Ortho Evra Maker Seeks Legal Immunity

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April 8th, 2008

"J & J Wants to use Pre-emption for Immunity"

The maker of the Ortho Evra birth control patch is seeking legal protection from lawsuits over injuries caused by the product with arguments in favor of a concept known as pre-emption.

Pre-emption

Johnson & Johnson is arguing that it cannot be held legally liable in cases brought by women claiming they were injured by Ortho Evra because the Food and Drug Administration approved the product.

This is essentially the legal standard known as pre-emption, which maintains that if the FDA approves a drug or medical device, the agency’s decision should not be second-guessed by courts.

Earlier this year, the Supreme Court granted pre-emption to makers of medical devices like implantable defibrillators, making them immune from legal claims. Plaintiffs’ lawyers and drug companies are expecting a similar ruling from the court on Ortho Evra.

Over 3,000 Lawsuits

Thousands of lawsuits have been filed against Johnson & Johnson in recent years. The claims are filed by women who have suffered heart attack or stroke because of the birth control patch, or by families of women who died as a result of Ortho Evra use.

Internal Johnson & Johnson documents reveal that the company knew about the dangers associated with the Ortho Evra patch before it was even approved by the FDA.

The patch delivers a much greater amount of estrogen than low-dose oral contraceptives and is consequently associated with a significantly increased risk of potentially fatal blood clots.

(Source: The New York Times)

Injured by Ortho Evra? Contact an experienced attorney near you today to learn more about your rights and options.