Tarallo v. Searle Pharmaceutical, Inc.

Decision Date16 December 1988
Docket NumberCiv. A. No. 8:86-3162-17.
Citation704 F. Supp. 653
CourtU.S. District Court — District of South Carolina
PartiesJeanette Renee TARALLO, Plaintiff, v. SEARLE PHARMACEUTICAL, INC., d/b/a G.D. Searle & Company, Defendant.

Steven M. Krause, Epps, Krause & Nicholson, Anderson, S.C., for plaintiff.

H. Simmons Tate, Jr., John C. Bruton, Jr., Boyd, Knowlton, Tate & Finlay, P.A., Columbia, S.C., Laura A. Kaster, Chicago, Ill., for defendant.


JOE F. ANDERSON, Jr., District Judge.

This matter is before the court on defendant Searle's motion for summary judgment pursuant to Fed.R.Civ.P. 56. Searle contends there is no factual dispute that Ms. Tarallo's claims are preempted by various federal statutes and regulations. Two hearings have been held regarding this motion and extensive memoranda and exhibits have been filed by each party. After a thorough review of the record, the factual allegations and legal principles, the court hereby denies Searle's motion.

Ms. Tarallo is seeking to recover damages for injuries she allegedly sustained as a result of using Searle's product, the Copper 7 intrauterine contraceptive (Cu-7). On or about March 5, 1979 Ms. Tarallo was fitted by her physician with a Cu-7. Ms. Tarallo alleges she became violently ill on December 6, 1980 and was hospitalized with pelvic inflammatory infection (PID). PID ultimately rendered her infertile.

Ms. Tarallo relies on several legal theories to support her claim: strict liability in tort (S.C.Code Ann. § 15-73-10 to — 30 (1976), negligence, and breach of implied and express warranties (S.C.Code Ann. §§ 36-2-314 and 36-2-315). Searle advances two preemption arguments which it maintains foreclose Ms. Tarallo from seeking any redress here.

First, Searle relies on this court's reasoning in Stewart v. International Playtex, 672 F.Supp. 907 (D.S.C.1987), to contend 21 U.S.C. § 360k of the Medical Device Amendments of 1976 (the Amendments) preempts Ms. Tarallo's state law claims. This argument is predicated on a finding the Cu-7 is a device within that statutory framework. Second, if the Cu-7 is deemed to be a drug rather than a device, Searle argues the federal Food and Drug Administration (FDA) regulations governing the approval and sale of the Cu-7 preempt any stricter state law requirements. See Hurley v. Lederle Laboratories, 851 F.2d 1536 (5th Cir.1988). Finally, Searle contends an adverse jury verdict would violate the Commerce Clause of the United States Constitution by imposing an unreasonable burden upon its interstate trade. U.S. Const. art. I, § 8, cl. 3.

I. The Medical Device Amendments

The court has previously recognized the preemptive effect of the regulations promulgated under the Amendments. Stewart, 672 F.Supp. at 909. In Stewart, the plaintiff sought damages resulting from his daughter's death, allegedly caused by her use of a tampon manufactured by the defendant. The tampon was conceded to be a Class II device within the meaning of the Amendments. The court granted partial summary judgment on behalf of the defendant based on the authority of 21 U.S.C. § 360k. The court reasoned that to allow a jury to impose labeling requirements different from those required by the FDA would vitiate the Act's purpose of setting uniform standards for manufacturers. Stewart, 672 F.Supp. at 909. As a result of this decision the plaintiff could recover under a theory of inadequate warning only if he showed Playtex deviated from the labeling requirements of 21 C.F.R. § 801.430(d) (1988), with respect to the tampons purchased and used by his daughter.

In this action Searle also relies on the following relevant portion of 21 U.S.C. § 360k:

No state ... may establish ... with respect to a device ... any requirement ... which is different from, or in addition to, any requirement applicable under this chapter to the device ... which relates to the safety and effectiveness of the device.

21 U.S.C. § 360k (emphasis added).

By its express terms § 360k only applies to "medical devices" and not "prescription drugs." A device is "an instrument ... implement ... or other similar or related article which is ... intended to affect the structure or any function of the body of man...." 21 U.S.C. § 321(h)(3) (as amended). A device does not carry out its purpose "through chemical action within ... the body of man ... and ... is not dependent upon being metabolized" in order to achieve the purpose for which it is intended. Id. Conversely, a drug is an article which is "intended to affect the structure or any function of the body of man ... but the category does not include devices. ..." 21 U.S.C. § 321(g)(1)(C). By their definitions the terms are mutually exclusive.

