Whistleblower / Qui Tam Plaintiffs Are Key to Exposing Unsafe Marketing of Pharmaceutical Drugs

By: Attorney Thomas R. Smith & Attorney Neal S. Solomon

The federal Food, Drug and Cosmetic Act (FDCA) requires a drug manufacturer to specify the intended uses of a product in its new drug application to the Food and Drug Administration. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. Though doctors are permitted to prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved as safe. Oral statements and materials presented for training, sales or education at conventions, seminars, workshops and the like must be confined to FDA approved usage. If such statements or materials promote a use that is inconsistent with the product’s approved labeling, the product is misbranded and the manufacturer is engaging in fraudulent activity.

In 2004, a whistleblower prevailed in a suit under the False Claims Act against Warner-Lambert, resulting in a $430 million settlement. It was the first off-label promotion case successfully brought under the False Claims Act.

To this day, drug companies continue to put patients’ health at risk in pursuit of financial gain by engaging in off label marketing. Just recently, whistle blowers exposed illegal promoting of a kidney transplant drug by Wyeth Pharmaceuticals (acquired by Pfizer in 2009), resulting in a $250 million civil settlement. Wyeth received approval from the FDA for use of the drug in renal (kidney) transplant patients only. The whistleblowers alleged that Wyeth trained its sales force to promote the use of the drug in non-renal transplant patients and then encouraged sales force members, through financial incentives, to target all transplant patient populations to increase the
drug's sales.

The whistleblowers were former sales representatives for the kidney transplant drug and a
pharmacist. The FBI cited the success obtained in the case against Wyeth as an excellent example of the importance of the public reporting of fraud, waste, or abuse.

About the Authors

Thomas R. Smith is a managing partner of the law firm and Chair of the Personal Injury department. Neal S. Solomon is a partner and Chair of the Estate and Trust and Commercial Law and Litigation department. Both attorneys have many years’ experience in these areas and can assist you in getting the best legal representation for Qui Tam / Whistleblower cases in New Jersey.

Legal Resources:
Articles Glossary