Women Sue Maker Of Birth Control Patch

Lawsuit Alleges Ortho Evra Caused Serious Illnesses, Death

(AP)  More than 40 women sued the makers of a popular birth-control patch Wednesday, claiming the contraceptive caused serious illnesses and at least one death.

One lawsuit alleges that 43 women suffered from blood clots and other health ailments after taking Ortho Evra, one of the fastest-growing forms of contraception in the U.S.

A second complaint claims that 25-year-old Kelly Bracken of Elk Ridge, Md., died of severe blood clots in her lungs and legs after she started wearing the skin patch.

The lawsuits, filed in San Francisco Superior Court, name as defendants the drug's manufacturer, Ortho-McNeil Pharmaceutical Co., a Titusville, N.J.-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp. The plaintiffs seek unspecified monetary damages.

Officials for Ortho-McNeil and McKesson did not immediately respond to calls seeking comment Wednesday.

Approved by the U.S. Food and Drug Administration in 2001, Ortho Evra is a birth-control patch that delivers the hormones estrogen and progestin directly into the bloodstream through the skin.

The lawsuit claims that Ortho-McNeil failed to properly investigate the product's safety and deceived the public about the severity of potential side effects, including strokes and severe blood clots.

"This product should not be on the market," said Shawn Khorrami, an attorney for the plaintiffs. "When you put out a product that gives women more hormones than they need, then you're increasing their risk of developing those ailments."

Similar lawsuits have been filed on behalf of nearly 400 women nationwide, Khorrami said.

In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth-control patch instead of the pill.

The product label was updated to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill. A second study, however, found no difference in risk between the two forms of birth control.

The case is Bracken-Hodge v. Ortho-McNeil, 06-457523; and Abel v. Ortho McNeil, 06-457524.

[cacee13601]

i agree.. every birth control method has some kind of side effect i have the IUD in and ive heard of people having problems with that and ive had nothing for side effects... i dont know about these women and their circumstance but i do know that youre not suppose to be a smoker if youre using the patch and theres other medications that react to it so are these women that have had problems with it doing any of this??

[apdepetris]

I have taken Ortho Evra for over 2 yrs. and I haven't had any problems with it. For me it has actually been better than the birth control pills I used to take. Blood clots, etc. are a risk of all hormonal contraception and I would assume would be slighly higher with the patch since it delivers a slightly higher level of hormones. But smoking increases the risk and of course some people are just naturally more at risk because of family history. Different people are going to react differently to medications and it's not always easy to predict what is going to happen. I talked with my doctor at my last exam about the concerns that were raised about the patch. She assured me that it was fine. Bottom line is that people need to discuss their individual situation with their doctors and determine if a medication is right for them and if they feel comfortable with the risks and side effects associated with it. People need to be informed and it's as much their responsibility to ask questions as it is the doctors or drug manufacturers to provide the information needed. I hope they don't take this product off the market. Now I don't know about these women's individual cases (and I certainly mean no disrespect to anyone who may have been legitimately harmed by this drug) but I think that people should start assuming responsibility for themselves and stop blaming everyone else for their problems when they just blindly went along with something instead of making sure they were informed.

[pudd54]

400 injured by a drug taken by 4 million, that is much better odds than aspirin.

All drugs have side effects, for estrogens its blood clots, especially if you smoke and are over 35. (That is ont thing that makes the Woman%u2019s Health Initiative such a poorly designed study - allowing 60 & 70 year old women who smoke to take estrogen)

Estrogen is not the only reason for blood clots multiple protein and enzyme deficiencies also can cause clots. Most of these are diagnosed after there is a clot causing symptoms.

[sylld]

have some pretty gruesome consequences for which someone should be held responsible.

I am not for taking it all off the market I just think there should be a clearer message about lying about the effects of our medicines.

[sylld]

I think that too often we hear about companies that play down (lie about) the risks, side effects, and possible drug interactions of their product. We tend to find out about this after it hits the news because people got hurt.

If they honestly reflected their products effects, both positive and negative, they might not sell as much of their product and I guess too many companies feel someone else%u2019s risk is worth their profit.

This means that people and doctors don't get a realistic picture of the medications which could be harmful even for healthy people.

Of course this is even more dangerous for people that do have a potentially higher risk for certain conditions. Many people have someone in their family with risk factors like diabetes, high blood pressure, heart conditions, breast cancer etc. these are some very, very common conditions and I think most people would be considered "at risk" for something or other.

Unless you actually have any of the conditions chances are you don't even really know it, or if someone has maybe checked out relatively healthy in the past someone may be more likely to try a product if the manufacturer lies about the risks of the product.

The point is that people don't get a fair view of what the medicine does and can't make a realistic choice, which can

[mortisha73]

I'm So tired of hearing Ortho Evra Badmouthed.
I've Been on it 2yrs and I love it. And did anyone ever bother to ask these women if they smoke or have Heart or blood problems in their family or personal medical history, Probably not.
For the 400 women that Ortha Evra caused problems
for there are atleast 1000 like myself for whom it works well please don't ruin it us!!!!!!!

[ms38654ob]

Well, the only thing sure in life is death. If you wait for everything to be absolutely perfect, then you will wait for eternity.

When you consider how many millions of people are taking this medication and the number of people who have had problems, it is a safe drug.

I suppose you could always not have *** and be totally safe!

[lanaedawn]

It sucks that you can never be absolutely sure the effects a drug will have on you before you take it. I wouldn't go on the patch because it hasn't been on the market long enough. It just seems so risky having these hormones being absorbed straight to your bloodstream. Sometimes, the quicker more convenient method isn't always the safest.

[jhindson1]

Here we go. . . . FDA asleep at the switch again letting corporations run the show!