Justice Sandra Day O’Conner tells this joke:
Two men on a balloon expedition became lost in a storm. When the storm cleared, they found themselves floating above a one-land road with nothing in site but wheat fields. There was no one, absolutely no one around. Finally, they spotted a woman walking down the road.
“Hey!” they called down. “Where are we?” To which the woman relied, “You’re up in a balloon about 25 feet off the ground.”
“She’s a lawyer,” one man commented to the other.
“How do you know?” his companion asked.
“Well,” he responded, “her answer was clear, precise, perfectly accurate – and totally useless!”
I think we can all agree that perfect accuracy in the interest of utter futility is not the highest calling of the profession. Nor is it, in my opinion, the answer to why lawyers do what they do.
The great strength of this country is our ability to harness the brainpower of people without regard to gender, race or age. But that hasn’t always been the case.
It may be helpful to keep in mind what one exceptional woman had to say about the decade of ‘70’s. “It must be a time,” she said, “when equality becomes reality and our nation does what, up until now, has been left undone.” That’s impressive – particularly when you realize that the woman calling for equality was Abigail Adams, and the decade she was talking about was the 1770’s. Abigail wrote the first “Dear John” letter in American history:
In the new Code of Laws, which I suppose it will be necessary for you to make, I desire you (to) remember the ladies and be more generous and favorable to them than (were) your ancestors. If particular care and attention is not paid to (us), we are determined to foment a rebellion, and will not hold ourselves bound by any laws in which we have no voice or representation.”
Husband John replied promptly in the first Dear Abby letter in American History, and informed her that men who would stand and fight the tyranny of a powerful king would never give in to the despotism of a petticoat.
The hand that rocked the cradle was allowed to rule the world only if that hand belonged to a queen.
In the decade of the 60’s my family took part in Civil Rights marches, anti-war rallies, and I participated in the beginning of the Women’s Movement. I went to consciousness-raising groups, although I did not need my consciousness raised. I went to feminist Seders and feminist marches. I read The Doctors’ Case Against the Pill by Barbara Seaman and in 1966, I joined NOW. I was aware of legal decisions affecting women and feminist events. I later became Chair of the National Women’s Health Network. We had the first Black Women’s Health Conference in Atlanta, the first Women’s Rural Conference in Appalachia, the first Conference on Women and Aids in New York, and the first Speak Out on Abortion in Boston.
I wanted my professional life to be about creating a better world, and I wanted to be at the forefront of those changes. I decided I could be a part of the solution by becoming a lawyer. I am also a card-carrying member of the Veteran Feminists of America (VFA). I know that I have a few more years of work ahead of me since my practice consists of suing corporate America on behalf of women, and, sadly enough, I will never lack for business.
I received my law degree forty years ago. Of the 169 students in my evening class, only 7 were women. As women, we had to forge our way in a profession that was overwhelmingly male, and where women’s issues were rarely considered.
Perhaps because law is the primary way women fight for their rights, men fought hard to keep them out of it. Law schools were even more resistant than medical schools (to admitting women). In 1962, while working on my Ph.D. in History at Columbia University, I noted that there was a joint Ph.D./J.D. program. I immediately applied to Columbia Law School, and was denied admission because I was told I would take the place of a man who would practice for 40 years. I was too old and the wrong gender. You could say that to a woman in 1962, when 3.6 percent of law students were women. After this rejection, I thought that using the law as an avenue to activism was closed to me forever.
Most of the early women legal pioneers faced a profession and a society that espoused the view that women were, by nature, different from men. Even Clarence Darrow, one of the most famous champions of unpopular causes, had this to say to a group of women lawyers:
“You can’t be shining lights at the bar because you are too kind. You can never be corporation lawyers because you are not cold-blooded. You have not a high grade of intellect. I doubt you can ever make a living.”
Any excuse for excluding women would suffice. The Brooklyn Bar Association justified its exclusion of women by its alleged inability to provide separate rest rooms.
In 1869, St. Louis Law School became the first law school to admit women and Belle Mansfield became the first woman lawyer. Although she could interpret the law, she would not be able to vote for another 50 years!
In 1872, exactly 100 years before I became a first-year law student, Myra Bradwell was refused admission to the bar. She appealed her case to the United States Supreme Court, who told her to remain in her place, and her place was not at the bar: “The paramount destiny and mission of women is to fulfill the noble and benign offices of wife and mother, this is the law of the Creator.” Myra was single.
