Biologics

‘High Bar’ for Vaccine Liability Claims

Three Morrison Foerster attorneys say a recent Connecticut federal court decision involving Merck’s Gardasil “makes clear there is a high bar for successfully pleading vaccine products liability cases.” The attorneys write that the decision is one of the first major vaccine preemption decisions since FDA authorized Covid-19 vaccines.

The post says the plaintiff in the Gardasil case was a 15-year-old girl who had parental consent to receive the first two doses of the vaccine and experienced side effects. After an unfavorable outcome in the “vaccine court,” the plaintiff filed suit in federal court alleging state law failure to warn, manufacturing defect, negligence, and common law fraud claims.

“The crux of the plaintiff’s complaint was her failure to warn claim,” the attorneys say. “She alleged that her mother believed the vaccine was safe based on Gardasil television advertisements and other marketing material.”

The court granted Merck’s motion to dismiss, concluding that all claims were either preempted or inadequately pled.

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