- msnbc.msn.com/id/43530903/
- msnbc.msn.com/id/41588330/ns/health-infectious_diseases/
- msnbc.msn.com/id/41694606/ns/health-infectious_diseases/
- msnbc.msn.com/id/41914778/ns/health-infectious_diseases/
List date(s) this work was published or aired.
Feb. 15, Feb. 22, March 3, March 11, May 9, June 13, July 11, Dec. 28, along with other dates of stories in the ongoing series.
Provide a brief synopsis of the story or stories, including any significant findings.
Starting Feb. 15, 2011, msnbc.com was the first news outlet to investigate how lax oversight by the federal Food and Drug Administration allowed rampant problems with medical wipes and other products used by millions and blamed for serious illnesses and deaths nationwide. Our stories were the first to reveal that FDA officials knew at least two years in advance about problems with contamination and sterilization at the Triad Group and H&P Industries of Hartland, Wis., and yet failed to enforce compliance until reports of illnesses and death surfaced. We later obtained documents showing the FDA had concerns about sterilization dating back a decade. We were the only news outlet to report that the wipes were used by more than a quarter of US Veterans Administration medical centers and the agency’s mail-order pharmacy. We also explored the human cost of the contamination, including alleged links between a Washington state newborn’s mysterious brain damage, a Tennessee man’s disabling heart infection and the death of a 2-year-old Houston boy.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The crucial discovery that led to this investigation was sparked by FDA Form 483 documents first provided to msnbc.com by a confidential source. The documents clearly showed that the FDA knew about problems with contamination and sterilization of medical wipes and other products at least two years before illnesses and a death were reported. Because of the FDA’s slow and laborious FOIA process, msnbc.com had to confirm the initial documents using documents available on FDAzilla.com, a resource not previously widely used. The stories also relied on several 483 inspection reports and responses obtained through FOIA, as well as internal FDA AERS reports of illnesses and deaths attributed to the products obtained through records requests. We also relied on FDA manuals and other documents related to bacterial contamination. In addition, we reviewed court records for at least 10 lawsuits that cited the potentially contaminated products. In addition, the stories relied on internal company memos and reports provided by confidential sources. Without being able to confirm independently the initial Form 483s using an outside source, this story would not have come to light so soon, or at all, if FDA had denied the request. It was only because of msnbc.com’s diligence and imagination in pursuing the original tip that this became more than just another story about a wrongful death lawsuit.
Explain types of human sources used.
Human sources included the entire range of participants in this saga: Alleged victims, their lawyers, FDA and CDC officials, U.S. senators and their staffers, former employees, hospital officials in several states, experts in contamination and sterilization, experts in infection control and confidential sources.
Results:
Our stories prompted attention by other media outlets and spurred the plant’s closure, seizure of more than $6 million in potentially contaminated medical supplies and a U.S. Senate inquiry into the FDA’s enforcement practices.
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.
None.
Advice to other journalists planning a similar story or project.
Our primary advice would be to pursue vigorously any tip provided after a seemingly ordinary feature story. In addition, we would urge other reporters seeking government records to invoke “the rule of three,” the mandate that three separate requests for the same records requires officials to post the documents online.