The Self-Critical Analysis Privilege in the Context of Drug & Medical Device Litigation

Between the reporting requirements of the Federal Food, Drug and Cosmetic Act (FDCA) and potential products liability exposure, drug and medical device manufacturers have very little room for error. Because established legal privileges provide insufficient protection for companies, many commentators have suggested application of the self-critical analysis privilege. The Self-Critical Analysis Privilege Defined The self-critical analysis privilege prevents disclosure of self-evaluative material where the public interest in maintaining confidentiality outweighs the public's need for discovery. (1) This privilege is not generally accepted, and though it has been applied by some courts, it has been rejected in many jurisdictions. Ideally, the privilege protects from discovery a corporation's reports generated from a required internal investigation, despite the relevance of the material the lawsuit. Commentators argue that refusing apply the privilege--which is promote the societal goal of encouraging candid appraisal of problems as an aid implementing beneficial change--results in a chilling effect on drug and device manufacturers' self-analyses. (2) The self-critical analysis privilege originated over thirty-five years ago in Bredice v. Doctors Hospital, Inc. (3) In Bredice, a medical malpractice case, the plaintiff sought the minutes and reports of any board or committee of the hospital or its staff concerning the decedent, and any reports, statements, or memoranda pertaining the decedent or his treatment. (4) The court found that the purpose of the committee meetings was improve the care and treatment of hospital patients through a thorough review and analysis of the clinical work done in the hospital. (5) It ruled that the information exchanged in these committee meetings was entitled a qualified privilege because to subject these discussions and deliberations the discovery process ... would result in terminating such deliberations. (6) Bredice caused many states codify the self-critical analysis privilege for medical peer review documentations; however, few courts extended the privilege beyond this context. (7) Since Bredice, courts have developed a four-criteria standard for application of the self-critical analysis privilege, regardless of the context: First, the information must result from a critical self-analysis undertaken by the party seeking protection. Second, the public must have a strong interest in preserving the free flow of the type of information sought. Third, the information must be of the type whose flow would be curtailed if discovery were allowed. Finally, the information created must have been intended be confidential and, in fact, remain confidential. (8) This test varies from one jurisdiction the next. Concerns and Impediments the Development of the Privilege Courts have been widely skeptical of the self-critical analysis privilege resulting in a narrow application of the rule. Courts have modified the original four-part test of Bredice and required that other criteria be met before its application. For example, some courts have required that the materials sought be protected must have been prepared for mandatory government reports. (9) Other courts have agreed that the privilege only extends subject or evaluative materials. Thus, factual or merely objective data in the same reports is not privileged. (10) Further, courts have not hesitated impose the limitations already in place for the established privileges on the self-critical analysis privilege. Like the work-product doctrine, application of the self-critical analysis privilege may be overcome if the party seeking disclosure demonstrates a compelling need for the information. (11) Also, like the work-product doctrine, the self-critical analysis privilege has only been applied in the discovery context. …