Thursday, December 17, 2009

Top Ten Worst Prescription Drug/Medical Device Decisions Of 2009

It’s that time of year. Yeah, we know, it’s neither new nor original to do top ten lists – but it’s still fun. Except when it isn’t.

How much fun can it be to review all those times in the past year when we’ve been kicked in the teeth? That’s right. Here are our top (or should we say bottom) ten worst prescription drug/medical device decisions of 2009.

True, there are still a couple of weeks left in 2009, but a court would really have to be pushing the envelope to beat this jurisprudential rogue's gallery (could happen, though, there are a couple of pending government-by-contingent-fee appeals that have potential).

Let’s get it over with, then. Here are our picks for the worst – the judicial decisions of 2009 that really make us hold our noses.

1. Wyeth v. Levine, 129 S. Ct. 1187 (2009). A true no-brainer (in more ways than one) at number one. Levine is a truly awful combination of an issue of great importance, mixed with:  (1) factual funny-business (compare id. at 1192 (“the labeling did not contain a specific warning about the risks”), with id. at 1225 (quoting label, which stated: “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE”)); and (2) weak reasoning at critical spots. The low point is probably Levine's reliance on a footnote in the lower court's decision to avoid the inconvenient fact that the plaintiff tried the case by arguing that the drug’s labeling should have prohibited an FDA-approved use. Id. at 1194; cf. plaintiff’s actual closing argument, quoted here (see J.A. 211-12). After Levine, implied preemption in prescription drug cases has become more or less a niche defense, heavily dependent upon a particular drug’s (or class of drugs’) peculiarly strong regulatory history. We ranted (publicly) about Levine here and here.

2. Abdullahi v. Pfizer, 562 F.3d 163 (2d Cir. 2009). We fail to see how a major drug company’s clinical trial of a potentially lifesaving product (an antibiotic) can possibly be equated with Nazi war crimes, but the Second Circuit seemed to have no trouble doing just that. Id. at 177-79. The legal reasoning was mushy, taking admittedly “nonbinding” statements as establishing supposed “norms” of the “law of nations.” Id. at 181-82. The Alien Tort Claims Act was meant to go after real war criminals, but the Second Circuit bent it all out of shape to accommodate a raft of new claims against American business by foreign plaintiffs injured overseas. If not corrected by the Supreme Court, we can expect to see all the world’s lawsuits beating a path to district courts in the Second Circuit. We blogged about Abdullahi here.

3. In re Prempro Products Liability Litigation, 586 F.3d 547 (8th Cir. 2009). Appellate courts don’t reverse a trial court’s mea culpa and reinstate a drug manufacturer’s exposure to punitive damages (even for mere negligence, which Arkansas seems to allow) very often, but that’s what happened in Prempro. Id. at 572-73. The court allowed use of the highly questionable heeding presumption, and also upheld a causation finding on a 1.24 relative risk – not even close to “more likely than not.” Id. at 570. Should the HRT litigation go south in a big way, this decision will be viewed as a major turning point. We blogged about Prempro here.

4. Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 517 (E.D. Pa. 2009), and Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 485 (E.D. Pa. 2009). Delaware has never recognized medical monitoring, and federal courts are not supposed to predict novel expansions of state-law liability. The Guinan decisions both do exactly that:  predict that Delaware would recognize medical monitoring in the absence of any present injury. But they’re even worse. Guinan-style medical monitoring is “in the air” – unattached to any viable negligence or strict liability theory, those claims all being dismissed. Nobody’s done that before, anywhere. The only bright spot is the court’s later agreement to certify an immediate, interlocutory appeal (with possible further certification to the Delaware Supreme Court). We blogged about the initial decisions here, and about the appeal here.

5. Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009). Without doubt, Hofts is the worst post-Riegel PMA medical device preemption decision. It makes a habit of ignoring recent Supreme Court decisions. First, it ignores Riegel and allows implied warranty claims to escape preemption. Second, it disses Twombly – claiming it would be an “unusually stringent application of Twombly” to throw out a purported violation claim “more specific” than what the Supreme Court considered in Lohr (Lohr, of course, being pre-Twombly and not raising pleading arguments). Not surprisingly, at least four courts (Horowitz, Covert, Funk, and Sprint Fidelis IIsee Device Preemption Scorecard) have since examined Hofts and found it wanting. So do we. We didn’t blog about Hofts at the time, but we discussed it in our Riegel at 1½ post.

