Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

NOVEMBER 28, 2022

2010) (Matsen); Nelson v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. , 316, 328-29 (D. 2013) (Painter); McClellan v. I-Flow Corp. , 2d 1092, 1119-25 (D. Tennessee Gas Pipeline Co.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Smith, LLC , 2010 WL 11566367, at *7 (N.D. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . Accord Dietz v.

FDA 59

FDA Doctors Malpractice Informed Consent 59