Devices

California Court Upholds Preemption for Medtronic

A California state court has upheld PMA preemption in a case involving a Medtronic spinal cord stimulator. Attorney Michelle Yeary (Dechert) writes in the Drug and Device Law blog that the plaintiff in the case brought claims for strict liability, failure to warn, negligence, and negligent misrepresentation.

Yeary says Medtronic demonstrated that the warning it provided with the device was the one approved by FDA and any different warning would impose additional requirements and thus was preempted.

Medtronic countered the failure to report claim by describing the firm’s compliance with its reporting obligations. The negligent misrepresentation claims also were dismissed.

Yeary writes that the company moved to dismiss the negligence claim on causation grounds, but the court decided the experts could debate it at trial. She points out that the negligence claim is based on the conduct of a company representative, demonstrating the perils, she says, of letting sales representatives have direct contact with patients.

While the negligence claim survived summary judgment, the court held that the company representative’s conduct failed to support damages as a matter of law. “Overall,” Yeary concludes, “the meat of plaintiff’s claims has been stripped away.”

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