Drug & Device Law

OCTOBER 10, 2022

3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. , In Ruan , the Supreme Court examined the case of two doctors who were convicted of violating the Controlled Substances Act (“CSA”), 21 U.S.C. § Not so, said the court. 124, 131 n.3

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Drug & Device Law

FEBRUARY 21, 2022

11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.”

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Drug & Device Law

JUNE 6, 2022

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” 2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal. Schering Corp. , 2d 1140, 1148 (N.J. 1993) (dissenting opinion).

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Drug & Device Law

JUNE 28, 2022

In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 1, 16-22 (2016) (collecting examples). Massachusetts was enjoined in Zogenix, Inc. Jones , 225 U.S.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. Our 2008 post discussed Ackermann v. There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries. 2d 1084 (Ariz.

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Drug & Device Law

DECEMBER 11, 2023

May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. Defendant] does not deny that it, the doctor, and the hospital are potential joint tortfeasors. . . . GlaxoSmithKline , 2008 WL 11515533, at *3 n.10 Zimmer, Inc.

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Drug & Device Law

AUGUST 29, 2023

Essentially, all the things doctors and medical device manufacturers do – collaborate on product development and education. The device is a Class III, Pre-Market Approved prescription medical device. The device is a Class III, Pre-Market Approved prescription medical device. 312 (2008). Medtronic, Inc. ,

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