Filing Reveals Solicitor General’s Opinion of Government Involvement in Off-Label Marketing

As we have reported in the past, the U.S. Circuit Courts are split on several issues involving the federal False Claims Act. One of the most divisive issues facing the courts today involves the application of Federal Rule of Civil Procedure 9(b). Rule 9(b) requires heightened pleading requirements for plaintiffs […]

Pharmaceutical Sales Whistleblower Sheds Light on Off-Label Marketing Scheme

It is unlawful for a pharmaceutical company to market a drug for purposes beyond those that have been approved by the Food and Drug Administration. When a company decides to sell a new drug to American consumers, the FDA ensures the drug is rigorously tested to reveal any deadly or […]

Par Pharmaceuticals Pleads Guilty to Civil & Criminal Allegations of Off-Label Marketing

Par Pharmaceuticals recently pled guilty in federal court to charges of off-label marketing and will be forced to pay $45 million in order to resolve the company’s criminal and civil liability. Par allegedly promoted its prescription drug, Megace ES, for off-label uses that were not approved as safe or effective […]