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. As readers of this blog are aware, case law is divided over whether alleged CGMP violations can ever support a non-preempted claim (with the more persuasive cases holding that they cannot). McMullen v.

FDA 59

FDA Fraud 59

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. 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. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72