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Intrauterine Devices: Malpractice and Product Liability

Published online by Cambridge University Press:  28 April 2021

Guerry R. Thornton Jr.
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Extract

The use of a mechanical device is an ancient and crude form of contraception. Desert dwellers in ancient Africa placed stones in the uteruses of their camels to prevent conception during long treks across the Sahara. The metal intrauterine devices (IUDs) used in the late 1800s caused severe pelvic infections that, in the absence of antibiotics, often proved fatal. The first stainless steel and polyethelene IUDs were developed around 1960, and these attained a relatively reliable degree of safety. New compositions and materials decreased the risk of infection, and innovative devices could be inserted without dilating the cervix.

As mechanical means of contraception grew in popularity, pharmaceutical companies began to fight for a competitive edge, each touting the design or materials of its product as safer and niore efficient. By the mid-l970s, it is estimated, more than 15 million IUDs had been distributed throughout the world, many in developing nations.

Type
Article
Information
Law, Medicine and Healthcare , Volume 14 , Issue 1 , February 1986 , pp. 4 - 12
Copyright
Copyright © American Society of Law, Medicine and Ethics 1986

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References

McCombs, Szaller, , The Intrauterine Device: A Criticism of Governmental Complaisance & Analysis of Liability, Cleveland State Law Review 24: 247 (1975).Google Scholar
Johns Hopkins University, Population Information Program Reports, Series B, no. 3: Intrauterine Devices B-90-91 (May 1979); National Women's Health Network, Washington, D.C.Google Scholar
Prosser, W., Handbook of Law of Torts, 4th ed. (West, St. Paul, 1971), 139 note 2, at §§641 et seq.Google Scholar
Marshall, B.R. Hepler, J.K. Jinguji, M.S., Fatal Streptococcus Pyogenes Septicemia Associated with an IUD, Obstetrics & Gynecology 41(1): 83 (January 1973).Google Scholar
See In re A.H. Robins Co., Inc., “Dalkon Shield” IUD Products Liability Litigation, 406 F.Supp. 540 (MDL Panel 1975).Google Scholar
Morris, C., Defective Devices—Who's Liable?, Hospital Medical Staff 8(5): 2 (May 1979). E.g., Vergott v. Deseret Pharmaceutical Co., 463 F.2d 12 (5th Cir. 1972) (catheter); Mattair v. St. Joseph's Hospital, 234 S.E.2d 537, aff'd, 238 S.E.2d 366 (Ga. 1977) (hospital bed).Google ScholarPubMed
But see Terhune v. A.H. Robins Co., 577 P.2d 975 (Wash. 1978) (upholding physician's discretion not to give manufacturer's brochure to patient).Google Scholar
American College of Obstetricians & Gynecologists, Technical Bulletin No. 40 (June 1976).Google Scholar
21 C.F.R. §310.502 (1985).Google Scholar
In re Robins, A.H., supra note 5, at 540.Google Scholar
E.g., Newberry v. Tarvin, 594 S.W.2d 204 (Tex. App. 1980);Terhune, supra note 7; Godard v. Ridgway, 445 P.2d 757 (Wyo. 1968).Google Scholar
21 C.F.R. §310.502 (1985).Google Scholar
Tresemer v. Barke, 150 Cal. Rptr. 384 (1978);Martinez v. Rosenzweig, 387 N.E.2d 1263 (Ill. 1979);Newberry, supra note 11.Google Scholar
See Martinez, , supra note 13.Google Scholar
Killebrew v. Johnson, 404 N.E.2d 1194 (Ind. App. 1980).Google Scholar
See Flitt v. A.H. Robins Co., Case no. 81-734 (E.D. Cal., May 3, 1985) ($14 million structured settlement for birth defects where Dalkon Shield caused premature delivery).Google Scholar
Id.Google Scholar
Sponaugle v. Pre-Term, Inc., 411 A.2d 366, 368 (D.C. 1980).Google Scholar
Gugino v. Harvard Community Health Plan, 403 N.E.2d 1166 (Mass. 1980).Google Scholar
Tresemer, supra note 13.Google Scholar
Gugino, supra note 19.Google Scholar
See In re A.H. Robins Company, Inc., Chapter 11. Case no. 85-01307-R (E.D. Va. 1985).Google Scholar
Harre v. A.H. Robins Co., 750 F.2d 1501 (11th Cir. 1985) (perjured expert testimony); See also Hewitt v. A.H. Robins Co., Case no. 3-83-1291 (3d Div. Minn.) (special masters report finding “a strong prima facie case that defendant, with the knowledge and participation of in-house counsel, has engaged in an ongoing fraud by knowingly misrepresenting the nature, quality, safely, and efficacy of the Dalkon Shield from 1970–1984”).Google Scholar
