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An Indiana defective medical device attorney can help patients who have been injured by a medical device. The U.S. Food and Drug Administration (FDA) must approve medical devices such as IVC filters and hip implants before doctors use them with patients. However, as a Senate report released in January 2016 indicates, the process is far from foolproof. The results can be life threatening, potentially leading to death. Although most medical devices are designed to benefit patients, some patients are prompted to file lawsuits with the help of an Indiana defective medical device attorney after allegedly suffering from severe complications due to the use of a defective medical device.
What Are Medical Devices?
A medical device can be something relatively simple, say, a bedpan, or something much more complicated such as an implant, as the FDA explains.
Examples of medical devices include:
- Bair Hugger warming blankets
- Jaw implants
- IVC filters
- Contraceptive devices such as Mirena IUD and Essure
- Transvaginal mesh devices
- Hip replacement devices and implants
The FDA classifies medical devices as Class I, Class II or Class III, with Class III devices having the greatest potential for harm. Examples of such devices include breast implants and replacement heart valves. On the other hand, a wheelchair is an example of a Class II device, and Class I devices include gloves.
Possible Problems with the Medical Devices Reporting System
There are many possible pitfalls with FDA approval and supervision of medical devices. For example, as Bloomberg reports, problems are not always reported correctly, and medical device manufacturers may not adequately warn all parties of possible risks. Additionally, the FDA system of “passive” supervision makes for an infrastructure in which many problems can go unreported or fall through the cracks. The Bloomberg report, based on findings from Washington state Senator Patty Murray’s office, also indicates that the FDA takes too long to strengthen warning labels.
510(k) Process and the FDA
According to the Regulatory Affairs Professional Society, another problem with the medical device approval system is with the FDA’s 510(k) process, which allows a device manufacturer to bypass some FDA approval requirements as long as it can show that the device is somewhat equivalent to a device already on the market. Problems with this process include the fact that less attention is paid to the results of clinical trials. Instead, the focus may be on the track record of the device that is said to be equivalent.
Why Some People May Want an Indiana Defective Medical Device Attorney
Many people and their families have been adversely affected by defective medical devices, or believe they have been. For instance, according to a November 2013 deal, Johnson & Johnson agreed to pay in excess of $4 billion to people negatively affected by its hip implants. The matter concerned more than 7,500 lawsuits. Stryker is another company that reached billion-dollar figures in settling implant lawsuits. Zimmer, too, has been sued. In July 2015, a jury awarded one plaintiff a $9.1 million settlement due to problems with his Durum Cup hip implant. He had to have two surgeries that caused muscle damage and scarring.
People have also filed lawsuits over devices such as IVC filters; the lawsuits often allege that manufacturers such as C.R. Bard did not properly notify doctors and consumers that the filters were at increased risk of breaking and spreading metal fragments through a person’s veins. In fact, C.R. Bard has been accused of going as far as forging a signature on an FDA application to get approval to sell IVC filters.
How an Indiana Defective Medical Device Attorney Can Help
Device makers have a duty to provide safe products. If there are risks of harm associated with their products, 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.