Modern medicine has made our lives so much better in so many ways. Medical devices like pacemakers, artificial hips, surgical meshes and more keep us healthy and active for much longer than what was possible in years past. Unfortunately, many of the medical devices currently being used today are prone to malfunctioning or otherwise doing more harm than good.
While defective medical devices are rare, they can be potentially deadly. What’s more, the companies that manufacture these devices are often hesitant to make the issue known to the public. That means the Food and Drug Administration generally has to step in and issue a recall. Because recalls come after months of complaints and investigations, hundreds or even thousands of people could be affected before the issue is ever made public.
At Auger & Auger, our attorneys have over 26 years of experience helping people in Charlotte get the help they need if they or their loved ones have been injured or killed by a defective medical device. We know what it takes to get compensation from the manufacturers of these devices, whether it’s through an individual lawsuit or a class action suit.
If you or a loved one has been injured or killed by a defective medical device, we’re here to help you. Give us a call at (704) 751-1475 or contact us online today to speak to a defective medical device lawyer in Charlotte.
Your Options for Compensation After an Injury Caused by a Defective Medical Device in Charlotte
When you or a loved one has been injured by a defective medical device in Charlotte, you have a few different legal options to recover compensation. The most common option is a personal injury lawsuit. This means you, as an individual, are seeking compensation for the losses you suffered. You may be able to recover compensation for:
- Pain and suffering
- Medical bills, past, and future, including surgery or other procedures to remedy the situation
- Past and future lost wages
- Lost earning capacity
- Mental anguish
- Physical disfigurement
- Temporary or permanent disability
- Wrongful death
- And more
If a large group of people is affected by the same type of device from the same manufacturer, you may be able to join a class-action lawsuit or an MDL (multidistrict litigation). Each of these options has its own nuances, but the main similarity is that they all involve a large group of people filing similar lawsuits together against a single manufacturer. While these types of lawsuits can take longer, you are more likely to get the compensation you deserve. After all, there’s power in numbers!
How Does a Medical Device Get Approved By the FDA?
According to the FDA, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that is used to diagnose, treat or prevent a disease or other condition, or “intended to affect the structure or any function of the body” of a person. There are three general classes of medical devices based on their intended usage. Each class has different requirements for getting approved by the FDA.
A Class I device is generally considered the lowest risk. These may include elastic bandages and stethoscopes. Generally, Class I devices are approved in under a month, and most are exempt from any kind of premarket approval requirements. Around 35 percent of medical devices are in this class.
Class II devices are those that present a moderate risk of harm but are often not too dangerous if used properly. These types of devices could include a powered wheelchair, contact lenses, or syringes. Class II devices generally have to go through a 510(k) premarket notification, basically stating that this device is equivalent to other devices already on the market. About 53 percent of devices fall into this class.
Finally, Class III devices are considered the highest risk. They are used to support or sustain life, are implanted, or otherwise present a high risk of injury or illness. Pacemakers, implanted prosthetics like metal hips, and defibrillators. Class III devices have to go through a rigorous approval process, including a premarket approval or humanitarian device exemption. About 10 percent of all devices are Class III.
There are also unclassified/not classified medical devices. About 3 percent of devices simply haven’t been classified yet. In addition, most Class I and some Class II devices don’t need to be approved before hitting the market. However, the manufacturer is still required to register their business with the company with the FDA, including a list of their devices.
Common Defective Medical Device Cases We Handle
At Auger & Auger, our lawyers have over 26 years of experience handling defective medical device cases. We represent clients if they have been injured by certain medical devices, and if we don’t specifically handle your type of case, we have a large network of other law firms to whom we can refer you.
Examples of defective medical products that have been known to cause injury include:
- Bair Hugger warmer blanket
- Hernia mesh
- IVC Filters (Bard & Cook)
- Metal hip replacements
- Power morcellators
- Stryker hip replacements
- Transvaginal mesh
No matter the product, it’s important to know who you can hold accountable for your injuries. In most cases, the manufacturer is held responsible. You simply have to prove that the device was defective, and therefore it caused harm. Common types of defects include:
- Design defects, meaning harm was inevitable because of the design or the materials used. For example, if a metal-on-metal hip replacement is prone to degrade with use, shedding tiny amounts of metal or other debris into the joint, that would be a defect in the design.
- Manufacturing defects, meaning the device was created using suboptimal practices – the design is not a problem, but something went wrong in the manufacturing stage. In some cases, this may affect a product that has been in use for years without causing any difficulties. Something changes at the manufacturing plant and one or more batches are produced with a serious flaw. The healthcare provider who receives some of these defective devices has no way of knowing they’ve received a bad batch, so they implant the device as usual.
