Drugs

Drug Design Defect Cases Still Not Settled

A Mississippi federal court decision in a prescription drug preemption case has muddied the waters for the legal status of design defect as a claim under state law, according to a blog post by attorney Eric Alexander (Reed Smith). He writes that the judge dismissed without prejudice the design defect and eight of the nine other claims offered by the plaintiff. The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication at about the time that FDA issued a public health advisory about the risk of ketoacidosis in SGLT-2 inhibitors. The post says that several months later the drug’s labeling was revised to include warnings about ketoacidosis and urosepsis.

Alexander writes that confusion arises from the court’s decision to address preemption before determining whether state law imposes the duties that might create the conflict leading to preemption. He quotes the judge as writing, “If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim, but not under the doctrine of conflict preemption.”

The plaintiff disputed that there can be a conflict between state and federal law when it comes to a drug’s design. However, the court held that a post-approval change in design would be preempted, regardless of what it entailed.

Alexander says there was no reason for the court’s abstract analysis because the plaintiff’s asserted design defect claim was not sufficient under Mississippi law. The court allowed only the plaintiff’s express warranty claim, but also gave her a chance to re-plead all of her claims, including design defect.

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