[Drug and Device Law] "May the Odds Be Ever in Your Favor" - The Ten Best Prescription Drug/Medical Device Decisions of 2015

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The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015.  These are results that put the “happy” in Happy New Year – which we wish all our readers as the year in question draws to its inevitable close.

So, with cannons sounding for the plaintiffs involved, we give to you our picks for the ten best judicial decisions of 2015 (along with our customary ten additional honorable mentions) involving prescription drugs and medical devices. 

  1. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., ___ F.3d ___, 2015 WL 8538119 (6th Cir. Dec. 11, 2015).  This year’s number-one arrived relatively late, but it was definitely worth the wait.  When we first read Bartlett (2013 +1), we were struck by the Court going out of its way to state expressly that the FDA-pre-approval requirement for design changes applied to all prescription drugs.  That reference to “branded or generic” had to have a purpose.  Yates is the first court of appeals expressly applying the logic that all design changes requiring prior FDA review are preempted.  Post-approval, the FDA must review all “major” or “moderate” changes to drug design, rendering simultaneous compliance with an immediate state-law duty to use a different design impossible.  A “pre-approval” design defect claim (that the defendant should have submitted a different design to the FDA in the first instance, was speculative and would have required FDA approval of the different design in any case.  This “never-start selling” claim was also preempted because it was the same as the “stop-selling” claim rejected in Bartlett.  States cannot preclude the sale of what the FDA approved.  The bad Wimbush case (2008 -1) – from the same court of appeals (indeed, both originating in N.D. Ohio) – is limited to its facts (a drug already removed from the market), and doesn’t prevent preemption of design defect claims where the FDA continues to approve the product.  Application of a good No. 1 decision to confine a bad No. 1 decision is indicative of another good No. 1 decision.  Beyond that, Yates-based preemption would erase the non-generic stop-selling claim allowed in Pennsylvania in Lance (2014 -2).  Yates suggests that design defect claims against branded prescription drugs (and eventually §510k devices) are on their way out.  We wasted no time yacking about Yates here.
  2. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  Over the last couple of years, there have been a lot of good trial court decisions on off-label promotion and preemption (most, but not all, involving Infuse).  None of those decisions was better than Caplinger (2013 +9).  Because it was so good (a complete dismissal), Caplinger could be appealed.  This year it was affirmed, and the affirmance was just as good.  Off-label use does not provide plaintiffs with a get-out-of-preemption-free card.  If Congress had wanted to exempt off-label use (which it knew about, see 21 U.S.C. §396), from preemption, it would have done so expressly.  Claims that would require changes to labels or design are “different from or in addition to” what the FDA approved and are preempted.  Challenges to the legality of purported off-label promotion are purely matters of federal law and thus aren’t equivalent to any recognized state-law claim.  Indeed, to the extent plaintiffs identified any federal regulations at all, their claims “substantially exceed[ed]” them.  Adulteration/misbranding are FDCA, not state-law, violations.  If Congress wishes to set a different balance, it can, but until it does, all the plaintiffs’ litany of claims about off-label use/promotion of a PMA medical device are preempted.  The fact that plaintiffs have sought Supreme Court review in Caplinger (#15-321) only underscores its significance as a preemption milestone.  We celebrated Caplinger here and here.  Full disclosure:  Reed Smith is involved in Caplinger, so consider this entry a non-RS post.
  3. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015).  Where it exists, federal preemption is the strongest defense our clients have.  So it shouldn’t be much of a surprise that our top three decisions are all appellate courts recognizing that FDCA-related preemption extends to new areas.  Celexa was the first appellate decision recognizing that Mensing (2011 +1) impossibility preemption cannot be limited to generic drugs.  Celexa was brought by some rather self-important plaintiffs seeking, under state law, to enjoin the sale of an FDA-approved drug because the efficacy data on which approval was based was allegedly wrong.  That presented a problem – the efficacy data at issue had already been reviewed by the FDA, and plaintiffs offered nothing new.  Since the rationale Levine (2009 -1) employed against preemption was that innovator manufacturers were free to change their labels based on “new” information (the changes being effected (“CBE”) exception), a label-related claim that fell outside the scope of the CBE exception, here, that involved only “old” information, was preempted.  While this type of informational claim isn’t all that common, the principle that Celexa established – that Mensing’s implied preemption logic extended beyond generic drugs – is critical.  We pointed out the broader implications of Celexa here.
