In April 2010, The U.S. Department of Justice got agreement from AstraZeneca LP and AstraZeneca Pharmaceuticals LP on the price to settle allegations the drug companies had violated U.S. law with the off-label promotion of the drug Seroquel.
In a complex scheme that preyed upon trusting doctors and their vulnerable patients, AstraZeneca caused false claims to be filed with various federal insurance programs such as Medicaid, Medicare, TRICARE, the VA, the Federal Employee Health Benefits Program, and the Bureau of Prisons.
The drug in question, Seroquel had received Food and Drug Administration approval for various purposes over the years:
- September 1997 — Approved for the treatment of psychotic disorders
- January 2004 — Approved for short term treatment of acute manic episodes in patients with bipolar disorder
- October 2006 — Approved for bipolar depression
However, in March 2006, AstraZeneca began a pattern of illegal behavior that lasted until December 2006. During that time, the company promoted its product as safe and effective for unapproved uses that included the treatment of:
- Aggression and anger
- Alzheimer’s disease and dementia
- Anxiety
- ADHD
- Bipolar maintenance
- Depression
- Insomnia
- Mood disorder
- PTSD
Federal healthcare programs and state Medicare did not provide coverage for Seroquel for these uses.
The promotional scheme for the unapproved uses involved undue influence upon materials and speakers in company-sponsored continuing medical education programs. The company paid doctors to give talks on off-label uses for Seroquel to physicians who did not generally treat patients with conditions for which Seroquel was indicated and approved.
Rather, these doctors dealt with children, adolescents, and the elderly as primary care physicians, as well as patients in nursing facilities and prisons. Thus, the company was illegally expanded its market using doctors who didn’t know any better and the expense of patients who deserved better.
But, perhaps the most brazen aspect of the scheme was the way AstraZeneca recruited physicians to put their names on ghostwritten articles touting studies they had not done. AstraZeneca later used those bogus articles to advertise unapproved uses of Seroquel.
Under the settlement, the U.S. government received more than $300M in civil damages. Since the legal action began as a whistleblower lawsuit in the Eastern District of Pennsylvania under the federal False Claims Act, that plaintiff, James Wetta, was able to share in the government’s recovery. Mr. Wetta received more than $45 million, about 15 percent of the government’s share.