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Ortho Evra appeared innovative in 2002: The contraceptive was the first patch the FDA approved for co-pay, and compared to standard pill methods, this birth control form only required once-a-week application.

Studies emerging over the next few years, however, showed a strong correlation between blood clots in the legs and lungs, as well as cardiovascular risks, and a class action lawsuit followed.

Risks

Ortho Evra’s design exposes women to roughly 60 percent more estrogen than typical pills, putting 35 micrograms of the hormone into the blood stream. As a result, birth control’s standard side effects appear magnified.

Lawsuits further allege that the FDA and the manufacturer Ortho McNeil, a Johnson & Johnson subsidiary, knew of the side effects before approving Ortho Evra, as both claim the patch is equally as safe as other hormonal birth control methods.

Warnings

A 2004 study showed that 800,000 women using the patch were found to have a three-fold greater risk of blood clots than if they used standard birth control pills.

Following this up in July 2005, the Associated Press reported that close to a dozen women died as a result of birth control-related blood clots. At the time, as well, 16,000 reports filed with the FDA revealed a pattern of strokes and other blood clot-related side effects.

What was particularly surprising is, most reports filed concerned younger women, who are usually at a lower risk for blood clots.

By November 2005, Ortho McNeil, which has generated around $1 billion in sales from the patch, revised its warning label. The new statement emphasized such side effects as blood clots, strokes, and cigarette-related cardiovascular issues.

A second study’s results appeared in 2006, confirming the 2004 findings regarding blood clot association; particularly, that Ortho Evra doubles a woman’s risk for blood clots when compared to birth control pills.

Along with these instances, Johnson & Johnson Chief Medical Examiner Dr. Joel Lippman started a whistleblower lawsuit. In it, he alleged that Johnson & Johnson refused to recall dangerous products to which he objected, with Ortho Evra being one.

Dr. Lippman claimed that his research indicated Ortho Evra increases risks of deep venous thrombosis and pulmonary embolism.

By 2011, the FDA requested Ortho McNeil and Johnson & Johnson strengthen the drug’s warning label.

Lawsuits

A class action lawsuit against Johnson & Johnson alleged that the manufacturer knew of Ortho Evra’s risks but failed to adequately warn women about its potentially-fatal side effects. Since that point, Johnson & Johnson has paid $68.7 million to settle 4,000 lawsuits at state and federal levels.

Nevertheless, 4 million women have used Ortho Evra since 2002, and it’s estimated that only 10 percent of all problems have been reported. If you had been prescribed this birth control method, only to be admitted to the emergency room for blood clotting, a stroke, or heart attack, you may be eligible to start a new or take advantage of past claims.

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