Thompson v. Carter

Decision Date07 October 1987
Docket NumberNo. 56874,56874
Citation518 So.2d 609
PartiesLynette Inez THOMPSON v. Dr. Robert CARTER.
CourtMississippi Supreme Court

Crymes G. Pittman, Robert G. Germany, Cothren & Pittman, Jackson, for appellant.

Paul J. Delcambre, Jr., Page, Mannino & Peresich, Biloxi, for appellee.

En Banc:

PRATHER, Justice, for the Court:

At issue in this appeal are two evidence questions addressing the conditions under which (1) a "package insert" accompanying a pharmaceutical product may be introduced into evidence, and (2) the admissibility of a non-physician's expert testimony on the issue of a physician's standard of care with respect to the use and administration of pharmaceutical drugs.

In this medical malpractice action, Lynette Inez Thompson contended she developed Stevens Johnson Syndrome as a result of Dr. Robert Carter's negligent prescribing of the drug Bactrim. From a directed verdict in the Circuit Court of Harrison County, Thompson appeals, assigning as error:

(1) The court erred in refusing to admit into evidence the package insert relative to the drug Bactrim.

(2) The court erred in refusing to admit the testimony of Michael P. Hughes, a pharmacologist and toxicologist, on the issues of liability and causation.

(3) The court erred in sustaining appellee's motion for a directed verdict.

This Court reverses.


At 8:15 p.m. on February 7, 1976, Lynette Thompson (appellant) was taken to the emergency room of Howard Memorial Hospital in Biloxi, Mississippi. Ms. Thompson suffered pain in her right side that had persisted for two days, and she had experienced a recent episode of vomiting. After an initial examination by the emergency room physician revealed blood and pus in Thompson's urine, Ms. Thompson was admitted into the hospital. In the history given at the time of admission, Ms. Thompson indicated she had no known allergy to drugs.

Ms. Thompson was later seen by Dr. Robert Schmidt who sought consultation with Dr. Robert Carter, a urologist. Dr. Carter diagnosed Thompson's ailment as pyelonephritis secondary to pyelitis cystica, a form of kidney infection. According to Dr. Carter, Thompson's kidney infection exhibited characteristics of being both acute and chronic.

To treat Thompson's kidney infection, Dr. Carter prescribed Bactrim, a sulfonamide antibiotic, beginning February 10, 1976. Ms. Thompson was discharged from the hospital February 11, 1976, with instructions to continue taking two Bactrim tablets per day and to visit Dr. Carter's office February 17, 1976.

At Thompson's February 17, 1976 visit to Dr. Carter's office, a urinalysis revealed a continued presence of pus and blood in her urine but in lesser amounts. Dr. Carter advised Ms. Thompson to continue taking Bactrim and to return to his office early in March.

Around February 22, 1976, Ms. Thompson began experiencing a sore throat, accompanied by coughing, spitting, and mouth sores. For her flu-like symptoms, Ms. Thompson refilled a penicillin prescription she had received in September, 1975 from another doctor and had taken without incident. She took the penicillin from February 25th until February 28th.

Ms. Thompson returned to Dr. Carter's office early in March. 1 Ms. Thompson contends she was still experiencing a nagging cough and a mild sore throat, but no complaints were made to Dr. Carter who determined Ms. Thompson was well from her kidney infection. Additional Bactrim was not prescribed to Ms. Thompson.

During the evening of Friday, March 5, 1976, Ms. Thompson began to notice red marks across her back and a swelling sensation over her entire body. By the following Monday, Ms. Thompson's arms, feet and face were swollen, her eyes were blurry, red bumps had arisen over her body, and blisters had formed in her mouth and genitals.

Ms. Thompson was hospitalized March 8, 1976 and was diagnosed as having Stevens Johnson Syndrome, a severe allergic response which causes the formation of blisters in the mouth, nose, and genitals. According to Dr. Carter's trial testimony, Stevens Johnson Syndrome is a recognized danger associated with Bactrim. Thompson remained hospitalized some twenty days and allegedly suffered severe and permanent scars.

In June of 1979, Thompson filed suit against Roche Laboratories, producer of Bactrim, and Dr. Robert Carter, appellee. Praying for $500,000 damages, Thompson employed breach of warranty, negligence and strict liability theories against Roche Laboratories, and a negligence theory of recovery against Carter. Thompson elected a voluntary nonsuit against Roche Laboratories, but the case against Dr. Carter was tried January 14 and 15, 1985. Because Thompson was unable to provide expert medical testimony, the trial ended with a directed verdict in favor of Dr. Carter.

II. Initial Considerations

"The law has never held a physician or surgeon liable for every untoward result which may occur in medical practice, and a physician is not a warrantor against bad results." Dazet v. Bass, 254 So.2d 183, 187 (Miss.1971). "[A] physician may incur civil liability only when the quality of care he renders (including his judgment calls) falls below minimally acceptable levels." Hall v. Hilbun, 466 So.2d 856, 871 (Miss.1985).

To present a prima facie case of medical malpractice, a plaintiff, (1) after establishing the doctor-patient relationship and its attendant duty, is generally required to present expert testimony (2) identifying and articulating the requisite standard of care and (3) establishing that the defendant physician failed to conform to the standard of care. Boyd v. Lynch, 493 So.2d 1315, 1318 (Miss.1986); Hammond v. Grissom, 470 So.2d 1049, 1053 (Miss.1985). In addition, (4) the plaintiff must prove the physician's non-compliance with the standard of care caused the plaintiff's injury, as well as proving (5) the extent of the plaintiff's damages. Boyd v. Lynch, 493 So.2d at 1318.


Did the court err in refusing to admit into evidence the package insert relative to the drug Bactrim?

The issues under this assignment of error may be divided into two parts: (1) Was the package insert inadmissible hearsay? and (2) If admissible, for what purposes may the package insert be used.


Was the package insert inadmissible hearsay?

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. Sec. 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 § 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.


For what purposes may the package insert be admitted into


Other jurisdictions have allowed package inserts into evidence to serve a variety of purposes. See, Dixon, Drug Product Liability, Sec. 7.02 (1986). One of the strongest cases to date in favor of allowing package inserts into evidence was Ohligschlager v. Proctor Community Hospital, 55 Ill.2d 411...

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