To facilitate its task of ensuring the safety of medical devices in the United States, the Food and Drug Administration (FDA) collects “adverse event reports” regarding illnesses or injuries that may have been caused by the use of a medical device. Hospitals and similar institutions are required by a federal statute to report life-threatening and other serious illnesses or injuries to the FDA, but anyone may voluntarily report less serious incidents as well. To encourage reporting, the aforementioned statute and the FDA’s regulatory scheme take certain measures to protect the identities of individuals who make the reports. The statute generally disallows the use of mandatory reports in civil litigation, including barring their admission as evidence. Separately, the FDA’s regulation prohibits the FDA or other parties from divulging any information in a voluntary report that could be used to identify a subject or reporter. The information contained in both types of reports, however, remains useful to litigants bringing suit against device manufacturers, and production of the reports often is requested during discovery. But allowance of this type of disclosure could have a chilling effect on the reporting that Congress and the FDA have tried to encourage, and thus, inquiry is needed as to the proper treatment to be accorded discovery requests for adverse event reports.This Note draws a clear distinction between mandatory reports, governed by the statute, and voluntary reports, governed by the regulation, and explores the problematic treatment that these provisions have been given. Beginning with a discussion of the statute and regulation, this Note details the competing interests which courts have sought to balance in their interpretations of these rules. It then proceeds to a deeper analysis of the case law, arguing that the flawed interpretations advanced by many courts are out of touch with congressional and FDA intent and are suboptimal solutions to the balancing of interests presented. The proposed solution would treat the two types of reports separately. Mandatory reports’ inadmissibility limits the value that they could have to litigants, and thus, courts should concentrate on protecting reporters’ identities by disallowing discovery of the reports. On the other hand, the admissibility of voluntary reports, coupled with the plain language of the regulation, necessitates courts’ allowance of disclosure of these reports, as long as appropriate measures are taken to protect the identities of reporters. The Note concludes that, in any case, Congress and the FDA should amend the statute and the regulation, respectively, to establish their preferred solutions to this question, and end the confusion created by the disparate treatment given by courts.
The full text of this Note is available to download as a PDF.