News

December 23, 2022 In Brown v. GlaxoSmithKline, LLC and Providence Health System – Oregon, 323 Or. App. 214 (Ct. App. Or. 2022), the Oregon Court of Appeals recently found that a hospital could be a “seller” of pharmaceutical drugs under Oregon law, subjecting it to strict products liability for alleged drug defects.  This decision contravenes—and thus threatens to upset—the overwhelming...

October 10, 2022 On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The guidance clarifies the agency’s scope of oversight and regulation of clinical decision support software based on the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also describes the criteria used to assess...

May 5, 2022 Reaffirming its landmark decision in Parker v. Mobil Oil Corp., New York’s highest court last week overturned a $16.5 million jury verdict for the husband of a woman who had died from peritoneal mesothelioma allegedly caused by a decade of daily exposure to asbestos-contaminated talcum powder. The ruling is the latest in a series by the Court of Appeals requiring toxic tort...

January 16, 2020 Inspections While the number of enforcement actions implemented by the Food and Drug Administration (FDA) has decreased throughout the years – the quantitative data tells only part of the story. A review of this past year’s enforcement actions reveal that the agency remains committed to enforcing compliance with its regulations by utilizing a risk-based approach to...

January 29, 2020 The Office of Administrative Law has approved amendments to California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (aka “Proposition 65”) regulations regarding the responsibility to provide consumer product exposure warnings and the meaning of “actual knowledge” as used in the regulations.1 The amendments, which are set to go into effect on April 1, 2020,...

February 3, 2020 For the seventh time in the past ten years, the United States Supreme Court has agreed to address the contours of personal jurisdiction over out-of-state defendants. The question presented, in two consolidated product liability cases, is whether a lawsuit can be said to “arise out of or relate to” a defendant’s contacts with the forum state1 when none of those...

February 4, 2020 With the recent rise of federal Food & Drug Administration (FDA) warning letters to the manufacturers of various ingestible cannabidiol (CBD) products, we can expect an increase in false advertising claims against manufacturers, distributors and sellers of those products. Nonetheless, in an important case of first impression in this arena, a federal trial court in...

February 12, 2020 Form 483 Observations This article is the second installment of a four-part series which leverages available FDA enforcement data from 2016 to present, with an emphasis on the pharmaceutical and medical device industries, to provide companies with insight on how to best comply with FDA regulations and avoid common pitfalls in 2020. The first installment in this series...

February 19, 2020 As artificial intelligence (AI) decision-making begins to equal or surpass that of physicians, the potential for increased reliance on AI could also mean that liability traditionally assigned to physicians through malpractice suits shifts to AI companies. It is critical that companies developing this technology consider potential liability as they position the...

March 5, 2020 A series of Supreme Court decisions in the past decade has generally limited the exercise of general jurisdiction over a corporation to its place of incorporation and its principal place of business.1 The Supreme Court has, however, indicated that in an exceptional circumstance a corporation could be subject to general jurisdiction where it was not incorporated and did...