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Dalkon Shield

January 26, 2023

The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A.H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of women, which eventually led to numerous lawsuits, in which juries awarded millions of dollars in compensatory and punitive damages.

Sketch of a Dalkon Shield IUD.

History

 
Dalkon Shield with insertion device and packaging card

Hugh J. Davis, M.D., a physician, and Irwin Lerner, an electrical engineer, invented and applied for a patent for the Dalkon Shield in 1968.[1][2][3] In 1970, the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Davis. The Dalkon Corporation had only four shareholders: the inventors Davis and Lerner,[4] their attorney Robert Cohn, and Thad J. Earl, M.D., a medical practitioner in Defiance, Ohio. In January 1971, Dalkon Shield went into the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign.[2][5] At its peak, about 2.8 million women used the Dalkon Shield in the U.S.

At the time of its introduction, the Dalkon Shield was promoted as a safer alternative compared to birth control pills, which at the time were the subject of many safety concerns.[4] Dr. Davis himself was a participant in the 1970 Nelson hearings, which were congressional hearings led by Senator Gaylord Nelson regarding the safety of oral contraceptives. He asserted that oral contraceptives with high doses of hormones were dangerous and that the efficacy of the pill was "greatly overrated."[6]

Design flaw

A string composed of hundreds of nylon monofilaments enclosed within a nylon sheath was tied to the Dalkon Shield. The string tended to harbor bacteria and to deteriorate inside the body; it conducted bacteria through the cervix into the uterus, bypassing the cervical mucus which normally acts as a barrier against infection.[7]

Initial reports in the medical literature raised questions about whether its efficacy in preventing pregnancy and expulsion rate were as good as those claimed by the manufacturer, but failed to detect the tendency of the device to cause septic abortion and other severe infections.[8]

Infections

In June 1973, the Centers for Disease Control and Prevention (CDC) conducted a survey of 34,544 physicians with practices in gynecology or obstetrics regarding women who had been hospitalized or had died with complications related to the use of an IUD in the previous 6 months. A total of 16,994 physicians responded, yielding 3,502 unique case reports of women hospitalized in the first 6 months of 1973. Based on the survey response rate, the CDC estimated that a total of 7,900 IUD-related hospitalizations occurred during this 6-month period. Based on an estimate of 3.2 million IUD users, the CDC estimated an annual device-related hospitalization rate of 5 per 1000 IUD users. The survey also provided 5 reports of device-related fatalities, with four of these related to severe infection. One of the five was associated with the Dalkon Shield. Based on these data, the CDC estimated an IUD-related fatality rate of 3 per million users per year of use, which it compared favorably to the mortality risks associated with pregnancy and other forms of contraception. Importantly, the survey showed that the Dalkon Shield was associated with an increased rate of pregnancy-associated complications leading to hospitalization.[9]

By 1974, approximately 2.5 million women had received the Dalkon intrauterine device. In June of that year, the medical director of A.H. Robins published a letter to the editor of the British Medical Journal stating that the company was aware of an "apparent increase in the number of cases of septic abortions" including 4 fatalities, but stating that "there is no evidence of a direct cause-and-effect relationship between wearing of the Dalkon Shield and the occurrence of septicemia". The letter recommended precautions including pregnancy tests for women who missed their period and the immediate removal of the device in women who were found to be pregnant.[10] That same month, A.H. Robins suspended sales of the device in the United States at the urging of the Food and Drug Administration.[11] In October 1974, a series of four case reports of septic pregnancies were published in the journal Obstretics and Gynecology.[12] In 1975, the CDC published a study associating the Dalkon Shield with a higher risk of spontaneous abortion-related death compared to other IUDs.[13]

As many as 200,000 women made claims against the A.H. Robins company, mostly related to claims associated with pelvic inflammatory disease and loss of fertility. The company eventually filed for bankruptcy. The company's representatives argued that pelvic infections have a wide variety of causes, and that the Dalkon Shield was no more dangerous than other forms of birth control. Lawyers for the plaintiffs argued that the women they represented would be healthy and fertile today if not for the device. Scientists from the CDC stated that both arguments have merit.[14]

Aftermath

More than 300,000 lawsuits were filed against the A.H. Robins Company – the largest tort liability case since asbestos. The federal judge, Miles W. Lord, attracted public commentary for his judgments, impositions of personal liability, and public rebukes of the company heads.[15] The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in 1985. As a result, Robins sold the company to American Home Products (now Wyeth).[citation needed]

