California State Court Green-Lights Essure Product Liability Suits Against Bayer
Posted on behalf of Janet, Jenner & Suggs on Aug 08, 2016 in Consumer Alerts
We recently obtained groundbreaking rulings from a California state judge whose decisions have permitted us to continue the fight on behalf of our clients, despite significant preemption, statute of limitations, and jurisdictional obstacles thrown at us.
Eleven Separate Essure Lawsuits Filed
Our firm has teamed up with the law firm of Grant & Eisenhofer to represent women nationwide who have been impacted by the Essure device. The plaintiffs’ actions are currently being brought as 11 separate suits in California. The suits contend that Essure, an FDA-approved medical device on the market since 2002, has since caused a number of problems and physical injuries in thousands of women who have had the device implanted.
The device, which consists of two spring-like coils that are inserted into the fallopian tubes, is implanted as a quick outpatient procedure and is designed to be implanted for life. The suits contend that the Essure device can come out of place and could puncture the uterus and in various cases cause chronic pelvic pain, excessive bleeding, and can result in unintended pregnancies. Plaintiffs contend that one key problem with the device is that, given its high failure rate, its problems are exacerbated because there is no established procedure for its removal.
Defense ‘Preemption’ Claim Rejected
In three separate rulings dated Aug. 2 and authored by Judge Winifred Y. Smith, the Superior Court of California in Alameda County rejected several defenses raised by the Bayer defendants.
The first decision rejected Bayer’s defense of federal preemption, in which Bayer argued that because the FDA approved the marketing and warning labels they should not be held liable for any injuries associated with the device. 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 Bayer defendants’ argument that plaintiffs’ claims accrued outside of the statute of limitations. The court agreed with the plaintiffs’ contention that the discovery of their causes of action occurred no earlier than September 2015, when the FDA held hearings, and that patients were unable to have made earlier discovery because of the defendants’ concealment of essential relevant facts.
“The preemption ruling is especially important,” said Thomas Ayala, senior counsel with Grant & Eisenhofer. “It demonstrates that when the FDA approves a product label for a medical device, that approval is based on information then available to the FDA, primarily provided by the company. But after approval, responsibility lies with the company to maintain and update the label to reflect the most current data available regarding the risks associated with the product.”
He continued, “In this case, 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 the FDA.”
Essure Still Being Implanted Today
Essure is still being implanted in patients today; but FDA announced in February 2016 that the device will require a black-box warning indicating extreme risks and possible serious injuries associated with its usage. It includes warnings that the device can migrate out of place, cause chronic pelvic pain, and related symptoms.
“Most drug companies play by the rules. Bayer, on the other hand, decided the rules don’t apply to them, and concealed the magnitude the risk from women who needed a permanent contraception alternative. As a result, we believe that thousands of women suffered needless pain as a result of being deprived of vital information regarding the safety of this product,” said Robert K. Jenner, who leads the Janet, Jenner & Sugg’s Mass Tort Department