Drugs

Court Action on 3 Claims Explained

A Foley Hoag online product liability update explains a Massachusetts federal court’s actions in a case in which a plaintiff sued the manufacturer and distributor of a drug used to treat Cushing’s disease, alleging that it caused ovarian cysts and uterine bleeding that required surgical dilation and curettage and made it unlikely she could carry a pregnancy to term. The suit first brought failure-to-warn claims based on Corcept Therapeutics’ product labeling and its reporting of adverse event data to FDA, the report says.

The court ruled the failure-to-warn claims were preempted by federal law and said the adverse events concerning dilation and curettage and hysterectomies were not “newly acquired information” that would have allowed Corcept to unilaterally change the labeling.

The court declined to rule on whether claims for failure to report adverse events to FDA were preempted, pending a Massachusetts Supreme Judicial Court ruling on whether state law recognizes such claims independent of the Federal Food, Drug, and Cosmetic Act.

Finally, the attorneys write, the court disagreed with the company’s position that the plaintiff’s claims for failure to monitor her for adverse events were preempted as “poorly-disguised” failure-to-warn claims. The court said the claims were predicated on different facts, including that the company assigned a patient care advocate and the advocate’s inaction when the plaintiff stopped menstruating.

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