The FDA, while a useful regulatory body in many ways, has now been proven unable to reign in the profit-hungry pharmaceutical industry. Whether through the lack of resources or the lack of motivation – or both – the FDA has utterly failed to protect patients from dangerous drugs and devices. The Chicago personal injury lawyers at Passen & Powell have seen the disastrous effect of the FDA’s failure on innocent victims of pharmaceutical greed – and that failure’s disproportionate impact on women.
That’s where the American court system comes into play. Due to the lack of successful protection by the FDA, lawsuits have been a critical tool in forcing the drug companies to show concern for the welfare of patients. Only when lawsuits and verdicts make it costly for the drug companies to callously injure women (and men) – more costly than the profits reaped from the sale of dangerous drugs and devices – can we be certain that the drug companies will act in the best interests of patients. Even former FDA commissioner David Kessler has acknowledged this, stating that, “the tort system has historically provided a critical incentive to drug and device companies to disclose important information to physicians, patients, and the FDA about newly emerging risks.” Products liability lawyers like those at Passen & Powell thus play a critical role in keeping the pharmaceutical industry honest and on track.
The failure of the FDA has, unfortunately, had a disproportionate impact on women. Many argue that the greater impact on women is due to a form of sexism: a heightened disregard for the health and welfare of women. While this is no doubt part of the picture, it is also true that certain kinds of drugs are more commonly targeted at women: from late adolescence to the twilight of their lives, women are encouraged and pressured to consume an endless string of products designed to keep them both sexual and infertile.
The perfect example is the mass marketing and prescription of the drugs commonly known as “HRT” or “ERT” (hormone replacement therapy or estrogen replacement therapy). These drugs, which consist of large doses of synthetic or animal-derived estrogen, have for decades been routinely prescribed to menopausal or post-menopausal women to control or reverse the natural aging process and its effect on the female reproductive system. HRT became wildly popular in 1966 with the publication of “Feminine Forever,” a book by Dr. Robert Wilson, whose research was entirely funded by drug companies marketing HRT. In it, Dr. Wilson described post-menopausal women as “no longer women,” “eunuchs,” “castrates,” and “caricatures,” simply because they are no longer fertile and may have reduced sex drive – the natural effects of aging.
After the publication of “Feminine Forever,” HRT sales shot through the roof, with some forms of HRT quickly becoming among the top five most-prescribed drugs in the country, and with major pharmaceutical companies recording nearly 15% of their revenue from HRT.
The problem was that decades before this highly successful marketing push, research had established that estrogen was a carcinogen, particularly in unnatural forms and levels. Indeed, this evidence had been around since the 1930s and 40s. Yet it was not until 2002 that the FDA finally took action, labeling steroidal estrogens as a “known human carcinogen.” Over the course of the nearly 40 intervening years, countless women were willfully exposed to this known threat – while the drug companies raked in obscene profits. In the meantime, evidence had also been amassed that estrogen therapy causes other problems, including the risk of heart attack. Although evidence of the extreme risks of HRT continued to mount, it was only with the advent of large numbers of lawsuits against the manufacturer that we began to see real change.
The Chicago personal injury attorneys of Passen & Powell are shocked by this course of neglect and malfeasance. If only it were an isolated occurrence – but instead, it is only one of many examples of the pharmaceutical industry’s nonconcern for the safety of women. There are many other recent examples of this disturbing pattern of behavior in the area of birth control and women’s reproductive medicine, including:
• The Ortho-Evra weekly birth control patch, which the drug companies and the FDA knew could cause blot clots, heart attacks, and stroke. The FDA and the companies concealed this information until it was forced out in litigation.
• The Dalkon Shield IUD, which caused hundreds of thousands of injuries up to and including infertility. Although the FDA suspended distribution of the device due to safety concerns, it allowed the company to promote and sell its existing stock for 10 years before litigation forced the company to stop.
• The Copper-7 IUD, which caused numerous injuries and deaths but was not withdrawn until litigation forced the company’s hand
• The Ortho-Novum 1/80 birth control pill, whose dangerously high estrogen levels caused blood clots, blood disorders, and life-threatening injuries. The estrogen levels were not corrected until litigation forced this change.
• The synthetic estrogen DES, marketed as preventing miscarriages, which in fact was not only ineffective but also caused cancer, infertility, and other tremendous problems not only in the women to whom it was prescribed, but also in the children they carried. Even after these problems emerged, the company was allowed to promote the drug until litigation halted them.
• High-absorbency tampons, which can cause such problems as toxic shock syndrome, which has in turn caused many deaths. Only punitive damage awards have put a stop to these dangerous products.
• The drug Parlodel, used to supress lactation after birth in mothers who intend to bottle feed, but which causes heart attack and stroke. The FDA simply asked the pharmaceutical industry to stop making the drug voluntarily – a request with which many did not comply. The drug was marketed and used for an additional five years before lawsuits forced the last company making the drug to stop.
These examples, and others, demonstrate that only lawsuits and the threat of civil accountability can force the pharmaceutical industry to act responsibly. If you or someone you love has developed health problems after using these or any other reproductive drug or device for women, you may have a cause of action. The products liability attorneys of Passen & Powell urge you to meet with an attorney who can help you to investigate your case, and to pursue any claims you might have. The health and lives of the women who come after you may depend upon your action.
For a free consultation with an experienced Chicago wrongful death lawyer at Passen & Powell, call us at (312) 527-4500.