The United States government has joined two Qui Tam suits filed by whistleblowers in the Northern District of California against drug makers Scios Inc. and Johnson & Johnson Inc. The lawsuits claim that Scios and its parent, Johnson & Johnson, marketed the heart medication Natrecor for a use that had not received Food and Drug Administration approval. Further, alleges the government, the companies caused fraudulent claims to be made to federal health care programs, such as Medicare.
The use of a drug for treatment not approved by the FDA is known as an “off-label” use. The Food, Drug and Cosmetic Act requires that the FDA approve a drug as safe and effective for its intended uses, which uses are then indicated on a drug’s label. After a drug is approved, it may not be marketed for unapproved, or off-label, uses.
In August 2001, the FDA approved Natrecor for patients with advanced congestive heart failure. Almost immediately, Scios launched an aggressive advertising campaign to market Natrecor for patients whose heart disease was not advanced, even though this use had not been included in the FDA-approved label and was ultimately shown to be of no significant benefit to the patients. Medicare will not pay for off-label uses of drugs unless the use is shown to be medically necessary. Still, as a result of Scios’ marketing scheme, Medicare paid substantial amounts for the unapproved use of Natrecor for patients with less severe heart disease.
The whistleblowers in the two separate suits were former Scios sales managers. Under the False Claims Act, a private person may bring a whistleblower suit to provide the government with information about wrongdoing. If the government is able to resolve the case, the whistleblower who initially brought the suit can receive between 15 to 25 percent of the government’s recovery.
For the full story, go to Department of Justice’s Press Release.