Monday, March 03, 2008

First Thoughts About Kent

1. A 4-4 split by the Supreme Court is of no precedential value. It doesn't bind any lower court to any position. Here, this means that the circuit split between the Second Circuit and Sixth Circuits remains. That means that immunity statutes are not subject to fraud-on-the-FDA exceptions in Ohio, Michigan, Tennessee, and Kentucky (the states in the Sixth Circuit), but are subject to that exception in New York, Connecticut, and Vermont (the states in the Second Circuit - none of which have such a statute). Elsewhere the courts are free to make their own decisions, based on their readings of the law.

2. Look for all sorts of forum shopping (filing complaints in jurisdictions other than their own natural home-state forum) by Michigan plaintiffs in mass tort cases. They were rewarded in Kent when they avoided preemption by having the issue decided in a different circuit than Michigan's. They won't need to be told twice.

3. Tea leaves for fraud on the FDA could be read either way. On the one hand, lower courts can look at the split, look at who recused, and draw their own conclusions. One such conclusion would be that Justice Roberts, whom plaintiffs complain is "pro-business," is the missing vote, and that any revisiting of the same issue will be 5-4 in favor of preemption (at least with the current court composition). That might influence other courts in the direction of preemption. On the other hand, the 9-0 unanimity of Buckman no longer looks so imposing after Kent. That might influence other courts in the opposite direction. All in all, judges remain free to follow their own legal philosophies in this area.

4. We aren 't speculating what the law is going to be in other areas. We have enough trouble trying to figure out what this means for the field we know the best. Nor are we speculating who voted which way in Kent. If the Court isn't telling, we're not going to guess. We've learned our lesson there.

5. As for Wyeth v. Levine, it's an implied preemption case too. The result in Kent suggests that the quite explicit language in the MDA preemption clause moved the Court towards preemption in Riegel more strongly than will be the case when there's no express congressional guidance. If you look back over the history of the Court's preemption jurisprudence, you'll find a lot of 5-4 (or less) decisions in tort preemption cases - Lohr, Geier, Cipollone, and Silkwood come immediately to mind. Kent suggests something of a reversion to past form after the decisive majority preemption decision in Riegel. Anybody who thought Levine would be easy for the pro-preemption decision should be disabused of that notion - fortunately, we knew that in advance. It's also fortunate that the defense position in Levine enjoys, as we've pointed out before, a favorable set of facts.

2 comments:

Henry Greenspan, Ph.D. said...

For those of us (non-lawyers, non-plantiffs) who have fought Michigan's preemption law, I agree that this decision provides no solace re: the bigger picture.

The vast majority of potential litigants, and probably those with the most deserving cases, will not have the wherewithal to file elsewhere. Meanwhile, Michigan's law remains in place.

Its so-called "fraud exception" is tied to a second condition - that the drug in question "would not have been approved or would have been withdrawn" had the facts been fully disclosed.

Any hypothetical speculaton about what FDA would have done under X circumstances is obviously shaky at best. So they went out of their way to reaffirm in their Kent brief. In this instance, Rezulin was withdrawn. But no one at FDA directly involved in that decision has said that WL's behavior had an impact one way or other. (Whether it did not not is a separate question.)

Anonymous said...

Ann Urda, Supreme Court Ruling Could Impact Aredia Case, Product Liability Law 360: March 5, 2008. http://productliability.law360.com/Secure/ViewArticle.aspx?id=49045
(discussing the fact that the MDL Judge in the Aredia and Zometa cases asked parties to brief him on effect of Warner Lambert v. Kent’s outcome should have on defendants’ motion to dismiss)