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Family Blames Girl's Blindness on Motrin

UPDATED 7/18/08 From the Associated Press:

Parents of blinded SoCal girl lose Motrin suit

A jury refused to award damages Thursday to a couple who sued drug maker Johnson & Johnson for $1 billion, claiming its Children's Motrin nearly killed their daughter and left her legally blind.

The Los Angeles County Superior Court jury voted 9-3 that the company and McNeil Consumer & Specialty Pharmaceuticals, a division of the drug maker's McNeil PPC Inc. subsidiary, were not liable for the problems of 11-year-old Sabrina Johnson.

Plaintiffs' attorney Browne Greene said he will appeal.

The lawsuit asked for $14 million in actual damages, $103 million for pain and suffering and $950 million in punitive damages.

During the trial, Sabrina testified that her eyes were so sensitive and painful that for several weeks she spent daylight hours inside a cardboard box.

The syndrome is potentially deadly and experts say it may be caused by infections and by reaction to certain drugs, including anti-inflammatory medications, anticonvulsants and some antibiotics.

The main ingredient in Children's Motrin is ibuprofen, a commonly used anti-inflammatory and pain reliever.

At trial, doctors testified that the chances of having a severe allergic reaction to ibuprofen was one in a million.

"While we are sympathetic to the pain and hardships suffered by Sabrina Johnson, Children's Motrin has been proven safe and effective for treatment of minor aches and pains and fever when used as directed and the medicine is labeled appropriately," McNeil PPC Inc. said in a statement after the verdict.

The jury found in its verdict that Children's Motrin did carry "substantial and dangerous" potential risks to consumers and that the companies failed to properly provide warnings.

But the panel answered "No" to the question: "Was a lack of sufficient instructions or warnings a substantial factor in causing harm to Sabrina Johnson?"

One juror, Robin Nickel, said the girl's mother failed to follow directions on the label by giving Samantha Children's Motrin after the girl woke up with puffy eyes.

"It said on the label, any new symptoms call the doctor, and she didn't do that," Nickel said.

From WebMD:

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.

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."

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."

Posted: 6/18/2008 11:41:00 AM

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