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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HHS Proposes to Undo the Supreme Court Rulings in Pliva and Bartlett by Regulation Changes

In 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which affected “75 percent of all prescription drugs dispensed in this country.”  The court held that because the FDA requires generic drug manufacturers to use the same labels and warnings as those of the name-brand manufacturer, state law claims against generic companies regarding labeling and warnings are pre-empted. Put another way, because generic drug manufacturers cannot change their labels or warnings, even if they later learn of additional risks associated…
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Supreme Court Holds that State Law Tort Claims Regarding Labeling of Generic Drugs are Preempted

In Mutual Pharmaceutical Co. v. Barlett, plaintiff Karen Bartlett alleged that she took Mutual’s generical non-steroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.  She suffered a rare hypersensitivity reaction three weeks after she started taking and she was left severely disfigured with burn-like lesions over two-thirds of her body.  The plaintiff’s action was based upon a design defect theory after her failure-to-warn claims were dismissed prior to trial and the district court rejected the defendant’s preemption defense. A…
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