Topic Archives: Drug & Medical Device

Ninth Circuit Affirms No Private Right of Action to Enforce Lack of Substantiation Claims in SeroVital False Advertising Class Action Case

The Ninth Circuit recently affirmed a district court’s dismissal of plaintiff’s unfair competition law and consumer legal remedies claims, finding that neither claim provided plaintiff with a private cause of action to enforce the substantiation provisions of California’s unfair competition and consumer protection law.  See Kwan v. SanMedica International, No. 15-15496. Background of the Case.  ...›

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule.  The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of their abbreviated new drug application (ANDA) labels, allowing them to make ...›

Medical
February 17, 2017Drug & Medical Device, Product Liability

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions from strict liability afforded to manufacturers of certain “unavoidably unsafe” products. This decision comes as a surprise and represents an unexpected shift in the law with regard to medical device manufacturers. ...›

Branded Generic

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD) was withdrawn for reasons other than safety or effectiveness, providing insight on the responsibilities of ANDA holders to update their drug labels and the processes for doing so. ...›

Pharma

Federal Preemption Claims:
Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption. ...›