Beat reporter uncovers FDA’s failure to take action about contaminated products

By JoNel Aleccia

Here's a medical horror story for you: What happens when health care products that are supposed to protect against infection and illness turn out to be contaminated with potentially deadly bacteria?

Even worse, what happens when the federal agency that's supposed to oversee the safety of the products concludes that shoddy sterilization and known contamination don't pose "an imminent health hazard?"

How does a health reporter unravel the dual threads of human harm and regulatory mistakes to warn consumers about potential problems with medical wipes and swabs that could be in your local hospital, doctor's office – even your bathroom cabinet?

That's the situation MSNBC.com has been investigating since February, when we learned that the death of a Houston 2-year-old was being blamed in a lawsuit on allegedly tainted alcohol prep wipes used by the hospital that treated him.

MSNBC.com cracked the story of problems at H&P Industries Inc. and the Triad Group of Hartland, Wis., with a combination of persistent prodding, finding shortcuts to obtain and verify government records, cultivating friendly yet firm relationships with lawyers, public relations representatives and political aides – and getting a couple of lucky breaks from tipsters.

Through those efforts, MSNBC.com helped force government action on an issue that mirrors massive problems with tainted peanut butter and contaminated egg shells, but was virtually ignored by federal regulators for at least two years.

Earlier this month, federal officials filed a permanent injunction that has barred H&P Industries Inc. and the Triad Group, two firms run by the same family, from making and distributing medical wipes, pads, swabsticks and other products because they have the potential to be contaminated with two kinds of life-threatening bacteria.

That move followed the federal Food and Drug Administration's admission to two U.S. senators that agency officials should have issued warning letters to the Wisconsin firms last August, two months before a Colorado hospital detected the potentially deadly bacteria in two-thirds of the wipes it tested and four months before the toddler, Harrison Kothari, died. Instead, the FDA allowed the firms to pursue voluntary compliance. Since then, patients in at least six states have filed lawsuits claiming they were harmed by the products.

The stories, 15 in all so far, aren't the result of an investigative team pulled off of daily duties. Instead, it's been a single beat reporter for the website, covering each step of the story as it has unfolded.

In the spirit of sharing, here are our top lessons:

• Take the human interest story one step further.  We pursued the first story about the Kothari family and the loss of their son because it was a compelling topic for our readers and viewers at MSNBC.com and Today.com. But it raised as many questions as it answered, including how medical products could come to be contaminated and what role federal regulators played in detecting the problem – or not.

• Talk on background. It can't hurt. Within a day of running the Kotharis' story, we heard from industry insiders who wanted to share information on background about the plant that made the allegedly tainted wipes. Sure, they might have had an ulterior motive for spilling secrets, but we figured we could at least listen.

• Take the documents, then verify. A source offered us inspection documents that showed the FDA had known about problems with contamination and sterility as early as 2009. While we were happy to have copies of the records, known as Form 483s, we didn't know if they had been altered. The FDA's FOIA process can take forever, so we turned to FDAzilla.com, a new site that posts FDA documents, including Form 483s. It was a long shot, but FDAzilla.com did have copies of the inspection documents we wanted, and they matched exactly. Otherwise, we might have had to wait four months or more for the FDA to provide the documents.


Dr. Christine Nyquist, medical director of infection prevention at The Children’s Hospital in Aurora, Colo., holds a sample of the Bacillus cereus bacteria the hospital cultured from contaminated Triad wipes. (Photo courtesy of MSNBC.com)

• Find shortcuts, then exploit them.  During the course of the investigation, we have needed copies of new inspection reports and the company's responses. Because the FDA's FOIA response time can be so slow, we were pleased to learn of this trick, the so-called "rule of three:" If three or more parties request a document, it will be posted publicly – and fast – in the FDA FOIA reading room. So we asked other interested parties – read: lawyers – to request the documents we were after. They were happy to oblige.

• Pursue every public angle. We were stymied in our efforts to learn exactly how many hospitals and clinics across the country used these potentially tainted wipes. FDA said the information was proprietary and the company, of course, refused to divulge its distributors. We got a glimpse, though, when we asked the Veterans Health Administration if any of their medical centers had recalled the tainted products. As a public entity, of course, the VA would have an obligation to disclose whether it had recalled the medical products. The answer? Yes, indeed. A quarter of the VA centers – 38 of 152 nationwide – had used the potentially tainted wipes. That provided at least a snapshot of the scope of the problem.

• Nudge the public officials who should know. When we'd exhausted our own efforts at getting answers from government agencies, we raised the issues with members of Congress. Two senators, Michael F. Bennet, D-Colo., and Lamar Alexander, R-Tenn., responded to our reports about the FDA's delayed response with sharp questions of their own. They followed up with official inquiries about the impact of potentially tainted medical products on the veterans in their states. Those questions put pressure on the FDA, sparking an internal review that concluded the agency should have issued warning letters to the Wisconsin firms last summer, months before any harm was detected.

• Be polite, but be persistent. Really persistent. None of the agencies involved in this story have been overly pleased with our coverage at times, but we've managed to maintain a friendly but firm relationship that allows us get what we need – and keep going back for more. While some reporters insist on aggressive confrontation at every opportunity, we've learned that's the quickest way to not have your calls returned. The best trick we know is to be politely frank about what we need, when we need it and – as much as possible – why we need it. And then repeat as often as necessary. Maybe the press rep returns only one out of three e-mails or calls we make. But when they do call back, in our experience, it's to give us a tip slightly ahead of everyone else.

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JoNel Aleccia is a health writer/editor for MSNBC.com and Today.com. On Twitter she is @She was a member of the inaugural class of AHCJ-CDC Health Journalism Fellows.