FDA Knew of Serious Sterilization Issues in Plant That Produced Contaminated Wipes


February 23, 2011

A massive recall of tens of millions of supposedly sterile pads and wipes has been issued linked to problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wisconsin following the tragic death of a two year old Houston boy, Harrison Kothari. The boy died after being infected with a rare bacteria Bacillus cereus. Another hundred reports regarding contaminated alcohol prep pads have been logged by the FDA since the recall of Triad products because of contamination with the bacteria Bacillus cereus.

In addition to these complaints, a lawsuit has been filed by Donovan Joseph Postich, a Tennessee man, requesting $30 million in damages against Triad based on his developing an infection from Bacillus cereus after using the wipes. As a result of the infection, Donovan had to undergo open-heart surgery and is now permanently disabled following the surgery.

If you have developed a serious medical condition following exposure to the bacteria Bacillus cereus, which may be linked to your use of contaminated Triad products including swabs and wipes, you may be entitled to compensation for your injuries. Montlick and Associates, Attorneys at Law, has been representing Georgia residents injured by defective products throughout Georgia for over 27 years. Our experienced defective products lawyers are committed to providing exemplary service as part of our ongoing goal of being the best Atlanta product liability law firm servicing the entire state of Georgia.

It is particularly troubling that government documents reveal that FDA inspectors became aware of contamination and sterilization issues at the Triad plant as early as July of 2009. FDA inspection reports indicate that the Triad plant failed to comply with procedures designed to prevent microbiological contamination of sterile drug products. It does not appear that the FDA sent a warning letter to Triad following the investigation to direct Triad to implement remedial measures and follow appropriate procedures for preventing contamination. The FDA inspection documents indicate that Triad’s failure to follow appropriate sterilization and anti-contamination practices was widespread and affected other supposedly sterile Triad products including hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly.

The FDA inspection reports identify issues with Triad’s gamma radiation process that ensures sterility. Another issue that was identified was the release of products for distribution that had been identified as being contaminated. The report also identified other product safety issues including broken manufacturing equipment and misidentified batches of hemorrhoid cream. It appears that the contamination problems were significant and affected a wide range of Triad products. Although only two deaths have been reportedly linked thus far to the contamination problems with Triad pads, swabs and other products, the emerging claims of other injuries suggest there may be many other people that have not yet come forward.

If you or someone you love has suffered a serious medical condition caused by the bacteria Bacillus cereus after using a pad, swab or other Triad product, the Georgia defective medical products attorneys of Montlick and Associates will work diligently in your best interest to get you the compensation that you deserve. Our experienced Georgia defective medical products lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.


Please Note:
Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.