Devices

Claims Surviving Preemption Have Hard Going: Attorney

Attorney Michelle Yeary says that medical device suits that survive preemption challenges often have difficulty proceeding due to stringent requirements placed on them. Writing online in a Drug and Device Law Blog post, Yeary cites Swisher v. Stryker Corp in which a plaintiff claiming injury from a hip implant asserted a parallel claim based on alleged violations of PMA specifications and applicable good manufacturing practices.

The suit originally was dismissed for not meeting pleading standards, Yeary writes. Then the plaintiff amended the complaint with sufficient facts to maintain a parallel claim and the case proceeded. However, she says, a company challenge to a plaintiff expert witness resulted in an Oklahoma federal court determining that the engineering expert could testify about the heat treatment used in the manufacturing process and the effect of that heat treatment on the metal used in the device. But the court would not allow the expert to express an opinion on the FDA regulatory scheme and whether the device did or did not comply with manufacturing standards.

“So plaintiffs are going to need more and varied experts if they are going to maintain their parallel violation claims,” Yeary writes. “This means the cases are more difficult and more expensive for plaintiffs.”

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