ORTHO EVRA was approved by the Food and Drug Administration (FDA) in November
2001. It was the first contraceptive product to be approved as a skin patch. In
2004, the drug accounted for more than 9.9 million prescriptions with sales
topping $411 million. The drug is sold by Ortho-McNeil Pharmaceuticals, Inc., a
division of Johnson & Johnson Company.
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The statistics speak volumes about who is responsible for the problems of heart attack and stroke associated with ORTHO EVRA, and why class action lawsuits have been filed.
The FDA has logged 9,116 reports of adverse reactions to the ORTHO EVRA birth
control patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control
pill, only generated 1,237 adverse reports in a six year period.
During a 12-month period, 44 serious injuries, deaths and strokes have been associated
with ORTHO EVRA birth control patch, whereas only 17 such reports were linked to
the birth control pill during a similar time period.
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Coincidentally in October 2005, Bayer HealthCare and Ortho-McNeil
Pharmaceutical, Inc. announced that they have concluded an agreement to jointly
develop and market a new drug for the prevention and treatment of thrombosis.
(Thrombosis is the technical term for blood clots.) The drug called BAY 59-7939
is currently undergoing Phase II clinical trials. Phase III clinical trials will
assess its effectiveness in the prevention of venous thromboembolism (VTE) and
will be initiated in the next weeks. This may help prevent the problem of stroke associated with ORTHO EVRA, but to date there are no studies to support this. You should ask you doctor whether this could prevent a stroke associated with ORTHO EVRA.
With 9.9 million prescriptions the numbers of women with extreme complications
leading death are just starting to receive media exposure. In July 2005, a
young, healthy married mother of two children experienced shortness of breath
and died the next day. Symptoms may include shortness of breath, difficulty
breathing, anxiety, chest pain, fainting, and convulsions. It is no wonder that ORTHO EVRA class action lawsuits have been initiated and invidivudal claims have been brought.
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.
In the new warning, Ortho McNeil admitted for the first time that women who use
the patch will be exposed to up to 60% more estrogen than they would be exposed
to if they were taking birth control pills. The patch is only intended to
deliver 20 micrograms of estrogen. Throughout the medical community, it is a
well-known fact that increased exposure to estrogen greatly increases the risk
of blood clots, which can cause further serious injury or death.
It is alleged that Ortho-McNeil was aware of the increased medical risks
associated with ORTHO EVRA birth control patch before the drug was approved and
when approved -- the company failed to adequately warn patients about these
risks.
We believe that the deep-pocketed manufacturers of ORTHO EVRA are responsible for misleading
women about their birth control options. Have you or a family member experienced
a life-threatening problem with the birth control? Are you
eligible for an ORTHO EVRA lawsuit or to participate in an ORTHO EVRA class action?
Fill out the below form to see if you qualify for an ORTHO EVRA lawsuit. Ask our
experienced lawyers to review your potential lawsuit. No obligation. Don’t
delay.
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