Here we go again. At the end of every year, we look back over the past twelve months – the highs and the lows – the thrill of victory and the agony of defeat. We always start with the agony, however, and this year’s no exception. Despite our best efforts, our side didn’t win everything everywhere. So as we’ve done for the past four years, we’re handing out lumps of coal right before Christmas, specifically the ten worst prescription medical product liability decisions of 2011. These noxious weeds seem to pop up all over. We have federal cases and state cases. We’ve been burned, of course, by hellhole jurisdictions, but also at least as much (if not necessarily as frequently) in jurisdictions that, until now, hadn’t earned that sobriquet.
Like last year, there’s still a week and a half left for courts to continue plumbing the depths. There could be a new number one before the end of the year. But, frankly, we want to get this over with before that vulture over there keels over and falls off its dung heap. The last week of the year we reserve for the fun stuff, that is to say our top ten best decisions.
So let’s take the plunge – holding our noses all the way. Here are our ten levels of hellhole, our bottom ten worst judicial drug and device decisions of 2011.
1. DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. 2011). The worst drug/device product liability decision of 2011 earned its dubious distinction by encouraging plaintiffs to lose the product that allegedly caused their injuries. DiCosolo involved a pain killing patch used by a drug addicted (8 different drugs in the bloodstream) decedent whose death was initially ruled a suicide (before the plaintiff’s lawyer prevailed on the coroner to alter his findings). The plaintiff had used recalled patches, but the patch found on the decedent’s body was tested and unequivocally did not exhibit any sign of the defective condition that prompted the recall. No worries, held DiCosolo, the plaintiff can sue over the patch before that – the so-called “penultimate patch – that conveniently had been thrown away and was unavailable for similar testing. A suspiciously timed affidavit (after a long period of silence) by the financially interested plaintiff just happened to remember seeing the problem that prompted the recall present in the discarded patch. Thus the plaintiff was allowed to bring in the recall to the jury’s attention, even though only a minute fraction of the recalled product had the defect. That fraction included the only patch that could be tested (all others having since gone missing), but despite that test result, DiCosolo let the plaintiff proceed under res ipsa loquitur, even though a drug overdose is not a visible malfunction. Nor did DiCosolo trouble itself overly with alternative causes, even though the plaintiff’s deficient list had induced the coroner not to test the decedent’s blood for overdoses of several other drugs. Goes to the weight, the court held, wrongly, since circumstantial proof only holds together in the absence of such causes. Season this mess with some incompetent fraud on the FDA testimony , and an $18 million verdict was the result. What’s the message of this terrible decision? Plaintiffs – throw away your products! You have nothing (in Illinois) to lose but your cases. We made our best Calvin and Hobbes face at this unappetising decision here.
2. Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011). Hughes allowed an improper private FDCA-violation claim – the defendant’s “algorithm” for reporting adverse events allegedly violating some obscure regulation – to masquerade as a tort suit. Why did plaintiff even bother with such a bizarre claim? Because the product was a PMA device and all the usual claims were preempted. This duty-to-report based claim wasn’t even plausibly “parallel” to any tort cause of action ever recognized in Mississippi, so Hughes simply “assumed” that the Mississippi Supreme Court (hotbed of judicial liberalism that it is) would recognize the claim. Hughes called it “negligence per se” even though Mississippi doesn’t recognize negligence per se where an allegedly-violated statute bars private causes of action. What about Buckman? Hughes bobbled that, too, holding that Riegel (unlike Buckman, an express preemption case) “unequivocally held” that there was an exception for parallel claims (actually, Riegel held only that the plaintiffs waived the whole subject). In one decision Hughes messed up Mississippi common law, express preemption, and implied preemption – a trifecta that warrants a #2 ranking. We vented our frustration at Hughes here.
3. In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 6302287 (S.D. Ill. Dec. 16, 2011). What happens when one plops a federal MDL in the vicinity of Madison County (yeah, we know, us Philadelphians should talk)? Whatever it is, it’s not looking very pretty at the moment, having just yielded the #3 worst decision, and the lowest by a trial court. Before Y/Y, even the worst MDL Daubert decisions at least clipped the wings of the other side’s Through-the-Looking-Glass coterie of purported “FDA experts.” Not this time. In a spectacular abdication of judicial gatekeeping authority, the Red Queen, the Mad Hatter and the rest get to testify unrestrained – even about purported FDA-related fraud and foreign regulations. Y/Y will overdose the jury with FDA-related fantasy until the supposed “law” bears only passing resemblance to what the FDA actually enforces. All this in a state – Illinois – where the highest court forbids FDCA-based common-law causes of action (see Martin v. Ortho, 661 N.E.2d 352 356-57 (Ill. 1996)) – something that supposedly matters under Lexecon. We haven’t blogged before about this lump of coal in our stockings because it just happened.
4. Forman v. Novartis Pharmaceuticals Corp., 793 F. Supp.2d 598 (E.D.N.Y. 2011). Judicial hubris is bad. Judicial hubris that ignores Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), is worse. Combining the two moves Forman into the #4 slot of our list, ahead of a number of bad appellate cases. As step one, Forman held that New Jersey appellate courts didn’t know what they were doing when those courts applied Buckman preemption to the fraud-on-the-FDA exception of New Jersey’s punitive damages statute. As step two, Forman held that predicating punitive damages on a finding of fraud on the FDA was okay, despite the unanimous Buckman holding that this was a no-no and the likelihood that punitive damages can exceed compensatory damages, and thus raise even more acutely...