  4. David v. Medtronic, Inc., 188 Cal. Rptr.3d 103 (Cal. App. 2015).  CAFA provides that actions including more than 100 plaintiffs are removable to federal court as “mass actions.”  Predictably, the other side started filing complaints with dozens (but never 100) of blatantly misjoined plaintiffs from all over the country with nothing in common except suing over the same drug/device.  There would always be a couple of plaintiffs from the forum state, and a couple of plaintiffs from the defendant’s home state to destroy diversity as another ground for removal.  This gamesmanship has been particularly widespread in California.  The David decision goes a long way to putting a stop to this in the nation’s largest and most litigious state by affirming severance of all the out-of-state plaintiffs on the basis of forum non conveniens, since the defendant wasn’t based in California either.  There were Bauman personal jurisdictional problems with the case, and the court recognized that the “same transaction” standard for joinder wasn’t met by anybody anywhere in the country claiming the same injuries from the same product.  The medical treatments were different, and so were the doctors, hospitals, and the informational and temporal context in which each individual case arose.  The non-California claims could be brought in those plaintiffs’ home states, so litigation tourists go away and stop clogging our courts.  Peripheral claims against nominal defendants don’t count against forum non conveniens, and if plaintiffs chose, they could continue with those peripheral claims in California.  We harmonized with David’s beautiful music here, and put the decision in perspective here.  Full disclosure:  David is a Reed Smith case, so this entry is also non-RS.
  5. Sergeants Benevolent Ass’n Health & Welfare Fund v. Sanofi-Aventis United States LLP, 806 F.3d 71 (2d Cir. 2015).  We admit we were a bit depressed after the Third Circuit went south in the Avandia decision (2015 -3).  Then along came the Second Circuit to cheer us up again.  Like Avandia, SBA was a third-party payer RICO case; unlike Avandia court of appeals shut the SBA plaintiffs down.  The allegations had a Buckman-like tinge – that a questionable clinical study supported FDA approval, and then the defendants promoted off-label.  Because RICO is a federal statute, however, preemption isn’t a defense.  But causation is.  SBA rejected the doctors-don’t-matter refrain from Avandia.  To the contrary, prescribing physicians are central where prescription medical products are concerned.  “Generalized proof of causation was impossible because of the intervening actions of prescribing physicians.”  The varying effects of differing misrepresentations on independent decision makers make causation impossible to prove on anything but an individualized basis.  Against an FDA-approved drug, plaintiffs could not claim that “nobody” would have used it had the purported “true” risks been know.  That is “stop selling” by another name.  Nor could plaintiffs avoid the learned intermediaries’ role with “simplistic” statistical analysis.  Plaintiffs could not get to a class action by dumbing down the elements of their substantive claims.  Thus some inordinately long-running litigation (more than seven years) finally came to an end.  We bid SBA adieu here.
  6. Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  Holy cow.  Bye-bye baby.  Outta here!  When we (well, Bexis) started advocating the First Amendment as a defense in the off-label promotion context twenty years ago, there wasn’t much traction.  Bone Screw cases turned out to be much easier to win on other grounds.  Fast forward two decades − past WLF, Pearson, Western States, Sorrell (2011 +5), and Caronia (2012 +7) − and things sure have changed.  At least in the Second Circuit, thanks to Caronia, truthful off-label promotion is First Amendment-protected speech, which the FDA (and, by extension, private plaintiffs) cannot prosecute.  Amarin was the first case in which the regulated manufacturer went head-to-head with the FDA, stuck it out, and won in court.  The plaintiff company’s science wasn’t what the FDA considered “substantial evidence,” but it was valid science.  What the plaintiff company wanted to tell potential prescribing physicians was truthful, properly disclaimed, and thus not “false or misleading” even though it concerned off-label use.  The FDA doesn’t want to appeal.  We went yard over Amarin here and here.
