Ortho Evra^®
Ortho Evra^® is a contraceptive skin patch used to prevent pregnancy (the "Patch").  The Patch is combination hormonal contraceptive because it contains two hormones, estrogen and progestin.  It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream.  Ortho Evra^® was the first skin patch approved for birth control.  An examination of the documents submitted to the FDA in connection with the approval (see links in the right column) of the Patch suggests that the safety of the Patch was an issue prior to approval.  Despite the concerns, the Patch was ultimately approved and has been purportedly used by more than 4 million women since it went on sale in 2002.

In July 2005, the Associated Press reported that the Patch was potentially linked to an increased risk of blood clots and death as a result of exposure to higher levels of hormones. The investigation, based on FDA data, found that 17 of 23 reported deaths may have been related to blood clot formation in women who used the Patch.  This was potentially alarming as the FDA receives reports for only a small percentage of serious adverse drug reactions for approved prescription drugs.  The actual number of women who experience serious side effects when using the Patch is probably much higher than reported by the FDA.

On November 10, 2005, the FDA approved updated labeling for the Ortho Evra^® contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills.  The new bolded warning specifically states that women who use Ortho Evra^® are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra^® than with typical birth control pills. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Orthro Evra^®.

On September 20, 2006, the FDA updated the Ortho Evra^® label with the results of two separate epidemiology studies sponsored by Johnson and Johnson.  The studies were designed to evaluate the risk of experiencing serious side effects (especially due to venous and arterial blood clots) when using Ortho
Evra^®.  The studies were conducted to evaluate the risk of developing a serious blood clot in women using Ortho Evra^® compared to women using a different, commonly prescribed, oral contraceptive. Concern about this risk was originally based on reports of serious blood clots to FDA and to the sponsor that suggested that Ortho Evra^® may have a greater risk for venous thromboembolism (VTE), at least in some women, compared to oral contraceptives.

The first study was conducted by the Boston Collaborative Drug Surveillance Program. This study found that the risk of non-fatal VTE events associated with the use of the Ortho Evra^® contraceptive patch is similar to the risk associated with the use of oral contraceptive pills (OCs) containing 35 micrograms of ethinyl estradiol (an estrogen) and norgestimate (a progestin hormone).

The second study, which also included patient chart review, was conducted by another group of investigators (i3 Ingenix). Results of this second case-control study show an approximate 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra^® compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen. Longer follow-up for VTE, heart attack and stroke, has been requested by FDA.

The results of the second study supported FDA’s concerns regarding the potential for Ortho Evra^® use to increase the risk of blood clots in some women. The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare provider about using Ortho Evra^® versus other contraceptive options.

The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra^® to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.  The FDA is continuing to monitor safety reports for the Ortho Evra^® patch.

Consult A Doctor On Medical Issues
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from using medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. The FDA advises women to talk to their doctor or healthcare provider about whether the Patch is the right method of birth control for them.

Consult A Lawyer on Legal Issues
The Steinberg Law Firm recommends that you contact experienced legal counsel as soon as possible after an injury. Involving legal counsel early can help preserve the evidence that is important to your claim and help ensure that you receive proper compensation. Please call or e-mail us for a free legal consultation if you or a loved one has experienced a heart attack, stroke, pulmonary embolism or blood clot while using the Patch. You will not be charged any fee for the consultation and, if we take your case, you will not be charged a fee unless we win your case.

Please E-Mail Andrew E. Steinberg* at:  andrewsteinberg@lawyer.com for a free, confidential consultation. Or call us at 713-529-0025.

*Not Certified by the Texas Board of Legal Specialization.

Other lawyers likely to be associated with the handling of these claims.