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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Takeda Pharmaceutical Co. , Never mind that, since Bausch the Supreme Court has entertained preemption issues under Rule 12(b)(6) on multiple occasions, including the Mensing ( 2011+1 ) prescription drug preemption decision. Luitpold Pharmaceuticals, Inc. Avoiding barnyard expletives – we shoveled Shikada here. Crockett v.

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Another RICOdiculous Decision

Drug & Device Law

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , 3d 1243 (9th Cir. 1 (highlights). 3d at 1247. 3d , 2023 WL 4191651 (C.D.

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50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Drug & Device Law

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion. Ethicon, Inc. ,

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We Said It Before; We’ll Say It Again – Drug/Device Companies Should Join PLAC

Drug & Device Law

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). Boehringer Ingelheim Pharmaceutical, Inc. Janssen Pharmaceuticals, Inc.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th Monsanto Co. ,

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The FDA and Feasible Alternative Designs

Drug & Device Law

223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design: [T]he [design] decision is surely not an easy one. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. In Bruesewitz v. Wyeth LLC , 562 U.S. McNeil-PPC, Inc.

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