Allen v. GD Searle & Co.

Decision Date03 March 1989
Docket Number86-1659-FR.,Civil No. 86-1402-FR
Citation708 F. Supp. 1142
CourtU.S. District Court — District of Oregon
PartiesDebra Joan ALLEN and Anthony Paul Allen, husband and wife, Plaintiffs, v. G.D. SEARLE & CO., a Delaware corporation, Defendant. Donna KEYS, an individual, Plaintiff, v. G.D. SEARLE & CO., a corporation, and Searle Pharmaceuticals, Inc., a corporation, Defendants.

Thomas J. Conlin, Robins, Kaplan, Miller & Ciresi, Minneapolis, Minn., and Gayle L. Troutwine, Williams & Troutwine, Portland, Or., for plaintiffs.

Timothy A. Pratt, Gregory L. Fowler, Shook, Hardy & Bacon, Kansas City, Mo., and Carol A. Hewitt, Janice R. Wilson, Lindsay, Hart, Neil & Weigler, Portland, Or., for defendants.

OPINION

FRYE, Judge:

The matters before the court are the following motions:

1. Plaintiff Debra Allen's motion to strike G.D. Searle & Co.'s (Searle) affirmative defenses, or for partial summary judgment on those defenses (# );

2. Plaintiff Donna Keys' motion to strike Searle's affirmative defenses, or for partial summary judgment on those defenses (# );

3. The motion of both plaintiffs for declaratory judgment or for partial summary judgment concerning Searle's duty to warn plaintiffs directly (# ); and

4. Searle's motion to dismiss and for summary judgment (on 11 separate issues) (# ).

Background and Outline of Issues

Plaintiffs, Debra Joan Allen and Donna Keys, bring these actions against Searle to recover for personal injuries allegedly caused by the Copper-7 IUD contraceptive (Cu-7). Allen and Keys allege that their use of the Cu-7 caused pelvic inflammatory disease and subsequent infertility.

The Allens filed their complaint on November 10, 1986. The Allen complaint contains claims for negligence, misrepresentation and fraud, strict liability, implied warranties, express warranties, deceptive trade practices under both Montana and Oregon statutes, and punitive damages. Anthony Allen joined in each of the claims, but he has recently been voluntarily dismissed from the action. Debra Allen seeks compensatory damages of at least $500,000, plus punitive damages of at least $500,000.

Keys filed her complaint on November 12, 1986 in the Circuit Court of the State of Oregon for the County of Multnomah. Searle removed the action to this court. Keys alleges claims for strict liability and negligence, seeking $2,000,000 general damages and $5,500 special damages.

The legal issues in plaintiffs' motions largely overlap the issues raised in Searle's motion. In addition, the motions of Allen and Keys set forth virtually the same legal arguments to the facts in each case. To avoid repetition, the Discussion section of this memorandum will address all of the motions relating to each legal issue in a single subsection. The following is an outline of the issues raised by each of the motions:

1. Allen's motion to strike affirmative defenses or for partial summary judgment on those defenses attacks the following affirmative defenses asserted by Searle: statute of limitations (No. 1), federal preemption (Nos. 3, 5 and 6), superseding cause (No. 4), state of the art (No. 7), misuse (No. 8), contributory fault (No. 9), Comment k (No. 10), warranty disclaimer (No. 11), and lack of privity (No. 12). The issues of statute of limitations, federal preemption, Comment k, warranty disclaimer, and lack of privity are also raised in Searle's motion for summary judgment.

2. Keys' motion to strike affirmative defenses or for partial summary judgment on those defenses attacks the following affirmative defenses asserted by Searle: federal preemption (Nos. 3, 5 and 6), superseding cause (No. 4), state of the art (No. 7), misuse (No. 8), contributory fault (No. 9), and Comment k (No. 10). The issues of federal preemption and Comment k are also raised in Searle's motion for summary judgment.

3. Allen and Keys' motion for declaratory judgment or partial summary judgment concerning duty to warn plaintiffs directly; this issue is also raised in Searle's motion for summary judgment.

4. Searle's motion to dismiss and for summary judgment covers the following issues:

a) Summary judgment against Allen and Keys regarding federal preemption b) Summary judgment against Allen and Keys regarding Restatement (2d) of Torts section 402A, Comment k;

c) Summary judgment against Allen and Keys regarding adequacy of warnings;

d) Summary judgment against Allen regarding punitive damages;

e) Motion to dismiss and summary judgment against Allen regarding the Deceptive Trade Practices Act;

f) Summary judgment against Allen regarding fraud and misrepresentation;

g) Motion to dismiss and summary judgment against Allen regarding express and implied warranties;

h) Motion to dismiss and summary judgment against Allen regarding the statute of ultimate repose;

i) Motion to dismiss and summary judgment against Allen regarding impairment to future earning capacity;

j) Motion to dismiss and summary judgment against Anthony Paul Allen's non-consortium claims; and

k) Summary judgment against Keys regarding the statute of limitations.

