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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. In Bruesewitz v. Wyeth LLC , 562 U.S. As a result, appellee was prohibited by federal law from employing either of these [alternatives]. Wyeth Laboratories, Inc. ,

FDA 59
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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The law presumes that licensed doctors know what they are doing. 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.”