United States: The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

Last Updated: December 22 2016
Article by James Beck

The "pits of hell," "black as a pit," a "bad feeling in the pit of my stomach" – that's how we feel about 2016's bottom ten decisions of the year arising from prescription medical product liability litigation. This year's collection of coal in our collective stockings is as justifiable a cause for seasonal affective disorder as almost anything we can think of, since we do not discuss politics on the blog.

So here we go. Don't shoot us, we're only digital piano players.  If any of these cases is yours, we sympathize.  We've been there (see 2013 -2), and we know how it feels.  We can't wait for next week we get to toast in the New Years with the best, instead of drowning our sorrows with the worst.

For today however, drowning our sorrows is on the agenda.  Except these sorrows, at least for the moment, have learned to swim:

  1. Bristol-Myers-Squibb v. Superior Court, 377 P.3d 874 (Cal. 2016).  Ultimately (and fortunately) there was not much contest for the worst drug/device product liability decision of the year.  The highest court of the largest state in the country – check.  Direct defiance of United States Supreme Court precedent on a significant constitutional issue – check.  Significant impact on the litigation of mass torts – check.  In Bauman, the Supreme Court condemned "exorbitant exercises" of general jurisdiction that do not "permit out-of-state defendants to structure their primary conduct with some minimum assurance as to where that conduct will and will not render them liable to suit."  Such "unacceptably grasping" "[e]xercises of personal jurisdiction [are] so exorbitant" that they "are barred by due process."  The paradigm of such overly "grasping" jurisdiction is that which "would presumably be available in every other State in which a [defendant's] sales are sizable."  So the California Supreme Court promptly fashions a theory of "specific" jurisdiction that allows masses of plaintiffs, anywhere in the country, to sue a drug company (and presumably any other large corporation), as long as one Californian (or, here, 86 of 678) is suing over the same conduct.  The reason?  Because the defendant does significant general business in California.  If your reaction is that BMS simply shifted the pre-Bauman "continuous and substantial" jurisdiction standard from general jurisdiction to specific jurisdiction, you would be right.  We haven't seen such blatant defiance of Supreme Court precedent in our bailiwick since the First Circuit in Bartlett (2012-1), and that one headed up our bottom ten, too.  Here's hoping for a similar result in the Supreme Court.  We chronicled California sliding to the bottom of the slippery slope here and here.
  2. C.R. Bard v. Cisson, 810 F.3d 913 (4th Cir. 2016). The Fourth Circuit's massive mesh muddle was the only other serious contender for the worst drug/device decision of 2016, largely because, as a January decision, it was the early frontrunner.  Nothing else was nearly as bad until BMS was worse.  How bad?  Well, back in 2013 we analyzed the worst of Cisson's legal mistakes – not even allowing the jury to find out about an FDA-regulated product's §510k clearance – before that issue was decided in the MDL.  The law was overwhelming that all forms of FDA compliance (or non-compliance) were admissible, albeit not controlling, in product liability litigation.  The analogy to preemption cases is transparently flawed.  Just because FDA clearance wasn't a sufficient safety determination to be conclusive for preemption purposes doesn't mean that FDA clearance isn't even admissible – especially where punitive damages (which the jury awarded at a 7-1 ratio) are at issue.  Indeed, the state law involved (Georgia), like a number of states, counts regulatory compliance as nearly conclusive evidence against punitives.  In Cisson, the Fourth Circuit validated this error, stating that the "clear weight" of authority was that an FDA clearance had "little or no evidentiary value."  Horse feathers.  Every case Cisson cited (pp. 920-21) for this proposition was about preemption, not evidence.  Not only that, but Congress has considerably toughened §510k clearance over the last thirty years.  Too embarrassed to affirm on the district court's holding of no relevance at all, the Fourth Circuit held under Rule 403 that any relevance was outweighed by "confusion of issues."  Horse feathers, again.  Evidence that is accorded significant weight under state law should never excluded because of the other side's smoke and mirrors, and non-preemptive compliance evidence has been, and is, routinely admitted in other trials.  There's more.  Also affirmed was admission of a supplier's hearsay (and CYA) materials handling data sheet despite all of grounds asserted at trial for doing so having been held erroneous – it could come in for "notice" so the hearsay rule didn't matter.  But given how the trial court ruled, that evidence wasn't used at trial for mere "notice."  A 7-1 punitive damages award was also affirmed, despite it exceeding Supreme Court ratio guidelines.  To us, Cisson epitomizes the "affirm or waste years of effort" MDL mentality that we decried earlier this week, as the Fourth Circuit goes into how large and long-running the MDL is, as well as the trial's duration, in affirming despite multiple questionable rulings.  It is a huge MDL; thus, the errors in Cisson will be perpetuated in thousands of other cases.  We (the non-RS side, that is) analyzed the Fourth's flub here, after first alerting our readers of it here.
