Ortho Evra Patch News

What is Ortho Evra?
Ortho Evra is the registered trademark for a prescription birth control method, norelgestromin/ethinyl estradiol transdermal system, that many call "the Patch" for short. It is the first birth control method on the market that is considered a weekly form of birth control, in other words it is effective for an entire week before it needs to be replaced.

Ortho Evra is manufactured by Ortho-McNeil Pharmaceuticals headquartered in Raritan, NJ, a subsidiary of Johnson & Johnson and was approved by the US Food and Drug Administration (FDA) in 2001. It made its debut in 2002. It continues to be manufactured today despite recent litigation against the company, in which claimants allege the patch caused pulmonary embolisms, and in a few cases, death from its use.

Ortho Evra is marketed as being a safe and effective method of reversible birth control that when used correctly according to package directions is 99% effective, the same rate of efficacy as the Pill. The Pill is a common type of birth control that is taken orally and, as the name implies, is in the form of a pill. The Patch works in a similar manner to that of the Pill, preventing ovulation, the process that involves the release of an egg or ovum from the ovary, preventing conception from occurring. In addition, Ortho Evra also thickens cervical mucus and causes changes to the endometrial lining.

Many women use the Ortho Evra birth control patch because it is convenient and easy to use. As the name implies, it is a very thin smooth beige color patch, approximately 1 3/4 inches square, that actually consists of three layers; an adhesive to adhere the patch to the skin, a layer that holds the medicine, and a top layer that serves a protective function. The patch is worn on the skin in one of four areas of the body, the outer portion of the upper arm, the chest (avoiding the breasts) or back, the abdomen, or the buttocks.

The Ortho Evra birth control patch uses what the medical industry calls patch technology to deliver a steady stream of medication. Many people are familiar with the nicotine patch, which works in a similar fashion. Medication is delivered transdermally or through the skin into the bloodstream on a continuous basis.

What are the Negative Side Effects?
The Ortho Evra birth control patch contains two types of hormones called progestin (norelgestromin) and estrogen (ethinyl estradiol). For most women who use the patch, side effects are minimal and may include nausea and/or vomiting, a skin reaction at the where the patch is applied on the skin, breast discomfort, headache, and a feeling of being emotionally unstable.

Cigarette smoking is contraindicated for all women using the Patch, but especially for those women over the age of 35 years old, as it may increase the risk of cardiovascular side effects. Women who have blood clots, certain cancers, or a history of heart attack or stroke should not use the patch either, nor should women with high blood pressure, diabetes, or high cholesterol or women who are or think they may be pregnant.

Unfortunately, some women using the Ortho Evra birth control patch may experience a more intense reaction to the hormones used in the patch. Medication delivered via the skin is absorbed into the bloodstream much more efficiently than a medication in pill form. As such, using the Ortho Evra birth control patch means that women are exposed to higher amounts of estrogen levels. It is the increased in the amount of estrogen that may cause serious side effects in some women such as blood clots.

According to the manufacturer of Ortho Evra, the patch exposes women to approximately 60% more estrogen than taking the Pill does, which contains 35 micrograms of estrogen-a significant difference. On November 10, 2005 the FDA approved a mandate to update the label for Ortho Evra stating this fact. In addition, The Associated Press reported that it had obtained FDA records indicating that women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. Apparently the FDA received 9,116 reports of serious adverse side effects from April 2002 through September 2003.

Current Litigation
While Ortho-McNeil Pharmaceuticals continues to study the risks associated with developing blood clots for women using Ortho Evra as compared to typical birth control pills, a number of lawsuits have been filed against them. The lawsuits allege that Ortho-McNeil knew about the increased risk of blood clots as a result of the higher levels of estrogen, but failed to warn consumers about the additional risk by omitting it from the package label.

Ten women, ranging in ages from 18 to 47, from ten different states filed a lawsuit in Hudson County, N.J., Superior Court in July of 2005 against both Johnson & Johnson and Ortho-McNeil Pharmaceuticals stating that they had suffered blood clots and strokes as a result of using the Ortho Evra birth control patch, alleging that it is "defectively designed" and "unreasonably dangerous." On September 14, 2005 a lawsuit was filed on behalf of a women who suffered a pulmonary embolism, usually caused by a blood clot that travels from the leg to the lung, after using the Ortho Evra birth control patch. In November of 2005, the parents of a 14-year old girls also filed a lawsuit against Ortho-McNeil, this time claiming that their daughter's death from blood clots in her pelvis, had been caused by the patch, which she had started using eight weeks prior.

In September 12, 2005 a mass torts Application was filed in the New Jersey Supreme Court to "designate all litigation (pending and subsequently filed) alleging damages arising from the use of the birth control patch Ortho Evra as a mass tort." On November 28, 2005 the New Jersey Supreme Court denied the application stating that, "Ortho Evra litigation does not at this time meet the criteria for designation as a mass tort."