Ortho Evra Birth Control Patch

Frequently Asked Questions about the Ortho Evra® birth control patch

The San Diego plaintiffs law firm of Casey Gerry Schenk Francavilla Blatt & Penfield, which has a national reputation in pharmaceutical litigation, has assembled this information about serious side effects associated with Ortho Evra® as a service to people who may have been injured.

What are the most serious known side effects of the Ortho Evra birth control patch?
Some of the most serious drug reactions associated with use of the Ortho Evra birth control patch include:

• Heart attack
• Stroke
• Transient ischemic attack (TIA), a type of stroke
• Blood clots
• Embolisms
• Coma
• Death

In February 2006, the first results of two separate ongoing studies were released. The study found a two-fold increase in the risk of venous thromboembolic events (VTE) in users of the Ortho Evra birth control patch compared with users of daily birth control pills. VTE include deep vein thrombosis, also known as DVT (blood clots in the large veins of the leg) and pulmonary embolism (blood clots in the lung). The studies continue but this finding was so significant that it was released prior to the completion of the research.

When were the Ortho Evra® birth control patch ’s dangerous side effects first made public?
In July 2005, the Associated Press ("AP") released an article headlined, "Birth Control Patch Linked to Higher Fatality Rate, Report: Device has three times greater risk of stroke, blood clot than pill." The AP filed a Freedom of Information Act ("FOIA") request with the FDA seeking information on adverse reactions from women using the Ortho Evra birth control patch. The reporters found that 16,000 adverse reaction reports had been filed with the FDA. Not all of these were serious drug reactions; some were minor, including skin rashes, and some were duplicates. The reports also included 23 deaths associated with the Ortho Evra birth control patch. Seventeen of these deaths were clot-related. Their findings alarmed the medical community and the public, and later that year the FDA required Ortho-McNeil to change the label in the Ortho Evra birth control patch’s packaging.

How widely used is the patch?
Approximately 800,000 women used the patch in 2004. These women faced a three times greater risk of suffering serious drug reactions, including potentially fatal blood clots, compared to women using birth control pills. A non-smoking woman under 35 who takes daily birth control pills has a 1 in 200,000 risk of developing a fatal blood clot. For a similar group of women using the patch instead of the pill, their risk of dying from a blood clot rose to 3 in 200,000.

Why are blood clots a risk with hormonal birth control?
Blood clots are a known risk of hormonal birth control because their principal ingredient, estrogen, promotes blood coagulation. The hormones in the Ortho Evra birth control patch pass directly into the woman’s blood stream, while hormones in the pill pass through the intestinal tract before entering the blood stream.

What did the manufacturer know about the Ortho Evra birth control patch’s safety?
Even before the FDA approved the Ortho Evra birth control patch, Ortho-McNeil had evidence that the patch increased a woman’s risk of nonfatal blood clots by three times that of the pill.

What steps has the FDA taken?
Doctors at the FDA recommended a warning label to reflect this increased risk of a serious drug reaction, and follow-up studies to monitor clot problems after it was introduced on the market. Ortho-McNeil Pharmaceuticals failed to implement either of these recommendations.

In November 2005, following publication of the AP article, the FDA required Ortho McNeil to update its label on the Ortho Evra contraceptive patch. The FDA’s press release stated that, "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."

Has the Ortho Evra birth control patch been recalled?
No. The Ortho Evra birth control patch remains on the market, but the FDA has required the company to issue stronger warnings, and many doctors have stopped writing prescriptions. On November 22, 2005 Anne Marie Chaker reported in the Wall Street Journal that prescriptions were decreasing sharply, especially at university health centers. Pennsylvania State University’s health services no longer prescribes the patch and is considering contacting all current and former students who may still be using the patch from older prescriptions. Other universities, such as the University of Texas at Austin’s health center, still prescribe the Ortho Evra birth control patch, but write refills for only three months, rather than the typical one year supply.

Should you continue to use the Ortho Evra birth control patch?
That is a decision that you should discuss with your prescribing physician. Ortho McNeil Pharmaceutical recommends that some women should not use the patch, including women who have blood clots, certain cancers, history of heart attack or stroke, as well as those who may be pregnant. If you begin to suffer from any of the known serious side effects you should contact your physician immediately.

Should you contact an attorney?
If you or a loved one took Ortho Evra birth control patches and developed a serious drug reaction or other side effect, such as a blood clot, heart attack, stroke, embolism, coma or death, then you should contact a personal injury lawyer immediately to evaluate a potential claim against Ortho McNeil Pharmaceuticals, the manufacturer of Ortho Evra birth control patches. There are deadlines, called statutes of limitation, set by law which regulate the filing of lawsuits. These vary state by state. If you know that you or a loved one was harmed by Ortho Evra birth control patch, you should not delay in contacting an attorney. If the statute of limitations expires, your right to pursue a claim against the manufacturer may be barred.