Drug maker pays undisclosed settlements over health complications and deaths caused by birth-control patch, while Planned Parenthood dispenses it "without reservation."
-- From "J&J Paid $68 Million to Settle Birth-Control Cases" by David Voreacos, Bloomberg News 10/10/08
Johnson & Johnson has spent at least $68.7 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the company's Ortho Evra birth-control patch, court records show.
J&J, the world's largest maker of health-care products, avoided trials through the confidential settlements and hasn't released the financial details to investors.
Of 562 complaints reviewed by Bloomberg News, the vast majority of users alleged the patch caused deep-vein thrombosis, or blood clots in the legs, and pulmonary embolisms, or blood clots in the lungs. Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women.
One settled case involved Ashley Lewis, a 17-year-old high school junior from St. Louis who died in 2003. She developed a blood clot in her lung after wearing the patch for six months, according to Roger Denton, an attorney for Lewis's family, including her son, who was a one-year-old when she died.
Complaints filed on behalf of 4,000 women in state and federal courts claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra. More than 5 million women have used the patch since sales began in 2002. The New Brunswick, New Jersey-based company voluntarily strengthened the warning label in 2005, 2006 and 2008 with the approval of the U.S. Food and Drug Administration.
"Ortho Evra provides a needed birth-control option for women and physicians," said Gloria Vanderham, a spokeswoman for Ortho Women's Health & Urology unit, a division of J&J subsidiary Ortho-McNeil Pharmaceutical. "When used according to the FDA-approved label, Ortho Evra is a safe and effective method of hormonal birth control."
J&J, which makes diaphragms and birth-control pills, developed the patch as an alternative method of hormonal birth control for women who might forget to take their pills daily.
Planned Parenthood Federation of America offers the patch at more than 880 U.S. health-care centers and considers it safe and effective for eligible women, according to Dr. Vanessa Cullins, vice president for medical affairs.
Cullins, a former assistant professor at Johns Hopkins Medical School, said Planned Parenthood has studied all medical data on the patch and advises women on the risks.
"We make Ortho Evra available without reservation for healthy women who are candidates for combined hormonal contraceptive methods such as the patch, the pill, and vaginal contraceptive rings," Cullins said. "We're not making distinctions among this class of contraceptive methods."
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