Find Legal Topics > Product Liability Laws > Ortho Evra Lawsuit

Ortho Evra Lawsuit

Ortho Evra Lawsuit

A Brief Guide to Filing an Ortho Evra Lawsuit

What is Ortho Evra?

Ortho Evra, which is better known as the “patch”, is used to prevent pregnancy.  Ortho Evra is comprised of Norelgestromin Transdermal and Ethinyl Estradiol—the former is a progestin and the latter is an estrogen (both female sex hormones). When combined, the hormones prevent ovulation (the release of eggs from the ovaries) by altering the cervical mucus and lining of the uterus. The contraceptive patch—or Ortho Evra—is regarded as one of the more effective methods of birth control. That being said, Ortho Evra does not prevent the spread of HIV (condition that causes AIDS) or other sexually transmitted diseases.

Ortho Evra Side Effects:

Ortho Evra side effects are fairly common regardless of dosage levels or adherence to intake instructions. Please inform your doctor if any of these Ortho Evra side effects are persistent or severe:

• Common Ortho Evra Side Effects Include: redness, irritation or rash in the place where the patch was applied; breast discharge, enlargement or tenderness; vomiting; nausea; stomach bloating or cramps; fluctuations in weight; change in appetite; acne; hair loss; swelling of the feet, hands, ankles or lower legs; painful or missed periods; white vaginal discharge; vaginal irritation or itching; bleeding between menstrual periods.

Some Ortho Evra side effects are classified as severe. If you experience the following Ortho Evra side effects, seek immediate medical help:

• Serious Ortho Evra Side Effects Include: speech problems; dizziness; weakness of an arm or leg; sudden vomiting or headache; double vision; bulging eyes; chest tightness; shortness of breath; calf pain; severe stomach pain; extreme fatigue; fever; light-colored stool;dark colored urine; rash.

In addition to these Ortho Evra side effects, application of the patch may increase the risk of developing breast cancer, liver tumors, gallbladder disease, blood clots, heart attack and stroke. If you experience any severe Ortho Evra side effects, you or your medical professional may file a report with the United States Food and Drug Administration’s MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or via the phone at 1-800-332-1088.  

Ortho Evra and the FDA:

Considering the bevy of Ortho Evra side effects (listed above), the USFDA has extensively studied and reviewed the contraceptive patch to ensure safe-use. In December of 2011, a panel of federal health advisers announced that the Ortho Evra Patch from Johnson & Johnson poses a significant risk of blood clots when compared to older contraception options. These results; however, did not institute an Ortho Evra recall, as the agency claimed that Ortho Evra benefits outweigh its risks. In addition to its efficiency in limiting pregnancies, panelists said Ortho Evra can pose great benefits to younger women who have difficulty sticking to a daily pill regimen.

The Ortho Evra patch was approved by the FDA in 2001 and has been marketed by Johnson & Johnson as a convenient contraception for busy women. Ortho Evra works as well as other contraceptive medications, allowing approximately one unplanned pregnancy per year for every 100 women.

Recent studies by the FDA found that users face a 50 percent higher risk of developing clots than women taking the pill. As a result of these Ortho Evra side effects, panelists ruled that Ortho Evra’s warning label is inadequate and should reflect recent test results. Despite these concerns, the FDA believes that the Ortho Evra patch fills a niche among contraception medications.

Ortho Evra Lawsuits:

Widely due to the aforementioned side effects, over 4,000 people have filed Ortho Evra  lawsuits in an attempt to secure compensation for damage imposed by the drug. The bulk of these Ortho Evra lawsuits point to Ortho Evra side effects relating to increased production of estrogen—the reaction that triggers the formation of blood clots.

These Ortho Evra lawsuits are filed by former users of the patch. The Ortho Evra lawsuit concerning the development of blood clots is filed to recoup the costs associated with the reaction, including pain and suffering, lost wages from missed work and medical bills. To win Ortho Evra lawsuits and collect a settlement, the plaintiff must definitively prove that her blood clot was a direct result of Ortho Evra use. Moreover, the plaintiff, in an Ortho Evra lawsuit, must prove that Johnson & Johnson was negligent in reporting the adverse reaction or failed to adequately test the drug for said effects.

From April 2002 to December 2004, hundreds of Ortho Evra lawsuits were filed claiming that Johnson & Johnson did not sufficiently test the drug before releasing it to the public. These Ortho Evra lawsuits, along with the others, were consolidated by multidistrict litigation—a procedure that groups all Ortho Evra lawsuits into one federal court proceeding.

Under multi-district litigation, the first 14 Ortho Evra lawsuits (known as the “bellwether Ortho Evra lawsuits”) aimed at establishing precedent. Seven of these Ortho Evra lawsuits concerned non-fatal Ortho Evra side effects, including blood clots, fatigue and bleeding, while the remaining Ortho Evra lawsuits were filed by survivors of patients who committed suicide while on the patch. The majority of these Ortho Evra lawsuits were settled out-of-court.

In April 2006, 11 New Jersey plaintiffs won Orthro Evra lawsuits from Johnson and Johnson. By October 2008, it was reported that the manufacturer had paid at least $68.7 million as part of its Ortho Evra settlement expenses.

 

Source:

1. Huffington Post “Ortho Evra: Birth Control patch’s Benefits Outweigh Risks:

FDA” by Perrone, Matthew retrieved from: http://www.huffingtonpost.com/2011/12/09/ortho-evra-birth-control-patch-fda_n_1139955.html

2. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm319219.htm

3. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110402.htm

4. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110403.htm

5. United States National Library of Medicine “Ethinyl Estradiol and Norelgestromin Transdermal” retrieved from:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000187/

Related Topics