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A federal caution about potentially life-threatening effects of Johnson & Johnson’s Ortho Evra contraceptive patch has fanned the flames of what could become nationwide litigation. Since Nov. 10, when the Food and Drug Administration ordered the New Brunswick, N.J., drug maker 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 20s, 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, Conn., underwent two heart surgeries after suffering a massive blockage of the right pulmonary artery in May 2004, having. used Ortho Evra for nine months. Another, Tammy Leitheiser, 32, of Emery, S.D., 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 Nov. 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, N.Y., who represents D’Amato and Leithauser’s estate among other plaintiffs. “If they had a clot-related injury, they figured it was a normal side effect.” And if they don’t notice the FDA directive, plaintiffs lawyers are there to educate 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, N.J., and three in Superior Court in Middlesex County, N.J. Another suit, on behalf of 12 users, was filed in Hudson County on Oct. 6 by the Austin, Texas, firm of McGinnis, Lochridge & Kilgore, with Joseph DePalma, of Lite, DePalma, Greenberg & Rivas in Newark, as local counsel. 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 Nov. 22, Michael Hugo of Lopez, Hodes, Restaino, Milman & Skikos in Boston filed in the District of Massachusetts, and Ellen Relkin, of Weitz & Luxenberg in New York City, filed in the Eastern District of New York. Michael London of New York City’s Douglas & London, filed on Aug. 2 in the Southern District of New York on behalf of five users. Patrick Broderick of Dechert in New York, J&J’s counsel in the New York federal cases, did not return a call. J&J’s attorney in the New Jersey cases, Susan Sharko of Drinker Biddle in Florham Park, 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. CONSOLIDATION EFFORTS With the number of federal districts involved growing, Parker petitioned the federal Judicial Panel on Multidistrict Litigation last month 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 last Wednesday said no. The fact that only four patch cases are pending in state court “was probably a big factor” in the denial, says Michelle Perone, chief of civil court programs for the New Jersey Administrative Office of the Courts. 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 co-counsel in one of the federal cases, Christopher Seeger, who is still reeling from his loss of a trial against Merck & Co. Inc., over the claimed side effects of its painkiller Vioxx, is more stoical. “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. Still, “we’re pretty convinced it’s a strong case.” HIGHER ESTROGEN THAN THE PILL J&J marketed the contraceptive patch, the first transdermal hormone-based birth control device, as a convenient alternative to oral contraceptives. The patch, applied once a week and designed to stay on during bathing or exercise, was promoted in TV commercials featuring supermodel Naomi Campbell and the Norwegian Olympic beach volleyball team. But 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 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 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 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. WAS THERE A LEARNED INTERMEDIARY? 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. Klein points out that because J&J advertised Ortho Evra directly to the public, it has an additional duty to warn consumers of any dangers. But that duty, set out by Perez v. Wyeth, 161 N.J. 1 (1999), is presumed satisfied if the company complies with FDA labeling and advertising regulations, he says. “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.” Most of the patch suits are brought individually but one, filed in Newark, Izzi v. Johnson & Johnson, 05-5394, seeks class certification of all purchasers of Ortho Evra, regardless of whether they suffered any negative side effects. PUTATIVE CLASS ACTION That case, filed by attorney Jeffrey Carton, seeks to recover under the New Jersey Consumer Fraud Act, N.J.S.A. 56:8-1 et seq. “The message we’ve heard was, had [users] known of the increased risks, they wouldn’t have bought it. That’s the case we intend to bring,” says Carton, of Meiselman, Denlea, Packman, Carton & Eberz in White Plains, N.Y. Superior Court Judge Carol Higbee of Atlantic County, the judge supervising New Jersey’s Vioxx litigation, certified a class of third-party providers of health benefits earlier this year in International Union of Operating Engineers Local 68 Welfare Fund v. Merck & Co. Inc. However, there is no known precedent for certifying a class of drug users claiming detrimental health effects, since the requirement of commonality of injuries is not met.

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