Dec. 28, 2011 at 6:39 PM ET
Federal health officials have given a green light for a first step toward reopening for a Wisconsin business shut down after making and distributing contaminated medical wipes blamed for illnesses and deaths nationwide.
Food and Drug Administration officials on Wednesday said they’ve approved a so-called “reconditioning plan” submitted by H&P Industries and the Triad Group of Hartland, Wis. The plan, required under terms of a June court order, stipulates how the sister firms will be allowed to rework more than $6 million of seized medical supplies so that they’re safe for use -- or destroy products that can’t be repaired.
But the public won’t be allowed to know exactly how the firms intend to fix the problems with products distributed to hospitals, clinics, stores and homes in the U.S. and around the world, the FDA has ruled.
The agency has denied an msnbc.com public records request for copies of two reconditioning plans submitted by the firms. In a letter, officials said release of the documents would disclose trade secrets and confidential commercial information and could interfere with law enforcement proceedings.
The approval of the reconditioning proposal comes a year this month after the death of a 2-year-old Houston boy, Harrison Kothari, from an infection caused by the same bacterium detected in alcohol prep wipes made and distributed by H&P Industries and the Triad Group. At least 11 deaths, including Harry’s, have been tied to alcohol prep wipes, including those made by the Wisconsin firms, FDA records show.
The plan approval also comes nearly a year since those firms launched a global recall of tens of millions of wipes, swabs and other products at the FDA’s urging because of potential contamination with Bacillus cereus bacteria and other organisms.
For Shanoop and Sandra Kothari, parents of the Houston toddler, it makes a difficult anniversary even tougher.
“You’ve got something hanging over you that’s not anything but a constant reminder of the loss,” said Jim Perdue, the Texas lawyer representing the Kotharis in a lawsuit filed in February.
H&P Industries officials and lawyers did not respond to msnbc.com requests for comment about the company’s future plans. Nor would they comment on industrial real estate listings that show that the firm’s 285,000-square-foot plant at 700 W. North Shore Drive in Hartland is for sale for $14.2 million. A representative for The Dickman Company Inc. on Wednesday said the site was an active listing.
The FDA has a mixed record with enforcing good practices at the Wisconsin medical supply plant and other manufacturers of medical wipes. Records obtained by msnbc.com showed officials failed to issue warning letters or demand other sanctions despite documented problems with sterilization and contamination dating back to 2009, and nearly a decade earlier. When officials finally did investigate, they demanded seizure of more than $6 million in H&P Industries products and, later, the plant closure.
H&P Industries was only the first medical supply firm to recall potentially tainted products this year. In September, Professional Disposables International Inc., or PDI, of Orangeburg, N.Y. voluntarily recalled all lots of five different kinds of non-sterile alcohol prep padsbecause of potential contamination with Bacillus cereus.
In April, Rockline Industries of Springdale, Ark., recalled nearly a million units of baby wipes, including brands sent to Walmart and Winn Dixie Stores because of potential contamination with Enterobacter gergoviae, a bacterium that can cause serious infections in babies and people with compromised immune systems. As first reported by the Milwaukee Journal Sentinel, Rockline Industries had similar trouble with contamination dating back to 2006, but the FDA took no enforcement action.
The FDA’s crackdown on H&P Industries and the Triad Group came only after msnbc.com reports sparked the interest of Sen. Michael Bennet, D-Colo., and Sen. Lamar Alexander, R-Tenn., who demanded explanations from the FDA after residents of their states said they were sickened by bacterial contamination from alcohol prep wipes, swabs and other products recalled by the Wisconsin firms.
Under terms of the consent decree agreed to by H&P Industries and the FDA, the reconditioning plans are supposed to describe specific steps for correcting bacterial contamination and other violations.
The family-owned firms, run by brothers David R. Haertle and Eric C. Haertle and their sister, Donna L. Petroff, were shuttered in June after world-wide recalls of alcohol wipes and swabs and povidone iodine products found to be potentially contaminated with dangerous bacteria, including Bacillus cereus.
The consent decree lays out specific steps the company must follow in order to resume operations, including revamped quality assurance steps and new management to oversee it. If the firms fail to comply, the company and its individual officers can face steep fines and other sanctions. But it doesn’t reveal how the company plans to meet those demands.
The firms face at least 10 lawsuits in several states filed by families who claim contaminated alcohol pads led to serious infections and, in at least three cases, deaths. The Kotharis were the first to seek legal action.
Other alleged deaths include a 69-year-old Alabama woman, Ruby Hutcheson, who died in August days before she was scheduled to give a deposition in her suit against H&P Industries. The family of a 66-year-old Illinois man, Garry Rockett, also claimed in a July lawsuit that he died in 2009 after being treated for cancer using contaminated Triad wipes.
The latest lawsuit was filed in November by a 57-year-old Washington, D.C., multiple sclerosis patient who said he developed a Bacillus cereus infection after using tainted wipes made by H&P Industries and the Triad Group and supplied by Bayer Healthcare Pharmaceuticals. William Preston West Jr. is seeking $10 million in compensatory and punitive damages; his wife, Carolyn B. Gleason, is seeking $1 million.