Women across the country are filing Essure lawsuits against Bayer, seeking damages for personal injuries caused by the birth control medical device. (In 2013, Bayer purchased Conceptus, the original maker of Essure.) Essure is a permanent method of birth control that does not require surgery.
The procedure involves the insertion of two metal coils (the Essure device) into a woman’s fallopian tubes. After insertion, the coils can break into pieces. They may also migrate to other parts of the body. This can result in punctured organs and other personal injuries.
Recently, Bayer challenged 11 consolidated claims filed by 14 women in California state court. Bayer asserted that federal law preempts the claims because Essure is a Class III medical device approved by the FDA in 2002. The judge ruled against Bayer, finding that the women could proceed with their claims that:
- Bayer did not give the FDA or the public adequate warning of the risks of serious side effects and injuries from use of Essure, and
- Bayer breached warranties regarding Essure and misrepresented the device’s safety and effectiveness through improper promotion and advertising of Essure
The court also ruled that the following additional claims could survive Bayer’s preemption challenge if plaintiffs re-plead the claims, adding more details as to how Bayer’s conduct caused the women’s injuries:
- Bayer negligently trained doctors on insertion of Essure, and
- Bayer improperly manufactured Essure
While this ruling is specific to the 11 claims asserted by these women, the court’s decision indicates that other Essure lawsuit claims may survive Bayer’s state and federal preemption challenges.