women who took the drug during pregnancy. Experts estimate that the drug thalidomide led to the death of about 2,000 children and serious birth defects in more than 10,000 children, about 5,000 of them in West Germany. East German regulatory authorities did not approve thalidomide, and the U.S. Food and Drug Administration (FDA) also declined to approve the drug. One reason for the initially unobserved side effects of the drug and the subsequent approval in Germany was that at that time drugs did not have to be tested for teratogenic effects. Thalidomide had only been tested on rodents, as was usual practice at the time. In the UK, the British pharmaceutical company The Distillers Company (Biochemicals) Ltd, a subsidiary of Distillers Co. Ltd. (which became part of Diageo plc in 1997) marketed thalidomide under the brand name Distaval as a remedy for morning sickness throughout the United Kingdom, Australia, and New Zealand. Their advertisement claimed, "Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child...Outstandingly safe Distaval has been prescribed for nearly three years in this country." Around the world, more and more pharmaceutical companies started to produce and market the drug under license from Chemie Grünenthal. By the mid 1950s, 14 pharmaceutical companies were marketing thalidomide in 46 countries under 37 (some reports suggest 51) different trade names. In the US, representatives from Chemie Grünenthal initially approached Smith-Kline and French with a request to market and distribute the drug in North America. The U.S. Food and Drug Administration refused to approve thalidomide for marketing and distribution. However, the drug was distributed in large quantities for testing purposes after the American distributor and manufacturer Richardson-Merrell had applied for its approval in September, 1960. The official in charge of the FDA, Frances Oldham Kelsey, did not rely on information from the company which did not include any test results. Richardson-Merrell was called on to perform tests and report the results. The company requested approval six times and was refused each time. Nevertheless, a total of 17 children with thalidomide-induced malformations were born. A Long Island, New York family sued the drug maker after their twins were born with deformities in May 1961. Their son was born without arms, with hands growing from his shoulders, and their daughter suffered from a number of internal deformities. The mother was a German woman who