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 the investors.
Of the 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 death 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 one-year-old when she died.
"It's a very tragic case,'' Denton said. Her parents "were completely unaware that there was any significant risk to her by using the birth-control patch,'' Denton said.
Complaints filed on behalf of 4,000 women in the state and federal courts claim that 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, a New Jersey-based company voluntarily strengthened the warning label in 2005, 2006 and 2008 with the approval of the US Food and Drug Administration.
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Benefit fund
The $68.7 million estimate of J&J's payments is based on the size of a so-called common benefit fund that finances a group of lawyers who gather evidence available for use by all attorneys who sued the company.
Participants pay 3 per cent of their settlements to the fund, which had $2.06 million as of March 31, according to a filing by Janet Abaray, an attorney. She is helping to lead litigation before US District Judge David Katz in Toledo, Ohio, where 1,330 patch cases were consolidated.
"Several hundred individual cases'' had been settled by March 31, Abaray said in an April 17 court document. "There have been a significant number of cases that have settled since then,'' she said in an interview. Court papers don't indicate how much J&J paid in each case.
'Safe and effective'
"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.''
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 J&J was settling cases, declining to be more specific.
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.
The company's current label warns that Ortho Evra exposes women to 60 per cent more estrogen than the typical birth-control pill and that higher estrogen increases side effects. Studies show Ortho Evra can double the risk of serious blood clots compared with the pill, according to the label.