Failure To Warn Quiz: Do You Know Children’s Motrin Side Effects?

They say you learn something new every day. Here’s what you’re going to learn today:

Over-the-counter Motrin can burn the skin off your face.

Commonly prescribed drugs like the yeast-infection treatment Nystatin and the antibiotic Azithromycin can do the same. All of them, and over a dozen other drugs, can also cause ulcers and lesions to develop on the membranes in your mouth and on your lips, making it impossible to eat.

Take a step back and think of how many of those you took in the last year. Who didn’t take Motrin or some other ibuprofen in the past year?

Who didn’t give it to their kid?

Janet Leland gave Children’s Motrin to her nine year old daughter, Kiley Wolfe, just like her pediatrician told her to, to relieve headache, stomach pains, and a fever. As the District Court for the Eastern District of Pennsylvania described last week:

Despite taking Children’s Motrin, plaintiff’s symptoms did not improve. Instead, she developed a rash on her cheeks. Nonetheless, nurses at plaintiff’s pediatrician’s office advised Leland to continue administering the drug to plaintiff. Leland proceeded to give plaintiff doses of Children’s Motrin until Saturday, June 1, when she noticed blisters on plaintiff’s ears while the family was staying in Boston.

Later that day, Leland took her daughter to Boston Children’s Hospital. Doctors there diagnosed her with Stevens-Johnson Syndrome (‘SJS’) [2] While hospitalized, plaintiff exhibited symptoms of acute Vanishing Bile Duct Syndrome (‘VBDS’). [3] Because of damage to her liver, plaintiff eventually required a liver transplant.

FOOTNOTES

2 SJS is ‘a rare, serious disorder in which your skin and mucous membranes react severely to a medication or infection.’ Mayo Clinic, Stevens-Johnson Syndrome, http://www.mayoclinic.com/health/stevens-johnson-syndrome/DS00940 The disease is ‘sometimes fatal.’ Dorland’s Illustrated Medical Dictionary 1833 (30th ed. 2003).

3 VBDS is a condition where the bile ducts in the liver are destroyed.

Wolfe v. McNeil-PPC, Inc., 2011 U.S. Dist. LEXIS 34714, at *4–5 (E.D. Pa. Mar. 30, 2011).

 

Stevens-Johnson Syndrome is perhaps the most catastrophic adverse drug reaction, an insidious immune system response that can cause necrotizing of tissues anywhere from the skin to the internal organs. It is thankfully quite rare, around 300 cases reported each year, roughly the same number of people being struck by lightning. But it happens, and if you develop a rash from taking ibuprofen — or, really, any medicine — you should get it checked out immediately.

Did you know that? I bet you also didn’t know that, as the Court summarized, “[i]n 2006, the FDA recommended that warnings for OTC ibuprofen products be strengthened. Specifically, the FDA recommended that such labels include reference to skin reddening, rashes and blisters — allergic reactions associated with SJS — and warn customers that ‘[i]f an allergic reaction occurs, stop use and seek medical help right away.’” Wolfe v. McNeil-PPC, Inc., 2011 U.S. Dist. LEXIS 34714, at *5 (E.D. Pa. Mar. 30, 2011).

McNeil thought otherwise, and didn’t bother.

Janet’s mother sued the pharmaceutical company on Janet’s behalf, alleging four types of negligence in the design of Children’s Ibuprofen (specifically, (1) negligent failure to warn, (2) negligent failure to test, (3) negligent marketing and (4) negligent design defect), along with claims for strict liability, manufacturing defects, design defects, breach of express warranty, breach of the implied warranty of merchantability, and consumer protection violations, the whole product liability toolbox.

All of those claims lost but one, the failure-to-warn, which survived thanks to Wyeth v. Levine, 129 S. Ct. 1187, 1199, 173 L. Ed. 2d 51 (2009). The folks at Drug and Device Law thought that claim should have failed too; how come, they asked, McNeil couldn’t get the same result as it did in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010), where Judge Posner — the judge who never reads the contracts he signs — personally felt that Children’s Motrin had more than enough warnings to suit his tastes and so didn’t allow the Robinson family to go to a jury trial.

Here’s why not: Judge Posner is a judge. He’s not a jury. He never heard one word of testimony from anyone — not the parent, not the pediatrician, not the drug company, not the experts, nobody — about the case. He was in no position to decide anything about what, exactly, should have been on that label. Maybe there’s nothing to be done differently. Maybe it should look like an article from McSweeney’s. (Hat tip: Craig Niedenthal‘s Twitter feed.)

 

We have a law for those situations. The Framers of the Constitution didn’t agree on everything, but they agreed that:

In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury shall be otherwise re–examined in any Court of the United States, than according to the rules of the common law.

It doesn’t say that “the right of pre-trial decision by a judge who never heard any testimony shall be preserved.” It says the right of trial by jury shall be preserved.

Janet Leland deserves her day in court, deserves to have a jury determine if McNeil should have done what the FDA told it to do and if that would have made a difference.

Thankfully, she’s going to get it.

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  • MEM

    Thank you for making children’s safety in medicine (at all touchpoints of care – pharma, surgical, clinical,etc) a priority and giving it a place to be seen & heard.