3rd Circuit Revives Fosamax MDL Over Questions of Preemption

The decision, which the U.S. Court of Appeals for the Third Circuit said was a “close call,” hinged on whether an informal communication in the form of a letter the FDA sent to Merck was sufficient to establish preemption.

The U.S. Court of Appeals for the Third Circuit has rejected arguments that the plaintiffs’ claims in the Fosamax litigation should be preempted by U.S. Food and Drug Administration regulations.

The Friday ruling in In re: Fosamax Litigation means that the more than 500 lawsuits targeting Fosamax’s manufacturer, Merck & Co. Inc., can proceed after they were initially dismissed at the summary judgment phase. The decision, which the Third Circuit said was a “close call,” hinged on whether an informal letter the FDA sent to Merck was sufficient to establish preemption.

According to the opinion, Merck had proposed a label change that would have addressed the risk of bone fracture associated with Fosamax, a biphosphonate, which is the subject of the current litigation. The FDA, however, rejected Merck’s proposed label change for lack of sufficient scientific support.

Although U.S. District Judge Freda L. Wolfson of the District of New Jersey had determined that the letter established that the claims should be preempted, the Third Circuit panel determined ruling was an error.

“With real respect for the thorough and thoughtful work the district court did in this complex case, we nonetheless conclude that it erred in its preemption analysis by giving too little weight to the required presumption against preemption,” Third Circuit Judge Kent A. Jordan wrote for the court.

Jordan said the court would apply the presumption against preemption to conclude that the plaintiffs’ state claims are not preempted. The district court judgment in Merck’s favor was vacated and remanded.

Third Circuit Judges Peter J. Phipps and Arianna J. Freeman joined Jordan.

The plaintiffs allege that Merck failed to warn that using Fosamax is linked to femur fractures.

According to Jordan, in May 2009, the FDA sent a letter to Merck, which agreed to the company’s proposed changes to the “adverse reactions” sections of the label but rejected the proposed changes to the “precautions” section. However, the opinion also noted that the response letter informed Merck that it had one year to resubmit its application to make the changes to the label. Merck withdrew its application and made changes only to the adverse reactions section, according to the opinion.

On appeal, the plaintiffs argued that the district court erred in its conclusion that Merck satisfied the preemption test under the U.S. Supreme Court holding in Merck v. Albrecht. The plaintiffs contended that Merck failed both prongs of that test. First, they contended that Merck did not fully inform the FDA of the justifications for the warning and, second, that Merck cannot show that the FDA informed the company that it would disapprove a change to the label.

The plaintiffs also argued that the FDA letter did not carry the force of law and that FDA regulations allowed Merck to make appropriate label changes through the “changes being effected” supplement, which allows the manufacturer to make a labeling change without prior FDA approval.

Merck asserted that it met its burden on both prongs of the Albrecht preemption test: that the FDA letter had the force of law and that the “changes being effected” process adds nothing to the preemption analysis.

Jordan, however, held that Congress’ intent, which is to preserve state law claims in the drug-labeling context, would be undermined by siding with Merck in this case. The judge also added that the presumption against preemption would have a diminished effect if informal communication is allowed to serve as determinative evidence in answering a question of preemption.

“We acknowledge that this is a close case, but, in a close case, the strong presumption that the Supreme Court has established will likely be determinative,” Jordan said. “The ‘difficult’ and ‘demanding’ clear-evidence standard is one that ‘a drug manufacturer will not ordinarily be able to show.’”

Counsel to the plaintiffs, David C. Frederick of Kellogg, Hansen, Todd, Figel & Frederick, and Merck, Jacob M. Roth of Jones Day, did not immediately return requests for comment.