Ortho Evra Lawsuit
Ortho Evra, or “the birth control patch,” as it is widely known, is a transdermal birth control patch manufactured by Johnson & Johnson (“J&J”) subsidiary Ortho-McNeill-Janssen Pharmaceuticals, Inc. Ortho Evra is indicated to prevent pregnancy. The patch releases a synthetic combination of the female hormones estrogen and progestin which prevent ovulation. Ortho Evra also provides a secondary pregnancy prevention mechanism by thickening the user’s cervical mucus making it difficult for the sperm to reach the uterus. Ortho Evra has been on the US market since April 2002. However, J&J no longer actively markets the product which may be due to the thousands of Ortho Evra lawsuits filed.
Ortho Evra Lawsuits
Thousands of Ortho Evra lawsuits have been filed and allege that J&J’s initial labeling and marketing did not adequately warn consumers of the higher risk of certain life-threatening side effects. The lawsuits allege that because Ortho Evra is administered directly through the skin (as opposed to ingested and diluted through the digestive tract) the hormones, particularly estrogen, are delivered at a much higher concentration. Indeed, Ortho Evra’s official website now states that Ortho Evra users are exposed to 60% more estrogen than women who use typical oral contraceptive methods. According to the FDA, this increased level of estrogen may cause an increase in adverse health effects, including pulmonary embolism, deep vein thrombosis, as well as stroke, heart attack, and even death.
Ortho Evra Deaths
The first known Ortho Evra related death occurred in April of 2005 when an 18-year-old New York City fashion student collapsed in a subway station. It was later determined that she died from a pulmonary embolism caused by the Ortho Evra Patch. A pulmonary embolism is a blood clot that travels into the lungs, that can result in life-threatening complications if undiagnosed. In July 2005, the Associated Press released a Food and Drug Administration (“FDA”) study which concluded that Ortho Evra Patch users are three times more likely to develop blood clots than women who use typical oral birth control methods.
Then, in November 2005, the FDA issued a warning for consumers and health care providers regarding the potentially fatal side effects of the Ortho Evra birth control patch and forced J&J to strengthen the patch’s warning label. Since that time, J&J has amended the Ortho Evra warning label twice. On September 20, 2006, J&J’s revised labeling disclosed that women using the birth control patch may be more than twice as likely to develop a pulmonary embolism, as well as blood clots in the legs, when compared to women using 35 micromilligram oral contraceptives.
On January 18, 2008, the label was updated again to include the results of a January 2008 study conducted on behalf of J&J in which researchers found that Ortho Evra Patch users were at higher risk for developing serious blood clots (venous thromboembolisms) compared to users of oral combination birth control pills. At least 23 deaths have been linked to Ortho Evra, 17 of which were caused by fatal blood clots. Unfortunately, in most of these cases, Ortho Evra’s revised warning labels came too late.
Ortho Evra Side Effects
The Ortho Evra birth control patch has been associated with a number of complications, including but not limited to the following Ortho Evra side effects:
- Dizziness
- Headaches
- Nausea and/or vomiting
- Menstrual cramps
- Breast tenderness
- Abdominal Pain
- Anxiety and/or depression
- Hair loss
- Change in appetite
- Blood clots
- Deep Vein Thrombosis
- Pulmonary Embolism
- Stroke
- Heart Attack
- Death
Ortho Evra’s potentially severe side effects may require immediate medical treatment. If you or a loved one has suffered from any of the above Ortho Evra side effects, or additional adverse health events while using the Ortho Evra birth control patch, contact a physician as soon as possible.
Ortho Evra Attorneys
J&J has paid at least $68.7 million to settle some Ortho Evra lawsuits.. To learn more about a potential Ortho Evra claim, contact our experienced and trial-ready attorneys today. Chaffin Luhana’s Ortho Evra lawyers are dedicated to helping injured women and their families recover financial compensation for physical pain, financial losses including significant medical bills, and emotional suffering. In fact, founding partner Roopal Luhana is currently leading another prominent birth control litigation, as one of only two women on the Plaintiffs’ Steering Committee in the national Yaz, Yasmin and Ocella birth control litigation.
To speak with someone regarding your potential claim, contact us toll-free for a no-cost, confidential case evaluation at 1-888-316-2311, or via email.