Marder v. GD Searle & Co.

Decision Date19 March 1986
Docket NumberCiv. No. Y-82-3506,Y-83-3735,Y-84-4569,Y-84-3958,Y-83-864,Y-83-1144,Y-84-4504,Y-84-2770,Y-84-286,Y-83-3370,Y-84-3779,Y-84-775,Y-84-4599 and Y-84-4691.,Y-83-387,Y-84-2248
Citation630 F. Supp. 1087
CourtU.S. District Court — District of Maryland
PartiesSue Ellen MARDER, et al., Donna J. Guba, et al., Karen Lee Irvin, Louise Lewellen, Shirley Gamble, et al., Nancy Jean Tillery, et al., Jayne Tsuchiyama, Oteria T. Myers, et al., Mary Ann Heininger, Lori Kushner, Deborah Gustafson, et al., Karen M. Buell, et al., Judy Perlov, et al., Robin R. Reeder, Nadine Allen, et al., Susan Eve Roza, et al., v. G.D. SEARLE & CO.

Gertrude C. Bartel, Baltimore, Md., Roger L. Pardieck, Seymour, Ind., and Patricia Jo Stone, Denver, Colo., for plaintiffs.

Paul F. Strain, Nell B. Strachan, Baltimore, Md., and Robert Tucker, Cleveland, Ohio, for defendant.

MEMORANDUM

JOSEPH H. YOUNG, District Judge.

Following a trial on the basic issue of causation, and the failure of the jury to agree on a verdict on that issue, defendant moved for judgment. Plaintiffs also moved to delay entry of a final judgment dismissing their fraud claims pending a new trial, or in the alternative, requested that the dismissal of their fraud claims be without prejudice.

This case arises out of the seventeen plaintiffs' use of the Copper 7 (Cu-7) Intrauterine Device (IUD), manufactured by G.D. Searle Company, Inc. (Searle). Plaintiffs allege three types of injuries: pelvic inflammatory disease (PID), ectopic pregnancy, and perforation of the uterus, and the central issue in the first portion of the trial was whether the Cu-7 can cause these disorders. Additional issues were the adequacy of the manufacturer's warnings, and whether Searle breached an express warranty, fraudulently misrepresented the safety of the Cu-7, or was negligent. In this portion of the trial, there were common legal and factual issues, and the proceedings were consolidated for all plaintiffs.

At the close of plaintiffs' case, Searle moved for a directed verdict. That motion was denied as to all issues except for the fraud claim, for which Searle's motion was granted. Judgment has yet to be formally entered on that ruling. On December 13, 1985, after three weeks of trial, the case was submitted to the jury which failed to agree on a verdict. The Court declared a mistrial, and defendant now moves for judgment in its favor.

Motion for Judgment

Defendant's motion for judgment in its favor is filed pursuant to Rule 50(b), Fed.R. Civ.P. Searle contends that plaintiffs offered no proof that the Cu-7 caused the types of injuries which plaintiffs allegedly suffered, and insists that epidemiological evidence was required to prove causation of PID.

It is undisputed that it is plaintiff's burden to prove causation, as well as the other basic elements of liability. Plaintiffs insist that they have met their burden of establishing causation by a preponderance of the evidence, by proving that more likely than not the Cu-7 IUD can cause the types of injuries which plaintiffs allegedly suffered. In support of this assertion, they have outlined evidence presented at trial. PID causation evidence was provided primarily by Dr. Haverkamp and Dr. Perlmutter, and was supplemented with testimony from Dr. Fives-Taylor and Dr. Baier describing how the disease could be caused. Plaintiffs also maintain that Dr. Orleans reinterpreted Searles's epidemiological evidence to demonstrate a causal connection and that this epidemiological relationship was supported by testimony of two of defendant's witnesses: Dr. Roy and Dr. Daling. Dr. Haverkamp, plaintiffs' chief causation witness, also presented all of the evidence on causation of ectopic (or tubal) pregnancy, and he presented some of the evidence on causation of perforation of the uterus. Drs. Hatcher and Baier, as well as defendant's witness, Dr. Guzinski, offered additional evidence which plaintiffs rely upon to prove causation of perforation of the uterus.

