Drugs

WLF Brief: Brand Drug Makers Not Liable for Generic Harm

A Washington Legal Foundation brief has urged U.S. Court of Appeals for the Seventh Circuit to reject a “novel theory of liability” that would hold pharmaceutical manufacturers liable for injuries caused by drugs they did not manufacture. In Dolin v. GlaxoSmithKline, Wendy Dolin alleges that her husband’s 2010 suicide was caused by generic Paxil (paroxetine), indicated for treating depression and anxiety. Because federal law requires paroxetine’s generic label to be identical to that of Paxil, Dolin asked the court to hold Glaxo liable for injuries caused by its competitor’s drug.

In its brief, WLF argues that the plaintiff’s theory of liability “marks a sharp and unwarranted break from longstanding principles of tort law by conflating the ‘foreseeability’ of an injury with the existence of a legal duty in the first place. WLF also dismissed the plaintiffs’ suggestion that federal preemption of certain state-law tort claims against generic drug manufacturers somehow justifies shifting the liability burden to the innovator or brand manufacturer. “Because pre-empting state tort liability for generic manufacturers is necessary to accomplish the policy objectives Congress wrote into federal law, WLF contends that state courts are in no position to second guess Congress’s carefully calibrated regulatory regime for generic and branded drugs,” the group said. “Instead, WLF urges the court to reject the plaintiffs’ call to alter the delicate policy balance that Congress has watchfully maintained for many decades.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome