Drugs

Mixed State Court Decision in Tenofovir Case

A California state appeals court has issued a split ruling in a case involving Gilead Life Sciences and 24,000 plaintiffs in a coordinated proceeding who say they suffered adverse effects from their use of the company’s tenofovir disoproxil fumarate (TDF) to treat HIV/AIDS. The decision says the plaintiffs argued that when Gilead was developing TDF it found that tenofovir alafenamide fumarate (TAF) could be as effective as TDF and with a lower risk of side effects.

The plaintiffs did not claim that TDF was defective and thus caused their injuries, but instead said that Gilead breached its duty of reasonable care to TDF users when it allegedly deferred the development of TAF to preserve its financial return from TDF.

Before the San Francisco Superior Court, Gilead had filed a motion for summary judgment or adjudication. It claimed that there could not be a finding of negligence without arguing that TDF was defective. It further said it had no duty to disclose facts relating to TAF before it received FDA approval. The court denied Gilead’s motion in its entirely and Gilead appealed.

The appeals court affirmed the trial court’s denial of Gilead’s motion insofar as it sought summary adjudication of the negligence claim. The court said there are circumstances in which a manufacturer’s duty to exercise reasonable care can go beyond not marketing a defective product. It discusses two possible exceptions, one of which it said is unwarranted and the other is unsupported on the record but possibly could be established in a more developed record. It reversed the trial court’s decision that denied Gilead’s motion for summary adjudication of the plaintiffs’ claim for fraudulent concealment of information about TAF, saying that the company’s duty to plaintiffs did not extend to the disclosure of information about TAF.

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