Defective Medical Device Attorneys

A device is unavoidably unsafe when it cannot be made completely safe, but its value and benefits surpass the potential risks. 

• It is determined that in order to continue to research and develop new medical products, it is necessary to make unavoidably unsafe products available on the market.
• These are available as long as they have adequate warnings and are not deemed defective due to faulty manufacturing.

A device can be considered defective if there is a failure to issue the required warnings of potential risks associated with the device.

• The prescribing physician must be warned of any dangerous potential risks associated with a medical device. The doctor then weighs the potential risks against the benefits of the medical product and considers how the warnings may affect their patient and to proceed as they best see fit.
• Manufacturers do not have a duty to warn the patient of any risks. The physician may be considered the "informed intermediary" between the manufacturer and the patient.
• Warnings are made in accordance with the FDA in the Physician's Desk Reference and package inserts on medical products. The manufacturers have a legal duty to warn doctors of potential risks associated with a drug or medical device. The risks must also be current and updated when necessary to make the warnings complete and clear.

The FDA tests medical devices and gives approval before they are on the market for consumers. Some defects may come from inadequate testing and rushing the approval process to get a product on the market.

• Pressure on the government to approve new medical devices comes from companies as well as from the public. Attempts to speed up the process can result in inadequate testing.

Defects that do not become apparent until a product is in use for a period of time. 

• These long-term defects are difficult to determine during short-term testing to approve a device for consumer use. For this reason, the FDA monitors medical devices once they are on the market. When a dangerous defect or risk is discovered, the instrument is recalled.