Category Archives: News

Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…

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New Alternative Causation for Pharma Defendants in Surgeon General’s Smoking Report?

Last week, the Office of the Surgeon General of the U.S. Department of Health and Human Services released a new report on the health consequences of smoking on the 50th anniversary of the first Surgeon General’s report on smoking and health.  The report is available, click here. The 2014 report – entitled “The Health Consequences of Smoking—50 Years of Progress” – adds colorectal and liver cancer to the list of cancers causally linked to smoking. The report also adds several non-cancers to the list of…

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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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        Litigation

Regulatory

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PA Court Vacates $28 Million Verdict in Knee Replacement Case

A Pennsylvania Superior Court recently vacated a $27.6 million jury verdict against medical device manufacturer Zimmer Inc. (Zimmer), and marketing firm Public Communications, Inc. (PCI) in a case that involved Zimmer’s Gender Solutions Knee. The decision, which vacated the verdict on causation grounds, is available here. Zimmer’s Gender Solutions Knee is a knee replacement device specifically designed and manufactured for women. Zimmer hired PCI to produce a sales video featuring footage of patients who had received the Gender Solutions Knee. The plaintiff Margo Polett…

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This Week’s Life Science Headlines

        Litigation

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