The Food, Drug and Cosmetic Act of 1938 makes it illegal to distribute labeling that accompanies a drug and prescribes, recommends, or suggests that the drug may be used for unapproved uses [21 U.S.C. § 331(d)]. Section 331(a) of the same statute makes it a crime to market a drug with labeling that bears inadequate directions for use, or which is false or misleading.
Drug companies that are alleged to have violated these provisions of the Act may be liable for a wide variety of civil and criminal penalties as well as a negative presumption and increased review in future marketing efforts. Since 1986, the False Claims Act (FCA), 31 U.S.C. § 3729 et seq., has given whistleblowers (or relators, in FCA terminology), who are the first to inform the government of alleged off-label marketing, some protection against retaliation resulting from filing a civil lawsuit on behalf of the government. The FCA also gave relators comfort that, should the government support their claims, they could recover a significant percentage of the damages, fines, and fees collected by state and federal governments.
It is unknown how many off-label marketing whistleblower lawsuits are filed each year. These cases are filed under seal (i.e., they are not publicly available), and they remain under seal for months or years while the government investigates the allegations and decides whether to intervene, i.e., join in the lawsuit.
The government does not intervene in all of such suits, and relators do not always pursue their claims where the government declines to support their cause. However, the combination of expanded press coverage of healthcare issues and the irresistible story of do-gooders—not to mention the potentially significant financial reward—has led to more reports of huge whistleblower settlements. The last few months have been no exception.
In September, Forest Laboratories pleaded guilty to a felony charge of obstructing justice, a misdemeanor charge of distributing Levothroid (an unapproved drug), and a misdemeanor charge of illegally promoting Celexa for treating children and adolescents suffering from depression. Included among the consequences for the plea were a $150 million criminal fine, a $149 million FCA settlement, and an agreement to forfeit $14 million in assets to the federal government.
According to court filings, Forest Labs had illegally directed the promotion of Celexa for pediatric use in sales calls, hired outside speakers to talk to pediatric specialists, submitted inaccurate information to the FDA, and obstructed justice by distributing as much Levothroid as possible before expiration of a warning letter deadline. Forest also admitted it had obstructed justice by submitting inaccurate information to the FDA during the course of its investigation. The whistleblowers who brought certain of these acts to the government’s attention will recover $14 million from the federal share of the civil settlement amount.
Approximately one week after the Forest Labs plea was announced, DOJ intervened on behalf of two whistleblowers who have alleged that Wyeth marketed the kidney transplant drug Rapamune, an immunosuppressant, for use in heart, lung, liver, pancreas, and islet cell transplants, even though the FDA had approved it only for use in kidney transplants.
The complaint alleges misbranding and off-label marketing for several years’ time. Nineteen states and the District of Columbia have joined the suit, which whistleblowers filed in 2005.
Astute followers of qui tam cases may recall that this is not the first time in recent history the government has intervened on behalf of relators against Wyeth. For example, in May 2009, the U.S. and 16 states intervened in an action alleging that the company failed to give the government the same discounts it provided to private drug purchasers. That suit is ongoing.
On the heels of the Wyeth announcement, on September 30, DOJ informed the public it had reached a $422.5 million settlement with Novartis. In that case, Novartis agreed to pay $185 million in criminal fines and forfeitures for the off-label promotion of Trileptal as an anti-epileptic drug for the treatment of partial seizures but not for any psychiatric, pain, or other approved uses.
Novartis also agreed to pay $237.5 million to resolve civil FCA allegations that the company unlawfully marketed Trileptal and five other drugs, and submitted false claims for reimbursement. The settlement resolved four separate whistleblower lawsuits, for which relators (and their attorneys) will recover more than $25 million.
These are just the latest in a busy 2010. Johnson & Johnson, Ortho-McNeil, and Eli Lilly are among other drug companies to have settled with the government and/or pleaded guilty to off-label marketing charges. The pleas and settlements reflect over $1 billion in payments to state and federal governments.
Recent DOJ announcements tout its recoveries from FCA lawsuits, and set the recovery amount at $4.4691 billion since January 2009 alone. While not all of these cases were initiated by whistleblowers, even if they received the minimum recovery permitted under the FCA (15%), they could collect over $400 million.