Federal officials on Friday sought a permanent injuction against the Wisconsin firm accused of making and distributing medical products potentially tainted with life-threatening bacteria, a spokeswoman for the Food and Drug Administration said.
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Filed by the U.S. Department of Justice's Office of Consumer Protection Litigation and the U.S. District Court of the Eastern District of Wisconsin, the move seeks a consent decree against the Triad Group and H&P Industries of Hartland, Wis., which are accused of violiating good manufacturing standards and failing to heed FDA inspections and warnings about problems with contamination and sterility.
Contaminated products from the firms, which are owned and operated by the same family, have been blamed in lawsuits for serious infections and the death of 2-year-old Harrison Kothari.
Once the decree is signed by a judge, H&P Industries Inc. and the Triad Group of Hartland, Wisc., won't be able to "manufacture or distribute drugs or any medical devices until they have established acceptable quality assurance" in conformity with the Current Good Manufacturing Practice, said Shelly Burgess, FDA spokeswoman. She expects the judge to sign "fairly quickly." Officials from H&P Industries and the Triad Group must sign the consent decree as well, acknowledging duty to conform with its demands.
A spokeswoman for H&P Industries and the Triad Group did not have an immediate comment on the injunction but said the firms planned to issue a statement on Monday.
Jim Perdue Jr., a Houston lawyer who represents the family of Harrison Kothari, a toddler who died of bacterial meningitis after using wipes supplied by Triad , said a permanent injunction against was the only way to protect the American consumers. "Despite an established history of breaking safety standards, H&P continues to show no remorse."
FDA officials late Friday could not provide further comment on the action, including why it took the agency more than five months after the recall of hundreds of millions of potentially tainted products to take action against the Wisconsin firm in court.
Late Thursday, FDA officials admitted to U.S. senators that they should have taken stronger action sooner.
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 firms 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.
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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.
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. A lawsuit filed by Kothari's family alleges that contaminated wipes led to his death 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.
H&P Industries and the Triad Group 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.
Follow health reporter JoNel Aleccia on Twitter @jonel_aleccia.
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