Suzanne Robotti started MedShadow Foundation,an independent health journalism site which informs the public about the side effects, risk, benefits and adverse effects of medicine in 2013 because she was harmed by a medicine called DES (diethylstilbestrol). DES was given to her mother while pregnant and as a result she was unable to have children. Generations later, this hormone disruptor has been found to cause rare cancers, autoimmune diseases and infertility in DES daughters, sons and grandchildren. In 2017 Robotti was appointed to the FDA Advisory Committee on Drug Safety and Risk Management, joining a panel of doctors and pharmacists as the sole consumer representative. Together, the Committee reviews research and decides if a drug is safe enough for use.
This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.