We’re doing our duty. We don’t have to like it. The subject of today’s post is distasteful, but necessary. Here is our annual compilation of the ten worst court decisions of the year (2014) that occurred in prescription drugs and medical device products liability litigation. These are decisions that left us shaking our heads at the colossal injustice of what all-to-often passes for civil justice in this sometimes crazy country of ours. Occasionally, the barbarians are a lot closer than at the gates. If this is memory lane, there may be something to be said for amnesia. But take heart, next week for we’ll be in a more festive mood with our favorites.
So, now for a few words from the Grinch:
1. Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014). So how does the same case make the bottom ten (also 2013 #-5) two years running? By issuing a lousy opinion on a critical issue, then reconsidering (because – amazingly – the first opinion was issued without oral argument) and then doubling down on the same, ill-considered position. In Weeks Alabama became the only state high court to recognize innovator liability (which we also call “Conte”), meaning that where the innovator didn’t even sell the product, received no economic benefit from the generic prescription the plaintiff took, and indeed may well have been driven out of the market by generic competition, it’s still liable if the generic labeling (and thus its own) is “defective.” Being liable for purported defects in a competing product means, of course, that the costs of such liability can only be recouped by charging ones own customers more for other, non-defective products, but there are more plaintiff lawyers than innovator drug companies in Alabama. This sort of liability, being open-ended and completely uninsurable, is the most thoroughly destructive, and irresponsible theory we’ve encountered since we started this blog, and that’s saying a lot. Alabama getaway indeed. For all these reasons Weeks richly deserves its designation as our #1 worst case of the year. We (the non-Dechert side) chastised the decision here, but that was only a reprise of our original 2013 critique, here – all of which remains valid.
2. Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). Poor Wyeth, having the two worst decisions of 2014 inflicted on it. The year wasn’t very old when Pennsylvania Supreme Court decided that it didn’t need strict liability to impose essentially the same thing under negligence. After taking close to three years to decide this fen-phen case, the theory the court settled on was a real stinker. Would you believe negligent design – with no alternative design requirement? In so doing it all but adopted Restatement Third §6(c) in a prescription drug case, which is also unique for a state high court. We don’t know of any other decision, in Pennsylvania or elsewhere in the country, that does away with the alternative design requirement in a negligence case. To add insult to injury, the court had the chutzpah to claim that this unique, novel result was really just an extant, but utterly unrecognized, part of negligence “duty” all along. What really happened was the creation out of whole cloth of “negligence” liability that amounts to a failure to recall claim – that the product was “too harmful to be used by anyone,” and thus should not be marketed, notwithstanding FDA approval. Maybe the theory is limited to already-withdrawn products (footnote 33 suggests that it might), but maybe not. If not, we think that, eventually, the theory will fall to Bartlett (2013 #+1) preemption (Bartlett was decided just before Lance was decided and was not briefed to the court), for prescription medical products (but not others). All this is bad enough, but there’s also disruptive dicta in Lance questioning (musing about, is more like it) the “underpinnings” of the learned intermediary rule. So we’ll be dealing with that, too, for the foreseeable future. Under the rubric “if this is negligence, who needs strict liability,” we (the non-Dechert side) lacerated Lance here.
3. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832 (W.D. La. Sept. 2, 2014). Much could be said about this 100+ page opinion, and we said some of it here). We slot this particular Actos decision as our #3 worst decision of 2014. For some reason (perhaps embarrassment) the opinion fails to mention in its 52 Westlaw pages or 285 footnotes that the runaway verdict it was upholding was for $9 billion. At trial, the plaintiff was allowed to try a blatantly preempted fraud on the FDA claim under another name. That’s not hard to show, since the opinion states no fewer than 37 times (yes, we counted) that the defendant supposedly “concealed,” “misinformed,” “obfuscated,” “withheld,” or other-similar-verbed information from the FDA. Neither the court nor the plaintiffs are the least bit subtle in their fraud on the FDA rhetoric, so we’re hopeful for an appellate reversal, but in the interim, this outlier verdict will waste everyone’s time and money. That’s the opposite of what an MDL was supposed to do.
