SAN FRANCISCO, Nov. 2, 2006
Women Sue Maker Of Birth Control Patch
Lawsuit Alleges Ortho Evra Caused Serious Illnesses, Death
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Play CBS Video Video Patch Birth Control Warning New safety risks have been discovered for a birth control method that hundreds of thousand of women use. Dr. Emily Senay explains to Julie Chen what the FDA wants from the Patch's manufacturer.
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(AP)
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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.
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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.
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.
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
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!!!!!!!
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!