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:
- Heart Valves
- Hernia Mesh
- Hip Devices
- Intrauterine Devices (IUD)
- Knee Replacements
- Pain pumps
- Transvaginal Mesh
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:
- 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.
- 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.
- 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.
As we move forward into 2020, last year’s outbreak of vaping injuries and deaths seem to have diminished with time. E-cigarettes sent the nation into panic overdrive when hundreds of patients, mostly minors, were reportedly seeking emergency care for lung injuries related to vaping. This epidemic saw its peak in September 2019; and, like many…Continue reading
Takata is recalling more than 10 million front airbags that have been utilized by 14 different automakers. The recall was made after it was discovered the airbags were exploding with accelerated force and hurling shrapnel in the process. Faulty Takata inflators have been linked to at least 25 deaths worldwide to date. Takata has a…Continue reading
The U.S. Food and Drug Administration (FDA) has released a new policy requiring companies to cease manufacturing and distribution of flavored e-cigarette cartridge tobacco products within 30 days. The policy is aimed specifically at fruit and mint flavors, which have been found to be most popular among minors. The FDA has taken another step in…Continue reading
Though the practice of vaping has been around for many years, it skyrocketed in popularity during the past decade. While many turned to vaping to cut down or quit smoking cigarettes, the effects of e-cigarette use have proved to be damaging for users. Now, a study in the American Journal of Preventative Medicine linked vaping to a long-term risk of respiratory disease.Continue reading
With the rise in popularity of vaping devices, many people now either use a vaping device or know someone who does. A lot of people find the devices to be a welcome alternative to cigarettes and other forms of tobacco use. But a months-long national outbreak of health-related issues related to vaping continues, and the…Continue reading
JUUL was founded four years ago with a promise it could help smokers quit. It quickly spawned the vaping movement. Over the course of the last year, high school students experienced a 78% surge in e-cigarette use, according to a report by the CDC. Successful marketing to minors, coupled with the current mystery vaping lung…Continue reading
Back in May 2016, Ethicon recalled its Physiomesh hernia mesh after reports determined recurrence and reoperation rates were higher than average. Following these reports, many patients who had been implanted with the defective mesh filed lawsuits seeking compensation.Continue reading
Most people believe that any medical device available on the market goes through a thorough and effective approval process. The truth is, this is not always the case. The U.S. Food and Drug Administration (FDA) is charged with analyzing new device applications and granting approval to reasonably safe devices; however, the agency has more than one avenue for approval. In addition to the ordinary application process, the FDA has an approval process called 510(k) approval and it’s putting many patients at risk.Continue reading
Patients with Medtronic Defibrillators already know firsthand how defective these devices can be. In addition to previously known issues, the U.S. Food and Drug Administration (FDA) issued another warning for patients: these devices could be vulnerable to hacking. In a recent warning letter, the FDA cautioned patients that a software update must be made to protect the device from cybersecurity vulnerabilities.Continue reading
If you have been injured by product such as a medical device, you may have run into the phrase “mass tort” and be wondering exactly what it means. Many injury cases are handled in consolidated litigations called mass torts; and, this type of case can be very beneficial for plaintiffs. Mass torts have several key features that make them different from other types of cases.Continue reading
- Bad Faith Insurance
- Bus Accidents
- Car Accidents
- Construction Injuries
- Dangerous Drugs
- Defective Devices
- Distracted Driving
- Drunk Driving
- Maritime and Offshore Accidents
- Motorcycle Accidents
- Oilfield Accidents
- Pedestrian Accidents
- Personal Injury
- Refinery Explosion
- Truck Accidents
- Workplace Accidents
- Wrongful Death