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Defective Devices

The addition of technological advancements in the medical field has made life better for countless Americans. A medical device is a product that assists medical professionals in treating patients. These devices are used to diagnose, prevent, and treat illnesses, injuries, and more. Every year, more medical devices designed to improve the quality of life for patients everywhere enter the marketplace and are put into use by medical professionals. Unfortunately, not all medical devices perform as intended and some are defective devices that actually cause more harm than good. In fact, each year the Food and Drug Administration (FDA) receives more than 100,000 Medical Device Reports (MDRs) for devices that have caused death, illness, or serious injury.

Dangerous medical device claims are typically product liability cases and should be handled by attorneys familiar with defective devices. To prevail, you must be able to prove you were injured by a defective product (either in the design, manufacture, or marketing), your injuries were caused by the product’s defect, and you were using the product as intended at the time of your injury. These lawsuits have their basis in design defects, improper warnings, insufficient testing, and failure to provide sufficient information on performance and/or proper use, among others.

Medical Devices That Commonly Cause Injuries

A defective medical device can cause extraordinary harm. While any medical device can malfunction or cause a bad reaction, some devices are more commonly defective than others, including:

  • Defibrillators
  • Heart Valves
  • Hernia Mesh
  • Hip Devices
  • Intrauterine Devices (IUD)
  • Knee Replacements
  • Pacemakers
  • Pain pumps
  • Stents
  • Transvaginal Mesh
  • Ventilators
  • Wheelchairs

The Code of Federal Regulations (CFR) divides medical devices into 16 specialties, such as cardiovascular or hematology devices. In addition, the FDA has three regulatory classes of medical devices, categorized based on the amount of government oversight needed to ensure their safety. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk. These three categories are:

  1. Class I: The lowest risk medical devices – such as bandages and electric toothbrushes – are classified as Class I. This is the most common type of medical device, constituting 47 percent of approved devices on the market.
  2. Class II: These devices are intermediate-risk devices including CT scanners, catheters, and contact lenses. The majority of Class II devices are FDA approved for the market through the Premarket Notification, or 510(k) process.
  3. Class III: These high-risk devices are very important to health or sustaining life, and they include pacemakers, breast implants, and cochlear implants.

Attorneys for Defective Devices

You have the legal right to seek compensation for harm caused by a defective medical device. If you were harmed by a dangerous medical device, you deserve justice. Understanding how a complex medical device case works can be intimidating and confusing. That’s why you should reach out to an experienced defective device attorney to ensure your rights are protected. Our team has handled injury and death cases causes by defective devices in forums across the country. There is no fee for an initial consultation with the defective device attorneys of Dax F. Garza, P.C., so contact us today.

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