In 1956,^[1]K. I. Macduff, Thalidomide – The Aftermath, 1 Auckland U. L. Rev. 53 (October 1970). This article is found in HeinOnline’s Law Journal Library. the West German pharmaceutical company Chemie Grünenthal brought a brand-new sedative to market. The new drug was thalidomide, which Chemie Grünenthal sold under the tradename Contergan.^[2]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. Thalidomide was somewhat of a wonder drug. Testing on laboratory animals failed to produce any apparent side effects whatsoever:^[3]K. I. Macduff, Thalidomide – The Aftermath, 1 Auckland U. L. Rev. 53 (October 1970). This article is found in HeinOnline’s Law Journal Library. no changes in blood pressure, in respirations, in metabolic functions or cellular structure were observed in animals. What’s more, human patients raved about thalidomide, reporting that it induced “a deep, natural, all-night sleep without a hangover.”^[4]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. An early thalidomide advertising campaign from Chemie Grünenthal proclaimed, “In pregnancy and during the lactation period, the female organism is under great strain. Sleeplessness, unrest and tension are constant complaints. The administration of a sedative and hypnotic that will hurt neither mother nor child is often necessary.”^[5]Patricia Howlett, Compensation for Drug Induced Fetal Deformities in Common and Civil Law Systems, 2 Touro J. Transnat’l L. 243 (1991). This article is found in HeinOnline’s Law Journal Library.

Thalidomide quickly became very popular in West Germany. It was sold over-the-counter^[6]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. and combined with aspirin and other medicines to treat a wide array of common conditions: coughs, colds, headaches, and especially morning sickness in pregnant women. Its popularity and efficacy spread thalidomide across West Germany’s borders throughout Europe, into Australia, New Zealand, Japan, Canada, and dozens of other countries. In September 1960,^[7]Ani B. Satz & Liza Vertinsky, Customary Corruption, 66 Wm. & Mary L. Rev. 693 (February 2025). This article is found in HeinOnline’s Law Journal Library. the American pharmaceutical company Richardson-Merrell applied for approval from the Food and Drug Administration to bring thalidomide to market in the United States.

But thalidomide was not free of side effects as its laboratory testing had initially suggested. For the women who turned to thalidomide for relief, it had devastating consequences.

Thalidomide’s Tragedy Unfolds

The first inkling that thalidomide was not completely harmless came from patients who reported experiencing peripheral neuritis^[8]K. I. Macduff, Thalidomide – The Aftermath, 1 Auckland U. L. Rev. 53 (October 1970). This article is found in HeinOnline’s Law Journal Library.—nerve damage in their limbs—after taking thalidomide; for many, the damage was irreversible, even after they stopped taking the drug. But since the number of cases reported was relatively small, alarm bells did not ring. Chemie Grünenthal, which had known that peripheral neuritis was a potential side effect of thalidomide, had never informed its British licensee, Distillers, of the possibility when they licensed them thalidomide. Compounding this siloing of information, Distillers did not inform Chemie Grünenthal when British patients began reporting cases of peripheral neuritis. Distillers’ solution was to add a warning to thalidomide’s label about the potential for peripheral neuritis.

Frances Oldham Kelsey and the FDA

While thalidomide was popular throughout much of the world, its use was much less widespread in the United States. In 1960, the United States Food and Drug Administration (FDA) hired Dr. Frances Oldham Kelsey to review drug approval applications. One of her first assignments^[9]Ani B. Satz & Liza Vertinsky, Customary Corruption, 66 Wm. & Mary L. Rev. 693 (February 2025). This article is found in HeinOnline’s Law Journal Library. was to review Richardson-Merrell’s application to bring Kevadon, its brand name for thalidomide, to market in the United States as a tranquilizer and to treat morning sickness.

Thalidomide was already in circulation in the United States on an investigatory basis; more than 2.5 million thalidomide tablets^[10]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. had been distributed to 1,000 physicians^[11]Ani B. Satz & Liza Vertinsky, Customary Corruption, 66 Wm. & Mary L. Rev. 693 (February 2025). This article is found in HeinOnline’s Law Journal Library. throughout the country. Thalidomide had subsequently been dispensed to nearly 20,000 patients.^[12]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. It was later estimated that more than 3,700^[13]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. of those patients were women of childbearing age.

With the thalidomide application on her desk, Dr. Kelsey, a pharmacologist by training, requested further data^[14]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. from Richardson-Merrell about how the human body absorbed thalidomide, concerned about a lack of evidence on its effects in humans. During World War II, Dr. Kelsey had worked on the federal government’s anti-malaria project,^[15]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. where she studied quinine, a teratogen—a substance that disrupts fetal development. Aware that one of the intended uses for thalidomide was to alleviate morning sickness, she also requested further data that showed^[16]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. thalidomide was safe to use during pregnancy.

