Friday, May 12, 2006

Birth-control patch linked to blood clots, strokes

Dozens of womanm have sued Ortho Evra manufacturer Ortho-McNeil Pharmaceutical Inc. and its parent company, Johnson & Johnson, arguing that the country's only birth-control patch causes debilitating blood clots, strokes and even death. The patch is still on the market.

In U.S. District Court in Newark, N.J., where 37 cases have been filed, the stories are similar: An otherwise healthy Georgia woman develops a pulmonary embolism; a Maine woman suffers from a blood clot in her right lung; a 12-year-old girl in Indiana is diagnosed with deep-vein thrombosis.

Julie Keenan, spokeswoman for Ortho-McNeil, declined to comment on the allegations because of the ongoing litigation.

For many of the women, the long-term effects have been devastating. Some will be on blood thinners for the rest of their lives.

The lawsuits contend that Ortho-McNeil rushed the patch onto the market without adequate testing. The company may have been nervous that it would lose money when its patent for the birth-control pill Ortho Tri-Cyclen ran out, the suits say, and pushed to get the patch on pharmacy shelves to offset any red ink.

Lawyers handling the cases, which have been filed in federal courts across the country as well as in Superior Court in Hudson and Middlesex counties, say they are more clear-cut than other recent pharmaceutical litigation, such as the Vioxx lawsuits.

"You're dealing with primarily women ages 18 to 35 who don't have a lot of pre-existing conditions to begin with," said, a Hackensack lawyer who is working with a South Carolina law firm on a dozen cases. "The reason why people are getting the blood clots is a lot cleaner."

At a hearing last week in U.S. District Court in Ohio, where the federal cases have been consolidated, a Johnson & Johnson lawyer announced the company hopes to settle the lawsuits. Already, 11 women who filed suit in Hudson County have received settlements, although the amounts are sealed.

Generally lawsuit settlements are viewed as positive outcomes for plaintiffs, but they can be a mixed blessing in drug cases.