We revisit the story of Brianna Hutto, a five-month-old who lost her life after a mix-up between two Tylenol products. It was an all-too-easy mistake to make -- and both the FDA and the Johnson & Johnson unit that makes Tylenol knew it had happened before

OPELOUSAS, La. — On a chilly Friday night in January 2003, Christina Hutto took her 5-month-old daughter to Opelousas General Hospital, a brown building squatting near the center of this small Louisiana town.
 

A chubby girl with bright blue eyes and blond hair, Brianna had suffered from a cold and fever for several days. A nurse suggested Tylenol. He scribbled the dose on a piece of paper: one teaspoon every four hours.
 

Within days, Brianna was lying comatose in a pediatric intensive care unit — her life threatened not by a deadly virus or rare disease, but by an accidental overdose of one of the nation’s most popular over-the-counter pain relievers. Her liver had been destroyed by a toxic byproduct of the medicine that was supposed to help her.
 

The Huttos were blindsided. Like many Americans, Christina and Eric Hutto had trusted Tylenol, a brand synonymous with safety. Tylenol, as the advertisements proclaimed, was the No. 1 doctor-recommended brand of pain reliever; the one hospitals used most; the one used by moms decade after decade.
 

Yet Tylenol’s pediatric products had the potential for lethal confusion — and this was no secret to federal regulators or McNeil Consumer Healthcare, the division of Johnson & Johnson that manufactures the drug.
 

For at least 15 years, until 2011, McNeil continued selling two versions of Tylenol for young children, despite knowing that parents and even medical professionals mixed them up, sometimes with serious consequences. And the Food and Drug Administration failed to intervene.
 

The two types of pediatric Tylenol had a counterintuitive difference. Drop for drop, the strength of Infants’ Tylenol far exceeded that of Children’s Tylenol.
 

In addition, the active ingredient in Tylenol, acetaminophen, has what the FDA deems a narrow margin of safety. The drug is generally safe at recommended doses, but the difference between the dose that helps and the dose that can cause serious harm is one of the smallest for any over-the-counter drug.
 

By confusing the pediatric products and administering too much of the infants’ version, parents could inadvertently overdose their children. Other manufacturers also made two children’s products with different concentrations of acetaminophen.
 

Between 2000 and 2009, the FDA received reports of 20 children dying from acetaminophen toxicity – a figure the agency said likely “significantly underestimates” the problem. Three deaths were tied directly to mix-ups involving the two pediatric medicines. Such errors may have caused some of the other deaths, but the agency has acknowledged that its data lacks sufficient detail to determine the precise cause.
 

Similar gaps exist in data for non-fatal liver injuries. The FDA has estimated it may capture less than 1 percent of such cases. Still, one small study found that confusion between the two pediatric products was the most common reason for overdoses among kids with acetaminophen-related liver damage. A study conducted by McNeil found that about one child a year on average was hospitalized because of mix-ups involving its drugs.
 

Such tragic accidents are among the reasons that between 2001 and 2010, there were about twice as many deaths annually associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from the American Association of Poison Control Centers. On average, more than 150 Americans die accidentally each year from acetaminophen poisoning, most of them adults, Centers for Disease Control and Prevention data shows. Tens of thousands more are hospitalized for overdoses.
 

Over a span of decades, federal regulators have been slow to protect consumers in the face of the drug’s rising toll, and McNeil has argued against warning labels, dosing restrictions and other protective measures that would have affected its flagship brand.
 

The company and the FDA said they have done what they can to reduce overdoses through labeling changes, public education efforts and other measures.
 

McNeil pressed the FDA for years to allow it to add dosing instructions for children under 2 to its pediatric products; the government-approved label said only to ask a doctor how much to give kids of that age. The company presented mountains of data and made repeated public pleas in arguing for the change.
 

For more than a decade, the FDA deliberated on the company’s petition but never took action. The issue “requires careful consideration of myriad inter-related factors,” the agency said in a statement, including that “limited safety and efficacy data” existed for acetaminophen in children under two. Today, the agency said, it is continuing an effort to write “user-friendly” instructions for pediatric acetaminophen.
 

All along, there was another option. At any time, the FDA could have pushed McNeil and other manufacturers to switch to a single pediatric concentration. Or McNeil could have done so voluntarily, ensuring that no one could mix up the dose. Neither did.
 

Having two products allowed the company to sell to different consumers — parents of babies and toddlers on the one hand, and older children on the other.
 

Under oath in a lawsuit brought by the Huttos, McNeil’s former medical director, Anthony Temple, was asked how often mixing up the two pediatric products had led to liver injury. Over a 30-year period, he said, “There are maybe a couple of dozen, maybe a little more, where incidents of significant liver injury has occurred, and there’s probably a handful of those cases that were fatal.”
 

“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?” he was asked.
 

