Devices

Appeals Court Backs Lanx in Spinal Device Case Dismissal

The 5^th Circuit Court of Appeals has upheld a Mississippi federal court’s grant of summary judgment to Lanx Inc. in a state law suit involving its Telluride system. A patient in whom the system was implanted to fuse spinal vertebrae filed the suit after screws in the system fractured and broke. The appeal covered two claims that were dismissed — manufacturing defect and fraudulent concealment. It also covered denial of the plaintiff’s motion to compel production of all FDA pre-approval submissions for not only the Telluride pedicle-screw based system but also the company’s Aspen system.

A three-judge panel held that the lower court did not abuse its discretion in refusing to draw an adverse inference against the company because neither the hospital nor the plaintiff retained the broken screws when they were removed in a surgery that replaced the first implant. The judges also found that the fraudulent concealment claim was impliedly preempted under the Supreme Court’s Buckman ruling. And it said that the trial court did not abuse its discretion in denying the motion to compel production of FDA documents, given the dismissal of other claims.

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