Case Name: Lynette Inez THOMPSON v. Dr. Robert CARTER
Court: Mississippi Supreme Court
Jurisdiction: Mississippi
Decision Date: 1987-10-07
Citations: 518 So. 2d 609
Docket Number: No. 56874
Parties: Lynette Inez THOMPSON v. Dr. Robert CARTER.
Judges: HAWKINS, P.J., and ROBERTSON, SULLIVAN and ANDERSON, JJ., concur.
Reporter: Southern Reporter, Second Series
Volume: 518
Pages: 609–621

Head Matter:
Lynette Inez THOMPSON v. Dr. Robert CARTER.
No. 56874.
Supreme Court of Mississippi.
Oct. 7, 1987.
Dissenting Opinion Oct. 10, 1987.
Rehearing Denied Jan. 13, 1988.
Crymes G. Pittman, Robert G. Germany, Cothren & Pittman, Jackson, for appellant.
Paul J. Delcambre, Jr., Page, Mannino & Peresich, Biloxi, for appellee.
. WALKER, C.J., VOTED ON THIS CASE PRIOR TO LEAVING THE COURT ON OCTOBER 1, 1987.
. Chief Justice Walker voted on this opinion prior to his retirement October 1, 1987.

Opinion:
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 appel-lee's motion for a directed verdict.
This Court reverses.
I.
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 sulfonam-ide 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. 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.
III.
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.
A.
Was the package insert inadmissible hearsay?
Pursuant to congressional directives, the Pood 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 Refer ence, 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.
B.
For what purposes may the package insert be admitted into evidence?
Other jurisdictions have allowed package inserts into evidence to serve a variety of purposes. See, Dixon, Drug Product Liability, § 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, 303 N.E.2d 392 (1973) in which the court allowed the manufacturer's instructions regarding the use of a drug to establish the professional standards ordinarily established by expert testimony.
It is suggested by some writers in this field of pharmaceutical drugs that caution should be exercised by courts in accepting the manufacturer's test results as conclusive. Notwithstanding the government regulations in this field, the package insert is a marketing or merchandising procedure to promote sales. Drug manufacturers have had to answer for alleged dilution of warnings by over-promotion in sales programs. Magee v. Wyeth Laboratories, Inc., 214 Cal.App.2d 340, 29 Cal.Rptr. 322 (1963); Love v. Wolf, 226 Cal.App.2d 378, 38 Cal.Rptr. 183 (1964); Sanzari v. Rosenfeld, 34 N.J. 128, 167 A.2d 625 (1961).
Likewise, independent researchers have reached contradictory results to drug manufacturers and have recommended different dosages. Updated information gained from a broader base usage of a drug is not always reflected in the original insert until a new distribution of the drug or new publication of the Physicians' Desk Reference. Text writers suggest that antibiotic drugs represent an exception to set dosages. This rationale is explained by the assertion that as bacteria become more resistant to drugs, the dosage may be increased. A doctor's experiences offers a basis for varying dosages.
With these considerations in view, this Court is persuaded by the reasoning of the Idaho Supreme Court in Julien v. Barker, 75 Idaho 413, 272 P.2d 718 (1954). In Julien v. Barker the Court held:
[The package insert] is not conclusive evidence of standard or accepted practice in the use of the drug by physicians and surgeons, nor that a departure from such directions is negligent. But it is prima facie proof of a proper method of use, given by the maker, which must be presumed qualified to give directions for its use and warnings of any danger inherent therein.
Id. 272 P.2d at 724.
This Court agrees that the package insert in the instant case should not be taken as conclusive evidence of the physician's standard of care, nor should a departure from the directions contained in the package insert be considered to establish a pri-ma facie case of negligence. However, this Court holds the package insert contains prima facie proof of the proper method of use of Bactrim and, for those purposes, was admissible at trial. See, Nolan v. Dillon, 261 Md. 516, 276 A.2d 36, 49 (1971); Salgo v. Leland Stanford Jr. University Board of Trustees, 154 Cal.App.2d 560, 317 P.2d 170, 180 (1957). The package insert can be given weight as authoritative published compilation by a pharmaceutical manufacturer. It is some evidence of the standard of care, but it is not conclusive evidence. The prescribing physician can be permitted to rebut this implication and explain its deviation from the manufacturer's recommended use on dosage. The holding will shift the burden of persuasion to the physician to provide a sound reason for his deviating from the directions for its use, and will require corroborative evidence to determine whether the physician met or violated the appropriate standard.
