5-Month Old Baby Dies Allegedly from Tylenol Liver Damage

5-Month Old Baby Dies Allegedly from Tylenol Liver Damage

By Jessica Tyner

In 2003, Louisiana woman Christina Hutto rushed her 5-month-old daughter Brianna to a hospital. Brianna had been suffering from a cold and fever for a few days —  nothing strange for an infant. At the hospital, one of the nurses suggested that Hutto try Tylenol. The suggested serving was scribbled down for Hutton which was one teaspoon every four hours. 

A few days later, Brianna was in a coma after her liver was torn apart allegedly from the popular over-the-counter (OTC) medicine. It was an accidental Tylenol overdose, and it happened at lightning speed. There are also a number of types of Tylenol available, and this is what led to the confusion. The main ingredient in Tylenol, acetaminophen, can cause liver damage in patients of all aleges.

The arm of Johnson & Johnson which markets Tylenol, McNeil Consumer Healthcare, has sold two types of Tylenol for young children for the past 15 years. Sometimes parents and healthcare providers can mix up the types. Infants’ Tylenol is much stronger than Children’s Tylenol, and acetaminophen — the active ingredient which can cause liver damage — can cause liver damage with a very narrow margin of safety.

From the years 2000 to 2009, the U.S. Food and Drug Administration has received reports of 20 children dying from a Tylenol overdose which led to liver failure. These are just the reports which made it to the FDA and does not include children who have survived Tylenol. In these reports, three of them specifically cited a mix-up in prescribing the wrong type of Tylenol. Still, the FDA says that they likely capture less than one percent of these types of cases.

McNeil conducted a study which revealed that one child per year is hospitalized because of a mix-up, but this study may come with a generous side of bias. However, in the first decade of the 2000s, there were twice as many annual deaths connected to acetaminophen than all over OTC painkillers combined, according to the American Association of Poison Control Centers.

Over 150 Americans die each year from accidental acetaminophen poisoning, and “tens of thousands” are allegedly hospitalized. Most of these alleged Tylenol victims are adults, but some, like Brianna, are not. As for McNeil, company spokespersons have argued against changing the warning label, afraid changes will impact the flagship brand. In the autumn of 2013, some updates were made to the Tylenol warning label, but those in Tylenol class action lawsuits say the warnings still aren’t adequate.

However, McNeil has also made some positive moves — the company requested by the FDA for years to add specific dosing instructions just for children under the age of two to the packaging. Otherwise, the label just told parents to ask doctors how much to give children. However, the FDA couldn’t decide — it hemmed and hawed over the data McNeil presented without ever giving a concrete green light. It “requires careful consideration of myriad inter-related factors,” which may include “limited safety and efficacy data,” said the FDA.

To this day, the FDA says it’s working on providing user-friendly information for pediatric Tylenol usage. Of course, some critics say the simpler solution would be to offer just one pediatric product, at least avoiding accidental overdoses from a mixup. McNeil saw the two products are key for great profits, so that two marketing targets were pinpointed: Parents of young children, as well as parents of older children.

The Legal Side of Things

When the Huttos sued McNeil, the company’s Medical Director Anthony Temple was asked in court how common is it to mix up the two products. He said “maybe a couple of doze, maybe a little more,” in a 30-year span. “Probably a handful of those cases were fatal,” he added.

“And for 25 years you’ve elected to continue to offer Infants’ Tylenol in the concentrated form that has led to the death of babies, correct?” Temple was asked.

“Yes, we’ve continued to do it,” he agreed. “It’s easy looking back to say maybe we should have made a fix,” he continued, but he passed the buck to the FDA, saying that Tylenol was waiting for years for the FDA to make a move on dosing instructions.

Of course, Temple and his views have plenty of critics. A pharmaceutical marketing ethicist at the University of Colorado, Peter Max Miller, says simply, “One death is too many. I would not have had any hesitation at all about yanking it off the shelf overnight. Everywhere. And Johnson & Johnson knows how to do that.”

Just a couple of years ago, McNeil opted to pull the stronger infant drug formula from US shelves, but that was too late for the Huttos. “There was no crying. There was no movement. She just became a vegetable,” Hutto recalls.

Once hospitalized, Brianna’s liver enzymes were almost 200 times higher than what should be expected. A priest administered last rites, and a liver transplant was Brianna’s last chance — but she had to be breathing on her own to qualify, and she couldn’t come out of the coma. She died on January 8, 2003.

Did You or a Loved One Experience Tylenol Liver Failure?

If you have a personal story about Tylenol liver failure or poisoning, you may qualify for a Tylenol claim review. Discover more about next steps by visiting the Tylenol Liver Damage, Stevens Johnson Syndrome Lawsuit Investigation. Once you submit your information, an attorney will contact you if you qualify for a free Tylenol claim review.