How Serious are Defective Medical Devices?
Imagine needing a medical device to help improve your condition, heal a serious injury, and more. It’s an unfortunate situation, but there are numerous situations when medical devices that individuals rely on turn out to be defective.
Items such as pacemakers, prosthetics, and more are supposed to improve the patient’s life when they suffer from a serious condition. However, even when these items are approved by the United States Food and Drug Administration, there can be issues regarding effectiveness, overall quality, and safety.
These dangers are very serious, often causing significant harm to those who have the need for such items. Knowing what the FDA’s role in these medical devices is, as well as what can happen when they’re defective and who can be held accountable is very important.
What Role Does the FDA Play?
Before any medical device can be used in the medical profession, it must undergo strict scrutiny from the FDA to determine whether or not it is safe and will work effectively in the role that it has for any patient.
Unfortunately, it is this agencies requirements and long process that often leads to manufacturers finding any way to shortcut the process, including the 510(k) process. This means the product only needs to be shown that it is substantially equal to another product already on the market.
Going through this process means the manufacturer may avoid the strict testing process in place. If this happens and there are problems with the product, the FDA can also recall the device to help protect individuals who may have had the product used, or protect others from it in the future.
What Happens When a Medical Device Is Defective?
The effects of a defective medical device are dependent on what type of device it is, the use, and overall problems that may occur. For instance, if a person has a metal-on-metal hip replacement, they may experience some immediate help from the device.
However, there are numerous risks that can arise over time, specifically with various models. This can include fretting and corrosion resulting in pain, swelling, tissue problems, inflammation, metallosis, and even immobility.
Similarly, some hip implants are known to cause significant damage to the patient, including tissue death, heart issues, damage to the liver and kidney, and even poisoning or allergic reactions from the metal or other materials used.
When someone is harmed by these defective medical devices, they not only have to deal with the immediate pain and discomfort they cause, but the individuals may also have to undergo further dangerous medical procedures to fix the issues. These can be costly and painful.
Who Is Held Responsible for the Damages?
When pursuing legal action after sustaining an injury due to a defective medical device, there are plenty of factors to consider before moving forward. Understanding who may be liable—and who you can file the lawsuit against—is one of the first steps before filing.
There is a chain events leading to the injuries sustained by the patient. The manufacturer must have produced a product, there may be a distributor or seller involved, the hospital allows the use of the product, and the doctor is the one who prescribes the device. In some ways, each of these parties may be considered responsible.
- The Manufacturer: In most cases, it is the manufacturer’s fault for creating a product that is unsafe to the patient. Their device may have a defective design, been made incorrectly, or had a danger they failed to issue a warning on. The manufacturer may have bypassed the safety tests of the FDA and put a dangerous product on the market. This makes the manufacturer accountable for the damages.
- The Doctor: If the doctor who prescribes the device knows of the dangers prior to the surgery and fails to warn the patient, they may be held liable for the pain the patient endures. Similarly, if they in any way alter the device from the intended purpose or design in a manner that causes harm, they can be considered responsible for the damages.
- The Hospital, Seller, or Distributor: Similar to the situation of the doctor knowing of the defect, if the hospital allows use of the product or the seller distributes the product to a medical facility while having knowledge of the potential dangers to a patient, they may be held accountable when the product experiences a defect.
More often than not, it is the manufacturer who carries most of—if not all—of the liability for a defective medical device. It is their responsibility to ensure that their products are not only considered safe by their own standards, but that they also meet FDA standards.
When manufacturers fail to put the safety of patients first, they are acting in negligence. As such, they should be held financially accountable for the damages the injured party experiences. This can include the costs for any future medical procedures, lost income, and more.
At Peterson & Associates, we put the rights of patients first. You’re already dealing with a serious condition; you shouldn’t have to suffer from even further harm because a device you expected to help you was defective.
Our Kansas City defective medical device attorneys are committed to helping you navigate complex legal matters when you need it most. Trust that we work hard to help you seek compensation and hold negligent parties accountable because you deserve justice.
To speak with a lawyer in a free consultation, we encourage you to call us today at (816) 298-8708 and discuss your potential case.