IV.
Did the court err by excluding the testimony of Michael P. Hughes?
At trial, appellant offered Michael P. Hughes as an expert witness in the fields of Pharmacology and Toxicology. Mr. Hughes testified that he had received a bachelor's degree from Millsaps College with major in chemistry and minor in biology and a master's degree in both Pharmacology and Toxicology. In the process of obtaining his degrees, he had taken five or six courses in Pharmacology and between eight and ten courses in Toxicology. After completing his graduate degree programs, Mr. Hughes became coordinator of the Regional Poison Control Center for the entire State of Mississippi. As coordinator for the Poison Control Center, which is located at the University of Mississippi Medical Center, Mr. Hughes was often consulted by physicians for suggested treatment of poisoning victims and other types of adverse reactions to various compounds or drugs. Mr. Hughes further testified he was on the teaching staff at the University of Mississippi Medical School and taught Pharmacology and Toxicology to both dental and medical students. Additionally Hughes had taken training to render emergency medical care as an "emergency medical technician."
Mr. Hughes testified that by virtue of his education and work experience, he was familiar with the drug Bactrim and its indications as well as its contra-indications. Likewise, he was familiar with Stevens Johnson Syndrome and its causes.
The trial court found that Hughes was qualified to testify as an expert witness as to causation in the field of Pharmacology and Toxicology, but was not qualified to testify concerning the standard of care to which physicians are required to conform with respect to the use and administration of drugs.
Pharmacology is defined as "The science that deals with drugs, their sources, appearance, chemistry, actions, and uses." Steadman's Medical Dictionary, p. 952 (3rd ed. 1972). Toxicology is "a science that deals with poisons and their effect on living organisms, with substances otherwise harmless that prove toxic under particular conditions, and with the clinical, industrial, legal or other problems involved." Webster's Third New International Dictionary, p. 2419 (1961).
Appellant had no other expert witness to testify concerning causation or standard of care with respect to use and administration of drugs. A proffer of Mr. Hughes' testimony was offered which, if admitted, would have made a prima facie case. After the proffer, the trial court granted Carter's motion for directed verdict on the grounds that Thompson failed to establish the standard of care by an expert possessing a medical degree.
A.
Was Hughes qualified to testify concerning causation?
In Sonford Products Corp. v. Freels, 495 So.2d 468 (Miss.1986), this Court reversed a circuit judge's order which disallowed a toxicologist from testifying as an expert witness in a workmen's compensation proceeding. Because he was not a medical doctor or a licensed physician, the toxicologist was not allowed to testify concerning the "medical causation" between the decedent's employment and his fatal condition.
The key to the Sonford decision was the Court's recognition that " 'medical causation' is no more than causation in fact." Id. at 472. The Court held further:
It is this Court's opinion that Dr. Ver-langieri is qualified to give an opinion regarding such "cause in fact" and should not be disqualified from testifying because his degree is a Ph.D. instead of an M.D. The Commission's inquiry should be whether the witness is in fact qualified — by knowledge, skill, experience, training or education — not by what degree he holds. It is certain and probable that Ph.D. biochemists and toxicologists are at least equally competent to testify as to the cause and effect of chemicals in our environment as medical doctors.
495 So.2d at 473, see also, Mississippi Farm Bureau Mutual Ins. Co. v. Garrett, 487 So.2d 1320, 1325-27 (Miss.1986).
The Sonford rationale concerning causation would apply equally to the present case. A pharmacologist/toxicologist would be at least equally competent to testify concerning what effect a certain drug would have on the human body.
B.
Was Hughes qualified to testify concerning medical standard of care?
The issue under this question is whether an expert witness, called to establish the standard of care in pharmaceutical litigation for physicians, must possess a medical degree. This Court holds that he does not. What is necessary is that the witness possess medical knowledge, however obtained.
Generally, if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, an expert witness may testify thereto in opinion form or otherwise. Anchor Coatings, Inc. v. Marine Indus. Res. Insul. Inc., 490 So.2d 1210, 1217 (Miss.1986); Hardy v. Brantley, 471 So.2d 358, 366 (Miss.1985); Hall v. Hilbun, 466 So.2d 856, 873 (Miss.1985).