In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act mandated the U.S. Food and Drug Administration, for the first time, to require testing and approval of "medical devices", including IUDs.[16]

The Dalkon Shield became infamous for its serious design flaw: a porous, multifilament string upon which bacteria could travel into the uterus of users, leading to sepsis, injury, miscarriage, and death. Modern intrauterine devices (IUDs) use monofilament strings, which do not pose this grave risk to users.[citation needed]

References

  1. ^ Krismann, Carol H. (17 December 2015). "Dalkon Shield". Encyclopedia Britannica. Retrieved 2 January 2023.
  2. ^ a b Kolb, Robert W. (2018). The SAGE encyclopedia of business ethics and society. pp. 813–814. doi:10.4135/9781483381503. ISBN 978-1-4833-8151-0. OCLC 1030656249.
  3. ^ US patent 3633574, Lerner, "Intrauterine contraceptive device", published 1972-01-11, issued 1972-01-11 
  4. ^ a b Robert McG., Thomas Jr. (October 26, 1996). "Hugh J. Davis, 69, Gynecologist Who Invented Dalkon Shield". The New York Times. Retrieved September 11, 2016.
  5. ^ Mintz, Morton (7 April 1985). "Questions Arose Early On Contraceptive's Safety". The Washington Post. Retrieved 2 January 2023.
  6. ^ United States (1967). Competitive problems in the drug industry: hearings before Subcommittee on Monopoly of the Select Committee on Small Business, United States Senate, Ninetieth Congress, first session ... Washington: U.S. Govt. Print. Off.
  7. ^ C., Anna (March 28, 2016). ""Instrument of Torture": The Dalkon Shield Disaster". Planned Parenthood Advocates of Arizona.
  8. ^ Jones, R.W.; Parker, A.; Elstein, Max (1973). "Clinical experience with the Dalkon Shield intrauterine device". Br Med J. 3 (5872): 143–5. doi:10.1136/bmj.3.5872.143. PMC 1586323. PMID 4720765.
  9. ^ CDC (October 17, 1997). "Current trends IUD safety: report of a nationwide physician survey". MMWR. 46 (41): 969–974.
  10. ^ Templeton, J.S. (1974). "Letter: septic abortion and the Dalkon Shield". Br Med J. 2 (5919): 612. doi:10.1136/bmj.2.5919.612. PMC 1610760. PMID 4833976.
  11. ^ "Dalkon Shield Sale Halted by the Company". The New York Times. 29 June 1974. Retrieved 2 January 2023.
  12. ^ Hurt, W.G. (1974). "Septic pregnancy associated with Dalkon Shield intrauterine device". Obstet Gynecol. 44 (4): 491–5. PMID 4607058.
  13. ^ Cates, W.; Ory, H.W.; Rochat, R.W.; Tyler, C.W. (1976). "The intrauterine device and deaths from spontaneous abortion". N. Engl. J. Med. 295 (21): 1155–9. doi:10.1056/NEJM197611182952102. PMID 980018.
  14. ^ Kolata, Gina (December 6, 1987). "The sad legacy of the Dalkon Shield". The New York Times.
  15. ^ Serrill, Michael S. (July 23, 1984). . Time. Archived from the original on October 29, 2010.
  16. ^ Adler, Robert (1988). "The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction". Food, Drug, Cosmetic Law Journal. 43 (3): 511–532. ISSN 0015-6361. JSTOR 26658558.

Bibliography

  • Szaller, Jim (Winter 1999). . Ohio Trial. 9 (4). Archived from the original (Reprint) on 2006-05-13. Retrieved 2006-08-17. – Chronicles legal team of Brown & Szaller's involvement in the Dalkon Shield Litigation.
  • Speroff, L.; Glass, R.H.; Kase, N.G. (1999). Clinical Gynecological Endocrinology and Infertility (6th ed.). Lippincott, Williams & Wilkins. p. 976. ISBN 978-0-683-30379-7.
  • Gordon, Meryl (February 20, 1999). "A Cash Settlement, But No Apology". New York Times. Retrieved 2006-08-17.
  • Sivin, I. (1993). "Another look at the Dalkon Shield: meta-analysis underscores its problems". Contraception. 48 (1): 1–12. doi:10.1016/0010-7824(93)90060-k. PMID 8403900.
  • Anselmi, Katherine Kaby (1994). "Women's response to reproductive trauma secondary to contraceptive iatrogenesis: A phenomenological approach to the Dalkon Shield case" (Abstract): 1–226. {{cite journal}}: Cite journal requires |journal= (help) – Dissertation[unreliable source?]
  • "Robins Plan Is Approved". New York Times. Associated Press. June 17, 1989.
  • Shereff, Ruth (February 13, 1989). "How to Reward The Criminals". The Nation. 248 (6).

