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December 21, 1988

G.D. SEARLE & CO., Defendant

The opinion of the court was delivered by: BARRY

 Patricia Spychala brings this action against G.D. Searle & Company ("Searle") alleging that Searle's failure to adequately warn her of the risks associated with use of its Copper 7 ("Cu-7") intrauterine device was a proximate cause of the pelvic inflammatory disease ("PID") she developed and her subsequent infertility. More specifically, Spychala alleges that the information provided to her by Searle, the manufacturer of the Cu-7 device, was insufficient to allow Spychala to make an informed choice as to whether or not the Cu-7 should be utilized. Searle moves for summary judgment, asserting that Spychala's tort claims are preempted by the Food, Drug & Cosmetic Act, 21 U.S.C. §§ 301 et seq., and that, in any event, Searle had no duty to warn the patient directly of the risks associated with use of the Cu-7 device.


 On September 20, 1984, Spychala visited her gynecologist, Edwin Gervitz, M.D., seeking advice regarding contraceptive devices. She questioned Gervitz about IUD's and asked if he would prescribe one for her. (Spychala Deposition at 23). Spychala acknowledges that, at the time, she was familiar with the Cu-7 manufactured by Searle. (See Plaintiff's Opposition at 1). A pelvic examination was performed, Spychala was found to be healthy, and the Searle Cu-7 was prescribed and placed by Dr. Gervitz. (Spychala Deposition at 23-24).

 Dr. Gervitz testified that he discussed the complications that can occur with use of the Cu-7 with Spychala and provided her with the patient information pamphlet supplied by Searle. (Gervitz Deposition at 30-31). Spychala read the pamphlet and signed an acknowledgement that she had received and reviewed it. (Spychala Deposition at 26). The pamphlet directed that a patient consult her physician if she had any questions about the Cu-7. (Defendant's Exhibit 1B at 9). Spychala testified that she had no questions for Dr. Gervitz as she "understood pretty much what the book said." (Spychala Deposition at 26).

 Within a little more than one month, Spychala began to experience pain and pelvic irritation and on November 2, 1984 was treated at a hospital emergency room. (Complaint, para. 6). The attending physician noted that the IUD was inverted but could not remove it because the thread could not be located. Id. Removal of the IUD was, however, recommended and it was removed some time on or near November 8th, after Spychala experienced severe pain and spotting. Id. In March, 1985, Spychala was diagnosed as suffering from bilateral pelvic inflammatory disease and was hospitalized for treatment. In April, Spychala was readmitted to the hospital, at which time her left ovary and tube were surgically removed. Apparently, a left tubal ectopic pregnancy was terminated at the time of the surgery. (Complaint, para. 9). In July of 1987, Spychala suffered a right tubal ectopic pregnancy. She contends that the ectopic pregnancies, along with the left tube and ovary removal and adhesions from the PID, have rendered her infertile. (See Defendant's Exhibit B, Reports of Dr. Laird).

 The Cu-7 is a plastic and copper intrauterine device which releases small amounts of copper into the uterus, and, it is believed, irritates the lining of the uterus thereby interfering with implantation of the egg onto the uterine wall. (See 40 Fed. Reg. 27,276, 27,798 (1975)). The Cu-7 may be dispensed only with a prescription and is inserted into the uterus only by or under the supervision of a physician. (Physician labeling, Defendant's Exhibit 1A). In 1970, when Searle decided to market the Cu-7 in the United States, the FDA had broad authority to treat medical "devices" as drugs, thereby subjecting the products to its extensive pre-market review. (See United States v. Bacto-Unidisk, 394 U.S. 784, 22 L. Ed. 2d 726, 89 S. Ct. 1410 (1969); Defendant's Exhibit 4, Devices Hearings at 213). Although determining not to reclassify all IUD's as drugs, the FDA decided that certain new products would be treated as "new drugs" and would be regulated as such. (Devices Hearings at 246). The FDA notified Searle that its proposed Cu-7 would be treated as a new drug, and Searle began preparing the applications for approval of the IUD and its labeling. On February 25, 1974, the FDA concluded that the Cu-7 was "safe and effective for use as recommended in the submitted labeling." (Defendant's Exhibit 16).

