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California Ortho Evra Attorneys

Practice Area : Harmful Drugs

FDA Probes Safety of Ortho Evra Birth Control Patch

On March 2, 2006, the FDA announced that it was launching a review of the safety of the Ortho Evra birth control patch, after receiving evidence that the patch is associated with a higher risk of side effects than previously thought. The agency warned women in November 2005 that Ortho Evra was tied to a higher prevalence of blood clots.

The recent announcement came as part of a larger probe to investigate the safety of a number of patches. The FDA is concerned that patch defects may lead to higher absorption rates of medication by patients, causing too much medication to be delivered. One study has shown that women using the patch are exposed to approximately a 60 percent higher level of estrogen than those women using traditional birth control pills.

FDA Warns Women About Ortho Evra Birth Control Patch

On November 10, 2005, the FDA advised that women using the Ortho Evra birth control patch were at an increased risk for blood clots than women taking the pill. The labeling on Ortho Evra has been updated to reflect this latest warning.

The warning alerted that women who use the patch are exposed to about 60 percent more estrogen than with a typical birth control pill. A higher risk of experiencing side effects can occur with higher doses of estrogen.

Side Effects of Ortho Evra

On July 16, 2005, The Associated Press reported that women who used the Ortho Evra birth control patch were at a markedly greater risk of suffering a blood clot when compared to women taking birth control pills.

By using the Freedom of Information Act, the AP forced the FDA to turn over reports of adverse drug reactions for Ortho Evra. The data cited in the FDA reports showed that women using the Ortho Evra patch were three times more likely to suffer a blood clot than those taking pills. The results were exceptionally alarming because the victims of these serious health problems are mostly young, healthy women.

The FDA reports showed that since the patch was approved in 2001, at a minimum, 17 women using Ortho Evra have died of blood clots. The actual number of women who died from blood clots while using Ortho Evra patches may be significantly higher, because the FDA notes that it is informed of only a small percentage of adverse drug reactions.

The FDA approved the Ortho Evra birth control patch in November 2001. The patch, which works by releasing hormones into the bloodstream through the skin, is available by prescription only and is used to prevent pregnancy.

If you or a loved one has used Ortho Evra birth control patches, we encourage you to investigate the Ortho Evra side effects further.

Lawsuit Filed Against Manufacturer of Ortho Evra

Eleven days after the Associated Press story came out in 2005, ten women filed a lawsuit against Johnson & Johnson and its subsidiary, Ortho McNeil. In their suit, they alleged that the Ortho Evra patch caused them to suffer blood clots and strokes. The lawsuit called the product "unreasonably dangerous" and asserted that the patch is "defectively designed."

As of the date of this suit, the FDA had still not taken action to protect women from these serious possible side effects. In fact, FDA approved the patch in 2001 despite evidence that Ortho Evra greatly amplified the risk of blood clots and strokes. This is just one of a series of medications for which the FDA has come under fire for its inadequate response to public health concerns, notably its slow response to the prescription drug Vioxx.

What You Can Do

If you have suffered a blood clot or stroke while using the Ortho Evra birth control patch, you may be entitled to compensation. You should act immediately and contac at a lawyer experienced in defective pharmaceutical lawsuits.

Our Lawyers Can Help

If you or a loved one has suffered side effects related to blood clots as a result of being on the patch, you may be entitled to significant financial compensation. We have recovered more than $120 million for our California clients with injuries caused by dangerous medications, medical devices, and unsafe medical practices.

We encourage you to call our California Ortho Evra side effect attorneys today at (800) 840-2111 or email us at lawfirm@gjel.com.

We respond promptly to all inquiries and provide free case consultations. And we have offices throughout the state to serve our clients.

Defective pharmaceutical lawsuits against powerful drug manufacturers like Ortho McNeil require vast legal resources and experience. Our firm has a proven track record in these cases. Call or email us today.

For more information about your legal rights, please call us toll-free at 1-866-218-3776 or complete our online contact form.