The history of the soft alliance between trial lawyers and pro-lifers has never been given the attention it deserves by pro-life Republicans. The Founding Fathers warned repeatedly against entrusting bureaucrats with decisions that belong in the hands of a local jury. Trial lawyers serve the pro-life cause by challenging FDA decisions to approve dangerous medical devices and drugs taken as birth control by women. History has shown the FDA is too often influenced by political forces and by the industry it seeks to regulate, and the FDA cannot always be trusted to keep unsafe drugs and medical devices off the market. When the FDA approves unsafe products, or allows dangerous products to stay on the market, lawsuits by injured patients are often the last line of defense to provide protection to innocent victims. Civil suits forced many of these dangerous drugs and devices off the market, while the FDA did nothing. Here are some examples.
The Dalkon Shield IUD was implanted in an estimated 2.5 million women from January 1971 through June 1974 before it was taken off the market, thanks to civil litigation brought by injured women. At the time, medical devices were not required to receive pre-market approval from the Food and Drug Administration. Approximately 200,000 women claimed they were injured by the device and filed lawsuits against the company. The Dalkon Shield IUD often became imbedded in the uterus, and the multifilament tail string on the device became a vehicle for bacteria. As a result, women wearing the shield were seven times more likely to develop pelvic infections than women using no contraceptives. There were over 200 documented cases of a rare, potentially lethal type of infected miscarriage called spontaneous septic abortion. Twenty women died of complications associated with the Dalkon Shield. The dangers of the Dalkon Shield were not revealed until the first device lawsuit went to trial in 1974, where the public found out that the IUD’s manufacturer knew about the life-threatening risks of the device but withheld this information.
Meanwhile, thanks to aggressive marketing efforts, about 10 million women in the U.S. used the Copper-7 IUD between 1974 and 1986. By 1986, hundreds of lawsuits were filed claiming that the Copper-7 caused pelvic inflammatory diseases, ectopic pregnancies, perforated uteruses and sterility. As a result, the Copper-7 was taken off the market, solely because of the lawsuits brought against the manufacturers. But the FDA never withdrew its approval of the Copper-7.
RU-486 was never tested in uncontrolled trials or tested for use by women under 18, despite being approved for any age. By approving RU-486, the FDA also mandated a previously unapproved use of misprostol over the objections of its manufacturer Searle, who originally created misprostol to reduce the risk of ulcers. According to 9,300 pages of documents uncovered by Judicial Watch, standard procedural and scientific requirements were circumvented during the expedited FDA approval of RU-486 in 2000. A host of pro-life organizations, including the American Association of Pro-Life Obstetric Gynecologists and the Christian Medical Association, have opposed RU-486 from its testing period to today.
The Ortho Evra transdermal birth control patch was approved by the FDA in 2002 as a supposedly safe alternative to the birth control pill – this despite the FDA’s own pre-approval findings that the patch led to three times as many non-fatal blood clots. This FDA finding was kept quiet as women switched over to the patch – by 2004, 800,000 women were on the patch. A 2005 FOIA request finally revealed that the FDA had received 16,000 different adverse reaction reports associated with the patch, including 17 deaths that appeared to be clot-related. The women who died included Kathleen Thoren, a 25-year-old mother of three; Sasha Webber, a 25-year-old mother of two; and Zakiya Kennedy, an 18-year-old Manhattan fashion student. Ortho Evra’s manufacturer waited until 2006 to warn women that the patch would expose them to the possibility of blood clots. Worse still, FDA kept that information quiet in 2002 when it approved the patch. Lawsuits continue against the company.
Norplant was introduced in 1991, and women began noticing that Norplant’s label inadequately warned about severe side effects like excessive menstrual bleeding, headaches, nausea, dizziness, and depression. In a complaint filed against Norplant’s manufacturer Wyeth-Ayerst, women who used the system suffered significant weight gain, felt numbness and pain in their arms (where the silicone rods were implanted), and experienced excessive bleeding for two
weeks. Many of these women also experienced great difficulty exiting from the Norplant protocol – some women became scarred after having to undergo surgery under a general anesthetic to remove the implants. In 1999, Wyeth-Ayerst agreed to pay out at least $50 million to settle the claims of 36,000 women. The American Life League maintains a Norplant page on its website, explaining its qualities and the testing deficiencies.
Last year, the FDA approved the pill “Ella,” a product of the French maker HRA Pharma, which reduces the chance of pregnancy up to five days after sex. The pro-life Family Research Council claims that Ella blocks progesterone receptor proteins, and thereby starves a developing baby of this needed protein, much like RU-486. FRC cites numerous studies in Europe that show “that Ella causes abortions in animals, including rats, rabbits, guinea pigs and macaques (similar to monkeys).”
And FRC says that “there is compelling reason to believe that it (Ella) will likely have similar side effects” as RU-486, such as “excessive bleeding and increase(d) vulnerability to infection.” In other words, trial lawyers exercising the 7th Amendment right to a jury trial for civil suits may have to ride to the rescue of the women who will be harmed by Ella, just as they have with respect to other devices and drugs dangerous to women.