Off label drug use and kickbacks to doctors become the foundation of a whistleblower lawsuit

American multi-national drug company, Amgen, the world’s largest biotechnology firm, agrees to pay $762 million to settle whistleblower case.

This is a wide ranging story that includes at least ten whistleblower lawsuits filed in numerous states. The qui tam suits suggest Amgen defrauded Medicare, Medicaid and other government health care programs, by promoting off label uses for Aranesp or darbepoetin alfa, which is used to treat anemia as a result of chronic renal failure. Aranesp is apparently not the only drug the company was suggesting that doctors use off label either. Their campaign was to encourage physicians and other health care professionals, to prescribe Aranesp and Sensipar, among other drugs, and pay kickbacks to them.

The whistleblower in this case, United States ex rel. Cantor v. Amgen, Inc., Civil Action No. CV-04-2511 (E.D.N.Y.), is Tom Cantor. His suit alleges Amgen, in essence, bribed doctors to boost the sales of six of their drugs, the two already mentioned and four others, Neupogen, Neulasta, Engrel and Epogen. The idea was to get doctors to prescribe their drugs for off label uses, earning the physicians cash back in the deal. Using a drug off label means it is utilized for a different disease/condition than the drug was created to treat, is given in a different manner than suggested or given in a dose that differs from what is approved on the FDA approved drug label.

The suit was filed under seal in 2004 in New York City and just recently, all the lawsuits were unsealed, with the government, who had joined the suit, announcing the settlement with Amgen. Typically a defendant will settle out of court if they feel they stand to lose more by going to court. It provides them some measure of damage control. While they suggest a settlement is not an admission of guilt, 9 out of 10 people would think otherwise. Amgen also pled guilty to illegally introducing Aranesp, a misbranded drug, into the marketplace, which is a misdemeanor. Overall, their legal leg to stand on was not that solid or convincing.

Paying someone to make a decision based on how much money they stand to make for prescribing a drug is not only illegal, it is immoral and unethical. Drugs are supposed to be prescribed based on medical reasons and medical necessity, not in the anticipation of greenbacks. While off label marketing and drug usage is sometime done in the medical field, the fact is that doctors should prescribe their patients drugs that will help them. If doctors do that with integrity and honesty, that is one thing. If they do that with an eye on their bank account, that is another.

Without whistleblowers filing qui tam lawsuits, the federal government would continue to be ripped off for millions of dollars every year. There appears to be an attitude that the government is fair game when it comes to taking money for fraudulent activities. Whistleblowers are slowly leveling the playing field.

Are you in a situation where you have evidence of fraudulent activities being perpetrated against the federal government? Contact an experienced and knowledgeable Cleveland whistleblower lawyer. You will need one to file suit.

Tom Robenalt is a Cleveland whistleblower Lawyer specializing in Cleveland whistleblower cases cases in Ohio. To learn more, visit

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