Every day, I read news stories that remind me to appreciate my daughters’ health. This was especially true when I read the story of Harrison Kothari, a 2-year old boy from Houston, who tragically passed away on December 1, 2010 after developing a sudden and severe infection.
For almost a month, Harrison’s parents, Sandra and Shanoop Kothari, had no idea why their son had developed an infection while recovering well from a surgery at Children’s Memorial Hermann Hospital. What was especially confusing was that cultures showed that Harrison had acute bacterial meningitis caused by Bacillus cerus which is a bacteria typically found in food poisoning, not hospital infections.
Approximately one month later, Sandra’s sister saw an online posting from the FDA which indicated that all alcohol swabs and prep pads manufactured by a Wisconsin company, the Triad Group, were being recalled. It was later confirmed that the alcohol wipes used with Harrison were from Triad. Now, the Kothari’s have filed a lawsuit against Triad.
What happened to Harrison is tragic, but this tragedy is even further compounded by reports that Food and Drug Administration inspectors identified contamination and sterilization problems at a Triad Group plant as early as July 2009. FDA inspectors expressed concerns following July 2009 and April 2010 visits to the Triad plant. One FDA inspection included the following quote: “procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.” The FDA inspectors also noted that Triad failed to evaluate complaints that were received from a hospital and doctor.
Amazingly, after these inspections, the FDA did not send a warning letter or take any formal action against Triad. Triad also appeared to have taken no corrective action before the recall. As consumers, we place our trust in others. We trust that companies will manufacture safe products. We trust that if the companies fail to meet safe manufacturing standards, that the government regulators will protect us. In this instance, neither industry nor the government acted as it should have. Both need to review their policies and protocols so that this type of event is not repeated.
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