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 Defects
Ortho Evra defects have received widespread consumer concern since the publication of a report indicating birth control patch users are three times more likely to suffer fatal vascular side effects than women taking oral contraceptives. Ortho Evra is the first and only birth control patch ever approved for use in the United States. Ortho McNeil, a subsidiary of Johnson and Johnson, has aggressively marketed Ortho Evra to millions of American women who have not been informed about Ortho Evra defects.
Some experts believe Ortho McNeil knew of possible Ortho Evra defects before this drug was available to consumers but failed to warn consumers about the serious risks associated with birth control patch use. In a pre-marketing clinical trial sponsored by Ortho McNeil, 3,000 women were given Ortho Evra to determine this product’s safety and efficacy.
During the course of this clinical study, two Ortho Evra users developed deep vein thrombosis (DVT), which led to pulmonary embolism (PE), a serious and deadly complication of DVT. DVT is a blood clot that forms in the deep veins of the leg or pelvic region. When this blood clot breaks off and travels to the lungs where it blocks an artery, the condition is called pulmonary embolism.
In response to this study, FDA medical experts expressed concern about possible Ortho Evra defects that could pose a significant threat to patient health. One expert recommended that, “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.”
Some experts believe that the drug’s hormone delivery system is responsible for tripling a patient’s risk of developing life threatening vascular complications. Oral contraceptives are first processed through the digestive system before hormones enter the blood stream. The Ortho Evra transdermal patch delivers hormones directly into the patient’s blood stream. This is thought to be the cause of increased Ortho Evra health risks.
Though Ortho McNeil knew of possible Ortho Evra defects prior to this medication’s approval, the company took no action to further investigate Ortho Evra side effects. In 2004, the Associated Press conducted an evaluation of all FDA adverse drug reports for Ortho Evra. They discovered that Ortho Evra defects tripled a woman’s risk of developing a potentially fatal blood clot.
At least 23 deaths have been linked to patients using the Ortho Evra patch, 17 of whom died of blood clot complications. These Ortho Evra users were all young and healthy with no history of vascular conditions before dying of unexplained blood clots and other complications. Ortho McNeil states that it is currently investigating these deaths to determine the link to Ortho Evra defects. If you are concerned about Ortho Evra defects or have been injured by this medication, please contact us to speak with a qualified and experienced attorney.
