Think Your Sex Life is Private? Think Again!

You may or may not recall the birth control method called an intrauterine device or “IUD,” but many women relied on them after assurances from their doctor that they were “safe and reliable” and needed minimal care, compared to the side effect of the Pill. In the 70s and into the 80s, they were widely used.

The Dalkon Shield IUD was introduced in 1970. At the time, medical device manufacturers were not required to conduct tests proving their product’s safety or efficacy to the Food & Drug Administration (FDA).

Prior to its introduction, only one study was performed to determine its effectiveness in preventing pregnancy. Additionally, the study’s chief investigator (and developer of the Dalkon Shield as well as a faculty member at Johns Hopkins Medical School) Hugh Davis, M.D., failed to reveal a conflict of interest. Because he was a developer in the product, he was entitled to a percentage of the profits on its sales. Dr. Davis claimed to have studied 600 women using the Shield for a full year and found a failure rate of only 1.1%.

Although the company that purchase the rights to the Shield, A.H. Robins, was forewarned of the problems with Davis’ research, they ignored the admonitions and proceeded with their marketing. The Dalkon Shield was presented as a technological breakthrough, producing a lower infection rate and expulsion than other IUDs on the market. These claims were wrong.

The Dalkon Shield itself looked like it could hurt the wearer. I remember seeing a picture of it and thinking, “Why would someone want to insert that in their uterus?” It looked menacing. It had five prongs on each side which (in many instances) caused it to become imbedded. There was a multifilament tailstring attached to the Shield that extended into the vagina which was a superhighway for bacteria.

Approximately 235,000 American women suffered life-threatening pelvic infections from their use of the Shield. Many were severe enough to cause hospitalization, permanent infertility, complete hysterectomy, and/or chronic pelvic pain. There were over 200 documented cases of spontaneous septic abortion. In the end, 20 women died of complications associated with the Dalkon Shield.

Although Robins ceased all sales of the Shield in 1974, they did not recall those already sold. These remained in the patients. Some doctors ignored recommendations to remove them and women who had used it beyond the recommended five year timeframe suffered severe infections upon removal.

Lawsuits were filed and in the course of litigation it was discovered that Robins knew of the life-threatening aspect of the device, but withheld that information and destroyed some evidence. In addition, the company knew that the failure rate of the device was five times greater than what they had originally stated.

To stem the tsunami of lawsuits, A.H. Robins filed for Chapter 11 bankruptcy protection in 1985. (This is debt reorganization, not liquidation.) With that move, the injured women lost their right to go to court, and a trust fund was set up for compensation. In effect, this merely puts them in line with other creditors.

The bankruptcy placed a fixed dollar amount on the company's liability. The injured women received considerably less damages than they would have had Robins not filed for bankruptcy. The few women who gave birth to babies with cerebral palsy won $2 million awards, but the majority received only $725 or less.

In order to award damages to the women who filed claims, the Dalkon Shield Claimants Trust Fund was established. In defending the Trust Fund, all sorts of work was done to discredit the claimant so they would eventually settle for much less than they had asked for. It was the dark and seamy underbelly of defense work. Private detectives were hired to investigate the pasts of women who presently were married and had families. They managed to dig up information from 15 to 20 years prior and actually interviewed former partners of these women. They would then present this information to the claimant and nine times out of ten, they would capitulate and settle for a much lower figure, just to end the nightmare of someone digging up their past.

I also learned in researching and working on this case that (back in the mid-90s) there were over 235 known sexually-transmitted diseases. Bring that figure forward 15 years and you really get some religion!

As a result of the Dalkon Shield case, stringent pre-market testing requirements are in place before a medical device can be prescribed. However, filing Chapter 11 remains a refuge for offending manufacturers.