Drugs

Judge Allows 3 Liability Claims Against Invokana

A Louisiana federal court says that three state liability claims against Janssen over its diabetes drug Invokana may proceed toward trial. The judge ruled in a case brought by a woman who claims the drug caused her kidneys to fail. Her initial suit was dismissed for lack of specificity, but she was given the opportunity to amend her complaint and the court ruled on the amended complaint.

The suit claims that Invokana overworks a patient’s kidneys because the drug eliminates excess blood sugar through urination rather than through reabsorption. It cited five alleged defects: composition or construction, design, failing to provide adequate warning, breach of express warranty, and because it is either useless or so inconvenient that a knowing buyer would not have purchased it. Janssen responded that the suit still did not contain sufficient facts or, alternatively, was preempted by federal law. (Mitsubishi Tanabe Pharma defendants won dismissal of claims against them for lack of jurisdiction because there was no connection alleged between the company that co-developed Invokana with Janssen and Louisiana.)

The court dismissed the composition or construction claim and the breach of express warranty claim, but said that on the remaining three claims, the plaintiff had presented sufficient facts to warrant allowing them to go forward. The court also determined that these claims were not preempted by federal law.

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