Topic Archives: Drug & Medical Device

Pharma

Bristol-Myers Squibb: The Aftermath

Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants have wasted little time in moving to dispose of claims from nonresident plaintiffs under this ruling. As previously reported, on June 19, 2017, the ...›

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a citizen’s petition calling for the same warnings.  Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). ...›

Supreme Court Says “No” to “Litigation Tourism”

There has been a lot said already about the effect on product liability (especially drug) cases and “mass actions” as a result of the United States Supreme Court’s June 17, 2017 decision in Bristol-Myers Squibb Co. v. Superior Court of California, No. 16-466.  But what about consumer class actions?  California is a destination venue not ...›

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. ...›