The second of pharma's trifecta of must-watch Supreme Court decisions on preemption was a fizzle, as the Court in a 4-4 split decision on Monday upheld a Second Circuit decision stating that FDA decisions do not preempt claims against the pharma industry. Good news for the plaintiffs, but what does it mean for pharma?
"When a case goes before the Supreme Court, you hope to get a decision and that it goes your way," said Jones Day partner Mark Herrmann. "When it comes down four to four, it is as though the Supreme Court had not taken the case. Everyone was so excited to hear something, and we got nothing."Only eight judges decided on the case because Chief Justice John Roberts recused himself due to conflict of interest. Roberts owns stock in Pfizer, which merged with Warner-Lambert in 2000.
At the heart of Warner-Lambert v. Kent was a Michigan statute that stated that plaintiffs couldn't file a claim against a drug manufacturer unless an exception applied. Michigan is one of eight states that offer some form of immunity to pharma companies with a big exception—when approval of the product has been obtained by fraud, which is what the plaintiffs claimed had happened in the case of Warner-Lambert's Rezulin.
Warner-Lambert claimed preemption, and the district court agreed. The Second Circuit reversed that decision, however, and the appeal ended up in the Supreme Court. Now the case returns to the trial court.
"In the Supreme Court, there was a lot of discussion among the justices and with the parties about the fact that allowing these kinds of claims to proceed would unnecessarily burden FDA and would potentially require FDA employees to give deposition testimony and involve them in the lawsuit," said John Q. Lewis, partner in trial practice group at Jones Day in Cleveland. "The potential impact of the court's decision might give us a real-world view of what level of involvement we'll see with FDA in this kind of claim."
More to Come
There is now only one major preemption case remaining—Wyeth v. Levine. While Kent dealt with a specific state statute and the implications of an exception to that statute, Levine deals with state versus federal preemption for pharmaceutical products brought to market, much like the recent Medtronics vs. Riegel case did for medical devices.
"In Levine, the issue is different because preemption analysis is different between medical devices and pharmaceuticals, but the result is going to have the same broad impact on the industry," Lewis said.
In the medical device context, a federal statute states that if a state law requirement conflicts with a federal law requirement, the state law requirement is invalid. In pharmaceuticals, there is no such statute, so it is merely an implied idea that if a federal agency regulates in a field, conflicting state law has to give up.
"All eyes are now on Wyeth vs. Levine?the 600-pound gorilla in the room," Hermann said. "The Levine case would apply to every state in the country. So if the FDA approved the drug and dictated the terms of the label, then private plaintiffs can't sue."
Wyeth vs. Levine is presently before the Supreme Court and will likely be determined by this summer.