Ellis v. International Playtex, Inc.

• Decision Date: 25 September 1984
• Docket Number: No. 83-1275,83-1275
• Citation: 745 F.2d 292
• Parties: , 16 Fed. R. Evid. Serv. 561 Jefferey Dale ELLIS, Administrator of the Estate of Margaret Ann Ellis, deceased, Appellant, v. INTERNATIONAL PLAYTEX, INC., a Delaware Corporation, Appellee.
• Court: U.S. Court of Appeals — Fourth Circuit

Page 292

745 F.2d 292

53 USLW 2202, 16 Fed. R. Evid. Serv. 561

Jefferey Dale ELLIS, Administrator of the Estate of Margaret Ann Ellis, deceased, Appellant, v. INTERNATIONAL PLAYTEX, INC., a Delaware Corporation, Appellee.

No. 83-1275.

United States Court of Appeals Fourth Circuit.

Argued Dec. 8, 1983.

Decided Sept. 25, 1984.

Henry E. Howell, Jr., Henry E. Howell, III, Norfolk, Va. (Howell, Anninos, Daugherty, Brown & Lawrence, Norfolk, Va., on brief), for appellant.

William H. Robinson, Jr., Richmond, Va. (Lucie Adele Baker, McGuire, Woods & Battle, Richmond, Va., Charles M. McCaghey, Glenn J. Pogust, Olwine, Connelly, Chase, O'Donnell & Weyher, New York City, on brief), for appellee.

Before RUSSELL and ERVIN, Circuit Judges, and BUTZNER, Senior Circuit Judge.

ERVIN, Circuit Judge.

Jefferey Dale Ellis, administrator of the estate of his wife, Margaret Ann Ellis, appeals from the district court's denial of a motion for a new trial. Margaret Ellis, a user of Playtex tampons, died unexpectedly in May of 1981. Convinced his wife had died from toxic shock syndrome (TSS), and that the TSS had been induced by a Playtex Super Deodorant tampon, Jefferey Ellis brought a wrongful death action against Playtex International, Inc. After a full trial the jury found for Playtex. Ellis immediately moved for a new trial on the grounds that the verdict was not supported by the weight of the evidence and that certain critical exhibits had been improperly excluded. His motion was denied.

On appeal, Ellis argues that the district court committed a variety of reversible errors during the course of the trial. Specifically, Ellis contends that (1) the court applied the wrong standard in determining whether the jury's verdict was supported by the clear weight of the evidence; (2) the court erred in refusing to admit Toxic Shock Syndrome Studies carried out by the Center for Disease Control (CDC) and various state health departments; (3) the court improperly excluded a list of complaints received by Playtex from users of Playtex tampons; (4) the court erred in failing to permit the plaintiff's experts to read from a medical treatise; and (5) the court tendered an incorrect charge to the jury on the defendant's duty to warn.

We conclude that the CDC and state TSS studies were improperly excluded from evidence. Because we believe that the studies may have played a critical role in the outcome of the trial, we reverse the judgment of the lower court and remand for a new trial.

I.

On Friday, May 22, 1981, Margaret Ellis informed her husband that her menstrual period had begun and asked him to purchase a box of tampons for her at a local store. Jefferey Ellis complied with her request and promptly returned home with a package of Playtex Super Deodorant tampons.

Three days later, on Monday, May 25, 1981, Mrs. Ellis announced that she was not feeling well and took to her bed. The following day she remained in bed, complaining of a sore throat, aches, and a fever. Later that day Mrs. Ellis asked her son to run an errand for her at a local store. When he returned he discovered that his mother had collapsed on the bathroom floor. A rescue squad was summoned and Mrs. Ellis was immediately hospitalized. Early Wednesday morning Mrs. Ellis died.

At trial, Ellis advanced two theories of liability. The first alleged that Mrs. Ellis' death was proximately caused by the negligence of Playtex. The second claimed that Playtex breached an implied warranty of merchantability by manufacturing and marketing a dangerous product. In order to prevail under the implied warranty theory, Ellis had to prove that (1) Mrs. Ellis had TSS; (2) TSS is causally related to tampon use; and (3) the Playtex tampon used in this case was responsible for the toxic infection. To prevail on the negligence theory, the plaintiff had to prove, in addition to these first three elements, that Playtex knew of the dangers associated with tampon use and failed to provide an adequate warning to consumers.

