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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. Geri-Care Pharmaceuticals Corp. , 3d , 2023 WL 4191651 (C.D.

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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 4th 1263 (9th Cir.

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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. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” 1981) (applying Virginia law), both of which involved vaccines.

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The FDA and Feasible Alternative Designs

Drug & Device Law

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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