Kentucky woman sues maker of birth control patch, Ortho Evra
SHE CLAIMS DEVICE CAUSED BLOOD CLOTSAug 9, 2006 | www.kentucky.com
An Eastern Kentucky woman has filed a federal lawsuit against the makers of the popular birth control patch, Ortho Evra.
Tonya Dingess, 36, who works as an emergency medical technician for the city of Paintsville, filed suit Monday against Ortho-McNeil Pharmaceuticals and its parent company, Johnson & Johnson. Dingess, who lives in Louisa, may be the first Kentuckian to file a lawsuit related to the birth control patch.
Last summer, Dingess experienced blood clots in her legs, spleen and lung, which started about five weeks after she began using the patch.
"She came within hours of dying from this," said the attorney representing Dingess. Dingess was in excruciating pain for nearly two weeks, then was hospitalized for six days so blood thinners could begin to eliminate the life-threatening clots.
"It's amazing I ever lived through it," Dingess said, adding that other women did not.
An Associated Press report last year identified about a dozen young women who died in 2004 from blood clots presumed to be linked to the birth control patch. They analyzed 16,000 FDA reports of adverse events related to the patch and found that patch users were three times more likely to suffer blood clots and die, compared with women taking birth control pills. Millions of women have used the patch since it first arrived on the market in 2002.
In November, the FDA announced a new warning about Ortho Evra. The warning said that women who use Ortho Evra may be exposed to 60 percent more estrogen than women who take a typical 35 microgram estrogen birth control pill. The FDA also said that higher levels of estrogen could put some women at higher risk of getting blood clots.
More than 100 women around the nation have filed suit against the drug company.
"We can't comment on any ongoing litigation," said Gloria Vanderham, communications manager for Ortho Women's Health & Urology, the maker of Ortho Evra.
In February, the makers of Ortho Evra released results of two studies related to the patch. One of the studies found that the risk of developing blood clots in the leg or lungs was similar for users of the patch and those who used birth control pills that contain 35 micrograms of estrogen. The second study found a two-fold increase in the risk of developing blood clots in the legs or lungs in women who use the patch, compared to birth control pills. That's still a "relatively rare event," according to the company's press release, and it noted that further evaluation is ongoing.