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April 8, 2008 - Protection Focus of Estrogen Lawsuit

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 Johnson & Johnson 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 Johnson & Johnson spokeswoman called the patch effective birth control when used as directed, while plaintiffs' 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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