Couple Seeks $1.3 million from Maker of Ortho Evra
Posted by
Christina ColeJanuary 06, 2007 12:31 PMAn Illinois couple is seeking $1.3 million in damages from Johnson & Johnson and its subsidiary Ortho-McNeil Pharmaceutical claiming the birth control patch Ortho Evra was the cause of the user suffering from deep vein thrombosis.
Carla and Jason Fletcher filed a 27-count lawsuit on December 11th in St. Clair County Circuit Court claiming the pharmaceutical company negligently designed, developed, manufactured, tested, packaged, labeled and distributed Ortho Evra.
The suit alleges the defendants improperly relied on the safety and risk information derived by studies of contraceptive pills and failed to perform adequate tests on women using the patch in clinical trials "forcing plaintiff...to rely on safety information that applies to an oral contraceptive agent...which does not entirely and/or necessarily apply to the patch whatsoever."
The defendants were negligent in failing to adhere to and/or take into consideration warnings from the FDA, prior to approval by the FDA of Ortho Evra, who determined, that blood clots could be a risk with the patch, states the complaint. Additionally the lawsuit alleges the defendants should have known that the intake of hormones contained within the patch would result in a level of estrogen being much higher by about 60 percent, than the levels associated with taking birth control pills.
"As a result of the defective nature of the patch, plaintiff Carla Fletcher...was at a greatly increased risk of serious dangerous side effects, including, but not limited to, the deep vein thrombosis that she developed and suffered, as well as other venous thromboembolisms, pulmonary embolisms, blood clots, myocardial infarctions, coma and/or death, as well as other severe and personal injuries," the complaint states.
Fletcher is claiming her injuries from using the birth control patch are permanent and that she suffers physical pain, permanent scarring and disfigurement, mental anguish, diminished enjoyment of life and a future of high risk pregnancies.
Jason Fletcher is seeking damages for the loss of consortium and claims he has suffered the loss of his spouse's affection, companionship, services and society. The ability of said spouse "in those respects (has) been impaired and depreciated, and the marital association between husband and wife has been altered, and, accordingly, both plaintiffs have been caused great mental anguish," the complaint states.