Drugs

WLF Claims Win In Lexapro Case Dismissal

Washington Legal Foundation (WLF) says the 2nd Circuit Court of Appeals affirmed 7/28 a federal district court’s grant of summary judgment to Forest Pharmaceuticals in a case involving the company’s antidepressant Lexapro (escitalopram). A WLF statement says the decision was a victory for the legal advocacy organization that had filed an amicus brief urging that the lower court decision be upheld.

An earlier WLF press release says the plaintiffs were six women who alleged that using Lexapro while they were pregnant caused their minor children to develop autism spectrum disorder.

“Because plaintiffs adduced no admissible, reliable expert evidence to prove general causation,” WLF says, “the district court granted summary judgment for the manufacturer and dismissed plaintiffs’ claims.”

WLF says it used its brief to rebut plaintiffs’ suggestion that the methodological flaws in their experts’ testimony go to the weight that testimony should be given, rather than to its reliability. The brief also said that relaxing the reliability threshold for expert evidence of causation in pharmaceutical liability cases would significantly harm public health.

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