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A federal warning about the potentially life-threatening effects of Johnson & Johnson’s Ortho Evra contraceptive patch has fanned the flames of what could become nationwide litigation. Since November 10, when the Food and Drug Administration ordered the New Brunswick, New Jersey, drugmaker to add a stronger warning label, five suits have been filed, bringing the number pending to 17. The suits claim that patch users, some in their teens and twenties, have suffered strokes, heart attacks, and even death as a result of blood clotting caused by heightened estrogen levels. One user, Jessie D’Amato, 23, of Lyme, Connecticut, underwent two heart surgeries after suffering a massive blockage of her right pulmonary artery in May 2004, after using Ortho Evra for nine months. Another, Tammy Leitheiser, 32, of Emery, South Dakota, used the patch for 11 months and died last July after suffering clots in her right and left pulmonary arteries. Plaintiffs lawyers say the FDA directive appears to have prompted more users to seek counsel. “Before November 10 [users] didn’t know the clotting was related to the patch to the degree that it is,” says Jerrold Parker of Parker & Waichman in Great Neck, New York, who represents D’Amato and Leitheiser’s estates, among other plaintiffs. If users haven’t noticed the FDA directive, plaintiffs lawyers are there to tell them. Web sites around the country � like orthoevrainjury.net and orthoevralawyers.net � are publicizing the government action and the litigation options available. Parker has four suits in federal court in Newark, and three in superior court in Middlesex County, New Jersey. Another suit, on behalf of 12 users, was filed in Hudson County on October 6 by Austin’s McGinnis, Lochridge & Kilgore. Federal suits are popping up around the country. McGinnis, Lochridge has cases pending in the District of North Carolina and the Western District of Pennsylvania. On November 22 Michael Hugo of Boston’s Lopez, Hodes, Restaino, Milman & Skikos filed in the District of Massachusetts, and Ellen Relkin, of New York’s Weitz & Luxenberg, filed in the Eastern District of New York. Michael London of New York’s Douglas & London filed on August 2 in the Southern District of New York on behalf of five users. Patrick Broderick of Dechert in New York, Johnson & Johnson’s counsel in the New York federal cases, did not return a call. Johnson & Johnson’s attorney in the New Jersey cases, Susan Sharko of Drinker Biddle in Florham Park, New Jersey, says she is “not in a position to comment” on the suits. Michael Beckerich, a spokesman for Ortho McNeil, the J&J subsidiary producing the patch, says the company will not comment. With the number of federal districts involved growing, Parker recently petitioned the federal Judicial Panel on Multidistrict Litigation to consolidate all suits around the country in the District of New Jersey. The panel has yet to act. On the state level, Parker sought to have Ortho Evra cases in New Jersey superior court designated a mass tort, but the state supreme court refused. Parker says he is suing on both the state and federal levels to maximize his clients’ remedies and the fruits of discovery. “The discovery you might get in one venue might not be the discovery you get in another venue,” he says. But Parker’s cocounsel in one of the federal cases, Christopher Seeger, who is still reeling from his loss against Merck & Co. Inc., over the claimed side effects of its painkiller Vioxx, is more stoic. “Suing a New Jersey drug company in a New Jersey court on failure to warn is not the most popular thing to do,” says Seeger, of Seeger Weiss in Newark and New York. The lawsuits claim that while J&J depicted the patch’s health risks as equal to those of oral contraceptives, it delivers a far higher dose of estrogen. They also claim that J&J rushed the patch to market because the patent for its Ortho TriCyclen oral contraceptive was about to expire. Literature packaged with Ortho Evra said that “the contraceptive patch is expected to be associated with similar risks” to that of birth control pills and that the safety information they provide consumers is “derived primarily from studies of birth control pills.” It said further that “there is no epidemiological data available” about whether the safety of the patch is different from that of oral contraceptives. The plaintiffs charge that J&J, before obtaining FDA approval in 2001, conducted one clinical trial among 3,000 women and found an incidence of pulmonary embolisms and deep vein thrombosis six times higher than those associated with Ortho TriCyclen. The complaints cite an FDA report that said government officials should keep close tabs on any reports of embolisms and deep vein thrombosis. Seeger says J&J’s tests failed to take into account that Ortho Evra delivers estrogen directly into the bloodstream, while in oral contraceptives the estrogen is metabolized through the liver. Alan Klein of Duane Morris in Philadelphia, who defends drug companies in product liability suits but is not involved in the patch litigation, says that under the learned-intermediary doctrine, J&J need only prove that prescribing physicians had adequate notice of health risks. “The issue in this case will be, what did J&J know at the time they marketed the patch,” Klein says. “I think what happened here, after the patch went on the market, is that there were additional clinical trials that found the patch released more estrogen than they estimated, and it led to reports of adverse events.” A version of this story originally appeared in New Jersey Law Journal, a sibling publication of Corporate Counsel.

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