6. Mensing v. Wyeth, Inc., ___ F.3d ___, 2009 WL 4111209 (8th Cir. Nov. 27, 2009). We don’t represent generic drug manufacturers (this case might rank even higher if we did), but for those who do, this is a really bad decision.  Mensing adopted a rationale that rendered the generics’ major preemption argument (about availability of CBE label changes) entirely beside the point. Id. at *6-7. If Mensing stands, generic preemption probably doesn’t. We blogged about Mensing here.

7. In re Nuvaring Products Liability Litigation, 2009 WL 4825170 (E.D. Mo. Dec. 11, 2009), 2009 WL 3427974 (E.D. Mo. Oct. 23, 2009), and 2009 WL 2425391 (E.D. Mo. Aug. 6, 2009). This is a string of eyebrow-raising MDL rulings having the cumulative effect of denying the defendant any right under Rules 8 and 12 to challenge the plaintiffs’ (probably miserable) pleadings. The court put the cart before the horse – wanting to get on to discovery (2009 WL 4825170, at *1) – but without fulfilling an MDL court’s “most important function” (that’s not us speaking, that’s from the current Manual for Complex Litigation) of “defining” and “narrowing” disputed issues prior to discovery. If the court doesn’t want to do the work of “review[ing] all 223 (and counting) individual complaints and rule on whether each claim in each complaint comports with” Rule 8 (2009 WL 4825170, at *2), it could imitate what happened in the Bone Screw litigation and pick some bellwether complaints as vehicles for ruling on the pleadings. If the court doesn’t want to do that, maybe the MDL panel ought to find a judge who does. If Twombly/Iqbal mean anything, it’s that Rule 8 functions to protect defendants against excessive discovery on “implausibly” pleaded claims. We’ve been following the twists and turns of Nuvaring here, here, and here, and we expect we’ll have more to say.

8. Woodcock v. Mylan, Inc., 2009 WL 4730820 (S.D.W. Va. Oct. 14, 2009). This decision invoked “forum public policy” to apply West Virginia’s rejection of the learned intermediary rule to a forum shopping plaintiff from Alabama – a staunch learned intermediary state. That can’t be right. Practically all major tort law doctrines are grounded in a court’s sense of “public policy.” Thus the “forum public policy” exception (previously limited to legislatively set policy) becomes another constitutionally suspect means of applying forum law to cases with no significant ties to the state in question. Any other forum shopper can presumably make the same argument. We’re sure we haven’t seen the last of this.  We blogged about Woodcock here.

9. Fleeger v. Wyeth, 771 N.W.2d 524 (Minn. 2009). What’s a high court to do when its peculiar reading of the state’s peculiarly long statute of limitations has caused that state’s courts to become a Mecca for stale lawsuits from around the country? Why, nothing, of course. Because the legislature had “already acted,” but only prospectively, the court declined take action against the mass of existing ancient cases that its previous peculiar rulings has attracted. Id. at 529. But if the legislature had passed a retroactive statute, wouldn’t the plaintiffs be screaming about unconstitutionality? While it’s a state supreme court decision, we don’t rank Fleeger any higher because of its state-specificity and time-limited scope.   Here's the post we have about Fleeger.

10. In re OxyContin II, 881 N.Y.S.2d 812 (N.Y. Sup. 2009). Because “mass tort litigation is different,” id. at 816, this New York trial court decision ignores well-settled forum non conveniens principles and creates an aggregated dumping ground for all any and all OxyContin suits from anywhere in the country. If a company so much as has a single facility in New York (a “research and development laboratory” in OxyC II), this decision allows every plaintiff anywhere to flock in. The decision consciously undercuts a federal-court MDL decision that the same set of cases did not meet federal standards for MDL coordination. Id. at 980. OxyC II looks like a reprise from the bad old pre-CAFA, class-action days – after plaintiffs lose in federal court, they go out looking for some state-court judge somewhere who will do what they want. In this case, they found one, and New York’s taxpayers will be footing the bill for out-of-state Oxycontin cases for years to come.

Nowhere to go but up from here. Look for us to spread a little cheer next week with our list of the top ten best drug/device decisions of 2009. That will be more fun for us to write and for you to read.


Anonymous said...

Spoken like a true defense whore.

Beck, et al. said...

And proud of it.