News & Analysis as of

Medical Devices Daubert Standards

Faegre Drinker Biddle & Reath LLP

California Supreme Court Walks Middle Ground on Warnings Causation but Reaffirms Learned Intermediary Doctrine in Himes

As we reported in April, the United States Court of Appeals for the Ninth Circuit certified a question on California’s Learned Intermediary Doctrine in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The...more

Foley & Lardner LLP

Acetaminophen MDL: Judge Excludes All of Plaintiffs’ Causation Experts Pursuant to Newly-Amended FRE Rule 702

Foley & Lardner LLP on

On December 1, 2023, amendments to Federal Rule of Evidence (FRE) 702 geared toward emphasizing and explaining the responsibility of the judge as a “gatekeeper” for expert testimony took effect. On December 18, 2023, one of...more

Faegre Drinker Biddle & Reath LLP

Eleventh Circuit Holds Expert Qualified in Surgical Tool Suit Despite Lack of Experience Using the Product

The Eleventh Circuit recently reinstated a case alleging a surgical tool caused internal burns during a hysterectomy surgery, holding that the district court erred in disqualifying an expert on the basis that he had never...more

Butler Snow LLP

The Case for Non-Retained Expert Witnesses

Butler Snow LLP on

It’s not easy getting a drug or device to market. From concept to launch, it takes years of work and the involvement of countless professionals from the engineering, medicine and regulatory disciplines. If the product becomes...more

Butler Snow LLP

Pro Te: Solutio – Vol. 11, No. 4

Butler Snow LLP on

Fall has descended upon us, along with that nip in the air and the aroma of pumpkin spice. All of these herald our latest edition of Pro Te: Solutio, which contains three fascinating articles on topics of current interest in...more

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