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 lookingback over the past twelve months for the decisions that, in this instance, weliked the least. Because we like to endthe year on a high note, we always examine the bad decisions before the good ones, and thisyear’s no exception.
This post thus goes to show that you – that is, we– can’t win them all. So for our fifthstraight year we’re looking at the coal that has found its way into ourChristmas stockings, specifically the ten worst prescription medical productliability decisions of 2012. There's no particular pattern, these blots on the law are from all over, both in federal andstate court. While we’ve seen ATRA’slatest list of hellhole jurisdictions, our bottom ten doesn’t particularly correspond, probably since ATRA’s latest listhas 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 winsthan losses – that and 2012 still has a week and a half left for still morebottom-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.3d30 (1st Cir. 2012). Terrible result andworse reasoning, on several levels. After the plaintiff lost his warning claims for the prescriber’s failureto read the warning, he pursued a design defect claim with no alternative design thatamounted to a demand that an FDA-approved generic drug should be removed fromthe market altogether. All that wasbefore Mensing. After Mensingwe couldn’t see how the plaintiff could retain this $20 million+ verdict, butthe First Circuit found a way – a bad way, but a way. Even though the opinion all but conceded that designclaims would fail under the “sameness” analysis used by the SupremeCourt in Mensing, the First Circuit decided that reasoningdidn’t matter, dug in its heels, and ruled that, no matter what, it wasn’tgoing to preempt the plaintiff’s solesurviving claim. Period; full stop. The decision's rationale was that nothing requires amanufacturer actually to sell a drug that the FDA has approved, but argument that (likethe 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’sauthority 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 wassupposed to promote the availability of generic drugs, banning them outright isthe antithesis of that purpose. We bloggedabout this stinker here and here. The only good thing we can say about Bartlettis that the Supreme Court recently accepted the challenge and granted certiorari. So we’re hopeful that the worstdecision 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 hirescontingent fee counsel and lets that counsel pick the most pro-plaintiff county(called “Parishes” in Louisiana) in the state to sue over alleged failures towarn that were never actually hurt anybody? How about an eye-popping $257 million verdictalong with an extra $73 million fee and cost award for said counsel. Most ginned up state false claims suits like this oneget thrown out, at least on appeal, but not in Louisiana (at least not yet). On appeal, the court found no error in thetrial 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 wasoutright ignored in Caldwell, and both injury and causation were effectuvekt presumed (the “materials inand of themselves cause harm and injury”). The opinion also affirmed total exclusion of evidence (includingstatistics) that the defendant’s supposedly false statements were in factscientifically valid. The opinion itself is an embarrassment, consisting mostly of the court quoting the trial court’s barely coherent rulingsand reciting that there was no “manifest error.” Theonly 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 medicaldevice decision, the manufacturer was found liable where: (1) the hospital never inventoried the devicekit that it received, and (2) the surgeon used a screw driver as a substitutefor a spinal rod when he couldn’t find the right part during surgery. The screw driver, of course, broke almostimmediately, since it was not designed (let alone FDA approved) for implantation. Oh ... and the defendantmanufacturer produced an undisputed packing slip indicating that it had shipped all theproper parts to the hospital. And there's more: the doctors andhospital concealed from the patient what they had done. The jury got it right – hammering themalpractice defendants and excusing the manufacturer. Inexplicably, however, the appellate courtreversed, on the lame excuse that the judge used an outdated juryinstruction on substantial change. Sowhat? This wasn’t a substantial changecase, 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 dissentedhere.
4. In re Chantix Varenicline Products LiabilityLitigation, ___ F. Supp.2d ___, 2012 WL 3871562 (N.D. Ala. Aug. 21,2012). A really, really bad Daubert decision. Seven causation experts were allowed totestify that the drug caused suicide (of all injuries, one of the hardest to prove) despite lacking even one medicalstudy (at least none were cited) to support their opinions. Basically, the decision holds thatqualifications are enough and everything else is cross-examination fodder. Daubert? What Daubert? Opinions based on statistically insignificantdata? That’s OK. Adverse reactions that the FDA itself saysaren’t to be used for drawing causation conclusions? That’s OK, too. Extrapolation from animal studies with hugedosages? You bet. Ditto for cherry-picked data. The defendant’s labeling mentioning therisk also supported causation. Damned if you do; damned if youdon’t – even though FDA regulations outright specify that “a causalrelationship need not have been proven.” Also, any decision that favorablycites 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 thanfor being blatantly improper subjects of expert testimony. We found this opinion largely indigestiblehere.
5. Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J.2012). Usually adverse state supremecourt 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 oflimitations grounds, whichought to count for something (not all that much), and placedsome decent summary judgment limits on the claims it permitted to go forward (somewhat better). But those good points can’t make up formessing up two of our favorite issues, preemption and off-label use, in thesame opinion. In a PMA medical devicecase, 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 FDAregulation 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 thusshouldn’t support any negligence per se action at all. The off-label promotion claim was nothing more than an ill-disguisedinadequate 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 itcould survive summary judgment. If thetrial courts enforce these, there may not be all that many claims. But the tough nut remains, how can a statelaw claim be “genuinely equivalent” to anything when it’s based on a document that the FDAitself does not give legal force? Cornettends up with a “parallel” claim that in fact isn’t parallel to anything, sinceessential elements of fraud/misrepresentation such as reliance are simply notpresent in the FDA’s scheme of things (that’s still true even after Caronia. For setting such a claim loose on the law, Cornettmakes our bottom ten. We scratched ourheads over Cornett here.
