Dalkon Shield IUD Litigation Lawsuit

Dalkon Shield IUD Litigation

The Dalkon Shield IUD litigation is one of the largest product liability cases in U.S. history. Hundreds of thousands of women sued the maker of the Dalkon Shield intrauterine device, alleging that it caused serious infections, sepsis, and deaths. The case is also a standard reference point in the history of medical device regulation in the United States.

Product and manufacturer

The Dalkon Shield was a shield-shaped intrauterine device (IUD) used as a long-acting, reversible form of contraception. It consisted of a plastic body made of ethylene-vinyl acetate and a tail string made from Supramid, a cable-like suture material of many fine nylon fibers wrapped in a smooth outer sheath. Two models were produced, for women who had given birth and for those who had not.

The device was developed by physician Hugh J. Davis and engineer Irwin Lerner through their Dalkon Corporation, and it was marketed in the United States beginning in 1971 by the A.H. Robins Company, a pharmaceutical firm that had no prior experience with contraceptive devices. At the time, IUDs were not subject to the same premarket review as drugs. Promoted as an alternative to the birth-control pill, the Dalkon Shield became one of the most widely used IUDs in the country, and it continued to be sold in other markets even after it was withdrawn from the United States.

The alleged defect and the harm

The central design concern was the multifilament tail string. Its woven structure could draw bacteria from the vaginal canal up through the cervix into the uterus — a process known as wicking — bypassing the cervical mucus that normally acts as a barrier against infection. The string was also prone to deteriorating in the body, creating additional routes for bacteria.

Women who used the device reported severe complications, including pelvic inflammatory disease, septic abortions, and sepsis. The Centers for Disease Control and Prevention conducted an epidemiological survey of IUD-related hospitalizations and published a study associating the Dalkon Shield with a higher risk of death from septic spontaneous abortion than other IUDs. In 1974, at the urging of the Food and Drug Administration, A.H. Robins suspended U.S. sales, although the device remained available abroad for years. The company later sent letters to physicians recommending removal of devices still in place.

Litigation

More than three hundred thousand lawsuits and claims were filed against A.H. Robins over the device, making the matter one of the largest tort cases in the country. The company's representatives argued that pelvic infections have many causes and that the Dalkon Shield was no more dangerous than other forms of contraception; the plaintiffs' side argued that the device's design made these infections more likely. The cost of the litigation and the settlements reached over the years drove the company into Chapter 11 bankruptcy in August 1985, before the United States Bankruptcy Court.

Outcome

The case is recorded as resolved by settlement in 1985. In the Chapter 11 proceeding, a trust fund was created to pay claimants and to cap the company's exposure to further claims. At the time, the bankruptcy was controversial: the company was still profitable, and the arrangement let it limit the total damages paid, but it gave claimants a defined fund to draw from.

The litigation had lasting regulatory consequences. The 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act required the FDA for the first time to review and regulate medical devices, including IUDs, before they could be marketed. The Dalkon Shield episode also chilled investment in new IUDs; the device's memory lingered in the market for years, and IUD use in the United States stayed low through much of the following decade.