When you’re dealing with a serious health condition, the last thing you expect is to be harmed by the very device that’s supposed to help you. These devices can fail unexpectedly, leaving patients in pain, dealing with complications, or requiring additional surgeries. More often than not, they’re also left asking questions.
Was it a design flaw? A manufacturing mistake? Or did the device lack proper warnings or instructions? Understanding exactly what went wrong is crucial to a medical device malfunction lawsuit.
If you’re in this situation, you may have the right to file a medical device malfunction lawsuit.
That means holding the responsible parties accountable, whether it’s the manufacturer, distributor, or even a hospital that misused the product.
This process can seem complicated, but our experienced Montgomery personal injury lawyers are here to guide you every step of the way, helping you understand your legal rights and what compensation you may be entitled to.
What Constitutes a Defective Medical Device?
A defective medical device is any product used for medical treatment or diagnosis that doesn’t work as it should because of a design flaw, a manufacturing error, or a failure to provide proper warnings or instructions. Let’s explore each in turn.
When the defect begins with the design itself, it means the product was flawed from the very start. For example, a hip implant might be designed in a way that causes it to wear down too quickly, leading to joint pain, instability, or the need for revision surgery.
Sometimes, an error can be made during production, such as contamination, the use of incorrect materials, or inadequate quality control. For example, a catheter that wasn’t properly sterilized or a pacemaker that shorts out because of faulty wiring.
And other times still, a manufacturer may fail to provide adequate warnings about potential risks, side effects, or safe usage instructions, which in itself can render the device legally defective.
It’s also important to note that defects don’t always appear immediately. Some may not become obvious until months or even years after a procedure. You might feel like your pain or complications are just part of recovery, but the device may be to blame. For this reason, it’s crucial to pay attention to any new or worsening symptoms and consult a medical professional if something doesn’t feel right.
Common Injuries Caused by Malfunctioning Devices
Some of the most common injuries we see from defective medical products include:
1. Infections
Devices that aren’t properly sterilized or break down inside the body can lead to dangerous infections. In some cases, this can result in sepsis or the need for emergency surgery.
2. Internal Bleeding or Organ Damage
Surgical tools or implants, such as mesh or joint replacements, can damage nearby tissue or organs if they shift, break, or are defective from the outset.
3. Chronic Pain
A device that doesn’t work correctly can cause ongoing discomfort, inflammation, and nerve damage. Many people find themselves needing more medical procedures just to manage the pain.
4. Device Failure Requiring Revision Surgery
If a pacemaker, joint replacement, or implant fails, you may need to go through another painful and expensive surgery to fix or remove it. These revision surgeries often come with a longer recovery time and more risks.
Who Can Be Held Liable in a Defective Medical Device Case?
When something as serious as your health is at stake, it’s only natural to want answers and accountability. In many cases, the blame doesn’t fall on your doctor or hospital. Instead, the issue often begins long before the device ever reaches your body.
Here are some of the parties that could potentially be held liable:
- The Manufacturer: This is often the biggest target in a defective medical device case. If the design was flawed, the materials were subpar, or the product wasn’t properly tested, the company that made the device can and should be held accountable.
- Distributors and Suppliers: Defects can occur during shipping or storage. If a third party was responsible for handling or selling the product and failed to keep it safe, they could be part of the problem.
- Sales Reps or Marketers: Medical device companies often rely on sales reps to educate doctors about their products. If they misrepresented how the device works or failed to warn about risks, they could be partially liable.
- Testing Labs: Before devices hit the market, they go through rigorous testing (or at least they’re supposed to). If a testing company misses something critical, that’s a serious breach of responsibility.
- Healthcare Providers: In some rare cases, a surgeon or hospital might be liable, especially if they implanted the device incorrectly or used a product that had already been recalled.
How to Gather Medical and Product Evidence to Support Your Claim
Building a strong case often comes down to the details, such as clear documentation, medical records, and the device itself can make all the difference.
Start by collecting all your medical records related to the device, including surgical notes, follow-up care, prescriptions, and any hospital discharge papers. These records help establish a timeline and show that you used the device as instructed.
If the device was removed from your body, try to preserve the physical product. Hospitals don’t always return removed devices automatically, so ask your surgeon or medical provider if your device can be retained and properly stored. If the device isn’t available, photographs or documentation of its model, serial number, or packaging can also be helpful.
It’s also a good idea to keep any original instructions, packaging, or labels that came with the device, especially if you used it at home, like an insulin pump or portable oxygen machine. These materials can show whether proper warnings or instructions were provided or whether they were missing entirely.
Having an expert on your side can make a big difference. An experienced attorney can connect you with medical experts, engineers, or product safety professionals who can examine the device and offer testimony on whether it was flawed. This kind of expert input often plays a key role in winning defective medical products cases.
Contact an Experienced Montgomery Personal Injury Lawyer
If you’re struggling after an injury caused by a defective device, we’re here to listen. Our team is ready to help you understand your rights, gather the evidence you need, and take the steps toward filing a strong legal claim.
At Hunter | Everage, we believe every injured person deserves to have their voice heard. We understand the impact that these injuries can have on your health, finances, and future. Contact our personal injury lawyers at 704-377-9157 to request a free consultation.