Opinion ID: 528858
Heading Depth: 2
Heading Rank: 2

Heading: Is the CU-7 Within the Scope of Comment K?

Text: 12 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 that Searle failed to offer sufficient evidence to support a finding that the CU-7 falls within the scope of comment k. 13 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. 14 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. 15 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 addition, FDA approval cuts against a determination that the CU-7 is unavoidably unsafe. FDA approved the CU-7 on two standards: safety and efficacy. 21 C.F.R. Sec. 310.502(b) (an IUD, as a method of contraception, is generally safe and effective). Obviously, if FDA regulations declare a drug product to be generally safe, that declaration is evidence that the drug product is not unavoidably unsafe. 16 Several courts have concluded that comment k applies to all prescription drug products because of the public interest in the development and availability of reasonably priced prescription drug products. See, e.g., Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87 (2nd Cir.1980); Brown v. Superior Court, 751 P.2d 470 (Cal.1988); McKee v. Moore, 648 P.2d 21 (Okl.1982); Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975, 977-78 (1978). Others have limited the application of comment k to circumstances when it is shown that the product is incapable of being made safe given the present state of human knowledge but possesses such a high degree of social need so that its use is warranted, provided warnings are adequate. See, e.g., Wheelahan v. G.D. Searle & Co., 814 F.2d 655 (4th Cir.1987) (available on WESTLAW); 7 Coursen v. A.H. Robins Co., 764 F.2d 1329, 1337 (9th Cir.1985); Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293, 1301 (D.Minn.1988); Patten v. Lederle Laboratories, 676 F.Supp. 233 (D.Utah 1987); Hawkinson v. A.H. Robins Co., Inc., 595 F.Supp. 1290, 1303 (D.Colo.1984). We agree with the latter view. 17 The drafters of comment k did not intend to grant all manufacturers of prescription drugs a blanket exception to strict liability. Such an exception was proposed at the American Law Institute meeting where section 402A and comment k were adopted, but this proposal was defeated. 38 ALI Proc. 19, 90-98 (1961). The language of comment k suggests that only exceptional products, albeit such exceptional products are more likely to be found in the field of prescription drug products, should be excluded from the strict liability provisions. But more importantly, the example given--the vaccine for the Pasteur treatment of rabies--suggests that only special products, those with exceptional social need, fall within the gamut of comment k. 18 The better reasoned opinions support the view that the unavoidably unsafe exception should only apply upon a showing of exceptional social need. The plain meaning of comment k supports such a view, Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 307 (1987), as does the purpose of comment k. Wheelahan v. G.D. Searle & Co., supra note 7. 19 Furthermore, the premise generally relied on by those courts applying comment k to all prescription drugs--that the public interest in the development of prescription drug products requires the user to bear all the costs of injury unless the drug product was negligently manufactured or designed or unaccompanied by proper warnings--is unconvincing. In our view, this policy has no greater relevance to prescription drug products than to other products having life-saving or life-bettering characteristics. 20 It follows that whether a product is within the scope of comment k should be determined on a case-by-case basis. 8 Toner v. Lederle Laboratories, 732 P.2d at 303-09; Feldman v. Lederle Laboratories, 479 A.2d 374, 382-83 (N.J.1984); Collins v. Eli Lilly Co., 116 Wis.2d 166, 342 N.W.2d 37, 52 (1984), cert. denied, 469 U.S. 826, 105 S.Ct. 107, 83 L.Ed.2d 51 (1984). 21 In the case of the CU-7, Searle should bear the risk of injury caused by the CU-7, if the CU-7 is defective and unreasonably dangerous. The reasons are that alternative methods of birth control are available 9 and that Searle has made no showing that CU-7s, or IUDs in general, are exceptionally beneficial to society. Wheelahan v. G.D. Searle & Co., supra note 7. The CU-7 is certainly not the sine qua non for birth control, as is the Pasteur vaccine for the treatment of rabies. Another important factor is that IUD manufacturers, through mass advertising and merchandising practices, generated a general sense of product quality, making it difficult for consumers to fully understand the risks involved with the use of an IUD. Finally, manufacturers were in a better position than the users of IUDs to identify potential risks. By identifying and quantifying these risks, manufacturers could better spread the costs of injuries caused by IUDs to all customers of such products. Thus, Searle's argument that comment k should apply because the use of the CU-7 is no riskier than use of any other IUD is unpersuasive. For these reasons, we feel that the trial court erred in granting summary judgment to Searle on the issue of whether the CU-7 is within the scope of comment k.