Preventing compelled disclosure of adverse event reports.

• Author: Mayfield, Bonnie L.
• Position: Food and Drug Administration rule on reporting adverse drug reactions and other adverse events

DESPITE vigorous defense counsel protests, courts have compelled drug and device manufacturers to produce adverse drug reaction or product experience reports, which are to collectively as "adverse reports." Yet, those anecdotal, unexplained, unverified hearsay, reports, or summarizations of them, contain confidential and private information. They also have absolutely no bearing on causation in either the case in which a plaintiff seeks to compel their production or in the reported adverse events themselves.

Pursuant to the Food and Drug Administration's final rule, "Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules," manufacturer-compelled production of an unedited, voluntarily submitted adverse report will be disallowed. Indeed, the final rule, which became effective on July 3, 1995, also will protect the identities of the reporters of, patients experiencing, and others involved with adverse events that are the subject of voluntarily submitted adverse reports concerning human drugs, biologics and medical devices.

What is the background of the rule and what will be its impact on product liability litigation?

SETTING THE STAGE

Drug manufacturers, patients and health professionals send post-marketing adverse reports directly to the FDA. Patients and health professionals also send or report adverse events directly to manufacturers, who in turn complete adverse reports and forward them to the FDA. The FDA also relays adverse reports to manufacturers.

Adverse reports possessed by the FDA are governed by federal regulations protecting the confidentiality of voluntary reporters of, patients experiencing, and third parties involved with adverse events. Generally speaking, the regulations, Section 20.111(c) of the Code of Federal Regulations does not allow manufacturers, absent a court order, to withhold adverse reports or the identities of voluntary reporters of, persons experiencing, or others involved with adverse events.

Similarly, Section 519(b)(3) of the Safe Medical Device Act of 1990, 21 U.S.C. [sections] 360i(e), also is deficient in protecting the disclosure of confidential data and information possessed by manufacturers. As the FDA has recognized, Section 360i(e) is really not "sufficient to prevent manufacturers from being compelled to release the reporters' or patients' identities pursuant to a discovery order."(1)

Since neither Section 20.111(c), Section 360i(e) nor other federal regulations allows manufacturers to withhold adverse reports or the confidential, information contained in them, courts have compelled manufacturer disclosure of mandatory and voluntarily submitted adverse reports and information. Compelled disclosure, however, has a chilling effect on the voluntary reporting process because reporters, especially physicians, fear that submitting adverse reports increases their potential for being involved in litigation. Physicians also fear that patient identity would be disclosed, breaching the physician-patient privilege.(2)

In light of that chilling effect, the FDA filed position papers with courts and argued that compelled disclosure would impede its postmarket surveillance efforts. Subsequently, it issued a proposed rule amending its public information regulations.(3)

PROPOSED AND FINAL RULES

To enhance the protection of the identities of voluntary reporters, patients experiencing and others involved with adverse events, the FDA in January 1994 proposed an amendment to its regulations. After a period of comment, the final rule was published in the April 3, 1995, issue of the Federal Register and now is codified as Section 20.63(f) of the Code of Federal Regulations.

It states:

[sections] 20.63 Personnel, medical, and similar files,

disclosure of which constitutes a clearly unwarranted

invasion of personal privacy.

(f) The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report. This provision does not affect disclosure of the identities of reporters required by a Federal statute or regulation to make adverse event reports. Disclosure of the identities of such reporters is governed by the applicable Federal statutes and regulations.

(1) Exceptions

(i) Identities may be disclosed if both the voluntary reporter and the person identified in an adverse event report or that person's legal representative consent in writing to disclosure, but neither the FDA nor any manufacturer in possession of such reports shall be required to seek consent for disclosure from the voluntary reporter or the person identified in the adverse event report or that person's legal representative; or (ii) Identities of the voluntary reporter and the person who experienced the reported adverse event may be disclosed pursuant to a court order in the course of medical malpractice litigation involving both parties; or

(iii) the report, excluding the identities of any other individuals, shall be disclosed to the person who is the subject of the report under request.

(2) Preemption

No State or local governing entity shall establish or continue in effect any law, rule, regulation, or other requirement that permits or requires disclosure of the identities of the voluntary reporter or other person identified in an adverse event report except as provided in this section.(4)

THE RULE AND LITIGATION

The final rule prohibits certain persons from disclosing information. It protects only limited information from disclosure. Under circumstances defined by the rule, voluntary reporters, persons experiencing adverse events and even third- party strangers to the event can obtain the adverse report so long as it excludes certain identifying information. Nevertheless, defense counsel must attempt to exclude even the edited voluntary report from evidence.

1. Prohibited Persons

   The very first sentence of Paragraph (f) limits its application to the FDA and a "manufacturer in possession of such reports." Thus, it applies to the FDA, to manufacturers to whom adverse events are voluntarily reported, and to manufacturers who...