Triad Alcohol Wipes Recall Lawsuit
FDA Defends Delayed Action Against Triad’s Wisconsin Plant
The FDA knew about the contaminated alcohol wipes manufactured by the Triad Group of Hartland long before infection from these claimed the life of a 2-year-old Houston boy. But the Food and Drug Administration did not issue any warning in this regard. Now it defends its delayed action against the Triad Group, saying that it chose to “work closely” with the firm to “voluntarily” improve the quality of their work, hoping that the “corrective actions would be addressed.” Tainted alcohol wipes and sterile lubricating jelly manufactured by the Triad Group of Hartland resulted in infections, serious complications, and one death, following which, the company issued recall of all lots of alcohol-based products citing potential microbial infection. Parents of the 2-year-old toddler Harrison Kothari have sued the Triad Group for their child’s death.
Alcohol Wipes Recall
The Triad Group issued recall of all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks after ......
receiving complaints of potential contamination with an objectionable organism, Bacillus cereus. The recall came only after a 2-year-old toddler had died in December last after being infected with the Bacillus cereus, which resulted in multi-organ failure. The parents of the 2-year-old hold the Triad Group responsible for the death of their child, claiming that gross negligence on the part of the company to check their health products resulted in their child getting infected with the deadly bacteria. The plaintiffs assert that their child died after being treated with the alcohol swabs contaminated with the bacteria, which the Triad Group failed to check before marketing the same.
Role of FDA
The FDA was also aware of the possible contamination at Triad’s production unit and equipment but initiated no action against it, hoping that the matter would be sorted out voluntarily. FDA inspectors visited the production units of Triad in July 2009 and April and May 2010 and reported about possible contamination and sterilization issues, though FDA decided to wait for more evidence of contamination instead of taking a drastic action at that time or reprimanding them formally. Rather, the FDA decided to work alongside the Triad Group to implement new quality standards. Had the FDA taken a more drastic action at that point in time, the matter would not have complicated to this extent – resulting in hundreds of people getting infected and death of the little Harrison Kothari.
FDA asserts that its inspections concluded no serious or imminent health hazard from Triad’s products, thus it decided to voluntarily correct problems at the company’s plant. The FDA also found broken, old, and inefficient equipment that was not worthy of producing intimate care products used in hospitals and homes, but did not do anything in this regard. It is hard to note that despite finding problems with the equipment and sterilization techniques used at the Triad facility, FDA allowed the company to continue production of sensitive products, such as sterile and non-sterile alcohol swabs, pads, and wipes and lubricating jelly, all of which have now been recalled. The FDA did not consider this an imminent public health hazard and allowed Triad’s Wisconsin plant to produce millions of alcohol wipes, pads, which have now been recalled.
A Colorado hospital, too, reported to the FDA November last that it had detected a serious bacterium in the Triad sanitizing wipes, which was potentially life-threatening for a patient. It was only after this hospital complaint that an FDA inspection team realized the gravity of the problem and confirmed that contaminated wipes had been widely distributed.
Magnitude of the Problem
Sterile alcohol wipes found contaminated with “organisms” had been shipped to different hospitals, pharmacies, from where they have reached store shelves and people’s homes. Even after the FDA and Triad recall, many of these tainted products continue to be sold on Amazon. Neither the FDA nor Triad has initiated any action in this regard.
Further, Triad has also recalled sterile lubricating jelly after several cases of vaginal infection in women were reported. Before the recall, from July 2009 to May 2010, Triad received six complaints from hospitals about high rates of abnormal pap smear cases related to its understerilized lubricating jelly; however, it failed to evaluate and investigate these complaints or even address the previously detected high microbial bio burden levels in the jelly. FDA inspection reports found that the Triad Group released products for distribution despite the failure of another batch of the same product to meet quality standards. But what did the FDA do about it?
The Triad products have resulted in different types of injuries, including superficial skin infections, serious complications, endomyocarditis, and even permanent disability. One patient claims having got infected with Bacillus cereus after using the alcohol wipes, following which he had to undergo open-heart surgery. The patient accuses the Triad Group for the open-heart surgery as well as permanent disability post-surgery. He has sued the Triad Group for his injuries and the pain suffered. He also seeks an answer from the FDA as to how it ignored the interest and health of the people by allowing marketing of tainted products.
The Triad Group continues to claim that of the millions of its products, there has been only one report of a potential contaminant. If the Triad Group feels that by recalling all lots of its alcohol prep pads, alcohol wipes, and alcohol swabs, and some other tainted products, it has fulfilled its duty as a health product manufacturer, it is under the wrong impression. Can this heal the suffering, pain, and agony suffered by the Kotharis? Is it not responsible for Harrison Kothari’s death and infection to many people? By marketing tainted products despite complaints and FDA warning, the Triad Group has completely failed in its moral obligations toward society. Being a manufacturer of health products, it was all the more important for Triad Group to closely monitor its manufacturing process and equipment to ensure that the products that leave its manufacturing units for marketing should meet quality standards and norms so that nobody has to suffer in any way. There are many other products manufactured by Triad in the market, including children’s cold medicine, mouthwash, and who knows that even these are potentially infected and tainted.
On the FDA’s part, it seems the government body does not exercise tight control over health product manufacturers. From the Triad debacle, the FDA must learn to deal with manufacturers of health products strongly and quickly. It must ensure that it acts quickly against any loophole in the manufacturing unit of any plant and take a more determined course of action to save people from suffering and even losing their lives because of negligence of health product manufacturers. A quicker action on the part of both FDA and Triad in this case would have meant that Harrison Kothari would have been alive today.