A Montana man will not serve time in prison for his role distributing unapproved, misbranded and counterfeit cancer drugs to U.S. physicians after surrendering an estimated $4.5 million in cash and property purchased from the sale of illegal pharmaceuticals.
U.S. District Judge Dana Christensen on Friday sentenced Paul Daniel Bottomley, 48, to six months of house arrest and five years' probation after he pleaded guilty to misprision of a felony, meaning he failed to report a felony crime to authorities.
Federal prosecutors said Bottomley imported mislabeled and unapproved drugs for years, and was a contact for physicians who bought a fake version of the Roche cancer drug Avastin last year.
Prosecutors had asked for a one-year prison sentence for Bottomley, saying they wanted an example to deter others who might circumvent U.S. pharmaceutical regulations and put at risk patients who are looking for cheap drugs.
"Those like Bottomley, who ignore the law and circumvent the regulatory framework, are playing Russian roulette with the health of the American public," U.S. Attorney for Montana Mike Cotter said in a news conference after the sentencing in Missoula.
The judge sided with Bottomley's attorneys, who had asked for a probation sentence. Christensen cited Bottomley's cooperation with authorities in handing down the sentence.
FDA Office of Criminal Investigations director John Roth said all the fake Avastin has been accounted for and Bottomley's conviction is one of the final cases in an investigation into an underground distribution network of illegal pharmaceuticals.
Bottomley founded Montana Health Care Solutions in 2008 and illegally imported misbranded and unapproved cancer drugs, selling them to doctors in the United States for lower prices, an FDA investigation found.
Bottomley sold his company in 2010 to Rockley Ventures, a division of the Internet pharmaceutical company Canada Drugs Ltd. for $5 million, but he remained as an adviser who was paid $10,000 a month. He made sales calls for the company and worked on shipping matters with a mail-order pharmaceutical shipping company in Gainesboro, Tenn., called Volunteer Distribution.
Under Canada Drugs, Montana Health Care Solutions continued illegal drug imports, Cotter said. Last year, it distributed the counterfeit version of Avastin, prosecutors said.
The Food and Drug Administration issued warnings that the fake chemotherapy drug was sold to U.S. cancer clinics and hospitals, and it is unknown how much was administered to patients.
In January 2012, United Kingdom regulators informed U.S. officials that a shipment of fake Avastin was shipped to Volunteer Distribution. U.S. officials tested the drug, and found it did not contain the active ingredient in the legitimate drug and was little more than saline solution.
Thirty-six packs of the fake drug were distributed in the U.S., while five other packets were returned to the wholesaler in the United Kingdom.
FDA investigators interviewed customers that received the drugs, and most said Bottomley was their main contact. Others said the drugs they received from Volunteer Distribution were from orders placed with Montana Health Care Systems, prosecutors said.
Montana Health Care Systems sold the drug for $1,700 per vial, compared to the normal cost of nearly $2,300 per vial.
Even though Bottomley was only a "cog in the wheel" of Canada Drugs at that point, he should have notified the authorities when he became aware that the company was breaking the law, Cotter said.
"This really is a case about greed, the greed of the individuals like Bottomley, the greed of the physicians who purchased discounted, foreign drugs for distribution to their patients suffering from cancer and other serious ailments," Cotter said.
Calls to Canada Drugs were referred to the company's attorney, Curtis Unfried, who said he could not comment on the case because an investigation is underway.
Cotter declined to discuss whether Canada Drugs or the physicians who purchased the drugs would be charged.
Bottomley wrote Christensen a letter prior to the sentencing hearing, saying that he is a religious man with a wife and two teenage daughters whom he would not be able to support if imprisoned.
"We have surrendered everything we have to the Federal Government except our home and are now in a position of considerable debt," he wrote.
Bottomley forfeited an estimated $4.5 million, which included $1 million in cash, 10 parcels of land valued at $3 million and a 2011 Aston Martin sports car that was sold at auction for $110,000.