A witness may qualify as an expert based on his knowledge, skill, experience, training, education, or a combination thereof. Qualification as an expert does not necessarily rest upon the educational or professional degree a witness possesses. Sonford, 495 So.2d at 473. Hall v. Hilbun, 466 So.2d at 873. See also, Rule 702, Mississippi Rules of Evidence, effective January 1, 1986. Simply put, before one may testify as an expert, that person must be shown to know a great deal regarding the subject of his testimony. As a pharmacologist/toxicologist, Hughes was an expert in the area in which his testimony was offered. Mississippi Farm Bureau Mut. Ins. Co. v. Garrett, 487 So.2d 1320 (Miss.1986).
Other jurisdictions have held likewise. In Cornfeldt v. Tongen, 262 N.W.2d 684 (Minn.1977) a chief nurse anesthetist was not allowed to provide expert testimony relative to the use of anesthesia because he was not licensed to practice medicine. The Minnesota Supreme Court held the nurse was competent to testify notwithstanding the lack of a medical degree if he otherwise had sufficient scientific and practical experience about the matter to which he would have testified. Id. at 697.
Likewise, in Hudgins v. Serrano, 186 N.J.Super. 465, 453 A.2d 218 (1982), the Court held that a license to practice medicine was not a sine qua non for qualification as an expert witness in a medical malpractice case. The Court held:
We believe, as did the trial judge below, that while a license does indeed import the minimal technical training and knowledge essential to the expression of a meaningful and reliable opinion, that the prerequisite minimal technical training— and perhaps more — may also be gained otherwise and demonstrated as here.
Id. 453 A.2d at 223. See also, Smith v. St. Therese Hospital, 106 Ill.App.3d 268, 62 Ill.Dec. 141, 435 N.E.2d 939 (1982); Mellies v. National Heritage, Inc., 6 Kan.App.2d 910, 636 P.2d 215 (1981).
The instant record reflects that Michael P. Hughes, who taught medical students and advised and counseled physicians as to drug use and administration, through his skill, knowledge, training, and education, knew the standard of care to which physicians adhered when prescribing Bactrim. Therefore, this Court holds that he was qualified to deliver expert testimony, notwithstanding his lack of a medical degree, on the issue of a physician's standard of care in the use and administration of this drug.
This is not to say that every pharmacologist or toxicologist is qualified to testify as an expert to establish the physicians' standard of care. Only if the witness possesses scientific, technical or specialized knowledge on a particular topic will he qualify as an expert on that topic. This witness qualified as an expert and should have been permitted to testify as to a physician's standard of care in issue here.
V.
The proffer of Hughes' testimony suggested that Hughes, had he been permitted to testify, would have opined a departure from the standard of care in the use and administration of drugs in the following respects:
[That] the Defendant departed from the standard of care as established by recognized pharmacological literature in prescribing Bactrim to the Plaintiff; . that the Defendant violated the standard of care because Bactrim was not the drug of choice to treat acute pyelonephri-tis and in fact that said drug was contraindicated; . that after prescribing Bactrim though contraindicated, the Defendant should have conducted various urine test to determine whether there were crystals of the sulfur developing in her urine, whether her kidneys were properly functioning and the level of protein and sugar in the urine; . that the administration of Bactrim and the failure of the Defendant to properly monitor Plaintiff's condition after the administration of same were approximately contributing causes of the onset of the Stevens-Johnson syndrome....
Because Ms. Thompson was unable to produce an expert witness with a medical degree to establish the standard of care for physicians prescribing Bactrim, the trial judge directed a verdict in favor of Dr. Carter. This Court has now determined that the trial judge should have admitted the package insert into evidence and should have admitted the expert testimony of Hughes. Had this additional evidence been admitted in the complainant's proof, a pri-ma facie case would have been met sufficient to have withstood a motion for directed verdict.
For failure to admit the package insert, properly identified, and the exclusion of the expert testimony of Hughes, the case must be remanded for a new trial. Hardy v. Brantley, 471 So.2d 358, 373-74 (Miss.1985); Hall v. Hilbun, 466 So.2d 856, 880 (Miss.1985).
REVERSED AND REMANDED FOR A NEW TRIAL.
HAWKINS, P.J., and ROBERTSON, SULLIVAN and ANDERSON, JJ., concur.
WALKER, C.J., ROY NOBLE LEE and DAN M. LEE, P.JJ., and GRIFFIN, J., dissent.
. Dr. Carter contends Thompson's return appointment was March 3, 1976, but Thompson contends the return appointment was March 5, 1976.
. Marden G. Dixon and Frank C. Woodside, Drug Product Liability, Vol. 1: The Physicians Responsibility and Liability. (New York: Matthew Bender & Company, 1987), pp. 7-6, 7-7.
. Ibid. pp. 7-12.