884 F.2d 1064 (8th Cir. 1989), 88-1933, Hill v. Searle Laboratories, a Div. of Searle Pharmaceuticals, Inc.

Docket Nº:88-1933.
Citation:884 F.2d 1064
Party Name:Connie HILL, William Hill, Appellants, v. SEARLE LABORATORIES, A DIVISION OF SEARLE PHARMACEUTICALS, INC., G.D. Searle & Company and Searle & Company, Appellees, John Doe I and John Doe II.
Case Date:August 30, 1989
Court:United States Courts of Appeals, Court of Appeals for the Eighth Circuit

Page 1064

884 F.2d 1064 (8th Cir. 1989)

Connie HILL, William Hill, Appellants,



INC., G.D. Searle & Company and Searle & Company, Appellees,

John Doe I and John Doe II.

No. 88-1933.

United States Court of Appeals, Eighth Circuit

August 30, 1989

Submitted Jan. 11, 1989.

Rehearing and Rehearing En Banc Denied Nov. 9, 1989.

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David Hodges, Little Rock, Ark., for appellants.

Elizabeth J. Robben, Little Rock, Ark., for appellees.

Before MAGILL and BEAM, Circuit Judges, and HEANEY, Senior Circuit Judge.

HEANEY, Senior Circuit Judge.

In 1981, a Searle-manufactured copper intrauterine device (IUD), a CU-7, was implanted in Connie Hill. Three years later, she gave birth to a child. The next day, she had tubal ligation surgery. During this surgery, it was discovered that the CU-7 had perforated Hill's uterus and was partially embedded in her small bowel. Hill and her husband then brought suit against Searle. After six months of discovery, Searle requested and was granted summary judgment. 686 F.Supp. 720. The district court reasoned that the CU-7 was a prescription drug product falling within the scope of comment k of section 402A of the Restatement of Torts. She further reasoned that the learned intermediary rule applied to prescription drugs in general and to CU-7s in particular and that, because Hill's doctor had been given an adequate warning of the danger of perforation, Hill could not recover. Hill appeals. We reverse and remand because, in our view, Hill was entitled to be personally warned and there is a dispute in the record as to whether that occurred.


The CU-7, being made of copper, a possibly reactive chemical, is a prescription drug product. IUDs gained wide acceptance in the United States in the early 1970s when adverse publicity caused an estimated one million women to cease using oral contraceptives. Statement of Russel J. Thomsen, M.D., Hearings on Intrauterine Contraceptive Devices Before a Subcomm. of the House Comm. on Government Operations, 93d Cong., 1st Sess. (1973). The CU-7 was approved by the Food and Drug Administration (FDA) under its standard of "safety and efficacy." 1 The FDA also approved

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the contents of the package inserts and labeling that accompanied the CU-7, and the patient brochure. In 1977, the FDA promulgated new labeling requirements for use with all IUDs. 21 C.F.R. Sec. 310.502(b).

Dr. Davidson, who treated Hill, was fully aware of the risk of perforation associated with the use of a CU-7 or any IUD. Dr. Davidson was also familiar with the contents of the product literature accompanying the CU-7 and believed that it adequately informed physicians of the potential risks associated with the use of the CU-7. Dr. Davidson's opinion was seconded by Dr. Reynolds, the physician who removed the CU-7 from Hill. As to whether Hill, herself, received a warning, the evidence in the record reveals the following: (1) Dr. Davidson stated that it was his policy to discuss the risks involved with the use of an IUD with every patient but that he could not remember whether this discussion had taken place with Hill; (2) Hill stated that she never received the CU-7's patient brochure and that she received no warnings as to the risks involved with the CU-7; and (3) Hill signed a Batesville Health Department's informed consent form. Searle conceded at oral argument that there is a genuine dispute as to whether Hill received warning.

On the basis of the facts stated above, Searle moved for summary judgment. The trial court held that Arkansas courts, if faced with this issue, would adopt comment k to section 402A of the Restatement (Second) of Torts. 2 The district court also determined that the CU-7 fell within the scope of comment k, because all prescription drug products fall within the scope of that comment, 3 and that Searle had met its duty to Hill, under the asserted theories of strict liability, negligence, and breach of warranty, by warning Hill's treating physician.


The theories of strict liability, the comment k defense to strict liability, negligence and breach of warranty often merge, particularly when it concerns the legal significance of the adequacy of the warnings given. In Arkansas, a supplier of a product is liable under a strict liability theory if: (1) the product is in a defective condition which rendered it unreasonably dangerous, and (2) the defective condition was a proximate cause of the injury. 4 Defective design,

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defective manufacture or inadequate warning may provide the defective condition required for proof of strict liability.

