CORPUS CHRISTI, Texas (CN) - A Texas oncologist who was forced to close his practice after it was charged with distributing misbranded cancer drugs has sued his suppliers, claiming they told him the drugs were FDA-approved.
Dr. Mohamad Ayman Ghraowi once had a thriving business. His company, South Texas Comprehensive Cancer Centers, had five clinics in South Texas that treated patients with cancer and blood diseases. But a federal investigation spelled the end for the company.
Federal prosecutors filed a criminal information against the company in March. It agreed to pay a $900,000 fine - the price of the misbranded drugs - and to be put on probation for 5 years for its purchases since 2010 of cancer drugs from wholesale supplier Paul Bottomley.
The criminal information lists 23 misbranded drugs that Bottomley's company sold to Ghraowi's, many of them cancer therapies, including Erbitux, Herceptin, Rituxan and Neulastim.
When Bottomley started selling to Ghraowi's practice, he had just sold his company Montana Healthcare Solutions to Rockley Ventures, a subsidiary of online dealer Canada Drugs Ltd. of Winnipeg, and was working for them, according to Ghraowi's lawsuit, and to FDA statements about its investigation.
Ghraowi sued Bottomley, Montana Healthcare Solutions and Rockley Ventures on Oct. 8 in Federal Court.
The oncologist claims his purchasing manager, his pharmacist and he himself became concerned that the drugs Bottomley was supplying "may not have been FDA approved" because they had unusual markings.
Ghraowi says Bottomley eased his fears by telling him numerous doctors were buying the drugs. But that didn't help Ghraowi when the Department of Justice charged his company with buying "misbranded prescription drugs" from Montana Healthcare Solutions for two years, from February 2010 to January 2012.
The case broke when the Food and Drug Administration got word from a United Kingdom regulatory agency that counterfeit versions of Avastin - used intravenously with other drugs to treat brain tumors, lung, kidney and rectal cancers - had been shipped by a UK wholesaler to a company in Gainesboro, Tenn., called Volunteer Distribution.
Volunteer Distribution had a distribution contract with QSP, a subsidiary of Canada Drugs, according to the FDA and the Department of Justice.
Lab tests revealed the drugs didn't contain any of the active ingredient found in genuine Avastin, which typically goes for $2,300 a vial. Montana Healthcare Solutions sold it for $1,700 a vial, according to the FDA and federal prosecutors.
Bottomley was sentenced in July 2013 to 6 months house arrest, 5 years of probation, 200 hours of community service and ordered to forfeit $4.5 million for misprision of a felony.
In a separate civil proceeding, Bottomley agreed to forfeit $1 million, a 2011 Aston Martin and 10 plots of land in Gallatin County, Montana.
The federal investigation led to Ghraowi and his company, which pleaded guilty in April to a violation of the Food, Drug and Cosmetic Act.
Ghraowi says his business couldn't survive the prosecution and attendant bad publicity.
"South Texas Comprehensive Cancer Centers PLLC was forced to sell off its equipment, close its offices and Dr. Ghraowi was economically forced, as a direct and proximate result of the conduct of the defendants, acting jointly or severally, individually or collectively, to become, at this late stage in his career, basically a staff doctor at Spohn Hospital," the complaint states.
Ghraowi wants the defendants held liable for the $900,000 fine, lost wages and treble damages for RICO Act violations.
He is represented by William Tinning of Portland, Texas.
As for Canada Drugs Ltd., a federal indictment unsealed in Montana on Aug. 7 charged the company with selling $78 million worth of mislabeled, unapproved and counterfeit drugs to U.S. doctors for three years.
The Canadian Department of Justice and the Royal Canadian Mounted Police raided Canada Drugs headquarters in Manitoba in April. The company's wholesale prescription drug license was temporarily suspended in January 2014.
A spokesman for Canada Drugs referred Courthouse News to the company's subsidiary Rockley Ventures, and refused further comment.
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