The Dalkon Shield: Medical Device RegulationHow a flawed IUD led to crucial FDA oversight.

From the show

Rules Written in Blood

A contraceptive device meant to empower women instead caused devastating harm. In the early 1970s, the Dalkon Shield was aggressively sold without pre-market safety testing, a common practice at the time. A fatal design flaw led to widespread infections, infertility, and death, sparking one of the largest medical-legal battles in US history. The scandal directly resulted in the 1976 Medical Device Amendments, finally giving the FDA authority to regulate these products before they reach the market.