Providence Attorneys for Victims of Dangerous Medical Devices in RI and MA
People throughout Rhode Island and Massachusetts rely on medical devices for their day-to-day mobility, health, and general wellbeing. From wheelchairs to artificial heart valves, medical devices serve invaluable functions for people with all types of conditions and from all walks of life.
Unfortunately, while medical devices can significantly improve and even save people’s lives, they can also cause significant problems, and in the worst of scenarios can cause untimely death. When medical devices do more harm than good, the individuals who suffer as a result are entitled to compensation for their losses. At the Bottaro Law Firm, we provide compassionate, vigorous, and experienced representation for victims of dangerous and defective medical devices.
Dangerous Medical Devices and Medical Device Defects
Classifying Medical Devices
A “medical device” is any form of apparatus, instrument, implant, or machine that is used to diagnose, treat, or cure a medical condition. Some common examples include knee and hip replacement devices, prosthetics, and hospital equipment such as surgical tools and infusion pumps.
Medical devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA divides medical devices into three classes based on their risks and the level of control necessary to prevent dangerous devices from hitting the market. However, devices in all three classes are subject to certain baseline requirements, including: (i) registration with the FDA, (ii) compliance with safe manufacturing practices, and (iii) proper labeling.
Regrettably, the FDA’s procedures are not enough to stop all dangerous devices from making their way to operating rooms and pharmacy shelves. As our medical device attorneys know all too well, people suffer everyday as a result of defective implants and other problems.
Medical Device Defects
Like drug manufacturers, manufacturers of medical devices are subject to the rule of “strict liability.” This means that they are legally and financially responsible for the harm caused by their devices even if they were not negligent in allowing the harm to occur.
Strict liability provides individuals with protection for three specific kinds of medical device defects:
- Defective Design – These are defects that are inherent in the design of the device itself. Since the design is flawed, each and every device coming off of the assembly line will be potentially dangerous to consumers.
- Defective Manufacturing – With manufacturing defects, even devices that are safe in design become unsafe for actual use. Manufacturing errors can lead to defects in individual products; or, they may cause entire batches of medical devices to become unreasonably dangerous.
- Failure to Warn – The FDA requires medical device manufacturers to include warning labels on their products. However, even if a manufacturer meets the FDA’s minimum requirements, a label may still be insufficient to adequately warn consumers about all of the potential risks associated with a medical device. When a manufacturer fails to provide all of the necessary warnings about its products, it can be held strictly liable for injuries that device recipients suffer as a result of its failure to warn.
Medical Devices Sold Without Clinical Testing
Many people are surprised to learn that not all medical devices are subject to clinical testing. In fact, however, the FDA has a special process that essentially allows certain medical device manufacturers to self-select out of participating in clinical trials.
Under the FDA’s 510(k) program, manufacturers can submit what is known as a “premarket notification” in order to avoid clinical testing. If the manufacturer demonstrates that its device is substantially equivalent to another device already sold to consumers, it can immediately take its device to market. While the theory behind the 510(k) program is that it allows consumers quicker access to new and better innovations, the reality is that it often leads to the sale of devices that are not safe for their intended use.
Known Defective Medical Devices
The 510(k) program has resulted in widespread use of several unsafe devices. Examples of medical devices cleared under the 510(k) program and other devices known to cause serious health risks include:
- Automated external defibrillators
- Implantable cardioverter-defibrillators
- Hip replacements
- Knee replacements
- Lap bands
- Power morcellators
- Surgical mesh
- Vena cava filters
This is just a small sampling of known dangerous medical devices. If you are experiencing issues from any type of medical device, we want to hear about it.
Speak with an Attorney at The Bottaro Law Firm Today
If you rely on a medical device or were recently hospitalized and are experiencing complications from your procedure, we urge you to contact us right away. If a defective device is to blame for your situation, we can help you fight to recover your medical bills and other losses. To schedule a free, no-obligation consultation, call (866) 529-9700 or contact us online today.