An Illinois couple is seeking $1.3 million in damages from Johnson and Johnson and its subsidiary Ortho-McNeil Pharmaceutical claiming the birth control patch Ortho Evra caused the user to suffer deep vein thrombosis.
Carla and Jason Fletcher filed a 27-count suit Dec. 11 in St. Clair County Circuit Court claiming the pharmaceutical company negligently designed, developed, manufactured, tested, packaged, marketed, distributed and labeled Ortho Evra.
The Fletchers are represented by Seth Sharrock Webb of Brown & Crouppen in St. Louis.
The suit claims the defendants improperly relied on safety and risk information derived from studies of contraceptive pills and failed to perform sufficient 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."
"Defendants were negligent in failing to adhere to and/or take into consideration warnings from the FDA, prior to FDA approval of Ortho Evra, who determined inter alia, that blood clots could be a problem with the patch," the complaint states.
The suit also alleges the defendants should have known that the intake of hormones contained in the patch would result in a level of estrogen much higher, approximately 60 percent, than the levels associated with intake through the oral route, such as with 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.
Carla Fletcher claims her injuries from using the 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, seeking damages for loss of consortium, 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.