Why doesn’t the Motrin label warn about Stevens-Johnson Syndrome?

A $63 million verdict awarded by a jury earlier this week in Maine shows the lengths to which drug companies will go to make a profit.

It’s well known that NSAID pain relievers like Motrin (ibuprofen) can cause Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis; the life-threatening complication is well-known in the medical literature, and there have been successful lawsuit against Johnson & Johnson and its consumer drug subsidiary, McNeil Consumer & Speciality Pharmaceuticals, the maker of Motrin and children’s Motrin, in the past. (I wrote about one such lawsuit here in Philadelphia two years ago.)

There’s also nothing new about the difficulty in holding pharmaceutical companies liable for the catastrophic side effects of their medications. The United States Supreme Court has taken a very hostile approach to drug injury lawsuits; while lawyers can raise a number of legal claims, like negligence and strict liability, in the end all of the lawsuits have to be proven the same way, i.e., by proving that the prescribing information or warning label did not adequately disclose the actual risks of the drug. If it’s a prescription drug, the injured patient has to prove the doctor would not have prescribed it (that’s called the “learned intermediary doctrine,” and it’s a terribly unfair rule). If it’s an over-the-counter drug, the patient has to prove they would not have taken it had they known.

In practice, that means that drug manufacturers can usually escape responsibility for any of the harm they cause as long as they stick a warning somewhere on the label, in tiny print, that a horrific complication like Stevens-Johnson Syndrome might happen. That means for Johnson & Johnson and McNeil that, if they wanted to stop facing these Stevens-Johnson / Toxic Epidermal Necrolysislawsuits, all they need to do is update the label of Motrin and Children’s Motion to better warn consumers about the risks of taking the medicine, and to instruct them, in big bold letters, to stop taking Motrin immediately if they develop any sort of rash or hives.

Samantha Reckis would have had a different life if her parents had been warned. I have young children, and I know how easy it is to get into the routine of treating your child with Tylenol or Motrin for every illness the child has, and to give more of the medicine – so long as you have not given in the past four hours – if the child continues to be sick. After all, when the kids were babies, that’s usually the best thing to do, because it’s the only thing that can keep the baby’s temperature down, and thus let the baby rest and get over the virus on their own.

The problem for NSAIDs is that, once a child or even adult has started to develop any signs of Stevens-Johnson Syndrome, giving more is – almost literally – adding fuel to the fire, any additional medication will turn what would have been a really awful experience into a lifetime of agonizing injuries, like the ones that Samantha suffered, including blindness, burns over most of her body, and such injuries to her internal organs that she had to be put into a medical coma.

Now that Johnson & Johnson has faced more than $125 million in jury awards against them for failing to warn about the rare but horrific complications of Motrin, why don’t they just change the label already? The answer, I think, is obvious: it is more profitable for them to pay tens of millions of dollars in jury awards, and millions of dollars in defense attorneys fees, then it is for them to update the label and thus potentially reduce sales. And that is a terrible, tragic shame.