Evra Birth Control Patch Class Action Lawsuit Settled in Canada

A subsidiary of Johnson & Johnson has agreed to settle a class action lawsuit involving the Canadian version of the Ortho Evra birth control patch, resolving claims brought by women in Canada who allege that they were not properly warned about the risk of blood clots, pulmonary embolism, deep vein thrombosis, heart attacks and strokes.

The birth control patch class action suit was filed against Janssen-Ortho, Inc., which distributes the Evra skin patch in Canada. In the United States, the birth control patch is sold under the brand name Ortho Evra by Ortho-McNeil Pharmaceutical, another division of Johnson & Johnson.

Studies involving Ortho Evra have established that the birth control patch delivers about 60% more estrogen than the birth control pill on average. It has been found that this increases the risk of developing potentially fatal blood clots, causing many otherwise healthy young women to suffer heart attacks, strokes, pulmonary embolism and deep vein thrombosis.

In a statement released through Health Canada in November 2006, Janssen-Ortho indicated the results of studies in the U.S., but noted that the Canadian version of the birth control patch is manufactured differently and contains less estrogen than Ortho-Evra.

According to Bloomberg News, a confidential settlement was reached on Friday to resolve at least 22 individual claims brought by users in Canada. The drug company has also agreed to settle other valid cases brought by users of Evra birth control.

In the United States, it was reported that Johnson & Johnson paid at least $68.7 million to settle Ortho Evra lawsuits as of October 2008. Since that time, they have continued to reach confidential settlements for hundreds of other cases to keep individual lawsuits from going to trial. In addition, thousands of birth control patch lawsuits are still pending in various federal and state courts throughout the U.S.

Although the Ortho Evra warning label has been updated several times regarding the risk of blood clots, consumers and public interest groups have continued to argue that the warnings are inadequate. The manufacturer has been urged to place the risk information in a “black box” on the label, which would be the strongest warning that can be placed on a prescription medication.

In May 2008, the national consumer advocacy group Public Citizen filed a petition with the FDA on behalf of more than 80,000 individuals calling for an Ortho Evra recall due to the unreasonable risk of blood clots and the minimal benefits over other available forms of birth control.