Attorney General Christopher S. Porrino recently announced that New Jersey has filed a lawsuit against Insys Therapeutics, Inc. charging that the company engaged in a “greed-driven campaign of consumer fraud and submission of false claims to health insurers” to increase the market share for its opioid-fentanyl drug, Subsys.
What Does New Jersey’s Opioid Lawsuit Claim?
The complaint asserts that Subsys has Food and Drug Administration (FDA) approval only for the treatment of opioid-tolerant cancer pain, yet Insys unlawfully directed its sales people to “push Subsys for prescription to a broader patient population – patients suffering any type of chronic pain – and at higher doses.” The state’s lawsuit alleges that corporate decision-makers sought to expand the limited market for Subsys by aggressively pushing “off label” uses of the drug.
Based on independent medical judgment, physicians are permitted to legally prescribe drugs for off-label use. However, drug companies are prohibited from promoting drugs for off-label use in an untruthful or misleading way. Drug companies also cannot influence a physician’s prescription decisions by offering payments or other benefits.
The lawsuit further alleges that Insys repeatedly misled health insurance plans and pharmaceutical benefits managers to obtain coverage for Subsys prescriptions.
According to the complaint, since its launch in 2012, Subsys has accounted for approximately 98 percent of net revenues for Insys. Insys sold $74.2 million worth of Subsys in New Jersey between 2012 and the third-quarter of 2016.
The complaint seeks injunctive relief and other relief pursuant to the New Jersey Consumer Fraud Act for the harm that Insys’s conduct caused New Jersey’s residents. The Attorney General also seeks relief under the New Jersey False Claims Act for the financial harm to the state. The complaint also notes that New Jersey state employee health benefits plans paid approximately $10.3 million to reimburse Subsys prescriptions between 2012 and the third-quarter of 2016. The State Worker’s Compensation Program paid another $300,000.
What Harm Has the Expansion of Opioid Prescription Use Caused New Jersey Residents?
The complaint alleges that Insys’s conduct has put hundreds of lives in jeopardy and “led to the death of at least one New Jersey resident,” who allegedly was prescribed Subsys for fibromyalgia.
According to the lawsuit, more than 840 people in New Jersey died from heroin or opioid abuse in 2010. Further, the confirmed heroin/opioid death toll in New Jersey jumped to more than 1,000 in the first half of 2016. Concurrently, according to the complaint, the number of people admitted to state-licensed or certified substance abuse treatment programs in New Jersey due to abuse of heroin or other opiates increased from approximately 33,000 in 2012 to more than 38,000 in 2016.
The complaint adds that, according to the National Institute on Drug Abuse, 80 percent of new heroin users reported that their addictions began by misusing prescription pain medications. It also notes that opiate-related deaths in the U.S. have more than quadrupled since 1999, according to the national Centers for Disease Control and Prevention.
What Other Actions are Being Taken to Fight the Opioid Epidemic?
The pharmaceutical industry already faces dozens of lawsuits brought by cities, counties, and states — including Delaware County, Pennsylvania, Newark, New Jersey, Missouri, and Ohio. The defendants include opioid manufacturers such as Purdue Pharma and Teva Pharmaceuticals, and distributors such as Cardinal Health, among others. The lawsuits seek to hold the manufacturers and distributors accountable for the harm caused by dangerously addictive opioid drugs, including Oxycodone and hydrocodone. The complaints allege negligence and claim that aggressive sales tactics expanded the market for opioids even as the addictive properties were well-known. The lawsuits assert that drug manufacturers failed to disclose that opioid pain killers are addictive in their marketing strategies targeted toward doctors and patients. The state and local governments claim they have been left to struggle with the high costs incurred due to the opioid public health crisis.
In addition, the attorneys general of 41 U.S. states have banded together to investigate the makers and distributors of opioid painkillers. A press release indicates that subpoenas have been issued seeking information from opioid manufacturers Endo International, Janssen Pharmaceuticals, Teva Pharmaceuticals and Allergan, as well as additional subpoenas to Purdue Pharma. The coalition is also demanding documents from distribution companies AmerisourceBergen, Cardinal Health and McKesson.