Crime Junkie
Crime Junkie
"This tale could pose a serious danger to women and these multiple threads on the string could enable bacteria from outside of the body to travel up the string and enter the uterus kind of like climbing a rope or like the wake of a candle and the memo said that these could lead to mass infections." — Transcribed internal memo regarding the Dalkon Shield's design flaw.
"Your conscious does not pay your salary." — Boss's response to a quality control employee raising concerns about the Dalkon Shield's safety.
"He accused them of selling an instrument of death manipulation and disease and he said your company without warning to women invaded their bodies and caused injury to them he called them monsters and he said your corporate irresponsibility is at the meanest I've ever seen." — Judge Lord's severe condemnation of A.H. Robins.
The episode delves into the history of the Dalkon Shield, an intrauterine device (IUD) that became a significant public health crisis. It begins with the context of the birth control pill's approval and Barbara Seaman's book raising awareness of its side effects, leading to Senate hearings. However, a key figure, Dr. Hugh Davis, promoted IUDs as a safer alternative, while concealing his own financial interests in a newly developed IUD, later named the Dalkon Shield. The narrative highlights the inadequate testing and regulatory oversight at the time, as medical devices were not monitored by the FDA.
The Dalkon Shield was developed by the Dalcon Corporation and subsequently sold to A.H. Robins, a company that aggressively marketed it as a superior contraceptive. Despite early complaints about pain during insertion and questionable clinical trial data concerning its pregnancy prevention rate, A.H. Robins dismissed these concerns. Internal memos and quality control reports revealed critical design flaws, particularly the shield's string, which could allow bacteria to enter the uterus, leading to severe infections, pelvic inflammatory disease, and even death. The company's cost-cutting measures, including unsterilized devices and neglecting to address male comfort during intercourse over women's health, further exacerbated the risks.
The episode chronicles the extensive suffering of women due to the Dalkon Shield, including Linda Tao's story of irreversible damage and infertility. As complaints mounted, A.H. Robins engaged in victim-blaming and attempted to conceal evidence, even allegedly destroying documents. The company eventually filed for bankruptcy to avoid litigation costs, leading to a settlement where affected women received minimal compensation. However, the scandal led to significant reforms, including the FDA's requirement to approve medical devices, a crucial step towards improving consumer safety in the medical field.