Drugs

WLF Supports Dismissal of Lipitor Suit Against Pfizer

Washington Legal Foundation (WLF) says the 4^th Circuit Court of Appeals should uphold a South Carolina federal court ruling dismissing a multi-district suit against Pfizer over its Lipitor marketing, sales practices, and product liability. In an amicus brief, WLF says it “believes that the quality of decision-making in the federal courts largely depends on the willingness of federal judges to take seriously their responsibility as gatekeepers, to ensure that unreliable ‘scientific’ expert evidence is not presented to the finder of fact. When judges disregard that obligation by, for example, deciding that the reliability of an expert’s opinion goes to weight rather than admissibility, they undermine the civil justice system’s ability to produce a fair and just result.”

The brief says that in the Lipitor case, the judge found that the plaintiffs’ expert evidence was inconsistent with well-accepted scientific standards and therefore inadmissible. It says the court gave plaintiffs multiple opportunities to establish either general causation at doses of Lipitor less than 80 mg or specific causation at any dose, and then granted summary judgment to Pfizer.

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