OAKLAND, Calif., Aug. 5, 2016 /PRNewswire/ -- A California state court has given a green light to a series of product liability lawsuits brought against Bayer Corporation and several of its subsidiaries by 14 women who alleged that they sustained injuries from Bayer's permanent birth control device Essure.
The plaintiffs' actions are currently being brought as 11 separate suits in California; along with Grant & Eisenhofer, law firms Janet, Jenner & Suggs, LLC and Motley Rice LLC also represent plaintiffs in the actions.
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.
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 that 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 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.
"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 Mr. Ayala.
According to Kim Dougherty, a partner at Janet, Jenner & Suggs, "Essure's designers and manufacturers did not plan for failure, and there's no established method for removing this device when problems arise. The FDA recognized Essure's potential high risks when earlier this year it issued the black box warning — the strongest warning a medical device can have. We are satisfied that following these rulings women injured by this product can rightly move ahead with their claims. We look forward to litigating further on their behalf and holding the defendants accountable for the serious harm that they've inflicted on so many women."
About Grant & Eisenhofer
Grant & Eisenhofer is one of the top litigation and arbitration firms in the United States. The Firm represents institutional investors from across the globe in U.S. and international securities class actions, derivative lawsuits, antitrust suits, bankruptcy litigation and other complex financial litigation matters. The Firm has more than 60 attorneys, with offices in Wilmington, New York and Chicago, and an international docket of high-profile cases. G&E has recovered more than $28 billion in the last 10 years and has twice been cited by RiskMetrics for securing the highest average investor recovery in securities class actions. G&E has been named one of the country's top plaintiffs' law firms by The National Law Journal for the past 13 years, and was named one of the nation's "Most Feared Plaintiffs Firms" by Law360 every year since the inception of the list. For more information please visit http://www.gelaw.com/
SOURCE Grant & Eisenhofer, P.A.