CA Court Allows Essure Cases to Proceed
A California state court has allowed a series of product liability lawsuits to proceed against Bayer by 14 women who allege that they have been injured by the company’s birth control device Essure. The suits contend that the device can come out of place and puncture the uterus, and in various cases cause chronic pelvic pain, excessive bleeding, and even can result in unplanned pregnancies. They argue that one key issue, given its high failure rate, is that device problems are exacerbated because there is no established procedure for its removal.
In three separate 8/2 rulings by judge Winifred Y. Smith, the Superior Court of California in Alameda County rejected several defenses raised by the Bayer defendants. The first ruling rejected Bayer’s federal preemption defense. The second ruling on jurisdiction determined that California was the proper venue for the suits, rejecting Bayer’s argument that plaintiffs who were not California residents should be required to litigate in their home states. In the third ruling, the court rejected the company’s argument that plaintiffs’ claims accrued outside of the statute of limitations.
Attorneys for the defendants say the evidence will show that Bayer received thousands of adverse event reports from patients and failed to disclose that information in a timely manner to doctors, patients and to FDA. “We believe that Bayer concealed from patients and the public the magnitude of risk associated with Essure, and that thousands of women suffered needless pain as a result of being deprived of vital information regarding the safety of this product.”
The state rulings come about two weeks after Bayer won a court victory in an Essure product liability case in federal court in Connecticut. The judge there ruled in Norman vs Bayer and granted Bayer’s motion to dismiss because the claims were preempted by federal law or failed to provide facts to support them. 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).”
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.