Books

  • Bacigal, Ronald J. (1990). The Limits Of Litigation: The Dalkon Shield Controversy. Durham, N.C.: Carolina Academic Press. ISBN 0890893918.
  • Engelmayer, Sheldon D. (1985-09-22). "Lord's Justice : One Judge's War Against the Infamous Dalkon Shield" (New York Times Review). The New York Times. New York. ISBN 978-0-385-23051-3. Retrieved 2010-04-30.
  • Grant, Nicole J. (1992). The Selling of contraception : the Dalkon Shield case, sexuality, and women's autonomy. Columbus: Ohio State University Press. ISBN 978-0814205723.
  • Hawkins, Mary E. (1997). Unshielded: The Human Cost Of The Dalkon Shield. Toronto: University of Toronto Press. ISBN 0802008763.
  • Hicks, Karen M. (1994). Surviving The Dalkon Shield Iud : Women v. The Pharmaceutical Industry. New York: Teachers College Press. ISBN 0807762717.
  • Mintz, Morton (1985). At Any Cost: Corporate Greed, Women, And The Dalkon Shield. New York: Pantheon. ISBN 0394548469.
    • Abstract: Morton Mintz (January 15, 1986). "A Crime Against Women: A.H. Robins and the Dalkon Shield". Multimedia Monitor. 7 (1). – Includes full text of presiding judge Miles Lord's statement to Clairbone Robins, et al., at bottom.
    • Reviewed and summarised by: Tamar Lewin (1986-01-12). "What Standards For Corporate Crime?". New York Times.
  • Perry, Susan & Dawson, Jim (1985). Nightmare: Women And The Dalkon Shield. New York: Macmillan. ISBN 0025959301.
  • Sobol, Richard B. (1991). Bending The Law: The Story Of The Dalkon Shield Bankruptcy. Chicago: The University of Chicago Press. ISBN 0226767523.
  • Stern, Gerald M. (1976). The Buffalo Creek Disaster. New York: Random House. ISBN 0394403908.

