Tidler v. Eli Lilly and Co.

• Citation: 851 F.2d 418,271 U.S.App.D.C. 163
• Decision Date: 12 July 1988
• Docket Number: No. 85-5981,85-5981
• Parties: , 57 USLW 2044, Prod.Liab.Rep.(CCH)P 11,855 Suzanne E. TIDLER, et al., Appellants, and Helene Mankowitz, et al. v. ELI LILLY AND COMPANY.
• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)

Page 418

851 F.2d 418 271 U.S.App.D.C. 163, 57 USLW 2044,
Prod.Liab.Rep.(CCH)P 11,855 Suzanne E. TIDLER, et al., Appellants,
and
Helene Mankowitz, et al.
v.
ELI LILLY AND COMPANY. No. 85-5981. United States Court of Appeals,
District of Columbia Circuit. Argued March 4, 1988.
Decided July 12, 1988.

Aaron M. Levine, Washington, D.C., for appellants.

Kenneth Cohen, with whom James A. Hourihan, Washington, D.C., was on the brief, for appellees. Gail L. Heriot, Washington, D.C., also entered an appearance for appellees.

Before RUTH BADER GINSBURG, BUCKLEY and D.H. GINSBURG, Circuit Judges.

Opinion for the Court filed by Circuit Judge D.H. GINSBURG.

D.H. GINSBURG, Circuit Judge:

Plaintiffs are seven of the many so-called "DES daughters" who have sued various drug companies, alleging that they suffer from malformations of their reproductive tracts because they were exposed, in utero, to DES, which was prescribed for their mothers in order to prevent miscarriages. Appellee is Eli Lilly and Co., the only one of nine original defendants that plaintiffs did not voluntarily dismiss. Plaintiffs, who are residents of Maryland and of the District of Columbia, invoked the diversity jurisdiction of the District Court. That court granted Lilly's motion for summary judgment

Page 420

because it determined that the plaintiffs had no competent evidence that the defendant manufactured the DES ingested by their mothers, and under the laws of both the District of Columbia and of Maryland, plaintiffs cannot recover without proof that the defendant proximately caused their injuries. Plaintiffs brought this appeal and thereafter also moved this court to refer controlling questions of law to the highest court in each of those jurisdictions. We deny that motion and affirm the judgment of the District Court.

I. BACKGROUND

In 1938, British researcher Dr. E.C. Dodds developed a synthetic form of the female hormone estrogen, the drug diethylstilbestrol, or DES. Estrogen is essential to a female's sexual development and to her ability to carry a pregnancy to term. Unlike its natural counterpart, however, DES is relatively inexpensive to produce and is effective in oral doses. Dodds' research was accordingly regarded as a revolutionary breakthrough in biomedical science.

Dr. Dodds did not, however, patent DES. A dozen American pharmaceutical houses, including Lilly, submitted New Drug Applications (NDAs) to the Food and Drug Administration, proposing to market DES for a variety of medical conditions not involving pregnancy.

Because of the large number of NDAs, the FDA ordered all applicants to pool their supporting data in a single file. The applicants then formed a committee (the "Small Committee"), composing representatives of four companies, including Lilly, to collate and submit the various clinical studies. The FDA thereafter analyzed and supplemented the companies' submission, and determined that DES was safe in the uses for which they proposed to market it. The Small Committee was dissolved. In 1941, the FDA approved the individual companies' initial NDAs, under which DES has been marketed ever since for a variety of indications not occurring in pregnant women.

By 1947, researchers discovered a link between miscarriages and a deficiency of natural estrogen in pregnant women, which could be corrected either by injection with natural estrogen or by oral administration of DES. In 1947, the FDA approved the applications of several drug manufacturers, including Lilly, to market DES as a miscarriage preventative. After the FDA determined in 1952 that DES was no longer a "new drug" within the meaning of the Food and Drug Act, and thus, did not require further agency approval for any company to market it for use in recognized indications and in recognized dosages, hundreds of manufacturers entered the market.

DES was widely prescribed for use by pregnant women in the 1950's and 1960's. In 1971, however, when medical researchers discovered a rare form of vaginal cancer in some young women who had been exposed to DES while in utero, the FDA disapproved its continued marketing for use by pregnant women.

This case was filed in the district court in 1980 by 21 women, each of whom alleged that the various noncancerous injuries from which she suffers are attributable to her mother's ingestion of DES. Most of the original plaintiffs voluntarily withdrew their complaints, and of the nine major drug companies originally named as defendants, the remaining plaintiffs dismissed all but Lilly. On motion, the district court granted summary judgment in favor of Lilly against eight of the nine remaining plaintiffs who could not produce competent evidence that Lilly manufactured the DES that allegedly caused their injuries. Seven of those eight have pursued this appeal.

