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What Is A Medical Device?
According to the U.S. Food and Drug Administration (FDA), a product can be categorized as a medical device if it is:
- Recognized in the United States Pharmacopoeia or the official National Formulary
- Designed to treat, mitigate, cure or prevent a disease or other health condition
- Meant to alter the way the body is structured or the way it functions in any way
Medical devices vary greatly in terms of their complexity and can be as simple as a tongue depressor or as complex as a laser product that surgeons use while performing operations.
Medical Device Risks
Although medical devices come in many different shapes and forms, there are three primary situations that can occur where a medical product may be viewed as defective. First, a medical device may be defective if it was improperly produced or damaged in some way either during the manufacturing process, as it was being shipped or while it was being handled at a doctor’s office, hospital or another health care facility.
Second, a medical device can be defective if it is manufactured correctly, but if it was designed in a way that causes unreasonable danger to those who use it. The third situation can occur when a medical device fails to provide proper instruction on how to use it to consumers, or if it fails to include a warning. However, when a medical device exists that is marketed improperly, the issue does not always go back to the manufacturer. In some situations, the device can be incorrectly marketed by a medical provider, a hospital or the device’s sales representative.
Defective Medical Device Recall
When one of these three situations occurs, the medical device may be recalled either by the FDA or by the manufacturer. Although the FDA has been regulating medical devices since 1976 to prevent recalls and to improve device safety, the New York Times states that unsafe medical devices may be introduced to the market because the approval process is not stringent enough. Currently, certain medical devices receive approval after they undergo one clinical trial, while new medications usually have to undergo two.
An Ohio defective medical device lawsuit is an option for patients who suffered complications due to a defective medical device.
How an Ohio Defective Medical Device Attorney Can Help
Device makers have a duty to design and produce safe products, and to warn of possible risks associated with their products. Failure to fulfill that duty can result in injuries to patients, and the device maker being held liable for those injuries.
Patients who are injured by defective medical devices may be entitled to compensation for damages resulting from injuries. Compensation can be based on factors including:
- Past and future medical expenses
- Pain, suffering, and mental anguish from an injury
- Loss of income or ability to work due to loss of mobility
If a loved one dies after complications from a defective medical device, family members may be able to pursue claims for wrongful death damages, including:
- Conscious pain and suffering of a loved one prior to death
- Loss of financial support
- Pain, suffering, and mental anguish resulting from the loss of a loved one
Affected patients and their families are encouraged to seek the advice of an Ohio defective medical device attorney to discuss their legal rights and options for compensation.