Inequality between men and women has always been prevalent, but it is especially evident in the medical field, particularly with drugs and devices. Women have often been excluded from Phase 1 Clinical Trials in the past, which prevents pharmaceutical companies and device manufacturers from understanding the effects their products may have on women. Even when they are aware, drug companies and device manufacturers continue to obfuscate the side-effects and potential dangers of their products. Drugs and devices targeted at women make up a multi-billion dollar industry, however, manufacturers have refused to acknowledge the health risks of their products.
It was not until 1906, when the Food and Drug Administration was created, that product labels were regulated. However, the legislation had significant loopholes, including no recourse for claiming false efficacy. Following this in 1933, the horrors of dangerous products were revealed by Eleanor Roosevelt in her exhibit titled, “America’s Chamber of Horrors” iin which she featured poisonous hair dyes, lotions, and mascaras, all products used daily by thousands of women.
Not only were beauty products dangerous, but so were hormone therapies. In 1933, Ayerst Laboratories introduced an estrogen hormone replacement, which was said to prevent menopause, made from the urine of pregnant women. Later, in 1942, the same company
manufactured a different estrogen supplement made from pregnant mares. Almost forty years later it was discovered that these hormone replacements were linked to uterine cancer. Then in 2002, the federally funded Women’s Health Initiative, the largest clinical trial of hormone replacement therapy, was closed because links were found between hormone therapy and breast cancer, heart attacks, and blood clots in the lungs.
As time progressed, more forms of birth control became available, yet the possible ramifications of using these drugs and devices continued to be obfuscated. For example, the intrauterine device (IUD) Dalkon Shield (on the market from 1971-1980) caused tubo-ovarian abscess and pelvic infections. Later the Copper-7 IUD was also found to cause infertility and ectopic pregnancies, but the IUD remained on the market.
Not only this, but P&G Rely tampons were linked to Toxic Shock Syndrome (TSS), a bacterial infection, because they were extra absorbent and made from synthetic materials. The Playtex tampons were also known to cause vaginal infections.
One of the most devastating devices is the vaginal mesh. Vaginal mesh is often used to treat pelvic organ prolapse and urinary incontinence, but it can cause severe pain, bleeding, and oftentimes it hardens and erodes resulting in additional surgeries to remove it. Though the mesh manufacturers claim it is easy to remove, the removal process is both grueling and painful and can result in permanent problems.
The main issue that faces women, who have been harmed by a drug or medical device, is how to proceed. Unfortunately, in some cases, women killed or injured by drugs and devices may not be able to hold manufacturers accountable. The reason for this stems from two different Supreme Court cases. The first is Riegel v. Medtronic where Charles Riegel filed a lawsuit against the manufacturer of a balloon catheter because it ruptured during his angioplasty and caused serious complications. The device had already received FDA approval, but it was not given clearance under New York State Law. The Supreme Court ended up ruling in favor of Medtronic because federal law trumps state law, and since it was federally approved, the company could be not sued.
In the case PLIVA Inc. v. Mensing, Gladys Mensing filed a lawsuit against PLIVA Inc. because the diabetes medication she was taking caused her to have a neurological movement disorder, and this side-effect was not included in the medication’s warnings. Mensing was taking the generic version of the drug, and the generic drug’s label matched the label of the FDA-approved brand-name drug. Because of this, the Supreme Court ruled in favor of PLIVA Inc., giving generic manufacturers protection from all lawsuits.
The verdicts from both of these cases stifle the ability to sue large companies if they have FDA approval. This makes it more difficult for women, whom the drug was not tested on, to file a suit against a company that manufactured a drug or device that has caused them a serious and legitimate injury.