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Whistleblowers › Manufacturers › Food and Drug Administration (FDA)

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Skadden, Arps, Slate, Meagher & Flom LLP

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Skadden, Arps, Slate, Meagher & Flom LLP on

Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more

Kohn, Kohn & Colapinto LLP

Manufacturer of Defective Heart Devices Settles False Claims Act Case for $27 Million

Kohn, Kohn & Colapinto LLP on

St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more

Mintz - Health Care Viewpoints

FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?

Mintz - Health Care Viewpoints on

In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more

Husch Blackwell LLP

Updated: Top Employer COVID Vaccine Questions And Answers

Husch Blackwell LLP on

Announcements by both Pfizer and Moderna that their trial COVID-19 vaccines appear to be over 90% effective have led to a surge of interest by everyone, employers included, about exactly when and how a vaccine will save us...more

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