Medical Legal

Last week’s CBI Medical Device and Diagnostic Compliance Congress featured an “enforcement panel” that discussed recent trends in…

Minnesota-based medtech company, Medtronic Inc., has agreed to pay $2.8 million to resolve allegations that the company…

Senator Elizabeth Warren (D-Mass) plans to introduce legislation that she believes will “substantially increase federal funding…

The Supreme Court on Tuesday handed down an important decision regarding how patent claims are handled on appeal. The U.S. Court…

Each year the HHS Office of Inspector General (OIG) solicits recommendations for new or modified safe harbor provisions…

Japanese pharmaceutical company, Daiichi Sankyo Inc., with U.S. headquarters in New Jersey, has agreed to pay $39 million to…

  On December 22, the United States filed a civil False Claims Act complaint against Omnicare Inc. alleging that it solicited and…

GlaxoSmithKline’s 2012 Corporate Integrity Agreement made mandatory the company’s policy that it would not provide sales reps with…

A paralegal recently fired by French drug manufacturer Sanofi has filed a whistleblower lawsuit, claiming she was discharged after…

Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications.…