An expert witness is not supposed to pick a desired result and then reverse engineer inputs and methods that reach that result.  As the Ninth Circuit observed 30 years ago, “[c]oming to a firm conclusion first and then doing research to support it is the antithesis of [the scientific] method.”  Claar v. Burlington Northern R.R ..read more

Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products. Michigan Repeals Pharma Immunity Provision By Jacqueline E. McDonnell Michigan recently signed into law a repeal of the immunity provision under its Product Liability Act, presenting a new litigation ..read more

Product liability claims require proof of causation.  To be sure, they also require proof of some defect in the product and/or its accompanying warnings and product literature.  But defect and causation are separate elements of a prima facie claim, and both must be established – usually, through expert testimony.  As we have discussed on multiple ..read more

On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment ..read more

The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million. The final rule differs significantly from EPA’s initial proposed rule. See initial proposal ..read more

Federal preemption can be a very powerful defense.  For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. (“MDA”).  In Regwan v. Abbott Laboratories, Case No. B319606, 2023 WL 8818748 (Cal. App. 2d Dec. 21, 2023), the California ..read more

The longer and more frequently a principle is repeated by the courts, the more difficult it can be for courts to acknowledge change.  As illustrated by the First Circuit’s opinion in Rodriguez v. Hospital San Cristobal, Inc., 91 F.4th 59 (1st Cir. 2024) – the first reported appellate decision to cite the language of the ..read more

Venue rulings in Pennsylvania affect many defendants in products cases.  Those incorporated here, and those sued on allegations that their products caused harm here, of course.  And, for now at least, it includes corporate defendants registered to do business in Pennsylvania.  They are subject to general jurisdiction, including for claims unrelated to the Commonwealth, under ..read more

Michigan recently signed into law a repeal of the immunity provision under its Product Liability Act, presenting a new litigation risk in Michigan for pharmaceutical companies. The provision had granted near-complete immunity to pharma for the past 30 years, as the only of its kind nationwide.  Michigan’s new law—Senate Bill 410 (SB 410)—removes this immunity ..read more

Just before Christmas, the Pennsylvania Supreme Court delivered a lump of coal to products liability defendants: Sullivan v. Werner Co., 2023 WL 8859656 (Pa. Dec. 22, 2023), affirming a lower court ruling that barred evidence of a product manufacturer’s compliance with government and industry standards in a strict liability design defect case. The lower courts ..read more