Friday, December 21, 2012

The Bottom Ten – The Worst Prescription Drug/Medical Device Decisions Of 2012


Do we have to?  That depends on whether we mean “must” or should.”  There’s relatively little that’s really a “must,” but quite a bit that’s a strong “should.”  So yes, we have to.  It’s that time of year again, and we’re looking back over the past twelve months for the decisions that, in this instance, we liked the least.  Because we like to end the year on a high note, we always examine the bad decisions before the good ones, and this year’s no exception.

This post thus goes to show that you – that is, we – can’t win them all.  So for our fifth straight year we’re looking at the coal that has found its way into our Christmas stockings, specifically the ten worst prescription medical product liability decisions of 2012.  There's no particular pattern, these blots on the law are from all over, both in federal and state court.  While we’ve seen ATRA’s latest list of hellhole jurisdictions, our bottom ten doesn’t particularly correspond, probably since ATRA’s latest list has less to do with drugs and medical devices than the in some prior years.

Yeah, we’re procrastinating.  Like most lawyers, we’d rather focus on wins than losses – that and 2012 still has a week and a half left for still more bottom-dwelling decision to come down.  That said, we can’t delay any longer.  Here are the jurisprudential dregs of 2012.

1.                  Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012).  Terrible result and worse reasoning, on several levels.  After the plaintiff lost his warning claims for the prescriber’s failure to read the warning, he pursued a design defect claim with no alternative design that amounted to a demand that an FDA-approved generic drug should be removed from the market altogether.  All that was before Mensing.  After Mensing we couldn’t see how the plaintiff could retain this $20 million+ verdict, but the First Circuit found a way – a bad way, but a way.  Even though the opinion all but conceded that design claims would fail under the “sameness” analysis used by the Supreme Court in Mensing, the First Circuit decided that reasoning didn’t matter, dug in its heels, and ruled that, no matter what, it wasn’t going to preempt the plaintiff’s sole surviving claim.  Period; full stop.  The decision's rationale was that nothing requires a manufacturer actually to sell a drug that the FDA has approved, but argument that (like the lobbying argument rejected in Mensing) proves way too much.  The same thing could be said about any product in any case.  Moreover, nothing could more directly conflict with the FDA’s authority over drug approval than a state-law claim that says, “So what?  You can’t sell that here.”  "Yes" directly conflicts with "no." Finally, to the extent that Hatch Waxman was supposed to promote the availability of generic drugs, banning them outright is the antithesis of that purpose.  We blogged about this stinker here and here.  The only good thing we can say about Bartlett is that the Supreme Court recently accepted the challenge and granted certiorari.  So we’re hopeful that the worst decision of 2012 might produce the best of 2013.  Fingers crossed.

2.                  Caldwell ex rel. State v. Janssen Pharmaceutical, Inc., ___ So.3d___, 2012 WL 3761900 (La. App. Aug. 31, 2012).  What do you get when a state hires contingent fee counsel and lets that counsel pick the most pro-plaintiff county (called “Parishes” in Louisiana) in the state to sue over alleged failures to warn that were never actually hurt anybody?  How about an eye-popping $257 million verdict along with an extra $73 million fee and cost award for said counsel.  Most ginned up state false claims suits like this one get thrown out, at least on appeal, but not in Louisiana (at least not yet).  On appeal, the court found no error in the trial court’s allowing the plaintiff to proceed on an absolute liability theory from West Virginia that (unmentioned in Caldwell) the West Virginia Supreme Court later threw out as a matter of law.  The language of the relevant statute was outright ignored in Caldwell, and both injury and causation were effectuvekt presumed (the “materials in and of themselves cause harm and injury”).  The opinion also affirmed total exclusion of evidence (including statistics) that the defendant’s supposedly false statements were in fact scientifically valid.  The opinion itself is an embarrassment, consisting mostly of the court quoting the trial court’s barely coherent rulings and reciting that there was no “manifest error.”  The only saving grace is that the Louisiana Supreme Court might think so too.  We excoriated Caldwell here.

3.                  Dolan v. Hilo Medical Center, 278 P.3d 382 (Haw. App. 2012).  In this absurd medical device decision, the manufacturer was found liable where:  (1) the hospital never inventoried the device kit that it received, and (2) the surgeon used a screw driver as a substitute for a spinal rod when he couldn’t find the right part during surgery.  The screw driver, of course, broke almost immediately, since it was not designed (let alone FDA approved) for implantation.  Oh ... and the defendant manufacturer produced an undisputed packing slip indicating that it had shipped all the proper parts to the hospital.  And there's more:  the doctors and hospital concealed from the patient what they had done.  The jury got it right – hammering the malpractice defendants and excusing the manufacturer.  Inexplicably, however, the appellate court reversed, on the lame excuse that the judge used an outdated jury instruction on substantial change.  So what?  This wasn’t a substantial change case, rather it involved blatant and outrageous product misuse.  It may not be the worst decision of the year, but it sure is the dumbest.  We dissented here.

