Pre-emption: Levine vs. Wyeth (insiders view)
The oral arguments are complete and available on the Levine vs. Wyeth case. From the onset the Justices had a hard time figuring out how we came up with a system that: It's impossible for Wyeth to comply with the State law and at the same time the Federal label. As a textual matter, as a logical matter, I just -- I don't understand that. Justice Kennedy. The other questions they asked included: ...was it -- the risk of gangrene and amputation is there. No matter what benefit there was, how could the benefit outweigh that substantial risk? Justice Ginsburg According to the plaintiff attorneys: In approving the label, it (FDA) rejected stronger proposed language that Wyeth had presented. Both sides seemed to agree that Wyeth went to the FDA with stronger language and was rejected. Rightly so the justices had a hard time understanding why Wyeth would be liable for a labeling change they requested and was rejected by the FDA. I understand, but in the interim, you could -- could you be subject to a State tort suit for not changing the label when -- when you had the power to do so? You're saying FDA approval doesn't -- doesn't give you any protection at all? (Justice Scalia) According to John Kamp, Executive Director of the Coalition for Healthcare Communications, who just sat in on the Supreme Court testimony of Levine vs Wyeth: We all should be uneasy about today's Supreme Court argument in the Wyeth case. If Wyeth loses, marketing will be harder and more expensive because warnings will proliferate. If Wyeth wins, the decision could be overturned by the next Congress. Unfortunately, this case is more about politics and immediate emotions than it is about regulatory policy and facts. For example, expect today's media coverage to focus much more on the injured patient whose care turned tragic than on the legal arguments of Bert Rein, attorney in recent "friend of the court" briefs. All drugs have risks. Post Vioxx the politics around the FDA has been mostly about risk. In this case, Diana Levine lost her arm from risky administration of a drug marketed by Wyeth. Her personal misfortune will get most of the coverage. Expect little discussion of the thousands of persons aided by the drug in today's coverage. Nor, expect Ms. Levine's attorneys to fret much about the danger to the vast majority of patients well served by FDA marketing and labeling. You should worry because no matter how the Supreme Court decides this case, companies will almost certainly face more "failure to warn" cases from plaintiff's attorneys. The line of Supreme Court bar members started at 7:30 AM. It was the Oscars of the medical bar waiting in line to find their places. The plaintiffs attorneys seemed optimistic, even jubilant, compared to the company folks. Members of the Supreme Court bar arriving after 8, were shuffled like worker bees to an ante room. Plaintiff's attorneys care about this case because their right to sue on behalf of clients could be limited. Plaintiff's attorneys are focused. Justice Scalia at one point summarized the plaintiff's argument: You're saying that "When something goes wrong -- no matter what the FDA has said -- you have a lawsuit." Don't get caught up in the media hype about this being "the Case of the Century." It's hardly that because today the Supreme Court was not to interpret the U.S. Constitution where it has the final word. Instead, the Court will interpret what the Congress meant when it passed the applicable "preemption" provision in the FDA Act. If Wyeth wins, the Court will be saying that because Wyeth's professional communication, advertising, marketing and labeling conformed with the mandates of the FDA, Wyeth cannot be sued in state court for not saying more. Essentially, the Court will say that FDA sets the national standard for warnings, and Congress meant for that to preempt state law. Thus, juries cannot decide that additional warnings -- in contradiction to FDA mandates -- should have been given to Levine's doctors. Industry is worried because while it is never easy to be totally compliant with the vagaries of FDA regulation, that's simple compared with compliance with after the fact decisions by juries faced with a sad outcome. It's hard enough avoiding accidents looking out the windshield; it's probably impossible from the rear view mirror. Unfortunately, even if Wyeth wins today's case, the decision may not stick. Supreme Court decisions based on Congressional intent can be overturned by a new Congress passing another statute expressing a different intent. The political reality of this case -- is that the plaintiff's bar could win either way. Lose in Court this year, win in Congress next. And, as you watch the election results this week, remember that the plaintiff's bar has been a long time friend of Democrats. Some say the unions are the heart of the Democratic party and the plaintiff's bar is the billfold. It is amazing to me that companies who go to the FDA for labeling changes would be liable for adverse events caused by the FDA’s lack of responsiveness. But then again, trial lawyers will go after everyone to collect for their clients, that is why they get a percentage of the settlement. Levine vs Wyeth Oral Arguments WSJ: Court Weighs Amputee's Case, Limits on Drug Suits
