Category Archives: Preemption

District Court Judge Denies Manufacturer of OTC Pain Reliever Summary Judgment Based on Preemption

Judge Lawrence Stengel of the United States District Court for the Eastern District of Pennsylvania denied summary judgment to the manufacturer of an over-the-counter pain reliever. The manufacturer had sought to dismiss the plaintiff’s fraud and fraudulent misrepresentation claims as preempted by federal law. The Food and Drug Administration (FDA) regulates how OTC drugs should be labeled and sold. The Federal Trade Commission regulates whether an OTC drugs advertising is misleading. In the case before Judge Stengel, the OTC manufacturer argued that the fraud claims…

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Preemption Ruling: Federal Appeals Court Strikes Strict Liability and Warranty Claims As to “Off-Label” Use of Bone Graft Device

Last week, the U.S. Court of Appeals for the 10th Circuit in Denver, in a 2-1 decision, upheld a trial court ruling dismissing a complaint on the grounds that federal law preempted a plaintiff’s state law breach of warranty and design defect claims. The claims stem from complications following the alleged “off-label” manner of implantation of a spinal bone graft system. Click here for the opinion in Caplinger. Background As the majority explained, under the Food, Drug, and Cosmetics Act, and the Medical Device…

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U.S. Supreme Court Denies Certiorari in Generic Pharmaceutical Preemption Case

The United States Supreme Court today issued an order declining a generic pharmaceutical manufacturer’s petition for a writ of certiorari. The drug manufacturer had sought to challenge a ruling from the Iowa Supreme Court. In that state court ruling, the Iowa Supreme Court found that the U.S. Supreme Court’s preemption decision in Mensing did not necessarily prohibit failure to update claims. The U.S. Supreme Court’s decision in Mensing held that failure to warn claims brought against generic drug manufactures were preempted. The plaintiffs’ attorneys have…

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First Circuit Affirms Preemption of State-Law Claim for Consumer Fraud

labelIn a key preemption ruling late last month, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative class action. The First Circuit affirmed dismissal where the plaintiffs alleged consumer fraud, holding that state-law claims for false or misleading labeling are preempted by federal law. Read the full decision here. The First Circuit’s ruling built upon recent United States Supreme Court decisions holding that state-law claims aimed at generic drug labeling are preempted by applying this important defense to…

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…

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This Week’s Life Science Headlines

        Litigation

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Generic Defendants’ PA Preemption Battle Gets Potential Boost from NJ Judge

The issue of generic-drug preemption continues to be one of the key battlegrounds in pharmaceutical product liability litigation. Recently – as we discussed here – the FDA released a proposed rule that, if adopted, would eliminate the broad preemption of failure-to-warn claims against generic pharmaceutical manufacturers established two years ago by the U.S. Supreme Court in PLIVA v. Mensing. In the wake of Mensing, multiple courts across the country have taken up efforts by generic pharmaceutical defendants to dismiss failure-to-warn claims, as well…

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