Preemption Defense Not Completely Dead for Branded Drugs
As all who follow drug and device law know full-well, the 2009 decision from the United States Supreme Court in Wyeth v. Levine represented a significant setback for brand-name drug manufacturers seeking to defend failure-to-warn claims on preemption grounds. In Levine, the court held that state law failure-to-warn claims involving brand-name drugs are not preempted, unless there is “clear evidence” that the Food and Drug Administration (FDA) would not have approved whatever labeling change forms the basis for the failure-to-warn claim. Such a standard is, of course, difficult to meet.
However, a New Jersey Federal Court, in a case pending as part of the Fosamax MDL, recently found in favor of preemption and dismissed a plaintiff’s failure-to-warn claim. A copy of Judge Pisano’s opinion in the case – Glynn v. Merck Sharp & Dohme Corp. (June 27, 2013).
In Glynn, the plaintiffs claimed that the Fosamax ingested by Ms. Glynn had inadequate warnings about the risk of atypical femur fracture. The defendant, Merck, countered with evidence that it had sought FDA approval of a stronger warning about this risk before Ms. Glynn suffered her injury, but that FDA had rejected its proposed new warning.
After hearing oral arguments on Merck’s motion to dismiss on this basis, Judge Pisano elected to proceed with a trial so that a fuller factual record on this issue could be developed. A jury trial took place in April of this year, resulting in a jury verdict for Merck. Afterwards, Judge Pisano issued his written opinion on Merck’s preemption defense, finding that the evidence presented at trial indeed was sufficiently “clear evidence” that the FDA would not have approved the alternative warning proposed by the Glynns. Accordingly, Judge Pisano found that the Glynns’ failure-to-warn claims against Merck were indeed preempted.
While the Glynn decision is not likely to signal an avalanche of successful preemption motions in brand-name prescription drug litigation, it is important for defense practitioners, as well as branded drug manufacturers, to evaluate carefully the factual record in each failure-to-warn case to determine if the right facts to support such a defense are present. If they are, then a successful preemption defense might still be alive and well for that claim.