In 1874, Belva Lockwood, who had managed to gain admission to the National Law School by appealing directly to President Ulysses S. Grant, was rejected by the United States Court of the Claims with the simple announcement: “Mistress Lockwood, you are a woman.”
In 1981, Sandra Day O’Connor was appointed as the first woman Supreme Court justice. And she often quotes the following:
A toast to Potter Stewart,
His chivalry can’t be beat
The first Supreme Court Justice
To give a lady his seat.
After her appointment, Justice O’Connor received a letter, signed by a senior citizen, stating:
“Back to your kitchen and home, female! This is a job for a man, and only he can make the rough decisions. Take care of your children and husband.”
I had insisted on natural childbirth in 1950 after much wrangling with the doctor. I had read Barbara Seaman’s book The Doctors’ Case Against the Pill and we became friends. So when the women’s health movement began in the 1960’s and blossomed a decade later I joined. We marched into Washington waving signs saying “Feed estrogen to the rats at the FDA”. It has been particularly powerful in its attempt to demystify medicine, to challenge the power of the physician, and the entire medical establishment. It is women who questioned the Dalkon Shield, the birth control pill, the lack of patient package inserts, the medicalization of childbirth, the over-prescribing of tranquilizers and the attitude of the medical profession towards them.
Few other social movements have addressed medical and health care practices so directly and contributed to changing beliefs, practices and institutions. We have insisted on our right to be educated about our own bodies, to be partners in our healthcare, to confront doctors. We have insisted on accurate and complete information on sexuality, reproduction, childbirth and surgery. We believe that healthcare (not medical care) is a fundamental right for all.
Healthcare has become a market commodity. We are faced with the medicalization of our bodies from birth to death. This is particularly ironic because historically, women had served as society’s healers.
More and more of everyday life comes under medical influence and supervision so that medical definitions and medical treatments emerge for previously non-medical problems.
According to the Western model, pre-menstrual syndrome is a disease, menstruation is a disease, pregnancy is a disease, childbirth is a disease, and menopause is a disease. We are poisoned by prescriptions or hysterectomized, as 685,000 women are every year. From this model, I have reached the conclusion that being a woman is a disease.
We have lobbied, legislated and litigated. In the final analysis, the totality of the women’s contribution to public health practice is greater than the sum of its individual parts. Consciousness raising, health education as a right, alternative institutions and a critique of the system are more than separate elements of the women’s health movement. Together they have combined to offer a vision of a different social order – where women and men are equal, where healthcare is a collaborative effort involving the individual, society and health care workers, and where a constitutional right to privacy affords women the freedom to make decisions affecting their own bodies.
Women’s bodies and reactions to medications are assumed to be identical to men’s, and doctors treat them as such. Despite the social progress made by women in recent decades, we have not advanced far enough when it comes to our biology.
For example, Ambien, the sleeping pill, which was prescribed 40 million times just last year and approved 20 years ago, has been prescribed for women in a dose that’s twice as high as they need, putting them at risk for dangerous drowsiness while driving and a host of other problems. Indeed, it appears that women respond differently from men to a broad array of treatments, from aspirin to anesthesia, and often do not derive the same benefits from them as men. The extent of these effects, however, is thus far unknown and unresearched. Ambien is the only drug that has ever been looked at. We can only imagine how many other drugs are being prescribed to women at incorrect dosages.
The FDA has long known of the gender effect of Ambien: In the original 1992 FDA review of Ambien, a reviewer noted that two key measures of how much drug is in the bloodstream “were approximately 45 percent higher in females than in males.”
It wasn’t until 2014, that the National Institutes of Health announced that it would change its policies to ensure that female animals and cells were to be included, and sex differences analyzed, at all stages of the scientific process. Until that announcement, differences between the sexes had been ignored in both scientific and medical research. It should have been obvious that drugs can affect men and women differently. Yet, scientists have routinely studied only male animals. Indeed, all the medication given to women were studied only in male rats.
Women make an average of 4.6 doctor visits per year. Per capita health care spending averaged $5,246 for women compared to $4,125 for men. Their normal bodily stages and functions not only are medicalized but are patholigized. In every era of history and in every phase of women’s lives doctors have sought to control or intervene in women’s reproductive functions. Functions have become symptoms, and symptoms have become diseases. Changes in hormone levels have become deficiencies. In 2002, The National Institute of Health (“NIH”) concluded that the terms “deficiency” and “replacement therapy” were not supported by the data. Despite this conclusion, both terms continue to be used by the medical profession today.
