Devices

Court Finds State Court Defibrillator Case Preempted

A New Jersey federal judge has dismissed a state product liability suit against Boston Scientific, Guidant, and two related medical device companies because the state law claims are preempted by federal law. Attorney Elizabeth Boggia (Weil Gotshal & Manges) writes in an online blog post that the plaintiff filed suit over alleged flaws in her late husband’s defibrillator. The suit said the device contained defective leads and was unfit for the purpose — treatment of heart failure — for which it was sold. The plaintiff also claimed the device caused her husband serious harm and led to his death.

Boggia says the court held that under the state product liability act, a manufacturer is liable for failure-to-warn only if the plaintiff can prove that the device was defective, that is, not safe for its intended purpose, absent the desired warning, and that the warning was not actually provided. It determined that in granting pre-market approval, FDA evaluated the device’s safety and effectiveness and determined that its labeling was not false or misleading. “To find that the device is unsafe and defective because of the omission of a warning from an FDA-approved label would therefore overturn FDA’s determination and impose a stricter state standard,” the judge wrote.

Boggia says the case “illustrates the important role the FDA pre-market approval process plays in the assertion of a preemption defense.”

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