class action decision, albeit since it’s under state law, of less potential scope than UFCW1776.  The court vacated a 2004 nationwide (!!! a pre-CAFA case) class certification of third-party payer claims for economic loss from the withdrawal of a prescription drug from the market.  The court held that, yes, even under an unjust enrichment theory, you can’t certify a class involving the laws of all fifty states.  That’s a given in federal court, but it’s gratifying to have state high courts adopt the same principle.  The decision would have ranked higher, had the court also thrown out the TPP class for lack of standing (the TPPs didn’t lose any money).  We delved into Wyeth v. Blue Cross here, albeit on the standing issue.

8. IMS Health, Inc. v. Sorrell, ___ F.3d ___, 2010 WL 4723183 (2d Cir. Nov. 23, 2010). It’s not product liability, but rather a First Amendment case that combines excellent reasoning with potentially broad implications.  In a transparent attempt to hamstring pharmaceutical marketing, the state of Vermont made it illegal for data miners to sell physician prescribing information to pharmaceutical companies.  Rejecting a prior First Circuit decision – and thereby creating a direct circuit split – the court held that the state had unconstitutionally restricted truthful corporate commercial speech.  The court found the state’s interest speculative (in part), it’s methods indirect, it’s motives pretextual and paternalistic, and its approach overly restrictive of free speech about pharmaceutical products.  The circuit split means the issue might interest the Supreme Court.  Any commercial speech case involving pharmaceutical marketing necessarily implicates the FDA’s ban on truthful promotion of off label use, the demise of which would be a huge development.  We blogged about Sorrell here.

9. Cochran v. Wyeth, Inc., 3 A.3d 673 (Pa. Super. 2010).  How long would trials be if, instead of focusing on the injury allegedly suffered, the plaintiff could also attack warnings about risks that s/he never even encountered?  Well, in Cochran, the labeling warned very explicitly about the injury the plaintiff had, but not about a more common but considerably less serious risk.  The plaintiff claimed that, despite an adequate warning of the actual injury, the prescription would never have happened if the other risk had been mentioned.  Yeah, right - but it may well overcome summary judgment if the theory itself were viable.  This sort of non-injury warning theory is both attenuated and expansive.  Fortunately, Cochran said “no way” and held that “proximate cause,” the policy-based limits to remote causation, barred claims over warnings of injuries that a plaintiff never actually had.  We’re happy and relieved to see this obscure liability theory stay that way.  We discussed Cochran here.

10. O’Connell v. Biomet, Inc., ___ P.3d ___, 2010 WL 963234 (Colo. App. March 18, 2010), review denied, 2010 WL 4851480 (Colo. Nov. 30, 2010).  We like ringing appellate (heck, any) endorsements of the learned intermediary rule, especially in jurisdictions where the high court hasn’t settled the law.  O’Connell was the best of the year by far in that regard.  While it may be stretching things to say that O’Connell is the first Colorado decision ever to “directly” address the learned intermediary rule, it’s certainly the best, not to say the most recent.  Nor did the court clutter its opinion with any discussion of exceptions, whether relevant or otherwise.  As a cherry on top, there’s also a nice “captain of the ship” ruling concerning the presence of a manufacturer’s representative during surgery.  We told readers about O'Connell here.

That’s ten, but we find we still have a bunch of smaller, but quite nice, judicial presents under our 2010 tree.  Rather than allow them to go entirely unmentioned, here the next ten in summary form:

Honorable mentions:  (11) Guinn v. AstraZeneca Pharmaceuticals LP, 602 F.3d 1245 (11th Cir. 2010) (good Daubert opinion (temporal/differential diagnosis) affirming our #8 from last year, and helping kill off the Seroquel MDL; see our post here); (12) Ranes v. Adams Laboratories, Inc., 778 N.W.2d 677 (Iowa 2010) (a state supreme court applying its Daubert equivalent rigorously; a welcome change, as we discussed here); (13) Clark v. Pfizer, Inc., 990 A.2d 17 (Pa. Super. 2010) (class decertification affirmed; Pennsylvania really doesn’t like fraud on the market theories; we covered the decision here and here (as a exemplar of fraud on the marked jurisprudence)); (14) Hazlehurst v. HHS, 604 F.3d 1343 (Fed. Cir. 2010)/Cedillo v. HHS, 617 F.3d 1328 (Fed. Cir. 2010) (a bit out our sweet spot, but this pair killed off vaccine-autism litigation – some of the most socially harmful litigation of all time; for Hazlehurst see here, and for Cedillo here); (15) In re Oxycontin II, 908 N.Y.S.2d 239 (N.Y.A.D. 2010) (reversing last year’s #10 worst; forum non conveniens will not be diluted in mass torts; we hailed the decision here); (16) In re Baycol Products Litigation, 596 F.3d 884 (8th Cir. 2010) (good Daubert affirmance and sensible ruling on unjust enrichment (“the drug did it’s job", go away); (17) In re Neurontin Marketing & Sales Practices Litigation, ___ F. Supp.2d ___, 2010 WL 5037005 (D. Mass. Dec. 10, 2010) (dismissing most of long-running off-label promotion litigation on causation/non-reliance grounds; we were all over it, here); (18) In re Digitek Products Liability Litigation, 2010 WL 2102330 (S.D.W. Va. May 25, 2010) (certification of five class actions denied on grounds that pretty much cover the class action waterfront; we dug it, here); (19) In re Trasylol Products Liability Litigation, 709 F.Supp.2d 1323 (S.D. Fla. 2010) (Suzanne Parisian’s legal conclusions and other “expert” testimony excluded; nuff said; we celebrated here); (20) In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, 692 F. Supp.2d 1012 (S.D. Ill. 2010) (we’ve complained before about the Southern District of Illinois' crabbed approach to fraudulent joinder; this Y&Y case forthrightly breaks with those decisions; we blogged about it here).

Looking ahead to next year, there’s a raft of interesting Supreme Court cases on tap.  Foremost from our perspective have to be the two latest FDA preemption cases: the Bruesewitz vaccine case and the Mensing, et al. generic preemption trio.  There’s another non-drug preemption case, Williamson v. Mazda, that bears watching.  Beyond preemption, there are the two Supreme Court personal jurisdiction cases, Brown and Nicastro, and of course the Dukes class action whopper.

Other candidates – barring Supreme Court certiorari grants (notoriously difficult to predict) – are Hamilton v. Centocor (this year’s #4 worst) already in the Texas Supreme Court; Bartlett (#8), a lock for an appeal to the First Circuit; and possibly Lance (#6), with a petition pending in the Pennsylvania Supreme Court.  The various MDL decisions:  Gadolinium (#5), Fosamax (#7), ObTape (#9), and Levaquin (#10), all will require an individual case as an appellate vehicle.  We believe that’s in the works for all, save perhaps the first.  Of the cases we like, only Cochran (#9), with a petition pending, is reviewable at anything below the United States Supreme Court level.

On a more general note, there have been quite a few dismissals recently of cases involving:  (1) PMA preemption, (2) Conte-type theories of name-brand liability in generic cases, and (3) economic loss actions brought by third-party payers.  Given that volume, we would expect 2011 to see important appellate decisions addressing these issues.

1 comment:

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