And there will no doubt be many more filed against the company because in 2005, doctors wrote more than 9.4 million prescriptions for the birth control patch, according to IMS Health, an pharmaceutical industry monitoring firm.
On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra Patch.
In the new warning, Ortho McNeil admits for the first time that women who use the patch are exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. It is widely understood that any increase in the exposure to estrogen also increases the risk of blood clots.
A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.
Around the time the company introduced the patch to the market, the lawsuit claims, Ortho's patent for its contraceptive pill, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue.
In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, that showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth control pills.
The news segment also revealed that during the same time frame, 4 times as many strokes occurred in women using the patch when compared to women using the pill, even though 3 times more women were taking the pill. Overall, in medically confirmed cases, the risk of blood clots was found to be 14 times more likely to occur in women using with the patch.
Since the FDA only receives reports for between 1% and 10% of the serious adverse drug events, the actual death and injury rate for women on the patch is estimated to be much higher that the number of reports registered so far with the FDA
The Ortho Evra Patch was approved by the FDA in November 2001. Over 4 million women have reportedly used the patch since its approval and it remain on the market today.
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/patches.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)
On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra Patch.
In the new warning, Ortho McNeil admits for the first time that women who use the patch are exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. It is widely understood that any increase in the exposure to estrogen also increases the risk of blood clots.
A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.
In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, that showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth control pills.
The news segment also revealed that during the same time frame, 4 times as many strokes occurred in women using the patch when compared to women using the pill, even though 3 times more women were taking the pill. Overall, in medically confirmed cases, the risk of blood clots was found to be 14 times more likely to occur in women using with the patch.
Since the FDA only receives reports for between 1% and 10% of the serious adverse drug events, the actual death and injury rate for women on the patch is estimated to be much higher that the number of reports registered so far with the FDA
The Ortho Evra Patch was approved by the FDA in November 2001. Over 4 million women have reportedly used the patch since its approval and it remain on the market today.
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/patches.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)
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