After months of anticipation and speculation, the mammoth preemption case, Wyeth v. Levine, was heard before the US Supreme Court on Monday in a passionate exchange between justices and lawyers from both parties. The arguments added fuel to the already contentious case that pits the power of FDA and the federal government against states’ ability to bring liability suits against pharma.
On one side is Diana Levine, a musician who lost her arm after she was given Wyeth’s anti-nausea medicine Phenergan. The drug was administered by IV push into her vein and came into contact with arterial blood—which the drug’s label warns against—leading to gangrene and the amputation of her arm.
Levine’s lawyers acknowledge that the drug had stated warnings. (Phenergan’s label clearly notes that the drug should never be injected into the artery.) Instead, lawyers insist that the drug didn’t have a contra warning stating that the drug should never be given through IV push, given the high risk associated with such a route of administration.
A Vermont court agreed, ruling in favor of Levine and ordering Wyeth to pay her $6.8 million in restitution. Wyeth, however, appealed the verdict, claiming that it was protected by FDA’s approval of the drug and its label—and that when federal and state laws conflict, federal law (and by extension, FDA) takes precedent.
The case made its way to the US Supreme Court this week. According to reports, it was a fiery discourse, with justices interrupting attorneys mid-sentence, and attacking them with what seemed to observers an unending line of questioning.
One justice called the FDA’s approval decision into question. "How could the FDA conclude that IV push was safe and effective when on the benefit side you don't have a life-saving drug—you have a drug that relieves nausea—and on the risk side you have the risk of gangrene?” Justice Samuel Alito asked at one point.
Wyeth’s legal team countered that Phenergan’s warnings were disclosed, and it was up to the healthcare professional to determine when to administer the drug by IV push as opposed to the safer, traditional IV.
“This is labeling that is directed at medical professionals,” Wyeth’s lawyer Seth Waxman said on Monday. “It is labeling that is directed at physicians, who have to be able to determine what pharmaceutical and what method of administration to use.”
Some say this brings up the question of whether the case is about the right of FDA to pre-empt state law, or more simply about medical malpractice.
“This is not a good case to test preemption because basically everyone agrees that the elephant in the room is the woman who got the IV push into her vein was a victim of medical error, not a regulatory or liability error,” said Jim Huston, mass tort litigator at Morrison & Foerster. “So the drug company—which warned against this very risk and said if you try the IV push you better make sure you [don’t hit arterial blood]—gets hit for $6 million for a risk that they knew about, identified, and warned against.”
At this point, it seems there are three directions this case can go. The court could rule in favor of Wyeth and preemption, reversing the state verdict; it could vote in favor of Levine and allow the state ruling to stand; or there can be a reversal with a remand where the Supreme Court sends the case back to the state and asks it to look closer at its decision.
“Preemption is a pure question of law, it’s unlikely that you are going to see a remand in this case,” said Mark Herrmann, partner at Jones Day and co-author of the Drug and Device Law blog. “If you combine how the justices voted in earlier cases, plus the questions they asked in the Riegel [v. Medtronics] argument, plus the questions asked yesterday—I count five justices in favor of preemption. I’m guardedly optimistic that the ruling will come down in favor of preemption.”
The question then: How broadly will justices interpret the ruling? It may not be the large safety net against liability suits pharma was hoping for. “When the facts seem strong and positive, it is possible for the court to tie the decision close to those facts, and leave for another day the application of the doctrine to cases that aren’t completely identical to that one,” said Sean Wajert, partner at Dechert.
The final ruling is expected before June 2009, at which time the current Supreme Court term ends, and all pending cases will be closed. Until then, all we can do is wait.