Philadelphia, Pennsylvania - A Pennsylvania doctor pleaded guilty to fraud and drug importation charges for his role in a scheme to illegally import medications not approved by the U.S. Food and Drug Administration (FDA) and administer these medications to his patients, and unlawfully distributing oxycodone to his patients.

Thomas J. Whalen, D.O., 65, a Havertown, Pennsylvania, rheumatologist pleaded guilty to one count of health care fraud, one count of importation contrary to law and two counts of distribution of controlled substances before U.S. District Judge Timothy J. Savage of the Eastern District of Pennsylvania.  Sentencing is scheduled for April 1, 2020, before Judge Savage.

“The defendant endangered his patients’ health and safety by importing and administering non-FDA approved medications,” said Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division.  “This plea shows that medical professionals who prioritize profit over patient care will face the consequences for their crimes.”

“This guilty plea from Dr. Whalen is the latest example of my office’s commitment to stopping health care fraud and diversion,” said U.S. Attorney William M. McSwain of the Eastern District of Pennsylvania. “We work closely with our partners in the Fraud Section’s Health Care Fraud Strike Force and will continue to root out fraud in the medical profession. Specifically, we are committed to stopping criminals in the medical profession from stealing from public programs, threatening the safety of patients, and pushing illegal pills onto the streets.”

“Dr. Whalen placed the health of countless patients at risk by administering non-FDA approved drugs,” said Special Agent in Charge Maureen Dixon of the U.S. Department of Health and Human Services Office of Inspector General’s (HHS-OIG) Philadelphia Office.  “Such medications are not paid for by Medicare due to the risk they may pose to patient health.  Our watchdog agency, along with our law enforcement partners, will continue to protect the public and root out dangerous and costly fraud schemes.”

“Dr. Whalen has pleaded guilty to the unlawful distribution of oxycodone, which is a powerful prescription painkiller,” said Special Agent in Charge Jonathan A. Wilson of the U.S. Drug Enforcement Administration’s (DEA) Philadelphia Field Division.  “Of particular concern is that he knowingly prescribed oxycodone to patients who were abusing illegal street drugs such as cocaine and heroin.  Doctors have a professional and moral obligation to treat patients who are struggling with substance use disorder – not enable it.” 

“Dr. Whalen imported and used non-FDA approved drugs from Turkey and the United Kingdom, without any regard for the safety and health of his patients. In addition, he prescribed powerful pain killers to patients already struggling with addiction,” said Acting Special Agent in Charge William Walker of U.S. Immigration and Customs Enforcement’s Homeland Security Investigations (HSI) Philadelphia. “Doctors take an oath to do no harm. This oath was clearly betrayed by not only committing healthcare fraud for his own financial gain, but by contributing to our nation’s opioid crisis. Thanks to our partnership with Customs and Border Protection, we have brought one more person to justice, and many more individuals out of harm’s way.”

“When health care professionals import unsafe, untested prescription drugs from outside the drug supply chain that the FDA oversees, the American public's health and trust are jeopardized,” said Special Agent in Charge Mark S. McCormack of the FDA’s Office of Criminal Investigations (FDA-OCI), Metro Washington Field Office.  “The FDA is committed to pursuing and bringing to justice those who attempt to subvert the safeguards of our closed drug supply by distributing unapproved products.”

“Dr. Whalen falsely billed federal benefit programs, pocketing over a million dollars he wasn’t entitled to,” said Special Agent in Charge Michael T. Harpster of the FBI’s Philadelphia Field Office. “Between that and his unlawful diversion of prescription opioids, Whalen was doing damage on many levels. The FBI will continue to crack down on crooked medical professionals more interested in their profits than their patients.”  

In pleading guilty, Whalen admitted that, from about January 2014 through March 2018, he illegally imported non-FDA-approved biologic medications, including Remicade, Synvisc, Synvisc-One, Orencia, Prolia/Xgeva and Boniva.  Rather than purchase FDA-approved versions of these medicines from authorized distributors, Whalen devised a scheme to purchase much cheaper foreign, non-FDA-approved versions of these medications.  Unbeknownst to his patients, Whalen injected or infused his patients with the non-FDA-approved medications and then falsely billed federal health care benefit programs approximately $2.3 million and was paid directly approximately $1.1 million, and pocketed the profits for himself, he admitted. 

Whalen also admitted to unlawfully distributing oxycodone by prescribing oxycodone to patients outside the course of his professional practice and without a legitimate medical purpose. In particular, with two patients, Whalen prescribed oxycodone despite knowing from a review of patients’ urine drug screen tests that the patients were using illicit drugs, including heroin and cocaine, and/or that each was not taking the mediations that Whalen prescribed.

HHS-OIG, DEA, HSI, FDA-OCI and the FBI investigated the case with assistance from U.S. Customs and Border Protection.  Trial Attorney Debra Jaroslawicz of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Paul J. Koob of the Eastern District of Pennsylvania are prosecuting the case.

The Fraud Section leads the Medicare Fraud Strike Force.  Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged more than 4,200 defendants who have collectively billed the Medicare program for nearly $19 billion.  In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.