Bayer Wins Essure Case That Cited FDA Form 483
Bayer has won a court victory in a product liability case involving its besieged Essure contraceptive device. On 7/26, the federal court in Connecticut ruled on Norman vs Bayer, granting Bayer’s motion to dismiss because the claims were preempted by federal law or failed to provide facts to support them.
Injured patients have rallied to challenge FDA’s oversight and the company’s allegedly inadequate clinical trials that supported Essure’s approval. Recently, the patient group Essure Problems has written Congressman Jason Chaffetz (R-UT) urging a congressional investigation and hearing request over FDA’s approval and alleged injuries caused by the device. Chaffetz is chairman of the House Committee on Oversight and Government Reform. The letter says the investigation is needed because Essure’s clinical trials were inadequate and inappropriate from the beginning. “The clinical trials were insufficient as they followed too few women for too short a period of time,” the letter says. “The premarket approval was based on two non-randomized, non-blinded, prospective studies that lacked a comparator group and enrolled a total of 926 women.” The letter also complained that FDA did not adequately weigh complaints about serious side effects and injuries tied to Essure.
In Norman vs Bayer, the court noted that because Essure was approved under the PMA process, “any state law that imposes obligations on a medical device producer ― different from, or in addition to‖ the requirements of the [Medical Device Amendments] — is expressly preempted under § 360k(a).” So, plaintiffs are typically left to sue for conduct that violates the Food, Drug and Cosmetic Act, which was the case in Norman. The plaintiff alleged that, based on inspection findings cited in a Form 483, Bayer had used non-conforming material in Essure’s production at at least one plant.
The court dismissed this argument because the plaintiff did not allege “any plausible reason to think that her device came from the non-conforming batch, or that it suffered from any other manufacturing defect. In any case, she does not allege any facts that would make it plausible that the complications she suffered — which were known potential side effects — were due to any defect in the device. She does not, for example, allege that the device broke off, that it migrated from her fallopian tubes, or that it caused a puncture.”