Hightower v. E. Robins Claiborne et al. Case no. C85-4057A (N.D. Ga. 1985). See Casper v. Aetna Casualty & Surety Co., et al., Case no. 85-C-327 (E.D. Wis., Aug. 23, 1985) (notwithstanding court's dismissal of Dalkon Shield claims against Aetna, an insurer could be held liable for suppression of evidence or obstruction of justice if in complicity with misconduct such as that of A.H. Robins Company).Google Scholar
Beyette v. Ortho Pharmaceuticals Co., Case no. 82-71670 (E.D. Mich. 1985) (Lippes Loop); CU-7 Litigation Group, Denver, Colorado.Google Scholar
Daling, J.R. et al., Primary Tubal Infertility in Relation to the Use of an Intrauterine Device, New England Journal of Medicine 312(15): 937 (April 11, 1985).Google ScholarPubMed
See Physicians' Desk Reference Book, 35th ed. (Litton, Oradell, N.J., 1981).Google Scholar
Contraceptive Technology 1984-1985, 12th rev. ed. (Irvington, New York), at 93–96.Google Scholar
Mattair v. St. Joseph's Hospital, 234 S.E.2d 537, aff'd 238 S.E.2d 366 (Ga. 1977).Google Scholar
Gildiner v. Thomas Jefferson University Hospital, 451 F.Supp. 692 (E.D. Pa. 1978).Google Scholar
An unavoidably unsafe product is one whose benefit outweighs its risk of danger. A manufacturer of such a product will not be held liable under strict liability principles unless a proper warning of the dangers is not provided.Google Scholar
Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87 (2d Cir. 1980);Needham v. White Laboratories, Inc., 639 F.2d 394 (7th Cir. 1981), cert. denied 454 U.S. 927 (1981).Google Scholar
See Restatement (Second) of Torts §402A, comment K (West, St. Paul, 1985).Google Scholar
Weaver v. Searle, Prod. Liab. Rep. (CCH) ¶8690 (N.D. Ala. 1980).Google Scholar
E.g. Terhune, supra note 7.Google Scholar
Needham, supra note 32, at 402-3.Google Scholar
Carmichael v. Reitz, 95 Cal. Rptr. 381 (1971).Google Scholar
E.g., Carmichael, supra note 37; Vergott v. Deseret Pharmaceutical Co., 463 F.2d 12 (5th Cir. 1972).Google Scholar
Berry v. G.D. Searle & Co., 309 N.E.2d 550 (Ill. 1974); see also Skelton v. Druid City Hospital, 459 So.2d 818 (Ala. 1984).Google Scholar
Jones v. Sportelli, 399 A.2d 1047 (N.J. Super. 1979).Google Scholar
Lindsay, , supra note 32; Mahr v. G.D. Searle & Co., 390 N.E.2d 1214 (Ill. App. 1979).Google Scholar
Lukasiewicz v. Ortho Pharmaceutical Corp., 510 F.Supp. 961 (E.D. Wis. 1981).Google Scholar
See Pharmaceutical Manufacturers Ass'n v. Food & Drug Administration, 484 F.Supp. 1179 (D. Del. 1980) (holding that although 21 U.S.C. §§352 and 353, regarding misbranding of drugs, were intended to make the prescribing physician the primary source of information available to a consumer of a prescription drug, 21 U.S.C. §371(a) authorizes the Food and Drug Administration to require disclosure on the labeling of the drug of those possible side effects that are sufficiently serious as to be material to the patient's decision whether or not to use the drug).Google Scholar
See Dixon, M., Drug Product Liability, §9.05 (1974).Google Scholar
Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977).Google Scholar
See Flitt, supra note 16.Google Scholar
Roth v. Bell, 600 P.2d 602 (Wash. App. 1979).Google Scholar
Jones, supra note 40.Google Scholar
Husbands v. A.H. Robins Co., Case no. 84-5877 (11th Cir.) ($4 million in punitive damages returned Sept. 6, 1984); Tetuan v. A.H. Robins Co., Case no. 82-C-304 (18th Jud. Dist., Kan.) ($7.5 million in punitive damages awarded May 3, 1985).Google Scholar
Lindsay, , supra note 32.Google Scholar
Ballew v. A.H. Robins Co., 688 F.2d 1325 (11th Cir. 1982).Google Scholar
King v. Seitzingers, Inc., 287 S.E.2d 252 (Ga. App. 1981);Glass v. A.H. Robins Co., Case no. C84-2041A (N.D. Ga., June 24, 1985).Google Scholar
See Official Code of Georgia, Ann. §9-3-33.Google Scholar
See Givens v. A.H. Robins Co., Case no. 84-1482 (8th Cir. Dec. 27, 1984).Google Scholar
Mack v. A.H. Robins Co., 573 F.Supp. 149 (D. Ariz., 1983);Olson v. A.H. Robins Co., 696 P.2d 1294 (Wyo. 1985);Baker v. A.H. Robins Co., Case no. 83-3533 (D. D.C. 1985).Google Scholar
Baysinger v. Schmid Products Co., Case no. 9973 (Worcester Cir. Ct., Md., Feb. 4, 1985) (Saf-T-Coil IUD); Miller v. A.H. Robins Co., Case no. 83-3048 (7th Cir. July 1985).Google Scholar
Nelson v. A.H. Robins Co., 515 F.Supp. 623 (N.D. Cal. 1981).Google Scholar
Philpott v. A.H. Robins Co., 710 F.2d 1422 (9th Cir. 1983).Google Scholar
See Allen v. A.H. Robins Co., 752 F.2d 1365 (9th Cir. 1985);Knaysi v. A.H. Robins Co., 679 F.2d 1366 (11th Cir. 1982).Google Scholar