The notion that women need treatment from menstruation to death must be rejected. I believe that being a woman is perfectly normal for half of the population. Men do not go for regular check-ups until a friend drops dead playing tennis or jogging.
Women are the victims of so much unnecessary medical and surgical intervention that it makes them sick. There is no greater illustration of this point than that of the pharmaceutical industry since women are prescribed 70% of all medications. Not only do we usually take responsibility for contraception, we also visit the doctor four times more than men do, making us the key market for doctors and pharmaceutical companies to target.
Contraception is part of a long history of a culture willing to sacrifice women’s bodies for profit. Countless women have lost their fertility, their reproductive organs, and their lives because pharmaceutical companies have put unsafe, untested contraceptive drugs and devices on the market in pursuit of profit—and women trusting their doctors take them without question.
As Dr. J. Robert Wilson stated at the First International Conference of Intra-Uterine Contraception in 1962:
“If we look at this from an over-all long-range view — these are things that I never said out loud before and I don’t know how it is going to sound – perhaps the individual patient is expendable in the general scheme of things, particularly if the infection she acquires is sterilizing and not lethal.”
In 1970, A.H. Robins entered the contraceptive business with the Dalkon Shield, an inexpensive intrauterine device said to be tested by a doctor at a prestigious institution. Nine months after marketing the device, the company first began a two-year baboon safety study. One in every eight baboons died, and 30 percent suffered uterine perforation. The results were never made public.
The Shield was always promoted as preventing pregnancy without adverse effects, even though it was an untested product. FDA pressure led to suspension of marketing efforts in June of 1974, but not until 1984, 10 years later, did Robins recommend that women wearing a Shield have it removed. Through the 1980s, Dalkon Shields remained in the bodies of women in 80 countries. If our Toyota brakes fail, we return the car to the manufacturer. But if there’s a defective device in women’s bodies, we do nothing.
Approximately 2.3 million devices were sold in the U.S. between June 1970 and June 1974, and about two million were sold in other countries. As a result of using the Shield, thousands of women suffered severe uterine perforations, pelvic inflammatory disease, septic abortions, ectopic pregnancies, unplanned childbirth. Many women became sterile, and some had hysterectomies. At least 17 women died from Shield use.
On New Year’s Day 1971, Robins began a crash national advertising and promotional campaign that swept the country.
The typical themes used by Robins throughout Its promotional campaign in which the Shield was claimed to have a superior insertion technique, to have the lowest pregnancy rate, to conform to the shape of the uterine cavity, to reduce involuntary expulsion, cramping and bleeding, to be superior to the pill, and to combine minimal pregnancy rates with exceptional patient tolerance.
The Shield was promoted as preventing and unlike the pill, it would not cause weight gain, depression or headaches.
All these claims were made for a totally untested product. No mention was made of the possibility of widespread, fulminating pelvic disease, septic abortion, spontaneous movement of the device or ectopic pregnancy. The caution did state that “sepsis (infection) may result from unclean technique” and “perforation may result from traumatic insertions,” both statements indicating that if anything went wrong during insertion it would be the doctor’s fault. Although Robins did expand the warnings later, these basic promotional themes were used throughout the life of the product.
The advertising blitz contained false information generated via a widely disseminated statement that clinical trials on 5,000 women at Johns Hopkins University had shown a 1.1 percent pregnancy rate. The only such clinical trial conducted involved only 832 women.
It was not long before Robins began receiving numerous complaints from doctors that the Shield as not as effective as advertised and was causing pelvic inflammatory disease, septic abortions and uterine perforations.
When Shield sales began to slump after doctors discovered the device was not as safe or effective as Robins had been touting it to be, the company mounted a counterattack. Robins changed the patient brochure to claim that if a pregnancy should occur with the Shield, no harm would result to the fetus since the device would simply be gently moved aside by the bag of waters. It was the biggest ad campaign in the history of the IUD business and was repeatedly run in major obstetrics and gynecology journals.
In June 1974, Robins, under pressure from the FDA, suspended marketing of the Dalkon Shield in the U.S. although it continued to sell the device in other countries until April 1975. Not until October 1984, ten years later, did Robins recommend that women wearing the Shield have it removed.
