ORTHO EVRA® Birth Control Patch

If you or a loved one has suffered an injury or illness as a result of the use of the ORTHO EVRA® birth control patch, you're not alone. After using the ORTHO EVRA® patch, many women have experienced severe side effects and injuries such as blood clots, heart attacks, strokes, and embolisms. If you or a loved one has suffered from any of these serious injuries after using the ORTHO EVRA® birth control patch, contact the experienced injury attorneys at Levine & Glassman to discuss your case and ensure that you receive the highest possible recovery.

Florida ORTHO EVRA® Attorneys

Lisa Levine focuses in the areas of medical malpractice that affect women, including failure to diagnose cervical or breast cancers, plastic surgery errors, birth injuries, delivery room negligence, and defective drugs used by women. She prides herself on her dedication to women’s health issues, and has been featured on Good Morning America and NBC News.

Mark Glassman focuses a great deal of his practice on injuries resulting from defective and dangerous drugs, as well as pharmeceutical litigation, and wrongful death litigation. Mr. Glassman has been involved in pharmaceutical cases involving the infamous diet drug, Fen-Phen, and his cases have been highlighted in professional journals such as The Daily Business Review and Contractor Magazine.

The attorneys of Levine & Glassman are fully-versed in this area of law and can help you receive the best possible compensation for the damages suffered after using a defective or dangerous pharmeceutical drug.

ORTHO EVRA® Information Center

• What is ORTHO EVRA®?
• What is the issue with ORTHO EVRA®?
• What are the side effects of ORTHO EVRA®?
• ORTHO EVRA® Timeline
• ORTHO EVRA® Resources
• How we can help

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What is ORTHO EVRA®?

ORTHO EVRA® is a transdermal contraceptive patch (Ethinyl Estradiol and Norelgestromin Transdermal) manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson & Johnson. It was the very first “birth control patch,” introduced on the market in 2002. It was heavily marketed to young women as a more convenient alternative to the traditional oral contraceptives. By 2005, more than four million women had chosen to use the ORTHO EVRA® Patch.

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What is the Issue with ORTHO EVRA®?

Because the contraceptive in ORTHO EVRA® is delivered directly into the bloodstream through the skin, women who utilize the ORTHO EVRA® patch are exposed to approximately 60% more estrogen than those women who utilize a traditional oral contraceptive. Higher levels of estrogen in the blood stream had previously been tied to an increased risk of deep vein thrombosis and stroke because estrogen promotes blood coagulation. However, it was not until 2004 that the Food and Drug Administration conducted a study of ORTHO EVRA®. In that study, it was revealed that women who use ORTHO EVRA® had a 300% increase in the chance of a blood-clot related incident. Those incidents could include strokes, heart attacks, and pulmonary embolisms, all of which could result in serious injury or even death.

In a three year period, the Food and Drug Administration received over 16,000 reports of adverse side effects experienced by women using ORTHO EVRA®. In a one year period, there were 44 serious injuries or death related to the use of ORTHO EVRA®.

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Side Effects of ORTHO EVRA®

Many women have reported side effects such as:

• Severe Headaches
• Vision impairments
• Nausea
• Vomiting

Severe Side Effects of ORTHO EVRA® may include:

• Deep Vein Thrombosis (DVT): a condition wherein a blood clot (thrombus) forms in a vein of the muscle and can be life-threatening. DVTs can occur anywhere in the body but are most frequently found in the deep veins of the legs, thighs, and pelvis. Symptoms include swelling, pain, and tenderness in the legs.

• Pulmonary Embolism (PE): A condition where a piece of the clot from a DVT can break off and travel through the deep veins back to the heart, and eventually be pumped by the heart into the arteries of the lung. Symptoms can include sudden shortness of breath, sharp chest pain that is worse when you cough or take a deep breath, and a cough that brings up pink, foamy mucus.

• Heart Attack: An interruption of blood supply to a part of the heart, causing the heart cells to die. Symptoms can include pressure or pain the chest, irregular heartbeat, shortness of breath, sweating, and pain in one or both arms.

• Stroke: A condition where a blood vessel in the brain is blocked or bursts; without blood (and the oxygen the blood carries) that section of the brain begins to die. The part of the body controlled by that section of the brain cannot work properly. Symptoms of stroke come on suddenly and can include numbness, tingling, weakness, or paralysis in the face, arm, or leg, especially on only one side of your body, vision changes, trouble speaking, confusion or trouble understanding simple statements, problems with walking or balance, and/or a severe headache that is different from past headaches.

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Timeline for ORTHO EVRA®

• November 2001: ORTHO EVRA® is fast-tracked through the Food and Drug Administration approval process and is approved for release on the market by the FDA.

• 2002: ORTHO EVRA® is released by Ortho McNeil Pharamceutical on the market and is touted as a more convenient alternative to traditional oral contraceptives.

• 2004: A study conducted by the FDA reveals that ORTHO EVRA® causes a 300% increase in risk of blood clot related incidents, such as pulmonary embolisms, stroke and heart attacks.

• April 2005: Reports of the first death related to ORTHO EVRA® use are published in the media.

• November 2005: The FDA issues a warning on these dangers of ORTHO EVRA®, and requires Ortho McNeil Pharmaceuticals to change the package labeling to reflect the newly-recognized dangers.

• August 2007: A study conducted by the Boston Collaborative Drug Surveillance Program at the request of Ortho McNeil shows that use of ORTHO EVRA® led to an increased risk of blood clots and blood clot disorders.

• January 2008: The FDA requires Ortho McNeil to make additional changes to the ORTHO EVRA® packaging to reflect additional findings of the Boston Collaborative Drug Surveillance Program study.

• June 2008: Johnson and Johnson, the parent company of Ortho McNeil, settles a lawsuit involving a 14-year old who used the ORTHO EVRA® patch, suffered from a pulmonary embolism, and died.

• 2009: All lawsuits relating to the injuries and deaths suffered as a result of the use of the ORTHO EVRA® patch are condensed into a MultiDistrict Litigation Action inU.S. District Court for the Southern District of Ohio.

• January 2010: The Boston Collaborative Drug Surveillance Program publishes a new study that indicate that the risk of blood clot issues IS NOT materially different in users of the ORTHO EVRA® patch versus those individuals who have used traditional oral contraceptives.

• October 2010: The British Columbia government filed a lawsuit against pharmaceutical giant Johnson & Johnson Inc., claiming the maker of the "ORTHO EVRA®" contraception patch “aggressively marketed the contraceptive without disclosing the safety hazards associated with Evra.”

• Currently a class action consumer fraud lawsuit is being investigated.

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Resources

Food and Drug Administration Information on ORTHO EVRA®

National Institutes of Health Information on ORTHO EVRA®

ORTHO EVRA® Website

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Levine & Glassman, P.A. | Florida Defective Drug Attorneys

If you or a loved one has suffered from any of these side effects as a result of use of the ORTHO EVRA® patch, you need to ensure that you are well represented. The effects of the conditions like stroke and heart attacks can be long lasting and may require long term care. The attorneys of Levine & Glassman are experienced defective drug attorneys and are able to ensure that you receive fair compensation for the damages you or your loved ones have suffered. If you are anywhere in Florida, including: Fort Lauderdale, Miami, West Palm Beach, Boca Raton, or the surrounding areas of Broward, Miami-Dade, or Palm Beach counties, contact Levine & Glassman for an analysis of your ORTHO EVRA® case.