History has shown the FDA is too often influenced by political forces and by the industry it seeks to regulate, and the FDA cannot 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. None of these victims are more innocent than unborn children. Sadly, the FDA has a history of approving drugs and devices that operate as abortifacients. Abortifacients are contraceptives that end pregnancies after fertilization has occurred, thus ending the life of the unborn infant. Many abortifacients also threaten the life or health of the mother. The examples below illustrate how lawsuits brought by law firms forced many of these dangerous drugs and devices off the market, while the FDA did nothing.
But the long history of the soft alliance between trial lawyers and pro-lifers has never been given the attention it deserves. Moreover, as discussed below, recent events raise the possibility that trial lawyers will, once again, serve the pro-life cause by challenging the FDA's decision to approve a new contraceptive which will act as an abortifacient.
An Intrauterine Device (IUD) is a small, t-shaped object placed in the uterus to serve as a long-term birth control method. IUDs work by changing the lining of the uterus and fallopian tubes and the movements of eggs and sperm so that fertilization does not occur. If fertilization does occur, IUDs act as an abortifacient by preventing the fertilized egg from implanting in the uterine wall. Health risks associated with IUDs include developing a serious pelvic infection, perforation of the uterine wall, miscarriage, premature birth, ectopic pregnancy, and ultimately, sterility and loss of fertility. The history of the IUD in the U.S. is dominated by the terrible tragedies of the Dalkon Shield and Copper-7.
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. 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 claims 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 case 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.
Thanks to aggressive marketing efforts, about 10 million American women 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. The FDA never withdrew its approval of the Copper-7; the IUD was taken off the market solely as a result of the lawsuits brought against it.
RU-486, a two-drug regimen of mifepristone, followed by misprostol, 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 the abortifacient 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.
In 2004, an agency report on RU-486 revealed 676 adverse events, including 17 ectopic pregnancies, 72 cases of severe blood loss requiring transfusions, and 7 cases of serious infections, including 2 deaths, caused by incomplete abortions. After taking RU-486, 18-year-old Holly Patterson died from septic shock and infection resulting from an incomplete expulsion of the fetus. RU-486 continues to be sold in the U.S., with the full blessing of the FDA. It is clear that this drug will only be curbed or stopped as a result of lawsuits brought by its victims, not by the FDA.
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 appear to be clot related. The women who died include 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, Ortho McNeil, 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.
Norplant is a birth control method involving surgical insertion of six flexible match-stick sized rods into the inner upper arm. The rods (implants) contain levonorgestrel which is released slowly to prevent pregnancy for up to five years. Shortly after being introduced in 1991, 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 removing the rods - 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 abortifacient qualities and the testing deficiencies.
This month, 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 will have to ride to the rescue of the women who will be harmed by Ella, since the FDA has surrendered to political pressure to approve the drug.