Drugs

Latest Implied Preemption Case Reviewed

Three Winston & Strawn attorneys say the Supreme Court declined to hear an appeal of a 1st Circuit Court of Appeals decision upholding implied preemption of a putative class action suit against McNeil Nutritionals over its Lactaid dietary supplement. The attorneys write in an online post that the suit claimed the company violated FDA labeling requirements by marketing Lactaid as a dietary supplement rather than as a drug, even though it was marketed as a treatment for lactose intolerance. The suit also said the labeling violated state law claims related to unfair or deceptive trade practices, false advertising, and unjust enrichment, and was misleading to consumers.

A federal district court had dismissed the complaint because no reasonable consumer could find Lactaid’s product labels deceptive, the attorneys write. The 1st Circuit Appeals Court upheld the dismissal, but said the reason was that the claims were impliedly preempted by FDA’s enforcement authority.

“The Supreme Court’s decision to deny certiorari [hearing the appeal] affirms that conflict preemption with the Federal Food, Drug, and Cosmetic Act (FFDCA) may bar some state law product liability claims,” the lawyers conclude. “In terms of whether a conflict exists between the claim and the FFDCA, the underlying allegations will be dispositive. Thus, defendants facing state law claims such as failure to warn, deceptive practice, or misrepresentation should conduct a conflict analysis to determine whether the alleged conduct is tortious solely because it violates the FFDCA. If so, preemption could be a tool to dismiss these 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