Collins v. Eli Lilly Co.

Decision Date27 February 1984
Docket NumberNo. 82-1844,82-1844
Citation116 Wis.2d 166,342 N.W.2d 37
PartiesTherese Marie COLLINS, now known as Therese Marie Gastrow, Plaintiff-Appellant, v. ELI LILLY COMPANY; Rexall Drug Company; E.R. Squibb and Sons, Inc.; Abbott Laboratories; Boyle and Company; Cooper Laboratories, Inc. (formerly Brewer and Company, Inc., and Sherman Laboratories); Vale Chemical Company, Inc.; Upjohn Company, Cole Pharmacal Company; McNeil Laboratories, Inc.; Carnrick Laboratories, a division of G.W. Carnrick Company; Emons Industries, Inc. (formerly Amfre-Grant and Grant Chemical Company); E.S. Miller Laboratories, a division of Smith, Miller & Patch Products; Premo Pharmaceutical Laboratories, Inc.; Kremers-Urban Company; Merck, Sharp & Dohme; William A. Webster Company; and others, Defendants-Respondents.
CourtWisconsin Supreme Court

Thomas H. Bleakley, Detroit, Mich., argued, for plaintiff-appellant; Richard J. Dimanin and Thomas H. Bleakley, P.C., Detroit, Mich., and Gerald J. Bloch and Phillips, Bloch & Donohue, S.C., Milwaukee, on briefs.

There was a joint brief by Richard C. Ninneman and Whyte & Hirschboeck, S.C., Milwaukee, and Hugh L. Moore (argued), and Lord, Bissell and Brook, Chicago, Ill., for Abbott Laboratories, and on behalf of Harold A. Dall, Joseph J. Ferris and Kasdorf, Dall, Lewis & Swietlik, S.C., Milwaukee, Lane D. Bauer (argued), Leo P. Dreyer, Laura D. Stith and Shook, Hardy & Bacon, Kansas City, Mo., for Eli Lilly and Co.

Hanlin Hayes, Milwaukee, for E.R. Squibb and Sons, Inc., and Boyle and Co.

Irving W. Zirbel, Milwaukee, for Upjohn Co.

Robert W. Connell, Milwaukee, for Cooper Laboratories and E.S. Miller Laboratories.

William F. Reilly, Waukesha, for Vale Chemical Co., Cole Pharmacal Co. and Carnrick Laboratories, Inc.

Carl N. Otjen, Milwaukee, for Rexall Drug Co.

Edmund W. Powell, Milwaukee, for Kremers-Urban Co. and McNeil Laboratories, Inc.

Donald H. Carlson, Milwaukee, for Premo Pharmaceutical Laboratories, Inc.

John A. Kluwin, Milwaukee, for Merck, Sharp & Dohme.

Robert A. DuPuy, Milwaukee, for Emons Industries, Inc.

CALLOW, Justice.

This is an appeal from a judgment and an order of the circuit court for Milwaukee County, Judge Marvin C. Holz, granting summary judgment for the defendant drug companies and denying the plaintiff's motion to amend her second amended complaint to identify as a sole defendant Eli Lilly and Company. The plaintiff appealed and petitioned to bypass the court of appeals pursuant to sec. 808.05 and sec. (Rule) 809.60, Stats. We granted the petition to bypass. We reverse in part and affirm in part the judgment of the trial court granting summary judgment for the defendants, and we remand the case for further proceedings. We affirm the order of the trial court denying the plaintiff's motion to amend her second amended complaint.

The issues presented on appeal are whether the trial court erred in granting summary judgment for the defendants based upon its conclusion that no Wisconsin rule of law would permit the plaintiff to recover for her injuries stemming from her mother's ingestion of the drug diethylstilbestrol (DES), and whether the trial court erred in not permitting the plaintiff to amend her second amended complaint to name a single drug company, Eli Lilly and Company, as defendant. 1

In 1957 Mrs. Roseann Collins became pregnant with Therese Marie Collins, the plaintiff in this case. Because Mrs. Collins was having problems with spotting in the early stages of her pregnancy, she consulted her physician, Dr. William P. Wendt. Sometime in the course of his treatment of Mrs. Collins, Dr. Wendt prescribed DES, which he told her would prevent a miscarriage. Mrs. Collins took DES throughout her pregnancy. Mrs. Collins could not recall where she purchased the DES but did recall, without being certain, that "it was a little white [uncoated] pill ... smaller than an aspirin." Information adduced in the course of discovery revealed that the DES Mrs. Collins took was in the form of 25 milligram pills. The plaintiff was born March 11, 1958, in Milwaukee.

