Ortho Evra and Blood Clots

On September 20, 2006, the U.S. Food & Drug Administration (FDA) imposed a new warning on the label of the Ortho Evra birth control patch. The new warning suggests that women who use the patch are at a greater risk for developing potentially fatal blood clots than women who take a combination hormonal contraceptive pill.

An increased concentration of estrogen increases the risk of blood clots

It has long been understood that estrogen stimulates blood coagulation and that exposing a woman to an increased amount of estrogen increases her risk of forming potentially deadly blood clots. When birth control pills first came onto the market in the 1950s, they typically contained 50 micrograms of estrogen. In the 1960s, after studies found that high doses of estrogen can lead to an increased risk of blood clots (medically referred to as thromboembotic events), birth control manufacturers began reducing the amount of estrogen in birth control pills. Today, most pill forms of birth control contain about 35 micrograms of estrogen.

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How does Ortho Evra expose its users to more estrogen than a contraceptive pill?

WWhen a birth control pill is ingested, only a portion of the hormones contained in the pill actually enter the bloodstream. This is because the pill is first broken down through a process known as first-pass metabolism. During digestion, the body is only capable of absorbing little more than half of the hormones contained in the pill. The hormones that the body cannot absorb are excreted in feces and urine, while the absorbed hormones are further metabolized in the liver before entering the bloodstream.

The Ortho Evra patch contains the same kind and same quantity of hormones as a number of contraceptive pills. However, the hormones contained in Ortho Evra are absorbed into the bloodstream differently than they are absorbed in pill form. The hormones in the patch make their way into the body through a transdermal process - instead of undergoing first-pass metabolism the hormones are simply absorbed through the skin. Once they make their way through the layers of the skin, the hormones directly enter the bloodstream.

When a woman takes a birth control pill, her body is exposed to the maximum amount of hormones contained in the pill within the initial three hours following ingestion. Thereafter, as the pill is metabolized, the level of hormones absorbed into the body gradually decreases. It is not until the next day's pill is taken that the hormone level peaks once again. Unlike a contraceptive pill, which causes levels of estrogen exposure to peak and plunge between daily doses, the Ortho Evra contraceptive patch exposes its user to a relatively consistent amount of hormones throughout its seven day applicatory period. However, overall Ortho Evra exposes its users to 60% more estrogen throughout the day than the pill.

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Why did the FDA issue a warning about Ortho Evra?

In the application that Ortho-McNeil submitted to the FDA for Ortho Evra's approval, the pharmaceutical company noted incidences of two women who developed non-fatal but serious blood clots, called pulmonary embolisms (PE), during clinical trials of the patch. In its safety analysis of the patch, Ortho-McNeil chose to exclude one of the two cases of PE, claiming that the case was due to a "protocol violation" on behalf of the participant. The participant, a 34 year-old non-smoking American woman, discontinued use of the patch a day before undergoing major elective cosmetic surgery. The procedure for the clinical trial called for any participant who needed to undergo surgery to cease using Ortho Evra at least four weeks prior to the operation. The FDA scientist who reviewed the application for Ortho Evra's approval disagreed with the exclusion of the incident from Ortho-McNeil's safety assessment.

In the FDA review, the scientist stated, "The Reviewer does not agree with the sponsor's above conclusions. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the primary safety group. The incidence rates [of estimated blood clots] quoted by the sponsor may be misleading. The reviewer's rate is...double the sponsor's rate because both cases of PE must be counted...Because of the morbidity and mortality associated with a PE, the reviewer remains concerned...Some caution is warranted." Even so, the FDA approved Ortho Evra in 2001, and since then, more than 4 million women have used the patch.

A recent study published in the journal Contraception and sponsored by Johnson & Johnson (the parent company of Ortho-McNeil), claimed that the risk of non-fatal blood clots associated with use of Ortho Evra is no greater than that associated with the pill. The study was based on the analysis of information from two large databases of medical insurance claims. However, a similar but unpublished study that was also sponsored by Johnson & Johnson found that women who use the Ortho Evra patch have a two-fold increase in the risk of developing blood clots than women who take a pill form of birth control. The study - along with reports of over 17 allegedly blood clot related deaths associated with Ortho Evra in the two years following its approval - prompted the FDA to issue a new public warning in November 2005 about the increase in estrogen exposure associated with Ortho Evra. The FDA also requested that Ortho-McNeil change Ortho Evra's product label to include the new warning.

On September 20, 2006, the FDA announced that the results of the studies must be included in Ortho Evra's label. The FDA is now requiring Ortho-McNeil to change the patch's label to warn users and their doctors that "the risk of thromboembolic disease (blood clots in the legs and/or lungs) may be increased with Ortho Evra compared with that of oral contraceptives containing norgestimate and 35 micrograms of estrogen," along with the warning that users will be exposed to 60% more estrogen from Ortho Evra than they would be on a typical birth control pill.

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Numerous legal actions have been filed in which women attest to having suffered severe blood clots and other substantial physical injuries while using the patch. Some families have filed suit on behalf of female family members who died from strokes and other complications related to blood clots while using Ortho Evra. Some families have even filed wrongful death actions against the two companies.

If you or a family member has experienced severe adverse side-affects, such as blood clots, while using the Ortho Evra patch and you would like to speak to a professional regarding your rights, please fill out this short form and a member of Seeger Weiss's legal staff will contact you. Initial consultations are free of charge and do not create a legal relationship. Seeger Weiss LLP has offices located in New York and New Jersey and its attorneys are available to practice in courts throughout the nation.