Glaxo Smith Kline and Sanofi are being sued by children born half a century ago with birth defects that they allege were caused by the drug thalidomide.
Thirteen Plaintiffs claim Smith Kline French, a precursor company to GSK, conducted tests in animals in clinical trials in humans in the late 1950s without adequate consent that led to at least one case of disablement which was never publicly revealed.
It is alleged that the company’s decision to abandon the drug permitted Richardson- Merrel, now part of Sanofi, in turn to proceed with “investigational trials” with thalidomide in thousands of patients without surveillance for a year and a half before it unsuccessfully sought US regulatory approval in 1960.
The legal action claims the drug was more widely used in the US than previously thought and may have caused thousands of birth defects in children, despite the long standing belief that the Food and Drug Administration’s refusal to authorise thalidomide limited side-effects to a few cases.
Many children in Ireland suffered birth defects as a result of their mothers have been prescribed to help with morning sickness. There is currently a campaign ongoing by affected people in Ireland to secure greater compensation then that previously agreed by the Irish Government. Richardson-Merrel distributed more than 2.5 million tablets to 20,000 patients which were handed out by 1,267 doctors in a programme run by its marketing rather its medical department. After the link with birth defects forced the withdrawal, US regulators reported that Richardson-Merrel had not kept records of all the doctors who received or returned thalidomide, did not send them formal letters requesting them to withdraw it and could not subsequently track two tonnes of the medicine.