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Behind FDA action on tainted wipes: a reporter staying on the story

Michael Stravato / for msnbc.com

Sandra and Shanoop Kothari of Houston hold a photo of their two children, Hannah and Harrison. After a routine surgery for a benign cyst, Harrison Kothari, 2, died last year of bacterial meningitis caused by Bacillus cereus, a rare bacterium that was later linked to the recall of millions of alcohol prep wipes.

Here’s a medical horror story for you: What happens when the very products used to protect sick people against infection and illness turn out to be contaminated with potentially deadly bacteria?

That’s the situation msnbc.com has been investigating since mid-February, when first reports emerged that alcohol prep pads widely used in hospitals and clinics, and sold in most major drugstores in America, might be tainted with bad bugs.

The alcohol wipes were made and distributed by H&P Industries Inc. and the Triad Group of Hartland, Wis., which launched a voluntary recall out of what the firm’s owners said was simply an abundance of caution.

Four months later, amid lawsuits alleging infection and death, the federal Food and Drug Administration last week asked U.S. marshals to shut down the firm and seize more than $6 million worth of medical products.

That move came after dogged reporting by JoNel Aleccia, health reporter for the news website msnbc.com. She reported that the FDA knew as far back as 2009 about problems with contamination at the company’s plant, but that agency officials failed to take aggressive action, contending that there was no imminent public health hazard. In a series of special reports, she has consistently been ahead of the pack on this story.

Open Channel asked Aleccia a few questions about her coverage.

Q. This issue was first raised in February by a Houston family who blamed the death of their 2-year-old son on contaminated alcohol prep pads that were later recalled.  At the time, it seemed like just one tragic case. When did it become a bigger story?

msnbc.com

JoNel Aleccia, msnbc.com health reporter

JoNel Aleccia:  While we were aware that alcohol prep pads had been recalled, we didn’t know the problem was serious until we heard from the family of Harrison Kothari, the Texas toddler whose parents claim died from the same bacteria that contaminated the wipes, Bacillus cereus.

That story led to other potential victims, and then to documents supplied by a confidential source that showed the FDA knew about contamination and sterilization problems at this plant dating back to 2009.

Q. But you’re talking about only a few reported infections and, sadly, one death. Why should the general public care?

Aleccia: The question here is not just the infections we know about, but the ones we don’t. So far, this company has recalled nearly a million cases of alcohol prep pads, hundreds of millions of individual wipes used in hospitals, clinics and in private homes by people who must take medications regularly. One Colorado hospital used 2,500 Triad wipes every day, and its analysis found that 40 of 60 wipes tested -- two thirds -- were contaminated with Bacillus cereus. Two children developed life-threatening infections, one child with leukemia and an infant with heart problems.

Investigators also have recalled tens of thousands of povidone iodine wipes made by H&P Industries, and those wipes are used not only to cleanse skin for minor infections but also to prep skin for surgery. The FDA says tests show the wipes were contaminated with different bacteria, Elizabethkingia meningoseptica. And now FDA officials say they’ve detected more “opportunistic pathogens,” though they won’t say which ones.

In addition, the company has recalled lubricating jelly used in medical exams, and there are reports of problems with a wide range of intimate care products, including acne pads, laxatives and children’s cold medicine. These items could be in anyone’s bathroom cupboard.

Q. How have you been able to follow the story so closely?

Aleccia: We’ve been able to track the story with basic reporting techniques, asking questions and following up leads as they arise. When the FDA said a report from a Colorado hospital led to the first recalls, but wouldn’t reveal which hospital, we called state public health officials to confirm the hospital and the doctors and then asked them to tell their story.

We’ve also been helped by sources who provided crucial documents. We got 2009 and 2010 government inspection documents known as Form 483s from one source and then confirmed that those documents were legitimate by getting duplicate copies from a great FDA monitoring site: FDAzilla.com. We got an internal company letter from a confidential source, and then confirmed it by getting a duplicate copy from a separate, independent source.

We’ve also been pretty vigilant with the FDA, asking them repeatedly to explain why a plant with such serious issues did not receive a warning letter or other sanctions – including product seizure or court action – until two U.S. senators intervened last month, asking FDA to account for its actions.

Q. What does the company say?

Aleccia: We’ve offered Eric Haertle, co-owner of H&P Industries, many chances to comment, with limited response. A newly hired company spokeswoman, Christy Maginn, confirmed the U.S. marshals arrived at the plant with seizure orders. She referred us to a statement that says the company believes its products remain safe.  “We are aware of no confirmed link between any H&P Industries Inc. product and patient illness or death.”

Q. What might happen next?

Aleccia: For now, the products remain quarantined at the Wisconsin plant under court custody. In similar situations, the FDA and the Department of Justice have launched criminal probes into contaminated products that have endangered public safety. Criminal investigations followed recent massive outbreaks of salmonella infections traced to tainted eggs and peanut butter, for instance.

Q. Have other media been following this story?

Aleccia: The Milwaukee Journal Sentinel newspaper has tracked this situation as a local story, but other national media outlets have limited their coverage mostly to following our reports of the $6 million product seizure last week.

Full coverage
Here are the full links to Aleccia's coverage on msnbc.com, tracing the arc of the story so far:

Feb. 15: Parents blame toddler's death on tainted alcohol wipes.

Feb. 22: FDA knew of problems at plant that made tainted wipes.

Feb. 25: FDA defends actions at plant that made tainted wipes.

March 7: Colorado hospital blew whistle on contaminated wipes.

March 11: Under pressure, firm shutters line that made tainted wipes.

March 18: Deadly infection risk triggers new recall from embattled medical supply maker.

March 24: Two-thirds of alcohol wipes in test contaminated with bacteria.

March 28: FDA asks maker of tainted wipes to stop production.

March 31: Senators question FDA's response to tainted wipes.

April 4: Wipe-maker shuts doors after US marshals arrive on site.

April 6: Feds seize $6 million in products from wipe-maker.

Do you have more information?
Send an e-mail to msnbc.com health reporter JoNel Aleccia.