Judges’ comments: In this comprehensive examination of a serious health threat, the Milwaukee Journal Sentinel uncovered an equally significant danger posed by the breakdown of the government agencies that are supposed to be protecting us. While the FOI effort alone could constitute a first-place award, the reporting was humanized and made intensely relevant when the writers introduced us to the Kothari family’s loss. Overall, this effort exemplifies best practices in multimedia storytelling, with graphics, compelling photos and riveting video. This will become a hallmark for how to accomplish public service reporting.
Provide names of other journalists involved.
Raquel Rutledge, Rick Barrett, John Diedrich, Ben Poston
List date(s) this work was published or aired.
June 26, July 17, Sept. 22 and Dec. 28, 2011; plus supplemental stories Feb. 28, April 5, April 14, Sept. 12, Sept. 29 and Nov. 1, 2011.
All published in 2011 the Milwaukee Journal Sentinel and on JSOnline.com.
Main stories:
- “Shattered trust,” June 26, 2011; Raquel Rutledge and Rick Barrett
- “Are recalled wipes still in use?” July 17, 2011; Raquel Rutledge and Rick Barrett
- “Pads used despite bacterium,” Sept. 22, 2011; John Diedrich
- “FDA falling short on safety checks,” Dec. 28, 2011; John Diedrich and Rick Barrett
- “Priorities, staffing impeded oversight,” Dec. 28, 2011; John Diedrich and Ben Poston
Supplemental stories:
- “Wipes blamed in child’s death,” Feb. 28, 2011; Rick Barrett
- “Medical wipes-maker in Hartland stops production,” April 5, 2011; Rick Barrett
- “Sanitation spotty at H&P, say ex-workers,” April 14, 2011; Rick Barrett
- “6th lawsuit files against Triad group,” Sept. 12, 2011; John Diedrich
- “FDA, firm battle over tainted wipes,” Sept. 29, 2011; John Diedrich
- “Three more deaths reported,” Nov. 1, 2011; John Diedrich and Rick Barrett
Provide a brief synopsis of the story or stories, including any significant findings.
The public assumes sterile alcohol wipes are sterile, or at least clean enough not to be dangerous. But an ongoing investigation in the Milwaukee Journal Sentinel found that wipes, sterile and nonsterile, can be dangerously contaminated, and federal regulators were not doing much to protect the public. When there are recalls, the public is not finding out about because of lax communications and weak tools for regulators. Over the course of nine months, the Journal Sentinel found that for a decade a Wisconsin company, the Triad Group, routinely violated federal rules for making sterile products but the U.S. Food and Drug Administration took little action. The contaminated wipes surfaced as the suspected culprit behind numerous illnesses and deaths in hospitals in several states. Other media started on the trail of Triad but the Journal Sentinel went much further and confirmed the key detail: that Bacillus cereus, the same bacterium sickening and killing people who used the wipes, was found on the Triad wipes and in the plant. The newspaper also uncovered a fight between the FDA and a New York wipes-maker, Professional Disposables International. The company initially refused to recall its alcohol pads contaminated with Bacillus cereus. When the recall came, it was done quietly until the Journal Sentinel began asking about it. Then PDI posted it on its website. And the investigative team found another Wisconsin company, Rockline Industries, that had high levels of bacteria on its baby wipes along with dead bugs, a razor blade and tape on the product. The FDA missed several problems during its inspections and took no official action. Rockline and customers like Walmart said nothing about its recall. FDA learned of the problems from whistleblowers inside Rockline. The company then launched a hunt, even using handwriting analysis. The piece on Rockline revealed the light oversight that FDA has on the cosmetics industry in the U.S. and abroad. Performing data analysis, we found that there are several thousand drug and device makers that have not been inspected by the FDA in at least five years. Our analysis showed hundreds of agencies have not seen an FDA inspector in 10 years or more. No inspector had been at Rockline’s flagship plant since 1992, our work showed. Congress requires that FDA inspect drug firms every two years. Our analysis shows the agency falls far short of that mandate. FDA had not done such analysis– nor had any other media outlet. We have additional stories in the works, and have followed developments on the stories we have already published.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
Using FOIA, we received hundreds of pages of FDA inspection records. Initially, the FDA blacked out the kind of bacterium found in Triad wipes but after legal challenges by the Journal Sentinel, the agency relented. The report confirmed that Bacillus cereus was found on the wipes and in the plant– the same bacterium responsible for killing a 2-year-old Houston boy. We also obtained FDA’s inspection database, again through FOIA. Using Access, we joined the inspections list with the lists of drug and device makers, revealing the length of time since firms had been last inspected.
Explain types of human sources used.
For the Triad article, we spent extensive time with the family of Harry Kothari, the Houston boy who died shortly after being treated with a Triad wipe. We also interviewed several former and current Triad employees, who detailed the poor sanitation practices. For the Rockline piece, we interviewed a dozen microbiologists and industry experts who told us how abnormal the company’s practices were and how dangerous the level of bacteria was found on Rockline wipes. These interviews included one with a consultant who currently works for Rockline.
Results (if any).
After the Triad article ran, the FDA began taking a harder line on the presence of Bacillus cereus in products it regulates. The Journal Sentinel confirmed that in its reporting on the New York wipes-maker, PDI. The new position by FDA led to push-back by the industry. In November, FDA took the unusual step of holding a public meeting on contamination of products and has made it clear that it is rethinking its position. The newspaper’s reporting prompted wider recall notice in at least one case. PDI had said nothing about its recall of alcohol pads until the Journal Sentinel began asking about it. Then the company posted the recall on its website.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
No corrections.
Advice to other journalists planning a similar story or project.
We found it helpful to put in FOIA requests early and educate ourselves on the rules surrounding drugs and cosmetic manufacturing. Besides reading manuals and other FDA documents, we did this by contacting an array of experts, from industry insiders, former FDA and government watchdogs. We pushed to get parts of the inspections unredacted, using legal counsel at the paper. We sought inspection data early and then took our results to FDA for comment. We continued to look for other companies where problems may be occurring.