By Susan Brinkmann, OCDS
Johnson & Johnson, the manufacturer of the Ortho Evra birth control patch, has quietly paid out at least $68.7 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks, strokes, and even death after using the patch.
Introduced in 2002, the Ortho Evra patch is a transdermal birth control system in the form of a patch that is designed to deliver continuous levels of progestin and estrogen through the skin and into the bloodstream for seven-day periods. The patch is changed three times a month.
According to the current label on the drug, Ortho Evra exposes women to 60 percent more estrogen than typical birth control pills, a level that studies show expose women to twice the risk of potentially fatal side effects. More than five million women have used the patch since its introduction and hundreds of women have submitted claims after experiencing mostly blood clots in the legs and lungs, with some complaints blaming the patch for heart attacks and strokes. To date, 20 women have died from complications said to have been caused by the patch.
The most publicized case involved the sudden death of an 18 year-old aspiring model, Zakiya Kennedy, who collapsed in 2005 while waiting for a subway in New York. She died an hour later of what turned out to be a blood clot in her lungs, a condition blamed on the patch.
Another case involved Stephanie Rosfeld, a 25- year-old assistant volleyball coach at the University of Cincinnati who died of a heart attack in 2004 after using the patch for less than a month.
A 17-year-old high school junior from St. Louis, Ashley Lewis, began wearing the patch in 2003 and died six months later after developing a blood clot in her lung.
Even more tragic is the death of 14 year old Alycia Brown from La Crosse, Wisconson who developed two blood clots in her lungs after using the patch. Last year, Johnson & Johnson paid $1.25 million to settle the lawsuit filed by her parents.
According to Bloomberg News, complaints have now been filed on behalf of 4,000 women in state and federal courts who claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra.
The company disagrees, however, and continues to stand by its product.
“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 Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical. “When used according to the FDA- approved label, Ortho Evra is a safe and effective method of hormonal birth control.”
Vanderham declined to comment on any settlements or the company’s disclosure practices. In its only public statement about settlements, a company spokesman said in April 2007 that Johnson & Johnson was settling cases and declined further comment.
She said the company “recommended to the FDA that there should be label changes and then worked with the agency to determine what the actual changes would be.”
Johnson & Johnson also “regularly and properly disclosed data to the FDA, the medical community and the public in a timely manner,” Vanderham said.
Planned Parenthood Federation of America continues to sell 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.”
As the complaints continue to be filed, public health organizations are increasing their pressure on the FDA to do something about the patch.
The Public Citizen’s Health Research Group, a Washington-based advocacy organization, petitioned the FDA in May to ban the patch within six months, even after the three label changes.
“It still has dangerously high levels of estrogen,” said Sidney Wolfe, director of the group told Bloomberg News. “There are no unique benefits. If there is a drug with no unique benefits, and it has unique risks, and there are alternatives, why should anyone use it? What is the purpose of the FDA if not to regulate products like that?”
As long ago as 2005, Concerned Women for America President Wendy Wright expressed her sadness at the way health professionals were downplaying the risks associated with the patch.
“Sadly, some medical and pharmaceutical officials believe that it is OK for healthy women to die in exchange for selling more of their products. In their minds, dead or injured women are a worthy price for sexual freedom and higher profits.”
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