Federal Food and Drug Administration officials have admitted to U.S. senators that they should have taken stronger action to stop a Wisconsin firm from making and distributing medical products potentially tainted with life-threatening bacteria . The contaminated products have been blamed in lawsuits for serious infections and the death of a 2-year-old child.
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Instead of simply holding a meeting last August with officials from H&P Industries Inc. and the Triad Group of Hartland, Wis., the FDA should have followed two worrisome inspections and the regulatory session with a formal warning letter, an enforcement action that requires prompt and thorough response, said Jeanne Ireland, the FDA's assistant commissioner for legislation.
Such a letter would have served to "reinforce FDA concerns about GMP [good manufacturing practice] deviations," Ireland said in a letter sent late Thursday to Sen. Michael Bennet, D-Colo., and Sen. Lamar Alexander, R-Tenn. The letter followed an "internal retrospective review" of the agency's oversight of the company, she wrote.
Instead, the Wisconsin firms, which are owned and operated by the same family, were allowed to pursue voluntary improvements in safety and sterilization procedures. As a result, the company continued to make and ship the potentially tainted products, records show.
The two senators had demanded explanations from the FDA earlier this year after residents of their states alleged they were sickened by bacterial contamination from alcohol prep wipes, swabs and other products recalled by the Wisconsin firm.
“The incidents relating to Triad wipes, as well as the recent recalls of children’s medicine and deaths associated with heparin , remind us all too clearly that the supply chain for drugs and medical devices needs to be fixed," said Bennet. "The last thing families in Colorado and across the country should have to worry about is that the treatments they use may do them harm, or potentially worse."
Bennet and Alexander's attention followed a series of msnbc.com articles that reported that as early as July 2009 the FDA knew of problems with contamination and shoddy sterilization at the plants that made and distributed medical supplies and drugs widely used in hospitals, clinics and home care and sold by the nation's top drug and grocery store chains, including Walmart, Safeway, CVS and others.
In April, the FDA asked the U.S. Marshals to seize more than $6 million worth of H&P Industries Inc. products to prevent the firm from distributing products that may have been tainted with two dangerous bacteria, Bacillus cereus and Elizabethkingia meningoseptica, which can cause deadly infections.
Shortly before that, the FDA had asked the company to voluntarily cease all production and distribution. The firm halted operations on April 18, the FDA reported.
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The moves follow massive recalls starting in January of all lots of alcohol prep products and, later, povidone iodine products because of potential contamination. The firm also recalled lubricating jelly commonly used in medical exams and procedures because samples were tainted.
Lawsuits in six states
A Colorado hospital was the first to confirm contamination in the alcohol pad products through laboratory cultures that showed two-thirds of Triad Group wipes tested were tainted with strains of Bacilllus cereus. A review by the Centers for Disease Control and Prevention found that doctors could not rule out that the pads had caused dangerous infections in children already being treated for cancer and other ailments.
At least half a dozen lawsuits in six states now allege that tainted Triad products led to serious infections caused by the bacteria Bacillus cereus. One lawsuit, filed in Houston, alleges that contaminated wipes led to the death of a 2-year-old boy, Harrison Kothari, in December, four months after FDA officials allowed H&P Industries to pursue voluntary compliance.
Four other suits, filed on behalf of patients with multiple sclerosis who used Triad wipes to clean their skin before necessary drug injections, claim that the wipes led to disfiguring and life-threatening infections. In Tennessee, one man filed suit after claiming he used Triad pads and then contracted a Bacillus cereus infection that led to open-heart surgery.
Recalls of affected products have extended to dozens of distributors of medical kits in several countries, including Canada. In the U.S., the recalls extended to some U.S. Veterans Health Administration medical centers and the agency's out-patient, mail-order pharmacy system. They've also affected widely distributed first-aid kits and veterinary kits used to treat horses and other animals.
A spokeswoman for H&P Industries and the Triad Group said the firms had not seen the FDA's letter to the senators and couldn't provide comment. The firms contend that no infections, injuries or death have been confirmed to have been caused by their products. They say they are working closely with FDA officials to resolve problems addressed in recent inspections and product seizures.
A spokeswoman for the FDA said the agency's review of the Wisconsin firms continues.
Follow health reporter JoNel Aleccia on Twitter @jonel_aleccia.
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