Ortho Evra patch cited in suit against Ortho-McNeil, J&J

Ann Knef Oct. 23, 2007, 4:46am

A St. Clair County plaintiff claims her use of a transdermal contraceptive patch caused her to develop deep vein thrombosis.

Connie Lager and her husband Larry Lager filed a 27-count product liability suit Oct. 17 in St. Clair County Circuit Court against Ortho-McNeil Pharmaceutical and other defendants over its Ortho Evra patch.

The Lagers, represented by Stephen R. Wigginton and J. Brian Manion of Weilmuenster & Wigginton of Belleville, claim the defendants negligently relied on safety and risk information derived from studies of contraceptive pills.

Other defendants include Johnson and Johnson and Johnson and Johnson Pharmaceutical Research and Development.

The suit also claims the patch was not sufficiently tested in clinical trials.

"Defendants knew or should have known that the intake of hormones contained in Ortho Evra through the Patch would result in a level or estrogen...much higher (approximately 60% higher) than the levels associated with intake through the oral route, such as with birth control pills," the complaint states.

The Lagers claim the defendants failed to take into consideration warnings from the Food and Drug Administration which, according to the complaint, determined that blood clots could be a problem with the patch.

"...Plaintiffs seek compensatory damages as a result of Connie Lager's use of the Patch, which has caused her to develop and suffer from deep vein thrombosis, as well as other severe personal injuries which are permanent and lasting in nature, including but not limited to, suffering, physical pain, permanent scarring and disfigurement, and mental anguish, including diminished enjoyment of life, and any and all lasting complications, such as Plaintiffs need for lifelong medical treatment, medical monitoring and/or medications, and a fear of developing further adverse health consequences," the complaint states.

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