6. Hawkins v. Medtronic, Inc., ___ F. Supp. ___, 2012WL 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 preemptionand TwIqbal. It’s a PMA device,so there’s Riegel preemption. Theplaintiff’s attempt to plead a parallel claim was pathetic. The complaint simply listed a bunch of statutory andregulatory sections and alleged, without any explanation, that they were“violated” − classic boilerplate conclusions of law that aren’t allowed anymore, except in Hawkins. Theopinion 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 claimssuch as warning, design defect and warranty, that other decisions almost uniformlydismiss on the pleadings, to survive. Then,on a second motion, the fact that Lohr preceded TwIqbal waslikewise ignored. Hawkins is a goodcandidate for the worst PMA device preemption decision of the year. It’s only saving grace is that, on summaryjudgment, the plaintiff will have to back up these vague allegations (after thedefendant, of course, has to spend lots of time and money). We sounded off on Hawkins here.
7. Whitener v. PLIVA, Inc., 2012 WL 39487974 (E.D.La. Sept. 10, 2012). There’s expresspreemption and there’s implied preemption. As the Supreme Court has held repeatedly, these two forms of preemptionoperate independently. Whitenerdidn’t get the memo from the Supreme Court. The case involved generic drug preemption under Mensing. The plaintiffs alleged illegal off-labelpromotion. Even putting aside theproblem (highlighted in recent opinions) that neither the FDCA nor any FDAregulation prohibit off-label promotion, the proper response is, so what? Assuming there was an FDCA violation, thatdoesn’t matter in an implied preemption case. The notion of a “parallel violation claim” is wholly a consequence ofthe particular language of an express preemption clause applicable only tomedical devices. It has nothing to dowith generic drugs or implied impossibility preemption. For completely messing up fundamental preemptionconcepts and giving generic drug plaintiffs an out they are not entitled tounder 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 thisdecision, you wouldn’t believe that the plaintiff had the burden of proving causationin warning cases. These facts – that thedoctor never read the allegedly defective warning and didn’t listen to salesreps – have resulted in summary judgment in innumerable cases, but not in Bonander. Instead, the decision allowed rank speculationunsupported by any affirmative testimony to substitute for proof. The prescriber changed his practice based ona 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 thesame as testimony that would meet the burden of proof. As Carl Sagan was fond of saying, “absence ofevidence is not evidence of absence.” Atbest, Bonander was an absence of evidence case, which the plaintiffshould have lost, and that’s being charitable. The most vacuous warning causation case of 2012. We analogized it to monkeys at a typewriterhere.
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); andShiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012). Three differently situated defendants movedto dismiss this oddball case alleging that the plaintiff was injured during thecourse of an allegedly underground, totally unauthorized clinical trial. The result was a troika of opinions thatdisregarded multiple settled principles of federal and/or Pennsylvania law –those being: (1) no separate duty totest; (2) no private FDCA causes of action are permitted (3) no strictliability against manufacturers (except maybe manufacturing defect); (4) nostrict liability, ever, against doctors or hospitals; (5) no consumer fraudclaims involving medical treatment; (6) hospitals don’t obtain informedconsent; (7) informed consent is limited to risks, benefits, and alternativesto medical procedures; and (8) federal courts sitting in diversity aren’tsupposed 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 higherbut 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 arepeat performer. Last year, a decisionon payments to investigators and the (non-existent) direct-to-consumer exception made thebottom 10 at #8 (the DTC ruling now being overruled under Texas law – see ourupcoming Top 10). Murthy’s latestmangling of Texas law misreads the state’s immunity statute to allow theplaintiff to amend to allege a claim under the exceptions for off-labelmarketing. The exception, however, is worded to apply where the“defendant prescribed” off-label, so that obviously is intended to preserveclaims against physicians. The opinionpounds the square peg of a claim against a manufacturer into this very roundhole by asserting that the prescriber could be the manufacturer’s “agent.” Thus, Murthy appears to be doublingdown on the investigator payments = non-independence rationale of last year’slump of coal. This case might rank higher, exceptfor it being so state specific. We calledout 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 didconsider several other candidates; those that came closest to making the cutwere: 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 byaffirmance of the dismissal of so much of the case); Winter v. NovartisPharms. Corp., 2012 WL 827305 (Mag. W.D. Mo. March 8, 2012) (it’s a badParisian decision, but the worst was excluded – and the defendant later won (verdict less than the costs of trying the case) attrial); and the reconsideration in Fisher v. Pelstrung, 817 F. Supp.2dat 830-40 (D.S.C. Jan. 11, 2012) (while it was bad, it was only areconsideration).
Now that our unpleasant and masochistic exercise inrecapitulating our side’s worst defeats is over, stay tuned for next week (orpossibly the following Monday) when we have fun – reviewing and celebrating thetop ten best drug/device decisions of 2012.
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