The United States Food and Drug Administration (FDA) has announced further details in its plan to make it easier for physicians and patients to report problems with medical devices. The plan includes the use of unique device identifiers in electronic health records and billing claims, and creation of a nationwide registry of devices. The FDA also plans to use technology to make reporting adverse events, such as injury, easier by releasing the MedWatcher mobile app. The app will allow physicians and users to file adverse event reports on smartphones and tablets.
Attorneys are split on the impact the FDA’s plan will have on device maker’s liability. Many device makers are concerned that an increase in adverse event reports will heighten the risk that a particular device will be viewed as defective and result in a flood of lawsuits. Particularly troublesome to device makers is the fact that the filing of an adverse event report does not necessarily mean that the device in question caused the injury.
On the other hand, some believe that the new surveillance system will actually benefit device makers. It is believed that if the system works, device makers and the FDA will learn of defects more quickly, resulting in faster recalls. Increased reporting will hopefully improve the ability to pinpoint a specific problematic model, which would limit the scope of recalls and cut down the number of potential plaintiffs. The ability to pinpoint a problematic model will also limit the number of defendants in a case as it will be more clear who actually manufactured the device.
The FDA’s system highlights a trend in consumer reporting of making it easier for claims and complaints to be made. With smartphones and tablets becoming more pervasive, it can certainly be expected that the volume of complaints and reports will rise. It will likely be some time before the impact this has on products liability litigation is fully known.