  3. Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016).  The Missouri Court of Appeals thinks it's peachy keen to join scores of plaintiffs in the same complaint with nothing in common except suing over the same product for the same general sort of injuries.  It's equally peachy keen to misuse these multiple misjoinders to create venue for everybody in the same county, even where neither the plaintiff nor the defendant is even from the state – as long as a single one of the other misjoined plaintiffs is from that place.  As with BMS, a state appellate court is allowing mass torts to exist in fora where an individual case would never be permitted to be.  And that's hardly all.  The risk at issue carried an FDA-approved black box warning, but even that warning could be "defective" because the defendant did not include derogatory comparative risk information about its own product.  That bizarre warning theory had practically no legal support before Barron.  In federal court such claims are liable to be dismissed as preempted.  Oh, and the verdict itself was ridiculous − $48 million, including $23 million in punitive damages.  The only good thing we can say about Barron is that a concurrence points out that the legislature is free to change the joinder and venue rules if it wants, and we're hopeful that something along those lines can be accomplished in the reasonably near future.  We berated Barron here.
  4. In re Reglan Litigation, 142 A.3d 725 (N.J. 2016).  The New Jersey Supreme Court became the latest of several appellate decisions to gin up a novel state-law "failure to update" theory of liability in response to the preemption of just about every other claim involving generic drugs.  While we think that the "update" theory is really a bald-faced attempt to enforce the FDCA's warning "sameness" requirements under the guise of "common law" duties that never previously existed, that alone would not have ranked Reglan this high – because, as we have pointed out elsewhere, failure to update claims are pretty pathetic on their merits.  No, what really bugs us is the negligence per se rationale that Reglan employs to justify the update claim.  The court created a common-law duty to update "at the very earliest time possible," seizing on this language in an FDA guidance document that states (as do all such guidances) that it "does not create or confer" any rights.  This unprecedented ruling – using tort duties to enforce an FDA standard (not even rising to the level of a "requirement") that has no force of law to start with – is the most troubling aspect of Reglan.  We railed at Reglan here.
  5. T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016).  We hate innovator liability – forcing companies that invented drugs to pay damages for injuries caused by their generic competitors because physicians supposedly "foreseeably" relied on branded warnings where a generic was ultimately prescribed – ever since it was first adopted by a California appellate court in 2008.  That decision, Conte v. Wyeth, led our worst decisions list that year (2008-1).  Despite Bexis' best efforts, the California Supreme Court declined to consider innovator liability at that point.  As nearly every other jurisdiction proceeded to reject innovator liability, the situation in California festered.  In T.H., a second California appellate court made things even worse.  A company that only made the branded drug could be held liable despite it having sold its rights to the drug and left the market altogether seven years before the plaintiff was exposed.  Not only that, it could be held liable for an off-label use that other companies allegedly promoted illegally after the defendant left the market.  T.H. took an awful situation and managed to made it even worse.  Innovator liability in California is perpetual and unavoidable, not to mention uninsurable.  As did Conte before it, T.H. made a mockery of the public interest factors supposedly evaluated in deciding whether any given tort duty exists. The only reason we don't rate T.H. higher (lower) is that this time is that the decision has since been vacated as, finally, the California Supreme Court accepted an appeal. We unloaded on T.H. here, and reported on the grant of further appeal here.
  6. In re: DePuy Orthopaedics, Inc., 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016).  One of our bedrock propositions (we devote an entire topic to it) is that federal courts sitting in diversity should not under Erie v. Tompkins create novel, let alone weird, theories of liability in default of any state court authority for such theories. This decision in the Pinnacle Hip litigation committed that deadly sin several times over, and in so doing set the stage for astonishing verdicts that make this MDL another poster child for completely rewriting the MDL statute.  The questionable rulings are:  (1) extending negligent misrepresentation beyond "business transactions" to product liability, unprecedented in Texas; (2) ignoring multiple US Supreme Court decisions that express and implied preemption operate independently (as discussed here) to dismiss implied preemption with nothing more than a cite to the Medtronic v. Lohr express preemption decision; (3) inventing some sort of state-law tort to second-guess the defendant following one FDA marketing approach (§510k clearance) over another (pre-market approval), unprecedented anywhere; (4) holding that the learned intermediary rule does not apply whenever a defendant "compensates" or "incentivizes" physicians to use its products, absent any Texas state or appellate authority; (5) imposing strict liability on an entity not in the product's chain of sale, contrary to Texas statute (§82.001(2)); (6) creating a claim for "tortious interference" with the physician-patient relationship, again utterly unprecedented; (7) creating "vicarious" breach of fiduciary duty for engaging doctors to serve as expert witnesses in mass tort litigation also involving their patients, ditto; and (8) construing a consulting agreement with a physician as "commercial bribery" to avoid the Texas cap on punitive damages, jaw-droppingly unprecedented.  That's six utterly novel expansions of Texas tort law, and one more supported only by another Erie-violative district court decision, as well as misapplication of preemption law, all in one opinion.  With reason, this decision ranks as our worst trial level opinion of the year.  While we didn't blog on this opinion, specifically, we have chronicled the deluge that followed in considerable detail.
