Judge Winifred Y. Smith in Superior Court of California, Alameda County, issued a decision on Aug. 2, 2016, permitting the claims of 14 women who believe they were injured by Essure to proceed against the manufacturer, Bayer.
The court found that the claims were not expressly or impliedly preempted under federal or state law.
Ruling improves prospects
Motley Rice attorney Lou Bograd argued the preemption issue on behalf of the Plaintiffs and attorney Fidelma Fitzpatrick also participated in July 29 hearing. While this proceeding directly addressed claims in 11 consolidated cases filed in California State Court by the 14 women, it improves the prospects for recovery of thousands of women alleging they were seriously injured by their use of Essure, including hundreds of women represented by Motley Rice.
Thousands of women across the U.S. claim the permanent birth control device Essure has caused serious and permanent injuries. Essure manufacturer Bayer asserted that the Plaintiffs, and similarly situated women, are barred from bringing claims against it due to federal preemption law. Bayer claims that because Essure is a Class III medical device that was approved by the FDA in 2002, it is immune from lawsuits brought by the victims of the device.
Judge Smith rejected Bayer’s request for immunity, instead finding that the Plaintiffs could proceed with the causes of action related to:
- Bayer’s alleged failure to adequately warn the FDA, and thereby the public, of Essure’s potential dangers and adverse side effects.
- Claims that Bayer breached Essure’s warranties and misrepresented Essure’s safety and efficacy through advertising and promotional materials that were not approved by the FDA.
Negligently trained physicians
The judge stated that the Plaintiffs’ claims that Bayer negligently trained physicians and manufactured the Essure device improperly could also survive preemption, but that Plaintiffs must replead those claims with more details on how Bayer’s conduct caused the Plaintiffs’ injuries.
“I am extremely encouraged by Judge Smith’s decision,” says Motley Rice Essure lawyer Fidelma Fitzpatrick. “Bayer should not be allowed to hide behind preemption and should be made to answer to each woman injured by Essure.”
In February 2016, the FDA announced it will require Bayer to conduct a clinical study, implement a patient decision checklist to make sure potential users of Essure understand the risks of the product, and add a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.
“Bayer, like many other drug and medical device manufacturers, has been trying to use the doctrine of preemption to immunize itself from liability and deny women alleging injury by its product their day in court,” Bograd says. “In the Essure litigation, we are prepared to tackle all legal hurdles Bayer throws at us and to continue working toward allowing our clients to be heard.”
Read the rulings:
- Order on Statute of Limitations Demurrer
- Order on Preemption Demurrer
- Order on Forum Non Coveniens and Personal Jurisdiction Motion
Black box warning
The FDA issued a “black box warning” for the device in February 2016 amid allegations that Bayer concealed the risk associated with Essure. The agency’s warning indicates extreme risks and possibly serious injuries associated with the use of Essure and includes warnings that the device can migrate out of place, cause chronic pelvic pain, and related symptoms.
The plaintiffs’ actions are currently being brought as 11 separate suits in California, along with leading plaintiffs’ class action firm Grant & Eisenhofer, the law firms Janet, Jenner & Suggs, LLC and Motley Rice LLC also represent plaintiffs in the actions.
“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,” said Elizabeth Graham, who leads Grant & Eisenhofer’s complex pharmaceutical and medical device litigation practice, and who is litigating the case alongside G&E’s Thomas Ayala.