What would women’s health be like without the civil justice system?
Throughout modern history, women have suffered disproportionately from the effects of dangerous and defective drugs and medical devices. Corporations have consistently rushed products to market with little safety study, or worse, concealed known issues for the sake of profits. Even when the dangers become public knowledge, companies frequently continue to market them and play down the problems, anticipating that any repercussions will be more than justified by a continuing stream of profits. The civil justice system plays an invaluable role in keeping corporations in check when they prove unwilling to protect the health of women.
★ HORMONE REPLACEMENT THERAPY
The pharmaceutical industry has marketed estrogen supplements as “menopause treatments” since 1942, even with known links to breast cancer, heart attacks and blood clots. Despite recommendations from health experts, the global HRT market is expected to be worth $3 billion by 2017. The only thing standing in the drug companies’ way is the civil justice system. In 2012, Pfizer was forced to pay $896 million to settle claims its HRT drugs caused cancer. The company faces another 4,000 cases.
★ THE DALKON SHIELD
A.H. Robbins knew that its contraceptive IUD, the Dalkon Shield, caused fatal infections, but fought to keep the device on the market. By 1975, the FDA reported it knew of at least 15 fatal and 245 nonfatal septic abortions, among a host of other problems. But it was not until 1980, after lawsuits publicly revealed the extent of the problem, that the company finally agreed to issue a letter to doctors recommending the removal of the device.
★ SURGICAL MESH
As many as 70,000 women have vaginal mesh devices implanted each year. However, the devices cause organ perforation, infection and numerous other side effects. Early models were eventually recalled, but later versions went to market without FDA approval— and sometimes even without FDA’s knowledge—because of rules that allow medical device manufacturers to sell products claimed to be similar to prior products, even if they are known to be dangerous. By 2011, the FDA knew of at least 2,874 adverse events and warned doctors that complications were “not rare.” Facing 4,000 lawsuits from injured patients, Johnson & Johnson stopped selling its mesh device in 2012. Other mesh implants, however, are still heavily marketed and surgically implanted.
★ DEPUY ARTIFICIAL HIPS
DePuy Orthopaedics—a division of Johnson & Johnson—began receiving complaints about its ASR XL Acetabular hip replacement system immediately after its 2005 introduction. Doctors reported the device shed large quantities of metallic debris and frequently caused infection, fractures, dislocations, necrosis, and nerve damage. DePuy’s internal documents showed the company expected 40 percent of the devices to fail, but decided not to fix its flaws. The device remained on the market for five years until sales were finally halted in 2010. In 2013, Johnson & Johnson agreed to pay over $4 billion to settle thousands of cases.
Some of the most dangerous drugs and medical devices ever sold have been contraceptives. In the 1970s, poorly designed IUDs caused hundreds of thousands of pelvic infections, miscarriages, stillbirths, infertility, and even death. Modern contraceptives have often been similarly flawed. Users of the Ortho Evra patch were 18 times more likely to suffer blood clots than those on the pill, while contraceptives that used so-called third and fourth generation hormones, such as Yasmin/Yaz and the NuvaRing, have killed hundreds of women and seriously injured thousands more. In each of these cases, the civil justice system protected women when corporations were unwilling to do so.
In the 1960s, Hoffman-LaRoche’s cancer treatment division discovered that isotretinoin was effective against acne, but could cause severe birth defects. The company rebranded isotretinoin as the acne cure Accutane, and excluded women from pre-market testing so that it could release the drug with a label that claimed there had been no evidence of birth defects in children. In reality, 40 percent of pregnancies exposed to Accutane resulted in spontaneous miscarriage, and a quarter of babies carried to full term suffered major congenital deformities. In 1988, an internal FDA memorandum was leaked suggesting as many as 1,300 Accutane babies had been born, but Hoffman-LaRoche fought to keep Accutane on
the shelves, settling confidentially with victims to keep documents out of the public eye. In 2009, amidst claims that Accutane was linked to inflammatory bowel diseases and suicide, as well as birth defects, Hoffman-LaRoche finally pulled the drug from the market. Accutane is still available in generic form.
Originally published in “Why we need a strong civil justice system” by AAJ, June 2014.