Self-Critical-Analysis-Privilege

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

Tammy Meyer and Dina Cox describe the Self-Critical Analysis Privilege and its role in the context of drug and device litigation, give arguments for and against the privilege, and give a sense of its current application.

About the authors...

Tammy Meyer is a partner with Lewis Wagner, LLP in Indianapolis, Indiana where she practices in litigation with an emphasis in drug and device products litigation and other business litigation.

Dina Cox is also a partner with Lewis Wagner, LLP practicing in drug and device litigation and professional liability defense.

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. Patricia L. Andel, Inapplicability of the Self-Critical Analysis Privilege to the Drug and Medical Device Industry, 34 SAN DIEGO L. REV. 93, 95 (1997). 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. Id.

The self-critical analysis privilege originated over thirty-five

years ago in Bredice v. Doctors Hospital, Inc., 50 F.R.D. 249 (D.C. 1970). 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. Id. at 250. 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." Id. 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." Id. at 251. Bredice caused many states to codify the self-critical analysis privilege for medical peer review documentations. Andel, at 105-106. However, few courts extended the privilege beyond this context. Id. 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 to be confidential and, in fact, remain confidential.1

This test varies from one jurisdiction to the next.

Concerns and Impediments to 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 to be protected must have been prepared for mandatory government reports. See, e.g., Shipes v. Bic Corp., 154 F.R.D. 301, 301 (M.D. Ga. 1994). Other courts have agreed that the privilege only extends to subject or evaluative materials. Thus, factual or merely objective data in the same reports is not privileged. Id. See also Culinary Foods, Inc. v. Raychem Corp., 151 F.R.D. 297, 304 (N.D. Ill. 1993).

Further, courts have not hesitated to 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. Shipes, 154 F.R.D. at 301. See also In re Grand Jury Proceedings, 861 F. Supp. 386, 388 (D. Md. 1994). Also, like the work-product doctrine, the self-critical analysis privilege has only been applied in the discovery context. Shipes, 154 F.R.D. at 301. See also David. P. Leonard, An Emerging Privilege for Self-Critical Analysis, 14 Litigation 1, 3 (Spring 1988). The privilege has also been found to be easily waived, as is the case with the attorney-client privilege; traditionally any disclosure results in waiver. Id. at 4.

Recognition and acceptance of the self-critical analysis privilege has also been impeded by the Supreme Court. In 1990, the Court in University of Pennsylvania v. EEOC unanimously held that before it would recognize the privilege, "the privilege must promote sufficiently important interests to outweigh the need for probative evidence." 493 U.S. 182, 189 (1990). The Court was reluctant to recognize a privilege "where it appears that Congress has considered the relevant competing concerns but has not provided the privilege itself." Id. The Court refused to extend the privilege to faculty comments or decisions made during a faculty peer review procedure. Id. The Court has yet to consider the privilege in another context.

Policy Arguments

The question of whether to recognize the self-critical analysis privilege is really one of policy. On one hand, it is in the public's best interest to encourage drug and medical device manufacturers to critically evaluate themselves without the fear that such evaluations may one day be used against them in litigation. On the other hand, courts must balance the injured individual's right to broad discovery.Against the Self-Critical Analysis Privilege

The self-critical analysis privilege has been criticized for being inconsistent with the policy of broad discovery and the courts' reluctance to recognize privileges in general.

First, drug and medical device manufacturers do not have an expectation of confidentiality of their reports because product safety analyses are part of the FDA's public files under the Freedom of Information Act. Andel, at 142. Second, such confidentiality is not necessary to maintain the relationship between drug and medical device manufacturers and the FDA. Id. "By virtue of being an FDA-regulated industry, drug and medical device manufacturers must provide complete and accurate disclosures regarding the safety and effectiveness of their products..." Id. at 143. Finally, because the FDA plays an aggressive role in regulating drugs and medical devices that ultimately affect the health and welfare of the general public, the benefit of disclosure to the public outweighs the injury to the relationship between the parties. Id. at 144.

In addition, those who disagree with application of the self-critical analysis privilege are not convinced that without it, drug and medical device companies will not make thorough product safety analyses. They argue that the industry has strong incentive to make a thorough investigation; most notably, to avoid products liability exposure and accompanying punitive damages often awarded in our litigious society. Id. at 145.

For the Self-Critical Analysis Privilege

The self-critical analysis privilege helps protect the safety of society. It encourages drug and medical device manufacturers to carefully evaluate the safety of their products and make necessary improvements. Even though the privilege could potentially impinge upon an individual's right to broad discovery, this alone does not outweigh the benefits to society as a whole. Moreover, widespread acceptance of a different doctrine seemingly dictates acceptance of the self-critical analysis privilege.

The learned intermediary doctrine has been stated as "the obligation of a manufacturer to warn about risks attendant to the use of drugs and medical devices that may be sold only pursuant to a health-care provider's prescription [which] traditionally has required warnings directed to health-care providers and not to patients..." Restatement (Third) of Torts: Prods. Liab. § 2 cmt. b. (1998). The doctrine does not impose a duty on the drug manufacturer to warn the consumer as long as the manufacturer's warning to the physician is adequate. Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994).

If courts are willing to protect drug and medical device manufacturers pre-accident when they provide adequate warning, why shouldn't courts protect the companies post-accident by applying the self-critical analysis privilege? The documents and materials generated during an internal investigation are, in essence, ultimately protected by the learned intermediary doctrine because they are used to create an adequate warning. Failure to protect the companies from liability post-accident seems to contradict the willingness to protect them pre-accident. Drug and medical device manufacturers may be shielded from liability by the well-established learned intermediary doctrine as long as they provide an adequate warning to the physician. It must follow that these companies be protected from liability (as the court did in Dowling) regarding post-accident safety reviews by applying the self-critical analysis privilege. It is post-accident reviews that allow companies to take necessary steps, conduct more research, and run more tests so that they may provide adequate warnings with the safety of the general public in mind. If companies are protected pre-accident when adequate warnings are provided, companies should be protected post-accident, so that they can provide adequate warnings and make safe products in the future.

Notes for Practitioners

Neither state nor federal courts have consistently applied the self-critical analysis privilege. Moreover, when the privilege is recognized, the standard for its application varies from jurisdiction to jurisdiction. Thus, absolute reliance on the privilege is not recommended. Rather, drug and medical device manufacturers should structure internal investigations in such a manner to take advantage of the more established privileges, such as the attorney-client privilege and the work-product doctrine. Notwithstanding the need for broad discovery, there is a place for the self-critical analysis privilege.