Drugs

Appeals Court Backs Lipitor Case Dismissal

The 4^th Circuit Court of Appeals has upheld a lower federal court ruling granting summary judgment to Pfizer in multi-district litigation claiming that the company’s Lipitor led to patients developing diabetes. Washington Legal Foundation (WLF), which filed an amicus brief urging vindication of the district court’s application of the Daubert standard for ensuring reliable evidence, hailed the decision as a victory.

WLF says the district judge found that the plaintiffs’ experts failed to demonstrate any association between Lipitor and diabetes, and thus excluded the expert testimony under Daubert and Federal Rule of Evidence 702. Although all seven plaintiff experts were excluded, their appeal to the 4^th Circuit only covered three.

The WLF brief had argued that the district court acted well within its discretion in excluding the “plaintiffs’ scientifically flimsy expert opinions and that, without such expert testimony, the plaintiffs could not establish causation.”

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