Standard for Rule 50(b) Motions

Although Maryland law applies to the substantive issues, the allocation of trial functions between judge and jury is governed by federal law in a diversity action. Peacock v. J.C. Penney Co., Inc., 764 F.2d 1012, 1013 (4th Cir.1985); Wratchford v. S.J. Groves & Sons Co., 405 F.2d 1061 (4th Cir.1969). Because the jury failed to agree upon a verdict, defendant's motion bears a resemblance to both a motion for a directed verdict and to a judgment notwithstanding the verdict. But there is no need to distinguish between the two because the standard is identical for both motions. Whalen v. Roanoke County Board of Supervisors, et al., 769 F.2d 221, 227 (4th Cir.1985) (concurring opinion); Hawkins v. Sims, 137 F.2d 66, 67 (4th Cir.1943). After viewing the evidence in the light most favorable to the nonmoving party, judgment should be entered notwithstanding the jury's failure to reach a verdict if insufficient evidence was presented to support a verdict for the nonmoving party. Whalen v. Roanoke, 769 F.2d at 224; Gairola v. Commonwealth of Virginia Department of General Services, 753 F.2d 1281, 1285 (4th Cir.1985); Ralston Purina Co. v. Edmunds, 241 F.2d 164, 167 (4th Cir.1957), cert. denied, 353 U.S. 974, 77 S.Ct. 1059, 1 L.Ed.2d 1136 (1957). The issue can be removed from the jury if evidence provides a "mere possibility" yet not a "probability" of proof. Mayberry v. Dees, 663 F.2d 502, 510 (4th Cir.1981), cert. denied, 459 U.S. 830, 103 S.Ct. 69, 74 L.Ed.2d 69 (1982).

The Fourth Circuit has emphasized that special care should be taken when assessing the sufficiency of causation evidence, where causation evidence is wholly circumstantial. It is particularly important to be assured that an inference of causation is based upon at least a reasonable probability of causation, in an effort to remove purely conjectural and speculative questions from the jury. Lovelace v. Sherwin-Williams, 681 F.2d 230, 242 (4th Cir. 1982). Accord, Lohrmann v. Pittsburgh Corning Corp., et al., 782 F.2d 1156 (4th Cir.1986).

This emphasis, where causation is dispositive, upon "probability," "reasonable probability," "substantial probability" rather than mere "possibility" as the proper test simply bespeaks the special danger that in a matter so generally incapable of certain proof jury decision will be on the basis of sheer speculation, ultimately tipped, in view of the impossibility of choosing rationally between mere "possibilities," by impermissible but understandable resort to such factors as sympathy and the like. It is of course precisely to guard against this danger that the burden of producing rationally probative evidence—and the corresponding risk of nonproduction—is placed upon claimants and subjected to the ultimate jury control devices of directed verdict and judgment n.o.v.

Lovelace v. Sherwin-Williams, 681 F.2d at 242 (citations omitted). In order to determine the sufficiency of the causation evidence presented in the instant case, an analysis of the evidence proffered through each of plaintiff's witnesses in support of a conclusion that the Cu-7 can cause PID, ectopic pregnancy, and perforation of the uterus, must be undertaken.

Evidence of Causation
(a) Dr. Haverkamp

Plaintiffs' primary witness on the issue of causation of all three types of injuries was Dr. Haverkamp, who was proffered as an expert in obstetrics and gynecology. Dr. Haverkamp offered a theory about PID causation. Based on his observation that the IUD causes increased bleeding, he speculated that such bleeding breaks the protective barrier that normally prevents bacteria from infecting the uterus. He also speculated that with a broken barrier the bacteria would reach the uterus through a "capillary action" of the tail string of the Cu-7. The doctor's major complaint with the increased bleeding, however, seemed to be that it obscured the symptoms of PID, making diagnosis of the disease more difficult.

When asked pointedly whether use of the Cu-7 was causally related to the development of PID, Dr. Haverkamp's answer was carefully guarded and limited; he responded that the Cu-7 is "definitely related" to the development of PID but omitted any mention of causation. Dr. Haverkamp had not personally performed studies on the matter but based his opinion on his clinical experience and literature. At one point, Dr. Haverkamp stated that there is a three to five-fold increased rate of PID in women wearing IUD's, and the basis of his opinion was a study conducted by Dr. Ory which was completed in 1976. On cross-exam, it became clear that approximately 38% of the participants in Dr. Ory's study were wearers of the Dalkon Shield IUD, that the Dalkon Shield is associated with approximately a six-fold increase in PID, and therefore, that the study results were skewed by the dominant presence of the Dalkon Shield. Only one participant in Dr. Ory's study used a Cu-7 IUD, and that patient did not develop PID. Thus, Dr. Ory's study did not yield reliable evidence on the Cu-7 and could not furnish a reasonable foundation for Dr. Haverkamp's testimony.

Viewing Dr. Haverkamp's testimony in its entirety, the assertions of causation of PID were limited to professed relationships or associations between the IUD and the disease. The foundation for the testimony about that relationship was virtually nonexistent; it was not backed by sound scientific evidence that was related specifically to the Cu-7 or IUD's which were comparable to the Cu-7. The explanation of causation was equally speculative, based upon an untested theory that increased bleeding allows the introduction of bacteria. Had such theories been supported then a question for the jury would remain as to their probative value, but mere theory is too far removed from the type of proof required at trial to support a finding of causation. Theory must at least be consistent with supporting evidence to raise a jury question.

Dr. Haverkamp's testimony on ectopic...

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