By Rick Barrett of the Journal Sentinel Feb. 27, 2011 | A Hartland company that makes alcohol wipes and medical cleaning swabs, and recently announced product recalls, has been sued by a Texas couple who blame it for the death of their 2-year-old son. In the lawsuit, filed in federal court in Houston, Shanoop and Sandra Kothari say an alcohol wipe made by Triad Group Inc. was the likely source of a bacterial infection that killed their son, Harry, in November. After his death, the Food and Drug Administration posted a notice saying Triad was issuing an urgent recall of “all lots” of its swabs and wipes because the products might have been contaminated with the bacteria Bacillus cereus. The company said the bacteria could lead to “life-threatening infections” in at-risk populations, including surgical and immune-suppressed patients. The recall, according to the company, was being done out of an “abundance of caution” after one report of a non-life-threatening skin infection. Harry Kothari was exposed to Triad alcohol pads following the removal of a benign cyst from his brain. It was a relatively simple procedure. The boy was recovering well until he contracted the infection, which normally was not associated with a hospital and led to meningitis, said Donald Kidd, the Kotharis’ attorney. The alcohol pads and swabs had the exact bacteria contamination that killed the boy, Kidd said. “I believe there are still a great number of health care providers and doctors who have these products in their clinics and facilities and are not aware of the recall, which has been extremely quiet,” Kidd said. Triad did not return a reporter’s call asking about the swabs and wipes. The company also has issued a recall for a lubricating jelly that might not have been properly sterilized. FDA investigating Millions of wipes were sold, according to the company. The products were distributed nationwide to pharmacies in boxes of 100 packets. The affected alcohol prep pads, swabs and swab sticks can be identified by Triad Group as the manufacturer or by names on the packaging including Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS and Conzellin, according to Kidd’s law firm. The FDA said it was a Class 2 recall, in which the probability of serious adverse health consequences was remote. The agency did an inspection at Triad on Nov. 29, which led to the recall and an ongoing investigation, FDA spokesman Christopher Kelly said. That response was too little, too late, Kidd said. “There’s been almost nothing done to get the information out about the dangers of these products to the general public,” he said. The problem is bigger than just the wipes and swabs for individual use, Kidd said. Triad also provides “prep pads and swabs” included in prepackaged drug and surgical instrument packets. Two pharmaceutical companies have issued a warning that the drug Relistor was packaged with the pads, saying there was no problem with the drug but the pads should not be used. Bacillus cereus in the contaminated pads cannot be killed in the 70% alcohol solution the pads are packed in, said Frances Lee, a microbiologist who headed up Triad’s quality/regulatory/product development unit for three years, ending in 2002. Lee is now president of Minehaha Technolgy, a Dousman firm that investigates micro-contamination issues among other things. She said she left Triad over disputes about how the company handled regulatory compliance issues. Now she audits drug manufacturers for FDA compliance. “After 30 years in the drug and personal-care products world, I have seen a lot of blatant disregard for compliance and doing the right thing. But nothing compares to this,” she said about Triad.
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