The Dalkon Shield-Ignoring User Safety
The A.H. Robins company was at the center of the controversy over intrauterine birth control devices (IUDs). Between 1971 and 1975, Robins sold more than 4 million "Dalkon Shield" IUDs in over 80 countries, and the devices were blamed when thousands of women suffered serious damage, from pelvic inflammation to sterility, miscarriage, and even death.
Background
The concept of the IUD goes back to ancient times - a small device used to irritate the lining of the uterus to prevent a fertilized egg from taking hold. Because of growing fears of overpopulation, coupled with a more liberal societal attitude toward sexuality, the demand for more convenient birth control methods increased. At the same time, there were concerns about the long-term effect of oral contraceptives (the pill), which led companies to reintroduce, and consumers to accept, the IUD as a safe(r) alternative.
The Robins company was a small firm at the time, and had only a few successful products in the market (Robitussin and Chap Stick). The company seized the opportunity to purchase the rights for the Dalkon Shield product, which was all the more attractive because it was a device, not a medicine, so the regulations were much less restrictive for testing and licensing.
The company quickly went to production, and was aggressive in its promotion, in both medical journals as well as poplar women's' magazines, positioning its product as superior to alternative methods of birth control, and also superior to several competing IUD products.
The original version was designed for women who had borne children, and was thoroughly tested and monitored, but then the company came out with a smaller version geared to women who had never borne children, but did not do any safety or effectiveness training with the new version.
In 1973, the CDC got into the picture, noting that there was a statistically significant coincidence between the use of the device and the incidence of women hospitalized with complicated pregnancies. It was found that leaving the device in place was to blame, and the company advocated its immediate removal upon discovery of pregnancy.
Later, it was found that the devices multifilament tail, compared to monofilament tails in other products, was an excellent harbor for bacteria, which caused uterine inflammation and blood poisoning (sepsis). The company reacted to this by switching to a monofilament tail and informing doctors of the concern and the need to remove older devices.
Some news of this leaked to the press, and Robbins took the stance that the problems were mere side effects and it was common to all devices, not just theirs. A later investigation by the FDA concluded that the product was "as safe as any other IUD" and allowed the company to continue manufacturing the device.
While the government was appeased, the public was not, and there were an increasing number of individual lawsuits filed against the company in the late 1970s, which ranged from a suit that sought only $10,000 in compensatory damages to one that won a $475,000 settlement over the death of a consumer.
By 1980, the volume of suits was such that the company sent a letter to over 200,000 doctors urging them to remove the device from any woman still using it. The company cited a "new" study that revealed side effects. This letter was taken as an admission of guilt, and used as proof in an increasing number of lawsuits. At one time, there were over 4.300 suits outstanding, and a bevy of attorneys whose entire practice involved suing Robins.
Due to the success of other product lines, and the fact that they carried insurance for compensatory *but not punitive) damages, the company managed to remain profitable until 1985, when the firm filed for bankruptcy.
Analysis
From the surface details, this mishap seems ethically neutral: a company sought to provide a public good at a fair price, was straightforward in its efforts, and reacted responsibly at each instance where the safety of its product was called into question.
However, there are points at which the company deviated from sound strategy: the firm adopted a product in an area in which it had no experience, accepted the sellers' claims of efficacy and safety, and made no effort to do any testing or confirmation of their own.
The company also took only incremental actions as problems arose. Instead of doing their own investigation, they left this to others, and in each instance undertook minimal effort to address the problem. There was later discovery of internal communications that raised concerns taht were squelched without any investigation.
The company also employed aggressive defense attorneys, who commonly used a tactic of discrediting the plaintiffs: inquiring into the sexual practices of women who used the devices, and by implying that these practices were unusual (too frequent, too weird, too many partners) to clear the company, who had designed the devices for "normal" behavior. But because the behavior in question is sexual, the tactic was seen as a character assault designed to shame the plaintiff and discourage others from bringing suit.
Lessons Learned
When dealing with medical products, health and safety are issues to which a company must be extremely attentive, and do more than the minimum necessary to meet government requirements.
Suspicions and complaints about safety should be proactively investigated rather than waiting to a third party to "prove" their case. A company under siege should consider a salvage strategy: recognition and full admission of the problem, followed by restitution - and consider at what point this becomes preferable to allowing a problem to perpetuate and dealing with individual complaints.
Finally, there has been a sea change from caveat emptor to caveat vendor - the market expects the seller to take full responsibility for any side-effect of their product. It is no longer the buyer's sole burden.