![]() Two former pharmaceutical sales representatives will share a $4.4 million whistleblower reward for reporting their former employer’s off-label promotion of a drug to treat weight loss in AIDS patients. 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. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules.
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