Guilty Plea In Misbranded Cancer Drug Case In Somerset

(WTVQ-TV, LLC)
(WTVQ-TV, LLC)
Reported by: Tom Kenny
Set Text Size SmallSet Text Size MediumSet Text Size LargeSet Text Size X-Large
Share
Updated: 6/19 11:44 am

Hematology and Oncology Center PLLC (HOC) in Somerset pleaded guilty in federal court on Tuesday to charges of knowingly receiving a misbranded cancer treatment drug and administering it for payment, according to federal prosecutors.

HOC’s former office manager, Natarajan Murugesan, also pleaded guilty, according to documents.

Prosecutors said he admitted to aiding and abetting in the introduction of an unapproved oncology drug into interstate commerce.

HOC and Murugesan’s offenses qualify as misdemeanors under the Food,Drug, and Cosmetic Act.

Investigators said the criminal charges stem from a 2014 civil settlement in which HOC, Murugesan, and Dr. N Mullai agreed to pay $2 million, plus interest, to resolve allegations that they violated the False Claims Act by submitting false claims to the Medicare program for misbranded and unapproved chemotherapy drugs that were administered through HOC’s Somerset clinic.

“The Food, Drug and Cosmetic Act establishes a ‘closed’ system of drugmanufacturing and distribution to protect the safety of drugs used in the United States,” said U.S. Attorney Kerry Harvey.

“Efforts to bypass this system with non-FDA approved foreign source drugs put patients at risk of receiving counterfeit, contaminated, or ineffective medications. The government will continue to prosecute such efforts – particularly when motivated by profit – to minimize the chances of patients receiving unsafe medications, and to ensure that the Medicare program does not pay for unapproved drugs.”

Court documents showed the defendants admitted that, between January 2010 and July 2011, HOC purchased substantial amounts of chemotherapy drugs and other cancer treatment drugs from a foreign distributor in Canada, which was operating under the name Quality Specialty Products (“QSP”).

These drugs were sourced from foreign locations including: Turkey, India, the European Union, the United Kingdom, or other unidentified international locations.

Often, the drugs arrived at HOC with labeling and dosage instructions in foreign languages, according to investigators. 

Some of the QSP drugs were distributed with labeling that wasn’t approved by the United States Food and Drug Administration (FDA), and therefore were misbranded, according to court documents.

Also, many of these QSP drugs were not the version of the international oncology drug approved by the FDA for distribution within the United States, according to prosecutors.

Murugesan was responsible for ordering the drugs from QSP, prosecutors said.

Investigators said he and HOC purchased the foreign QSP drugs for prices substantially below what drugs from FDAapproved manufacturers and distributors cost. Mullai administered the QSP drugs to her patients, and HOC submitted claims for reimbursement to Medicare, which typically does not cover misbranded or unapproved drugs by the FDA.

The parallel civil and criminal investigation was conducted by the FDA, Office of Criminal Investigations (FDA-OCI), and the plea agreements and settlement resulted from joint efforts of FDA-OCI, the Department of Health and Human Services, Office of Inspector General (HHS-OIG), and the U.S. Attorney’s Office.

HOC and Murugesan are scheduled to be sentenced on October 3, 2014.

HOC faces up to five years of probation and a maximum fine of $200,000.

 Murugesan faces up to one year in prison and a maximum fine of $100,000.

However, any sentence will be imposed by the Court after consideration of the U.S. Sentencing Guidelines and other federal statutes.


Share
Most Popular
Witnesses Record Standoff In Richmond Saturday Night
Two men saw the standoff in Richmond Saturday night between multiple law enforcement agencies and 29-year-old Jesse Aaron Gibbons, and recorded it. Troopers said Gibbons died on the way to the hospital. Video Video
UPDATE: Suspect Shot To Death By Police Identified
The Fayette County Coroner released the name of the man shot and killed by police after a shootout in Richmond Saturday night. Video Video
Five Arrested In Laurel County Drug Bust
Five people were arrested Saturday morning after deputies found they had drugs in their home. Video Video
Suspect Dies After Chase And Shootout With Police
Lexington police say the suspect assaulted an officer in Lexington. The suspect fled south to Richmond, where KSP says the suspect fired at officers. KSP says officers returned fire, and the suspect died at UK Hospital
Judge: Too Late to Sue for Misdiagnosis of HIV
A big court ruling involving a Lexington man who claimed UK doctors mistakenly told him he was HIV positive only to find out nearly a decade later, he wasn’t. Video Video
Inergize Digital This site is hosted and managed by Inergize Digital.
   

WTVQ.com supports children's privacy rights. All persons under the age of 13 MUST have parental permission to use this website and direct parental supervision is strongly recommended.