  7. Albright v. Boston Scientific Corp., 58 N.E.3d 360 (Mass. App. 2016).  This is yet another bad mesh appellate decision, this time from state court.  In some ways, Albright replicates Cisson in state court – allowing the same MSDS into evidence for "notice" of some risk, despite the MSDS admittedly being totally without scientific basis, and dictum (citing MDL rulings) that FDA §510k clearance could have been excluded altogether.  Because the jury in Albright was told that the FDA cleared the device, a defense verdict was reversed so plaintiffs could use certain adverse FDA letters – despite their being sent several years after the plaintiff's implant.  In mesh litigation, one side's verdicts are evidently "more equal than others."  Comparing the harmless error results from Albright (where the jury found for the defense) with those in Cisson (where plaintiff won), leaves us shaking our heads.  Because Albright came after Cisson, it plowed much less new ground, and because the state court's misreading of a different state's (Ohio) law isn't as bad as misreading its own law, we lowered it a couple of positions.
  8. M.M. v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016). This is BMS lite – contorting personal jurisdiction to evade Bauman in order to preserve the litigation industry of certain notoriously plaintiff-friendly in-state localities.  Somewhat less ambitious than BMS, M.M. crafted a fact-specific expansion of "minimum contacts" specific jurisdiction tailored to drug and medical device mass torts.  Any plaintiff from anywhere can sue the defendant in Illinois if that defendant were so foolish as to include any Illinois medical facilities as investigational locations in FDA-regulated clinical trials that the plaintiffs decide to attack in the context of the litigation.  Merely "aggregating" Illinois data together with the rest of the country was enough, even without evidence of any errors actually occurred in the Illinois data.  Of course, non-resident plaintiffs not injured in Illinois had never before been able to assert specific personal jurisdiction at all, but that was glossed over in a rush to preserve the Illinois litigation industry.  M.M. was decided three days before BMS, and as a result was rather glossed over itself in the Blog.
  9. United States v. Kaplan, 836 F.3d 1199 (9th Cir. 2016).  At a time when the FDA appears to be (extremely grudgingly) giving ground on the legality of truthful off-label promotion, along comes the Ninth Circuit to bless an almost unprecedented criminal prosecution of a physician for engaging in off-label use.  Kaplan involved reuse of medical devices cleared for only single use.  While the facts were certainly read yuckily ("fecal matter" is not something we'd like to deal with in any case we defend), there is not a word in the opinion about anyone actually having been injured, so the prosecutors could be overstating things.  So, why prosecute this case?   Here's one reason.  Apparently, the defendant physician had the gumption to challenge the FDA publicly with a newspaper advertisement justifying her conduct.  Selective, revenge prosecution is a significant possibility.  To find a legal basis for a doctor being criminally liable for mere off-label use took some doing.  As a matter of "first impression," the Ninth Circuit had to construe the FDCA's "held for sale" language to "to physicians using both drugs and devices in the treatment of patients."  It relied on two appellate cases from other circuits, the most recent of which was 25 years old.  To avoid §396, which flatly prohibits the FDA from infringing on off-label use of medical devices, the government claimed that the devices were "adulterated." Maybe they were (see "fecal matter," above), but "adulteration" is an indiscriminate buzz-word that the FDA has historically thrown around any time off-label promotion of any prescription medical product is at issue.  As appellate approbation of the selective prosecution of a physician for an off-label use that apparently didn't hurt anyone, Kaplan makes our list.  We criticized the prosecution here.
  10. In re Tylenol (Acetaminophen) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 4538621 (E.D. Pa. Aug. 26, 2016), and 2016 WL 4039324 (E.D. Pa. July 27, 2016).  Could the next Bartlett be brewing in the blog's back yard?  These two decisions strongly suggest that possibility.  For a couple decades, the FDA has consistently permitted the products at suit to be marketed to the public pursuant to a "tentative" monograph.  This is another MDL in danger of going off the rails, as the court seems determined to disregard how the FDA has in fact chosen to regulate these products.  Plaintiffs are being allowed to attacks it is described as a "stagnated" regulatory process, even though the FDA, in its wisdom, decided to regulate these products in this fashion. While we think there is a good preemption case, it could get even better.  Allowing plaintiffs' to controvert to the Agency's handling of these products' "generally recognized as safe" status suggests to us that (as in Bartlett) the eventual trial will degenerate into a frontal attack on the ability of the defendants to sell at all what are FDA-approved OTC drugs.  Bartlett directly holds such a "stop-selling" claim to be preempted, and further implicates equivalent claims that involve state-law nullification of FDA yes/no marketing decisions.  Maybe the FDA's use of "tentative" monographs could be challenged under federal administrative law, but product liability suits are not a valid vehicle for state-law interposition that would overturn FDA decision-making.  These decisions seem poised to allow that to happen, so they qualify for the last slot on our bottom ten.

That's it; time to take a shower. We're done with our annual unpleasant task of cataloguing our side's biggest black marks of the year.  If any of them are yours, we apologize for resurrecting bad memories.  We know that the only way not to lose tough cases is not to be given responsibility for tough cases.  Coming up, the fun stuff:  the ten best drug/device decisions of 2016.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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James Beck
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