The former owner of Montana Health Care Solutions in Belgrade will serve no prison time for his part in the distribution of imported counterfeit chemotherapy drugs.
Chief U.S. District Court Judge Dana Christensen on Friday sentenced 48-year-old Paul Daniel Bottomley to five years of probation with six months of home confinement and 200 hours of community service.
The U.S. Attorney’s Office had asked for a year and a day of jail time. Christensen, in the Russell Smith Federal Courthouse in Missoula, called Bottomley’s crime “egregious and unlawful and I do not condone it in any way.”
But the judge noted Bottomley’s “unprecedented cooperation” with investigators and his forfeiture of some $4.45 million in personal assets. Those included $1.09 million in currency, 263 acres of land in Gallatin County and a 2011 Aston Martin sports car that sold for $110,000 at auction in April.
Bottomley pleaded guilty in April to the rare felony charge of misprision, or concealment of a felony. He opened Montana Health Care Solutions in 2008 and admitted to importing and distributing misbranded and unapproved drugs from foreign countries to health care professionals.
Bottomley sold the company in October 2010 to a division of Canada Drugs, Rockley Ventures, for $5 million. Bottomley was paid $10,000 a month as a consultant to Rockley, Canada Drugs and related companies following the sale as the company expanded its reach worldwide.
In January 2012, the Food and Drug Administration learned Rockley Ventures was selling the cancer drug Avastin at discount prices to health care professionals. Testing found the knockoff was “not much more than saline solution,” according to Michael Cotter, U.S. attorney for the District of Montana,
An investigation by the FDA’s Office of Criminal Investigations concluded that, while Bottomley had no involvement in the importation and distribution of the drug, he was aware of it by January 2012 and failed to put a stop to it or notify authorities.
Bottomley said he drew on more than 20 years of pharmaceutical experience in determining the drugs were safe and effective, even though he knew they weren’t approved by the FDA.
He told Christensen he accepted responsibility for his bad judgment and for “turning a blind eye” to federal regulations that are created to protect Americans who rely on professionals to administer safe, proper and effective medications.
Bottomley has lost everything except his home, his attorney Jay Lansing of Billings said in asking Christensen not to order incarceration. Bottomley had a spotless prior criminal record, and is a lay minister who hosts church and church-related activities in a barn on his property, Lansing said.
With a wife and two teenage children, Bottomley faces an uncertain future of employment as a convicted felon, Lansing pointed out.
Assistant U.S. Attorney Jessica Fehr argued a jail sentence was warranted, saying that before he was stopped, Bottomley was on a “slippery slope that was, quite frankly, driven by greed.”
The sentencing came on the heels of another in Missouri on Thursday in which Richard Taylor of England was sentenced to 18 months in prison and an $800,000 fine for distributing a Turkish version of Avastin to U.S. doctors. It turned out to be counterfeit.
John Roth, director of the FDA’s Office of Criminal Investigation, was in Missoula on Friday for Bottomley’s sentencing. He said it was only the most recent of a string of convictions in the U.S. for crimes related to distribution of unapproved prescription drugs in the past two years.
“The sentencing today represents a significant milestone in our efforts to protect the public health from substandard, unapproved and counterfeit medications,” Roth said at a news conference afterward at the U.S. Attorney’s Office in downtown Missoula.
Cotter said pharmaceutical distributors such as Bottomley who circumvent the regulatory framework of the industry “are playing Russian roulette with the health of the American public.”
“This case is 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,” said Cotter.
“The true losers in this case were the patients at the end of the distribution chain who received saline solution instead of life-saving chemotherapy drugs.”