FDA defends its oversight of syringe firm

Martin's two sons, 8-year-old Michael and 6-year-old Cody, are hemophiliacs who need regular injections of medicine to reduce the potential that they could bleed to death from even the smallest cut.

Martin uses pre-filled syringes of saline and the blood thinner Heparin to flush out ports in their chests so he can inject the life-saving drugs. In January 2008, a tainted syringe gave Michael the severe bacterial infection that almost killed him.

"He was lying on the couch. Normally, I go to bed, but for some reason, I went to watch the television, and I noticed the couch was shaking," Martin said, recalling the onset of his son's symptoms.

Within minutes, Michael's temperature shot above 106 degrees, and his father rushed him to a hospital, where Michael underwent emergency surgery and spent more than a week recovering.

"There's no way he could remember that. He couldn't even walk," Martin said, noting his son had fever-induced hallucinations before surgery. "It scared me bad. I thought that he had irreversible brain damage with a temperature that high, and he didn't know who I was."

Martin learned that he had used a tainted syringe from AM2PAT only after getting a tip that the syringes had been recalled a month before Michael's infection. He blamed himself for months, though, until he learned the scope of the danger that originated inside the AM2PAT syringe plant in Angier.

Syringes from AM2PAT were taken off the market early last year and the Angier plant was closed following an outbreak of the bacterial infection Serratia in Colorado, Texas, Illinois and Florida. Five people died of the infection, and at least 100 others were sickened.

"It shocked me. I'm not so sure it's still sunk in all the way," he said.

Two AM2PAT managers pleaded guilty last month to federal fraud charges, and authorities are searching for company's President Dushyant Patel. Prosecutors said AM2PAT officials operated a filthy "clean room" inside a former motorcycle plant and falsified safety records to make it appear as though the proper checks were in place before syringes were shipped.

Months after the plant closed, syringes and papers – one was a document on how to make a clean room – remain strewn about inside, and containers of Heparin still stack shelves.

"(It was a) sweatshop, bottom line," Martin said.

He fumed over what he sees as failures from AM2PAT, his medical distributor and the U.S. Food and Drug Administration.

"I just felt, why? Why didn't somebody stop this?" he said. "Not only did they hand me a loaded gun, they enabled me to pull the trigger on my own son."

"We now know that, shortly after the August 2007 inspection, the company ramped up production at a dramatic rate and that manufacturing processes became slipshod," DeLancey said. "We received no adverse event reports associated with Serratia infection until after the (Centers for Disease Control and Prevention) notified us on Dec. 11, 2007."

Within five days, AM2PAT shut the plant down as inspectors again noted serious violations, she said.

"The inspection history reflects a very conscientious record of inspection and of compelling the manufacturer to comply with regulations," she said.

The inspectors' report formed the crux of the federal criminal case against AM2PAT officials, DeLancey said, adding that the charges were based on manufacturing violations and not any health problems that might have been caused by the syringes.

"Evidence of a causal link between the AM2PAT product and the Serratia infections was never conclusively established," she said.

Martin said he doesn't believe the FDA's arguments, and he said he plans to pursue legal action.

"That's ridiculous to me. This is an item you're sending to a child to keep him alive, and you're not inspecting it before you bring it out? I don't get it," he said. "I have no clue each time I do it now if I'm injecting him with something safe or something unsafe. But I still have to inject him with it to keep him healthy."