Kociemba v. GD Searle & Co.

Decision Date01 February 1988
Docket NumberCiv. No. 3-85-1599.
Citation680 F. Supp. 1293
PartiesEsther R. KOCIEMBA and William J. Kociemba, Plaintiffs, v. G.D. SEARLE & CO., Defendant.
CourtU.S. District Court — District of Minnesota

Michael V. Ciresi, Roger P. Brosnahan, David L. Suggs, Roberta Walburn of Robins, Zelle, Larson & Kaplan, Minneapolis, Minn., for plaintiffs.

Michael Berens, Madge S. Thorsen, Paula D. Osborn of Oppenheimer, Wolff & Donnelly, Minneapolis, Minn., and Paul Strain of Venable, Baetjer & Howard, Baltimore, Md., for defendant.

MEMORANDUM AND ORDER

RENNER, District Judge.

INTRODUCTION

Before the Court are the parties' cross-motions for summary judgment and declaratory judgment pursuant to Fed.R.Civ.P. 56 and 57. On October 23, 1987, the Court held a hearing on the motions and took them under advisement. The Court also heard arguments on defendant's in limine motions brought pursuant to Fed.R.Evid. 401, 402, 403, 404, and 407. These non-dispositive motions will be addressed in a separate opinion.

Defendant G.D. Searle attacks plaintiffs' seven count complaint on numerous grounds. First, defendant seeks summary judgment on the entire complaint based on principles of federal preemption.

Second, defendant moves for partial summary judgment on all counts of the plaintiffs' complaint except for those allegations in Count One addressing negligent manufacture of the Cu-7 IUD. Defendant bases this motion on its assertion that it provided the plaintiff's1 physician with adequate warnings regarding the risks of IUD insertion.

Third, defendant moves for partial summary judgment as to Counts Three and Four, alleging breaches of implied and express warranties, respectively, on the grounds said causes of action are time-barred by the applicable Minnesota statutes of limitation.

Fourth, defendant moves for partial summary judgment as to those allegations in Counts One and Six alleging misrepresentation. Defendant bases this motion on its assertion that plaintiffs have not identified any specific acts of misrepresentation relied on by plaintiffs or Esther Kociemba's physician. In the same motion, defendant seeks summary judgment as to Count Five of plaintiffs' complaint. Defendant argues that the Minnesota Consumer Fraud Act, which serves as the basis for this count, is not, as a matter of law, appropriate for use in products liability cases, especially those cases involving the highly-regulated prescription drug industry.

Plaintiffs have filed a cross motion seeking a declaratory judgment, pursuant to Fed.R.Civ.P. 57, declaring that defendant had a duty to directly warn Esther Kociemba of the risks and hazards associated with her use of the Cu-7 IUD. Alternatively, plaintiffs seek summary judgment, pursuant to Fed.R.Civ.P. 56, on this issue.

Plaintiffs further seek summary judgment as to defendant's fourth affirmative defense alleging contributory negligence. Finally, pursuant to Fed.R.Civ.P. 12(f), plaintiffs move this Court to dismiss defendant's fifth, tenth, and eleventh affirmative defenses alleging failure to mitigate damages, lack of personal jurisdiction, and improper venue, respectively.

After careful review, the Court denies all of defendant's motions for summary judgment. The Court further denies plaintiffs' motion for declaratory judgment and alternative motion for summary judgment.

However, the Court grants plaintiffs' motion for summary judgment as to defendant's fourth affirmative defense. Moreover, without objection from defendant, plaintiffs' motion to dismiss the defendant's fifth, tenth, and eleventh affirmative defenses is also granted.

FACTS

G.D. Searle decided to market the Cu-7 intrauterine contraceptive device ("IUD") in the United States in 1970. At that time, the Federal Food and Drug Administration ("FDA") — the federal agency charged with overseeing the prescription drug industry — considered all IUDs, including the Cu-7, as medical devices. Prior to the passage of the Medical Device Amendments of 1976, Pub.L. 94-295, § 1(a), 90 Stat. 539 (codified as amended in scattered sections of Titles 15, 21, and 42 U.S.C.), medical devices were generally not within the province of the FDA. Therefore, pre-market clinical testing was not required.

Nevertheless, Searle commenced clinical testing of the Cu-7 before distributing it on the open market. In March of 1971, the FDA decided to reclassify all medical devices incorporating heavy metals as prescription drugs subject to the rules and regulations covering all such drugs. 21 C.F.R. § 310.502. The parties agree that the above-cited regulation includes the copper-based Cu-7. The relevant parts of section 310.502 took effect in February of 1973, prior to the time the defendant began distributing the Cu-7. Thus, Searle was required to obtain FDA approval for the sale and distribution of the Cu-7 as set forth in Section 505 of the Federal Food, Drug, and Cosmetic Act of 1938 ("FDCA"), 21 U.S.C. § 355 (1987).

