Source: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106221.htm
Timestamp: 2015-06-03 19:53:06
Document Index: 470565886

Matched Legal Cases: ['§ 331', '§ 331', '§ 331', '§1341', '§ 331', '§ 331', '§ 331']

Office of Criminal Investigation 2002 Quick Links: Skip to main page content
Office of Criminal Investigation 2002
Five Sentenced in Methamphetamine Case
Investigation Uncovers Conspiracy to Possess Methamphetamine with the Intent to Distribute
This OCI investigation involved the purchase of pharmaceuticals by Northland Providers, a closed door pharmacy, opened and financed by Peter Fenton, Tom Fenton and Jim Bottineau. The partners, upon receiving the pharmaceuticals, would transfer them to their wholesale business, Lakeside Medical Supply, for sale to secondary wholesalers in Michigan and Nevada. The parties collaborated with Candi Creamer and Robert Christy.
The scope of this investigation included historical witness interviews, information from industry sources, trash covers, pen register/toll record/trap and trace analysis, and physical surveillance provided probable cause for the Title III in captioned investigation during December 1998 -- February 1999. Agents executed search warrants simultaneously in 5 states and 31 forfeiture seizure warrants, executed in Minnesota and California, lead to the seizure of approximately $1 million in cash, $350,000 in vehicles, approximately $850,000 in pharmaceutical inventory, and bond default of $100,000.
October 6, 1999, Peter Fenton was convicted of four felony charges in the District of Minnesota, including conspiracy to commit mail fraud and wire fraud, money laundering, felon in possession of a firearm, and conspiracy to possess methamphetamine with the intent to distribute.
On November 18, 1999, Candi Creamer was convicted of two felony charges, including conspiracy to commit mail and wire fraud and money laundering.
On February 4, 2000, Robert Christy was convicted of one felony count of possession of methamphetamine with intent to distribute and distribution of methamphetamine to Peter Fenton and Candi Creamer.
On August 23, 2000, Peter Fenton was sentenced to 87 months incarceration and victim restitution of $4,750,000.
On August 24, 2000, Candi Creamer was sentenced to 30 months incarceration.
On August 25, 2000, Robert Christy was sentenced to 30 months incarceration.
On August 28, 2001, James Bottineau was sentenced to 27 months' incarceration and victim restitution in the amount of $4,750,000.
On September 30, 2002, Tom Fenton was sentenced to 24 months incarceration and victim restitution of $513,432.12.
The sentencing of Tom Fenton concluded the investigation.
Unapproved Drug Promoted for Treatment of Cancer
"Cancer" Drug Found to Contain Fungal Contaminants
This case involved that manufacturing and distribution of an unapproved drug, LK-200, by Private Biologicals Corporation (PBC), Woburn, Massachusetts. LK-200 is an injectable drug that was purported to treat cancer and to help ease the pain for patients suffering from cancer. It has not been approved for use in the United States. PBC was manufacturing LK-200 in its research facility in Woburn, Massachusetts, and was distributing it to cancer patients in the United States and the Bahamas.
Between 1993 and 1995, both Tom Rodgers and T. Ronald Theodore solicited approximately $2 million from numerous investors, by claiming that they had invented a promising new drug for treating cancer. Investors were told that because the drug had not been approved by the FDA, PBC would manufacture the LK-200 overseas using a highly proprietary method of production. Theodore was also holding himself out as an "M.D." to investors, employees and doctors, when he did not have a college degree, a medical degree from a recognized medical school nor was he licensed to practice medicine in the United States.
In reality, the LK-200 was not a result of any discovery by Theodore, but instead was a new name for a preparation that was identified in the 1970's for use in cancer research, which was produced through well known and widely published techniques.
Theodore was manufacturing the LK-200 and packaging it with disregard for good manufacturing practices as required. PBC, in manufacturing the LK-200, maintained a continuous cell culture and made no attempt to control mutation in the cell line being used. As a result, a series of mutations in the cell line occurred while PBC was making the LK-200, with no method in place to determine whether those mutations affected the safety or potency of the product. PBC also failed to maintain proper sterility controls in the final packaging for the product, which was shipped in syringes for injection into end stage cancer patients. In 1995, retained samples were sent for laboratory testing for contamination. Ten of sixty-two samples tested, showed a growth of fungal contaminants.
On May 4, 2000, Tom Rodgers appeared in U.S. District Court, Boston, Massachusetts, and was convicted of three FDA misdemeanor charges as follows: 21 U.S.C. § 331(p) - Unregistered Drug Manufacturing Facility; 21 U.S.C. § 331 (d) -- Unapproved New Drug, and 21 U.S.C. § 331(a) - Adulteration. Rodgers received a sentence of one year supervised probation and a $10,000 fine.
On February 12, 2001, defendant T. Ronald Theodore went to trial in U.S. District Court, Boston, Massachusetts. On March 1, 2002, the jury returned a verdict of guilty on all counts as follows:
9 felony counts of 18 U.S.C. §1341 - Mail Fraud;
1 misdemeanor count each of 21 U.S.C. § 331(p) - Unregistered Drug Manufacturing Facility;
1 count of 21 U.S.C. § 331 (d) Unapproved New Drug; and
1 count of 21 U.S.C. § 331(a) Adulteration.
On March 1, 2002, Theodore was sentenced to 121 months incarceration,