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FDA Seeks to Shut Down Maker of Tainted Wipes

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Federal officials are seeking a permanent injunction against two manufacturers claiming their medical products are potentially contaminated with life-threatening bacteria, reported MSNBC.com. On June 10, the U.S. Department of Justice’s Office of Consumer Protection Litigation and the U.S. District Court of the Eastern District of Wisconsin filed a consent decree against the Trial Group and H&P Industries alleging the companies violated manufacturing standards and disregarded inspections and warnings by the U.S. Food and Drug Administration (FDA) about problems with contamination and sterility.

Once the decree is signed by a judge, Triad and H&P will not be able to “manufacture or distribute drug or any medical devices until they have established acceptable quality assurance” that conforms to the Current Good Manufacturing Practice, said Shelly Burgess, an FDA spokeswoman.

According to MSNBC.com, the FDA’s recent action may have come too late.

The news staff ran a series of articles revealing in July 2009, the FDA knew of problems with contamination and poor sterilization at Triad and H&P plants responsible for distributing medicals supplies and drugs. The investigation sparked the attention of Sen. Michael Bennet, D-Colo., and Sen. Lamar Alexander, R-Tenn., who earlier this year demanded explanations from the FDA after state residents reported illness due to bacterial contamination from recalled Triad products.

Moreover, the agency is being ridiculed for taking five months after the recall to meet with Triad and H&P.

The agency admitted to U.S. senators that immediate, stringent action should have occurred, reported MSNBC.com. Instead of holding a meeting, the agency “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. However, the companies were allowed to make voluntary improvements and continued to make and distribute potentially contaminated products.

The voluntary recall notice said Triad was “recalling all lots of pads, wipes, swabs and swabsticks ‘out of an abundance of caution,’” adding that “use of contaminated pads ‘could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.’”

Although, Triad and H&P claim they received only one report of a non-life-threatening skin infection linked to Bacillus cereus, the companies face several lawsuits from plaintiffs alleging medical wipes and swabs infected with the bacteria caused serious injury or death.

In Houston, Texas, Sandra and Shanoop Kothari mourn the loss of their 2-year-old son, Harrison, who developed a severe infection and died from multi-organ failure on Dec. 1, 2010. According to MSNBC.com, Harrison was recovering from surgery to remove a benign cyst near his brain and spinal cord when he developed an infection and died.

In February, the Kothari’s filed a complaint against Triad in the U.S. District Court of Houston for gross negligence and seek damages for the loss of Harrison’s life. The family had no idea what caused their son’s sudden illness and death until a family relative informed them about a recall of all lots of Triad alcohol wipes due to contamination with Bacillus cereus. Bacillus cereus, a spore-forming bacterium found in soil, is known to survive standard sterilization and is associated with foodborne illness, reported MSNBC.com.

At least six lawsuits in various states were filed with similar claims to the Kothari family. Four suits, filed on behalf of patients with multiple sclerosis who used Triad alcohol wipes, claim the product left them disfigured with life-threatening infections, reported MCNBC.com

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