Lawsuit alleges pharmaceutical company illegally marketed fentanyl painkiller

Minnesota Attorney General Lori Swanson and the state pharmacy board are suing an opioid manufacturer for illegally marketing a fentanyl painkiller, meant to treat cancer patients, for other conditions and at higher doses than had been federally approved. 

Swanson and the Minnesota Board of Pharmacy filed a lawsuit Wednesday against Arizona-based Insys Therapeutics, Inc., over their marketing tactics for Subsys, a rapidly absorbed fentanyl spray approved by the U.S. Food and Drug Administration in 2012 to treat cancer patients “whose existing and long-acting opioids did not adequately control their pain.”

Fentanyl is an opioid painkiller 100 times stronger than morphine. 

The lawsuit alleges the company’s sales agents encouraged physicians to prescribe Subsys, to patients who did not have cancer. While doctors may prescribe a drug for unapproved or “off-label” uses, federal law prohibits pharmaceutical companies from promoting the drug for unapproved uses, according to a news release. 

Insys Therapeutics is also accused of incentivizing its sales agents to get physicians to increase the prescribed doses of Subsys to patients. Over 80 percent of initial prescriptions by Minnesota physicians were above the FDA-approved dose, the lawsuit states.  

Insys Therapeutics also allegedly gave kickbacks to physicians who prescribed Susbys. The company reportedly paid two physicians who were their top prescribers in Minnesota over $43,000 as part of their “Speaker Program.” The lawsuit alleges the Speaker Program was a way for the company to get around a state law that prohibits pharmaceutical manufacturers from paying gifts of over $50 per year to health care practitioners. The lawsuit claims the payments were not “reasonable honoraria” because the company could not prove the “speeches” were given to a legitimate audience. 

The U.S. Attorney General in Massachusetts has already indicted several of Insys Therapeutics’ top executives for their role in marketing the fentanyl painkiller. 

Insys Therapeutics released the following statement in light of the lawsuit: 

"Our new management team takes the allegations of past wrongdoing by former employees with the greatest seriousness and has focused extensively on instilling the highest respect for fundamentally sound values among all of the company’s more than 300 current employees. As a result, INSYS Therapeutics has become a new and better company in many important respects across the organization. We are determined to take responsibility for the past and to learn from it, while at the same time sustaining our investment in R&D to the extent possible to continue advancing our product pipeline, which includes several drug candidates across two platforms: pharmaceutical cannabinoids and spray technology."