The state of New Jersey has filed a lawsuit against Insys Therapeutics, Inc. (Insys), according to an announcement by Attorney General Christopher S. Porrino. The state alleges that the company engaged in consumer fraud and submission of false insurance claims to increase the market share for its drug, Subsys. The complaint filed with the court notes that although Subsys has U.S. Food & Drug Administration (FDA) approval limited to the treatment of opioid-tolerant cancer pain, Insys directed its salespeople to push for prescription to a broader patient population. The types of patients targeted by the company included those who suffered from any type of chronic pain, and the company suggested higher doses of the opioid-fentanyl drug. The complaint also asserts Insys repeatedly sought insurance coverage for Subsys prescriptions by misleading health insurance plans and pharmaceutical benefits managers.
It is true that physicians are permitted to legally prescribe drugs for off-label use. Drug companies, however, are prohibited from promoting off-label use of their drugs in an untruthful or misleading way. These companies are also forbidden from influencing a physician’s prescription decisions by offering payments or other benefits in exchange for prescribing the drug.
America’s Opioid Epidemic
According to the lawsuit, over 840 people in New Jersey died from heroin or opioid abuse in 2010. During the first half of 2016, New Jersey’s death toll jumped to more than 1,000. Approximately 38,000 people were admitted to state-licensed or certified substance abuse treatment programs in New Jersey due to heroin or opioid abuse in 2016. The National Institute on Drug Abuse (NIDA) notes that 80 of new heroin users report their addiction began with the misuse of prescription drugs, particularly pain medication. Statistics compiled by the Center for Disease Control & Prevention show that opiate-related deaths in America have more than quadrupled since 1999.
New Jersey’s complaint claims Subsys has accounted for about 98% of net revenues for Insys since the drug launched in 2012.
Fighting Big Pharma
The pharmaceutical industry is no stranger to litigation. The industry has faced dozens of lawsuits brought by states, cities, and counties. Some that are going after pharmaceutical companies include Delaware County, Pennsylvania, Newark, New Jersey, Missouri, and Ohio. Defendants in these lawsuits include opioid manufacturers as well as distributors. These claims generally seek to hold manufacturers and/or distributors liable for harm caused by dangerously addictive opioids.