Johnson & Johnson has settled hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the company’s Ortho Evra birth control patch. The drug manufacturer, the world’s largest maker of health-care products, has paid in confidential settlements. The financial details of the settlements to investors haven’t been released. 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 filed blamed Ortho Evra for the deaths of 20 women. The litigation before U.S. District Judge David Katz in Toledo, Ohio, where 1,330 cases were consolidated, is being watched closely.

Complaints filed on behalf of 4,000 women in state and federal courts contend 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, 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.

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. The company reports sales of the Ortho Evra patch with those of its birth control pills, folding both into overall sales of hormonal contraceptives. J&J reported 2007 sales of $900 million for that category, a decrease of 9%. The company’s total revenue was $61.1 billion. J&J’s annual report cited “a significant decline” in Ortho Evra sales because of “labeling changes and negative media coverage concerning product safety.”

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. Sidney Wolfe, Director of the Research Group, had this to say relating to the patch:

It still has dangerously high levels of estrogen. 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?

The company’s current label warns that Ortho Evra exposes women to 60% 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. If you want more information on this matter you can contact Chad Cook at 800-898-2034.

Source: Bloomberg

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