When a California judge ruled 14 lawsuits filed against Bayer A.G. over its Essure device could proceed, it ended Bayer’s successful track record of dodging lawsuits. The ruling not only paved the way for potentially thousands of lawsuits in the state, but could encourage similar rulings in other states around the country.

FDA Authority

Before the California ruling, Bayer was getting lawsuits dismissed based on federal preemption. Federal laws, like those governing the Food and Drug Administration and its devices (FDA), trump any state or local laws. Because Essure was approved by the FDA’s premarket approvals (PMA) process, it is governed by federal law, not state law.

In lawsuits filed in state courts, Bayer successfully argued for dismissal because the Essure device is not subject to state law. However, a California judge doesn’t believe all Essure lawsuits involve or conflict with federal law, so some lawsuits have been allowed to proceed.

Premarket Approval

When the FDA grants premarket approval, devices are either completely approved or conditionally approved. Devices that are conditionally approved are only allowed onto market if they follow strict guidelines set forth by the FDA. In Essure’s case, the device was conditionally approved, and plaintiffs believe Bayer failed to adhere to conditions set by the FDA and actively concealed its violations.

One of the conditions in the PMA was that Bayer would conduct post-market studies of the device within five years. However, Bayer was slow to perform studies and published its findings three years after they were due. The company also only tracked 70% of the women in the studies who had Essure implanted.

In addition to failing to complete post-market studies, Bayer also failed to report adverse events related to Essure, manufactured the device in an unlicensed facility, and used materials not originally approved by the FDA in the PMA.

Plaintiffs believe Bayer’s failure to meet the conditions of its PMA should forfeit the company’s protection under federal preemption laws. Doing so would allow more lawsuits to move forward against the company.