A federal judge has taken under advisement oral arguments on whether she should grant a motion by drug manufacturer Pfizer arguing preemption in contraception litigation.
In the product liability litigation concerning Depo-Provera, more than 1,300 lawsuits have been filed alleging that using Pfizer’s Depo-Provera leads women to allegedly develop a type of brain tumor called intracranial meningioma.
Depo-Provera is a birth control injection used by women. The lawsuits allege that Pfizer was aware of a link between the birth control injections and the development of brain tumors and that they failed to adequately warn of the risk and promote safer alternatives.
Northern District of Florida federal judge M. Casey Rodgers listened to oral arguments in Pensacola on Sept. 29.
The pre-emption defense, common in pharmaceutical litigation, involves the drug manufacturer arguing that they cannot be sued for failure to warn under state law because changes to a drug warning label are governed by federal law and the U.S. Food and Drug Administration (FDA).
Virginia Buchanan, lead plaintiffs' attorney, said thousands of women are living with meningiomas and deserve the chance to have their cases fairly considered by the courts.
“Pfizer is attempting to avoid accountability by invoking a preemption defense, yet there are serious questions about whether it ever provided the FDA with the full picture,” Buchanan said. “Preemption was never meant to serve as a shield for drug companies that fail to warn patients adequately.”
Pfizer did not respond to requests for comment by the time of publication.
The pre-emption defense asserted that the FDA rejected its request to add a tumor warning to the drug’s label, which pre-empts any state law claims that it failed to warn consumers and physicians, according to a press release.
"The plaintiffs argue that Pfizer’s pre-emption defense fails because the company’s request to the FDA was too broad because it grouped Depo-Provera with other lower dose hormonal contraceptives, and this led to the FDA’s decision not to approve a tumor warning on the drug’s label in the USA," Buchanan said.
However, the study also found that the high number needed to harm suggested low clinical risk overall.
“Despite this addition to the long-existing and growing body of evidence, Pfizer has continued to disregard the heightened and unnecessary risk associated with its injectable Depo-Provera and has consistently failed to take reasonable steps to alert patients and their physicians to this very real danger,” Buchanan added.