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Ortho Evra and Possible Side Effects

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Ortho Evra


If you or a loved one used the Ortho Evra patch and experienced a stroke, pulmonary embolism, blood clot, or another severe side effect, contact an experienced drug product liability lawyer near you immediately. Due to the adverse side effects of a medication, you may have rights and grounds for a product liability case against the pharmaceutical company. An experienced California drug product liability attorney from our law firm can review your potential case in detail in a free consultation. Our legal team is committed to holding manufacturers accountable for unreasonably dangerous products.

What is Ortho Evra?

The Ortho Evra birth control patch (Norelgestromin/Ethinyl Estradiol Transdermal System) received FDA approval in November 2001. The patch is intended to be adhered to the skin rather than the typical contraceptive products that are taken orally, implanted, or injected. The dosage for an adult is the weekly application of a new birth control patch for three weeks for a total of 21 days. The fourth week is drug-free to allow menstrual bleeding. At the end of the fourth week, the new patch cycle is initiated. The patch may be applied on the skin of the upper torso, lower abdomen, upper outer arm, and buttocks.

What Are the Severe Side Effects of Ortho Evra?

The popular contraceptive patch Ortho Evra, has been linked to severe and fatal side effects. Women using the Ortho Evra birth control patch may experience elevated estrogen levels which may lead to the development of blood clots. Such clots may affect the brain, lungs, heart, and other vital organs. This may cause severe illness or even death with the potential of stroke, heart attack, or other damage to vital organs in the body.

The adverse side effects prompted the FDA to step in and require labeling and marketing changes for the product in 2005. The following year, the FDA imposed further regulations, including a warning on the medication packaging on the risk of blood clots. Manufacturers may be subject to civil cases when a defective or unreasonably unsafe product is knowingly designed and marketed with the failure to warn consumers of potential risks from product use.

While contraceptives are generally safe, it is essential to be aware of the complications that may occur from their use. The video below discusses the risks that may occur from the use of an Ortho Evra birth control patch.

Types of FDA Recalls for Medical Drugs

Recalls are measures undertaken by a company for product withdrawal from the market. Recalls may be subject to FDA order, in response to FDA request, or initiated voluntarily by the company. The FDA defines product recalls as follows:

  • Class I: A scenario where it is reasonably expected that the exposure or use of a product will cause adverse side effects or fatality.
  • Class II: An incident where exposure or use of a product may cause short-term or reversible side effects or there is a remote possibility of adverse side effects.
  • Class III: A scenario where exposure or use of a product is unlikely to cause adverse side effects.
  • Product Withdrawal: A product can be subject to market withdrawal if the matter does not involve FDA legal action and is subject to a minor violation. The company is expected to perform corrective action for the issued violation or remove the product from the market.
  • Safety Alert for Medical Device: A safety alert for a medical device may be issued in cases where the product may cause an unreasonable risk of significant harm. Under specific circumstances, these matters may be deemed recalls.

The purpose of a recall for a medication is to protect the public from a potentially harmful or defective product. Companies are required to take voluntary action in FDA-issued recalls to provide warnings to consumers and patients about a potential risk or remove the product from the market.

Grounds for Drug Product Liability Cases

In the United States, the pharmaceutical industry is a thriving enterprise due to consumers depending on drug products for the treatment of many illnesses. Drug products must undergo extensive clinical trials and tests before FDA approval. However, adverse side effects may become apparent after the drug has been marketed and millions of patients have been prescribed the medication. According to a 2021 report by America’s Health Insurance Plans (AHIP), approximately 7 out of 10 top pharmaceutical companies spent more on marketing and selling instead on clinical research and development in 2020.

When pharmaceutical companies place profit over safety for medications, it may compromise the well-being of patients. Unsafe drug products may include medical professionals administering medications in surgical, hospital, or other healthcare facilities, over-the-counter (OTC) medications, and prescription drug products prescribed by a doctor. Drug products may be subject to FDA recalls for various reasons. The most common reasons include variations in potency or strength, contamination, mislabeling, and safety concerns like adverse side effects.

In cases where a drug product results in adverse side effects, a civil case may be a means for an injured party or surviving family member of a decedent to obtain full compensation for the resulting losses. In California, a plaintiff must demonstrate that the manufacturer was strictly liable for unreasonably dangerous or defective products. An experienced drug product liability lawyer will advocate for individuals or survivors of deceased relatives who suffered adverse harm from the use of medications. The right attorney will have extensive experience managing pharmaceutical litigation.

Drug Product Liability Lawyer in California

At our Northern California-based law firm, we are committed to protecting the rights of those we represent in drug product liability cases. Our team of lawyers has the experience, skills, and resources to effectively manage pharmaceutical litigation and assist clients who have experienced adverse effects from drug products in seeking maximum compensation. If you believe you suffered harm from the use of Ortho Evra birth control, let our California drug product liability lawyers review your potential case and provide free, friendly advice. Dial (916) 921-6400 or (800) 404-5400 for a free case review today.

Photograph Source: By sora-shimazaki via Pexels ds [cs 1019]

DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer/Services Agreement. No attorney-client relationship will exist between you and our firm unless and until we enter into a signed Retainer/Services Agreement. The information you obtain at this site is not, nor is it intended to be medical or legal advice. Do not stop taking any medication without consulting your physician.