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Minnesota Files Lawsuit Against Drug Company for Pain Reliever

— June 5, 2018

Minnesota Files Lawsuit Against Drug Company for Pain Reliever

Minnesota has joined in the opioid litigation, suing Insys Therapeutics Inc. for allegedly illegally marketing Subsys, a powerful fentanyl-based pain reliever, as a solution for unapproved uses.  Subsys, an under-the-tongue spray medication that is 80 to 100 times stronger than morphine, was originally intended to alleviate pain in cancer patients.  The drug was granted approval for this use in 2012.

Insys’ top executives have been fending off a federal criminal investigation involving the drug, and a former employee pleaded guilty in New Jersey for bribing physicians to overprescribe it.  Now, it will have to deal with the lawsuit issued by Minnesota Attorney General Lori Swanson last week in Hennepin County District Court while former Insys sales representative Michelle Breitenbach faces the criminal charges.  Breitenbach could get up to five years of prison time for second-degree conspiracy to commit commercial bribery, according to prosecutors working the case.

Included in the Minnesota lawsuit were allegations that Insys improperly paid two doctors who became the top Subsys prescribers $43,000 in “speaker fees.”  The Justice Department recently joined five whistleblower lawsuits accusing Insys of paying kickbacks to physicians prescribing Subsys.  In October 2017, federal prosecutors in Boston announced Insys founder John Kapoor’s arrest on charges he participated in the kickback scheme and for defrauding insurers.

Photo by rawpixel on Unsplash

Kapoor, 74, was a billionaire at the time of his arrest.  Prosecutors said the founder along with former Insys Chief Executive Michael Babich and others schemed to bribe medical practitioners using sham speaker programs that were marketed as a means to educate healthcare professionals about Subsys.  In reality, those in attendance were largely Insys employees and salespersons – not physicians.

Kapoor, Babich and five other former executives and managers have pleaded not guilty.  Acting United States Attorney William D. Weinreb said at the time of the founder’s arrest, “In the midst of a nationwide opioid epidemic that has reached crisis proportions, Mr. Kapoor and his company stand accused of bribing doctors to overprescribe a potent opioid and committing fraud on insurance companies solely for profit…Today’s arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles.  We must hold the industry and its leadership accountable – just as we would the cartels or a street-level drug dealer.”

Mark A. McCormack, Special Agent in Charge, FDA Office of Criminal Investigations’ Metro Washington Field Office added, “As alleged, Insys executives improperly influenced health care providers to prescribe a powerful opioid for patients who did not need it, and without complying with FDA requirements, thus putting patients at risk and contributing to the current opioid crisis.  Our office will continue to work with our law enforcement partners to pursue and bring to justice those who threaten the public health.”

The company announced it was under new management and has taken “necessary and appropriate steps to prevent past mistakes from happening in the future.”  Insys is currently in settlement talks with the Justice Department and may need to pay at least $150 million.

The company is facing lawsuits in many other states, including North Carolina, Arizona, New York, New Jersey and New Mexico over the pain reliver.  It has already settled cases brought forth in New Hampshire, Oregon, Massachusetts, and Illinois for $9.45 million. It issued a statement that it is taking the actions of its former employees seriously and is “determined to take responsibility for the past and to learn from it.”


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