Personal Injury Law

Critical Self-Evaluation Privilege

By John A. Day

Tim Edwards of Memphis has shared an opinion from the federal court in Memphis that refused to recognize the existence of the so-called "critical self-examination privilege."

The products case concerns the HiRes 90k cochlear implant, a Class ITI medical device that provides a sense of sound by direct stimulation of the auditory nerves.    The device was manufactured by Advanced Bionics.   

Advanced Bionics asked the Court to

establish the critical self-evaluation privilege under Tennessee law based upon "common law principles," the policies behind FDA's audit requirements for medical device manufacturers, the policy behind the Food and Drug Administration's ("FDA") decision to exempt those audits from disclosure to the FDA, and the stated policy in the Tennessee Peer Review Law of1967, see Tenn. Code Ann. § 63-6-219(b)(1), which includes fostering and encouraging candid evaluations in order to promote public health.

Here is the bottom line of the Court's ruling:

Although Advanced Bionics has cited persuasive authority to support the establishment of the critical self-evaluation privilege in Tennessee, the Court does not find that any persuasive authority is necessary when neither the Tennessee Supreme Court, the Tennessee Court ofAppeals, the Tennessee General Assembly, nor the sources listed in Rule 501 ofthe Tennessee Rules of Evidence have recognized the existence of the critical self-evaluation privilege in Tennessee.

Here is court's opinion. 

Full post as published by Day on Torts on August 03, 2009 (boomark / email).