4.                  In re Chantix Varenicline Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 3871562 (N.D. Ala. Aug. 21, 2012).  A really, really bad Daubert decision.  Seven causation experts were allowed to testify that the drug caused suicide (of all injuries, one of the hardest to prove) despite lacking even one medical study (at least none were cited) to support their opinions.  Basically, the decision holds that qualifications are enough and everything else is cross-examination fodder.  Daubert?  What Daubert?  Opinions based on statistically insignificant data?  That’s OK.  Adverse reactions that the FDA itself says aren’t to be used for drawing causation conclusions?  That’s OK, too.  Extrapolation from animal studies with huge dosages?  You bet.  Ditto for cherry-picked data.  The defendant’s labeling mentioning the risk also supported causation.  Damned if you do; damned if you don’t – even though FDA regulations outright specify that “a causalrelationship need not have been proven.”  Also, any decision that favorably cites the pre-Daubert Wells v. Ortho decision raises our hackles.  Even the good rulings (corporate intent, misleading the FDA), were precluded on a lame “speculative” basis rather than for being blatantly improper subjects of expert testimony.  We found this opinion largely indigestible here.

5.                  Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012).  Usually adverse state supreme court cases rank pretty high on our list.  Cornett isn’t ranked higher because all of it isn’t bad – specifically the court blew out the lead plaintiff’s case on unrelated statute of limitations grounds, whichought to count for something (not all that much), and placed some decent summary judgment limits on the claims it permitted to go forward (somewhat better).  But those good points can’t make up for messing up two of our favorite issues, preemption and off-label use, in the same opinion.  In a PMA medical device case, the court allowed a plaintiff to get by the pleading stage with a “parallel claim” based on off-label promotion, even though there’s not any FDA regulation that bars such promotion (the regs call it no more than “evidence”), and the FDA guidance that enunciates an outright ban doesn’t have force of law and thus shouldn’t support any negligence per se action at all.  The off-label promotion claim was nothing more than an ill-disguised inadequate warning claim (preempted under Riegel), but the court went along with the plaintiffs' ruse of renaming the claim.  Still, the court did impose some decently strong restrictions on the claim before it could survive summary judgment.  If the trial courts enforce these, there may not be all that many claims.  But the tough nut remains, how can a state law claim be “genuinely equivalent” to anything when it’s based on a document that the FDA itself does not give legal force?  Cornett ends up with a “parallel” claim that in fact isn’t parallel to anything, since essential elements of fraud/misrepresentation such as reliance are simply not present in the FDA’s scheme of things (that’s still true even after Caronia.  For setting such a claim loose on the law, Cornett makes our bottom ten.  We scratched our heads over Cornett here.

6.                  Hawkins v. Medtronic, Inc., ___ F. Supp. ___, 2012 WL 4364171 (S.D. Ohio Sept. 24, 2012), interlocutory certification denied, 2012 WL 6059361 (S.D. Ohio Dec. 6, 2012).  Ugly times two on medical device preemption and TwIqbal.  It’s a PMA device, so there’s Riegel preemption.  The plaintiff’s attempt to plead a parallel claim was pathetic.  The complaint simply listed a bunch of statutory and regulatory sections and alleged, without any explanation, that they were “violated” − classic boilerplate conclusions of law that aren’t allowed any more, except in Hawkins.  The opinion mentions “precise contours” but from the indefinite “contours” in this complaint, Cleveland might as well still be part of Connecticut.  On this flimsy pleading, the opinion allowed claims such as warning, design defect and warranty, that other decisions almost uniformly dismiss on the pleadings, to survive.  Then, on a second motion, the fact that Lohr preceded TwIqbal was likewise ignored.  Hawkins is a good candidate for the worst PMA device preemption decision of the year.  It’s only saving grace is that, on summary judgment, the plaintiff will have to back up these vague allegations (after the defendant, of course, has to spend lots of time and money).  We sounded off on Hawkins here.

