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Here's a decision that will hearten the pharmaceutical industry. A federal court recently issued a ruling that may allow drugmakers to defend themselves against product liability lawsuits by citing preemption – which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling.
Preemption, as you may recall, was at the heart of a contentious 2009 ruling by the US Supreme Court, which found that a Vermont woman was entitled to sue Wyeth – which is now owned by Pfizer (PFE) – because the drugmaker failed to adequately include safety warnings on one of its medicines (read here).
Why? There was no evidence to show the FDA would have rejected a stronger warning if Wyeth had sought to do so. In legal parlance, it was not “impossible” for Wyeth to have attempted to update its label. But the court also left the door open to another scenario that invites a preemption defense: If a drugmaker can provide “clear evidence” that the FDA would not have approved a unilateral labeling change to include an updated warning, a drugmaker could argue this demonstrated it was impossible to comply with both FDA requirements and a state law finding for a stronger warning.
And Merck won such a ruling. A federal court judge decided that Merck had, in fact, attempted to strengthen the warning about a possible link between its Fosamax treatment for osteoporosis and femur fractures, but the FDA did not approve such an addition to the precautions section of the labeling. This attempt occurred in 2008, before Bernadette Glynn, 58, an elementary school teacher from upstate New York, suffered such a fracture the following year. She argued Merck was aware Fosamax might increase fracture risks years before the drug was made available, but failed to include info in the label.
But in a 17-page ruling issued late last month, US District Court Judge Joel Pisano disagreed and wrote that “preemption is warranted, because there is clear evidence that the FDA would not have approved a change to the precaution section of the Fosamax label prior to Mrs. Glynn’s fracture.” In citing FDA e-mails to Merck in 2009, he noted that the FDA rejected the updated labeling during the same month in 2009 that Glynn suffered a fracture, and that the agency warned Merck its drug may have been considered misbranded if the labeling change was made before FDA consent was given (here is the ruling).
It was only after the American Society of Bone and Mineral Research issued a report in 2010 that the FDA required Merck and other drugmakers to strengthen the wording in their product labeling to reflect the possibility of an association between bisphosphonate drugs such as Fosamax and femur fractures (see this).
So should we now expect to see a torrent of briefs filed by drugmakers citing a preemption defense? “There are certainly some cases out there where companies will be able to establish by ‘clear evidence’ that FDA would not have approved a label change,” says Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer.
“But it is hard to know how many such circumstances there are out there. Certainly, pharmaceutical companies are trying to pigeonhole their cases into the “clear category” left open… In fact, the Supreme Court did not tell us in Wyeth v. Levine what quality and quantum of proof is needed to provide ‘clear evidence that FDA would have declined to approve a label change. So it is impossible to know exactly what impact the loophole will have going forward. While the Supreme Court majority in Wyeth v. Levine left this possibility open, I think they saw it as a very narrow opening that, presumably, would not apply in all that many cases.”
Just the same, it is quite likely that attorneys who represent the pharmaceutical industry are going to be looking for this opening now.
Glynn, by the way, lost her case in court. In late April, a jury found in favor of Merck, handing the drugmaker an important victory, because this was considered to be a so-called bellwether case. Pisano deferred a ruling on a preemption motion until after a jury had made a decision (back story).