The question of when a product is unreasonably unsafe has occupied a good many writers. The language of the Second Restatement of Torts in dealing with it is that for strict liability the product must be "in a defective condition unreasonably dangerous to the user or consumer or to his property." This terminology may perhaps leave something to be desired, since it is clear that the "defect" need not be a matter of errors in manufacture, and that a product is "defective" when it is properly made according to an unreasonably dangerous design, or when it is not accompanied by adequate instructions and warning of the dangers attending its use.

Prosser, Law of Torts, 659 (4th ed. 1971). If a product is found to fall within the scope of comment k of section 402A of the Restatement (Second) of Torts, this defense will negate any finding of defectiveness and unreasonably dangerous condition but only if the product was properly prepared and the supplier properly warned the user. Proper warning is also an element under the theories of negligence and breach of warranty. Haynes v. Am. Motors Corp., 691 F.2d 1268, 1273 (8th Cir.1982) (negligence); Reid v. Eckerds Drugs, Inc., 40 N.C.App. 476, 253 S.E.2d 344 (1979) (breach of warranty). At the time of Searle's motion for summary judgment, whether Searle's warning ever reached Hill became the factual underpinning for recovery. 5

In this case, since the CU-7 carries with it a substantial risk of uterine perforation, a warning as to the risks involved in using the device is clearly required. The question is whether Searle adequately warned Hill, and this question turns on whether a warning to a learned intermediary is sufficient.

A. Adoption of Comment K.

The district court held that the Arkansas courts, if confronted with this factual situation, would adopt comment k. Hill disputes this holding because the Arkansas legislature did not specifically adopt comment k when it adopted section 402A. Searle argues that comment k is a routinely-followed exception to section 402A and that the Arkansas Supreme Court has often referred to the comments of section 402A, implicitly adopting them. Other jurisdictions which have considered the issue have overwhelmingly adopted comment k. See, e.g. Werner v. Upjohn Co., 628 F.2d 848 (4th Cir.1980), cert. denied, 449 U.S. 1080, 101 S.Ct. 862, 66 L.Ed.2d 804 (1981); Basko v. Sterling Drug, Inc., 416 F.2d 417 (2d Cir.1969); Brown v. Superior Court, 751 P.2d 470 (Cal.1988). We agree with the district court and Searle that the Arkansas courts would join the majority of jurisdictions and adopt the defense to strict liability contained in comment k.

B. Is the CU-7 Within the Scope of Comment K?

The district court also held that all prescription drugs, including the CU-7, fall within the scope of comment k. Hill argues that this is not necessarily true, that comment k is an affirmative defense and

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that Searle failed to offer sufficient evidence to support a finding that the CU-7 falls within the scope of comment k.

The object of section 402A and strict liability is to shift the cost of an injury to the seller or manufacturer of a defective and unreasonably dangerous product. 6 The intent of the defense in comment k is to preclude certain unavoidably unsafe products from being classified as defective and unreasonably dangerous merely because they are, at the time of manufacture and distribution, incapable of being safe. The underlying policy is that some defective and unreasonably dangerous products benefit society to such an extent that placing the risk of injury on the consumer is justified unless there was negligence in the manufacturing or distribution process or inadequate warning. Thus, the comment k defense is unavailable to products negligently manufactured, negligently distributed or unaccompanied by proper warnings. In this sense, falling within the scope of comment k provides a manufacturer or supplier only a qualified defense from strict liability.

We agree with those courts that view comment k as an affirmative defense. Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293, 1301 (D.Minn.1988); Hawkinson v. A.H. Robins Co., Inc., 595 F.Supp. 1290, 1308 (D.Colo.1984); Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 307 (1987). Searle argues that three factors support a finding that the CU-7 is an "unavoidably unsafe" product falling within the scope of comment k: (1) the CU-7 received FDA approval; (2) the CU-7 is a prescription drug product and all prescription drug products fall within the scope of comment k; and (3) uncontradicted expert testimony stated that the CU-7 contains the same risks as any IUD. In our view, Searle's reasoning is insufficient.

FDA approval is not a shield to liability. Stromsodt v. Parke-Davis & Co., 257 F.Supp. 991 (D.N.D.1966), aff'd, 411 F.2d 1390 (8th Cir.1969). But see Stewart v. Internat'l Playtex, Inc., 672 F.Supp. 907 (D.S.C.1987). FDA regulations are generally minimal standards of conduct unless Congress intended to preempt common law, which Congress has not done in this area. See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 658 (1st Cir.1981); Salmon v. Parke-Davis & Co., 520 F.2d 1359, 1362 (4th Cir.1975). In...

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