State Files Action Against a Camden County Doctor For Allegedly Indiscriminately Prescribing "Subsys," a Highly Restricted Form of Painkiller Fentanyl to Patients, Including One That Died
NEWARK – Attorney General Christopher S. Porrino and the Division of Consumer Affairs today announced that the State has filed an action seeking the temporary license suspension of a Cherry Hill family physician for allegedly indiscriminately prescribing a powerful spray form of the painkiller fentanyl to three patients, one of whom died.
Dr. Vivienne Matalon, who maintains offices in Cherry Hill and Camden, allegedly 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. One of those patients, a 32-year-old woman, died in March from "adverse effect of drugs," according to her autopsy report.
"Given that opioid overdoses are killing more people in New Jersey than car crashes, it is appalling that a doctor would willfully disregard the federal restrictions placed on this extremely potent drug, and abdicate her professional obligation to keep her patients safesaid Attorney General Porrino. "Dr. Matalon's actions demonstrate a level of professional misconduct that requires immediate intervention to protect the health, safety, and welfare of the public."
In a Verified Complaint and Order to Show Cause filed before the state Board of Medical Examiners late last week, the State alleged Matalon's 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). Matalon is ordered to appear before the Board October 26, 2016 to show cause why her license should not be temporarily suspended pending final disposition of the allegations against her.
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.
"Doctors who prescribe Subsys for non-approved uses are deviating from the well-established standard of care regarding this drug and exposing their patients to grave risk of serious harm," said Steve Lee, Director of the Division of Consumer Affairs. "The Board of Medical Examiners, under the Division, will investigate and take action against any doctor acting in such an egregious and reckless manner."
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. 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.
Nonetheless, the State alleges, Matalon prescribed Subsys to three patients, identified in the Complaint by their initials, who did not fit the criteria for receiving the drug.
Patient "S.F." was being treated by Matalon for a wide variety of medical conditions, including chronic pain, diabetes, fibromyalgia, and urinary tract infection. The Complaint alleges that at no time during Matalon's treatment of S.F. did she diagnose the patient with, or treat her for, breakthrough cancer pain. Nonetheless, Matalon allegedly began prescribing Subsys to S.F. in January 2015, without ever explaining the risks or dangers associated with Subsys's use and misuse.
Matalon continued to prescribe Subsys to S.F. for 14 months, issuing her final prescription on March 17, 2016. Eight days later, on March 25, 2016, S.F. died. The postmortem toxicology examination revealed that S.F. had "significant levels of fentanyl metabolites in her blood at the time of death."
Patient "M.C." is a 61-year-old woman who has a prior history of cancer, but was not suffering with cancer or breakthrough cancer pain when Matalon was treating her. Nonetheless, Matalon placed M.C. on a pain management medication regime that included Subsys. From December 2014 to September 2015 Matalon prescribed the drug on and off to M.C., discontinuing it twice when the patient complained of nausea, vomiting and dizziness.
The Complaint alleges that Matalon's medical records for M.C. "contain pervasive misrepresentations regarding M.C.'s medical conditions, including but not limited to, false diagnoses of cancer." Matalon's records contained documentation from M.C.'s oncology group that reflected the woman had been cancer-free for five years, yet Matalon noted in some, but not all, of M.C.'s progress notes a present diagnosis of cancer. Matalon also allegedly submitted at least one form to an insurance carrier on behalf of M.C. in which she represented that she had diagnosed M.C. with cancer.
Patient L.A., a 25-year-old woman, was treated by Matalon for a variety of medical conditions, including rheumatoid arthritis, and Crohn's disease. As the Complaint alleges, at no time did Matalon diagnose L.A. with, or treat her for, cancer or breakthrough cancer pain. Nonetheless, Matalon prescribed L.A. Subsys in April 2015. L.A.'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 L.A. 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."
Investigators with the Enforcement Bureau within the Division of Consumer Affairs conducted the investigation.
Deputy Attorney General Christopher Salloum, of the Professional Boards Prosecution Section in the Division of Law, is representing the State in this matter.
Svetlana Ross, Esq., of Kern Augustine, PC is representing Matalon in this matter.
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.
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