7.                  Whitener v. PLIVA, Inc., 2012 WL 3948797 (E.D. La. Sept. 10, 2012).  There’s express preemption and there’s implied preemption.  As the Supreme Court has held repeatedly, these two forms of preemption operate independently.  Whitener didn’t get the memo from the Supreme Court.  The case involved generic drug preemption under Mensing.  The plaintiffs alleged illegal off-label promotion.  Even putting aside the problem (highlighted in recent opinions) that neither the FDCA nor any FDA regulation prohibit off-label promotion, the proper response is, so what?  Assuming there was an FDCA violation, that doesn’t matter in an implied preemption case.  The notion of a “parallel violation claim” is wholly a consequence of the particular language of an express preemption clause applicable only to medical devices.  It has nothing to do with generic drugs or implied impossibility preemption.  For completely messing up fundamental preemption concepts and giving generic drug plaintiffs an out they are not entitled to under Mensing, this decision makes our list.  We tried to put a stop to things here.

8.                  Bonander v. Breg, Inc., 2012 WL 4128386 (D. Minn. Sept. 18, 2012).  Reading this decision, you wouldn’t believe that the plaintiff had the burden of proving causation in warning cases.  These facts – that the doctor never read the allegedly defective warning and didn’t listen to sales reps – have resulted in summary judgment in innumerable cases, but not in Bonander.  Instead, the decision allowed rank speculation unsupported by any affirmative testimony to substitute for proof.  The prescriber changed his practice based on a medical journal article years after the fact.  Maybe something from the manufacturer (whom the prescriber already testified he didn’t pay attention to) would have done the trick.  “Foreclosing a possibility” simply isn’t the same as testimony that would meet the burden of proof.  As Carl Sagan was fond of saying, “absence of evidence is not evidence of absence.”  At best, Bonander was an absence of evidence case, which the plaintiff should have lost, and that’s being charitable.  The most vacuous warning causation case of 2012.  We analogized it to monkeys at a typewriter here.

9.                  Shiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa. June 1, 2012); Shiff v. Hurwitz, 2012 WL 1828035 (W.D. Pa. May 18, 2012); and Shiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012).  Three differently situated defendants moved to dismiss this oddball case alleging that the plaintiff was injured during the course of an allegedly underground, totally unauthorized clinical trial.  The result was a troika of opinions that disregarded multiple settled principles of federal and/or Pennsylvania law – those being:  (1) no separate duty to test; (2) no private FDCA causes of action are permitted (3) no strict liability against manufacturers (except maybe manufacturing defect); (4) no strict liability, ever, against doctors or hospitals; (5) no consumer fraud claims involving medical treatment; (6) hospitals don’t obtain informed consent; (7) informed consent is limited to risks, benefits, and alternatives to medical procedures; and (8) federal courts sitting in diversity aren’t supposed to make up novel claims and call them predictions of state law.  We described exactly how all this doesn't fit together here.  Shiff would have ranked higher but for only one state’s law being impacted.

10.              Murthy v. Abbott Laboratories, 2012 WL 6020157 (S.D. Tex. Dec. 3, 2012).  This case is a repeat performer.  Last year, a decision on payments to investigators and the (non-existent) direct-to-consumer exception made the bottom 10 at #8 (the DTC ruling now being overruled under Texas law – see our upcoming Top 10).  Murthy’s latest mangling of Texas law misreads the state’s immunity statute to allow the plaintiff to amend to allege a claim under the exceptions for off-label marketing.  The exception, however, is worded to apply where the “defendant prescribed” off-label, so that obviously is intended to preserve claims against physicians.  The opinion pounds the square peg of a claim against a manufacturer into this very round hole by asserting that the prescriber could be the manufacturer’s “agent.”  Thus, Murthy appears to be doubling down on the investigator payments = non-independence rationale of last year’s lump of coal.  This case might rank higher, except for it being so state specific.  We called out this “bad penny” of a case here.

So there they are.  We hope none of these not-just-wrong-but-loud-wrong losses were yours – if they were, we sympathize.  We did consider several other candidates; those that came closest to making the cut were:  Schilf v. Eli Lilly & Co., 687 F.3d 947 (8th Cir. 2012) (the facts were arguably squishy); Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (the bad parts were tempered by affirmance of the dismissal of so much of the case); Winter v. Novartis Pharms. Corp., 2012 WL 827305 (Mag. W.D. Mo. March 8, 2012) (it’s a bad Parisian decision, but the worst was excluded – and the defendant later won (verdict less than the costs of trying the case) at trial); and the reconsideration in Fisher v. Pelstrung, 817 F. Supp.2d at 830-40 (D.S.C. Jan. 11, 2012) (while it was bad, it was only a reconsideration).

Now that our unpleasant and masochistic exercise in recapitulating our side’s worst defeats is over, stay tuned for next week (or possibly the following Monday) when we have fun – reviewing and celebrating the top ten best drug/device decisions of 2012. 

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