Par Pharmaceuticals Settles Civil and Criminal Off-Label Marketing Charges for $45 Million
Last month, Par Pharmaceutical Companies Inc. pleaded guilty to federal criminal charges and agreed to settle civil allegations involving the company’s promotion of the drug Megace ES. Par was fined $18 million and ordered to pay an additional $4.5 million in criminal forfeiture. The company will also pay $22.5 million to resolve the civil allegations.
The civil suit accused Par of promoting Megace ES for non-FDA approved uses that were not covered by federal healthcare programs. Megace was approved specifically to treat anorexia, cachexia and other significant weight loss suffered by patients with AIDS and HIV. Par allegedly targeted sales of Megace to elderly nursing home patients suffering from weight loss. The company was also accused of actively ignoring some of the negative side effects Megace ES has on elderly patients when promoting it on its marketing campaigns. The criminal charges brought against Par also surround its labeling and misbranding of Megace ES.
Par’s settlement with the government resolves three separate but related whistleblower lawsuits filed against the company. At least some of the five relators who filed these cases worked for Par or their affiliates and were able to provide incredibly helpful information and documents to the government. Two of the whistleblowers, Mr. Michael McKeen and Ms. Courtney Combs will receive $4.4 million as their portion of the settlement. Any payments to the other whistleblowers, Ms. Christine Thomas, Mr. James Lundstrom and Mr. Elliott, are unknown at this time.
Promoting off-label uses for prescription drugs is not only illegal, it can be extraordinarily dangerous. When patients are given medicine for uses that have not been approved by the FDA the results could be disastrous. Tycko & Zavareei commends the individuals who took a stand to stop Par’s selfish and unsafe practices. If you are aware of a company using off-label marketing for its products, you have a duty to protect the individuals who could be harmed. Contact the experienced attorneys at Tycko & Zavareei today to get more information about how to start your case.