Exclusive: Women Claim Birth Control Patchs' Risks Undisclosed
Women Claim Ortho Evra Patch Gave Them Blood Clots, Pulmonary EmbolismsFeb 8, 2007 | www.thedenverchannel.com More than 4 million women use the birth control patch, but the patch may hold risks for some women who use it, risks they may not be aware of.
A number of women told 7NEWS that the patch ruined their lives. They all made the choice to use the patch because they said they were told it was just as safe as other birth control.
Six Colorado women said they believe they were victims of a corporate secret. Three of the women had pulmonary embolisms and three had blood clots. All six said they never were informed about the greater risks associated with taking the Ortho Evra birth control patch.
"I just remember thinking that I was going to die," said Merlinda Maldonado, who used the Ortho Evra birth control patch.
"I was awakened by what I thought was a heart attack. I was in excruciating pain," said Carrie Grater.
"I had a blood clot that went from my ankle up to my knee," said patch-user Myndee Allen.
All of them thought they were at no greater risk with the patch than with the pill, saying that's what they were told.
But it's what the women said they were not told that raises questions about patchmaker Johnson & Johnson.
When it hit the market in 2002, women were not told the patch contained 60 percent more estrogen than the common 35 microgram oral contraceptive.
They were not told that the patch more than doubled their chances of experiencing problems with clotting, heart attacks, stroke and pulmonary embolisms.
"They didn't do enough testing and they ultimately didn't know how much estrogen the patch was going to deliver," said a Colorado attorney who represents some of the more than 4,000 women nationwide claiming they were injured by the Ortho Evra patch.
"Their lives have changed for the rest of their life because Johnson & Johnson and Ortho-McNeil told them, 'Change your contraceptive. It's more convenient,' without telling them, 'Oh, by the way, we're going to double your risk of getting blood clots, pulmonary embolisms, strokes and heart attacks.' It's outrageous," the plantiffs' attorney said.
Burg's accusation gets support in a recent legal filing from a doctor who worked for patchmaker Ortho-McNeil and Johnson & Johnson.
In a lawsuit over wrongful termination, Dr. Joel Lippman claims he warned the company of serious health concerns connected to the patch claims that Johnson & Johnson has denied.
In the lawsuit, Lippman said the patch "released dangerously high levels of estrogen into patients."
The complaint also said Lippman advised that the company should "conduct further research to understand the impact of the hormones released by the patch."
Lippman said in the legal filing that Ortho disregarded his concerns and launched the product.
"He had told them not to put it on the market and his suggestion was just ignored," Burg said.
Last September, the Food and Drug Administration required the maker of the patch to provide better warnings, but for the six former users who talked to 7NEWS, they said the warnings came too late.
They said the change to the label and the addition of a 98-word warning inside a 19,000-word insert are far too subtle, leaving women at risk.
7NEWS Investigator Tony Kovaleski asked the group of women if they believed Ortho Evra is properly informing women today.
They all said "no."
Ortho-McNeil declined 7NEWS' request for an on-camera interview, saying they cannot comment on ongoing litigation.
The company did say the patch is a safe and effective birth control choice when used as directed.