ORTHO EVRA BIRTH CONTROL PATCH Studies reveal the Ortho Evra Birth Control patch has been linked to serious side effects of: Ortho Evra Patches are still on the market and prescribed by doctors and clinics to prevent pregnancy. We are prosecuting these cases for our birth control clients who developed these serious effects while using the patch. Because the hormones in the patch are processed by the body differently than hormones from birth control pills, women using the patch will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. FDA WARNINGS OF SERIOUS RISKS The FDA mandated the pharmaceutical manufacturers of Ortho Evra to change its warnings to adequately advise women of its serious risks. The labeling changes were based on studies revealing a marked increased risk of clots as compared with oral contraceptive. Read the numerous FDA warnings by clicking the links below:In November 2005, the FDA added information to the Ortho Evra label about the increased exposure to estrogen seen in women who use Ortho Evra compared with oral contraceptives. On January 18, 2008, the FDA approved additional changes to the Ortho Evra Patch label to include the results of a new epidemiology study that found users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills. Serious blood clots, also known as venous thromboembolism (VTE), can lead to pulmonary embolisms. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.
In October 2008, the FDA mandated a boxed warning to detail the findings of the studies that ranged from no increase in risk to an approximate doubling of risk of clots formed by using the patch. Ortho Evra was originally manufactured and distributed by Ortho McNeil, which was purchased by Johnson and Johnson. During the time that the patch has been sold in the United States, hundreds of injuries and deaths have been filed by patients using these products. SAFER ALTERNATIVES AVAILABLE
With all the multiple types of birth control on the market, there are numerous alternatives that do not carry the serious side effects associated with the birth control patch. Pharmaceutical companies owe a moral and legal responsibility to the public to ensure that the medications they manufacture and market are not unreasonably dangerous and to ensure that the consumer is made aware of the risks associated with the patch. The business of drugs in the United States is highly competitive and worth billions of dollars. Unfortunately, some pharmaceutical companies are hastily introducing and marketing new drugs prematurely and without adequate warnings, resulting in tragic losses that could have been avoided.
MEDICAL LEGAL TRIAL LAWYERS The Nations Law Firm has the commitment, the resources, the medical legal team and the trial experience necessary to fight the pharmaceutical giants and defend the rights of the people who have been wrongly and unjustly harmed.
FREE CALL AND CASE REVIEW Contact us at 1-800-814-4540 or fill out the form below for a free case review by an experienced pharmaceutical lawyer.
In September 2006, the FDA mandated the labeling changed to warn of a study showing a 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of oral contraceptives with longer follow-up studies needed for clots, pulmonary embolisms, heart attack and stroke requested by FDA. |