II. PLAINTIFFS' THEORIES OF LIABILITY AND THE DISTRICT

COURT'S DISPOSITION

The district court did not decide which jurisdiction's law governed appellants' claims. The court made no findings indicating the jurisdiction in which either their mothers were resident when they took DES or where the plaintiffs' injuries occurred. Instead, because it was exercising its diversity

Page 421

jurisdiction, and because all the plaintiffs are residents of either Maryland or of the District of Columbia, the court analyzed the plaintiffs' claims under the laws of both jurisdictions. Tidler v. Eli Lilly & Co., C.A. No. 80-2795, Mem.Op. at 19 n. 2 (D.D.C. Aug. 23, 1985). As neither party has argued that the law of a jurisdiction other than the District of Columbia or Maryland applies, we join the district court in assuming that the law of one or both of these jurisdictions is applicable to this case.

The seven appellants concede that, after consulting parents and their physicians and pharmacists, they are unable to identify the firm that manufactured the DES product to which they were allegedly exposed. Plaintiffs, therefore, cannot adduce evidence from which a jury could reasonably conclude that Lilly's product proximately caused their injuries. Because they lack an essential element of a traditional products liability claim, see generally Prosser, The Fall of the Citadel (Strict Liability to the Consumer ), 50 MINN.L.REV. 791, 840-48 (1966), they urged the district court, and now urge this court, to adopt any one or more of several so-called "non-identification" theories of liability that have been allowed in DES cases in a few states. Alternatively, the plaintiffs argue that liability may be predicated on a "bulk supply" theory, holding Lilly responsible as the manufacturer of DES powder later tabletized by an unidentified intermediary in the chain of production.

Plaintiffs' first theory of liability is an extension of the "concert of action theory," under which

those who, in pursuance of a common plan or design to commit a tortious act, actively take part in it, or further it by cooperation or request, or who lend aid or encouragement to the wrongdoer, or ratify and adopt the wrongdoer's acts done for their benefit, are equally liable.

PROSSER and KEETON on TORTS, Sec. 46, at 323 (5th ed. 1984) (footnotes omitted). Of course, the premise for liability under this head is that the defendant, either expressly or tacitly, agreed with another to pursue "a common plan or design to commit a tortious act," see id., which plaintiffs cannot show in this case.

Under the plaintiffs' extension of this theory, however, recovery could be predicated upon either "conscious parallelism" among manufacturers--for example, in negligently failing to test DES--or upon independent actions of the defendant "ha[ving] the effect of substantially aiding or encouraging" negligent or intentionally tortious activity on the part of others. In Bichler v. Eli Lilly & Co., 79 A.D.2d 317, 436 N.Y.S.2d 625, 631 (1981), aff'd on other grounds, 55 N.Y.2d 571, 436 N.E.2d 182, 450 N.Y.S.2d 776 (1982), a DES case was sent to the jury on this basis.

The district court rejected the theory, holding that "Bichler would not be applied in the District of Columbia or Maryland, because these jurisdictions retain the requirement of an agreement ... which the facts surrounding the marketing of DES as a miscarriage preventive [sic] do not support." See Stevens v. Hall, 391 A.2d 792, 795 (D.C.1978); Walker v. Hall, 34 Md.App. 571, 369 A.2d 105, 112 (1977).

Plaintiffs' second theory, commonly referred to as "market share" liability, requires only that they prove that their injuries were caused by a defective or unreasonably dangerous product, and that they join enough manufacturers as defendants to ensure that those that produced a "substantial share" of the relevant product market are present before the court. Each defendant is then presumed to be liable for damages in accordance with its respective share of the product market, and in order to avoid judgment must introduce evidence tending to prove that its product could not have caused the plaintiff's injuries. Thus, plaintiffs are completely relieved of the burden of establishing some causal connection between their injuries and the actions of any particular manufacturer. As stated by the California Supreme Court, which accepted the theory in a DES case, its premise is that "as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury." Sindell v. Abbott Laboratories, 26 Cal.3d 588, 607 P.2d 924, 936, 163 Cal.Rptr. 132

Page 422

(1980); accord George v. Parke-Davis, 107 Wash.2d 584, 733 P.2d 507 (1987).

The district court questioned whether this theory had been properly presented by the plaintiffs. Noting, however, that Sindell "is inconsistent with traditional principles of comparative negligence, which require that the defendant be causally connected with the actionable allegations, before he is liable," the court held that "Sindell will not be applied in the District of Columbia and Maryland, which require proof of causation."...