In the late 1950s, a German drug company told the world it had created the perfect sedative—one so safe that overdoses rarely killed and pregnant women could take it freely for morning sickness. Within years, more than 10,000 babies were born with missing or truncated limbs, their hands or feet sometimes emerging directly from their torsos. The drug was thalidomide. The scale of the disaster was driven by manufacturer negligence and regulatory systems that failed to demand basic safety evidence before approval. Chemie Grünenthal developed and aggressively marketed thalidomide (Contergan) across Europe, Canada, Australia, and elsewhere starting in the late 1950s. Testing was inadequate even by the standards of the day: animal studies were limited or poorly designed, and no proper evaluation of effects on a developing fetus occurred, despite the drug’s promotion for pregnancy. The company claimed safety in pregnancy with scant supporting data. When reports of irreversible nerve damage in adult users emerged around 1959, Grünenthal minimized or denied the connection, delayed critical publications, and in some accounts used private investigators against complaining doctors and patients. Internal awareness of serious risks grew; critics, including later court documents and investigative reporting, allege the company continued sales for weeks after strong indications of birth-defect links (including an internal communication suggesting knowledge by mid-October 1961) and threatened researchers such as German pediatrician Widukind Lenz who first publicly connected the drug to the epidemic of malformations. Company staff and their families themselves had affected children. A 1968–1970 German criminal trial of executives ended without convictions—the court assessed individual culpability as minor—but still found that Grünenthal had not met the standards of a conscientious manufacturer regarding nerve damage. The company later funded compensation and issued a 2012 apology widely criticized by survivors as too little, too late. Regulatory systems outside the United States were equally deficient. Approvals proceeded under frameworks that did not require teratogenicity testing or rigorous clinical data. In the United States, FDA reviewer Frances Kelsey repeatedly rejected the application on grounds of incomplete safety evidence, preventing formal marketing and limiting the toll (though investigational distribution still reached many patients). The contrast exposed systemic gaps elsewhere. Post-disaster reforms (including the 1962 U.S. Kefauver-Harris Amendments) mandated stronger efficacy and safety requirements, but they arrived only after thousands of children had been permanently harmed by a drug whose risks the manufacturer understated and regulators failed to catch.