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

MARCH 31, 2022

1995) (“the deceptive practice must occur in the sale or offer for sale to consumers,” not “entirely during the marketing of the [product]”); Penn-Plax, Inc. 2001) (“irrespective of the theory of recovery. . . Thus, the two sides of the Baltimore opinion remind us of the classic “ The Strange Case of Doctor Jekyll and Mister Hyde.”

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Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.”

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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.” Best Pharmacal , 577 P.2d Robins Co. ,

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Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

FEBRUARY 11, 2024

Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. 9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22

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Drug & Device Law

JANUARY 12, 2024

At issue was whether a product manufacturer could be liable to patients taking one drug for failing to bring a different, but allegedly safer drug to market sooner than it actually did. Instead, the plaintiffs claimed that the defendant should have developed and marketed a different drug sooner. Gilead Life Sciences, Inc. at *31-*32.

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