Women claim contraceptive didn't come with blood clot warning

Steve Gonzalez Jan. 30, 2006, 6:41am

Roger Denton

Jerome Schlichter

The popular contracreptive Ortho Evra is the target of seven product liability suits filed by women claiming the drug maker failed to warn them about the risk of developing blood clots.

The suits, filed in in U.S. District Court for the Southern District of Illinois on Jan. 23, each seek damages in excess of $75,000 against defendants Ortho-McNeil Pharmaceuticals and its parent company Johnson & Johnson.

"Defendants failed to warn consumers and their health care providers that the Ortho Evra transdermal birth control patch is more likely to cause blood clots than oral contraceptives," the complaints state.

Unlike oral contraceptives, Ortho Evra is transdermal, which means continuous levels of the hormones estrogen and progestin are delivered through the skin into the bloodstream. Ortho Evra is marketed as the "first and only" once-a-week birth control skin patch.

The plaintiffs also claim that records from the Food and Drug Administration show that a high number of women using the patch reportedly suffered injury or death due to blood clots compared to women using oral contraceptives.

They claim that the drug maker asserts that the most frequent side effect leading to discontinuation include nausea or vomiting, application site reaction, breast symptoms, headache and emotional liability.

According to the suit, the defendants' own clinical studies showed a higher rate of venous thromboembolism in women on the patch compared to those using the pill and concealed the extent of the side effects from the public, including the plaintiffs' and their doctors.

  • Maral Annayeva claims she was prescribed Ortho Evra between January and May 2005, and used it for 18 days suffering from bleeding, heart pain, headaches, nausea and general malaise.

  • Brandy Houk claims from February to October 2005, she suffered shortness of breath, fatigue, excessive bleeding, and passed large clots as a result of her use of the patch.

  • Melody Miller claims that on Dec. 21, 2003, she suffered multiple blood clots which resulted in the miscarriage of her child at the five month stage of pregnancy.

  • Tanya Lowe claims in January 2004, she suffered blood clots in her right leg which shattered and spread into her lungs.

  • Reannon Tutkus claims that on Dec. 24, 2004 and Jan. 1, 2005, she suffered blood clots.

  • Stephanie Curtis claims in March 2004 she suffered a red spot just above the patch so discontinued the patch and immediately became pregnant. In June or July of 2004, she claims she developed a blood condition which predisposed her to blood clots that required the use of blood thinners while pregnant.

  • Kristine Bailey claims in late October to early November 2005, she suffered blood clots, dizziness and fatigue.

    Plaintiffs are represented by Jerome Schlichter and Roger Denton of Schlichter, Bogard & Denton is St. Louis.

    After filing the cases, the attorneys filed a motion to consolidate stating that judicial economy would be best served in consolidated to assure consistent rulings and decisions and would permit the parties to avoid duplication of discovery and effort.

    The plaintiffs claim that prior to their injuries, the defendants knew or should have known that using Ortho Evra created a higher risk of thromboembolism which was unreasonably dangerous to consumers.

    They also claim that if the defendants would have been forthcoming to them and their doctors about the adverse side effects they would not have used the patch and would not have suffered the injuries they allege.

    According to the complaints, Ortho Evra was defective in its manufacture and construction when it left their hands because it deviated from product specifications which posed a serious risk of injury and death.

    "The foreseeable risks associated with the design or formulation of Ortho Evra include, but are not limited to, the fact that the design or formulation of Ortho Evra is more dangerous that a reasonably prudent consumer would expect when used in an intended or reasonably foreseeable manner," the complaint states.

    The plaintiffs claim they all suffered significant harm, conscious pain and suffering, physical injury and bodily impairment including permanent physical effects which will affect them throughout their lifetimes.

    They also claim they suffered significant mental anguish and emotional distress and will continue to suffer pain, injury, damages, harm, and mental and emotional distress in the future.

    The plaintiffs also claim that the defendants violated the Illinois Consumer Fraud Act by the use of false and misleading misrepresentations of the material fact in connection with the marketing, promotion and sale of Ortho Evra.

    "The plaintiffs are seeking compensatory and punitive damages, attorney fees and expenses and any other relief the court deems just and proper.

    "Defendants' actions and omissions demonstrate a flagrant disregard for human life, warranting the imposition of punitive damages."

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