Lieff Cabraser Heimann & Bernstein, LLP - Ortho Evra Side Effects Lawsuit
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  Women who use the Ortho Evra birth control patch are at risk to suffer from life-threatening blood clots and strokes.  
   
  Our law firm is representing women across America with Ortho Evra injuries.  
   
  Ortho Evra is a trademark of Ortho-McNeil Pharma-
ceuticals Inc. and is used for product identification purposes only. 		 


 

Ortho Evra Side Effects Warnings:
FDA Updates Labeling for Ortho Evra Contraceptive Patch
January 2008 FDA Update Documents
2008 Label Update
On January 18, 2008, the FDA approved additional changes to the warning label of the Ortho Evra Contraceptive Transdermal Patch to include the results of a new study. The study, conducted by the Boston Collaborative Drug Surveillance Program, was funded by Johnson & Johnson and found that users of the Ortho Evra birth control patch ages 15-44, were at a higher risk of developing serious blood clots or venous thromboembolism (VTE) than women using birth control pills. VTE can lead to pulmonary embolism, which is a life-threatening condition.
Previously, the Ortho Evra birth control patch label was updated in 2006 to include the results of two other studies, one of which found a nearly two-fold increased risk of blood clots for users of the patch over traditional birth control pills. A label update in 2005 also warned doctors and patients of the birth control patch's 60% higher estrogen levels over the pill due to the general finding that increased exposure to estrogen is associated with an increased risk of blood clots. Women with concerns or other risk factors for blood clots are encouraged to speak with their healthcare providers.
September 2006 FDA Information Update Documents
2006 Label Update
On September 20, 2006, the Food and Drug Administration announced a second update to the Ortho Evra label due to the results of two separate epidemiology studies sponsored by Johnson and Johnson that were designed to evaluate the risk of experiencing serious side effects (especially due to venous and arterial blood clots) when using Ortho Evra.
Though the first study found that the chances of blood clots were equal with the patch and a birth control pill, the second study, which reviewed patient chart data in addition to the health care claims data used in the first, found that women using the Ortho Evra patch faced twice the risk of blood clots in the legs and lungs than women on contraceptive pills. Despite the conflicting results, the FDA found enough cause for concern regarding the potential for Ortho Evra use to increase the risk of blood clots.
The current Ortho Evra label includes the results from the two studies and recommends that women with concerns or risk factors for thromboembolic disease talk with their healthcare provider about using Ortho Evra versus other birth control methods.

2005 Label Update
On November 10, 2005 the Food and Drug Administration isued the warning information below, prompting Ortho-McNeil Pharmeceutical Inc., the makers of the Ortho Evra patch to issue new prescribing information:

November 10, 2005

The Food and Drug Administration today 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. Ortho Evra was the first skin patch approved for birth control.

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. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.

Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.

The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

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.

FDA is continuing to monitor safety reports for the Ortho Evra patch. 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 new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm.
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Additional Lieff Cabraser Information: Lieff Cabraser Heimann & Bernstein, LLP, with offices in San Francisco, New York and Nashville, is one of the largest law firms in the United States that represents only plaintiffs. We have been nationally recognized for our representation of victims of dangerous and defective medical products. We are representing Ortho Evra birth control patch patients in individual peronal injury lawsuits.
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Trademark Notice: Ortho Evra is a trademark of Ortho-McNeil Pharmaceuticals Inc. and is used for product identification purposes only. The law firm of Lieff Cabraser Heimann & Bernstein, LLP, is in no way affiliated with Ortho-McNeil Pharmaceuticals Inc. or its subsidiary, Ortho Women's Health.
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