January 26, 2023
dalkon, shield, contraceptive, intrauterine, device, developed, dalkon, corporation, marketed, robins, company, found, cause, severe, injury, disproportionately, large, percentage, women, which, eventually, numerous, lawsuits, which, juries, awarded, millions,. The Dalkon Shield was a contraceptive intrauterine device IUD developed by the Dalkon Corporation and marketed by the A H Robins Company The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of women which eventually led to numerous lawsuits in which juries awarded millions of dollars in compensatory and punitive damages Sketch of a Dalkon Shield IUD The lead section of this article may need to be rewritten Use the lead layout guide to ensure the section follows Wikipedia s norms and is inclusive of all essential details January 2022 Learn how and when to remove this template message Contents 1 History 1 1 Design flaw 1 2 Infections 2 Aftermath 3 References 4 Bibliography 4 1 BooksHistory Edit Dalkon Shield with insertion device and packaging card Hugh J Davis M D a physician and Irwin Lerner an electrical engineer invented and applied for a patent for the Dalkon Shield in 1968 1 2 3 In 1970 the A H Robins Company acquired the Dalkon Shield from the Dalkon Corporation founded by Davis The Dalkon Corporation had only four shareholders the inventors Davis and Lerner 4 their attorney Robert Cohn and Thad J Earl M D a medical practitioner in Defiance Ohio In January 1971 Dalkon Shield went into the market beginning in the United States and Puerto Rico spearheaded by a large marketing campaign 2 5 At its peak about 2 8 million women used the Dalkon Shield in the U S At the time of its introduction the Dalkon Shield was promoted as a safer alternative compared to birth control pills which at the time were the subject of many safety concerns 4 Dr Davis himself was a participant in the 1970 Nelson hearings which were congressional hearings led by Senator Gaylord Nelson regarding the safety of oral contraceptives He asserted that oral contraceptives with high doses of hormones were dangerous and that the efficacy of the pill was greatly overrated 6 Design flaw Edit A string composed of hundreds of nylon monofilaments enclosed within a nylon sheath was tied to the Dalkon Shield The string tended to harbor bacteria and to deteriorate inside the body it conducted bacteria through the cervix into the uterus bypassing the cervical mucus which normally acts as a barrier against infection 7 Initial reports in the medical literature raised questions about whether its efficacy in preventing pregnancy and expulsion rate were as good as those claimed by the manufacturer but failed to detect the tendency of the device to cause septic abortion and other severe infections 8 Infections Edit In June 1973 the Centers for Disease Control and Prevention CDC conducted a survey of 34 544 physicians with practices in gynecology or obstetrics regarding women who had been hospitalized or had died with complications related to the use of an IUD in the previous 6 months A total of 16 994 physicians responded yielding 3 502 unique case reports of women hospitalized in the first 6 months of 1973 Based on the survey response rate the CDC estimated that a total of 7 900 IUD related hospitalizations occurred during this 6 month period Based on an estimate of 3 2 million IUD users the CDC estimated an annual device related hospitalization rate of 5 per 1000 IUD users The survey also provided 5 reports of device related fatalities with four of these related to severe infection One of the five was associated with the Dalkon Shield Based on these data the CDC estimated an IUD related fatality rate of 3 per million users per year of use which it compared favorably to the mortality risks associated with pregnancy and other forms of contraception Importantly the survey showed that the Dalkon Shield was associated with an increased rate of pregnancy associated complications leading to hospitalization 9 By 1974 approximately 2 5 million women had received the Dalkon intrauterine device In June of that year the medical director of A H Robins published a letter to the editor of the British Medical Journal stating that the company was aware of an apparent increase in the number of cases of septic abortions including 4 fatalities but stating that there is no evidence of a direct cause and effect relationship between wearing of the Dalkon Shield and the occurrence of septicemia The letter recommended precautions including pregnancy tests for women who missed their period and the immediate removal of the device in women who were found to be pregnant 10 That same month A H Robins suspended sales of the device in the United States at the urging of the Food and Drug Administration 11 In October 1974 a series of four case reports of septic pregnancies were published in the journal Obstretics and Gynecology 12 In 1975 the CDC published a study associating the Dalkon Shield with a higher risk of spontaneous abortion related death compared to other IUDs 13 As many as 200 000 women made claims against the A H Robins company mostly related to claims associated with pelvic inflammatory disease and loss of fertility The company eventually filed for bankruptcy The company s representatives argued that pelvic infections have a wide variety of causes and that the Dalkon Shield was no more dangerous than other forms of birth control Lawyers for the plaintiffs argued that the women they represented would be healthy and fertile today if not for the device Scientists from the CDC stated that both arguments have merit 14 Aftermath EditMore than 300 000 lawsuits were filed against the A H Robins Company the largest tort liability case since asbestos The federal judge Miles W Lord attracted public commentary for