A former executive at a Hartland manufacturer will plead guilty to knowingly shipping non-sterile alcohol prep pads that were labeled as sterile.
Eric Haertle will enter a guilty plea for one count of introduction of a misbranded drug into interstate commerce. The charge carries a maximum penalty of three years in prison, three years of supervised release and a $250,000 fine.
Haertle was chief operating officer, president and co-owner of H & P Industries Inc., which did business under the names Triad Group Inc., Triad Pharmaceuticals Inc. and Triad Disposables Inc.
The plea agreement says the Food and Drug Administration received a report in November 2010 that non-sterile alcohol pads originating from Triad and were then distributed by Cardinal Health were suspected as the cause of 11 skin infections experienced by patients at the Colorado Children’s Hospital in Denver. In two cases, children developed sepsis after exposure to the pads.
The FDA began inspections at Triad two days later on Nov. 29. The next day Haertle was told a lot of sterile pads had failed testing for microbial contamination. He allowed 48 cases from the lot to ship on Dec. 2 and over the following days and weeks he falsely represented to the FDA that there was no reason to suspect issues with the sterile pads, the agreement says.
After briefly suspending production, Triad resumed shipping sterile alcohol pads, shipping 305 cases from the lot that failed testing in total. The agreement says the company made around $3,617 in gross revenues on those cases.
The FDA didn’t find out about the testing issues until Dec. 21 and Triad agreed to recall the lot the next day, the agreement says. Cardinal Health, which received 190 of the cases, in turn recalled Triad sterile alcohol pads it had distributed. The agreement puts the cost of the recall at $326,563.
Haertle said he didn’t believe the failed lab results because the firm hadn’t failed a sterility test before. He didn’t explain why he didn’t disclose the result to the FDA, the agreement says.
The pads tested positive for the presence of bacillus cereus, which can cause illness and infection in humans. The agreement says the bacteria was present in on production lines that produced non-sterile and sterile pads for Triad.
In additional to the potential penalties from the federal charge, Haertle could have to pay Cardinal Health $326,563 in restitution, although that number could be reduced by a pending bankruptcy case.