Dalkon Shield - History

History

In 1970 the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Hugh J. Davis, M.D. The Dalkon Corporation had only four shareholders: the inventors Davis and Irwin Lerner, their attorney Robert Cohn, and Thad J. Earl, M.D., a medical practitioner in Defiance, Ohio. In 1971, Dalkon Shields went to the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign. At its peak, about 2.8 million women used the Dalkon Shield in the U.S. The aggressive marketing and defense of the Dalkon Shield intrauterine device—despite the manufacturer's knowledge of safety problems—resulted in a huge scandal.

According to a May 1996 article in the newsletter HealthFacts:

Only one small study was performed on the Dalkon Shield, solely to determine the device's effectiveness in preventing pregnancy. To make matters worse, the study's chief investigator never revealed his conflict of interest. As a developer of the Dalkon Shield, Hugh Davis, M.D., a faculty member of the Johns Hopkins Medical School, was entitled to a percentage of the profits on its sales. He claimed to have studied 640 women using the Shield for a full year and found a failure rate of only 1.1%.

Before A.H. Robins purchased rights to the Dalkon Shield, the company was warned by scientists that Davis' research was full of holes. Ignoring the warnings, Robins marketed the Shield's design as a technological breakthrough, which would produce a lower rate of infection and expulsion than other intrauterine devices. Both claims were later proven false.

According to a 1997 ethics group project paper by four students in a University of Minnesota undergraduate History of Science course:

A. H. Robins Company continued to use data from Davis' original studies in books and advertisements long after new data that put the Dalkon Shield in a more unfavorable light were available; while Davis received stock and a percentage of the profits of the A. H. Robins Company, his financial interests in the Dalkon Shield were never mentioned in their promotional information nor his numerous articles, books, and studies that supported the Dalkon Shield. The problems generated by the bias of researchers evaluating a product, from whose sales they would benefit were starkly apparent in Davis' work. During cross-examination in a court hearing, Davis admitted that there was a conflict of interest. He said "I did not feel I should be in a position of testing and evaluating a device in which on one side I was functioning as an evaluator and on the other side I was in a capacity to, as a private individual, profit from participating in the corporation" (Mintz, 176).

He did not disclose that he instructed women in the study to use spermicide with the Shield. He published a scholarly article entitled, "The Shield: a Superior Modern Contraceptive."