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The encyclopedia · R&D & Science · Strategic decision · 1971–1989

The Dalkon Shield caused infections in millions — and bankrupted A.H. Robins

A.H. Robins' IUD had a tail string that wicked bacteria into the uterus. 2.8M women used it, 327,000 lawsuits followed, and the company filed for bankruptcy.

A. H. Robins · 1971-01

What happened

The Dalkon Shield was an intrauterine device developed by Hugh J. Davis and Irwin Lerner and marketed by the A.H. Robins Company from January 1971. It was aggressively promoted as a safe, effective contraceptive with few side effects. At its peak, approximately 2.8 million women in the United States and 4 million worldwide used the device. The Shield had a unique multifilament tail string — a braided nylon cord — that was designed to make removal easier but created a fatal flaw.

The multifilament string acted as a wick, drawing bacteria from the vagina into the sterile uterus. This caused pelvic inflammatory disease, septic abortions, infertility, and in some cases death. The company's own quality control supervisor discovered the bacterial wicking in 1971 but management rejected the fix as 'cost prohibitive'. By 1974, A.H. Robins knew of at least four fatalities from septic abortion linked to the device, yet continued selling it overseas for years after suspending US sales.

More than 327,000 lawsuits and claims were filed. In 1985, A.H. Robins filed for Chapter 11 bankruptcy — not because it was insolvent, but to cap its liability. In 1989, American Home Products acquired A.H. Robins for $3.3 billion and established a $2.5 billion trust fund for claimants. Most women received less than $1,000 each. The Dalkon Shield is widely considered the worst medical device disaster in US history and permanently damaged the reputation of IUDs in America.

Why it happened

  • The multifilament tail string wicked bacteria into the uterus — a design flaw that the company's own quality control supervisor identified in 1971 but management rejected the fix as too expensive.
  • A.H. Robins continued selling the Dalkon Shield overseas for years after suspending US sales in 1974 — the company prioritised international revenue over women's safety.
  • A.H. Robins filed for Chapter 11 bankruptcy in 1985 while still profitable — it used bankruptcy not as a last resort but as a legal shield to limit its liability to victims.
What it cost$2.5B trust fund, 327,000 claims, company bankruptedcatastrophic

The lesson

A tail string that wicks bacteria into the uterus is not a design trade-off — it is a device that should never have reached a patient, and a company that knew about the flaw and sold it anyway.

Sources

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    Somewhere, someone solved the problem this company failed at. 2nd Opinion →