Wednesday, December 26, 2007

The Best and Worst of 2007: The Worst

We have two lists: our top ten best, and our bottom ten worst, drug and medical device product liability decisions of 2007. We thought briefly about starting off with the top ten, but we realized that closing out the year with the bottom ten would put us in a bad mood. So we're reversing the order.


Here are our choices for the ten worst drug and medical device product liability cases in 2007:

State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007). It ain’t even close for the worst decision of the year. ATRA calls West Virginia a hellhole jurisdiction, and West Virginia may be proud to be on the list. By a 3-2 vote, the highest court of the state becomes the first in the country (with 47 going the other way) to reject the learned intermediary rule outright. The court does so on a DTC-advertising basis, even though: (1) there wasn’t any DTC advertising for the drug in question (so the point wasn’t briefed), and (2) by requiring warnings to be made directly to patients, the decision practically demands more DTC advertising than currently exists. A concurrence practically admits that the intent of the decision is to encourage recoveries against large, out-of-state corporations. Our posts about this case are here and here.

Strong v. American Cyanamid Co., ___ S.W.3d ___, 2007 WL 2445938 (Mo. App. E.D. Aug. 28, 2007). This one’s bad in a lot of ways: on preemption, on causation, on negligence per se (which it allows in all but name), and on FDA “experts” on issues of law. We never posted on this decision, because it was too long and it hit us at a bad time (vacations). But the decision is final; further appeal was denied. And our decision is final, too: Strong is the second worst pharmaceutical product liability case of the year. No further appeal is available.

Ferrari v. American Home Products Corp., 650 S.E.2d 585 (Ga. App. 2007). This intermediate appellate court decision adopts an unusual reading of Bates and the presumption against preemption that would virtually abolish all forms of tort preemption, even under the Vaccine Act where Congress clearly intended it. The presumption trumps even clear congressional intent. Our post is here.

In re Zyprexa Products Liability Litigation, 489 F. Supp. 2d 230 (E.D.N.Y. 2007). A long opinion by a federal judge revered in some quarters and reviled in others for his inclination to expand tort liability as a means of effecting social change. (Given what we do for a living, we prefer law that is predictable, rather than unpredictably expansive. We realize that, come the revolution, it's our doors they'll be kicking in. We'll be cowering under our desks.) The decision rejects both implied conflict preemption and any deference to the FDA preemption preamble. The explication of the plaintiffs’ maximal position is very well presented. Our post is here.

Myers v. Hoffman-La Roche, Inc., 170 P.3d 254 (Ariz. App. 2007). This is a terrible learned intermediary decision, involving birth defect warnings that are about as explicit as humanly possible. Contrary to the great weight of precedent, the court holds that drug companies must warn doctors not only about product risks, but also about how to treat those risks – as if trained physicians don't know that depression adversely affects patient compliance. Not only that, but the decision permits a cause of action that, in everything but name, is a claim for “wrongful life.” All that can be said for this decision is that it involved a motion to dismiss rather than for summary judgment, so the defendants can try again on a full record. We didn’t post about this one before.

McDarby v. Merck & Co., Inc., 2007 WL 4206840 (N.J. Super. Law. Div. Aug. 7, 2007). We don’t care what the reasoning is, any decision that awards plaintiffs $3.7 million in attorneys' fees (and costs) for recovering $4045 in actual damages is simply wrong. Our post is here.

Notmeyer v. Stryker Corp., 502 F. Supp. 2d 1051 (N.D. Cal. 2007). Funny things happen when preemption meets tort law. Despite Ninth Circuit law (Papike) strongly indicating that the appellate court would follow the majority rule, this trial court instead opted to follow the only circuit (the Eleventh in Goodlin) that does not find broad preemption where the FDA has specifically decided that a Class III PMA device is safe and effective. We never posted separately about this one. If 2008 is good to the drug industry, the Supreme Court's decision in Riegel v. Medtronic (expected in Spring to early Summer 2008) will implicitly turn Notmeyer around.

In re Vioxx Products Liability Litigation, 501 F. Supp. 2d 776 (E.D. La. 2007). Another adverse prescription drug implied preemption decision in major litigation. It makes our bottom ten list over a number of others because of the length the decision, and its refusal to give more than minimal deference to the FDA’s decisionmaking process. We mentioned this case only in passing because of a combination of Bexis’ involvement with Vioxx litigation and Herrmann's sloth.

Wawrzynek v. Statprobe, Inc., 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007). The court rules that a fraud on the FDA claim isn’t preempted where the FDA actually found fraud. That much is at least a debatable point. What makes it a bad decision is that the FDA never found that the only defendant left in the case actually committed any fraud. Our post is here.

In re Guidant Corp. Implantable Defibrillators Products Liability Litigation (Duron), 2007 WL 1725289 (D. Minn. June 12, 2007). The latest of several decisions in defibrillator litigation that finds new and creative ways of avoiding Buckman and allowing plaintiffs to pursue fraud-on-the-FDA claims in common-law tort suits. We didn’t post about this one specifically, because we’d covered this issue elsewhere in 2006. Perhaps a favorable decision in Warner-Lambert v. Kent will bar this type of decision in 2008 and beyond. (We're living proof that hope springs eternal within the human breast.)

That's it for the ten worst of '07.

We know that you can hardly wait, but we'll be posting the ten best of '07 -- and a couple of honorable mentions -- before the year is out.

Stay tuned.

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