 In 1977, the FDA promulgated specific regulations governing the labeling of intrauterine devices considered to be new drugs, otherwise known as "drug IUD's." (21 C.F.R. § 310.502). The FDA was concerned with the availability of information regarding the complications associated with and the side effects of drug IUD use. In order to establish uniform physician and patient labeling, the FDA directed that the labeling directed to the prescribing physician accompanying each drug IUD be substantially as outlined in the regulations. (Id. § 310.502 (b) (1)). The required physician labeling explained, inter alia, the risks associated with ectopic pregnancy and pelvic infection. (Id.; see also Physician Labeling, Defendant's Exhibit 1A). Dr. Gervitz was aware of the information accompanying Searle's Cu-7, understood the contraindications for prescription and the potential side effects, and counselled Spychala accordingly. (Gervitz Deposition at 14-15, 28, 31).

 The 1977 FDA regulations also state that:

Labeling, in sufficient quantities to be available to patients who express interest in IUD's, shall accompany each drug IUD (packaged separately from the sterile packaging), be made available to the patient, and contain the following information. . . .

 (21 C.F.R. § 310.502(b)(2)). What followed in the information to be provided to prospective IUD users included a list of possible adverse reactions and directions for actions to be taken if particular warning signs appeared. (Id.). Among the adverse reactions listed were "Pelvic infection" and "Pregnancy outside the uterus (womb) (tubal or ovarian)." (Id.) The patient was advised to contact her physician if she experienced pelvic pain and cramps or experienced thread disappearance. (Id.)

 The Searle patient information booklet provided to Spychala by Dr. Gervitz was dated 1978. (See Defendant's Exhibit 1B; Defendant's Exhibit B). The booklet basically tracks the FDA guidelines at 21 C.F.R. § 310.502(b) (2) and lists ectopic pregnancy and pelvic infection as adverse reactions or side effects which occur "rarely" with the Cu-7. (Defendant's Exhibit 1B at 9). Pelvic pain and cramps and thread disappearance are listed as warning signs requiring the patient to call her physician. (Id. at 13).

 Spychala filed suit against Searle in October of 1986. As noted earlier, the basis of her claim is "that the Cu-7 IUD was dangerous and defective in providing inadequate warnings to the patient/user thereby inducing the patient to use the Cu-7 and thereby causing and contributing to the damages and injuries alleged." (Plaintiff's Opposition at 1). She asserts that Searle had a duty not only to advise the prescribing physician "about the product and its adverse reactions," but to directly warn potential users of the Cu-7. (Id. at 2). Its failure to do so, it is alleged, had the effect of: (1) rendering the product defective; and (2) reducing the information available to Spychala, who, if she had been appropriately apprised of the risks, would not have chosen the Cu-7 and would not have suffered the medical complications she did.

 Searle contends, and Spychala has not disputed, that the patient labeling provided with the Cu-7 to Spychala was approved by the FDA. (See Defendant's Brief at 4). Spychala's criticism of the information provided to her by Searle is, in actuality, a criticism of the FDA-required labeling and not an allegation that Searle did not comply with the federal regulations. Spychala contends that: (1) Searle should have provided information comparing the Cu-7 with other forms of contraception, although the FDA expressly declined to create such a requirement (42 Fed. Reg. 23,777); (2) Searle should have provided incidence rates for the various adverse reactions listed and given reasons for the 12% discontinuance rate of the Cu-7, although the FDA guideline labeling is not set up this way; (3) Searle should have listed PID as a possible adverse reaction, rather than merely listing pelvic inflammatory disease, although the FDA determined that explaining PID was better left to the prescribing physician (42 Fed. Reg. 23,773); (4) Searle should not have used the term "side effects" or the phrase "the effects on the offspring when pregnancy occurs with [the Cu-7] in place are unknown," although these are contained in 21 C.F.R. § 310.502 (b) (2); (5) Searle's pamphlet misleads the patient into believing that pelvic pain is not a symptom that occurs during the first cycle and that there is no need to call a physician promptly following thread disappearance, although the wording in the pamphlet substantially tracks the FDA guidelines and does not create this impression; and (6) Searle should have included journal and bibliographic references in the pamphlet, although none are required by the FDA and such references would not serve the purpose of § 310.502 (b) (2) which is to provide minimal uniform information directly from the manufacturer to potential Cu-7 users to aid in the immediate decision making process. Spychala seeks to impose upon Searle, by way of state tort law, a duty to warn prospective users above and beyond that required by federal law.

 Searle has moved for summary judgment, arguing that federal law preempts Spychala's tort claims and that, in any event, New Jersey's "learned intermediary" rule discharged any duty Searle may have had to warn Spychala directly. Although I cannot say with any assurance that Spychala's tort claims are preempted by federal law and, thus, are not properly before this court, I will grant summary judgment in favor of Searle because it has, as a matter of law, satisfied its duty to warn.


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