— A Wisconsin medical supplier that made millions of recalled alcohol prep products now blamed for serious infections and at least one death is shutting down the line that produces the wipes — at least for now.
The Triad Group of Hartland, Wis., plans to “move away” from its health care division, which produced contaminated alcohol pads and lubricating jelly, and focus instead on its private label and contract brands, according to an internal letter obtained by msnbc.com.
“We all need to rededicate ourselves to our customers and earn back their trust, this is an opportunity I relish,” Eric Haertle, Triad’s chief operating officer, wrote in a Feb. 25 letter sent to customers, vendors and employees.
The letter was prompted in part by a series of msnbc.com reports detailing potentially life-threatening problems with contamination at the plant.
In it, the Triad executive acknowledged that the 30-year-old family firm is facing “difficult times” in the form of massive recalls, at least two lawsuits, a federal Food and Drug Administration investigation — as well as news reports by msnbc.com.
Haertle admitted no wrongdoing and said he believes his firm eventually will be “cleared of all charges.”
“What has not been said is that we intend to fight any and all accusations against this company,” wrote Haertle, who contended that many issues identified in FDA inspections already have been addressed. “We continue to work on others and our pursuit toward compliance.”
Temporary closure not enough
But the parents of two children harmed by infections blamed on contaminated Triad products said the move is too little, too late, and raises more questions about why government regulators haven't taken stronger action against the firm.
"We still ask: Where is the FDA? Knowing of Triad's violations and what they have done, when will they shut down this company for good?" read an e-mail statement from the families of Harrison Kothari, 2, of Houston, who died in December from an infection blamed on the wipes, and Peyton Armstrong, 10, a leukemia patient who developed a life-threatening infection hospital officials said was tied to Triad pads.
Triad officials made the move voluntarily and did not notify the FDA about their plans to halt production of alcohol prep products named in a Jan. 3 recall beause of potential contamination, said FDA spokeswoman Shelly Burgess.
Triad will also stop production of sterile lubricating jelly, which was the focus of a Dec. 27, 2010 recall and has been tied to reports of vaginal infections that required medication for dozens of women. The prep pads and jelly are the two largest product lines in that division, Haertle said.
The Triad move to shut down the health care line, even “short term,” as Haertle indicated in the letter, is not part of any negotiation related to an ongoing investigation of Triad practices, Burgess added.
The FDA has issued no sanctions against Triad, despite government documents that identified ongoing problems with contamination and sterilization at the Triad plant dating back to at least 2009. FDA inspectors detected microbial contamination in both wipes and jelly, and problems with validation of Triad's sterilization process, documents show.
FDA officials said they were working with the firm to make voluntary improvements because there was no “imminent health hazard” — until a Colorado hospital reported life-threatening infections tied to the tainted wipes last fall.
A few children at The Children’s Hospital in Denver developed bloodstream infections from the rare bacteria Bacillus cereus, which was later cultured from the Triad wipes. Among the victims was Peyton Armstrong, 10, who developed a life-threatening infection within hours after an IV line and medical port were inserted to begin treatment for leukemia.
Michael Rogers, FDA's deputy director of the Office of Regional Operations, said the hospital’s report about Peyton and others prompted an immediate FDA investigation and voluntary recall of hundreds of millions of the alcohol products used in hospitals and clinics and widely sold under private labels in grocery stores and drugstores.
Since then, a lawsuit has been filed against Triad by Shanoop and Sandra Kothari, parents of Harrison Kothari, 2, of Houston, who died after developing meningitis caused by Bacillus cereus, which his parents blame on the wipes used to clean his wound. In addition, Joe Postich, 55, of Madisonville, Tenn., filed a lawsuit after he had to have open heart surgery following a Bacillus cereus infection tied to tainted wipes.
Peyton's parents, Noel and Jessica Armstrong of Glenwood Springs, Colo., intend to file a lawsuit as well, said their lawyer, Jim Perdue Jr. of Houston.
Bacillus cereus bacteria are common in the environment and sometimes associated with foodborne illness, but not usually with medically acquired infections. The bacteria form hard-to-kill spores that can survive heat and the 70-percent alcohol solution used in the wipes, microbiologists say.
FDA logs 161 reports about alcohol wipes
Since the recall, the FDA has received 161 reports of adverse events related to alcohol prep wipes, including three deaths, which don’t appear to be related to Triad products, Burgess said. Perdue said his firm has been contacted by more than 100 people reporting infections tied to the wipes.
Msnbc.com obtained copies of Triad’s recent letter to customers, vendors and employees from two confidential sources, including a broker who represents a large drugstore chain that buys private label products from the company.
According to the letter, Triad Group — which is owned by brothers David Haertle and Eric Haertle, both of Wisconsin, and their sister, Donna Petroff of Illinois — will continue to operate its divisions that produce other medical supplies and hygiene products, including suppositories, children’s cold medicines and mouth washes and rinses.
No recalls have been initiated for those products. However, the same FDA inspection documents that verified contamination in wipes and lubricating jelly also detected problems with a wide range of Triad medical and hygiene supplies.
Inspectors found microbial contamination of water pipes leading to vats that made batches of blue and yellow mouth rinse and glycerin suppositories, a Jan. 7 report known as an FDA Form 483 shows. They discovered employees packing acne pads into containers with their bare hands and a worker who failed to add the active ingredient to a batch of children’s multi-symptom cold medicine.
Inspection reports concluded that Triad employees in charge of microbial testing of finished drug products lacked the education and background to do the job. They alleged the company had too few employees to supervise the manufacture, processing, packing and holding of drug products and that some employees could not speak, read or write English in order to sign off on finished products in the warehouse.
The Kotharis and the Armstrongs, parents of children allegedly harmed by the Triad products, say they believe the government's action should be swift and comprehensive.
"We are united in the fight to make sure Triad Group products never injure another child, but a voluntary shut-down that may just be temporary does little to resolve our concern," their statement said. "A temporary shut-down without permanent changes is meaningless to the people who trusted these products."