In 1984, Judge Miles Lord called in the corporate officials in to admonish them:
“It is not enough to say, ‘I did not know,’ ‘It was not me,’ ‘Look elsewhere.’ Time and time again, each of you has used this argument in refusing to acknowledge your responsibility in pretending to the world that the chief officers and directors of your gigantic multi-national corporation have no responsibility for the company’s acts and omissions.
If one poor young man were by some act of his—without authority or consent—to inflict such damage upon one woman, he would be jailed for a good portion of the rest of his life. And yet your company, without warning to women, invaded their bodies by the millions and caused them injuries by the thousands. And when the time came for these women to make their claims against your company, you attacked their characters. You inquired into their sexual practices and into the identity of their sex partners. You exposed these women – and ruined families and reputations and careers – in order to intimidate those who would raise their voices against you. You introduced issues that had no relationship whatsoever to the fact that you planted in the bodies of these women instruments of death, of mutilation, of disease.
Please in the name of humanity lift your eyes above the bottom line. You, the men in charge, must surely have hearts and souls and consciences. If the thought of facing up to your transgressions is so unbearable to you, you might do as Roger Tuttle did and confess to your maker, beg forgiveness and mend your ways.”
Robins had Judge Lord’s statement stricken from the record. However, I informed him that I had circulated it around the world.
At the End of the Decade Conference on Women in Kenya, I organized a workshop on the Dalkon Shield and learned from Sister Bernadine Chiche that although she headed a women’s clinic Ethiopia, she had no notice of the Shield’s recall. She asked if I would represent her. I agreed but only if she would send out a recall notice to all Ethiopian women wearing the shield. She did and I represented her in the United States. In fact, I had hundreds of women worldwide and the women of Bangladesh and all other countries (79) received the same compensation as the women of New York.
Medicalization of pregnancy, starting in the 1940’s, was through the use of a synthetic l estrogen known as DES. Its inventor, Sir Charles Dodds, never patented it and was against the automatic prescribing of estrogen for any reason. The men in his laboratory were growing breasts and he thought DES might cause breast cancer. Dodds sent samples to the National Cancer Institute just being established in the United States to Dr. Morris Shimkin. Dr. Dodds asked Dr. Shimkin to investigate the carcinogenicity of stilbrestrol in male rodents. Shimkin and Grady reported in the Journal of the National Cancer Institute in 1950 that stilbestrol produced breast cancers in both male and female mice, which were normally resistant.
Six million American women were given this unsafe, untested, and ineffective drug during their pregnancies. By 1939, there were more than 50 articles documenting the carcinogenic effects of synthetic estrogens, including DES, that had been published in medical journals. From 1950 to 1952, Eli Lilly began the first double-blind controlled study of DES, using its own pills. The results showed that the incidence of miscarriage in DES mothers was twice that in mothers not given DES. DES did not save a single baby. This should have given the industry pause as the results were published in The Journal of Obstetrics & Gynecology in 1953.
In 1959, the Secretary of Health, Education and Welfare announced the potential cancer hazard to the public “occasioned by the use of Stilbestrol-treated poultry.” He ordered a blanket ban on the use of diethylstilbestrol as a poultry additive but not for pregnant women.
On December 15, 1961, Deputy Food and Drug Commissioner Harvey also ordered a blanket ban on the use of DES as a poultry additive, saying: “There is substantial evidence that this drug may be expected to produce, incite, or stimulate cancer growth in human beings.”
A case came into the firm involving a seventeen-year-old woman, Joyce Bichler, who had suffered from clear cell adenocarcinoma of the vagina. All of her reproductive organs and most of her sex organs had to be removed. This was due to her mother’s ingestion of the drug Diethylstilbestrol (“DES”), which had been prescribed during her pregnancy. At the time nobody had brought a DES case and no one thought it could be won.
Bichler v. Lilly case turned out to be the most important and pivotal case in the women’s health movement. It brought to light the callous nature of the pharmaceutical industry and is the most egregious example of the industry’s treatment of women.
In a subsequent case, the doctor denied prescribing DES and the plaintiff had clear cell cancer. The Court stated: “Maybe the mother ate Stilbestrol-fattened poultry.”
Among the six million American women in the United States given the drug was Dorothy Bichler, who had DES prescribed to her by Dr. Abraham Fleisher. The DES was prescribed by its generic name, and Dorothy purchased the prescription at the Willing Pharmacy across the street from her home.
