Medical devices such as pacemakers, prosthetics, insulin pumps, and others are supposed to improve a person’s life when they suffer from a serious condition. However, even when these items are approved by the U.S. Food and Drug Administration (FDA), there can be issues regarding effectiveness, overall quality, and safety.
Defective medical device cases are serious concerns because an individual has often suffered significant harm. Working with a knowledgeable defective medical device attorney who not only understands the FDA’s role in clearing the way for these products but also who should be held liable when they fail can make all the difference in the success of an injury claim.
Medical Device Development: What Role Does the FDA Play?
Before any device can be used in the medical profession, it must undergo strict scrutiny from the FDA. The agency’s rigorous approval process determines if a product is safe and works as intended.
Unfortunately, some manufacturers find shortcuts in this process to rush a device to market. For example, choosing the 510(k) submission regulation—meaning the product only needs to be shown that it’s substantially equal to another product already on the market. But if this is all the manufacturer does, and there are problems with the product, the FDA can recall the device to help protect individuals affected by the product 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, its intended use, and the problems that occurred.
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 present over time, specifically with various models. This can include fretting and corrosion, which causes tremendous pain, along with swelling, tissue problems, inflammation, metallosis (a build-up of metal debris), and even immobility.
Similarly, some hip implants are known to cause significant damage to an individual, including:
- Tissue death
- Heart issues
- Damage to the liver and kidneys
- Poisoning or allergic reactions from the metal or other materials used
When someone is harmed by defective medical devices, they not only have to deal with the immediate pain and discomfort, but also undergo further dangerous medical procedures to fix the issues, which are costly, frustrating, and result in even longer recovery times and complications.
Who’s Responsible for Your 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.
There’s a chain of events leading to the injuries sustained by the patient. The manufacturer must have produced a device, 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 could potentially be held responsible.
- The manufacturer. In most cases, it’s the manufacturer’s fault for creating an unsafe product. Its device may have a defective design, was produced incorrectly, or had a danger that it failed to warn the public about. A manufacturer may have also bypassed the safety tests of the FDA and put a dangerous product on the market. This makes the manufacturer accountable for the damages.
- The hospital, seller, or distributor. If hospital administration allows the use of a defective 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.
- The physician. If a doctor prescribes the device and knows of the dangers prior to the surgery and fails to warn the patient, they may be held liable. 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.
More often than not, it’s the manufacturer that carries most of—if not all—of the liability for a defective medical device. It bears the responsibility to ensure that products are not only considered safe by quality standards but also meet FDA standards.
When manufacturers fail to put the safety of patients first, they’re acting in negligence. As such, they should be held financially accountable for the damages injured parties experience. This can include the costs for any future medical procedures, lost income, and more.