Ortho Evra Overview

What is the Ortho Evra birth control patch?

Users of the Ortho Evra patch have an increased risk of causing risky side effects
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What is the problem with ORTHO EVRA?

Blood clots, strokes, heart damage, coma, death
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Who is responsible?

FDA has logged 9,116 reports of adverse reactions to the ORTHO EVRA
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What is being done?

The FDA approved updated labeling for the ORTHO EVRA birth control patch
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What can your ORTHO EVRA injury lawyer do?

What are the grounds for an Ortho Evra law suit? Do you need a lawyer?
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FAQs about the patch

How does the birth control patch work? Blood clots-Why dangerous?
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Web Resources

Understanding the possible risks and protecting your rights

Using pharmaceutical endorsed birth control products requires trust. First, you trust that the multi-million dollar pharmaceutical companies did their jobs well by researching and clinically-testing products to protect you from getting pregnant.

But what you least expect is for these birth control methods, such as Ortho Evra and Depo Provera, to cause life-threatening and diminished quality-of-life-side effects.

Ortho Evra is a weekly birth control patch. Once applied to the skin, the patch releases a steady supply of estrogen and progestin through the skin and into the bloodstream. Once a week, for three weeks in a row, a new patch is placed on the buttocks, stomach, upper outer arm, or upper torso. No patch is used during the fourth week.

The risk for using the Ortho Evra weekly birth control patch is increased by women who are 35 years or older, who smoke, and by having conditions associated with heart attacks such as diabetes, high blood pressure, high cholesterol, and certain inherited conditions that increase the risk of blood clotting.

The most serious complication from using the weekly birth control patch is having a blood clot that starts in your legs or lungs and moves to your heart or brain causing debilitating strokes, heart attacks, hemorrhage, and death.

In November 2001, the first ever weekly birth control patch was released into the marketplace and has since been embraced my millions of enthusiastic women who don’t want to remember to take daily birth control pills and enjoy the freedom of a weekly patch.

In 2004, Ortho Evra accounted for more than 9.9 million prescriptions with sales topping $411 million for Ortho McNeil, a division of Johnson & Johnson. In November 2005, the U.S. Food and Drug Administration (FDA) issued a black box warning label for the Ortho Evra birth control patch. The new warning belatedly acknowledges the increased dangers that were first noted by a FDA physician who reviewed the drug before the agency approved it. The agency has now admitted that women who use the weekly birth control patch are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill.

The FDA logged 9,116 reports of adverse reactions to the Ortho Evra birth control patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra birth control patch, whereas only 17 such reports were linked to the birth control pill during a similar time period. However, the FDA still allows the heavily advertised Ortho Evra on the market and is unwilling to ban or recall it.

Depo Provera is a long-acting hormonal form of birth control (progestin); it is also highly controversial. Since its inception into the marketplace, Depo Provera has attracted criticism from women’s health groups all over the world because it causes young, healthy women to lose bone density and bone mass and to develop osteoporosis, osteopenia, or osteophyte complex when there has been no family history of any osteo-related problems. Lack of bone mass density (BMD) continued to be a problem even after stopping the use of Depo Provera. Young women ready to start a family found they were unable to become pregnant after using Depo Provera.

As early as 1990, women’s health activists in New Zealand raised concerns about the potential loss of bone density in young women who took Depo Provera. Fourteen years later in 2004, the FDA issued a “black box” warning about the long-term use of Depo Provera. The warning states: The loss of bone mass density is of particular concern during adolescence and early adulthood which is a critical period of bone development. The warning also states that the longer that Depo Provera is used, the greater the bone loss.

In the 4th quarter of 2005, Pfizer reported a net income of $2.732 billion. As of 2005, Depo Provera has been used internationally for almost 25 years and in the United States for 13 years. In 2004, Pfizer issued the warning label. What’s wrong with this picture?

Women unknowingly used the Depo Provera injection for more than a decade before they were warned of the dangers.

What happened to that trust?

What can you do to fight back?

What can you or your mother, sisters, daughters, or best friends do if your or they trusted the pharmaceutical companies and confidently took Ortho Evra or Depo Provera without being made aware of the complications and side effects?

Do not alert the pharmaceutical companies because you’re the last person they want to hear from. You could ask your doctor to file an adverse reaction report with the FDA. Then call the FDA MedWatch at 1-800-FDA-1088.

But that’s not enough -- you should also consider contacting an expert Ortho Evra or Depo Provera law firm to discuss your legal rights. Since the pharmaceutical companies are so wealthy and powerful, you also need a savvy legal team in your corner.

Many people do not call a lawyer because they cannot afford one. A reputable law firm like Monheit Law will consider taking your case, if it is viable, on a contingency fee basis which means if you don’t win, you don’t pay for the legal services.

The likelihood of successful Ortho Evra and Depo Provera lawsuits vary based on the facts of each case. However, the number of law firms offering their services specifically to victims wanting to file Ortho Evra and Depo Provera lawsuits, is an indication of the need and the belief that there is a basis for recovery. The circumstances of each person’s use of birth control methods will differ and may determine the outcome of any Ortho Evra birth control patch and Depo Provera injection lawsuit brought by them.

By Karyn Zoldan and Michael Monheit, Esq.