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On October 10, 2008, Johnson & Johnson announced they spent an estimated $68.7 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the company’s Ortho Evra birth-control patch.

J&J, the world’s largest maker of health-care products, avoided trials through the confidential settlements and hasn’t released the financial details to investors.

Of 562 complaints reviewed by Bloomberg News, the vast majority of users alleged the patch caused deep-vein thrombosis (DVT), or blood clots in the legs, and pulmonary embolisms, or blood clots in the lungs. Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women.

Complaints filed on behalf of 4,000 women in state and federal courts claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra. More than 5 million women have used the patch since sales began in 2002.

The New Brunswick, New Jersey-based company voluntarily strengthened the warning label in 2005, 2006 and 2008 with the approval of the FDA.

On May 8, 2008, a consumer advocacy group lobbied that the U.S. government pull Ortho Evra birth-control patches off the market, calling it far riskier than the pill. “Ortho-Evra is a poor choice for women,” Dr. Sidney Wolfe of Public Citizen wrote the FDA.

Warnings about the Ortho-Evra weekly patch have soared since a 2005 investigation by the Associated Press found patch users suffer higher rates of life-threatening blood clots than women who take birth-control pills.

Blood clots are a rare side effect for estrogen-related products. Some, but not all, studies of the risk suggest patch users have twice the risk of clots in the legs and lungs, as do women who swallow the pill, because patients absorb up to 60% more estrogen via the patch. The FDA updated Ortho-Evra’s label in 2005, 2006 and earlier this year with clot warnings.

Demand has dropped, from approximately 9.9 million prescriptions filled in 2004 to 2.7 million filled in 2007, Wolfe wrote.

However Wolfe argued that the patch offers no better contraception in return for the extra risk. And he said lawsuits by women who claim they were harmed by the patch have unearthed two previously unpublished studies from Johnson & Johnson researchers that found higher estrogen exposure from the patch even before it won FDA approval in 2001.

A spokeswoman for patch maker Ortho Women’s Health & Urology, a Johnson and Johnson company, said “Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling.

“Hormonal birth control methods have benefits and risks,” said Gloria Vanderham. “The approved labeling has always stated the known risks associated with its use.”

The FDA said it has not had an opportunity to review the petition and, when it does, it will respond directly to Public Citizen.

Despite the risk, Wolfe said abruptly cutting off users could result in unwanted pregnancies. So he urged the FDA to phase out patch sales with a six-month period during which existing users could only get refills, allowing them time to switch to another contraceptive.