Until March 17, 2016, any litigation that existed against Bayer Pharmaceuticals over its Essure birth implant, a medical device linked to literally hundreds of severe side effects, was centered in Pennsylvania. 5 lawsuits, all filed by women who claim the implants caused them devastating harm, have been brought together in the US District Court for the Eastern District of Pennsylvania.
That changed, however, on Thursday, when 32 women filed a joint complaint against the Germany-based manufacturer in Missouri’s St. Louis Circuit Court, as reported by the St. Louis Post-Dispatch, among others. The women say Bayer’s device, marketed as an effective form of permanent birth control, causes “serious and permanent injuries.” Bayer has been well aware of those risks for years, Plaintiffs claim, but the company has failed to warn patients and health care providers.
Shielded From Liability, Bayer Comes Under Fire
Pursuing these lawsuits has been difficult, since Bayer is theoretically protected from product liability claims arising over alleged Essure side effects. The implants, considered “high-risk” at the time of their approval, were taken through the US Food & Drug Administration’s “Pre-Market Approval” process.
“Pre-Market Approval” is intended as the FDA’s most stringent evaluation of a medical device’s risks and, in exchange for undergoing increased scrutiny, at increased cost, device manufacturers are shielded from civil liability after their products have passed the test.
In their lawsuits, Plaintiffs have argued that Essure’s Pre-Market Approval has been invalidated, in part because the device’s previous manufacturer, Conceptus Inc., failed to submit multiple side effect reports to the FDA. Thus Bayer’s current protection from liability should also be stripped, the women have written.
German Company Stands Behind Controversial Implant
In a response sent to the St. Louis Business Journal several days after the 32 women filed their Essure lawsuit, Bayer acknowledged the contentious subject, writing:
“We have sound defenses including federal preemption. The design, manufacturing method, warnings and instructions for use for Essure were approved by FDA under the agency’s Pre-Market Approval authority, which subjected Essure to the highest level of scrutiny that exists in the federal regulatory system. FDA’s recent actions on Essure confirm that this lawsuit is preempted. As FDA has stated in numerous media articles, ‘Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.’ This complaint is an attempt by plaintiffs to second-guess the FDA.”
But according to Plaintiffs, it is Bayer’s conduct that should be looked into. It would be hard to fault women, especially those who have received Essure implants themselves, for “second-guess[ing]” Bayer’s actions under the current circumstances. The company is accused of “purposefully deceiv[ing] not only the FDA, but our nation’s physicians and ultimately their patients who entrusted their lives, health and well-being on the promise of a safe, effective product,” says Eric Holland, an attorney for the 32 women.
Black Box Warnings & Informed Consent
For its part, the FDA recently announced that it would require a “black box” warning on Essure’s packaging, and has begun investigating allegations that clinical trial results were falsified to “silence” patients who experienced side effects after receiving the implants. The agency is currently drafting a thorough checklist, describing the side effects associated with Essure, that every prospective patient will have to sign. After completing the checklist, a patient will have signed the document no less than 15 times.
Recent revelations have only increased the public’s indignation. “Nearly 10,000 formal complaints,” reports of debilitating side effects sent directly to the agency, are “related to Essure,” Congressman Mike Fitzpatrick says. Fitzpatrick hired an independent medical device expert to comb through those 10,000 reports. The analysis ultimately turned up 303 reports of fetal death associated with the implants, far more than the 5 events cited in the FDA’s publicly-available documents on Essure. Fitzpatrick is sponsoring a bill that would see Essure recalled entirely from the market.