OT: Did Motrin Blind This Girl- Court Battle Begins-- article

June 24, 2008

Did Motrin Blind A Little Girl? A Court Battle Begins

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By Ed Silverman // June 18th, 2008 // 11:22 am

A California couple is suing & for allegedly hiding

serious adverse events from the FDA when it sought to market the

widely used pain reliever, which contains ibuprofen, as an over-the-

counter salve for children, a Fox News TV station in Los Angeles

reports. The trial began yesterday in Malibu.

A J & J attorney countered there is no way to prove Motrin caused the

very rare allergic reaction, known as s- Syndrome. " You

have heard them suggest that & placed money over

children, " defense lawyer Christy told jurors, according to

Fox. " But that, ladies and gentlemen, is not what happened. "

was 6 years old in 2003 when her parents gave her

three doses of Motrin to fight a mild fever. Her parents, both

engineers with doctorates, wouldn't have given her more Motrin if the

drug had warnings that, in rare circumstances, life-threatening

allergies can develop, their lawyer told the court. He also contended

reports of blindings and deaths linked to ibuprofen weren't

investigated.

" The FDA is only as good as the information they got, and the drug

companies are responsible for giving them that information, " Dan

Balaban, the family lawyer, told the jury, adding that J & J was forced

to change its label slightly in 2005 when a group of doctors noticed

a pattern of disease linked to ibuprofen and successfully prodded the

FDA to order it, Fox reports.

A J & J lawyer argued that s- Syndrome can be caused by

dozens of drugs, and there is no proof that J & J's ibuprofen harmed

the girl. " The proof is, ladies and gentlemen, that the FDA was aware

of the very- rare reports of people getting s- Syndrome,

and the FDA continued to approve its use as safe and effective for

children, and continues to approve it today, " said.

added that, with the number of cases linked to ibuprofen, when

compared to the 6 billion doses consumed yearly around the

world, " you cannot say if a drug caused this as opposed to the

background rate - a certain number of people are going to have it

regardless of what drug they took, "

Fox reports.

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