Product malfunctioning isn’t limited to household items.
It also extends to faulty and sub-par medical devices that are supposed to aid people.
Yep, you read that right.
Even complex medical devices can result in life-threatening injuries and death. If a defective medical device has caused injuries or death of your loved ones, remember you have legal rights.
As TorHoerman Law puts it, bad things happen to good people, but you don’t have to fight alone.
This article will explain what you need to know about defective medical device injuries, including your legal rights and options.
Types of Defects in Medical Devices
A defective medical device is any medical device unfit for its intended use. Defective medical devices can include any of the following: implantable, surgical, diagnostic, and other medical devices.
The Food & Drug Administration (FDA) has recalled 185 medical devices in the US since 2020. When it comes to defective medical devices, they can be identified in the following ways:
- Design Defects: A design defect is a flaw in the device’s design that makes it unsafe and dangerous to use.
An example could be a pacemaker with a defective battery.
- Manufacturing Defects: A manufacturing defect is an error that occurs during the product’s manufacturing process. This error causes the product to deviate from the original design and affects the device’s performance.
For example, a surgical instrument made up of poor-quality materials.
- Marketing Defects: A marketing defect is a failure to provide adequate warnings through manuals or advertising about the risks associated with the device.
For example, a hip implant device that does not warn about the risk of serious side effects is considered a marketing defect.
How Do Defective Medical Devices Cause Injuries?
Defective medical devices can cause injuries in the following ways:
- An implantable device may malfunction, causing serious health problems.
- A surgical instrument may break during surgery, causing internal bleeding.
- A diagnostic device may provide inaccurate results, leading to misdiagnosis and improper treatment.
The most common types of injuries include:
- Internal bleeding
- Organ damage
- Nerve damage
Injured by a Defective Device: Taking Legal Action
Under product liability law, companies can be held accountable if they put a defective device on the market and it causes harm.
Patients can pursue legal claims even if they agree to arbitration clauses. Furthermore, patients can also recover damages for the pain and suffering, revision procedures, lost income, and other losses.
Take the Bard PowerPort lawsuit as an example.
Bard PowerPort devices help with vascular access and medicine delivery. However, many patients started facing serious complications due to catheter failure. The FDA recalled several PowerPort models in March 2020. A lawsuit against Bard is ongoing, with 50 cases combined into a single case called the Bard Implanted Port Catheter Products Liability Litigation (MDL 3081).
To win a case, the evidence must show the device had a design flaw or a manufacturing defect, or the company failed to warn of risks. An experienced medical device lawyer can help assess if you have a strong claim. They investigate similar incidents with the same device to demonstrate recurring problems.
Challenges With Medical Device Defect Cases
One of the biggest challenges in medical device defect cases is often the device itself. This is especially important for implanted devices, which are usually disposed of immediately after being removed by a surgeon.
If the device is preserved, it is easier to win a product liability case, as the manufacturer has a right to inspect the device in its condition at the time of the incident.
Here are some tips for preserving a medical device if you believe you’ve been injured by one:
- Put the device in a drawer if it is external, such as a thermometer. Do not use or handle it until you give it to your lawyer.
- Ask your surgeon to preserve it for you if it’s an implant. If not, take photographs of the device and make detailed records of its condition and how it failed.
It is possible to win, especially if you have other evidence to support your case, such as medical records, expert testimony, and eyewitness testimony. However, if you cannot preserve the medical device, your product liability lawsuit will be more difficult to win.
One example is when the New Jersey court dismissed a hernia mesh lawsuit in March 2020 because the plaintiffs did not preserve the device and could not prove that Johnson & Johnson (or its subsidiary Ethicon) manufactured it.
If your doctors believe your internal medical device is failing and they plan to remove it, talk to them well before the procedure. Request them to preserve the device. Your next best step is to speak to a personal injury lawyer about your situation and options.
Defective medical device injuries can be devastating.
You have legal rights if you or someone you love has been affected by a defective medical device. Reach out to an experienced product liability lawyer to discuss your case.
A product liability lawyer will help you understand your legal rights and options, and together, you fight to get the compensation you deserve.