Protection focus of estrogen lawsuit

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Protection focus of estrogen lawsuit

Published: April 6, 2008 at 12:59 PM

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COLUMBUS, Ohio, April 6 (UPI) -- Johnson & Johnson can't be sued for health

problems related to its Ortho Evra birth-control patch because U.S. regulators

approved it, company lawyers contend.

 

The legal argument of pre-emption faces a challenge in an Ohio court, The

New York Times reported Sunday.

 

A lawsuit against J & J cites estrogen-related ailments allegedly caused by

Ortho Evra, but the company contends it can't be sued because the U.S. Food and

Drug Administration approved the patch, the Times reported.

 

The FDA received reports of at least 50 deaths linked to the patches and the

lawsuit cites several cases of heart attacks and stroke. High levels of

estrogen intake can lead to debilitating blood clots.

 

Labeling for Ortha Evra allegedly did not factor in a dosage " correction

factor " that used high levels of estrogen to account for ingestion.

 

The Bush administration backs the company's claims, saying the FDA, and not

the courts, is the only body authorized to regulate drug makers.

 

But the U.S. Supreme Court ruled in February against the makers of medical

devices, who claimed similar protection and has another similar case on its

fall docket.

 

A J & J spokeswoman called the patch effective birth control when used as

directed, while plaintiff attorneys contend the company marketed them because

it

" knew that FDA does not have the funding or the manpower to police drug

companies. "

 

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