McNeil Pharmaceutical v. Hawkins

• Decision Date: 23 December 1996
• Docket Number: 94-CV-1396.,No. 94-CV-1346,94-CV-1346
• Citation: 686 A.2d 567
• Parties: McNEIL PHARMACEUTICAL, Appellant/Cross-Appellee, v. Delores HAWKINS, Appellee/Cross-Appellant.
• Court: D.C. Court of Appeals

686 A.2d 567

McNEIL PHARMACEUTICAL, Appellant/Cross-Appellee, v. Delores HAWKINS, Appellee/Cross-Appellant.

Nos. 94-CV-1346, 94-CV-1396.

District of Columbia Court of Appeals.

Argued November 28, 1995.

Decided December 23, 1996.

Richard A. Dean, Washington, DC, with whom Theodore B. Van Itallie, Jr. was on the brief, for appellant/cross-appellee.

David T. Smorodin, with whom Allen T. Eaton, Washington, DC, and Frank M. McClellan, Philadelphia, PA, were on the brief, for appellee/cross-appellant.

Bruce N. Kuhlik, Jennifer A. Johnson and Marjorie E. Powell, Washington, DC, filed a brief on behalf of Pharmaceutical Research and Manufacturers of America as amicus curiae.

Before WAGNER, Chief Judge, and STEADMAN and KING, Associate Judges.

KING, Associate Judge:

Three months after first ingesting a drug prescribed for muscle stiffness, Elva Mae Gilliam suffered severe liver failure and died. This is an appeal in a products liability action filed by Delores Hawkins on behalf of the estate of Gilliam against McNeil Pharmaceutical ("McNeil") alleging that its drug product, Parafon Forte DSC (containing the drug generically known as chlorzoxazone), caused the liver failure and death of Gilliam, Delores Hawkins's mother. A jury awarded Gilliam's estate $1.5 million in compensatory and $2.5 million in punitive damages. McNeil appeals the judgment against it arguing that it is entitled to a reversal of the trial court order denying its motion for judgment as a matter of law, or in the alternative, a new trial, and contending that there was insufficient evidence to allow Hawkins's claims to be submitted to the jury. In her cross-appeal, Hawkins contends that the trial court erred in excluding, in the punitive damages phase, evidence concerning two of McNeil's other drug products and in instructing the jury that punitive damages must bear a reasonable relationship to actual damages. We reverse in McNeil's appeal and remand with instructions to enter judgment for McNeil. We dismiss Hawkins's cross-appeal as moot.

I. Background

In March of 1990, Mrs. Gilliam consulted Dr. Arthur Burgerman for treatment for numbness and stiffness in her hands. Dr. Burgerman prescribed Gilliam Parafon Forte DSC, a skeletal muscle relaxant containing chlorzoxazone.¹ Approximately three months later, on June 9, 1990, Gilliam died from liver failure.

In July of 1991, Hawkins filed this action against McNeil, the manufacturer of Parafon Forte DSC.² Hawkins claimed, inter alia, that McNeil was negligent per se, based on violations of a federal criminal statute prohibiting false statements to the government, and numerous provisions of the Food Drug & Cosmetics Act ("FD & C Act") and Food and Drug Administration ("FDA") regulations. Hawkins also sought recovery based on strict product liability for McNeil's failure to adequately warn of chlorzoxazone's dangers.

After a month-long trial, the case was submitted to the jury on a special verdict form containing two liability questions and a punitive damages question. On June 24, 1993, the jury returned its verdict against McNeil. According to the special verdict form, the jury found liability by a preponderance of the evidence on both liability questions: (1) that "defendant McNeil Pharmaceutical was negligent in that it failed to give proper warning as to the effect or activities of Parafon Forte DSC and that such negligence proximately caused Elva Mae Gilliam's death," ("negligence per se" claim), and (2) that "defendant McNeil Pharmaceutical marketed its drug, Parafon Forte DSC and that said drug was unreasonably dangerous, without proper and adequate warnings and misleading labeling and thereby proximately caused Elva Mae Gilliam's death," ("strict liability" claim). The jury also awarded punitive damages, finding by clear and convincing evidence that "McNeil, through its officers, agents or employees acted or failed to act willfully or out of a reckless disregard for the rights of individuals in Elva Mae Gilliam's situation."³

After the verdict was returned, McNeil filed a renewed motion for judgment as a matter of law, or, in the alternative, for a new trial. See D.C.Super. Ct. Civ. R. 50(b) (1995). Hawkins filed a motion for a new trial limited to the issue of punitive damages. The trial court denied each of the motions, and these appeals followed.

