Any time a person uses a medical device, there is a risk of injury. These injuries could occur at no fault of the victim, which makes it even harder to cope when an injury does occur.
If a medical product has a design defect or manufacturing issue, then the medical product liability laws take over. During this type of case, a manufacturer may have failed to warn consumers about potential risks; therefore, they are liable for any injuries.
Some medical devices are more prone to injury claims, such as pacemakers, prosthetics, hip devices, ventilators, and heart valves. If a person is injured by a defective medical device, it is in their best interest to contact an accident attorney in Hudson Valley.
Why Do Medical Device Defects Happen?
While the United States Food and Drug Administration (FDA) requires that all manufacturers notify them when there are defects, that does not mean that the manufacturer or FDA overlooked potential issues. Instead, the manufacturer must have been aware or known there was a potential risk for injury or death using their product.
The FDA typically receives more than 100,000 medical device reports (MDRs) per year and about 5,000 from the MedWatch program. Therefore, they have their hands full when it comes to reviewing and acting on those complaints.
Even though the FDA is the authority on medical devices, these devices are not always tested in real-life situations. That is why the FDA has approved defective devices and drugs in the past. When something is tested in a laboratory or clinical setting, it is unclear how it will react to real-life situations.
The FDA does not contend that the product is safe even if they approve a device for the market. Instead, they are stating that the instrument has met their minimum safety requirements and passed the necessary criteria to be sold.
Establishing Negligence
An accident attorney in Hudson Valley must prove that the medical device is the cause of their client’s injury. This may involve holding the surgeon or hospital that sold the device liable, too. Also, an investigation must be done to determine if the doctor committed an error or if the device was responsible for the patient’s injuries.
Medical product liability is incredibly complex, which is why a person should contact an accident attorney in Hudson Valley rather than attempt to represent their own case. The legal professionals from a law firm can help investigate and gather evidence proving that the manufacturer, hospital, reseller, or surgeon are responsible.
A person that is injured by a defective medical device is likely to have long-term consequences as a result. They may need further surgeries to remove and replace the defective device, or they could encounter thousands in medical bills, lost wages, and associated costs. In some cases, defects are so severe that a person could suffer from life-threatening complications or death.
