Ortho EvraŽ, manufactured by Ortho-McNeil Pharmaceutical, Inc., is the first transdermal (skin) patch approved for birth control. Ortho Evra is a thin, beige patch that delivers continuous levels of the hormones norelgestromin and ethinyl estradiol (progrestin and estrogen, respectively) through the skin and into the bloodstream to prevent pregnancy.
Ortho EvraŽ was approved by the U.S. Food and Drug Administration in November 2001 and first became available by prescription in April 2002.
Ortho EvraŽ has recently been linked to the deaths of several women in the United States . In March of 2004, Sasha Webber, a 25-year-old mother of two from Baychester, New York died of a heart attack after six weeks on the patch. In April of 2004, 18-year-old Manhattan student Zakiya Kennedy collapsed and died from a blood clot that moved to her lung. In November of 2004, Kathleen Thoren, a 25-year-old mother in Texas died from a blood clot after using the patch for a few weeks.
The Associated Press recently obtained FDA records containing reports of adverse reactions associated with the patch. The Associated Press reported that within the collection of reports, 23 were death reports. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from 2004.*
On November 10, 2005 the FDA announced that the Ortho EvraŽ birth control patch can release up to 60% greater levels of estrogen than found in "the pill." The medical community has known for decades that high levels of estrogen can cause blood clots, leading to serious medical conditions such as deep vein thrombosis, pulmonary embolism, stroke, heart attack and even death in young, healthy women. Because the product labeling for the Ortho EvraŽ patch included claims that it was just as safe as "the pill," the FDA required Johnson & Johnson to add a warning in November 2005 about the increased risk of injury due to high levels of estrogen released from the Ortho EvraŽ patch.
Lopez Hodes is actively representing women who have been seriously injured due to blood clots caused by the Ortho EvraŽ birth control patch, and in April 2005 filed one of the first of many cases we anticipate will be filed across the country against the makers of the Ortho EvraŽ patch. As a result of this early filing, Lopez Hodes has taken a leading role in developing the case against Ortho-McNeil Pharmaceutical and its parent company, Johnson & Johnson. Several Status Conferences have already taken place in the United States District Court, Northern District of Ohio, before the Honorable David A. Katz. A protective order has been entered, discovery responses provided, and nearly 2 million pages of documents have been produced to Lopez Hodes. The defendant has agreed to consolidate discovery in other Lopez Hodes cases with the lead case in Ohio.
In November 2005, Lopez Hodes filed a wrongful death action on behalf of a family in Wisconsin, who lost its 14 year old daughter due to pulmonary emboli caused by the Ortho EvraŽ patch. The firm has several other cases filed on behalf of women who have suffered serious personal injury due to use of the Ortho EvraŽ patch, including recent filings in California and Massachusetts. The firm also has co-counsel relationships with firms representing clients in many other states throughout the country.
If you have suffered any side effects, such as blood clots, pulmonary embolism, stroke, and/or heart attack, from your use of Ortho Evra please contact one of our attorneys today.
* Martha Mendoz, AP, "Deaths linked to 'patch,' Cincinnati Enquirer, July 17, 2005 .