Devices

Court Tosses Boston Scientific Whistleblower Case

A Minnesota federal court has granted summary judgment in a whistleblower case alleging that Boston Scientific fraudulently induced FDA to approve two types of defibrillators that were later recalled. Three Sidley Austin attorneys write in an online post (contains a link to the court decision) that the federal government had declined to pursue the whistleblower’s case.

The court held that all of the whistleblower’s theories of liability were based on demonstrating that the company fraudulently induced FDA to approve the defibrillators by providing evidence that Boston Scientific made false statements that were material either to the agency’s initial decision to approve the devices or to its continued approval of them.

However, the court found that FDA was aware of all or most of the misrepresentations when it approved the defibrillators and said such knowledge demonstrates that the misrepresentations were not material to the agency decision.

“The case underscores the important role government knowledge continues to play in judicial assessments of materiality,” the attorneys write.

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