Premarket Approval Preempts Claims Against Manufacturers Unless Plaintiffs Can Establish “parallel Claims” That Mirror Fda Regulation Violations.

FDA Attorney

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Banning Essure would remove the device from the market for all patients—and would limit the options available to physicians and patients.” Bayer said in a statement that it “stands behind Essure, which is an important option for women considering permanent contraception.” The South Florida lawyers started a litigation groundswell over Essure with a handful of cases they filed in Philadelphia federal court in December 2014. But their efforts illustrate the difficulties of using the court system to raise questions about a device that has already received premarket approval from the FDA. Premarket approval preempts claims against manufacturers unless plaintiffs can establish “parallel claims” that mirror FDA regulation violations. “It creates some additional hurdles that you have to get over before filing a lawsuit,” Susen said. “That’s why no attorney wanted to take this case on originally.” The Philadelphia court pared down the initial claims as the lawsuits pushed through a half-dozen motions to dismiss. The surviving claims include allegations that Bayer negligently failed to train doctors to properly insert the devices and that the company did not properly report more than 16,000 complaints about Essure to the FDA. Other Essure lawsuits around the country include a case consolidated in California state court  brought on behalf of more than 800 women. Motley Rice leads the plaintiffs executive committee there. Bayer said the litigation has not been going well for the plaintiffs.

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