Cherry Hill Doctor Wrongfully Prescribed Powerful Painkiller To 3 Patients, Killing 1, State Says

Cherry Hill, NJ -- The State of New Jersey is seeking the temporary license suspension of a family physician in Cherry Hill it says indiscriminately prescribed a powerful spray form of the painkiller fentanyl to three patients, one of whom died.

Dr. Vivienne Matalon prescribed “Subsys,” an oral fentanyl spray approved by the federal Food and Drug Administration (FDA) strictly to treat breakthrough pain in cancer patients, to three patients who did not meet that criteria, authorities allege.

One of those patients, a 32-year-old woman, died in March from “adverse effect of drugs,” according to her autopsy report.

Matalon has offices in Cherry Hill and Camden, Attorney General Christopher S. Porrino and the Division of Consumer Affairs said on Monday. Matalon's attorney was not immediately available for comment.

The state says her conduct constitutes the use of fraud, deception, and misrepresentation; professional misconduct; gross negligence that endangered the life, health, safety, and welfare of the three patients; and indiscriminate prescribing of controlled dangerous substances (CDS).

It filed a Verified Complaint and Order to Show Cause filed before the state Board of Medical Examiners late last week, and Matalon must appear before the board on Oct. 26 to show why her license shouldn’t be suspended.

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, according to authorities.

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, authorities said.

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

The medicine is not for use in opioid non-tolerant patients because life threatening respiratory depression and death could occur at any dose in patients not taking chronic opioids.

Doctors who wish to prescribe Subsys must enroll in the TIRF REMS (Risk Evaluation and Mitigation Strategy) Access Program. The program requires prescribers to undergo educational training about the drug’s risks and enroll their Subsys patients in the program.

By enrolling in the 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, according to the state’s complaint.

Even after this, Matalon prescribed the drug to three people who didn’t meet the criteria for the prescription, authorities allege.

One patient was being treated for a wide variety of medical conditions, including chronic pain, diabetes, fibromyalgia, and urinary tract infection.

However, authorities allege that Matalon never diagnosed this patient with, or treat her for, breakthrough cancer pain, despite the fact that she prescribed Susbys to this patient in January of last year.

She also never explained the risks or dangers associated with Subsys’s use and misuse, the state says.

This prescription lasted for 14 months, before the patient was ultimately found dead on March 25, 2016, eight days following her last prescription, according to the state.

The postmortem toxicology examination revealed that the victim had “significant levels of fentanyl metabolites in her blood at the time of death.”

Another patient had a history of cancer, but wasn’t suffering with cancer or breakthrough cancer pain when Matalon was treating her.

Nonetheless, the state says Matalon placed this patient, a 61-year-old woman, on a pain management medication regime that included Subsys.

From December of 2014 to September of 2015, Matalon prescribed the drug on and off to this patient, discontinuing it twice when the patient complained of nausea, vomiting and dizziness.

The state alleges that Matalon’s medical records for this patient “contain pervasive misrepresentations regarding her medical conditions, including but not limited to, false diagnoses of cancer.”

Matalon’s records contained documentation from the woman’s oncology group that showed she had been cancer-free for five years, the state alleges.

However, Matalon noted in some, but not all, of her progress notes a present diagnosis of cancer.

The state also alleges Matalon submitted at least one form to an insurance carrier on behalf of the patient, in which she represented that she had diagnosed the patient with cancer.

The final patient, a 25-year-old woman, was treated by Matalon for a variety of medical conditions, including rheumatoid arthritis, and Crohn’s disease.

The state alleges that Matalon never diagnosed this patient with, or treated her for, cancer or breakthrough cancer pain, despite prescribing her Subsys in April of 2015.

That patient’s insurance carrier denied coverage of Subsys because Matalon had prescribed it for a reason that is not medically accepted.

In a letter to the insurance carrier, Matalon appealed the denial, saying the patient suffered from “almost constant severe pain” and “severe breakthrough pain” and recommending Subsys as a “medical necessity for offering this patient as much quality of life as possible.”

Last week, as part of an Attorney General initiative to determine whether doctors have been prescribing Subsys according to United States Food and Drug Administration Guidelines, investigators with the Enforcement Bureau within the Division of Consumer Affairs inspected patient records at six doctors’ offices statewide, and subpoenaed patient records from 10 others.

Inspections and investigations of off-label prescribing of Subsys will continue as part of this initiative.

The Attorney General’s Office and the Division of Consumer Affairs have undertaken a series of initiatives to combat heroin and opiate abuse in New Jersey, including the creation and upgrading of the New Jersey Prescription Monitoring Program database, which collects prescription data on Controlled Dangerous Substances (CDS) and Human Growth Hormone (HGH) dispensed in New Jersey, and Project Medicine Drop, which enables New Jerseyans to dispose of their unwanted medications, 24 hours a day, 7 days a week.

Recently, the Director of the Division of Consumer Affairs executed an emergency order to ban the manufacture, distribution and sale of seven illicit fentanyl analogs, including furanyl fentanyl and carfentanyl.

These analogs have no legitimate medical purpose, and have been linked to abuse, overdose, and even death, authorities said.

Patients who believe they were prescribed Susbys 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.