Ex-Triad owner guilty in tainted wipes case
Contamination tied to 2-year-old’s death
The former co-owner and chief operating officer of a Hartland pharmaceutical company — once among the nation’s largest manufacturers of alcohol wipes — has pleaded guilty to shipping a product he knew was contaminated with dangerous bacterium.
Eric Haertle, who owned Triad Pharmaceuticals and its sister company, H&P Industries, along with his two siblings, made “false representations to FDA,” allowing hundreds of cases of alcohol pads labeled as “sterile” to be sent out when he knew samples from the lot had tested positive for bacillus cereus, a potential--
ly deadly bacterium, according to the plea agreement filed in federal court.
The one-count conviction, filed in late February, is a felony and carries a three-year maximum prison sentence. Prosecutors with the U.S. attorney’s office, however, said they will agree to probation, as requested by Haertle. Sentencing is scheduled for June 15.
Triad and H&P were named in at least 10 federal and state lawsuits claiming their products sickened and in some cases killed someone, including a case involving a 2-year-old Houston boy.
A Milwaukee Journal Sentinel investigation in 2011 found the U.S. Food and Drug Administration had been in the company’s manufacturing plants repeatedly during the previous decade, citing the company for numerous health and safety violations.
At one visit, months before the Houston boy, Harry Kothari, died, FDA inspectors warned the company its product sterilization process was insufficient. But the agency took no formal enforcement action. It wasn’t until April 2011, several months after Kothari’s death from a bacillus cereus infection, that U.S. marshals raided the company and seized $6 million worth of product, essentially shutting down its operations.
Triad produced wipes for a variety of private-label companies such as CVS, Walgreens, Cardinal Health and Leader.
Workers interviewed by the Journal Sentinel at the time described filthy conditions in the plants and said little attention was paid to sanitation.
Triad and H&P Industries filed for bankruptcy in 2012, listing $37 million in claims against assets of less than $11 million.
Michael Steinle, Haertle’s attorney, did not return a phone call seeking comment.
According to the plea agreement, Haertle was notified in December 2010 of test results that showed
bacillus cereus growing on samples of supposedly sterile prep pads, but days later told FDA officials there was no reason to believe the products were contaminated. He refused to provide the FDA with all the quarterly test reports the agency requested.
He made “false representations to FDA even though he personally knew that the sterile alcohol pad products had failed their quarterly dose audit due to bacterial growth and that bacillus
cereus had been positively identified in sterile product samples,” according to the plea agreement.
Some of the products were ultimately recalled. Haertle agreed to restitution of about $327,000 to Cardinal Health for the costs incurred for that company’s recall, the plea agreement states.
He remains out of custody on a signature bond, but was ordered to remain in the eastern district of Wisconsin. He requested permission to travel to California, Arizona and Texas in March and April for family reasons, to conduct business, visit colleges and to coach AAU basketball.