The lawsuit alleges that a strain of Bacillus cereus bacteria from a contaminated pad caused a fatal meningitis infection.
On Jan. 3, 2011, a little over a month after the boy's death Dec. 1, Triad Group announced a nationwide recall of all lots of its alcohol pads and swabs, which are used to disinfect an area prior to an injection, due to concerns about Bacillus cereus contamination.
“The missing piece of the puzzle came when the FDA announced the recall for the Triad alcohol pads and swabs for the exact bacteria contamination that killed my son,” Sandra Kothari said in a statement issued by her law firm. “These alcohol wipes are used every day in hospitals, clinics and homes. People think they’re safe.”
“This little boy had undergone a relatively simple procedure for a benign cyst,” one of the Kotharis’ lawyers, Jim M. Perdue, Jr., of Houston-based Perdue & Kidd, said in the lawsuit.
“He was recovering well until he contracted a Bacillus cereus infection, which is not normally a hospital-acquired infection. Hospital staff had no idea how the bacteria got into the boy's spinal fluid.”
Purdue told India-West Jan. 22 that another lawsuit against Triad Group was filed in the last few days and that “over 50 people” have also contacted his law firm about skin infections and more serious problems with the alcohol prep pads. None of the new infections has been confirmed, he told another reporter.
Bacillus cereus contamination, Purdue pointed out, is typically associated with food poisoning and “not normally found in a hospital setting.”
Purdue said the Kotharis, after initial interviews with the press, are not available for further interviews. “They are exhausted…I promised them no more interviews,” he told India-West.
Shanoop Kothari, 38, “works in finance” and his wife, 37, is a “stay-at-home mother,” the attorney said. They have another child, a seven-year-old daughter. Purdue said the lawsuit has not specified the amount of damages.
According to the Houston Chronicle, the two-year-old was looking forward to going home three weeks after removal of a benign cyst from his brain at Memorial Hermann Children’s Hospital in Houston, when he experienced seizures and vomiting.
He was brain dead within hours, Shanoop Kothari told the newspaper. “We might never have known what happened if one of my aunts hadn’t signed up for regular updates from the U.S. Food and Drug Administration’s Web site for a course she teaches,” Sandra Kothari told the newspaper.
Triad alcohol pads were used to clean the drain connected to the spinal column to regulate the fluid pressure on the toddler’s brain, according to the Kotharis’ lawsuit. They said their son had been frequently swabbed with Triad products and they were given some to take home to use.
“We’re still in shock. We can’t understand how we got to this point,” Shanoop Kothari told the newspaper.
A month after Harrison’s death, the FDA posted a notice in which Triad announced it was issuing an urgent recall of “all lots” of its swabs and wipes - both sterile and non-sterile - because they may have been contaminated.
The FDA said “use of contaminated Triad Alcohol Group Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients."
MSNBC.com reported this week that FDA inspectors had known about problems with contamination and sterilization at a plant run by the Triad Group as early as July 2009.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed," FDA officials wrote in inspection report quoted by MSNBC. There is no record that the FDA sent any warning letters typically employed to force firms to comply, the report said.
The FDA said there have been 100 reports of problems with alcohol prep pads logged by the agency since the Jan. 5 recall of the Triad products.
In addition, a Tennessee man has also filed a $30 million lawsuit against Triad, claiming he developed a Bacillus cereus infection from the wipes, resulting in open-heart surgery.
Triad has sold millions of the alcohol prep products to hospitals and pharmacies in the U.S., Canada and Europe. They were also sold in prepackaged injection kits under the Triad Group and other private labels.
Triad company officials have not responded to calls for comment from the media. The company originally said the recall was being done out of an “abundance of caution” after one report of a non-life-threatening skin infection.
Donald Kidd, Purdue’s law partner, told the Houston Chronicle that the Triad recall was posted on the FDA Web site and sent to distributors, but not to consumers who may have stored the products in their medicine cabinets.
“Many, such as those with diabetes and multiple sclerosis, who have to give themselves injections, rely on these products.”
Kidd also noted that Triad posted a similar warning for its products in the United Kingdom in 2007.
H&P Industries, which does business as the Triad Group, is one of the largest providers in the U.S. of generic medical products sold under private labels in grocery stores and pharmacies.
Bacillus cereus is a spore-forming bacterium found in soil and occasionally associated with food-borne illness. It can be resistant to heat and to disinfectant and has been known to survive standard sterilization procedures.
“We’re confident that that’s the cause,” Shanoop Kothari told one reporter. “There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”
"People buy alcohol pads and they last a long time in your bathroom,” added his wife. “They’re sitting there now. I wouldn’t want any other mother to go what I’ve gone through.”
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