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FDA defends its oversight of syringe firm

Posted March 30, 2009

— Dusty Martin said he lost his faith in the federal government's consumer-protection system after almost losing his older son to a bacterial infection.

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.

Dusty Martin, father in AM2PAT case Father questions consumer protections

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."

Following a 2005 FDA warning letter to AM2PAT, government inspectors found no major safety violations in yearly visits to the Angier plant, FDA spokeswoman Siobhan DeLancey said.

"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."


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  • Milkman Apr 1, 2009

    Ok, let me get this straight, people died because this company didn't follow healthy procedures in making medical equipment, some employees told the FDA about what was going, the FDA didn't shut them down until more people died and this is all Bush's fault?

    It's not the lazy FDA inspectors who ignored it, it's not the owners of the syringe company, it's Bush's fault. Really?

  • pbjbeach Apr 1, 2009


    i am in total agreement with your above stated blog as to what you said about the previous bush & chenny adminstration all these republican have done is to strip out any an all government regulations because of their push to deregulated businesses in this country an the american people are no-way as safety as we used to be simply because they have striped out funding for so manny government agencys that were originally set -up to protect us the american citzens. these republican have refused to allow for federal inspectors in any agency to adequetly perform their assigned job duty's all in the name of deregulation thank you

  • pbjbeach Apr 1, 2009

    In my personnal opinion there definetly needs to be more federal oversight in any programs that are funded with federal taxpayers dollars from the border patrol to the fcc. fda. fhwa. fdol, faa, with out more federal oversight in these programs there is just to much room for waste fraud an abuse of the taxpayers dollars that provide the funding for the various agency's thank you

  • haggis basher Mar 31, 2009

    "As for the syringes and other medical products, all we can do is pray."
    No you need to lean on your politician so that they adequately fund the FDA and ensure that they do their job. Do you really think that if God cared less what was in the syringes he would have done something about it before you prayed? Praying is just an excuse for you not bothering to do anything actually useful.

  • haggis basher Mar 31, 2009

    Terrible, I agree. We can't safely eat lettuce, tomatoes, chicken, beef or peanut butter, or feed our animals food safely, or our children to play with Mattel products and not worry about getting killed."
    The odds of any of the above affecting you are tiny, way less the risk you take driving your car! It is important that these things are effectively regulated but one should not obsess about them.

  • haggis basher Mar 31, 2009

    "The successful WalMart model has everyone focused on cheap."
    What has Walmart got to do with this case.....nothing at all. It is the FDAs job to catch this sort of thing and they blew it. Maybe they are underfunded and that need to be fixed if true. Life sentences for those who allowed this in the company would make it clear to all in the industry that they cannot put profits ahead of safety.

  • JustOneGodLessThanU Mar 31, 2009

    AtALost said, "...all we can do is pray." That's ridiculous. Personally, I want a doctor who studied medicine and relies on it to treat me. Yes, medicine...something developed by humans to help other humans...no deity is necessary. Sheesh.

    As for the failure of the FDA, this should be no surprise. The Bush Adminstration & Repubs say government programs don't work, guts these same programs...and then says, "SEE! Gov't doesn't work." They've done the same thing with education...cutting it to core, so it struggles to help children. Bravo! Not.

  • AtALost Mar 31, 2009

    The successful WalMart model has everyone focused on cheap. Doesn't matter if it's safe or even nutritious (e.g., melamine in milk). If consumers spend more on food and drugs instead of rushing to WalMart or the Dollar store, maybe we wouldn't be in this mess. The least you can do is boycott stores / products that are clearly inferior. As for the syringes and other medical products, all we can do is pray. The FDA and many other agencies are understaffed and possibly corrupt. But, they'll never admit either.

  • mstan Mar 30, 2009

    Terrible, I agree. We can't safely eat lettuce, tomatoes, chicken, beef or peanut butter, or feed our animals food safely, or our children to play with Mattel products and not worry about getting killed. The last 10 years has been a joke.