In June or July, 1975, the plaintiff began to experience longer than normal menstrual periods accompanied by severe cramping. On July 24, 1975, Mrs. Collins took the plaintiff to consult Dr. Wendt. During the examination Dr. Wendt discovered a visible lesion in the plaintiff's vagina. Dr. Wendt referred the plaintiff to Dr. William Fetherston for further diagnosis. After examining the plaintiff, Dr. Fetherston concluded that she was suffering from a full cell cancer of the vagina. On August 26, 1975, Dr. Fetherston performed surgery on the plaintiff, removing her uterus, part of her vagina, and a number of lymph nodes. Subsequent analysis by Dr. David Carlson, a pathologist at St. Mary's Hospital in Milwaukee, confirmed that the plaintiff had adenocarcinoma of the vagina and benign adenosis of the vagina. Subsequent to the surgery, the plaintiff discovered that her bladder had ceased functioning because of the radical cancer surgery.

On January 6, 1977, the plaintiff filed suit against twelve drug companies which allegedly produced or marketed DES. On November 21, 1977, Judge William R. Moser granted defendants Lilly, Rexall, Squibb, and Abbott's motion to dismiss on the grounds of improper service. On February 28, 1978, the plaintiff filed a second amended complaint, naming five additional drug companies as defendants, and this time effectuated proper service on all defendants.

The plaintiff's second amended complaint alleged five causes of action: that the defendants were negligent in producing and marketing DES for use by pregnant women; that the defendants were strictly liable because DES was a defective and unreasonably dangerous product; that the defendants misrepresented that DES was safe and efficacious for use by pregnant women; that the defendants conspired to misrepresent that DES was safe and efficacious for use by pregnant women; that the defendants acted as a class in manufacturing and marketing DES. 2 The plaintiff demanded $3 million in compensatory damages, together with $3 million in punitive damages.

On May 26, 1981, the defendants jointly moved the court, pursuant to sec. 802.08, Stats., for summary judgment in their favor alleging that there was no genuine issue as to any material fact and that Wisconsin law provided no remedy for the plaintiff based upon the factual record. The defendants also individually moved for summary judgment, variously alleging that the statute of limitations barred recovery, that the defendant drug company had not manufactured or marketed DES in the relevant form, time period, or geographical area, or that the plaintiff's theory of recovery was not recognized under current law.

On April 23, 1982, Judge Marvin C. Holz rendered a memorandum decision on the defendants' joint summary judgment motion. The court granted the motion for summary judgment after examining various theories proposed by the plaintiff to avoid the problem of the plaintiff's inability to identify which defendant drug company produced or marketed the DES taken by her mother. The court concluded that all the theories would necessitate a radical departure from current law, and that if such a departure were appropriate, it should be decided by this court. Accordingly, on September 16, 1982, the trial court entered judgment dismissing the plaintiff's second amended complaint.

On May 20, 1982, the plaintiff filed a motion requesting permission to amend her second amended complaint if she did not appeal from the summary judgment decision of April 23, 1982, or if she appealed and the summary judgment was affirmed. The plaintiff wanted to amend her second amended complaint to name Eli Lilly as the sole defendant on the grounds that there was a reasonable probability that it manufactured the DES taken by the plaintiff's mother. In a memorandum decision dated August 9, 1982, the trial court concluded that the requested amendment was not appropriate because the plaintiff was not alleging any new facts which would support her recently asserted allegation that one drug company manufactured DES. The trial court entered an order denying the plaintiff's motion to amend on August 23, 1982. The plaintiff filed an appeal from the judgment entered September 16, 1982, and the order entered August 23, 1982.

The problem facing Therese Collins, who alleges injury by in utero exposure to DES, is that she is unable to identify the precise producer or marketer of the DES taken by her mother due to the generic status of some DES, the number of producers or marketers, the lack of pertinent records, and the passage of time. Several courts have applied existing theories of law or crafted new theories to permit DES plaintiffs to avoid the almost insurmountable obstacle of proving that a particular drug company produced or marketed the DES which caused them injury. 3 Other courts have simply denied DES plaintiffs recovery because existing tort law requires plaintiffs to prove that a particular defendant caused the plaintiffs' harm. 4 In determining our approach to this problem, it is appropriate to set forth the factual background against which the issues in this case must be analyzed.

DES is a synthetic estrogenic hormone which duplicates the activity of estrogen, a female sex hormone present in all women and, to a lesser extent, also in men. In women, estrogen is one of the hormones crucial to female sexual development and fertility.

In the late 1930's, DES was synthesized by a group of British medical researchers, but the drug formula was not patented and, therefore, remained in the public domain. In 1939 and 1940, several drug companies became interested in producing and marketing DES. In order for these companies to produce and market DES for medical use in the United States, they had to file a New Drug 5 Application (NDA) with,...

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