In a recent federal court ruling, pharmaceutical drug manufacturers may now defend themselves against product liability lawsuits through preemption, which means that the FDA’s approval of a drug outweighs any state law claims questioning safety, effectiveness or labeling.
In 2009, the US Supreme Court allowed a Vermont woman to sue Wyeth (now owned by Pfizer) because the drug manufacturer didn’t include adequate warnings on the nausea drug Phenergan, which was administered to her by IV and caused her to lose part of her arm. She won the suit because there was no evidence the FDA would have disallowed a stronger warning had Wyeth chosen to put one on its label. But the court also said that if a drug manufacturer can prove the FDA would not have approved a labeling change, it would be impossible to adhere to both the agency’s requirements and a state law’s finding for a stronger warning.
Believe it or not, Merck won just such a case when a federal court judge determined that the drug manufacturer had tried to include a stronger warning on the drug Fosamax, used to treat osteoporosis. Merck claimed it had attempted to update its label to include a potential link between Fosamax and femur fractures, but the FDA didn’t approve the warning. Bernadette Glynn, a 58-year-old school teacher in upstate New York had taken Fosamax and suffered a fracture the following year. But there’s the catch: Merck’s attempt to update its warning occurred just prior to Glynn’s claims against the manufacturer, and she lost her case in court.
Last month, US District Court Judge Joel Pisano said 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.” The FDA had sent several emails to Merck in 2009 warning the manufacturer that Fosamax may be considered “misbranded” if labeling changes were made prior to FDA consent. So in its usual incompetent fashion, the FDA’s procedures take precedence over public safety. It wasn’t until 2010 that the American Society of Bone and Mineral Research issued a report to the FDA to require Merck and other companies with similar drugs to Fosamax to strengthen their warnings to include a possible link between bisphosphonate drugs and femur fractures.
This ruling is disturbing, to say the least. It means the door is left open for drug manufacturers to use preemption as a ploy to avoid responsibility for their actions. However, according to a former FDA associate chief counsel and a former senior corporate counsel at Pfizer. “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.” Perhaps he’s right, but with a slew of high-powered, overpaid attorneys and political lobbyists on the side of Big Pharma, your guess is as good as mine.