The Dalkon Shield

In 1973, Carrie Palmer was a young mother of two. Although Palmer wanted more children, she also wanted to wait a few years before having her next child, so she began searching for an effective and safe contraceptive. Palmer was afraid of the widely used birth control pill because of the increasing number of reports on its hazardous side effects. She asked her doctor for an alternative to the pill, and he suggested an intra-uterine device (IUD).

IUDs, pieces of metal or plastic the size of a thumbnail inserted into the uterus to prevent conception, became popular during the mid-1960s as the dangers associated with the pill became known. Medical device manufacturers have marketed a wide range of IUDs that came in different shapes and under peculiar names such as Lippes Loop, SafT-Coil, Comet, Butterfly, Multiloop, and Ahmed.

Carrie Palmer's doctor had just recently come across literature promoting a new IUD called the Dalkon Shield, manufactured by the A.H. Robins company of Richmond, Virginia. A.H. Robins claimed its IUD had the lowest pregnancy rate - nearly 1 percent - and that its superior IUD was "safe."

Unfortunately for Palmer, A.H. Robins was wrong on both counts. In July of 1973, only months after her doctor had inserted a Dalkon Shield in her uterus, Palmer became pregnant.

On November 18, halfway through her pregnancy, Palmer was taken to the hospital with flu-like symptoms. As the hours passed her condition worsened. At 2:00 a.m. the following day, Palmer lost her baby, and then went into septic shock. She rapidly became critically ill. She was given massive blood transfusions but she failed to respond. Her blood pressure dropped dramatically to 60/20. Eventually doctors stabilized her condition and then attempted to find out what was wrong. A needle was inserted into the abdominal cavity and came back full of blood. To stop the bleeding and save Palmer's life, the doctors performed an emergency hysterectomy.

In 1979, Palmer took A.H. Robins to court alleging that the Shield was the cause of her injuries. After a two-month trial she was awarded $600,000 for her injuries and $6.2 million in punitive damages. The damage award was upheld on appeal.

Between 1971 and 1975, A.H. Robins distributed an estimated 4.5 million Dalkon Shields in at least 80 countries. The Shield injured thousands of women, most suffering from pelvic inflammatory disease (PID) which can impair or destroy a woman's ability to bear children. Shield induced PID killed at least 18 women in the United States. Of the estimated 110,000 women who became pregnant while wearing the Shield, 66,000 miscarried - most as a result of miscarriages known as spontaneous abortions. Others suffered infected miscarriages known as septic spontaneous abortions. And hundreds of women gave birth prematurely to stillborn children or to children with birth defects including blindness, cerebral palsy, and mental retardation.

A.H. Robins, perhaps best known to the American consuming public through its other products, including Chap Stick, Robitussin Cough Syrup, and Sergeant's Flea Collars, acquired the Shield in 1970. Despite disturbing reports from company insiders that the Shield's rate of effectiveness was misleading, the company marketed the lucrative Shield with claims that it prevented "pregnancy without any effect on the body, blood, or brain," and that it was "nearly as effective as the birth control pill."

The company's promotion campaign, though riddled with misleading information, was tremendously effective. Within a few years, 2.2 million women had had the Dalkon Shield implanted. A.H. Robins had captured roughly 45 percent of the IUD market and was reaping a high rate of return for a device that cost only pennies to make but sold to doctors for $4.35 apiece. A.H. Robins stock climbed on Wall Street, rising 20 points, to 40 3/4 during the three years after the Shield was first marketed.

With the profits came the complaints. In February, 1971, six weeks after A.H. Robins began selling the Shield, a doctor wrote to the company: "I have just inserted my tenth Dalkon Shield and have found the procedure to be the most traumatic manipulation ever perpetrated upon womanhood.. .1 have ordered all Shields out of my office and will do the same in all clinics with which I am affiliated."

Women complained about difficulty of insertion, difficulty with removal, pain and bleeding, perforations (sometimes the Shield would perforate the uterus, permitting the Shield to enter the abdominal cavity), high pregnancy rates and occasional infections. The greatest danger came when a Dalkon Shield wearer became pregnant. Pregnancy could lead to severe infections, miscarriages, stillbirths, and death.

