Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. 2012 WL 3265002, at *5 (N.D. has no power to enforce compliance”), aff’d , 405 F.

Doctors 52

Doctors Fraud Licensing Compliance 52

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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 2d 279, 287 (Mich.

FDA 52

FDA Compliance Fraud Hospitals 52

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

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. 2012), abrogated on other grounds by McCarrell v. 2012), and Garcia v. Boston Scientific Corp. 2022 WL 1261318 (3d Cir.

Compliance 52

Compliance FDA Fraud 52