June 13, 2008 -- Children's Motrin caused the severe Stevens-Johnson syndrome that blinded a California girl, a lawsuit claims.
The lawsuit -- and at least nine others scheduled this year and next in cities across the U.S. -- seeks stronger label warnings and punitive damages against drugmakers.
The girl, Sabrina Johnson, was 6 years old in September 2003 when she was sent home from school with a fever. Her parents gave her Children's Motrin drops that afternoon and again that night.
The next morning, the lawsuit says, Sabrina woke with a high fever. Her eyes were pink and her mouth was swollen and covered with sores. Her pediatrician had her hospitalized at Cedars Sinai Pediatric Intensive Care Unit. By the next day, she was blind in both eyes. Doctors diagnosed Stevens-Johnson syndrome.
"This is a very important consumer case involving the really potent tragedy of a little girl blinded by Children's Motrin, an over-the-counter, seemingly benign medication," Browne Greene, the attorney representing the Johnson family, tells WebMD.
Greene claims that McNeil PPC, a subsidiary of Johnson & Johnson, has long known of a link between ibuprofen, the active ingredient in Motrin, and Stevens-Johnson syndrome. While the prescription version of the drug has stronger warnings, Greene says, the over-the-counter version mentions nothing about this risk.
"The parents gave the Motrin to a very healthy little girl, 6 at the time, and soon thereafter she started getting worse, and there was nothing on the package insert or label that said anything significant or life-threatening might happen," Greene says. "The label carries only the most benign and general kind of stuff."
In a statement provided to WebMD by a McNeil spokesman, the company says it is aware of reports alleging an association between Children's Motrin and Stevens-Johnson syndrome. The statement notes that Stevens-Johnson syndrome has been linked with a wide variety of medications and even viral infections.
"We are deeply concerned about all matters related to our products and have reviewed case reports, reviewed the scientific literature, reviewed the latest studies and consulted with the top experts in the field," the statement says. "Based upon our investigation we firmly believe that it is unlikely ibuprofen can cause SJS and that Children's Motrin is safe and effective when used as directed, and is labeled appropriately."
Greene says one of the major goals of the lawsuit is to demand that ibuprofen products carry warning labels. The suit also asks compensation for medical and legal expenses, pain and suffering, and punitive damages.
Stevens-Johnson syndrome is a rare, often fatal adverse reaction triggered by many different kinds of drugs, particularly certain antibiotics and some painkillers. A recent New York study linked ibuprofen to nearly half of the 32 children referred to a local burn unit over an eight-year period.
Burn units generally treat patients because Stevens-Johnson syndrome attacks the skin and mucous membranes. It can cause the top layer of the skin to separate from the lower layer of the skin in affected areas. When large areas of skin are involved, the disease is known as toxic epidermal necrolysis, although there is overlap between the two diagnoses.
Often the eyes are involved, leading to blindness. Sabrina was not only blinded, but also left highly sensitive to light. When she goes out, she wears a large hat pulled down over her face.
Stevens-Johnson syndrome is fatal in about 5% of cases; toxic epidermal necrolysis kills about 30% of patients.
While ibuprofen has been linked to Stevens-Johnson syndrome, so have many other drugs. There is no definitive proof that ibuprofen causes Stevens-Johnson syndrome. Ibuprofen is in dozens of products and is used by millions of adults and children who do not suffer serious side effects.
Greene says he will file two more lawsuits against McNeil, each linking Children's Motrin to the death of a child.
Greene says that before Sabrina fell ill, there were 15 known cases of Stevens-Johnson syndrome in children who took ibuprofen. Since then, he says, there have been 12 more cases in which children were "blinded, burned, or killed."
"They have settled a bunch of cases. This isn't the first case they've had," Greene says. "They settle these all confidentially in which they get the victims to agree not to tell the settlement amount and to give back any information that they have. That's basically how they keep the other victims and the public from hearing about it."
One of those cases involved Kaitlyn Langstaff, a California girl who in April 2002 developed toxic epidermal necrolysis at the age of 9. After a heroic struggle chronicled by local media, she died in December 2003.
Jury selection began this week for the Johnson case, which is being heard in Los Angeles Superior Court. Arguments are expected to begin next week.