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Texas Woman Files Ortho Evra Suit

-December 5, 2008

A woman living in Texas filed a personal injury lawsuit against three defendant companies claiming she suffered injuries after using the Ortho Evra birth control patch.

Ortho Evra advertises itself as, “…the first weekly form of birth control. You put on a new patch once a week, for 3 consecutive weeks each month. Then go patch-free the fourth week when you get your period.”  East-Texan, Karentha Easterwood, 36, liked the idea of applying a birth control patch only once a week, so she began using Ortho Evra. 

Five months after applying the first patch, she started experiencing chest pain and breathing difficulties that resulted in a trip to the local hospital.  Doctors discovered multiple blood clots had formed in her lungs.

Suit Filed Against Makers of Ortho Evra

Following her unexpected trip to the hospital, on Dec. 1 Easterwood filed suit against Johnson and Johnson, Ortho-McNeil Pharmaceutical Inc. and Johnson Pharmaceutical Research and Development Inc.  She claims that the pulmonary embolism and blood clots she experienced were caused by her use of the Ortho Evra birth control patch.

Ortho Evra Label Fails to Warn of Increased Risk

Easterwood’s suit alleges that the defendants knowingly mislead consumers by failing to warn them that the patch is significantly more likely to cause serious side effects than oral contraceptives.

The suit points out that the product label lists the most common side effects associated with using Ortho Evra:

• Nausea
• Vomiting
• Application site reaction
• Breast symptoms
• Headache
• Labile mood

However, according to the suit, Ortho Evra labels omit the increased likelihood of serious side effects such as:

• Deep vein thrombosis
• Pulmonary embolism
• Stroke
• Death

“Unreasonable” risk

The complaint states that the defendants had knowledge from past clinical studies that Ortho Evra created an unreasonable risk of serious side effects, including death, to its users.

These clinical studies forced manufacturers to revise its label in the past to better inform consumers of the increased health risks associated with using a birth control patch instead of a pill. 

2006 Clinical Study and FDA Label Revision

In September 2006, the FDA implemented a revision of Ortho Evra’s label to warn women of the risk of Venous Thromboembolism (VTE) based on two conflicting epidemiology studies. One study showed that some women using the patch were at a two-fold greater risk of developing VTE. 

The other study maintained that the risk of developing VTE from a patch contraceptive was equal to that of an oral contraceptive.  Despite the conflicting results of the two studies, the FDA insisted on a label revision.

2008 Clinical Study and FDA Label Revision

More recently in January 2008 the FDA required another label revision as the result of a more definitive study showing that there is an increased risk of blood clots among women using a contraceptive skin patch.  The study indicated that these clots could potentially lead to a lung embolism. 

Jury Trial Demanded

The plaintiff insists her injuries are a result of the defendants' negligence.  She claims they exercised inadequate attention to labeling, failed to provide sufficient warnings, and knowingly did so while continuing to manufacture, market, and sell the birth control patch.

Easterwood is seeking compensatory damages in excess of $75,000 as well as punitive damages arguing the defendants "demonstrate a flagrant disregard for human life."

(Sources: The Southeast Texas Record, Washington Post)

Have you or someone you love suffered injuries after using Ortho Evra? If so, contact us today to speak with a qualified defective drug attorney who will fight to ensure you recover compensation for your losses.

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