Drug & Device Law

JULY 24, 2023

341 (2001). The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. Plaintiffs Legal Committee , 531 U.S. You can see where this is going.

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Drug & Device Law

AUGUST 26, 2022

On appeal, the plaintiff was allowed to carve out a previously unrecognized claim for what is generously called “negligent design” but is more accurately called “negligent failure to withdraw a legally marketed prescription medical product.” (We will skip the massive preemption issues with such a claim, but feel free to peruse some posts.)

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Drug & Device Law

FEBRUARY 11, 2024

AHM I thus relied on these retracted articles both to support its standing analysis and substantively to justify its injunction that would have removed mifepristone from the market. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. See Alliance for Hippocratic Medicine v. Buckman Co.

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Drug & Device Law

MAY 30, 2022

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.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” Weisgram v. Marley Co. , 440, 455-56 (2000). Fru-Con Inc. , 3d 734 (7th Cir.

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