Bayer (ETR:BAYN), which last week said it’s taking its Essure female sterilization device off the U.S. market this year, lost a bid yesterday to keep a clutch of personal injury lawsuits in federal court.
The German medical giant had a group of 16 cases that were originally filed in a Pennsylvania state court removed to the U.S. District Court for Eastern Pennsylvania, but the plaintiffs moved to have them remanded back to Philadelphia’s Court of Common Pleas. The plaintiffs argued that their claims involve violations of state law that parallel federal rules, making them exempt from preemption.
Judge John Padova agreed, ruling that Bayer failed to satisfy the four prongs that would keep the cases in federal court. Citing the U.S. Supreme Court decision in Reigel v. Medtronic and the Medical Device Amendments of 1976, Padrova found them to “make clear that Congress intended for the state courts to resolve cases such as this one, which ask whether a defendant violated state laws that parallel federal requirements applicable to Essure.”
“Bayer has simply not established that there is an actual disagreement about an interpretation of federal law that is material to the claims at issue,” Padova wrote. “Moreover, it has not established that the resolution of any dispute would have ramifications in federal cases outside of the Essure context or is otherwise important to the ‘federal system as a whole.’ Indeed, we conclude that Bayer has failed to identify any federal issue that holds significance for anyone other than the parties.
“Furthermore, it is important to reiterate that although the complaints in these cases allege that Bayer violated federal law, the central claims in the complaints are that Bayer violated state law and the complaints merely reference federal law to rebut any argument that their state law claims are preempted,” he wrote [emphasis his].
Padrova remanded the consolidated cases back to the Court of Common Pleas, ruling that Bayer failed to make its case regarding the federal issues at hand.
Bayer said July 20 that it will no longer sell or distribute Essure in the U.S., effective Dec. 31.
FDA commissioner Dr. Scott Gottlieb said the action follows a “series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use,” according to an FDA release.
“For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device,” Gottlieb said.
In April, the federal watchdog put restrictions on U.S. sales of Essure, a small metal coil that’s placed in the fallopian tubes via catheter, after concluding that some patients were not adequately warned of its risks.