The lawsuits involved the drug Aranesp, which was approved by the FDA for treatment of anemia in patients with chronic renal failure. The FDA approval was specific to calibrated doses for particular patient populations.
The lawsuits alleged that Amgen knowingly promoted the sale and use of Aranesp for dosing regimens and indications that were not approved by the FDA. The off-label marketing allegedly included promoting Aranesp for treatment of anemia caused by cancer, anemia caused by chronic disease, chronic anemia, and anemia caused by myelodysplastic syndrome.
Under the Food, Drug and Cosmetic Act, it is illegal for a drug company to promote a drug for uses or at doses not approved by the FDA. This is known as “off-label” marketing and renders the drug “misbranded.” Promotion of a misbranded drug may also violate the False Claims Act because any resulting claims for reimbursement from Medicare or Medicaid are considered “false claims.”
As the whistleblowers filed their lawsuits, the government conducted investigations and decided to intervene in the actions. The government alleged that Amgen engaged in three types of illegal conduct:
Off-Label Marketing: The government alleged that Amgen promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs. The government also alleged that Amgen used journal articles that were insufficient to support the safety and efficacy of the off-label uses at issue, and improperly obtained listings in medical compendia in an effort to establish that the off-label uses were medically accepted and thereby eligible for coverage by federal health care programs.
Kickbacks: The government alleged that Amgen offered illegal kickbacks to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary. The Anti-Kickback Statute prohibits offering, paying, or accepting anything of value in return for recommending the use of a product or service that will be reimbursed by Medicare and certain other government healthcare programs.
False Price Reports: The government alleged that Amgen engaged in false price reporting practices, including knowingly submitting false Average Sales Prices, Best Prices, and Average Manufacturer Prices for several drugs. Pricing reports from pharmaceutical companies are used by Medicare, Medicaid, and other government healthcare programs to set reimbursement rates.
The qui tam or whistle-blower provisions of the False Claims Act allow private citizens to bring lawsuits on behalf of the United States and share in any recovery. The lawsuits are initially filed “under seal” (in secret) to give the government an opportunity to conduct an investigation. If the lawsuit is successful, the whistleblower is entitled to a reward of between 15% and 30% of the amount actually paid to the government.
If you are aware of off-label marketing, kickbacks, false price reports, or other types of false or fraudulent marketing of pharmaceuticals, you may be eligible for a substantial reward and legal protection as a whistleblower.
To arrange a free and confidential consultation with an experienced False Claims Act attorney, call John Howley, Esq. at (917) 652-6504 or click here to contact our office via email. No legal fees are charged unless the case is successful.
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.