- Marketing defects, meaning the device was likely to be misused due to how it was presented to the public. If you’ve ever wondered why drug or medical device ads include such a long list of seemingly obvious warnings, it’s because the manufacturer wants to avoid these marketing defect claims. However, there are still some situations where consumers aren’t informed of the dangers of a device or are led to believe it should be used in ways that aren’t safe.
In some cases, the doctor who used the device could also be held accountable. This is generally the case when a recall has been issued or the problem with the device has otherwise been made public and the doctor still uses it.
You may also be able to sue the doctor if they make a mistake during the process to fix the problem, such as if a hernia mesh is improperly removed. However, these cases may be considered medical malpractice instead of defective medical device injuries. Your Charlotte personal injury lawyer can help you determine your best course of action.
Proving Your Case In Court
First, it’s important to know that many medical device cases are settled out of court, and only a small number culminates in a trial. We always try to negotiate with the manufacturer’s insurance company so that our clients can receive a settlement without the stress and time commitment of going to court. In many cases, we are able to do so, but in some situations, the other party simply won’t budge. If that happens, we will continue to trial.
Medical device cases are handled like other product liability claims, and the state of North Carolina differs from many other states in how these cases are handled. Some states, such as South Carolina, use strict liability, which simply means that if the product was defective, the manufacturer is liable. (Other people in the supply chain are potentially liable as well, although this is more likely to be an issue with a product resold in a retail store than with a medical device.) But in North Carolina, simply proving the device was defective isn’t enough. You and your attorney must show that the manufacturer was actually negligent. In other words, that they knew the device might cause harm. As a result, there are many possible defenses the other party may offer in court:
- The device was fine when it left the manufacturer but was changed by a third party in some way that made it unsafe. In Class III medical device cases, the defense sometimes claims that the doctor who implanted the device made a mistake or damaged the device when placing it, causing the defect that made it harmful. For Class I and II products, the defense may be that the end-user (you) made alterations to the product that caused its defect.
- The manufacturer could state that they had no real chance to warn consumers about the problem for various reasons. Usually, they will claim to have only very recently learned of the issue, well after the plaintiff (you) received the device.
- In another scenario, they may claim that the product obviously had risks and you chose to use it in a way that was clearly unsafe. Whether or not this defense works often rests on whether the jury agrees that the risks were obvious.
- Alternately, the manufacturer may claim that you just plain ignored their instructions, kept using a product knowing it was defective or chose not to “exercise reasonable care” while utilizing the device.
- In a few cases, the manufacturer may claim there is no proof the device is defective, and the problems people have reported can’t be proven to have been caused by the device.
It can be upsetting to hear the excuses a defective medical device manufacturer may come up with to defend themselves. These claims are often made in the settlement negotiation process as well. However, a skilled attorney knows how to assign investigators to the case, interview witnesses and medical experts, gather as much evidence as possible and let the other side know what they will be up against in court. Conveniently, this is also an excellent way to prepare for a trial in the event that negotiations stall. And in many situations, the other party may become more interested in negotiating when they realize the strength of your case.
If a trial does become necessary, your lawyer will talk over their strategy with you and answer any questions you have. They will work hard to refute whatever claims the plaintiff is making by presenting various kinds of evidence – medical records, testimony from doctors or other medical professionals, video or pictures of the device being used correctly, testimony from others injured by the same device, documents or other proof of when the manufacturer became aware of the problem, etc.
Often people want to know if they will have to testify in a trial. We always remind our clients that their case is more likely to settle without a trial. If it does happen, you are not required to testify. However, in many cases, it can be very helpful for the jury to hear your experience firsthand, so we usually recommend it. Even the most eloquent lawyer can’t tell your story better than you can. If you do decide to testify, we will help you prepare by going over the questions the other party’s attorneys will likely ask, so you can be ready and confident.
Get the Help You Deserve from a Defective Medical Device Lawyer in Charlotte
When you or a loved one is affected by a defective medical device, the results are often severe. You may deal with infections, internal injuries, severe illnesses, and more. In some cases, injuries and illnesses from defective medical devices can even result in death.
At Auger & Auger Accident and Injury Lawyers, we know how serious your injuries can be. We are also familiar with the process of helping you get the compensation you deserve, whether that’s through an individual lawsuit or a class action. Give us a call at (704) 364-3361 or contact us online today to speak to a defective medical device lawyer in Charlotte.
