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500 Ortho-Evra Birth Control Patch Victims Sue Johnson & Johnson
By Evelyn Pringle (about the author) Page 4 of 7 page(s)
The scientist also said that it would be important to study patch users for clot problems after the patch came on the market.
The reviewer might as well have been talking to himself, because when the device was approved, there was no warning on the label about the risks he identified and no requirements for post-surveillance studies other than routine monitoring of the adverse event reports from consumers, doctors and the drug makers.
The Associated Press also reviewed what had happened since the Ortho Evra patch arrived on the market in 2002, and determined that deaths of women on the patch appeared to be at least 3 times higher than women on the pill.
Under the FOIA request, the FDA released approximately 16,000 adverse event reports associated with the patch ranging from a mild rash to death. Within these reports, the AP found 23 different deaths associated with the patch and the doctors who reviewed the 23 deaths, found about 17 to be clot related.
But even after these reports became public, J&J continued to claim that none of the deaths could be directly attributed to the patch.
Nine months after the article in the Post about the 18-year-old women dying in the subway, a glimpse at the truth about the patch occurred in October 2004, when the first lawsuit was filed in Austin, Texas, on behalf of a paralyzed woman who suffered a stoke after only 12 days on the patch.
The lawsuit listed FDA records that showed forty-six women who were on the patch had suffered blood clot related injuries or death in a 1-year period between May 1, 2002 and April 30, 2003.
In the same 12 months, the lawsuit said, only half as many women taking birth control pills had developed clots even though there were six times more women on birth control pills.
Comparatively, the lawsuit alleged, 11 times more fatal or life-threatening clots were suffered by women on the patch when compared to women taking the pill.
On July 25, 2005, CNN reported on a lawsuit filed in New Jersey, on behalf of 10 women, who alleged the Ortho Evra patch had caused them to suffer blood clots and strokes.
The plaintiff's attorney told CNN that the women listed in the lawsuit were all between 18 and 47-years-old, from Arizona, Arkansas, California, Colorado, Connecticut, Maryland, Mississippi, New Jersey, Ohio and Oklahoma.
The plaintiffs had all suffered debilitating long-term health problems as a result of using the patch. Plaintiff, Amanda Bianchi, 19, developed a 10-inch blood clot in her brain, which doctors said was a direct result of the patch she used for 3 months in 2004, and according to the complaint she had suffered two strokes.
"I don't want any other woman to have to go through what I'm going through," Ms Bianchi told CNN. "It's not fun to have to get up and not be able to go to school and live the life that you were living," she said.
When contacted by CNN, sticking to its guns, J&J repeated its usual mantra of denial in a written statement saying, "The types of adverse event reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra product level."
And a spokeswoman for the industry owned FDA, did the same. She totally ignored the FDA's own database statistics to the contrary and told CNN:
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