Lopez, Hodes, Restaino, Milman & Skikos - Ortho Evra Help - The Birth Control Patch
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Potential Side Effects
Ortho McNeil has been accused of failing to adequately warn consumers about life threatening Ortho Evra side effects, such as deep vein thrombosis and pulmonary embolism.
Ortho Evra defects have received widespread consumer concern since the publication of a study indicating birth control patch users are three times more likely to suffer fatal vascular side effects than women taking oral contraceptives.
Ortho Evra Side Effects
Ortho Evra side effects have received serious attention since the publication of an Associated press study indicating that this contraceptive triples a patient’s risk of developing serious and life threatening blood clots. Experts believe that Ortho McNeil, the makers of the birth control patch, knew about serious Ortho Evra side effects before this medication was approved in 2001. Ortho McNeil has been accused of failing to warn consumers about these serious potential Ortho Evra side effects.
Ortho Evra has been prescribed to over two million women in the United States, in large part due to aggressive marketing tactics used to attract consumers to this potentially defective product. Ortho McNeil employed such marketing tactics as wide spread coupon distribution and catchy advertising slogans to encourage women to use this form of hormonal contraception.
What the pharmaceutical subsidiary of Johnson and Johnson failed to mention during their aggressive marketing campaigns were the significant Ortho Evra side effects discovered during pre-marketing clinical trials. Before this drug was approved for use in the United States, Ortho McNeil conducted a clinical trial designed to measure the safety and effectiveness of Ortho Evra in over three thousand patients. Two cases of serious Ortho Evra side effects were reported in women using the birth control patch. Both women had no history of blood clots before developing pulmonary embolism shortly after commencing Ortho Evra treatment.
Pulmonary embolism is one of the most serious and life threatening Ortho Evra side effects. When a blood clot develops in a deep vein of the leg or pelvic region, a condition called deep vein thrombosis (DVT), it can break off and travel to the lungs and block a major artery. This condition is called pulmonary embolism (PE). Both of these Ortho Evra side effects were known before this drug was approved. One FDA official stated before Ortho Evra was approved, “Post-marketing surveillance for DVT and PE events will be important, as there are potential serious adverse risks with the new delivery system for contraception.”
Ortho Evra chose to proceed with marketing the birth control patch, despite concerns about Ortho Evra side effects. The pharmaceutical company conducted no further investigation of these risks. Under the Freedom of Information Act, the Associated Press gained access to the FDA database of adverse drug reports to investigate Ortho Evra side effects. They discovered nearly 10,000 reports of Ortho Evra side effects logged by the FDA in a 17-month period.
At least 23 deaths have been linked to possible vascular Ortho Evra side effects. Seventeen of these deaths have been caused by blood clot complications like pulmonary embolism and subarachnoid hemorrhage. The majority of women who have suffered from fatal Ortho Evra side effects were young and healthy women with no history of vascular medical conditions. If you would like to learn more about Ortho Evra side effects, please contact us to speak with a qualified and experienced attorney.