  7. Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 135 S. Ct. 1378 (2015).  It’s from the Supreme Court and it involves prescription drugs, but it’s not directly applicable to product liability.  It is relevant to, and reinforces, first, the Buckman preemption rationale against private enforcement of statutes like the FDCA where private enforcement is not allowed; and, second, why alleged violations of vague regulations cannot escape preemption.  Armstrong involved a Medicare statute, not the FDCA, but the reasoning is the same – indeed Buckman is a fortiori because the FDCA’s prohibition against private enforcement is express, whereas that in Armstrong was only “implied.”  The implication came from the statute’s provision of a single remedy for violations, one conferring no rights to individuals.  No private enforcement was allowed because “express provision of one method” of enforcement “suggests that Congress intended to preclude others.”  On the second point, the Medicaid statute’s requirements were vague, and thus “judicially unadministrable,” providing a second basis for Congress wanting the remedy that it provided to be exclusive.  The same reasoning should preempt the holdings of a number of courts allowing “parallel” claims purporting to enforce vague FDA manufacturing-related regulations.  We discussed the implications of Armstrong here.
  8. State ex rel. J.C. v. Mazzone, 772 S.E.2d 336 (W. Va. 2015).  Just as in California (see Martin, above), forum-shopping litigation tourists took it on the chin in West Virginia.  Instead of Bauman, however, this case was decided solely on old fashioned forum non conveniens grounds.  It was the same game playing, though – dozens of out-of-state plaintiffs misjoined in the same complaint.  Because neither the plaintiffs nor the defendant was from West Virginia, and plaintiffs could all sue in their states of residence, West Virginia was an inconvenient forum.  The ordinarily “great deference” given to a plaintiff’s choice of forum is diminished where a nonresident sues over matters not arising in the state.  The defendant’s difficulty in obtaining discovery from fact witnesses in plaintiffs’ home states worked sufficient “injustice” to support the forum non conveniens finding.  All of the considerations discussed by the court would be the same in any litigation tourist case against an out-of-state corporation, thus Mazzone, if followed by the trial courts of West Virginia, effectively ends multi-plaintiff, out-of-state, CAFA avoiding complaints in this state.  We explained the significance of Mazzone here.
  9. In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  The best Daubert decision of 2015 was either this one or a similar decision (both excluding the same expert) in the Lipitor MDL.  We chose this one because Zoloft involved a higher degree of Daubert difficulty, since there actually were some (older, smaller, and otherwise less persuasive) studies that reached adverse, statistically significant results.  The plaintiffs, and their result-oriented statistical expert, were ultimately done in by more recent, more powerful studies that refuted the supposed connection between cardiac birth defects and Zoloft that plaintiffs’ expert tried very hard to invent.  This was a do-over – plaintiffs had their first batch of experts all excluded under Daubert − so this guy was their last chance, and they knew it.  Everything was heavily litigated, and, the lengthy opinion thoroughly addressed Daubert issues like a priori reasoning, statistical significance and p-values, cherry-picking, after-the-fact statistical manipulations, confounding, and re-analysis of published data.  Daubert is the second strongest MDL defense strategy (after preemption) and as the year draws to a close, the result here means that all the cases in the Zoloft MDL are likely subject to summary judgment.  We analyzed Zoloft here, after complaining about the do-over here.
  10. In re Incretin-Based Therapies Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 6912689 (S.D. Cal. Nov. 9, 2015).  The Levine (2009 -1) clear evidence test for implied preemption in prescription drug cases can be met – that’s the lesson of Incretin.  It’s tough, but it can be done, and successful preemption can shut down an entire MDL.  Plaintiffs claimed that the drug caused a disease (pancreatic cancer).  Trouble is, the FDA decided time and time again that any causal link was “indeterminate” and shouldn’t appear on the drug’s label.  Plaintiffs’ experts could manipulate the data (such as notoriously inaccurate – the court acknowledged this – adverse event reports) all they wanted, but the fact remained that the FDA had looked at everything and said “no.”  Hence, preemption existed under Levine’s “would have rejected” standard, which the court refused to make worse than the Supreme Court already had.  The court recognized that, when the FDA calls for data from all manufacturers of a class of drugs, it has more evidence at its fingertips than any one of the competing manufacturers, which was unlike Levine.  Nor is it necessary that the FDA definitively rule out causation; a conclusion that causation hasn’t been shown to the FDA’s regulatory standards is enough.  Finally, plaintiffs cannot avoid preemption by arguing fraud on the FDA.  That’s preempted, too, and plaintiffs can’t second-guess the FDA’s administrative process.  What the FDA considers, or not, is within the discretion of the Agency.  A final plus factor in Incretin was that both federal and state judges had heard argument of the motion, and the state judge agreed.  We announced that Christmas had come early in Incretin-land here and mentioned the state-court’s concurrence here.

