Johnson & Johnson executives received bad news last week when the U.S. Justice Department (DOJ) stated it would pursue two False Claims Act (whistleblower) lawsuits regarding the heart drug Natrecor. These government fraud whistleblowers’ lawsuits claim Natrecor was illegally marketed for off-label use. According to the qui tam provisions of the False Claims law, these whistleblowers (known as “relators”) stand to receive a percentage of damages recovered by the government for the big pharm company’s alleged corporate fraud.
The False Claims lawsuits allege that Scios, J&J’s parent company, marketed the intravenous drug Natrecor for uses other than the FDA-approved treatment shortly and continuously after its 2001 approval as a cardiac drug for acutely decompensated congestive heart failure (CHF) with shortness of breath (dyspnea). In doing so, the pharmaceutical company defrauded Medicare and other U.S. health programs to the tune hundreds of millions of dollars. While a doctor’s prescribing a pharmaceutical drug for off-label use is not illegal, the marketing of prescription drugs for unapproved uses is.
Despite its illegality, J&J marketers began pushing doctors to use Natrecor in less serious CHF patients, even though FDA had not reviewed the drug’s safety of such uses and although J&J released study results for Natrecor that showed no substantial benefits for off-label uses. Regardless, illegal marketing continued.
Additionally, Medicare does not cover prescription drugs prescribed for off-label use unless absolutely necessary.
The False Claims lawsuits were filed by two relators who formerly worked as sales managers for J&J. If it is found that defrauding the government has occurred, these two False Claims whistleblowers – thanks to qui tam provisions – will be compensated for their honesty and courage–handsomely compensated. Relators in Medicare, military contractor, and other forms of False Claims fraud receive 15% – 25% (up to 30% if they recover without the help of the government by working with a private False Claims act attorney) of the government’s award, which can be up to three times its losses to False Claims fraud plus $5,500 to $11,000 for every fraudulent claim filed.
This most recent move by DOJ is just one in a number of lawsuits against prescription drug companies for off-label Medicare fraud that includes Pfizer’s Bextra, GlaxoSmithKline’s off-label marketing and promotions of various of its products, and Medtronic’s off-label promotion of various of its productions.
If you are interested in learning more about federal or Tennessee False Claims Law, check out the Higgins Firm’s Nashville law office’s webpage on whistleblower/qui tam lawsuits or call me at (615) 353-0930.