Undisputed Facts
1. The Allen Case

Defendant Searle is a Delaware corporation which has its principal place of business in the State of Illinois. Searle designed the Cu-7 IUD and manufactured it from 1974 until 1986. The United States Food and Drug Administration (FDA) approved the Cu-7 as a drug on February 25, 1974. That approval has never been revoked, although Searle voluntarily withdrew the Cu-7 from the market in 1986.

Debra Dennison Allen was born on March 23, 1956 and raised in Choteau, Montana. She completed a three year nursing course in 1977 and worked as a nurse between 1977 and 1979. Debra Allen was inserted with a Cu-7 IUD on March 23, 1978 in anticipation of her marriage to Anthony Allen on May 26, 1978. She was 21 years old at the time.

Following the insertion of the Cu-7, Debra Allen experienced increased bleeding during and between her menstrual periods, along with cramping and pelvic pain which she characterizes as "severe." At times the pelvic pain required Debra Allen to lie down while at work, and the bleeding required her to wear sanitary pads daily. In addition, Debra Allen developed low back pain.

Pelvic pain, pelvic bleeding, and low back pain are symptoms which may be indicative of pelvic inflammatory disease (PID), which is a bacterial infection of all or portions of a woman's upper genital tract, including the uterus, fallopian tubes, and ovaries. PID may cause the development of adhesive tissue (adhesions), which can damage the reproductive organs and lead to ectopic (tubal) pregnancy and infertility. However, Debra Allen's medical records do not show that she was diagnosed with PID while using the Cu-7, and she testified in deposition that no physician or health care provider told her that the Cu-7 caused any infection.

On May 22, 1978, Debra Allen returned to Dr. Johnson's office due to her concern about bleeding and cramping, as well as her inability to locate the tailstring of the Cu-7. Dr. Johnson had advised her to check for the tailstring regularly. Debra Allen discussed the possibility of removing the Cu-7, and Dr. Johnson recommended waiting until Allen's next menstrual period to see if the tailstring would reappear.

On June 15, 1978, Debra Allen visited Dr. Wolfe and decided to have the Cu-7 removed because she continued to have bleeding, cramping, and pelvic pain, and the tailstring had not reappeared. On June 16, 1978, Dr. Wolfe performed a dilation and curettage and removed the Cu-7 while Debra Allen was under general anesthesia. The pathology report diagnosed "acute and chronically inflamed endometrium." Debra Allen's symptoms of cramping, increased bleeding, and pelvic pain subsided after the removal of the Cu-7. Debra Allen claims that she was unaware at that time that her reproductive organs had been damaged.

Debra Allen began attempting to become pregnant in November, 1978. She met for a fertility consultation with Dr. McKeown in March, 1979. Dr. McKeown performed exploratory surgery on Debra Allen in November 1980 and found adhesions on both fallopian tubes and ovaries. On April 2, 1981, Dr. Novy performed an exploratory laparotomy and made a post-operative diagnosis of PID and peritubal adhesions. Shortly thereafter, Debra Allen began taking fertility drugs. In July, 1983, Debra Allen underwent another surgical laprascopy by Dr. Novy to attempt to excise pelvic adhesions. In November, 1984, Debra Allen suffered an ectopic pregnancy, necessitating the partial removal of her right fallopian tube. In November, 1985, another ectopic pregnancy was diagnosed, necessitating removal of her left fallopian tube.

Debra Allen attempted in vitro fertilization in 1986 but was not successful. The Allens have adopted two children.

Debra Allen claims that she first became aware that the Cu-7 might have caused her infertility after reading a magazine article in early 1986.

2. The Keys Case

G.D. Searle & Co. and Searle Pharmaceuticals, Inc. (collectively, Searle) are Delaware corporations with their principal place of business in the State of Illinois. G.D. Searle & Co. designed the Cu-7 and manufactured it from 1974 until approximately June, 1978, and Searle Pharmaceuticals, Inc. manufactured the Cu-7 thereafter until it was removed from the market in 1986.

Donna Keys (then Mrs. Donna McBride) was inserted with a Cu-7 on December 2, 1975 by Dr. Manzer. She was 24 years old at the time. She wore the Cu-7 without apparent adverse symptoms until its removal on March 1, 1979. On that same date, she was inserted with a new Cu-7. Approximately four months after the insertion of the second Cu-7, Keys began complaining of dyspareunia (pain with sexual intercourse) and increased cramps, which can be symptoms of PID.

On March 4, 1980, Keys began suffering severe lower abdominal pain, frequent vomiting, chills, light-headedness, and fever. On March 5, 1980, her treating physician, Dr....

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