That’s our top ten, but as usual our side’s noteworthy wins in 2015 didn’t stop with ten.  Thus, we’re acknowledging ten more favorable decisions this year that fell just short of cracking our top ten.

Here are our Honorable Mentions:  (11) Shepherd v. Vintage Pharmaceuticals, LLC, ___ F. Supp.3d ___, 2015 WL 6956767 (N.D. Ga. Nov. 4, 2015).  Plaintiffs don’t dare bringing personal injury class actions against prescription medical products much anymore.  Shepherd is a timely reminder why that’s true.  We blogged about denial of class certification here.  (12) In re Accutane Litigation, 2015 WL 1504304 (N.J. Super. Law Div. April 2, 2015).  The court’s ruling that the drug’s warnings were adequate as a matter of law pretty well shut down this long-running litigation, as discussed here and here.  (13) PomWonderful, LLC v. FTC, 777 F.3d 478 (D.C. Cir. 2015).  The First Amendment applies to the FTC, too, and truth is not to be judged by the FDA’s “substantial evidence” test.  We celebrated another appellate free speech win  here.  (14) Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), and Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 5836973 (S.D. Ohio Oct. 2, 2015).  These twin decisions would have ranked higher, except that Yates stole some of their thunder.  Rheinfrank I was a relatively rare finding of preemption against plaintiff’s most dangerous warning claims under the Levine (2009-1), as well as some useful state-law (Ohio) rulings.  Rheinfrank II added design defect preemption.  We discussed Rheinfrank here, and Rheinfrank II here.  (15) Johnson v. Smithkline Beecham Corp., 2015 WL 1004308 (E.D. Pa. March 9, 2015).  How many of us – particularly in mass tort litigation – have thought that many of the plaintiffs’ cases are so patently weak as to be frivolous and sanctionable?  In this case, the court granted sanctions, based on the statute of limitations and product identification.  We never blogged on this case because of Reed Smith’s involvement in the litigation, but it merits an honorable mention.  (16) In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015).  TRT deflated the last-ditch generic plaintiffs’ argument that generic drugs that did double duty as FDA reference listed somehow lost the protection of preemption.  We got a rise out of that, here.  (17) Shuker v. Smith & Nephew, PLC, 2015 WL 1475368 (E.D. Pa. March 31, 2015), certif. for appeal denied, 2015 WL 4770987 (E.D. Pa. Aug. 13, 2015).  Component parts, off-label use, failure to report – you name it, plaintiffs threw it at PMA preemption – without success, as we discussed here.  (18) Mink v. Smith & Nephew, Inc., ___ F. Supp.3d ___, 2015 WL 7356285 (S.D. Fla. Nov. 19, 2015), the FDA has increasingly conditioned its approval of a product on the manufacturer conducting post-approval clinical trials.  Does participation in such a trial avoid preemption.  Fortunately, as a matter of first impression, Mink said “no” – a result we liked, here.  (19) Latimer v. Medtronic, Inc., 2015 WL 5222644 (Ga. Super. Sept. 4, 2015).  Believe it or not, the best reasoned trial court-level Infuse decision anywhere might just be state trial judge’s opinion from Bexis’ home town of Atlanta, Georgia.  Read it and marvel, here.  (20) In re Actiq Sales & Marketing Practices Litigation, 307 F.R.D. 150 (E.D. Pa. 2015).  Nationwide third-party payer class action alleging state-law causes of action.  While denial of certification is the rule, this opinion is jam-packed with the defense-side goodies that we detailed here.

