Ortho Evra Lawsuit: Birth control patch side effects were hidden from FDA
According to federal court filings in the Ortho Evra litigation, Johnson & Johnson hid data from the FDA about their birth control patch’s side effects and failed to address flaws in the manufacturing process which could increase the risk of serious and potentially fatal problems. Although lawyers for both sides have been bound by rules limiting public disclosure of evidence learned during discovery in Ortho Evra lawsuits, the factual allegations were publicly released as part of the plaintiffs’ opposition to a motion by Johnson & Johnson to dismiss the claims of women injured by their birth control patch.
>>INFORMATION: Ortho Evra Lawsuits
Ortho Evra was introduced in 2002, and it remains the only form of birth control that is delivered through a patch placed on the skin. As a result of manufacturing defects and the delivery of the medication through a membrane placed on the skin, the dosage of estrogen provided is very unpredictable. Studies have demonstrated that the birth control patch delivers 60% more estrogen than oral contraceptives, and this results in Ortho Evra side effects that could increase the risk of blood clots, deep vein thrombosis, pulmonary embolism, heart attacks, strokes and death in otherwise healthy young women.
Although Johnson & Johnson was aware of the Ortho Evra problems as early as 1998, the warning label was not amended until November 2005. The drug maker has filed a motion to dismiss the Ortho Evra lawsuits filed against them, claiming that because the FDA approved the product and its label, the claims by injured women should be pre-empted by federal law. However, evidence outlined in the opposition provides several examples of how Johnson & Johnson hid or altered data on the health risks, and misled the FDA, the medical community and the public about the Ortho Evra blood clot risks:
A clinical trial in 1999, conducted prior to FDA approval, showed that the patch released 38.1 micrograms of ethhinyl estradiol into the blood stream every 24 hours when placed on the buttocks and 30.4 micrograms when applied to the abdomen. However, Johnson & Johnson provided information to the FDA that the level was 20 micrograms, after applying a “correction factor” which was not part of the outlined study protocol defined before the research started.
As a result of a different clinical study, Johnson & Johnson learned in June 1999 that the patch delivered as much as three times more estrogen than some types of the pill. However, they did not provide the results to the FDA until October 2001.
In 2003, after Johnson & Johnson began selling the birth control patch, an internal scientist urged the drug maker to conduct epidemiology studies due to a large number of cases identified involving clotting disorders and death. However, the request was disregarded.
Manufacturing problems with the birth control patch have resulted in different levels of estrogen being delivered from one batch to another, and Johnson & Johnson has not fully informed the FDA about the extent of the problems or taken steps to adjust the manufacturing process.
Although Johnson & Johnson continues to sell their Ortho Evra birth control patch and publicly denies that the side effects pose an unreasonable danger, several news sources have publicly reported about otherwise confidential Ortho Evra settlements the company made. These settlements were reportedly made as specific Ortho Evra lawsuits were scheduled to go to trial, where additional evidence surrounding their actions would have been made available to the public.
ORTHO EVRA LAWSUITS
The birth control patch lawyers at Saiontz & Kirk, P.A. have been representing women injured by side effects of the patch since 2005. For users who have suffered from blood clots caused by the patch, potential Ortho Evra lawsuits are still being reviewed by our firm. If you, a friend or family member have experienced a heart attack, stroke, deep vein thrombosis, pulmonary embolism or death, request a free consultation and claim evaluation.
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