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. 2006), aff’d , 526 F.3d We saw more of the same with the discussion of consumer fraud claims in CPAP II. Plaintiffs Legal Committee , 531 U.S. 341 (2001).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

DECEMBER 12, 2022

Nothing in DeCostanzo suggests that the defendant’s vaccine lacked whatever warnings the FDA had approved, and the likelihood that the FDA would give these antivaxxers the time of day on any violation claim is minimal. 2006 WL 2038436, at *8 (N.D.N.Y. Olin Corp. , 3d 148, 154 (2d Cir. 1997) (“a manufacturing defect. . .

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

FEBRUARY 2, 2023

2006) (reversal concerned warning issues); Blackmon v. 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. Hoffman-La Roche, Inc. 15, 2007); McNeil v.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Auto Owners Ins.

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

MAY 26, 2022

9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake. Under Fed.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 2006), aff’d by equally divided court , 552 U.S. 3d 281 (6th Cir.

FDA 64

FDA Fraud Compliance 64

Drug & Device Law

MARCH 22, 2022

Her current lawsuit brought claims under the Connecticut Product Liability Act (CPLA) and for common law fraud. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval.

Fraud 59

Fraud FDA Doctors 59