New York, NY – Geoffrey S. Berman, the United States Attorney for the Southern District of New York, and William F. Sweeney Jr., the Assistant Director-in-Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), recently announced the unsealing of an Indictment in Manhattan federal court charging five Manhattan doctors, GORDON FREEDMAN, JEFFREY GOLDSTEIN, TODD SCHLIFSTEIN, DIALECTI VOUDOURIS, and ALEXANDRU BURDUCEA, with participating in a scheme to receive bribes and kickbacks in the form of fees for sham educational programs (“Speaker Programs”) from a pharmaceutical company (“Pharma Company-1”) in exchange for prescribing millions of dollars’ worth of a potent fentanyl-based spray manufactured by Pharma Company-1 (the “Fentanyl Spray”), among other offenses. FREEDMAN, GOLDSTEIN, SCHLIFSTEIN, VOUDOURIS, and BURDUCEA were arrested this morning. All are expected to be presented before U.S. Magistrate Judge Sarah Netburn in Manhattan this afternoon.
Also unsealed were the guilty pleas of two former Pharma Company-1 employees, Jonathan Roper and Fernando Serrano, in connection with their participation in the bribery and kickback scheme. Both Roper and Serrano are cooperating with the Government.
Manhattan U.S. Attorney Geoffrey S. Berman said: “These prominent doctors swore a solemn oath to place their patients’ care above all else. Instead, they engaged in a malignant scheme to prescribe Fentanyl, a dangerous and potentially fatal narcotic 50 to 100 times more potent than morphine, in exchange for bribes in the form of speaker fees. Payments from pharmaceutical companies should not influence how doctors prescribe — especially when a potent and dangerous drug like Fentanyl is involved. This scheme to use their patients as an instrument for profit has resulted in the indictment of five physicians.”
FBI Assistant Director-in-Charge William F. Sweeney Jr. said: “A substance as powerful as Fentanyl should be prescribed based only on doctors’ own independent medical judgment. In this case, as alleged, a series of doctors were convinced to push aside their ethical obligations and prescribe a drug for profit to patients who turned to them for help. Doctors and medical professionals everywhere should be reminded of the faith and trust placed upon them, and that the health and safety of their patients is not for sale.”
As alleged in the Indictment unsealed in Manhattan federal court:
The Fentanyl Spray
The Fentanyl Spray, which is manufactured by Pharma Company-1, is a powerful painkiller that is approximately 50 to 100 times more potent than morphine. The FDA approved the Fentanyl Spray only for the management of breakthrough pain in cancer patients. Prescriptions of the Fentanyl Spray typically cost thousands of dollars each month, and Medicare and Medicaid, as well as commercial insurers, reimbursed prescriptions written by the defendants.
The Speaker Program Bribery and Kickback Scheme
Pharma Company-1 launched a “Speakers Bureau” in or about August 2012. While the Speakers Bureau was purportedly aimed at educating other practitioners about the Fentanyl Spray, in reality Pharma Company-1 used its Speakers Bureau to induce the doctors to prescribe large volumes of the Fentanyl Spray by paying them Speaker Program fees.
Speakers were supposed to conduct a slide presentation for other health care practitioners regarding the Fentanyl Spray at each Speaker Program. In reality, many of the Speaker Programs led by the defendants were predominantly social affairs where no educational presentation about the Fentanyl Spray occurred. Attendance sign-in sheets for the Speaker Programs were frequently forged by adding the names and signatures of health care practitioners who had not actually been present.
Freedman’s Participation in the Scheme
FREEDMAN was a doctor certified in pain management and anesthesiology who owned a private pain management office on Manhattan’s Upper East Side. FREEDMAN, who was also an Associate Clinical Professor at a large hospital in Manhattan (“Hospital-1”), received approximately $308,600 in Speaker Program fees from Pharma Company-1 in exchange for prescribing large volumes of the Fentanyl Spray.
In March 2013, a Regional Sales Manager for Pharma Company-1 sent an email to FREEDMAN informing him that he would receive more Speaker Programs in the coming months because Pharma Company-1 wanted prescriptions of the Fentanyl Spray to increase, and urging FREEDMAN to put more patients on the Fentanyl Spray. FREEDMAN responded, in part, “Got it,” and significantly increased his Fentanyl Spray prescriptions in the following months, during which he received approximately $33,600 in Speaker Program fees.
In 2014, FREEDMAN’s prescriptions of the Fentanyl Spray rose even further, and he was the fourth-highest prescriber of the Fentanyl Spray nationally in the final quarter of 2014, accounting for approximately $1,132,287 in overall net sales of the Fentanyl Spray in that quarter. During 2014, FREEDMAN was the highest-paid Pharma Company-1 Speaker in the nation, receiving approximately $143,000.
GOLDSTEIN’s Participation in the Scheme
GOLDSTEIN was a doctor of osteopathic medicine who owned a private medical office on the Upper East Side. GOLDSTEIN received approximately $196,000 in Speaker Program fees from Pharma Company-1 in exchange for prescribing large volumes of the Fentanyl Spray. After GOLDSTEIN began prescribing a competitor painkiller, Pharma Company-1 pressured him to stop doing so and switch patients to the Fentanyl Spray, which GOLDSTEIN did.
