The self-critical analysis privilege in the context of drug & medical device litigation.

• Author: Meyer, Tammy

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 to the lawsuit. Commentators argue that refusing to apply the privilege--which is "intended to promote the societal goal of encouraging candid appraisal of problems as an aid to 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 to the decedent or his treatment. (4) The court found that the purpose of the committee meetings was to 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 to a qualified privilege because "to subject these discussions and deliberations to the discovery process ... would result in terminating such deliberations." (6) Bredice caused many states to 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...