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

Drug & Device Law

Takeda Pharmaceutical Co. , The decision simply ignored the minuscule increased risk, and didn’t compare it to the risks of any alternative treatment – or to the risks of leaving the disease, diabetes, untreated. Luitpold Pharmaceuticals, Inc. Avoiding barnyard expletives – we shoveled Shikada here. 3d , 2023 WL 4191651 (C.D.

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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. PATDC82 I , 943 F.3d 3d at 1251.

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

Drug & Device Law

at 526 (citation omitted). “[R]esearch and innovation in medical equipment and treatment would be inhibited.” Janssen Pharmaceuticals, Inc. , 2019), analogously held that the standard for admission of expert testimony was “procedural” and therefore Pennsylvania’s Frye rule applied, not Texas’ stricter expert admissibility standard.

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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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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 4th 1263 (9th Cir.

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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.

FDA 59
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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. Bayer HealthCare Pharmaceuticals, Inc. ,