Law Offices of John David Hart: New Ortho Evra Warnings Long Overdue; FDA Announcement Too Late for Woman Who Had Miscarriage, Many Others

FORT WORTH, Texas, Sept. 21 /PRNewswire/ -- The U.S. Food and Drug Administration's announcement that additional warnings have been added to the label for Johnson & Johnson's Ortho Evra birth control patch are long overdue, according to a Fort Worth attorney who represents numerous former Ortho Evra patients.

"This announcement unfortunately is too little, too late for many women who relied on this dangerous product," says John David Hart of The Law Offices of John David Hart in Fort Worth. "While these new warnings are a step in the right direction, the simple truth is that a lot of women are hurt today because they were not fairly warned."

Mr. Hart represents a group of women who have suffered serious health problems as a result of their use of Ortho Evra. One of Mr. Hart's clients developed potentially life-threatening blood clots in her lungs and suffered a miscarriage after using the Ortho Evra patch. Her claim is currently pending in federal court in Marshall, Tex.

The FDA's announcement on Wednesday, Sept. 20, 2006, about the new label warnings followed two recent studies, one of which found a twofold increase in blood clots among Ortho Evra users compared to users of birth control pills. In its announcement, the FDA said the study results "support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women."

Mr. Hart says the FDA announcement is further proof that the package insert that came with Ortho Evra was misleading and in direct conflict with Johnson & Johnson's own data. Before the latest revisions, the insert suggested the risk of blood clots among Ortho Evra users is equivalent to that of women using oral contraceptives.

However, from April 2002 to December 2004, the company logged 27,974 adverse events among Ortho Evra users. During that same time period, Johnson & Johnson noted only 5,571 adverse events for one of its oral contraceptives, even though it was used three times more than Ortho Evra.

The Law Offices of John David Hart is a group of experienced and dedicated legal professionals working to protect the rights of people injured by the acts of others. Across the country, the firm represents people in cases of catastrophic personal injury, wrongful death, medical negligence, automobile and truck accidents, workplace injuries and other matters. More information is available at http://www.hartlaw.com/ .

For more information on the Ortho Evra label change, please contact Mike Androvett at 800-559-4534 or mike@legalpr.com .