Drug & Device Law

DECEMBER 21, 2023

Allegedly, consumers deprived of efficacy (not risk) information had their informed consent rights infringed, which in the case of persons without the genetic difference, meant that they were spared the expense of undergoing negative genetic testing. Remember Riegel ( 2008+1 )? He heckled Holley here.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

JUNE 6, 2022

2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal. 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . 2008 WL 544739, at *11-12 (N.D. 2008 WL 4691626, at *7 (E.D. 2008 WL 483574, at *6 (E.D.

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MAY 30, 2022

This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. He “did not consider the additional information contained in the [updated] label to significantly add to his corpus of knowledge” so “failure to include this information in the previous. . . Our 2008 post discussed Ackermann v.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

JUNE 24, 2022

Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility. 312 (2008). Vesoulis rejected the plaintiff’s contention that the written consent form he signed did not include a statistical presentation of the risk at issue. Medtronic, Inc. ,

Informed Consent 52

Informed Consent 52