While Dr. Kelsey waited for more data from Richardson-Merrell, she happened by chance to come across a reference in the British Journal of Medicine about reports of thalidomide-induced peripheral neuritis. In turn, she asked Richardson-Merrell for more data about the cases of peripheral neuritis and learned that warnings^[17]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. about this side effect had been part of the labeling of the British version of thalidomide since August of 1960. This warning was not supplied by Richardson-Merrell as part of its application to market thalidomide in the United States. Dr. Kelsey, concerned^[18]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. that no one could apparently determine what was causing the peripheral neuritis or whether it was reversable, refused to approve thalidomide and continued to press Richardson-Merrell for more data. Correspondence^[19]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. between Richardson-Merrell and Dr. Kelsey revealed that throughout 1960 and 1961, Richardson-Merrell continued to press her to approve its application to bring thalidomide to market, which she continually denied.

The Thalidomide Generation

While Dr. Frances Kelsey pressed for more scientific data on thalidomide’s side effects, across the Atlantic, West German doctors started noticing an alarming increase in children born with phocomelia.^[20]Zelman Cowen, The Press, the Courts and the Law, 12 Melb. U. L. Rev. 1 (June 1979). This article is found in HeinOnline’s Law Journal Library. Phocomelia is usually a very rare congenital defect that results in children born with extremely short arms and legs with flipper-like^[21]Patricia Howlett, Compensation for Drug Induced Fetal Deformities in Common and Civil Law Systems, 2 Touro J. Transnat’l L. 243 (1991). This article is found in HeinOnline’s Law Journal Library. hands and feet. But doctors were now seeing more and more cases of this normally rare disorder. Two such cases^[22]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. were presented at the annual meeting of West German pediatricians in October 1960. Both children almost completely lacked upper arm bones, causing their hands to extend almost directly from their shoulders, and had a large vascular tumor (called a hemangioma) extending from their forehead down to their upper lip. Neither child had a family history of these conditions. The presenting physicians, who worked at the Institute of Human Genetics in Münster, noted that they had never seen such a combination of birth defects in their careers.

In November 1961, Dr. Widukind Lenz, a West German pediatrician, first publicized a tentative link between thalidomide taken during the early stages of pregnancy and these birth defects. In another hemisphere, Australian doctor William McBride also linked an increase in phocomelia to thalidomide when taken in early pregnancy. As more doctors around the world shared similar reports, the circumstantial evidence seemed to link thalidomide to the birth defects. On November 26, 1961 Chemie Grünenthal pulled thalidomide^[23]K. I. Macduff, Thalidomide – The Aftermath, 1 Auckland U. L. Rev. 53 (October 1970). This article is found in HeinOnline’s Law Journal Library. from the West German market in response to the reports. Thalidomide was withdrawn from the British market on December 2, with other countries withdrawing the drug shortly thereafter.

In January 1962, renowned pediatric cardiologist Dr. Helen Taussig,^[24]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. who helped develop the revolutionary Blalock-Thomas-Taussig shunt at Johns Hopkins to treat the congenital heart defect Tetralogy of Fallot, traveled to West Germany to examine the thalidomide babies and interview their doctors. Dr. Taussig shared her findings with Dr. Frances Kelsey^[25]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. and published her findings in the June 1962 issue of the Journal of the American Medical Association.

With thalidomide’s risks now apparent, Richardson-Merrell withdrew its application for thalidomide from the FDA on March 8, 1962.^[26]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents.

Thalidomide’s Aftermath

Later studies would prove that when taken in the early stages of pregnancy, thalidomide caused severe birth defects,^[27]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. including phocomelia, congenital heart disease, and organ deformity. Data suggested that the risk of such birth defects were “probably higher than fifty percent.”^[28]Max Sherman & Steven Strauss, Thalidomide: A Twenty-Five Year Perspective, 41 Food Drug Cosm. L.J. 458 (1986). This article is found in HeinOnline’s Law Journal Library. More than 10,000 babies^[29]Charles L. Hooper & David R. Henderson, Two Thalidomide Disasters: Myths about the FDA’s Role in the Thalidomide Tragedy Have Resulted in Decades of It Obstructing Many Beneficial Drugs, 47 Regulation 8 (Winter … Continue reading around the world were born with thalidomide-induced birth defects.

