As a pharmaceutical liability attorney, I was pleased to see an announcement that yet another drug maker will pay heavy fines for illegal marketing of its products. The New York Times reported Dec. 19 that Amgen Pharmaceuticals will pay $762 million to settle charges by the federal government, all 50 states and a group of whistleblowers that it marketed drugs including the anemia drug Aranesp for off-label uses and at off-label doses. The company admits only to criminal charges involving Aranesp that it has settled, but the total also includes a settlement of civil allegations that it illegally marketed other drugs, including Enbril, for psoriasis, and Neulasta, for increasing white blood cell counts.
The article opens with an anecdote from one whistle-blower, who was wearing a recording device at a meeting in which one participant joked that she hoped no one was recording what she said. That discussion was about a $10,000 unrestricted grant to the pet project of a doctor who advised the local Medicare contractor, to encourage him to influence Medicare to reimburse for an unapproved use of Aranesp. Amgen is also accused of offering kickbacks to doctors and clinics in exchange for the use of Amgen drugs; knowingly mis-reporting prices of drugs; promoting a reduced dosage schedule without proven effectiveness or safety; giving doctors more drugs than they paid for, encouraging them to resell at a profit; and firing employees who objected to the illegal marketing. In all, 10 whistle-blower lawsuits were unsealed in December.
Aranesp is approved for anemia resulting from cancer treatments or chronic renal failure, and directly competes with the better-established Johnson & Johnson drug Procrit–perhaps one reason why the marketing was so aggressive. Doctors are permitted to prescribe drugs for any use they like, but the FDA forbids drug companies from marketing drugs for any unapproved use. As a defective prescription drug attorney, I know that off-label marketing can have some unsavory implications for safety. For example, Aranesp is a synthetic form of a natural body hormone that stimulates red blood cell production, but its use is known to increase risk of cardiac arrest, heart attack, stroke and seizure. These risks are so serious that they should be assumed only when the benefit has been carefully studied and deemed worth the risks.
The Associated Press notes that the settlement, like many high-profile drug mismarketing settlements, is smaller than the revenue that can be generated by a top-selling drug. As a dangerous drug lawyer, I wish the settlements were higher than the potential profit created by breaking the law. The AP article notes that Amgen set aside $780 million for this settlement, which means that it is arguably coming out ahead by settling for less than that amount. Only when it is not profitable to break the law will the law-breaking stop, which is why it’s vital for federal authorities to charge very high fines to companies that expect very large profits. There’s certainly negative publicity from these settlements, but because so few patients have the tools to make a true consumer choice, that may not be enough to stop illegal marketing.
If you or someone you love suffered a health problem because of a dangerous drug, you should call Carey, Danis & Lowe to discuss how we can help. For a free, confidential consultation, send us an email or call 1-877-678-3400.
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