4. Mississippi ex rel. Hood v. AU Optronics Corp., ___ U.S. ___, 134 S. Ct. 736 (U.S. 2014). In this case the United States Supreme Court held that a state attorney general action (really brought by contingent fee counsel proceeding in an AG’s name), ostensibly on behalf of all the citizens of a state, did not qualify as a “mass action” under the Class Action Fairness Act (“CAFA”) so as to allow removal to federal court. So state AG actions remain in state court where, combined with the usual “home cooking,” they can generate monstrous verdicts – practically all of which have so far been overturned (more on that next week). Hood is it not ranked higher because, frankly, we always thought this CAFA argument was a very long shot (the Court unanimously rejected it). Since the defense position was already a distinct minority view, Hood didn’t change the legal landscape much. Hood would have been a great victory had it gone the other way, but this result basically continued the status quo. It’s the Supreme Court, so it belongs on the list, but we found other decisions to be worse. We alerted readers to the adverse result here.
5. Hardin v. PDX, Inc., 173 Cal. Rptr.3d 397 (Cal. App. 2014). Hardin has to take the cake for the weirdest liability theory held to state a claim by an appellate court in 2014. It’s a generic drug case (no surprise there), so the plaintiff has a serious preemption problem. When all else fails, use Restatement §324A “Good Samaritan” liability to punish somebody for doing something intended to be helpful. Here, that somebody, or rather those somebodies, had prepared a monograph about the drug that was distributed by the plaintiff’s pharmacist. Plaintiff did not sue the pharmacist, since California law holds that pharmacists don’t have a duty to warn about prescriptions that they properly fill. Plaintiff sued the publisher of the monograph. That didn’t work because of the First Amendment, which is enforced in California by an anti-SLAPP (“strategic lawsuit against public participation”) statute. Plaintiff was as undaunted as the appellate court was credulous of new liability theories. A software manufacturer, whose program allegedly truncated the monograph’s original 8-paragraph text to 5 paragraphs, was also sued, and the court allowed that claim to proceed – despite two layers of intermediaries closer to any purported failure to warn (pharmacist and publisher) both having no duty to the plaintiff as a matter of law. This unfortunate defendant did not make the product, did not write the monograph, and never had any contact with the plaintiff. As we said in our post criticizing Hardin, it was like holding (in pre-electronic times) a maker of white out liable for someone else’s deletion. Another loose nut slides to the coast.
6. Payne v. Novartis Pharmaceutical Corp., 767 F.3d 526 (6th Cir. 2014). The name says it all. The Sixth Circuit reversed the “strong” application of warning causation principles that had made the district court opinion in Payne a #17 honorable mention last year. The problem with this Aredia/Zometa case was the same as with most such cases – no evidence that there was any choice but to prescribe this drug, which was effective against cancer, under the circumstances (plaintiff had bone-metastasized cancer). Yes, this drug could cause osteonecrosis, a nasty but not fatal condition, but the prescriber was trying to save the plaintiff’s life. So, the prescribing oncologist testified that he would have prescribed no matter what, but now he gives warnings that patients should have a dental exam because of the osteonecrosis risk. With benefit of hindsight, plaintiff was willing to testify that she would have taken her chances with cancer, and not used the drug at all, had she known about the lesser condition. While admitting that the plaintiff’s testimony was “speculative,” the appellate court found it sufficient, drawing from malpractice and informed consent cases where the physician-patient relationship was implicated. We were pained with that result here.
7. Scott v. C.R. Bard, Inc., ___ Cal. Rptr.3d ___, 2014 WL 6475366 (Cal. App. Nov. 19, 2014). This is a dangerous case for two reasons. First, it used “Good Samaritan” liability (a California favorite) to hold a medical device manufacturer liable for negligently undertaking to train surgeons in the use of its device. Training doctors is a good thing, but if liability can be predicated on allegedly doing it “negligently,” companies will be less likely to do it at all, since they have no training duty (except where imposed by the FDA). Second, it allowed subsequent remedial measures – FDA regulatory actions post-dating the plaintiff’s surgery – into evidence. While an old, loopy California decision from the glory days of strict liability (Ault, decided in 1974) still allows such evidence for “policy” reasons, this wasn’t a strict liability case. Strict liability is not recognized in California for design defect claims against prescription medical products. Thus, the jury learned that the product was later removed from the market. Harmless? No way; the court was California dreaming. We (the non-RS side, that is) discussed that Thanksgiving turkey here.
