Raquel Rutledge reports that Eric Haertle knew the medical products he sold were infected:
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 potentially deadly bacterium, according to the plea agreement filed in federal court….
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 of 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.
See, also, full coverage of this matter in the Journal Sentinel‘s Shattered Trust series.
There’s an oft-repeated quotation that one should ‘never ascribe to malice that which is adequately explained by incompetence.’ (The remark is commonly misattributed to Napoleon; its provenance lies elsewhere, and is more recent.)
In any event, self-professed incompetence is an all-too-easy (and often false) defense among sophisticated wrongdoers.
Eric Haertle wasn’t merely negligent.