We hope all our readers had an excellent holiday-of-your-choice. We did, and we’re back just in time for our favorite (and nearly last) post of the year, our choices for the best prescription medical product liability decisions of 2012. This time, we have to admit, there’s no obvious winner, since the year passed without a United States Supreme Court decision from our area of interest to top our tree. But that’s happened before and we certainly haven’t let that stop us. All that means is that, who knows, maybe an intermediate state appellate decision might make this list. Keep reading and you’ll find out.
Without further ado, let’s start the celebrations. Here are our ten favorite judicial decisions (and some honorable mentions) involving drugs, medical devices, and vaccines in 2012.
1. Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012). We had to think a bit on this one – as we do any time we list a case in which any of us were involved. But only a little. Texas was by far the largest remaining state where its supreme court had not adopted the learned intermediary rule. Not anymore. In Hamilton, the court did that in unanimous fashion. And there’s lots more. The court all but did away with any semblance of a direct-to-consumer exception to the rule (the recognition of which landed the intermediate decision that Hamilton reversed in #-4 of our worst of 2010). If a DTC exception lurks out there after Hamilton, it would only be in a case of intentional and deliberate falsehood (which just isn’t in all those bland TV ads), that must go beyond mere “fraud” – which the court held doesn’t vitiate the rule. Hamilton also held that the learned intermediary rule wasn’t an affirmative defense. Thus the plaintiff retains all relevant burdens of proof. The learned intermediary rule requires warnings only to prescribing physicians – not to any other health care provider with which the plaintiff may happen to come into contact. Nor does information designed for patient consumption in any way trump the learned intermediary rule. Finally, Hamilton applied the rule and held as a matter of law that prior prescriber knowledge broke any possible causal link. So the result went from a multi-million plaintiff’s verdict to judgment n.o.v. It’s hard to win a more total victory than that. We exulted in Hamilton here.
2.Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012). Walker is our favorite preemption case of 2012. In Walker the court interpreted the “parallel claim” exception to preemption in a PMA medical device case in a quite limited fashion. The plaintiff claimed that a statistic in the FDA-approved package insert wasn’t met by this particular device and thus could be a violation supporting a parallel claim. The Fourth Circuit said “not so fast.” Unless the FDA had promulgated a formal “performance standard” by notice and comment rulemaking, no standard existed to be violated. Instead, the plaintiff was asserting a tort requirement “different from or in addition to” the FDA’s oversight of the device. Short of a formal performance standard, mere deviations from expected performance could not support parallel claims. Thus, an arguable device malfunction, by itself, did not defeat preemption under Riegel. If only every circuit took the skeptical view of parallel claims adopted in Walker, we’d be pretty happy. We praised Walker here.
3.Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012). This is another really good appellate preemption case. It slips in under Walker mostly because Lofton is not as unique. Preemption is a bit of a hash in the Fifth Circuit right now, but Lofton is on the good side of that morass. In Lofton, the court held that the fraud on the FDA exception to the Texas FDA compliance immunity statute was preempted by Buckman. In so doing, the court explicitly rejected the Desiano approach (which we revile), for all the right reasons – chiefly because Buckman is more than a mere pleading case and to follow Desiano would ignore the practical consequences that drove the result in Buckman. Sooner or later the Supreme Court is going to have to clear this up, but until now, we’ll hail decisions such as Lofton, as we did here.
4.Rodriguez v. Stryker Co., 680 F.3d 568 (6th Cir. 2012). Pain pump litigation is hot all over the country right now, and the state of the art defense is at the heart of almost all of these cases. In the first published appellate ruling on the issue, Rodriguez affirmed summary judgment, holding that the hodgepodge of old, largely tangential articles the plaintiff had collected did not establish inquiry notice of the causal connection in question (that certain anesthetics could damage joint cartilage) as a matter of law. These articles were “isolated instances” relating to other substances. An inference that anesthetics would have the same consequences was unreasonable. The snippets that the plaintiffs offered were “too conjectural and too many steps removed from the problem that developed.” Nor did the FDA’s rejection of a §510k (substantial equivalence) application establish anything about safety. All that meant is that there was no predicate device to compare the pain pump to. Lohr established that §510k did not evaluate safety – and plaintiffs have to live with that decision just like defendants do. Nor is there a duty to test a product in the absence of any knowable risk. A defendant is not an insurer. Nor does off-label promotion create any kind of claim, in the absence of any knowable risk. Finally, the prescriber’s testimony failed to show that any warning would have made changed the outcome, so Rodriguez is a win on warning causation as well. We haven’t conducted complete research, but we think that Rodriguez is probably the best Pain pump decision to date. We urged other courts to emulate Rodriguez here.
5. In re Pelvic Mesh/Gynecare Litigation, 43 A.3d 1211 (N.J. Super. App. Div. 2012). We’ve been kvetching for years about the ongoing erosion of defense rights to contact treating physicians (supposedly guaranteed by the Stempler decision) in New Jersey mass tort litigation. In Pelvic Mesh, an appellate court finally did something about this. The Pelvic Mesh mass tort procedures were very restrictive of defense access to treating physicians, so that defendants had a hard time simply finding experts. A high percentage (over 1,000 in number) of the relevant medical specialists had treated one or another of the plaintiffs and thus were forbidden to serve as defense expert witnesses. On mandamus (a tough standard) the court reaffirmed a simple principle – that plaintiffs waive any physician/patient privilege as to relevant injuries when they bring lawsuits. Physicians have no duty of loyalty requiring them to support...
