Medical Kit Company Sues Triad
[Milwaukee Journal Sentinel (WI)] April 23--Triad Group, the Hartland medical products firm that has faced recent product recalls and a plant shutdown, is being sued by a client that says Triad's alcohol wipes and other items were unsafe for use in medical facilities.
Since January, the FDA has received 201 reports about Triad alcohol prep pads, including allegations of seven deaths, 114 infections and 87 minor problems such as rashes, according to MedWatch, the agency's reporting system. A preliminary assessment shows that six of the seven deaths did not cite a specific microbial pathogen or a specific cause of death, the FDA said. The agency's inspections from Nov. 29 through March 28 revealed numerous issues at the Hartland plant, including a water system susceptible to contamination, and alcohol pads released for shipment after they were found to be contaminated with bacteria.
Triad faces at least three consumer lawsuits alleging its products caused sickness and death. In the lawsuit filed Thursday in U.S. District Court, Medikmark Inc. alleges that Triad failed to assure that its products were safe, resulting in Medikmark having to replace items such as alcohol wipes in its product line. Medikmark is a medical-kit company based in Waukegan, Ill. Its products are used in hospitals, nursing homes and other medical facilities. Triad was aware of problems involving lack of sterility and contamination at its manufacturing plants as early as 2002, Medikmark alleges in the lawsuit.
"Triad breached its contractual obligations by delivering products that were not fit for the ordinary purpose for which they were intended, not safe for use by Medikmark's customers and subject to recall," the lawsuit says. Since the product recalls, Medikmark has replaced Triad Group products in its kits with other products and has notified customers of the recalls.
Triad had not yet seen the lawsuit, a company spokeswoman said Friday. H&P Industries and Triad have denied wrongdoing in an FDA investigation and have said they hope to resume production in Hartland soon. "If there has been any encouraging sign over the last few months, it's the way that some of our customers have hung with us," H&P CEO Eric Haertle said in a recent interview.
At this time, the company does not intend to leave Wisconsin, H&P spokeswoman Christy Maginn said. This month, medical device maker Smith & Nephew Inc. recalled Triad wipes used to protect skin before medical tapes and films are applied, and adhesive removers that clean residues from skin. "The decision was made to recall these affected lots after a thorough review of available information regarding conditions at the manufacturing site ... It has been determined that the recalled lots were made in the same facility as other wipe products, including wipes, swabs and swab sticks, that are the subject of other voluntary recalls," Smith & Nephew said in an April 6 letter to customers.
"Testing has been performed on some Smith & Nephew products already distributed and/or under quarantine, and test results received to date show no contamination," the letter notes, adding that the recall was done out of an abundance of caution. Also this month, the U.S. Marshals Service, at the request of the Food and Drug Administration, seized more than $6 million in products made by H&P in Hartland. The seized products, normally distributed by Triad Group, included cough and cold medicines, nasal sprays, suppositories, medicated wipes, hemorrhoidal wipes and antifungal creams. "We took this action to stop Triad from continuing to distribute products which may pose a risk to public health," Dara Corrigan, FDA associate commissioner for regulatory affairs, said in a statement.
Copyright (c) 2011, Milwaukee Journal Sentinel
Distributed by McClatchy-Tribune Information Services.