Drugs

Reject Novel Liability Theory for Rx Drugs: WLF

Washington Legal Foundation (WLF) says California’s First District Court of Appeals should overturn a trial court ruling that advances a “radical new theory of liability for manufacturers of non-defective prescription drugs.” A WLF statement says the case involves Gilead’s HIV/AIDS drug tenofovir disproxil fumarate (TDF).

Although the plaintiffs allege injury from TDF, WLF says, they allege no defect with the drug’s design, manufacture, marketing, or labeling. In denying Gilead’s motion for summary judgment, the post says, the trial court ruled that Gilead could be held liable in tort simply for not developing tenofovir Alafenamide (TAF), a completely different drug from TDF.

“To be clear,” WLF says, “the plaintiffs do not argue that Gilead should be liable for not implementing a reasonable alternative design of the same drug under well-settled California product liability law. Rather, they contend that Gilead should be liable in tort for not developing and selling an entirely different product.”

WLF says its amicus brief explains why eliminating the product defect element from product-based claims would open the door to untethered liability and undermine product innovation. “And because nothing in the trial court’s ruling limits this new tort theory to prescription drugs,” it adds, “the decision invites a torrent of abusive suits against the makers of other beneficial and non-defective products.”

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