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

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

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

MAY 30, 2022

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. at *3 (emphasis original). 2d 806, 817 (5th Cir.

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Drug & Device Law

AUGUST 24, 2023

Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention , a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams. at *3 (internal quotation marks and citations omitted).

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