Background/Procedural History:
In May 2019, after a federal jury trial in Boston, the founder and four former executives of Insys Therapeutics Inc. were convicted in connection with bribing medical practitioners, through the provision of speaker event fees, to prescribe Subsys, a sublingual fentanyl spray intended for patients experiencing breakthrough pain, and for defrauding Medicare and private insurance carriers.
Following the trial in that matter, in November of 2020, the New Jersey Attorney General’s Division of Law (NJAG), on behalf of the New Jersey Board of Medical Examiners (NJBME), filed complaints against four separate New Jersey-based physicians, who were identified as having prescribed Subsys and also participating in speaker programs on behalf of Insys. The primary allegation in all four of these complaints was that these doctors accepted speaker fees from Insys as “bribes” in exchange for prescribing Subsys to their chronic pain management patients. Our law firm represented one of those physicians, a former Mayor, US Army veteran and fellowship-trained pain management physician based in underserved Union City in northern Hudson County, New Jersey. In settlement discussions, the NJAG sought a full revocation of our client’s license to practice medicine in the State of New Jersey, along with the AG’s legal and investigative costs totaling $194,629.50, an “offer” which, if accepted, would have effectively ended our client’s 30-year career.
Based on the underlying facts and the report of our own quadruple board-certified pain management expert, we became convinced that the allegations directed against our client were completely and unequivocally false. Our investigation concluded that our client had only limited interaction with only one Insys sales representative, Susan Beisler. A review of the transcript of Ms. Beisler’s own (prior) sworn testimony during the aforementioned 2019 Insys criminal trial introduced no evidence, or even implication, that our client was aware of any quid pro quo regarding prescribing and speaker fees, or any indication that Ms. Beisler herself ever suggested any quid pro quo to our client. Rather, the evidence clearly demonstrated that:
(1.) Our client prescribed Subsys due to its efficacy and effectiveness in abating chronic pain, not for any monetary reward.
(2.) Prescribing fentanyl-based medications off-label does not violate any applicable standard of care.
(3.) No applicable law or regulation prohibits providers from prescribing Subsys for non-cancer patients and in fact, the evidence demonstrates that most TIRF REMS prescriptions by pain prescribers across the United States were written for non-cancer pain.
(4.) The patients for whom our client prescribed Subsys suffered long term, intractable pain for many years and obtained genuine pain relief which helped them function in their life’s activities.
With regard to alleged “kickbacks” in the form of speaker fees, it was clear to us that neither the Code on Interactions with Healthcare Professionals, adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA) (Section 7) or any other applicable New Jersey and federal laws and regulations were violated, as our client received only “reasonable payment for bona fide participation as a speaker at a professional workshop or seminar” pursuant to applicable state law. In addition, the NJAG’s own expert had accepted ten times more speaker fees than our client from various pharma companies over the same five-year time period.
Initial Decision of the ALJ
The matter was the subject of multiple days of testimony before an Administrative Law Judge (ALJ) in the New Jersey Office of Administrative Law during the summer of 2023, in which we presented our client, two experts and two of our client’s patients (who have been using his services for decades) as witnesses to refute the NJAG’s allegations.
On November 27, 2023, the ALJ issued her Initial Decision, which rejected all of the Attorney General’s complaint alleging bribery and improper prescribing, but concluded that our client’s recordkeeping violations, although not of a gross nature, failed to meet the appropriate standard of care. The ALJ accordingly recommended a six-month active license suspension, a remedial course in record-keeping and 20% of the applicable costs and fees.
Exceptions Brief
In our Exceptions Brief, we requested that the NJBME to sustain the ALJ’s decision with regard to discarding the AG’s allegations of bribery and improper prescribing. However, we argued further that a six-month suspension for a record-keeping violation that, in the ALJ’s opinion, was “not of a gross nature,” was excessive and that our client should receive only a reprimand. To bolster our case, we provided five prior NJBME Orders relating to violations of record-keeping, for which all of the subjects received only reprimands.
The Board‘s Final Decision
In a January 10, 2024 hearing before the Board of Medical Examiners, the NJBME adopted the ALJ Initial Decision in full, but after a Mitigation Hearing, reduced the penalty from a six-month active suspension to only a reprimand, with costs and penalties of less than half the amount of the $194,629.50 demanded by the AG.
By sustaining our opposition to this prosecution and fighting it through, our client’s livelihood was preserved and his good name clear, and he is now able to resume using his valuable dedication and expertise to relieve pain.
Our health care practice group focuses on defending healthcare providers and other clients in the healthcare space in connection with state and federal criminal investigations/prosecutions related to healthcare fraud, commercial bribery/kickbacks (including EKRA), and other criminal offenses, civil actions under state and federals False Claims Acts, insurance fraud laws (e.g., the Insurance Fraud Prevention Action), the Racketeer Influenced Corrupt Organization Act and other civil laws (including by no-fault/personal injury protection carriers), as well as Medicare/Medicaid, regulatory agency investigations/actions (e.g., DEA, Bureau of Fraud Deterrence, Drug Control Unit), and third-party payor/pharmacy benefits manager audits, investigations, self-disclosures and actions. Please contact us regarding any questions.
These stories are successful case results from our attorneys. Please note that results may vary depending on your particular facts and legal circumstances.