In its appeal, McNeil principally contends that the trial court erred in not entering judgment as a matter of law in its favor on both the negligence per se and the strict liability theories.⁴ Specifically, McNeil argues that the only theory of negligence that was presented was one of per se negligence, which was not supported by the evidence because: (1) the statutes were not appropriate for that purpose; (2) Hawkins did not establish that the statutes were violated; and (3) there was no evidence of proximate causation, because the prescribing physician did not read or rely upon the package insert and did not testify as to how he would have proceeded had he read the insert's warnings. Because the strict liability claim was also based on the alleged violation of statutes and regulations, McNeil contends that the court also erred in denying its motion for judgment as a matter of law on that claim for essentially the same reasons.

II. The trial

A. Hawkins's evidence

Hawkins's theory at trial was that McNeil withheld from the medical community in general, and Dr. Burgerman in particular, true and accurate information about chlorzoxazone's relation to liver damage. In particular, Hawkins claimed that McNeil inadequately labeled its chlorzoxazone-containing products, including Parafon Forte DSC, from 1958 through 1990. As a basis for her negligence per se claim, Hawkins relied on numerous federal statutes and regulations, which she claimed had been violated. To establish that McNeil was untruthful in its labeling of chlorzoxazone, Hawkins placed considerable emphasis on three clinical studies conducted during chlorzoxazone's trial stage of development. In order to set the context of the issues that have been presented, we will review in some detail the labeling information for chlorzoxazone, the clinical studies on the drug's effect on the liver, the statutes and regulations submitted to the jury, and the testimony of Hawkins's and McNeil's witnesses at trial.

1. Labeling

As required by federal law, Parafon Forte DSC was distributed with an FDA-approved label, which sets forth various categories of information about the drug, including its indications, contraindications, warnings, precautions, and adverse reactions. Parafon Forte DSC's 1987 FDA-approved label, which was substantially the same for all of McNeil's chlorzoxazone-containing products, warned of the following:

WARNINGS

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

PRECAUTIONS

PARAFON FORTE DSC chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.

If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

ADVERSE REACTIONS

After more than twenty-six years of extensive clinical use of chlorzoxazone-containing products in an estimated thirty-two million patients, it is apparent that the drug is well tolerated and seldom produces undesirable side effects. Occasional patients may develop gastrointestinal disturbances. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.

Approximately thirty-six patients have been reported in whom the administration of chlorzoxazone-containing products was suspected as being the cause of liver damage. In one case, the jaundice was subsequently considered to be due to a carcinoma of the head of the pancreas rather than to the drug. In a second case, there was no jaundice but an elevated alkaline phosphatase and BSP retention. In this patient there was a malignancy with bony and liver metastases. The role of the drug was difficult to determine. A third and fourth case had cholelithiasis. Diagnosis in a fifth case was submassive hepatic necrosis possibly due to abusive use of the drug for approximately one year. The remaining cases had a clinical picture compatible with either a viral hepatitis or a drug-induced hepatitis. In all these latter cases, the drug was stopped, and with one exception, the patients recovered. It is not possible to state that the hepatitis in these patients was or was not drug-induced.

2. Clinical investigations

a. Dr. Arthur L. Drew

In the mid-1950s, Dr. Arthur L. Drew, Associate Professor of Neurology at the Indiana University Medical Center, began a clinical study assessing the effect of chlorzoxazone on the liver. In September of 1956, Dr. Drew informed a McNeil representative of preliminary results of his study. Dr. Drew reported that after administering chlorzoxazone to fifteen patients who suffered from severe cerebral palsy, fourteen developed a numerical increase in liver function tests: an elevation of cephalin-cholesterol flocculation⁵ and a positive test for bilirubin⁶ in the urine. Two months later, Dr. Drew reported that nine patients remained in the study, and after all were taken off chlorzoxazone for one week, four of the five patients who had notably elevated cephalin cholesterol flocculation had...