This Week’s Life Science Headlines

        Litigation
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Court Reverses Preemption of Medical Injury Suit

A California Appellate Court recently ruled in Coleman v. Medtronic, Inc. that state law tort claims against medical device manufacturers are not preempted by federal law. Medtronic manufactures and sells a medical device called Infuse that is used in spinal surgery. The U.S. Food and Drug Administration granted premarket approval of Infuse for use in certain types of spinal surgery where the incision is made on a patient’s abdomen, but did not approve the device for spinal surgeries where the incision is made on a…
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This Week’s Science Headlines

        Litigation
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Indiana Appellate Court Holds Negligence Action Involving Medtronic Defibrillator Not Preempted by Federal Law

An Indiana appellate court decided that oral representations by a medical device manufacturer during a surgery about the function of device are not preempted by federal law.  Could this be a significant exception to the U.S. Supreme Court’s seminal decision in Riegel vs. Medtronic? In 1997, David Malander received an implanted Medtronic defibrillator and right ventricular lead (“Lead”), which remained in place until he began experiencing problems several years later.  The Lead was a Class III medical device subject to premarket approval by the…
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Does a Medical Device Manufacturer Have a State Law Duty to Advise the FDA of Post-Market Problems? The U.S. Supreme Court May Tell Us

This week, the U.S. Supreme Court has asked the Solicitor General to comment about whether a state law personal injury claim against a medical device manufacturer for a post-market failure to warn the FDA of a subsequently-discovered potential problem is preempted by federal law.  While any pre-market duty to warn claim for an FDA-approved medical device is pre-empted, there is an open question as to whether a state law claim can be pursued against a medical device manufacturer for failure to inform the FDA of…
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