SILVER AWARD: Raquel Rutledge and Rick Barrett, reporters at the Milwaukee Journal Sentinel, received the silver award in the 2011 Barlett & Steele Awards for Investigative Business Journalism for their series “A Case of Shattered Trust.”
By Raquel Rutledge and Rick Barrett
In early 2011, call after call came into the Journal Sentinel newsroom from current and former employees of one of the nation’s largest manufacturers of alcohol wipes describing filthy conditions at the plant in nearby Hartland: A worker had packaged the wipes with bloody hands. An owner drank coffee in the supposedly-sterile production area.
Triad Group and its manufacturing arm H&P Industries had voluntarily recalled some lots of alcohol wipes out of contamination concerns. And in Texas, the parents of a 2-year-old boy blamed the death of their son on contaminated wipes.
When Shanoop and Sandra Kothari filed their lawsuit in February 2011, blaming Triad for their son’s death, the story had been picked up in the Houston media and MSNBC.com began investigating the issue.
But with Triad in our backyard, a privately-held company that had attracted little attention over the years, we were uniquely situated to provide depth to a developing story with major national implications. The accountability, we would find, fell at the doorstep of the plant and the U.S. Food and Drug Administration.
(The company denies its products are to blame for that death, as well as other deaths or injuries that are the subject of various lawsuits around the country)
Opportunities to alert hospitals and clinics and the public to an emerging problem – common alcohol wipes contaminated with a potentially deadly bacteria – had been missed. Indeed, there is no public alert called for in such outbreaks, even when deaths occur. And the FDA had known of problems in the production facility for years, but had not taken action against the company.
What’s more, we’d later find that wipes were still in personal medicine cabinets – they also were sold by major drug store chains, sometimes under their own label – many months after the recall.
To tell the story in a way that would resonate with readers, we broke the mold of our traditional investigative stories and weaved the multiple elements into a single accountability narrative. We worked on that story, but spun off shorter-term watchdog pieces and followed developments, such as when U.S. Marshals raided the plant in April, seizing $6 million worth of product and effectively shutting down the plant.
The timeline of the case gave us a framework of accountability:
Harrison Kothari, a healthy and typical 2-year-old when he was admitted to a Houston hospital for a low-risk surgery, was set to go home when he suddenly became ill on Nov. 29, 2010. He quickly died.
When the autopsy results came back, it showed his death was caused by Bacillus cereus. Weeks earlier, nurses at a hospital in Colorado had noticed strange infections cropping up among their patients. Blood cultures tested positive for Bacillus cereus.
Hospital workers notified the Colorado Health Department, but officials there didn’t notify the FDA or the U.S. Centers for Disease Control and Prevention until the following week. It took another six weeks for Triad and the FDA recall the wipes.
But we dug much deeper than the timeline.
We requested FDA inspection reports detailing the agency’s visits to the plant dating to 2000. The agency provided them, but with heavy redactions.
They showed investigators had found the company wasn’t following proper procedures to sterilize wipes in May 2010, but they took no enforcement action. Instead, they accepted the company’s promise to correct the problem.
That followed a pattern from earlier inspections. A close look at the reports showed FDA inspectors repeatedly found serious violations of good manufacturing practices at Triad’s plants. For instance, we found the FDA was aware the company wasn’t properly testing its water supply, that drugs that didn’t meet specifications were tagged as acceptable, that equipment was dirty and products were left uncovered. The FDA was also aware that suppositories had been contaminated with metal shavings.
Never once did the agency – tasked with protecting public health – issue even a warning letter, demanding improvement. In June 2011, FDA officials admitted they should have taken a tougher stand with Triad in 2010.
One of the challenges of this story was that it was investigative in nature, with numerous accountability angles, but also the personal story of a family’s horrible loss. We viewed the story in terms of key scenes and wrote it in chapters, which we rearranged several times for maximum impact. Some key information, including that Harry had died, was not included until later in the story, building tension and suspense. The story opened with a narrative scene (Harry’s hospital room as he took ill), which we broke in the middle, and then returned to. So, the writing took a risk – which our editors encouraged – and it paid off in engaging the readers and leading them through a complicated story.
Since the story ran, we have continued our work.
We learned that the company many hospitals and drug stores turned to after Triad’s wipes were recalled also had a troubled manufacturing history. We searched the FDA’s records and learned that company had recently recalled wipes and are pursuing more documents.
In that same story we revealed how the FDA refused to release the recall audit reports, making it impossible to assess how effective the recall was. One area woman had wipes in her medicine cabinet six months after the recall but got the runaround from the FDA when she called to ask whether they were part of the recalled lots. They were. Simple changes to the bar-code tracking system, experts said, could mean a more efficient recall process, both from stores and within hospitals and clinics.
The calls from potential sources, of course, have continued.
And so has our reporting.