At least two women died from blood clots that developed after using the patch. In most cases, the women were healthy prior to using the patch with no known factors that would have heightened their risk of developing blood clots or other serious disorders.
Some of the women who filed lawsuits claim that the Patch has not been properly tested for serious side effects and they include the credibility of a chief researcher after it was learned that he faked data in earlier scientific studies that he conducted on other products. According to the New York Post, "Dr. Andrew Friedman admitted to fabricating 80 percent of patient data and altering files in three studies of hormonal drugs for women." Although Friedman was not involved in the clinical trials for the Ortho Evra patch he later became part of the research team on the device's links to blood clots.
So far, hundreds of lawsuits have been filed regarding the patch. Since it has yet to be recalled it is likely that many more lawsuits will be filed in the future. Here is a history of some of the lawsuits filed so far.
- December 2006: A wrongful death lawsuit is filed against Ortho-McNeil alleging the Ortho Evra patch was responsible for the death of a 26-year-old woman. The woman began using the patch in April 2003 and died of a pulmonary embolism in June 2003. The victim's mother filed the lawsuit, arguing that the public was misled about the risks of using the patch, including "pulmonary embolism, stroke, deep vein thrombosis and blood clots."
- November 2006: A lawsuit is filed on behalf of 43 women who developed blood clots after using the patch.
- October 2006: A woman filed a lawsuit in federal court arguing that the Ortho Evra patch was responsible for her deep vein thrombosis, which occurred one month after she began using the patch. Deep vein thrombosis can be fatal and is characterized by blood clots in a vein, usually in the leg, that can break off and move to the lungs. The plaintiff claims that she now takes daily anti-clotting medications and seeks compensatory damages and future medical expenses. According to the lawsuit, Ortho-McNeil failed to properly test the patch and mislead consumers by stating that the risks associated with the patch were the same as the risks associated with other methods of birth control.
- July 2005: Ten women filed a lawsuit against the makers of the Ortho Evra birth patch, alleging that the patch is "defectively designed" and "unreasonably dangerous." The women claim that the patch caused them to suffer strokes and blood clots.
- December 2005: More Ortho Evra lawsuits are filed, claiming that women suffered serious injuries as a result of using the birth control patch. In one case, a 23-year-old required two heart surgeries to repair a massive blockage of her right pulmonary artery. She had been on Ortho Evra for nine months. Another woman died of clots in her right and left pulmonary arteries after using the patch for 11 months. One of the plaintiffs said she now has a 10-inch blood clot in her brain after using the patch for only three months. The woman suffered two strokes and now experiences frequent migraine headaches. In an interview with CNN, the woman said, "I don't want any other women to have to go through what I'm going through."
- October 2004: A man from Austin, Texas filed a lawsuit alleging that his wife suffered a stroke after using the patch for only twelve days.
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Despite the arguments by the makers of the patch that the risk of serious injury is the same as that of other contraceptive devices, at least one study found the patch comes with double the risk of blood clots than the birth-control pill. Furthermore, a study reported by the Associated Press also found a higher risk of blood clots for women who use the patch.
If you have been seriously injured after using the Ortho Evra birth control patch, contact a lawyer to discuss your options.
More lawsuits will likely be filed against Ortho-McNeil. Check back with Lawyers and Settlements for updates on this story.