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Another Preemption Decision Sheltering Drug Makers from Liability

Posted  July 24, 2013

By Marlene Koury

Pharmaceutical companies are on a roll.  They continue to prevail in court by relying on the preemption doctrine to block injured consumers from suing over defective drugs.  First, in the recent Mutual Pharmaceutical v. Bartlett and PLIVA v. Mensing decisions, the Supreme Court held that federal law bars suits against generic drug companies for defects in the design or labeling of their products.  Click here for our prior post.  These decisions set up a troublesome outcome: if you are injured from a brand-name drug, you can sue the manufacturer for damages because of its ongoing obligation to ensure the drug’s safety and effectiveness, and an appropriate and up-to-date label.  But if you are injured from a generic drug, you cannot sue because generics have no such obligation.  In response to the ruling, the FDA is apparently considering adopting regulations that would permit generics to change their labeling in appropriate circumstances, eliminating the preemption argument that currently shelters them from liability.

And now, in another major victory for drug companies, pharmaceutical giant Merck successfully relied on the preemption doctrine to block a consumer injury case based on the inadequate labeling of Fosomax, a drug that prevents postmenopausal osteoporosis.  Click here for the decision.  In that case, a school teacher who fractured her femur claimed that Fosomax caused her injuries.  She argued that Merck knew of this risk, but failed to provide any warnings on the drug’s labeling.  Merck argued that it attempted to update the label to provide for this warning, but that the FDA rejected its labeling request.  The court held that plaintiff’s claims were preempted “because there is clear evidence that the FDA would not have approved a change to the Precautions section of the [label].”

This result follows directly from the Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), which, despite coming to the opposite conclusion on preemption, left a loophole that Merck successfully stepped through in Glynn.  In Wyeth, the court held that the preemption doctrine did not bar a state law claim of inadequate labeling because Wyeth did not attempt to update its label to warn of the risks of its drug.  The Court reasoned that “absent clear evidence that the FDA would not have approved a change to [the drug’s] label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”   That is the crux of Merck’s defense in Glynn: Merck submitted emails from the FDA rejecting a labeling update request and advising Merck that Fosamax may be considered misbranded if the label were changed without FDA consent.  Unlike in Wyeth, Merck could not have complied with state law to update its label without running afoul of the FDA.

Glynn is a bellwether case that is sure to impact future litigation – there are more than 3,000 cases against Merck claiming that Fosamax causes femur fractures.  But more broadly, Glynn provides a path of defense for other pharmaceutical defendants facing similar lawsuits.  Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, said that “[c]ertainly, pharmaceutical companies are trying to pigeonhole their cases in the ‘clear category’ left open.”  However, Friede was cautious in his views as to how far this loophole would be exploited going forward, stating that “I think [the Court] saw it as a very narrow opening that, presumably, would not apply in all that many cases.”  It remains to be seen if Glynn represents an isolated loophole to Wyeth, or the first movements of a sea change that will undermine the remedies and protections state laws provide for consumers against drug companies for selling defective drugs.

Tagged in: Court Decision, Healthcare Fraud, Pharma Fraud,