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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4 Comments
Jon Lewis
Greg, I had not even heard about this issue with Triad. How tragic? What many don't understand is that money will not bring back Harrison, but money is the only thing that speaks to these companies, and it will make them think, and verdicts/settlements in these types of cases will make other companies think.
It is awareness, responsibility, and accountability that are the issues. It has to be more to these companies than simply making money. It is their responsibility to put out a safe product; otherwise, they have to pay the consequences.
That is the law! Somehow, people need to understand that these cases are not about "greedy attorneys". They are about people and safety. Do we get paid for the work we do? Yes, and we work hard for that pay. On top of that, we help people and companies understand the value of safety.
Thanks for the post.
Gregory Spizer
Jon -
Thanks for your comment. I completely agree. A company's number one priority should be the safety of the products that it places into the stream of commerce.
Tom C.
Being a lifelong diabetic, I use alcohol swabs 2-3 times a day. There has been none available in any store for months and I have had to adjust my use of them. Stores didn't have a reason why they couldn't get them. This company and all money first corporations need to be held criminally liable for their negligence. It ranks up there with BP,Toyota,those egg farms and any that harm or kill humans from their disregard for public safety. Shut them down, fine them big and put the top people in charge in jail. FDA,EPA and other government agencies that protect us need to have more power to do the right thing.
Gregory Spizer
Tom -
Thanks for your comment. I agree - industry and the government agencies overseeing those companies must work together to make sure that our products are safe.
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