TRENTON, NJ - Attorney General Gurbir S. Grewal announced that a former sales representative for Insys Therapeutics, Inc., maker of the powerful fentanyl-based opioid painkiller Subsys, pleaded guilty today to participating in a scheme in which doctors were bribed to increase off-label prescribing of the drug.
Michelle Breitenbach, 38, of Middletown, N.J., pleaded guilty today to a second-degree charge of conspiracy to commit commercial bribery before Superior Court Judge Benjamin S. Bucca Jr. in Middlesex County. In pleading guilty, she admitted that as a New Jersey sales representative for Insys, she participated in a scheme in which doctors, in return for off-label prescribing of Subsys, were paid kickbacks and bribes in the form of purported speaker fees for marketing/education events. Pursuant to the terms of the plea agreement, the state may recommend a sentence of up to five years in prison for Breitenbach.
Doctors who participated in the “Speakers Bureau Program” for Insys purportedly spoke at events to educate other doctors about Subsys. In reality, the events involved free meals at expensive restaurants, and doctors were paid as speakers even if they did not speak, or if other doctors did not show up to listen. Breitenbach stated that management at Insys pressured sales representatives to promote the Speakers Bureau Program as a primary means to drive increased sales of Subsys. She admitted that the payments made to the doctors as “speakers” were actually rewards for prescribing more Subys.
Last year, the New Jersey Attorney General’s Office filed suit against Insys and its billionaire founder, John N. Kapoor, accusing the defendants of endangering the public through an unlawful marketing campaign designed to exponentially increase sales of Subys by making fraudulent claims and unlawfully incentivizing health care providers to prescribe Subsys to an inappropriately broad array of pain patients. The dangerously potent and addictive drug is a spray form of fentanyl that has FDA approval only for intense breakthrough pain related to end-stage cancer. While doctors have discretion to legally prescribe drugs for off-label use – meaning purposes beyond what is approved by the FDA – drug companies are prohibited from promoting their drugs for off-label use in an untruthful or misleading way, and from influencing healthcare providers’ prescription decisions with payments or other benefits.
The New Jersey Attorney General’s Office also filed suit last year against Purdue Pharma L.P. in connection with its alleged deceptive marketing of opioid painkillers, particularly OxyContin.
“As we have alleged in multiple court filings, a primary cause of the devastating opioid epidemic gripping the country has been overprescribing of prescription opioids, driven by the greed of manufacturers like Purdue Pharma and Insys,” said Attorney General Grewal. “We are fighting the opioid epidemic on all fronts, including through criminal prosecutions and civil actions against mercenary pharmaceutical companies, their employees, and irresponsible prescribers.”
“This former sales rep admitted her role in a scheme to pressure doctors to prescribe more Subsys in return for so-called speaker fees and other perks,” said Director Veronica Allende of the Division of Criminal Justice. “When doctors receive improper incentives to prescribe drugs, self-interest can cloud or supplant their medical judgment, with dangerous results, particularly when a risky, addictive opioid like Subsys is involved.”
Deputy Attorneys General Brian Faulk and Jillian Carpenter are prosecuting the case, and Deputy Attorney General Faulk took the guilty plea for the Division of Criminal Justice Financial & Computer Crimes Bureau. They are assigned to the investigation with Detective John Neggia, under the supervision of Lt. Lisa Shea and Deputy Director Christine Hoffman of the Division of Criminal Justice.
Sentencing for Breitenbach is scheduled for July 6.
On May 4, the Attorney General’s Office and Division of Consumer Affairs announced that the Board of Medical Examiners had revoked the license of a Cherry Hill, N.J., family physician, Dr. Vivienne Matalon, for indiscriminately prescribing Subsys to three patients, including a woman who died while taking the drug. The Attorney General’s Office also has filed a pending complaint seeking to revoke the license of Warren County pain management practitioner Dr. Kenneth Sun for allegedly accepting over $136,000 from Insys while indiscriminately prescribing Subsys. His license currently is suspended.
For Breitenbach: Nicholas C. Harbist, Esq., Blank Rome LLP, Princeton, N.J.