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Defective Medical Devices
A Minnesota defective medical device attorney can assist patients who have been injured by a medical device. Medical devices are used for a number of different purposes, including the treatment and management of various health conditions and diseases. Although it is assumed that medical devices are thoroughly tested for safety and effectiveness, patients who suffer severe complications from these products may be eligible to recover compensation with the help of a Minnesota defective medical device attorney.
How are Medical Devices Classified?
According to the U.S. Food and Drug Administration (FDA), a medical device is any implant, instrument or apparatus that cures, mitigates, treats or prevents disease, or affects the structure or the way the body functions in any way. The FDA has established three regulatory classes that determine how much risk a medical device poses to patients.
FDA regulatory classes:
- Class I devices — This class of medical devices is considered to pose the lowest risk to patients. Some devices classified under this category include handheld surgical tools, examination gloves and elastic bandages.
- Class II devices — Devices classified under this category are not entirely devoid of risk and are subject to special controls. Powered wheelchairs, surgical drapes and infusion pumps are all examples of Class II medical devices.
- Class III devices — These devices generally pose the greatest amount of risk to patients and include things like implanted cerebellar stimulators, replacement heart valves and silicone gel-filled breast implants.
Ultimately, how much control the FDA exhibits over a medical device is determined by which class it falls under.
The FDA and Medical Devices
Like a drug, a medical device is regulated by the FDA and must undergo testing before and after being marketed to consumers, based on standards set by the administration. Medical devices are also required to be registered with the FDA.
While the FDA is meant to keep consumers safe from potential harm caused by defective medical devices, it has recently come under scrutiny by the United States Senate. A Bloomberg article released the findings of a Senate investigation released in early 2016 in which it was discovered that 250 people or more developed infections caused by contaminated endoscopes since 2012.
According to the report, the FDA’s monitoring system did not raise red flags of a problem quickly enough. Once the problem was discovered by the FDA, it wasn’t until 17 months later that a warning was released to hospitals country-wide. Those involved in the investigation question whether the FDA’s current system is doing its job of keeping patients safe.
How a Minnesota Defective Medical Device Attorney Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by defective medical devices may be eligible to recover money for:
- Medical expenses
- Lost wages
- Pain and suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.