A. The Cu-7 Approval Process

When Searle applied for market clearance of the Cu-7 the FDA had the authority to require premarket testing of drugs but no similar ability to regulate the introduction of devices to the public. The FDA determined the Cu-7 would be considered a new drug. See S.Rep. No. 670, 93d Cong., 2d Sess. 5 (1973). Three factors led to this conclusion: an expansion of FDA power,1 recognition of previous safety problems arising out of intrauterine contraceptive (IUD) use and the metallic composition of the Cu-7. Devices Hearings, supra note 1, at 208-9 (letter from Peter B. Hutt, Assistant General Counsel, Food, Drugs and Product Safety Division); 293 (statement of Dr. Jennings). The device IUDs already on the market were not reclassified at that time for a number of reasons. Devices Hearings, supra note 1, at 211-12, 217-18 (Jennings), 260 (Hutt), 253-54 (memorandum from L. Pilot), 208-09 (Hutt).

After a three year process, in 1974 the Searle Cu-7 was approved by the FDA as a safe and effective drug. Marketing was thus allowed two years prior to the enactment of the Amendments. See Defendant's Exhibit 16, FDA Approval Letter (Feb. 24, 1974). In seeking approval, Searle was required to complete a seemingly rigorous regulatory process including clinical investigations and submission of documentary evidence and proposed labeling requirements. See generally 21 C.F.R. § 130 (1971).

The Cu-7 differed from other IUDs in that the inflammatory reaction within the body was enhanced by a small amount of copper wire coiled around the vertical limb of the IUD. See Battelle Memorial Institute Report 118-119 (August 11, 1975). In exclusively plastic IUDs the action is caused by the plastic itself. Searle maintains the general mechanism by which either IUD achieves the contraceptive effect is identical and that the Cu-7, like all IUDs, promotes contraception through an inflammatory reaction, not through direct chemical or metabolic action.

Searle argues the FDA's initial decision to classify the Cu-7 as a drug was merely an administratively convenient method by which the FDA could require its premarket testing. The FDA recognized the copper in the IUD slowly dissolved in the body. Ms. Tarallo contends the drug classification was not an anomoly, as the copper in the Cu-7 interacted pharmacologically with the body tissue. Devices Hearings, supra note 1, at 209 (Hutt).

B. The Effect of the Amendments

Two years after approval of the Cu-7 the Amendments granted the FDA expanded authority over devices. The Amendments set forth three classifications, for which different controls apply. 21 U.S.C. § 360c. Class I devices require general controls and the category includes items such as dye and chemical solution stains, synthetic cell and tissue cultures, chromosome culture kits, tissue processing equipment, blood bank supplies and examination gowns. 21 U.S.C. § 360c(a)(1)(A); 21 C.F.R. §§ 864.1850, 864.2220, 864.2260, 864.3010, 864.9050, 880.6265 (1988).

Class II devices are controlled through performance standards, such as labeling requirements. 21 U.S.C. § 360c(a)(1)(B). Anesthetic gas masks, oxygen masks, tampons, diaphragms, visual field laser instruments and eye movement monitors are examples of Class II devices. 21 C.F.R. §§ 868.5550, 868.5580, 884.5460, 884.5470, 884.5350, 886.1360, 886.1510 (1988).

Class III devices must be approved prior to their being marketed. Premarket approval assures testing of those devices which pose "potential unreasonable risks of ... injury." 21 U.S.C. § 360c(a)(1)(C). Included in this category are soft contact lenses and associated agents and solutions, obstetric data analyzers, and bone cement. 21 C.F.R. §§ 886.5925, 886.5928, 886.5933, 884.2050, 888.3027 (1988).

It is important to note the distinctions between the classes and the amount of FDA involvement with each since the Stewart reasoning would preempt only that which is governed by the FDA. In other words, the preemptive effect of § 360k on a Class II device is not as broad as its effect on a Class III device, where any cause of action based on testing, labeling or marketing is preempted by the FDA standards for premarket approval. In Stewart, the court only preempted the imposition of labeling requirements different from those set by the FDA. The question of compliance remained open.

Under Fed.R.Civ.P. 56, summary judgment is appropriate if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. Rule 56(c).

When the defendant is the moving party and the plaintiff has the ultimate burden of proof on an issue, the defendant must identify the parts of the record that demonstrate the plaintiff lacks sufficient evidence. The nonmoving party, here the plaintiff, must then go beyond the pleadings and designate "specific facts showing that there is a genuine issue for trial." Rule 56(e). See also Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

C. Current Classification of the Cu-7

There is no dispute the FDA initially classified the Cu-7 as a "new drug" in order that...

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