his judgments impositions of personal liability and public rebukes of the company heads 15 The cost of litigation and settlements estimated at billions of dollars led the company to file for Chapter 11 bankruptcy protection in 1985 As a result Robins sold the company to American Home Products now Wyeth citation needed In 1976 the Medical Device Amendments to the Food Drug and Cosmetic Act mandated the U S Food and Drug Administration for the first time to require testing and approval of medical devices including IUDs 16 The Dalkon Shield became infamous for its serious design flaw a porous multifilament string upon which bacteria could travel into the uterus of users leading to sepsis injury miscarriage and death Modern intrauterine devices IUDs use monofilament strings which do not pose this grave risk to users citation needed References Edit Krismann Carol H 17 December 2015 Dalkon Shield Encyclopedia Britannica Retrieved 2 January 2023 a b Kolb Robert W 2018 The SAGE encyclopedia of business ethics and society pp 813 814 doi 10 4135 9781483381503 ISBN 978 1 4833 8151 0 OCLC 1030656249 US patent 3633574 Lerner Intrauterine contraceptive device published 1972 01 11 issued 1972 01 11 a b Robert McG Thomas Jr October 26 1996 Hugh J Davis 69 Gynecologist Who Invented Dalkon Shield The New York Times Retrieved September 11 2016 Mintz Morton 7 April 1985 Questions Arose Early On Contraceptive s Safety The Washington Post Retrieved 2 January 2023 United States 1967 Competitive problems in the drug industry hearings before Subcommittee on Monopoly of the Select Committee on Small Business United States Senate Ninetieth Congress first session Washington U S Govt Print Off C Anna March 28 2016 Instrument of Torture The Dalkon Shield Disaster Planned Parenthood Advocates of Arizona Jones R W Parker A Elstein Max 1973 Clinical experience with the Dalkon Shield intrauterine device Br Med J 3 5872 143 5 doi 10 1136 bmj 3 5872 143 PMC 1586323 PMID 4720765 CDC October 17 1997 Current trends IUD safety report of a nationwide physician survey MMWR 46 41 969 974 Templeton J S 1974 Letter septic abortion and the Dalkon Shield Br Med J 2 5919 612 doi 10 1136 bmj 2 5919 612 PMC 1610760 PMID 4833976 Dalkon Shield Sale Halted by the Company The New York Times 29 June 1974 Retrieved 2 January 2023 Hurt W G 1974 Septic pregnancy associated with Dalkon Shield intrauterine device Obstet Gynecol 44 4 491 5 PMID 4607058 Cates W Ory H W Rochat R W Tyler C W 1976 The intrauterine device and deaths from spontaneous abortion N Engl J Med 295 21 1155 9 doi 10 1056 NEJM197611182952102 PMID 980018 Kolata Gina December 6 1987 The sad legacy of the Dalkon Shield The New York Times Serrill Michael S July 23 1984 A Panel Tries to Judge a Judge Time Archived from the original on October 29 2010 Adler Robert 1988 The 1976 Medical Device Amendments A Step in the Right Direction Needs Another Step in the Right Direction Food Drug Cosmetic Law Journal 43 3 511 532 ISSN 0015 6361 JSTOR 26658558 Bibliography EditSzaller Jim Winter 1999 One Lawyer s 25 Year Journey The Dalkon Shield Saga Ohio Trial 9 4 Archived from the original Reprint on 2006 05 13 Retrieved 2006 08 17 Chronicles legal team of Brown amp Szaller s involvement in the Dalkon Shield Litigation Speroff L Glass R H Kase N G 1999 Clinical Gynecological Endocrinology and Infertility 6th ed Lippincott Williams amp Wilkins p 976 ISBN 978 0 683 30379 7 Gordon Meryl February 20 1999 A Cash Settlement But No Apology New York Times Retrieved 2006 08 17 Sivin I 1993 Another look at the Dalkon Shield meta analysis underscores its problems Contraception 48 1 1 12 doi 10 1016 0010 7824 93 90060 k PMID 8403900 Anselmi Katherine Kaby 1994 Women s response to reproductive trauma secondary to contraceptive iatrogenesis A phenomenological approach to the Dalkon Shield case Abstract 1 226 a href Template Cite journal html title Template Cite journal cite journal a Cite journal requires journal help Dissertation unreliable source Robins Plan Is Approved New York Times Associated Press June 17 1989 Shereff Ruth February 13 1989 How to Reward The Criminals The Nation 248 6 Books Edit Bacigal Ronald J 1990 The Limits Of Litigation The Dalkon Shield Controversy Durham N C Carolina Academic Press ISBN 0890893918 Engelmayer Sheldon D 1985 09 22 Lord s Justice One Judge s War Against the Infamous Dalkon Shield New York Times Review The New York Times New York ISBN 978 0 385 23051 3 Retrieved 2010 04 30 Grant Nicole J 1992 The Selling of contraception the Dalkon Shield case sexuality and women s autonomy Columbus Ohio State University Press ISBN 978 0814205723 Hawkins Mary E 1997 Unshielded The Human Cost Of The Dalkon Shield Toronto University of Toronto Press ISBN 0802008763 Hicks Karen M 1994 Surviving The Dalkon Shield Iud Women v The Pharmaceutical Industry New York Teachers College Press ISBN 0807762717 Mintz Morton 1985 At Any Cost Corporate Greed Women And The Dalkon Shield New York Pantheon ISBN 0394548469 Abstract Morton Mintz January 15 1986 A Crime Against Women A H Robins and the Dalkon Shield Multimedia Monitor 7 1 Includes full text of presiding judge Miles Lord s statement to Clairbone Robins et al at bottom Reviewed and summarised by Tamar Lewin 1986 01 12 What Standards For Corporate Crime New York Times Perry Susan amp Dawson Jim 1985 Nightmare Women And The Dalkon Shield New York Macmillan ISBN 0025959301 Sobol Richard B 1991 Bending The Law The Story Of The Dalkon Shield Bankruptcy Chicago The University of Chicago Press ISBN 0226767523 Stern Gerald M 1976 The Buffalo Creek Disaster New York Random House ISBN 0394403908 Retrieved from https en wikipedia org w index php title Dalkon Shield amp oldid 1133366426, wikipedia, wiki, book, books, library,

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