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FDA Resumed Triad Inspections Only After Colorado Hospital Found Contamination

By March 9, 2011July 16th, 2019Defective Medical Device litigation

Last month, I wrote a blog post about allegations that contaminated alcohol wipes were to blame for the death of two-year-old Harrison Kothari in Texas. As a dangerous medical device attorney, I’m disappointed, but not surprised, to see the wipes popping up again in news reports that the same infection triggered an investigation by a Colorado children’s hospital. As MSNBC reported March 7, The Children’s Hospital in Aurora, Colo. began an internal investigation after several children were infected with Bacillus cereus. It eventually found that the problem was contamination in Triad brand alcohol wipes. The discovery was credited with triggering the recall of the wipes, but critics wonder why the agency didn’t take action when it originally discovered problems with the plant in July of 2009.
Bacillus cereus is best known for causing food poisoning; it’s not an infection that typically gets passed around a hospital. So doctors at The Children’s Hospital were alarmed when they diagnosed it as a blood infection in several patients in late November. Those included Peyton Armstrong, 10, who was there for a medical port to start chemotherapy for leukemia, but developed an infection that nearly killed him and delayed his treatment. The wipes were used to sterilize children’s skin, and Triad was the only supplier; a spokeswoman said the hospital used about 2,500 a day.
After the hospital reported the problem, the FDA sent an inspector to the plant on the next business day, which eventually led to a Jan. 6 recall. But the FDA’s own documents show that it found problems in the plant as early as July of 2009, more than a year before the Colorado outbreak, and didn’t launch a recall or penalties because it did not believe the problems posed an imminent health hazard.
Clearly, that has turned out not to be true — certainly not for the Armstrong and Kothari families, and as many as 100 others who have contacted the Kothari family’s attorney. As a defective medical device lawyer, I know this could be extremely widespread and extremely serious. Alcohol prep pads, swabs and swabsticks are used as disinfectants before an injection or surgery, which is important because bacteria can cause an infection when the skin is cut. These contaminated pads don’t just fail to protect patients — they actually introduce the infection into some of the most vulnerable populations. Hundreds of millions of pads and swabs have been recalled, many of them packaged with injectable prescription medications or sold under a store brand name. We may only be seeing the beginning of a flood of complaints and lawsuits from people who were seriously hurt by contaminated Triad products.

Patients and hospitals should be able to trust that products sold as sterile won’t actually make them sicker. When medical device manufacturers and drug makers fail to live up to basic manufacturing standards, and patients are killed or seriously injured as a result, victims have the right to hold the manufacturers responsible. Carey, Danis & Lowe can help. Based in St. Louis, our medical product liability attorneys represent patients and families from around the United States who suffered serious harm because of a dangerously defective medical device. A lawsuit cannot return patients to the way they were before they got sick, but it can help them hold manufacturers responsible for their actions. It can also help them recover the money they need to pay for the medical care, lost wages and other costs created by the injury.
If someone in your family developed serious health problems after using Triad alcohol wipes or any other medical device, don’t hesitate to contact Carey, Danis & Lowe for help. To set up a free, confidential case evaluation, send us a message through our website or call toll-free at 1-877-678-3400.