Millions of Americans depend on medical devices to keep them healthy and alive. However, when a medical device is defective and causes serious injuries, you need to know where to turn. At the SMA Law Group, we will investigate your case and work to secure the compensation you deserve. Our knowledgeable team has extensive experience handling these cases and we are not afraid of taking on big companies. When you need a medical device injury attorney, we are standing by.
What are the medical devices regulated by the FDA?
There are going to be risks when it comes to any medical procedure or device used on or inside our bodies. Medical devices are used every day, and there are various classes of devices on the market. Each level of device faces differing levels of inspection scrutiny by the US Food and Drug Administration (FDA). Nearly all medical devices used in the US must be approved by the FDA before they can be used on patients.
There are three classes of devices that require inspection and approval by the FDA:
- Class I devices. These are low-risk devices These devices are considered non-invasive and can include:
- basic surgical instruments
- Class II devices. These are intermediate-risk devices These devices are considered moderately-invasive, though they do not necessarily have to be implanted inside a person’s body. Common Class II devices include:
- insulin pumps
- IV infusion pumps
- CT scanners
- Class III devices. These are high-risk devices. Class III devices face the most rigorous inspections and are usually invasive, implanted inside a person’s body for life-sustaining purposes. Some of the most common Class III devices include:
- spinal cord stimulators
- deep-brain stimulators
- heart valves
As you can see, Class III devices are riskier to patients due to their invasive nature. A Class III device malfunction will cause more serious consequences than a Class I devices failure.
Studies have shown that defective medical devices have caused more than 80,000 deaths in the US from 2008 to 2018. Two of the leading injury-causing devices are metal hip implants and insulin pumps, both of which require prior FDA approval before use.
Victims of medical device malfunctions must often undergo extensive medical procedures to correct the problem and repair the damage done to their bodies.
We will investigate your case
If you or someone you love has been injured due to a defective medical device, you need to seek legal assistance as soon as possible. At the SMA Law Group, our qualified and experienced team understands that this type of product liability case can become complicated. We will investigate what happened and work to secure the compensation you deserve. This can include:
- Cost of your current and future medical bills
- Recovery of income lost if you are unable to work
- Mental anguish damages
- Loss of enjoyment of life damages
- Punitive damages against a company, manufacturer, or healthcare provider