The Oregon state attorney general’s office investigated the company after the three deaths. David Hart, who prosecuted the case against ApotheCure for the attorney general’s office, said he thinks the FDA missed a critical opportunity in 2004 when it didn’t get the search warrant.
“Arguably, if action had been taken earlier by the FDA, this could have been prevented,” he said.
When the FDA was notified of the 2007 deaths, this time the agency got a warrant for the facility. The agency identified 13 deficiencies and Texas authorities found 80 deficiencies and violations, records show.
In its report, the FDA noted that products were not tested for potency prior to shipping — something that could have prevented the deaths. But that didn’t violate the law because testing for potency and sterility is not required of compounders, noted ApotheCure attorney James J. Doyle III in a written comment.
The agency’s and state board’s findings became the backbone for state complaints in Texas and Oregon and a Justice Department lawsuit filed against Osborn and his company, state and federal records show.
At the time of the fatal incidents, Osborn told the Associated Press that the colchicine mishap was due to “human error.” Osborn declined interview requests from The Post. His attorney, Lawrence J. Friedman, said he thinks his client was unfairly singled out.
“They decided to make an example out of ApotheCure,” Friedman said.
After the 2007 incident, Friedman said, his client hired consultants and “doubled, even tripled,” safety precautions.
However, a Dec. 20, 2010, internal audit of ApotheCure, obtained by The Post, showed that three years after the FDA investigated, the pharmacy was still riddled with unsanitary conditions.
Insect body parts were found in “clean rooms” where sterile products were compounded. A suspended ceiling, with exposed pipe, wiring and duct work, allowed “contaminants to flow over the sterile suite and fall through the suspended ceiling.”
The Texas pharmacy board returned last year and found a few minor problems. All of them have since been corrected, said Gay Dodson, the board’s executive director.
In 2012, Osborn pleaded guilty to misdemeanor criminal violations of the federal Food, Drug and Cosmetic Act for the colchicine-related deaths. Osborn was ordered to pay a combined $400,000 in fines to settle the DOJ, Texas and Oregon complaints directed at him and his company. The terms of settlements with victims’ families are confidential.
Osborn’s company — which has about $10 million in annual sales — is still in operation.
“People make mistakes, but there is nobody watching over these people,” said Christopher Long, whose 56-year-old mother died after receiving the toxic colchicine made by ApotheCure. “The regulatory piece of this, nothing has changed. I realize it takes a long time to rein things in, but my mother is dead, ApotheCure is still in operation and people have died again.”