Michael McKeen and Courtney Combs started a qui tam or whistleblower lawsuit against their former employer, Par Pharmaceuticals, under the False Claims Act. They alleged that Par Pharmaceuticals, a generic drug company, promoted Megace® ES for uses that were not approved by the Food and Drug Administration (FDA) and not covered by federal healthcare programs.
While the FDA approved Megace® ES to treat dangerous weight loss in AIDS patients, Par actively promoted the drug for cachexia or weight loss suffered by elderly patients with no diagnosis of AIDS. This was not an FDA-approved use, nor was this use covered by Medicare or Medicaid.
Under the federal False Claims Act, sales representatives and other individuals with knowledge of off-label marketing may start a whistleblower or qui tam lawsuit on behalf of the government and share in any recovery. The qui tam lawsuit is filed “under seal” (in secret) and provided only to the U.S. Attorney. The U.S. Attorney then must conduct an investigation into the claims in the sealed lawsuit.
In this case, the government found that “Par deliberately and improperly targeted elderly patients with weight loss residing in nursing homes, regardless of whether such patients suffered from AIDS or any other medically accepted indication.” The government therefore intervened or joined in the qui tam lawsuit.
After the government intervened, Par agreed to pay $22.5 million to settle the qui tam lawsuit. The company admitted that it promoted Megace® ES for older patients without AIDS, and that it instructed its sales staff to falsely claim that the drug was more effective than other products.
The settlement agreement provides that the two whistleblowers will receive $4.4 million as their whistleblower reward. Par will also pay their attorneys’ fees.
If you are aware of off-label promotion of pharmaceuticals, or other false and fraudulent marketing practices involving prescription drugs, then you should consult with an experienced whistleblower attorney immediately. You may be entitled to a significant whistleblower reward and legal protections.
The consultation is completely free and confidential. No attorneys’ fees are charged unless your lawsuit is successful.
To arrange a free and confidential consultation with an experienced whistleblower attorney, call John Howley, Esq. at (212) 601-2728 or click here to reach our offices via email.
John Howley, Esq.
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