Feb. 14, 2011 — -- After complications from surgery to remove a benign cyst near his brain and spine, 2-year-old Harrison Kothari seemed to be recovering well.
"He was supposed to get discharged the next day," said Shanoop Kothari, Harrison's father.
But on December 1, Harrison's organs began failing from acute bacterial meningitis. He died soon after.
"Nobody from the hospital could tell us how he got this rare bacteria, what caused it, it was a mystery," said Shanoop Kothari.
Harrison's death was a mystery to his family until they heard of a recall of the same brand of sterile alcohol pads used during his procedure, the kind used in many hospitals and doctors' offices.
Late yesterday the family sued the Triad Group, the largest makers of those pads, claiming gross negligence, according to Miranda Sevcik, a spokesperson for the lawfirm Perdue & Kidd, who represent the Kotharis family.
The parents' lawsuit states that the company issued an urgent voluntary recall of these products on January 3, citing "potential contamination" by a potentially life-threatening "objectionable organism."
That organism, bacillus cereus, can cause meningitis, the kind of infection that killed their son.
"We are, out of an abundance of caution, recalling these lots and revalidating our production lines to ensure that we are not the source of these contamination issues," the Triad Group wrote in their recall statement.
"There has been ONE report of a potential contaminant out of hundreds of millions of products sold," the Triad Group stated on their website.
"We know exactly what the bacteria was. It's the same bacteria on these pads," said attorney Jim Perdue Jr., who represents the Kotharis family.
The Kotharis have no direct evidence the swabs used during their son's procedure were contaminated but believe they could have been because the recall went out just a month after Harrison died.
"Triad group owes no more basic responsibility than putting out a safe medical product," said Perdue.
The FDA says the Triad Group followed all the right steps, notifying the FDA and quickly issuing a voluntary recall.
The FDA followed up with their own recall, noting that Triad Group products are sold under familiar generic labels.
"They could be potentially in everybody's home, in their bathroom, they have no idea. I wanna make sure that this doesn't happen to anybody else," said Sandra Kothari.
Triad alcohol prep products are included in pre-packaged pharmaceutical products used throughout the healthcare industry. Because of this, the FDA and many pharmaceutical companies have issued recalls for certain prepackaged pharmaceuticals containing Triad alcohol prep products. The only reason for these recalls is the potentially contaminated Triad alcohol prep product included in the package. The pre-packaged products include:
• Bayer HealthCare Pharmaceuticals for its Betaseron product
• GlaxoSmithKline for its ARIXTRA Starter Kits
• Genentech, Inc., a member of the Roche, for Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase products
• Progenics Pharmaceuticals Inc. and Pfizer Inc. for its Relistor injection kits
• Merck & Co., Inc. for its Pegintron product
• Teva Pharmaceutical Industries for its Copaxone product
• Novaris Pharmaceuticals for its Extavia (interferon beta 1-b) product
• Watson Pharmaceuticals for its Trelstar product
• Neuro Resource Group, Inc. for its medical devices and products for injury management, rehabilitation, and pain management
The FDA recall was not a Class 1 recall, used for "dangerous or defective products that predictably could cause serious health problems or death," but a Class 2 recall, used for "products that might cause a temporary health problem, or pose only a slight threat of a serious nature."