The burgeoning problem of septic abortions was brought to A.H. Robins' attention in the summer of 1972. A.H. Robins received communications from doctors around the country reporting spontaneous septic abortions as well as reports from its own sales representatives. But for 18 months A.H. Robins did little to warn doctors and Shield users of its apparent dangers nor did it launch an investigation into the reports. For 18 months the company allowed doctors to continue to insert the Shield into thousands of women, many of whom became pregnant, and many, like Carrie Palmer, became seriously ill.

Although there were many problems with the design of the Shield, the most damaging was acknowledged in an internal memo, where company doctors expressed concern over the Dalkon Shield's tail. The tailstring of the Dalkon Shield, which is made of about 400 tiny strands encased in a nylon sheath, hangs out of the uterus so a woman can check to see if the Shield is still in place. Dr. Ellen Preston, chief of the company's Anti-Bacterial Division, feared that the tail might display "wicking qualities," thus facilitating the movement of bacteria into the uterus. These fears were confirmed months later when independent tests indicated that bacteria from the vagina would enter the open end of the tailstring and "wick" upward through the string. During pregnancy, bacteria from the tailstring would be drawn into the previously sterile womb, thereby increasing chances of a spontaneous abortion in the third trimester.

One internal A.H. Robins memo from R.W. Nickless, management coordinator for pharmaceutical products, informed almost 40 A.H. Robins executives in December 1970, just before the Shield was to hit the market, of the wicking properties of the string.

Morton Mintz, author of At Any Cost, a detailed account of the Dalkon Shield, reports that A.H. Robins executives were "repeatedly warned of the string's wicking properties, but they failed or refused to listen. Instead, they stonewalled, deceived, covered up, and covered up the cover ups. And in doing so they inflicted on women a worldwide epidemic of pelvic infections."

At one point, E. Wayne Crowder, a quality control supervisor in the Shield manufacturing plant in Richmond warned his supervisor, Julian W. Ross, about the wicking problem. "I told [Ross] that I couldn't, in good conscience, not say something about something I felt could cause infections. And he said that my conscience did not pay my salary," Crowder said.

As the problems with the Shield mounted and the atrocities attracted national media attention, A.H. Robins finally decided to stop marketing the Shield in 1974. Six years later, in September 1980, as the number of lawsuits against A.H. Robins climbed, the company urged physicians to remove the Shield from women still wearing it.

More than 10,000 women have taken A.H. Robins to court seeking compensation for Shield-related injuries. A.H. Robins settled about 6,900 of the cases for more than $200 million. The remaining plaintiffs have chosen to take their chances before a jury. At trial, the company has, in some instances, sought to defend itself by shifting the blame to the victims. A.H. Robins' attorneys have argued that frequent sexual intercourse with multiple partners could cause injuries currently being blamed on the shield.

The sexual innuendoes were only one segment of the company's war of dirty tricks perpetrated on the Shield victims suing A.H. Robins for compensation. Throughout more than 10 years of litigation, the attorneys for the Shield users alleged that Robins had effectively avoided discovery of relevant documents by improperly hiding behind the attorney/client privilege and work product doctrine.

A. H. Robins' courtroom tactics prompted Judge Miles Lord, who heard some 400 Shield cases in his federal court in Minneapolis, Minnesota, to lash out against the company in what is destined to become a classic in the history of judicial reprimand. After approving a $4.6 million settlement of seven product liability cases involving the Shield, Lord summoned to his courtroom E. Claiborne Robins, Jr., the company president, Carl D. Lunsford, senior vice president for research and development, and William A. Forrest Jr., vice president and general counsel. He gave each of the men a statement that he said he hoped "bums its mark into your souls." He accused the company of "corporate irresponsibility at its meanest."

In all the thousands of Dalkon Shield lawsuits that have been filed against A.H. Robins, however, only a handful have gone to trial. A.H. Robins has settled the vast majority of these cases out of court for amounts ranging from $250 to $1.375 million. By June 30, 1984, in those cases that did go to trial, juries had awarded punitive damages in eight cases totaling $17.2 million.

Once a promising money-maker, the Dalkon Shield in the end cost the company dearly. A.H. Robins estimated that payouts to Shield victims would hit $1 billion by the year 2002. On August 12, 1986, A.H. Robins asked a federal judge to let it reorganize under Chapter 11 of the Bankruptcy Code. Victims' attorneys immediately blasted the filing as a "sham" and "unjustified" action that would protect it from future claims of victims of the Shield. The decision on bankruptcy is pending.