8. Messick v. Novartis Pharmaceutical Corp., 747 F.3d 1193 (9th Cir. 2014). This is one ugly Daubert decision, reversing a favorable district court ruling. Sure, “fit” requires relevancy, but the “relevancy bar is low.” How low? How about a causation expert who wouldn’t even come out with an opinion that the drug caused the injury? That’s poor. Daubert is supposed to exclude ipse dixit, but Messick allowed in what passed for “differential diagnosis” because the expert “repeatedly referred to his own extensive clinical experience as the basis for his differential diagnosis.” And so the ipse dixit spider was allowed to weave its web in Messick. Sole cause is cast into the dustbin of medico-legal history. A supposedly scientific opinion can be based on “substantial factor” causation. Association thereby morphed into causation. We castigated Messick here.
9. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 355995 (W.D. La. Jan. 30, 2014). This terrible decision imposed discovery sanctions based on conduct that occurred many years before Actos litigation – about bladder cancer – ever existed. Given that timing, whatever the defendant did with respect to this MDL couldn’t be worse than negligence, since nobody plausibly intends to impede unknown future litigation. About the only good thing that could be said about this opinion is “Never again.” Fed. R. Civ. P. 37(e) is being amended to prevent this result in two ways: (1) sanctions must be predicated on “intent” to interfere with “the litigation,” and (2) negligence (Zubulake) is no longer sufficient for sanctions. We discussed this Actos decision (and other issues relating to litigation holds) here.
10. Hornbeck v. Medtronic, Inc., 2014 WL 2510817 (N.D. Ill. June 2, 2014). We’ve settled on Hornbeck as the worst InFuse case of the year. There was competition, particularly from Coleman, an appellate case in California, but for sheer all-around awfulness, Hornbeck takes the cake. Despite the status of InFuse as a pre-market approved device entitled to preemption under Riegel (2008 #+1), Hornbeck refused to preempt anything (even Coleman, bad as it was, preempted a majority of the plaintiff’s claims). That wasn’t even Hornbeck’s most egregious failure. The utter lack of support for its rulings was. Hornbeck is a monument to “I don’t care what the law is, I don’t like preemption, and that’s that.” As readers of this blog know, there are literally dozens of InFuse preemption cases on our device preemption scorecard. Hornbeck cites precisely none of them – not a single InFuse opinion − even those that might support aspects of its outcome. The opinion interprets Bausch as allowing plaintiffs to call anything a “violation.” Hornbeck also gets Illinois law 180° wrong on FDCA-based negligence per se (the Illinois Supreme Court actually rejects it), and even allows component by component analysis, effectively denying physicians any discretion to use components separately. Some opinions simply don’t get it, and Hornbeck is one of those. We didn’t “get” Hornbeck either, and didn’t write a post about it, except for including it in our scorecard.
We’re also sure that Bristol-Myers Squibb Co. v. Superior Court, 2014 WL 3747250 (Cal. App. July 30, 2014), would have made our bottom ten list, had a further appeal not been accepted by the California Supreme Court, thus wiping that personal jurisdiction atrocity (discussed here) from the books. Other near misses were the OTC drug case Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. 2014) (discussed here), and In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. Apr. 24, 2014) (discussed here), which would import “parallel claims” into generic drug preemption based on impossibility.
You can come out now, we’re done. If you lost one of these monstrosities, you have our condolences. If you haven’t – there, but for the grace of God….
We’re glad this is over, too. Next week you (and we) get the fun stuff: our thumbs up list of the ten best drug/device decisions of 2014.