Looking over our 2014 lists, we’re pleased that our number one bad decision, Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (2014 -1), was erased by the legislature before that opinion even had time to receive a reported citation.  Unfortunately, courts arrogate to themselves authority to change law retroactively while refusing that power to legislatures, so there could still be some Weeks-governed stragglers.

All the other bad boys from 2014 still survive, although Lance (2014 -2) is menaced by Bartlett (2013 +1) preemption.  Discretionary review in Hardin (2014 -5) and  Scott (2014 -7) failed.

An appeal in Actos (2014 -3 and -9) vanished with a settlement, however, the pre-suit spoliation rationale of the earlier Actos decision (2014 -9), has been done away with by the new Rule 37(e)(2) (effective 12/1/15 and discussed here), limiting severe sanctions for intentional spoliation to intent related to “the litigation.”

Our entire roster on the plus side of the 2014 ledger is intact, although as we mentioned last week Corber (2014 +4) was a victim of drive-by distinguishing by a subsequent panel.  On the other hand, the preemption result in Booker (2014 +7) was effectively affirmed by Yates. 

Looking ahead, the California Supreme Court in Bristol-Myers-Squibb will eventually rule on personal jurisdiction post-Bauman – almost certainly a top- or bottom-ten case depending on result, with an eventual appeal to the United States Supreme Court likely, again regardless of the result.  United States Supreme Court certiorari petitions are currently pending in this year’s POMWonderful (good) and Reckis (bad).  Guvenoz may join them, the Illinois Supreme Court having denied review, but the Supreme Court has turned down all post-Bartlett generic preemption (including Pennsylvania (2014 -4) and Iowa (2014 +3)) to date.  Other cases almost sure to land on our top- or bottom-ten list for 2016 Cisson v. Bard, currently pending in the Fourth Circuit, on the issue of admissibility of FDA §510k clearance, and the Arizona Supreme Court’s review of Watts (2105 -6), concerning the learned intermediary rule.

Finally, on the administrative front, as we predicted, the FDA’s proposal to change the rules to eliminate generic drug preemption got nowhere in 2015.  It’s now not even scheduled to be finalized administratively until July, 2015, at the earliest.  Given the legal hurdles that await after a final rule, frankly, we don’t expect it ever to go into effect.  We’re a lot less certain what will happen with the FDA’s proposal (discussed here) to amend the “intended use” regulations that it has used to prohibit truthful off-label promotion.  Here’s hoping the Agency is forced to confront First Amendment issues so that, assuming this rule is finalized, the validity of the FDA’s ban can likewise be challenged directly via appeal from the Agency’s final rule.

So now we’re done with 2015.  All in all, a pretty good year.  We wish a Happy New Year to all our readers, especially to those  on the right side of the “v.”.


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Posted By Bexis to Drug and Device Law at 12/31/2015 08:00:00 AM

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