HIPAA Journal

JANUARY 23, 2024

The Theranos Scandal Theranos was a blood testing startup founded by Elizabeth Holmes in 2003. The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. The company was investigated by the Federal Bureau of Investigation and shut down.

Fraud 70

Fraud FDA Medicaid Medicaid 70

Drug & Device Law

DECEMBER 12, 2022

2003), and Doe v. 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. DeConstanzo , 2022 WL 17338047, at *4 (citing Laughter v. Aventis Pasteur, Inc. ,

FDA 115

FDA Public Health Fraud Hospitals 115

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