Probation given in tainted wipes case

The former co-owner and chief operating officer of a Hartland pharmaceutical company received a year of probation and was ordered to pay nearly $40,000 in restitution and fines Wednesday for knowingly shipping contaminated sterile wipes.

Eric Haertle, who owned Triad Pharmaceuticals and its sister company, H & P Industries, along with his two siblings, pleaded guilty in federal court to shipping a product he knew was contaminated with dangerous bacterium. Triad was once among the nation’s largest manufacturers of alcohol wipes.

“This is a case about a man’s decision to ship a product marked as sterile that he knew darn well was not sterile to make money,” said Assistant U.S. Attorney Scott Campbell. “Mr. Haertle deserves a felony conviction.”

Both sides initially agreed to recommend probation, which was called for in the federal sentencing guidelines. Haertle’s attorney asked for no probation time on Wednesday while the government called for a probation term of up to five years.

Haertle has already paid about $34,500 in restitution to Cardinal Health, which incurred the costs in a recall. Haertle also was ordered to pay a $5,000 fine.

U.S. District Judge J.P. Stadtmueller agreed it was a serious case, saying the facts “demanded prosecution.” But the judge also wondered why it took more than six years for the case to be concluded, saying that Haertle was “under the thumb” of the U.S. Food and Drug Administration

for that time, comparing it to “water torture.”

Campbell said part of the delay was due to FDA investigators trying to establish a link between the contaminated alcohol wipes and people getting sick or dying as a result, which they were unable to establish.

Triad and H& P were named in several federal and state lawsuits claiming their products sickened and in some cases killed someone, including a case involving a 2-yearold Houston boy.

A Milwaukee Journal Sentinel investigation in 2011 found the 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.

Michael Steinle, attorney for Haertle, asked Stadtmueller to give his client no probation, saying a felony conviction, the fine and restitution and losing the family business was punishment enough. Steinle also bemoaned the fact that Haertle, 50, who is married with five children, was the only one of his siblings charged. According to Steinle and Campbell, Haertle accepted early responsibility for his conduct. Haertle is

working at another pharmaceutical firm, according to his attorney

Haertle said he and his wife are trying to get past the matter.

“I sincerely apologize for these circumstances and we would like to move forward to put this behind us,” he said.

Haertle 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 potentially deadly bacterium, according to the plea agreement.

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.

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. That amount was paid as part of the bankruptcy.