Devices

Summary Judgment in Class 3 Device Case

An Alabama federal court has granted summary judgment to Sanofi-Aventis on both medical causation and preemption grounds in a case involving a Class 3 medical device that is a gel-like substance injected into a knee to reduce pain. Attorney Michelle Yeary (Dechert) writes in an online post that it was undisputed that the plaintiff’s injection came from a product lot that was later found to be contaminated with bacteria.

Yeary writes that the plaintiff’s claims fell under Alabama law for lack of medical causation because the plaintiff’s medical expert failed to make the case that the patient suffered from septic arthritis and that the contaminant causes septic arthritis generally and this particular patient’s condition specifically.

While that was sufficient to grant summary judgment, Yeary says, the court went further and indicated that even if the plaintiff’s state court claims were viable, they are preempted because they impose requirements in addition to or different from those required by FDA under federal law. The court said the plaintiff failed to connect the company’s conduct to any specific binding regulation, instead citing guidances and regulations applicable to drugs rather than medical devices.

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