A Missouri Court of Appeals ruled against Bayer on December 5, 2017, holding that a lower court had incorrectly dismissed the Essure lawsuit filed by a 33-year-old woman who experienced chronic pain after receiving the birth control implant, the St. Louis Post-Dispatch reports.
Missouri Judges Preserve Essure Side Effect Lawsuit
Last year, the Circuit Court of Boone County threw out the woman’s lawsuit, in which she leveled fourteen separate claims for compensation against Bayer, along with several claims for alleged negligence against her doctors.
The case’s plaintiff, a 33-year-old woman who lives in Boonville, Missouri, filed suit against Bayer after receiving Essure implants in 2013. She suffered severe pain, court documents report, and soon decided to undergo a removal procedure. An X-ray performed prior to a hysterectomy found evidence that at least one of the woman’s Essure implants had broken apart and pierced her uterus.
In her lawsuit, the plaintiff accused Bayer of misrepresenting Essure’s safety, violating various warranties, manufacturing and selling an unreasonably dangerous product, failing to warn the public of a serious health risk and failing to train participating medical providers adequately.
These claims, the trial court determined, were preempted by federal law, because Essure had been approved through a program of the US Food & Drug Administration known as Pre-Market Approval. Designed to capture serious health risks, Pre-Market Approval is the FDA’s most-stringent approval process, federal officials say, requiring an extreme investment on the part of medical device manufacturers.
Legal Loophole For Medical Device Manufacturers
Pre-Market Approval is reserved for medical products that could pose a serious risk of patient harm and / or death. But in exchange for the increased scrutiny, lawmakers in Congress offered manufacturers a measure of legal protection, by making federal law the be-all-and-end-all in the world of medical devices. State laws, according to the Medical Devices Amendment of 1976, cannot place any additional or different requirements on medical device manufacturers.
The problem, in the end, is that the vast majority of product liability lawsuits, including those related to dangerous medical devices, are based in state law. Bayer’s central argument in the Essure litigation has been that every case should be dismissed, since Essure was approved via the Pre-Market Approval pathway and it can’t be touched by claims of wrongdoing that are premised in state law.
Appeals Court: Essure Claims Parallel Federal Requirements
The Missouri Court of Appeals didn’t buy that argument, Law360 says. The Court’s opinion, rendered on December 5, reinstated one woman’s claims of negligence, defective manufacturing and insufficient practitioner training, arguing that, while these claims were premised in state law, they directly mirrored requirements enforced under federal law.
In short, the woman isn’t saying Bayer should do anything extra to protect patient health; she’s simply asking Bayer to follow the tenets already imposed by Essure’s Pre-Market Approval.
MO Supreme Court Considers Essure Jurisdiction Dispute
The State Appellate Court’s decision comes as E-Sisters around the country eagerly await an opinion from the Missouri Supreme Court. Heard at the beginning of November, the case pits 92 plaintiffs, most of whom do not live in Missouri, against the German multinational pharmaceutical company.
Bayer argues that the case, in which dozens of women say Essure caused them to suffer severe complications, should not proceed in Missouri’s courts, according to Missourinet. As defense attorneys note, only 7 of the 92 plaintiffs are residents of Missouri.
Plaintiffs counter by pointing to several clinical studies conducted in Missouri, along with Bayer’s general business activities in the State, to argue that Missouri’s courts have jurisdiction over the dispute. Bayer is appealing a lower trial court’s decision, in which State Judges refused to dismiss the case outright. In total, over 2,000 women have sued Bayer over alleged Essure-related injuries in the St. Louis court.