Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. We saw more of the same with the discussion of consumer fraud claims in CPAP II. American Home Products , 2005 WL 2277518, at *11 (S.D. 341 (2001).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

APRIL 21, 2022

The plaintiff asserted all the usual claims and then one: manufacturing defect; failure to warn; breach of warranty; and fraud. Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. For example, the court took judicial notice of an FDA recall notice. McMullen v.

FDA 59

FDA Fraud 59

Drug & Device Law

FEBRUARY 2, 2023

Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72