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OCTOBER 07, 1987




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. *fn1 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.


 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 noncompliance with the ...

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