Ortho Evra Birth Control Patch Failure, Injury and Death | Howard L. Nations National Pharmaceutical Law Firm

ORTHO EVRA DEFECTS AND FAILURE

Ortho Evra is a transdermal patch. That means that once it’s placed on the skin, the drug is released through the skin and into the bloodstream. The patch will deliver a steady flow of the hormones, progestin and estrogen for a period of 7 days.

Progestin and estrogen have been used in oral contraceptives for years. But what has changed dramatically over the past decades is the formulation of oral contraceptives. There are several different classes or types of progestin and estrogen. In an effort to reduce the multiple adverse side effects of both hormones, birth control pills have been modified and new ones have been developed using different classes of the hormones, and in different amounts.

“The Pill” which arrived on the market in 1960 as the first oral contraceptive contained high doses of progestin and estrogen. Over the years, the drug companies have decreased the level of estrogen in oral contraceptives from 150 micrograms (µg) to 50 micrograms (µg) and then to 20-35 micrograms (µg). This was necessary because the estrogen was causing blood clots.

On its face, the amount of estrogen in the Ortho Evra patch appears to be in line with the industry standards. In contains the same amount of estrogen as many popular birth control pills. However, studies have shown that women using the patch absorb about 60 % more estrogen than with the pill.

When women take the pill, the medication is absorbed into the bloodstream through the digestive tract. In the process, about half of the estrogen dose is lost. The hormone levels peak about 1 to 2 hours after taking the pill, and within 12 hours, the estrogen levels in the body are quite low. The patch, on the other hand, delivers a steady stream of hormones directly into the bloodstream 24 hours a day for 7 days. This causes higher estrogen levels in the body which increases the woman's risk of suffering from life-threatening blood clots. Studies have shown that women on the patch are actually 3 times more likely to have blood clots and die than those on the pill. See Ortho Evra Injuries and Deaths for more information.

There has always been a warning on the Ortho Evra label about the risks associated with estrogen. However, the original warning was the same one used for birth control pills. This warning failed to explain the increased risk caused by use of the patch as opposed to taking the estrogen in pill form.

ORTHO EVRA INJURIES AND DEATHS

The Ortho Evra patch is an estrogen based contraceptive that works by releasing estrogen directly into the bloodstream. Estrogen has long been linked to an increased risk of blood clots. Both the patch and the estrogen based birth control pills contain a warning label outlining such risks. But women who used the Ortho Evra patch have suffered blood clot related injuries and death at a rate 3 times higher than women who used the leading birth control pills.

According to the FDA, at least 44 women using the Ortho Evra patch suffered serious blood clot related injuries and deaths during its first 12 months on the market. Only 17 such reports were made for the leading birth control pill Ortho Tri Cyclen during same time period, even though the pill was used by almost 6 times as many women. In its first 17 months on the market (April 2002 through September 2003), the FDA logged 9,116 reports of adverse reactions from the Ortho Evra patch. The birth control pill, Ortho Tri Cyclen, only generated 1,237 adverse reports to the FDA in the 6 year period from November 1997 through September 2003.

In its first 2 years on the market, at least 17 young women between the ages of 17 and 30 died after using the Ortho Evra patch. The following year, in 2004, 12 more young women died after using the patch. All of them died from blood-clot related injuries. Most of them were in their late teens and early twenties. Dozens more survived strokes and other blood-clot related injuries during that time period.

The young women who died were apparently at low risk for blood clots — women like Zakiya Kennedy, an 18 year old Manhattan fashion student who collapsed and died in a New York subway station. Or Sasha Webber, a 25 year old mother of two from Baychester, N.Y., who died of a heart attack after six weeks on the patch.

The FDA estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious adverse drug reactions that actually occur, indicating that the actual rate of injury and death is much higher.

A woman has the right to choose what type of birth control she wants to use. Every form of birth control carries risks, albeit a risk of injury or a risk of pregnancy. It is vitally important that women are allowed to make informed decisions. For this, they must rely on their health care providers and the drug manufacturers. In the case of Ortho Evra, the drug company chose to hide the increased life-threatening risks and push young women to use the patch because of its convenience. As a result, millions of young healthy women have chosen the patch, completely unaware of the magnitude of the risks that they were taking. As a tragic consequence, many young women have died just for the sake of convenience.

If you or someone you know has been seriously injured from using the Ortho Evra patch, please contact our offices for a free case evaluation with one of our pharmaceutical attorneys.

FAILURE TO WARN THE PUBLIC

On November 10, 2005, 3 ½ years after Ortho Evra was approved, the FDA and Ortho McNeil Pharmaceutical issued a warning to healthcare providers and revised the warning label on the Ortho Evra Patch. This came in the wake of numerous investigative reports published by the Associated Press and CBS News which revealed the increased risks of Ortho Evra. This also came after many young women had died and suffered debilitating injuries caused by the Ortho Evra patch.

The warning states that women who use the patch are exposed to approximately 60% more estrogen than women who use an average birth control pill. Estrogen is the hormone that is known to cause blood clots. Following is an excerpt from the FDA Press Release:

The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

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.

According to Associated Press reports, the FDA and Ortho McNeil Pharmaceutical were aware of this increased risk before the drug was even approved. The dangerous elevated risk was noted by the FDA physician who reviewed the drug before the agency approved it. The reviewer said "the label should clearly reflect this reviewer's safety concern about a potential increased risk." He added that it would be important to study users of the patch for blood clot injuries after the patch was on the market.

But once Ortho Evra was on the market, Ortho-McNeil did everything it could to keep the public from finding out about the increased risks. As reported by CBS News, an internal Ortho-McNeil memo shows that in 2003, the company refused to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen birth control pill because of concerns that there was "too high a chance that study may not produce a positive result for Evra" and there was a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen." In response to questions from the Associated Press about the Ortho-McNeil memo, company spokesman Michael Beckerich said in a written statement that "decisions to fund studies are based upon scientific merit."

Ortho-McNeil Pharmaceutical thought that studies comparing the risks of the patch vs. the pill had no scientific merit. Apparently, they also thought that a woman’s right to make an informed decision about birth control had no merit. As a result, many women have died and suffered devastating injuries. If you or someone you know has been seriously injured from using the Ortho Evra patch, please contact us for a free consultation with one of our pharmaceutical attorneys.

As of this time, Ortho Evra has not been recalled and is still being marketed and sold throughout the United States and other parts of the world as "... convenient birth control ... great for the active woman."

FOLLOW-UP STUDIES YIELD CONFLICTING RESULTS

In September of 2006, the warning on the Ortho Evra label was updated yet again, this time to include the results of two studies funded by Johnson & Johnson. The research was conducted after the news became public that Ortho Evra was exposing women to about 60 % more estrogen than birth control pills. The studies were designed to compare the risks between the patch and the pills. One must keep in mind that these were not independent studies. They were paid for by Johnson & Johnson, the parent company of Ortho-McNeil Pharmaceutical, who manufactures the Ortho Evra patch.

The studies were conducted by two different investigating groups and consisted of reviewing patient records. They came up with conflicting results.

The first study found that the risk of non-fatal blood clots was "similar" between women using the Ortho Evra patch and those taking the birth control pills. The second study found that women using the patch were approximately two times as likely to suffer from a blood clot as those women on the pill.

For more information, see FDA Questions and Answers.