Category Archives: Recalls

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This Week’s Life Science Headlines

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This Week’s Life Science Headlines

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Last Week’s Important Life Science Headlines

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This Week’s Life Science Headlines

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This Week’s Life Science Headlines

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This Week’s Life Science Headlines

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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

Regulatory

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This Week’s Life Science Headlines

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