Department of Justice Joins Mallinckrodt Whistleblower Suits

What’s New/Significant

The U.S. Department of Justice joined a pair of whistleblower lawsuits alleging pharmaceutical manufacturer Questcor improperly promoted H.P. Acthar Gel — a treatment for infantile spasms, a rare infant seizure disorder — for off-label adult use, and paid kickbacks to doctors to promote and prescribe the drug. Mallinckrodt Plc acquired Questcor in 2014. The two suits were filed under the False Claims Act by former employees in 2012 and 2013, before Mallinckrodt acquired Questcor. The DOJ intervened in the case after conducting its own investigation.

Allegations

The suits in the United States District Court for the Eastern District of Pennsylvania allege that Questcor:

• Defrauded government health care programs, including Medicare and Medicaid, by illegally marketing Acthar.
• Used deceptive and misleading marketing tactics to promote Acthar for off-label treatment of illnesses in adults — in particular, multiple sclerosis, among others — including by:
  • Promoting the drug in marketing materials as an effective and better-tolerated alternative treatment for MS patients experiencing flare-ups who had side effects from less-expensive IV steroid treatments, although the known side effects were similar.
  • Promoting as effective a shortened dosing schedule that was not only an unapproved use but also had no reliable data to establish that it was safe and effective.
  • Providing prefilled insurance forms for use by physicians and their staff to use for the Questcor-exclusive distribution program.
  • Promoting Acthar for “pulse therapy” for control of symptoms MS, another off-label use

• Paid physicians and their staff  illegal kickbacks, including bribes, speaker fees and consulting deals, to promote and prescribe Acthar for off-label use.
• Coached health care providers on how to fill out prescription forms, including by mislabeling the patients’ condition/diagnosis, so that off-label uses of Acthar would be covered by insurance or Medicare.
• Improperly promoted a co-pay assistance program.

Status

The DOJ has until June 4, 2019 (90 days from March 6, 2019, the date it intervened in the suits) to file its own complaint against Mallinckrodt.

Mallinckrodt has stated that the claims in the suits were based on pre-merger conduct by Questcor, and the company is cooperating with the government and expects the allegations to be settled shortly.