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Drug and Device Law Blog Blog

Articles: 1-10 of 10

When PMA Preemption Stops at the Operating Room Door

USA - March 26 2026 Manufacturers of Class III medical devices have long relied on federal preemption under the Medical Device Amendments (“MDA”) as a powerful…

Weight Loss Wonders, Legal Woes: The Price of GLP-1 Popularity

USA - January 28 2026 Explores GLP-1 drugs’ surging use, alleged risks and defenses in emerging product-liability suits centralized in MDL-3094, and compounding…

AI-Enabled Medical Devices Here To Stay?

USA - October 20 2025 This summer, FDA published a list of AI-Enabled Medical Devices as a resource to quickly identify AI-enabled medical devices authorized for…

All Claims Means ALL: The PREP Act Provides Immunity in COVID-19 Vaccination Case

USA - June 15 2023 The Kansas Court of Appeals recently issued a decision in M.T. V. Walmart Stores, Inc., addressing the applicability of the PREP Act…

Jackson County, Missouri Jury Rejects 3M Surgical Blanket Infection Claims

USA - November 4 2022 Katherine O'Haver v. Anesthesia Associates of Kansas City PC et al., Case No. 1816-CV30710. Plaintiff claimed that 3M Co.’s Bair Hugger Forced Air…

Can't satisfy both the FDA and the State? The judge will be the judge of that.

USA - June 20 2019 In May 2019, in a move rejecting the reasoning of the Third Circuit, the U.S. Supreme Court dove into two critical aspects of preemption analysis in…

FDA Announces Strengthened Focus On Cybersecurity

USA - October 11 2018 In a statement issued from FDA Commissioner Scott Gottlieb, M.D., the FDA made clear the threat of cybersecurity attacks are no longer…

Breaking Up [Plaintiffs] Is [Not] Hard To Do

USA - March 28 2018 While Neil Sedaka may have convinced many that breaking up is hard to do, Judge Stephen N. Limbaugh, Jr. of the United States District Court for the…

Missouri Supreme Court May Be Signaling a Change in Analysis of Misjoinder of Claims in Multi-Plaintiff Product Liability Cases

USA - October 19 2017 On October 13, 2017, the Missouri Supreme Court issued a preliminary writ of prohibition directed to Circuit Judge Rex Burlison of the Circuit Court…

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 2 of 3)

USA - January 11 2017 Continuing from our prior post in this three-part series on effectively addressing cybersecurity breaches in…