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
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. Women who believe their injuries were caused by Essure deserve their day in court, and we have vigorously argued on their behalf for the right to pursue personal injury claims against Bayer," said Motley Rice Essure lawyer Fidelma Fitzpatrick. "We continue to believe Bayer should not be allowed to hide behind preemption and should be made to answer to each and every woman injured by Essure through the legal system."
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.
"It was an honor to go before Judge Smith and fight for these women and their families," said Bograd. "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. 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."
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About Motley Rice LLC
Motley Rice is one of the nation's largest plaintiffs' litigation firms. With a tradition of representing those whose rights have been violated, Motley Rice attorneys gained recognition for their pioneering asbestos lawsuits, their work with the State Attorneys General in the landmark litigation against Big Tobacco, and their representation of 9/11 families in the ongoing lawsuit against terrorist financiers. The firm continues to handle complex litigation in numerous areas, including securities fraud; antitrust; consumer protection; mesothelioma; environmental contamination; prescription and over-the-counter drugs; other medical devices; human rights; aviation disasters; and wrongful death. Motley Rice is headquartered in Mt. Pleasant, S.C., and has additional offices in Connecticut; Louisiana; Washington, D.C.; New York; Missouri; Rhode Island; and West Virginia. For more information, contact Motley Rice attorneys Kimberly Barone Baden (CA, SC) Fidelma Fitzpatrick (DC, MA, NY, RI) or Carmen Scott (SC) at 1.800.768.4026 or visit www.motleyrice.com. Connect with us on Facebook, LinkedIn, and Twitter.
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SOURCE Motley Rice LLC