South Jersey Doctor's License Revoked After Patient's Death: AG

CHERRY HILL, NJ — The State Board of Medical Examiners has permanently revoked the license of a South Jersey doctor it says indiscriminately prescribed a powerful spray form of the painkiller fentanyl to three patients, killing one, Attorney General Gurbir S. Grewal and the Division of Consumer Affairs announced.

The fatality is at the center of allegations leveled against the company that makes the powerful opioid-fentanyl drug Subsys and its billionaire founder, John Kapoor.

The state had previously temporarily suspended the license of Dr. Vivienne Matalon, who practices in Cherry Hill, in October of 2016, eight days after it filed a Verified Complaint accusing her of professional misconduct and gross negligence in the indiscriminate prescription of Subsys.

Matalon had claimed she was misled by sales representatives into prescribing the drug to a Camden County woman who ultimately died of a Subsys-related overdose.

Subsys is approved by the federal Food and Drug Administration (“FDA”) only for use in cancer patients suffering from breakthrough pain. Matalon prescribed the drug to treat chronic pain and other medical conditions in non-cancer patients, one of whom died from “adverse effects of drugs.”

According to the state's allegations, Matalon jeopardized her patients' welfare by ignoring the documented risks associated with Subsys and by flouting the rules for its use, which is restricted to treat breakthrough pain in certain cancer patients.

In resolving the matter the Board found “the manner in which Subsys was prescribed to patients for the conditions presented and at the doses initiated constitutes a deviation from the standard of care.”

In November of last year, John N. Kapoor — billionaire founder of Insys Therapeutics, Inc. — was also charged in connection with the patient’s death. Kapoor, who is one of Arizona's wealthiest men, was added as a defendant to an amended consumer fraud and false claims complaint that had been filed one month earlier against Insys Therapeutics, Inc., which makes Subsys.

The suit is still pending in Middlesex County Court and accuses Insys illegally directed its sales force to push Subsys for prescription beyond its narrow purpose as a cancer pain medication to a broader population. It is alleged Insys pushed the drug as a cure for patients suffering any type of chronic pain, and pushed it in higher doses.

In the complaint, authorities say both Matalon and an Insys sales representative invited 32-year-old Sarah Fuller into Matalon’s office to teach her about a “new drug that could treat her chronic pain.” Fuller had fibromyalgia.

During that meeting, Matalon and the Insys sales representative told Fuller that Subsys would help greatly with her chronic pain, but neither told her that Subsys was an opiate-based medication or explained the risks associated with its use or misuse, according to the complaint.

Matalon prescribed Subsys to Fuller for 14 months, issuing her final prescription on March 17, 2016. Eight days later, on March 25, 2016, Fuller died. The postmortem toxicology examination revealed the woman had "significant levels of fentanyl metabolites in her blood at the time of death."

Matalon has said she was also misled by the Insys sales representative about using Subsys to treat Fuller.

In the complaint, the state maintains that by enrolling in the TIRF REMS (Risk Evaluation and Mitigation Strategy) Access Program, Matalon acknowledged she had read the risks associated with Subsys, and understood that it was approved only for narrow uses as a cancer pain medication and that any "off-label" use could result in a fatal overdose.

Subsys is the brand name of one of six transmucosal immediate release fentanyl ("TIRF") medications that instantly deliver the powerful painkiller fentanyl through the oral membranes. The only federally approved use for TIRF substances, including Subsys, is for the management of breakthrough pain in adult cancer patients who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.

Because TIRF medicines carry a high risk for misuse, abuse, addiction, overdose, and serious complications due to medication error, the FDA has subjected them to significant restrictions.

Doctors who wish to prescribe these medications must enroll in this program, which requires prescribers to undergo educational training about the drug's risks and enroll their TIRF patients in the program.

Matalon resolved the allegations against her in a Consent Order with the Board that revokes her license and her NJ CDS Registration that allowed her to prescribe controlled substances in this state last week.

Matalon must also pay a civil penalty of $40,000, $20,000 of which will be stayed if she complies with the terms of the Consent Order; and orders her to reimburse the state $19,500 in costs and attorney’s fees.

Matalon is ineligible to reapply for her license for three years, six months from the date that the temporary suspension of her license became effective, Oct. 31, 2016.

Before reapplying for her license, Matalon must successfully complete a Board- approved course in ethics. She must also successfully complete a Board-approved course in CDS prescribing should she wish to resume prescribing controlled substances upon her return to practice.

As part of the re-application process, she would have to appear before the Board to demonstrate her fitness to resume practice, at a minimum demonstrating her compliance with all the terms contained in the Consent Order, including payment of all penalties and costs.

Patients who believe they were prescribed Subsys or any other TIRF medication in violation of the FDA restrictions should contact the Division of Consumer Affairs by calling 1-800-242-5846 (toll free within New Jersey) or 973-504-6200.

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