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. 2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. Schering Corp. ,

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Drug & Device Law

NOVEMBER 7, 2022

The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Back in 2009, the defendant’s “production stalled due to various problems at its manufacturing facility.” Nowhere does the package insert state that a lower dosage is FDA-approved. 2022 WL 4237528, at *2.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” at *3 (emphasis original).

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