Federal Law Preempts State Law Product Liability Claims Involving “Hybrid” Medical Devices

On an issue of first impression in the federal Circuit Courts of Appeals, the Third Circuit held that federal law preempts state law claims involving hybrid medical devices where any part of the device requires FDA pre-approval of the device’s safety and effectiveness. The 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act brought medical devices under the regulatory authority of the Food and Drug Administration. The Amendments established a system whereby certain types of devices, termed Class 3 devices, require approval by…
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Third Circuit Adopts Heightened Materiality Standard under False Claims Act

On May 1, 2017, the Third Circuit issued a decision in United States ex rel. Petratos v. Genentech Inc., 855 F.3d 481 (3d Cir. 2017) narrowing the ability of qui tam relators to show materiality under the False Claims Act (FCA). In essence, the court held that to be material, a misrepresentation or omission by a drug company must relate to the United States’ decision to pay a claim, not a doctor’s decision to prescribe a drug that would lead to a reimbursement claim…
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Third Circuit Affirms Summary Judgment for Pfizer in Zoloft MDL

A Third Circuit Court of Appeals panel recently upheld a lower court’s decision to dismiss plaintiffs’ claims at summary judgment in a multi-district litigation involving Zoloft, an anti-depressant manufactured by Pfizer. The MDL involved 315 plaintiffs alleging that Zoloft causes cardiac birth defects when taken during early pregnancy. The decision, which upheld an earlier ruling by the U.S. District Court for the Eastern District of Pennsylvania, has both good and bad aspects for defendants facing pharmaceutical product liability claims. The plaintiffs introduced several expert witnesses…
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