As a defective medical device attorney, I was interested to see a growing number of stories about contaminated alcohol wipes blamed for the death of a little boy in Texas. MSNBC originally reported Feb. 15 on the lawsuit by Shanoop and Sandra Kothari of Houston, who lost their two-year-old, Harrison, in December. Harrison Kothari was supposed to have surgery to remove a benign cyst from his brain and spinal cord. But as he recovered at a children’s hospital, he was treated with Triad alcohol wipes that were supposed to be sterile. A few days later, he died of bacterial meningitis that was later determined to be caused by the bacterium Bacillus cereus. The Triad wipes were later recalled for possible contamination by Bacillus cereus, and the Kothari family is now suing the manufacturer Triad Group of Wisconsin.
Bacillus cereus is typically found in cases of food poisomning and is an unusual bacterium to find in a hospital. However, MSNBC followed up with a Feb. 22 report showing that the FDA knew there was a problem with the wipes as long ago as July of 2009. Plant visits by FDA inspectors in that month, and later in the spring of 2010, found that Triad couldn’t show that its sterilization process was working, but was continuing to sell its products as sterile anyway. Documents sent to MSNBC anonymously showed that the FDA was concerned about the low levels of radiation used in the sterilization of products, as well as Triad’s failure to address high levels of microbes found in a supposedly sterile lubricating jelly.
The reports show that the president of the company even authorized the shipment of a product that failed tests, only to recall it after some had already been sold. Triad also failed to evaluate and investigate a complaint by a hospital that one of its jellies was not sterile — one of six such complaints. Nonetheless, the FDA took no action to penalize the company or incentivize it to correct its problems. A note in the papers says only that Triad promised to correct the mistakes. In the week since the report, 50 people have contacted the Kothari family’s attorney to report their own health problems blamed on the Triad wipes, which range from skin infections to another death. And Joe Postich of Tennessee has also sued, alleging that contaminated wipes caused him to develop a heart infection that left him too disabled to work.
As a dangerous medical device lawyer, I’m pleased that these reports have focused public attention on the regulatory lapses at the FDA. The FDA exists to protect us from contaminated, ineffective or otherwise dangerous foods, drugs and medical devices. But when it cannot or will not do that job carefully, Americans can be lulled into a false sense of security that products offered for sale are guaranteed to be safe, and seriously hurt or even killed. The pharmaceutical industry has been complaining in the past months about the FDA’s choice to increase regulatory actions — but this case shows that the agency may not be going far enough.
There are very real consequences when drug safety processes fail: deaths and permanent, irreversible disabilities. Further FDA action can help prevent more people from falling ill — but it can’t help the people and families who are already victims of the drug company’s negligent failure to ensure its “sterile” products are actually sterile. To recover the costs of their injuries, those families should consider contacting a defective medical device attorney about suing the negligent manufacturer. St. Louis-based Carey, Danis & Lowe represents people from around the United States who are seeking to hold manufacturers legally liable for actions that permanently harmed them. In a lawsuit, victims can claim all of the costs of the injury, including all related medical costs and any income permanently lost because of a disability or untimely death. They can also claim damages for the personal losses suffered when a loved one is taken too soon.
If you or someone you love was seriously harmed by a tainted or otherwise dangerous drug or medical device, don’t wait before you call Carey, Danis & Lowe for help. To set up a free, confidential consultation, send us an email or call us toll-free at 1-877-678-34000.