Scios, a pharmaceutical company based in California, has been accused of submitting false claims to the federal healthcare programs for the cardiac drug Natrecor. The allegations were made in a whistleblower suit filed by two former Scios sales managers. The suit claims that Scios marketed Natrecor for a use not approved by the FDA, a practice known as an ‘off-label’ use.
According to the allegations, Scios began marketing Natrecor for scheduled, serial outpatient infusions for patients with less severe heart failure in 2001, shortly after receiving FDA approval for the drug. However, the FDA had only approved Natrecor for use in hospitalized patients with severe heart failure. The government’s investigation revealed that Scios continued to market Natrecor for off-label use despite receiving a warning from a panel of leading cardiologists in 2005.
The whistleblower suit alleges that Scios submitted false claims to Medicare and other federal healthcare programs for the off-label use of Natrecor. The government’s investigation found that these claims were paid by the federal healthcare programs. The suit also alleges that Scios released the results of a clinical study in 2007 that showed no significant benefits of serial outpatient Natrecor infusions.
The False Claims Act allows for private individuals to file whistleblower suits to provide the government information about wrongdoing. If the government is successful in resolving or litigating its claims, the whistleblower can receive a share of the amount recovered. The investigation was conducted by the Civil Division of the U.S. Department of Justice, the U.S. Attorney’s Office for the Northern District of California, the Federal Bureau of Investigation, and the Offices of Inspector General of the Department of Health and Human Services, the FDA, the Department of Veterans Affairs, the Office of Personnel Management, and the Department of Defense.
The government’s intervention in the whistleblower suit is focused on the allegations that Scios marketed Natrecor for serial infusions in the outpatient setting. The suit contains additional allegations, but the government is only intervening with regard to the allegations related to the marketing of Natrecor for off-label use.
The allegations against Scios are a significant development in the ongoing investigation into the company’s marketing practices. The government’s intervention in the whistleblower suit is a strong indication that the allegations against Scios are serious and warrant further investigation.
Related Federal Cases
- Omnicare Inc., False Claims Act Violations, Sacramento CA, 2023 · Texas
- Frank Hamilton Sentenced to 5.5 Years for SBA Scam, California, 2023 · Texas
- McKenzie Marie Earley, $10M Wire Fraud, C.D. California, 2023 · Pennsylvania
- McKenzie Earley Faces Federal Charges in California · California
- Five California Residents Indicted for Cocaine Trafficking, Clevela… · California
Key Facts
- State: Federal
- Category: Drug Trafficking|Fraud & Financial Crimes
- Source: DOJ Press Release â†â€â€
ðŸâ€Â’ Get the grimiest stories delivered weekly. Subscribe free →
