Medical Device Reporting: Litigation Concerns

​​When a medical device is involved in a serious injury or death, healthcare organizations must comply with U.S. Food and Drug Administration (FDA) medical device reporting (MDR) requirements. However, certain questions regarding litigation may exist. This article discusses some of these concerns and provides guidance for how to address them. For a broader overview, see Medical Device Reporting.

The plaintiff in a medical malpractice or product liability action may try to obtain medical device-related adverse event reports through discovery and bring them to a jury's attention in court to prove causation or notice. This is a highly sensitive issue for user facilities and manufacturers, who worry that anecdotal early-warning reports may be erroneously regarded as accurate and scientific. In reality, reports are often incomplete, speculative, and erroneous, and might prejudice a jury.

Some statutory protection exists. The Safe Medical Devices Act of 1990 (SMDA) states that user facility reports are inadmissible into evidence and may not otherwise be used in any civil action involving private parties unless the user facility, individual, or physician who made the report knew that the report contained false information. This statutory protection applies to reports made by a device-user facility, an individual employed by or otherwise formally affiliated with such a facility, or a physician who is not required to make such a report. It does not extend to reports made by medical device manufacturers or distributors. (21 U.S.C....