In 2014, GOLDSTEIN was approximately the fifth-highest-paid Pharma Company-1 Speaker nationally. He was the sixth-highest prescriber of the Fentanyl Spray in the last quarter of 2014, accounting for approximately $809,275 in overall net sales of the Fentanyl Spray in that quarter.
SCHLIFSTEIN’s Participation in the Scheme
SCHLIFSTEIN was a doctor certified in physical medicine and rehabilitation who co-owned with GOLDSTEIN a private medical office on the Upper East Side. SCHLIFSTEIN, who also worked as an attending physiatrist and consulting physician at two other Manhattan hospitals, received approximately $127,100 in Speaker Program fees from Pharma Company-1 in exchange for prescribing large volumes of the Fentanyl Spray.
In or about October 2013, SCHLIFSTEIN expressed an interest in becoming a Speaker for Pharma Company-1. So a senior Pharma Company-1 executive traveled to New York, and took SCHLIFSTEIN, GOLDSTEIN, and others, to a Manhattan strip club where Pharma Company-1 spent approximately $4,100 on a private room, alcoholic drinks, and “lap dances” for SCHLIFSTEIN and GOLDSTEIN. In the month following that outing and SCHLIFSTEIN’s nomination as a Speaker, SCHLIFSTEIN’s Fentanyl Spray prescriptions increased substantially.
In late 2014, Pharma Company-1 significantly decreased SCHLIFSTEIN’s Speaker Programs in order to send a message to SCHLIFSTEIN that he would need to prescribe larger volumes of the Fentanyl Spray. In response, SCHLIFSTEIN repeatedly requested more Speaker Programs. Pharma Company-1 told SCHLIFSTEIN it would assign him more Speaker Programs only if he prescribed larger volumes of the Fentanyl Spray. SCHLIFSTEIN’s Fentanyl Spray prescriptions then increased substantially, and Pharma Company-1 rewarded him with more Speaker Programs.
By the end of the second quarter of 2015, SCHLIFSTEIN was approximately the 19th-highest prescriber of the Fentanyl Spray nationally, accounting for approximately $593,373 in net sales in that quarter.
VOUDOURIS’s Participation in the Scheme
VOUDOURIS was a doctor specializing in oncology and hematology who worked at a private medical office on the Upper East Side, and was an Assistant Clinical Professor at Hospital-1. VOUDOURIS received approximately $119,400 in Speaker Program fees from Pharma Company-1 in exchange for prescribing large volumes of the Fentanyl Spray.
In September 2014, VOUDOURIS, who had recently been nominated as a Speaker, had dinner with, among others, several Pharma Company-1 executives, as well as Roper and Serrano. During the dinner, the Pharma Company-1 Vice-President of Sales told VOUDOURIS that he wanted her to prescribe the Fentanyl Spray to one new patient every day, and that VOUDOURIS would be allocated Speaker Programs if she continued prescribing the Fentanyl Spray.
In the week that followed the dinner, VOUDOURIS did not prescribe what Pharma Company-1 viewed as an adequate quantity of the Fentanyl Spray. Roper and Serrano met with VOUDOURIS and told her that Pharma Company-1 expected VOUDOURIS to write more Fentanyl Spray prescriptions. In the months that followed the dinner and this conversation, VOUDOURIS’s Fentanyl Spray prescriptions rose significantly.
By the end of the first quarter of 2015, VOUDOURIS was approximately the 10th-highest prescriber of the Fentanyl Spray nationally, accounting for total net sales of the Fentanyl Spray of approximately $581,500 in that quarter.
BURDUCEA’s Participation in the Scheme
BURDUCEA was a doctor certified in pain management and anesthesiology, was an Assistant Professor of anesthesiology at Hospital-1, and practiced at an anesthesiology and pain management office associated with Hospital-1. BURDUCEA received approximately $68,400 in Speaker Program fees from Pharma Company-1 in exchange for prescribing large volumes of the Fentanyl Spray. In addition, Pharma Company-1 hired BURDUCEA’s then-girlfriend, now wife (“CC-1”), to work as BURDUCEA’s sales representative and paid her in large part based on the volume of Fentanyl Spray prescribed by her assigned doctors, including BURDUCEA.
By the end of the end of the second quarter of 2015, BURDUCEA was approximately the 14th-highest prescriber of the Fentanyl Spray nationally, accounting for total net sales of the Fentanyl Spray of approximately $621,345 in that quarter.
The maximum potential sentences in this case are prescribed by Congress and are provided here for informational purposes only, as any sentencing of the defendants will be determined by a judge.
Mr. Berman praised the investigative work of the FBI, and thanked HHS OIG and the New York City Police Department for their participation in the investigation.
The case is being prosecuted by the Office’s Complex Frauds and Cybercrime Unit. Assistant U.S. Attorneys Noah Solowiejczyk and David Abramowicz are in charge of the prosecution; paralegal specialist Jake Sidransky provided additional support.
 As the introductory phrase signifies, the entirety of the text of the Indictment and the description of the Indictment set forth herein constitute only allegations, and every fact described should be treated as an allegation.
Source: US Attorney’s Office