Subsequently, Searle submitted its application for the Cu-7 to the FDA. On February 25, 1974, the FDA notified Searle that the Cu-7 had been approved as a prescription drug for sale and distribution in accordance with the FDCA.

After receiving approval to manufacture and distribute the Cu-7, Searle began a marketing campaign designed to encourage physicians, as well as potential consumers, to use the Cu-7. Searle contemplated, but never implemented, direct consumer advertising of the Cu-7. Searle did, however, issue press releases to media throughout the country promoting the Cu-7's safety and effectiveness. Searle also placed informational brochures regarding the Cu-7 in physicians' waiting rooms to attract the attention of potential users.

On June 6, 1977, Esther Kociemba went to her physician, Dr. Timothy Scanlan, at the Melrose Clinic in Melrose, Minnesota, to request an IUD. She did so, in part, because of her concern over the reported risks of the oral contraceptives she was then taking. Esther Kociemba did not specifically request the Cu-7.

Dr. Scanlan inserted the Cu-7 that day. At that time, Searle provided a patient brochure with each Cu-7 that read:

What serious complications have been reported?
Pelvic infections have been reported following insertion of the Copper 7. These can occur anyway, but it is certainly possible for the Copper 7 to pick up germs in the vagina and carry them into the uterus on insertion. Even though the Copper 7 was packaged sterile, the vagina is not sterile. Most infections can be eliminated by antibiotic therapy, but if not, the Copper 7 should be removed.

Dr. Scanlan believes that he did not receive the brochure and therefore, did not give it to plaintiffs.

Even if Esther Kociemba saw the warning, it did not mention the possibility of Pelvic Inflammatory Disease ("PID") or the risk of infertility. In defendant's favor, warnings specifically citing the risk of PID were not required by FDA regulation until November 7, 1977 — five months after Esther Kociemba received her Cu-7. 21 C.F.R. § 310.502.

A separate warning was also provided by Searle for exclusive use by the physician. That warning stated, in part, that "uncommonly, pelvic infection has been reported" and that an "aseptic technique" should be employed for insertion. The physician's warning, like the patient brochure, did not provide a specific warning regarding the possibility of PID.

Twelve days after her Cu-7 was inserted, Esther Kociemba awoke with severe cramping caused by an infection. Dr. Scanlan diagnosed the infection as mild endometritis and treated it with the antibiotic Keflex. The infection disappeared within a month.

Plaintiff continued wearing her Cu-7 for almost a year and a half, until November, 1978, when she and her husband decided to begin a family. At plaintiffs' request, Dr. Klotter of the River's Edge Clinic, removed the Cu-7. Klotter told the plaintiffs to return to his office in six months if Mrs. Kociemba was not pregnant. The Koceimbas returned to Dr. Klotter's office in June, 1978 because Esther Kociemba had not conceived. Dr. Klotter instructed Mrs. Kociemba to check her cycle and basal temperature and to engage in sexual intercourse on a monthly basis when ovulating.

On August 15, 1980, fifteen months later, the Kociembas returned to Dr. Klotter. Again, they complained of their inability to conceive a child. After examining Mrs. Kociemba, a physician at the River's Edge Clinic noted "no obvious cause of infertility." A follow-up note, written in Esther Kociemba's medical chart on August 28, 1980, indicated that William Kociemba had a low sperm count. Dr. Klotter referred plaintiffs to Dr. David Lees, a specialist in artificial insemination. Dr. Lees treated Esther Kociemba from October 30, 1980 through 1982.

On January 18, 1982 Dr. Lees performed a hysterosalpingogram ("HSG") on Esther Kociemba. As a result of the test, he concluded that plaintiff's fallopian tubes were blocked. Dr. Lees gave Esther Kociemba no reason for the blockage.

On March 9, 1982 Dr. Lees performed an exploratory laparotomy and bilateral salpingoplasty on Esther Kociemba. Following the surgery, Dr. Lees remained uncertain as to why the ends of plaintiff's fallopian tubes were blocked.

In April, 1982, Dr. Lees referred plaintiffs to Drs. Tagatz and Nagel at the University of Minnesota Hospitals. During plaintiff's first appointment with Dr. Tagatz, Dr. Kreider, a resident assisting Drs. Nagel and Tagatz, met with plaintiff to take her medical history. Dr. Kreider and Esther Koceimba discussed plaintiff's infertility problem at that time. During their discussion, Kreider suggested that PID, caused by the Cu-7, was the cause of plaintiff's infertility. Plaintiff stated in deposition testimony that the April, 1982, discussion with Dr. Kreider was the first time she ever heard of a connection between her use of the Cu-7 and her infertility. Deposition of Esther Kociemba, December 19, 1985, p. 72.

Esther Kociemba continued seeing...

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