Drugs

High Court Rules that Judges, Not Juries, Determine Preemption

The U.S. Supreme Court has unanimously ruled that FDA preemption questions are for a judge to decide, not a jury. In a 5/20 opinion in a Merck product liability lawsuit involving osteoporosis drug Fosamax, the high court reiterated that “clear evidence that the FDA would not have approved a change to the drug’s label preempts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.”

The opinion is in line with a U.S. Solicitor General amicus brief that said the 3rd Circuit Court of Appeals erred in holding that a jury must determine whether an FDA 5/2009 decision declining to approve a Merck proposal to revise Fosamax’ Warnings and Precautions labeling sections to warn against low-energy fractures of the subtrochanteric and proximal femoral shaft preempted later failure-to-warn claims arising from the same type of injury.

The Solicitor General brief asserted that when FDA declines to approve a drug labeling change, the interpretation of that administrative decision and its significance for a failure-to-warn claim are legal questions for a court to resolve and not factual questions for a jury. “Moreover,” the Solicitor General said, “because FDA’s decision here prevented petitioner from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting petitioner’s impossibility-preemption defense.”

The Supreme Court opinion said the 3rd Circuit Court of Appeals treated the pre-emption question as one of fact, and not law. It remanded the case to the appeals court for further proceedings consistent with the opinion.

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