Opinion ID: 1953829
Heading Depth: 1
Heading Rank: 4

Heading: Was the package insert inadmissible hearsay?

Text: Pursuant to congressional directives, the Food and Drug Administration (FDA) has developed a regulatory procedure to inform the medical profession about prescription drugs. 21 C.F.R. § 1, 201; 50 Fed.Reg. 51108 (1985) The package insert distributed with the drug by the pharmaceutical manufacturer is the basis of this system of notification concerning composition, dosage, indications, contraindications, potential side effects, and adverse reactions of drugs. The package insert information is based upon data the manufacturer has submitted to the FDA as proof that the drug is safe and effective for the uses the manufacturer wishes to market the drug. Jennings, The RX Label Basis for all Prescribing Information, FDA Papers (Nov. 1967) 14-15. The insert advises the physician, based upon the manufacturer's testing results, of (1) the conditions under which the drug should be prescribed, (2) the disorders it is recommended to relieve, (3) the precautionary measures which should be observed, and (4) warning of adverse effects that may result. A compilation of these package inserts on drugs, referred to as the Physicians' Desk Reference, is annually distributed to the medical profession. Under the common law scheme of hearsay exceptions, market quotations, tabulations, lists, directories and other published compilations generally used and relied upon by the public or by persons in particular occupations were excepted from the rule against hearsay. See e.g. Tucker v. Donald, 60 Miss. 460, 470 (1882); Yazoo & M.V.R. Co. v. M. Levy & Sons, 141 Miss. 199, 210, 106 So. 525, 527 (1925). Since January 1, 1986, those hearsay exceptions have been compiled in Rule 803(17) of the Mississippi Rules of Evidence, which do not significantly alter the common law scheme. Applying this rule of evidence to the instant case, the Court notes the testimony of Dr. Robert Carter, the defendant, identifying the package insert accompanying a pharmaceutical drug as one source of reference and one source of information. He relied upon this package insert for information of adverse affects, or contraindications, of the drug Bactrim. Further, Dr. Carter identified the Physicians' Desk Reference as a good reference with some authority and that it represented the standard of care in the local area of Biloxi with respect to the administration of the drug Bactrim at the time Lynette Thompson was treated by him. Carter used and relied upon the information contained in the Bactrim package insert in his practice and particularly for the treatment of Lynette Thompson. Although Dr. Carter testified that other medical publications and information were used and relied upon by him in his practice, that testimony does not diminish the admissibility of the package insert after identification by Dr. Carter of its acceptance by him as one source of information and by the medical profession in the Biloxi area as a standard of care in the administration of drugs. The package insert is a compilation of information concerning pharmaceutical drugs and is generally relied upon by the public as well as physicians prescribing the drug. Therefore, we hold that the package insert, properly identified, was admissible by virtue of the above described exception to the hearsay rule.