In the August 11, 1962 issue of the medical journal The Lancet, an editorial^[30]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. concluded with the following lamentation:

How had such a serious side effect been missed when animal testing of thalidomide seemed to indicate it was safe? Further studies would reveal that in order to produce the same birth defects in animals, staggeringly high doses of thalidomide needed to be administered to replicate the same results that occurred in human subjects. For example, one study on rats only produced one malformed offspring after the mother rat had been given 1,200 times the usual dose.^[31]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. Studies done on rabbits required dosages 90 to 120 times higher^[32]Interagency coordination in drug research and regulation. Part 1 (1963). This hearing is found in HeinOnline’s U.S. Congressional Documents. than the comparable human dose to produce malformed offspring. That the drug would behave differently in humans than it did in animals had not been appropriately considered.

In the years after the thalidomide disaster, many affected countries passed legislation to compensate victims. In 1968, German prosecutors^[33]Ioan-Radu Motoarca, Asymmetric Procedural Protections and Corporate Crime, 51 Am. J. Crim. L. 1 (Spring 2025). This article is found in HeinOnline’s Law Journal Library. brought manslaughter and injury charges to nine executives at Chemie Grünenthal. In 1970, Chemie Grünenthal agreed to establish a compensation fund for victims, into which they paid 100 million DM, with the government also contributing to the fund. In 1976, Germany passed legislation that strengthened liability and compensation laws for drug-induced injury.

In the United Kingdom, protracted litigation stalled compensation for British thalidomide victims.^[34]Wing-wah Mary Wong, Sunday Times Case: Freedom of Expression Versus English Contempt-of-Court Law in the European Court of Human Rights, 17 N.Y.U. J. Int’l L. & Pol. 35 (Fall 1984). This article is found in … Continue reading Suits against Distillers were first brought in 1962, and by 1968 all but five of these original suits were settled out of court. Still, hundreds of victims were excluded from compensation. On September 24, 1972, the Sunday Times ran an article titled “Our Thalidomide Children: A Cause for National Shame,” decrying the paltry settlements that Distillers’ had paid out and the legal system that was stymieing further victims from receiving justice. Distillers argued that the article constituted contempt of court, and an injunction was granted against the Sunday Times to stop publishing articles on the thalidomide victims. After protracted appeals, in 1974 the Sunday Times took the case to the European Commission of Human Rights, arguing their freedom of expression had been violated. The Commission agreed in its 1977 ruling.^[35]Judgment in Sunday Times Case (Government Interference with the Press; U.K. Law of Contempt of Court), 18 I.L.M. 931 (July 1979). This article is found in HeinOnline’s Law Journal Library. Public outcry^[36]Jonathan Bradshaw, The Origins of the Family Fund, 8 Nonprofit & Voluntary Sector Q. 17 (January – April 1979). This article is found in HeinOnline’s Law Journal Library. spurred by the Times’ articles eventually led to the establishment of a multi-million pound compensation fund for the victims.

In the United States, the full effects of the thalidomide tragedy were largely avoided. The thalidomide tragedy, and Congressional testimony from Drs. Frances Kelsey and Helen Taussig on the crisis, were instrumental in passage of amendments to the Federal Food, Drug, and Cosmetic Act.^[37]52 Stat. 1040. This law is found in HeinOnline’s U.S. Statutes at Large. The 1962 amendments, more commonly known as the Kefauver-Harris Amendment,^[38]76 Stat. 780. This law is found in HeinOnline’s U.S. Statutes at Large. expanded FDA oversight over drug manufacturers and required manufacturers to prove their drugs were safe and effective before approval.

For resisting pressure to grant FDA approval to thalidomide, in 1962 President John F. Kennedy granted Dr. Frances Kelsey the President’s Award for Distinguished Federal Civilian Service, the highest federal award for civilian employees.

Thalidomide has found a second life as an effective cure for leprosy^[39]Sue McGrath, Only a Matter of Time: Lessons Unlearned at the Food and Drug Administration Keep Americans at Risk, 60 Food & Drug L.J. 603 (2005). This article is found in HeinOnline’s Law Journal Library. and a modified version^[40]Charles L. Hooper & David R. Henderson, Two Thalidomide Disasters: Myths about the FDA’s Role in the Thalidomide Tragedy Have Resulted in Decades of It Obstructing Many Beneficial Drugs, 47 Regulation 8 (Winter … Continue reading of thalidomide is currently on the market in the United States as a treatment for multiple myeloma. It continues to be studied as a potential treatment^[41]Sue McGrath, Only a Matter of Time: Lessons Unlearned at the Food and Drug Administration Keep Americans at Risk, 60 Food & Drug L.J. 603 (2005). This article is found in HeinOnline’s Law Journal Library. for an array of diseases.

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