A couple from Ellensburg, Washington State, are suing the pharmaceutical company, Johnson & Johnson, after their two-year-old son, River, died of sudden liver failure the day after taking Children’s Tylenol from a batch of medicine that had been recalled.
The medicine was part of a 30th April, 2010 recall of several children’s medicines including Children’s Tylenol, Motrin, Zyrtec and Benadryl products. The recall was issued due to a manufacturing concern that more of the active drug may be placed into the medicine than medically necessary, meaning children who took the medicine may be at risk of overdose. There were also problems with particles being found in the medicines.
River was given Children’s Tylenol Very Berry Strawberry flavor and within half an hour of taking the drug was spitting up blood. He was rushed to hospital, where despite their best efforts he died the next day.
Tests showed he did not have a virus or bacterial infection and that his liver enzymes were above the normal level. Very high enzyme levels are usually the result of ingestion of medication so the pathologist found that he died from sudden liver failure.
Lawyers for the family said they believe that River received an overdose because the medication was too potent. They argued in their writ that the company ignored the low standard of manufacturing conditions at their plants, demonstrated by a string of recalls that continues to this day. The latest recall, of Motrin, occurred in late December of 2011.
The lawyers also alleged that in 2008 Johnson and Johnson initiated a secret recall of Motrin and Children’s Tylenol and instead of alerting the FDA to the problems they were having, they sent agents into the stores to buy up all the defective products in order to save their money and their reputation.
"This clandestine phantom/stealth recall was done without notification to the customers or the retailers to avoid the public shame, the financial impact and regulatory ramifications of a formal recall," they stated in their complaint.