Does Ortho Evra Patch Put Lives at Risk?

Odessa, TXThis is likely not what the makers of the Ortho Evra patch had in mind when they developed the birth control patch: women suffering life-threatening complications and a string of lawsuits alleging the company put women's lives at risk. Yet that is what has happened. Lawsuit after lawsuit has been filed claiming that the Ortho Evra birth control patch caused blood clots and other serious conditions in women whose only goal was to avoid a pregnancy.

It's not that the women did not expect some side effects; after all, those are normal when one is exposed to a medication. However, the generally accepted side effects include nausea, headaches and maybe a bit of stomach cramping. Most people would probably not accept a pulmonary embolism, or a venous thromboembolism (a clot that can cause a pulmonary embolism), as a suitable side effect for a birth control product.

The Ortho Evra Patch was supposed to make life a little easier for women. Instead of a daily pill, women only had to remember to change their patch once a week. Not only was it marketed as convenient, the birth control patch was also marketed as having similar health risks to oral contraceptives. However, what the makers may not have realized—or may not have told people—was that because the hormones in the Ortho Evra patch are absorbed directly into the blood stream, the women using the patch receive a higher concentration of the medication than with an oral contraceptive.

So, the women receive a higher dose of estrogen and estrogen can increase the risk of blood clots and heart attacks—issues that healthy young women should not normally have to worry about.

Unfortunately, allegations have been made that Johnson & Johnson knew about the high levels of estrogen, and its risks, well before making the public aware of the issue. Which puts yet another company in the hot seat for possibly having put profits before people. One recently filed lawsuit claims that the company misled consumers about the true nature of the risks associated with Ortho Evra up until a labeling change was made in January 2008. The label that now appears on Ortho Evra states that women using the patch are exposed to 60 more estrogen than they would be if they took a birth control pill.

That is a lot of extra estrogen to be exposed to, considering the only benefit to Ortho Evra is the convenience it provides. Aside from that convenience, the patch has no benefits over the pill—it simply comes with much higher risks.

Some lawsuits against Johnson & Johnson have been settled, but those have been confidential settlements, so it is difficult to know exactly what the claimants received. Bloomberg News reported that the medical firm has so far paid a minimum of $68.7 million to settle hundreds of lawsuits. That estimate was the result of examining court records and an examination of a common benefit fund, which finances lawyers who gather evidence in the case.

It is very unsettling that otherwise healthy women, in the prime of their lives, are dying from blood clots and embolisms. Some of those who died were as young as 14. Others were very active women, including a volleyball coach. In some cases, the women died, or suffered seizures and other serious complications, within a month of using the patch.

Now, heartbroken families who have lost a loved one and women who suffered life-changing complications are turning to the courts to make things right. However, some critics are asking why the Ortho Evra Patch isn't just pulled from the market entirely.