FDA Knew About Safety Concerns at Tainted Alcohol Wipes Plant
March 3rd, 2011
By: Catherine Donaldson-Evans
Federal safety inspectors knew of contamination problems at a medical supplies plant long before millions of its tainted alcohol wipes were recalled and a 2-year-old Texas boy died from a rare infection blamed on the swabs, according to MSNBC.com.
Now others who used the products made by the Triad Group are coming forward to say that they too, may have been sickened, the website reported.
Government documents obtained by MSNBC.com show that officials from the Food and Drug Administration had flagged the Triad plant for issues with sterilization as early as July 2009.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” FDA plant inspectors wrote. But MSNBC found no evidence that the agency did anything about the lapse or tried to enforce compliance with proper safety practices.
The Wisconsin-based Triad Group makes the alcohol wipes used on little Harrison Kothari while he was in the hospital in November to have a tumor near his spine removed. The toddler was recovering normally and was about to go home when he became gravely ill with what was later diagnosed as acute bacterial meningitis.
The infection was caused by a strain called Bacillus cereus that is normally associated with foodborne illness and can be heat- and disinfectant-resistant. The alcohol pads at the Houston hospital where Harrison was treated were found to be contaminated with that bacteria.
Within hours of contracting meningitis — and on the morning he was to go home — the child was brain-dead.
Since MSNBC reported on Harrison’s Dec. 1 death and the subsequent lawsuit his family filed against Triad last week for gross negligence, dozens of others have contacted the Kotharis’ lawyers. At last count, more than 50 people had come forward with concerns that they, too, might have been infected by the tainted pads, the website said.
Among them: a Tennessee man who is suing Triad for $30 million. Donovan Joseph Postich, 55, claims that his Bacillus cereus infection from the alcohol wipes forced him to have heart surgery and left him permanently disabled, according to MSNBC.com.
“That was the most scared I’ve been in my life,” Postich told the website. “They told me about the tainted pads and you just kind of put two and two together.”
None of the new reports of infections and injuries have been confirmed, said Jim M. Perdue Jr., who is representing the Kothari family.
“We’re seeing a wide spectrum of complaints,” Perdue told MSNBC.com. Reports of everything from mild skin infections to serious illness and even another claim of a death have flooded in and are being investigated, he said.
Triad recalled all lots of its alcohol prep wipes, pads and swabs on Jan. 5 over fears they’d been tainted with Bacillus cereus. The family-owned company warned that using the contaminated products “could lead to life-threatening infections, especially in at-risk populations, including immune-suppressed and surgical patients.”