Devices

Court Addresses Device Preemption ‘Catch 22’: Attorney

Attorney James Beck (Reed Smith) says a North Carolina federal court has addressed a Catch 22 that existed in the preemption of state tort claims against PMA medical devices. Writing in an online blog post, Beck says that to survive preemption, plaintiffs suing the manufacturers of PMA medical devices have to allege parallel claims in which all common law claims must be genuinely equivalent to violations of FDA regulations. But, in earlier cases not involving medical devices, courts have held that the more “federal” looking the cause of action, the more likely it is to support federal question jurisdiction.

According to Beck, Burrell v. Bayer Corp. involved the company’s Essure contraceptive device. The plaintiff filed a complaint consisting of almost entirely parallel violation claims, he writes. Bayer removed the claim to federal court despite the presence of non-diverse prescribing physicians.

Beck says the court relied on a three-part test to determine whether there was a federal question:

the action involves a federal question that was necessarily raised as well as actually disputed;
the question must be substantial; and
the federal question must be capable of review “without disrupting the federal-state balance.”

“The existence of extensive federal preemption, in and of itself, is a strong indication that Congress preferred federal to state court jurisdiction in this aspect of the Federal Food, Drug, and Cosmetic Act,” Beck concludes. “That plaintiff pleaded claims brimming with FDA standards and allegations of violations of federal law further demonstrated the propriety of federal jurisdiction. Federal-state balance is not a code word for shrinking federal court dockets, but rather entails balancing the federal and state aspects of the plaintiff’s allegations.”

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