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 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 if 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.