“Yes, we’ve continued to do it,” Temple testified.
 

The company viewed moving to a single concentration as “a second-best option,” Temple said in an interview.
 

“It’s easy looking back to say maybe we should have made a fix,” he said. But he explained that McNeil believed for years that the FDA was going to add dosing instructions. During that period, he said, the benefit to children warranted keeping the two versions on the market.
 

PeterMax Miller, a pharmaceutical marketing ethicist at the University of Colorado in Denver and a former executive at a Johnson & Johnson competitor, said he saw the math — and the morality — differently. First, do no harm.
 

Asked if just one infant death should trigger a drug maker to pull a product, he replied that it would be “more than a trigger, that is a huge cannon.”
 

“One death is too many,” he added. “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.”
 

Two years ago, as federal regulators were considering pulling the product, and as lawmakers in Louisiana were weighing their own solution to the problem, McNeil and other companies voluntarily withdrew the stronger formulation of their infant drugs from U.S. store shelves.
 

That came too late for the Huttos.
 

Both Infants’ and Children’s Tylenol were on the shelves when Christina and her mother walked into the local Walmart after leaving the hospital in early 2003. They purchased what they had previously given Brianna — a bottle of the more concentrated Infant’s Tylenol.
 

They drove to their home in Krotz Springs, a tiny community of trailers and small tin-roofed houses nestled against a levee on the dark brown Atchafalaya River. It was here that Eric Hutto had fallen in love with Christina after they met at the “kissing log” — a creosote-covered post over a ditch that was a make-out spot in town.
 

They were young when they got married, only 17. With Christina pregnant, the couple worked hard to make their home safe for Brianna. Before her birth, they tore up the old carpet in their trailer to put in new, allergen-free carpet. They did the same thing in the kitchen, replacing the worn, old flooring with new linoleum. They furnished a nursery for her.

A construction worker who loved hunting and fishing, Eric doted on his young daughter. He held her to him swaddled in a blanket, fed her, watched television with her. Christina loved her baby more than she could have believed — “like the sun had just opened a door in our lives,” she would say.
 

Over the weekend, the Huttos remembered, they dutifully began giving Brianna the dosage recommended by the nurse at the hospital. They used a small plastic cup with teaspoon indicators to measure the syrup. They used the dropper that came with the package to administer it. They made sure they were giving her the medicine at the right time intervals — no sooner than every four hours.
 

By Sunday morning, Brianna seemed worse. She was restless and vomiting. By that evening, she was listless. She wasn’t even responding to the sound of Christina’s voice. “Sunday, there was no crying. There was no movement. She just became a vegetable,” Christina said.
 

Christina had to go to her job at a truck stop, so Eric and his father, Jimmy, the local fire chief, decided to take Brianna back to Opelousas General.
 

As the evening wore on, things went from bad to worse. Brianna wasn’t responding to stimuli. She was dehydrated. The doctors were having trouble getting an IV into her. Her veins kept collapsing. Christina rushed to the hospital. She and Eric spent a sleepless night at the hospital with Brianna.
 

At the morning shift, Brianna’s regular pediatrician came into the hospital. Christina remembers that she saw Brianna and immediately screamed: “Why wasn’t I called? This baby is in bad shape!”
 

The doctor was confused. She suspected Brianna had ingested poison, but didn’t know what. She asked Eric if the family had lead or other dangerous substances in the house. Finally, she ordered up tests to check for liver damage and the levels of acetaminophen, the active ingredient in Tylenol, in Brianna’s blood.
 

The results showed Brianna’s liver enzymes were nearly 200 times higher than normal. And the amount of acetaminophen in her blood indicated that she had taken far more than the recommended dose.
 

Time was now of the essence. McNeil had helped to fund the development of an antidote to acetaminophen poisoning that is remarkably effective if administered within the first eight hours. Then its efficacy declines. Brianna had passed the window. Her liver was failing fast. But there was still a chance.
 

A medical helicopter whisked Brianna to New Orleans Children’s Hospital, where she could receive more specialized care.
 

There was no room on the helicopter for the Huttos. So Christina, Eric and Jimmy piled into Jimmy’s pickup, and started driving down Interstate 10, past swamp and cypress forest, toward New Orleans.
 

The two-hour drive was agony. Christina sobbed the entire way. Eric was bewildered. Three days ago, he had a child with a fever. Now she was being airlifted for a liver transplant.
 

“It was a long, long ride,” Eric said. “It was like it was just a tunnel we was riding through that never was going to end.”
 

It would take several years to sort out what happened. Opelousas General, as it turned out, did not use Infants’ Tylenol — precisely because hospital administrators wanted to avoid the risk of overdosing by confusing two different formulations. Nurses were used to giving dosage instructions based on the less-potent form, Children’s Tylenol.
 

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Courtesy: ProPublica.org