In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about additive manufacturing (AM)—the broad field of 3D printing—of medical devices. Specifically, AM makes objects by …›
In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other manufacturers. The U.S. Food and Drug Administration also recognizes the growing …›
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 …›
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. …›
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 …›
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. …›
Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th Cir. Feb. 21, 2017). This defense decision is another step …›
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 …›
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.[1] …›
Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety.[1] The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to dismiss after Defendant Ferring Pharmaceuticals removed the suit to federal court based …›