The first factual issue--the presence of TSS--was hotly contested. Expert medical witnesses on both sides offered conflicting theories to explain Mrs. Ellis' sudden death. All five of the doctors who examined and treated Mrs. Ellis testified that she died from a heart attack that had been induced by toxic shock syndrome. They noted that high levels of toxins had been found in several of Mrs. Ellis' major organ systems, and that the damage to her heart resembled that found in other toxic shock cases. They also noted that there was no evidence of pre-existing heart disease. Each of the five doctors concluded that the most likely source of the toxins was the Playtex tampon that Mrs. Ellis had been using before she became ill.

Playtex, on the other hand, offered medical testimony by three physicians who concluded that it was Mrs. Ellis' unique susceptibility to heart trouble, and not TSS, that caused her death. These doctors pointed out that Mrs. Ellis did not exhibit several symptoms commonly associated with toxic shock syndrome and that staphylococcus aureus--the bacteria many experts believe has been responsible for toxin production in TSS-related cases--was not found in her vagina. Moreover, these experts noted that Mrs. Ellis had suffered a series of fainting spells in the past. In their view, therefore, it was more likely that the cardiac arrest was related to a fainting spell than to TSS.

The second issue--causation--was also strenuously contested at trial. To support its position the plaintiffs sought to introduce two epidemiological studies authored by the Federal Center for Disease Control in Atlanta (CDC) and an epidemiological study supervised by the Wisconsin, Minnesota, and Iowa state health departments (Tri-State Commission). These studies indicated that a statistically significant link existed between tampon use and TSS. The CDC data was particularly helpful to the plaintiff because it revealed that the more absorbent tampons, like the Playtex deodorant tampon used by Mrs. Ellis, had a higher statistical correlation with TSS than the less absorbent tampons. Furthermore, the CDC data revealed that most TSS cases began on the second day of the victim's menstrual cycle--the same day Mrs. Ellis' illness began.

The court, however, refused to admit the studies and data into evidence on the ground that they constituted hearsay. The court reasoned that there was insufficient foundation testimony about the methodology used in the studies to "secure for the reported information some essence of reliability or trustworthiness." J.A. at 6-7.

Like the causation issue, the failure to warn issue was also heavily disputed at trial. Playtex maintained that it had made every effort to warn consumers through newspaper, magazine, and television advertisements as soon as it learned of the potential TSS risk in 1980. Playtex also argued that an explanatory warning had been placed on all boxes of Playtex Super Deodorant Tampons produced after November, 1980, and on store shelves. Ellis testified, however, that he had not seen a warning when he purchased the tampons, and he offered into evidence a Playtex tampon box, purchased in January 1982, that did not contain a warning or explanation of any kind. Ellis also sought to admit records of consumer complaints received by Playtex from Playtex tampon users. The records purported to reveal the types of injuries that users were experiencing. Ellis offered the records to indicate the types of risks Playtex either was aware of or should have foreseen and included in a warning.

As with the CDC and Tri-State reports, the court refused to admit the Playtex records into evidence. The court reasoned that because the "truth or falsity" of the consumer complaints was not in issue, the records need not be actually admitted into evidence as long as the jury was informed that complaints had been received.

At the end of a full trial the jury returned a verdict for Playtex. Shortly thereafter Ellis' motion for a new trial was denied.

II.

We address first Ellis' contention that the district court applied the wrong standard in reviewing the verdict. It is well established in this circuit that a trial judge must employ two different legal standards when considering a motion for a directed verdict and a motion for a new trial. A motion for a directed verdict does not require the court to weigh the plaintiff's evidence against that offered by the defendant. Rather, the court's sole duty is to examine the sufficiency of the evidence tendered by the party opposing the motion. If the evidence is sufficient, the judge should not direct the verdict. The court, however, need not examine the evidence tendered by the party seeking a directed verdict.

A motion for a new trial, on the other hand, involves a "comparison of opposing proofs." William v. Nichols, 266 F.2d 389, 393 (4th Cir.1959). The district court may set aside a verdict supported by substantial evidence if "it is contrary to the clear weight of the evidence, or is based upon evidence which is false," or is "necessary to prevent a miscarriage of justice." Aetna Casualty v. Yeatts, 122 F.2d 350, 354 (4th Cir.1941).

The distinction between this standard and that of a directed verdict was succinctly summarized in Garrison v. United States, 62 F.2d 41 (4th Cir.1932), in which we stated:

'Where there is substantial evidence in support of plaintiff's case, the judge may not direct a verdict against him, even though he may not believe his evidence or may think that the weight of the evidence is on the other side; for, under the constitutional guaranty of trial by jury, it is for the jury to weigh the evidence and pass upon its credibility. He may, however, set aside a verdict supported by substantial evidence where in his opinion it is contrary to the clear weight of the evidence, or is based upon evidence which is false; for, even though the evidence be sufficient to preclude the direction of a...