Category Archives: News

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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New Liver Disease Medical Device May Help Cut Number of Transplants

Royal Free Hospital in London is conducting a trial of a new medical device to treat liver disease on a group of patients with severe alcohol-related liver failure.  Results have already shown that that patients’ liver damage can be reversed, which can dramatically improve a patient’s quality of life.  The new device, called an alfapump, is manufactured by the Swiss medical device company Sequana Medical and may radically change the treatment options for patients with severe liver disease in the future. Liver disease impacts the…

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