Ortho Evra ("The Patch") May Cause Blood Clots

http://www.courthousenews.com/Jump.Aug.3.htm#Patch

10 Women Claim 'The Patch' Causes Blood Clots
NEW JERSEY (CN) – Johnson & Johnson’s Ortho Evra contraceptive patch causes disabling blood clots, 10 women claim in Hudson County Court. The complaint claims defendants, which include Johnson & Johnson subsidiary Ortho-McNeil, introduced and “heavily marketed” the patch beginning in April 2002 “to offset the timing of Ortho-McNeil’s best-selling oral contraceptive, Ortho Tri-Cyclen, going off patent and being subject to competition from generic contraceptive pills.” The company’s own testing showed the patch caused “at least six times more serious blood clots than a widely used class of oral contraceptives,” the complaint states.
The FDA approved the patch, “with express misgivings … about the drug causing venous thromboembolisms,” the complaint states, quoting from an FDA report. Despite the FDA’s concern, defendants spent millions of dollars marketing the patch directly to consumers and to doctors and “downplayed the safety risks of the drug,” the complaint states. “Those Defendants have elected to imply on the package-insert warning that the clotting risk of the Patch is equivalent to that of oral contraceptives,” it states, yet in another place on the same warning, defendants state, “it is unknown if the risk of venous thromboembolism with Ortho Evra is different than with use of combination oral contraceptives.”
That statement is contradicted by defendants’ own research, the complaint states. Furthermore, the number of adverse reactions to the patch has been “staggering,” the plaintiffs say: 9,166 reports of adverse reactions in the first 17 months of the patch’s entry into commerce. In comparison, “the leading oral contraceptive, Ortho Tri-Cyclen, which during 2003 was used by almost six times as many women as the Patch, only generate 1,237 adverse event reports to the FDA over a six-year period from November 1997 through September 2003,” it states.
Citing reports of serious injuries and deaths, the complaint states, “These numbers translate into an indication that Ortho Evra is causing serious blood clot injuries at a rate approximately 1,500% higher than the leading oral contraceptive.”
Plaintiffs claim defendants are deceiving consumers by failing to warn them. It also claims that defendants’ spokesman for its ad campaign, “Dr. Andrew Friedman, Ortho-McNeil’s Director of Research for Women’s Health … lost his privileges to practice medicine (in 1996) and was suspended from practicing before any agency of the United States Government, including the FDA. These disciplinary actions were taken against him for admitting to fabricating clinical trial results for another drug manufacturer whose product caused scores of injuries to women.”
Plaintiffs, represented by Lite DePalma Greenberg & Rivas of Newark, N.J., seek compensatory and punitive damages.