Joyce’s case went to trial before Judge Arnold Guy Fraiman. The only question the first jury had to answer was: Did Mrs. Bichler ingest Eli Lilly’s pills? The pharmacist had previously informed me that he only carried “Lilly’s, the best”. But at trial, Lilly provided him with a defense through its attorneys. It is not strange, under those circumstances that the pharmacist testified at trial that he didn’t know whose pills he used to fill Mrs. Bichler’s prescription.
When the jury was out in the second trial, Lilly’s lawyers made a settlement offer to Joyce of $100,000, good until noon. I told Joyce to sleep on the offer and if she and her husband were not in dire need of the money, not take the settlement because her victory would be a victory for all women. Joyce Bichler is a heroine. In her 20’s, she turned down money for justice. (After a 5-week trial, the Bronx jury returned a verdict for Joyce.)
The verdict was unanimously affirmed by the Appellate Division and the Court of Appeals. The jury found that Eli Lilly had wrongfully marketed the drug for use in preventing miscarriages without performing laboratory tests on pregnant mice. The jury also found that had those tests been performed, Lilly would have learned that DES was capable of causing cancer to develop in female offspring and would not have marketed it.
Bichler v. Lilly was a landmark case, the first mass tort dealing with women, and the first products liability case ever won on a non-identification theory. It held the pharmaceutical industry jointly and severally liable for marketing a generic untested drug that crossed the placenta and caused injuries to the fetus. Lilly’s expert said at the trial that the human is the best test animal.
The Appellate Division succinctly summarized the pharmaceutical industries’ activities:
In 1947, Lilly and other drug companies filed supplemental treatment of certain applications with the FDA for permission to market DES for treatment of certain complications of pregnancy involving early termination of the pregnancy or death of the fetus. The dosage contemplated for this use was several times stronger than the maximum permitted in 1941. This application was made primarily on the strength of two studies by independent researchers, which indicated that DES therapy saved a significant percentage of such high risk pregnancies.
Despite the favorable indications of the few specific studies relied on, serious questions have also been presented, some prior to FDA approval and other prior to use by plaintiff’s mother, concerning the drug’s potential carcinogenic effect and its efficacy for accidents of pregnancy.
Expert testimony was presented at trial to establish the state of scientific knowledge at the time of application to the FDA and during the following years prior to the date DES was prescribed for Mrs. Bichler. It was well known, before FDA approval was sought, that substances given a pregnant woman would pass through the placenta into the fetus. It was also well known that there were available tests in mice which, if conducted, would have demonstrated within six months the danger of cancer developing in the fetus after it reached maturity. In fact, three prominent Chicago physiologists had administered DES to rats and mice in 1939 and concluded that the hormone crossed the placenta and had malforming action on the fetus. In 1938, Dr. Charles Dodds, one of the British researchers responsible for synthesizing DES, had published a summary of conclusions, Dr. Dodds stated that DES could actually cause miscarriages or abortions, not save them. In the late 1940’s, one of the studies cited in Lilly’s supplemental application asked specific questions:
1. Will diethylstilbestrol in large doses cause pituitary or other glandular imbalances which will become manifest later in life?
2. Is diethylstilbestrol in such large doses carcinogenic, and as such unsafe to pregnant women?
3. Can diethylstilbestrol in ay way affect the glandular imbalance of the child in utero, particularly the male child?
None of the questions were noted on the application to the Food and Drug Administration.
My next DES plaintiff was Susan Helmrich. Her injuries were similar to Joyce’s, but her legal status was not. In New York, prior to adoption of a “tort reform” package in 1986 under Governor Mario Cuomo, the general limitations period for bringing a claim resulting from exposure would begin at birth and run until the DES-exposed daughter or son reached the age of twenty-one. Thus, the biggest hurdle for DES litigants was the statute of limitations. This posed a significant dilemma as it related to the litigation, and consequently numerous plaintiffs, including two of my clients, Susan Helmrich and Linda Fleishman, were left without remedies. Susan was twenty-one and a half, Linda was twenty-five.
When Susan’s case was dismissed by the Court of Appeals, we went to the Legislature. Five years later Governor Mario Cuomo signed the Revival and Discovery Statute thus making compensation possible for thousands of women and their children. I ran around the corner in Albany and filed Susan’s case that day. Hundreds of DES and asbestos cases were filed under the Revival Statute as victims sought compensation for their injuries.
In Hymowitz v. Eli Lilly and Company, the Court of Appeals upheld the Revival statue as rationally based and constitutional, although its shift to a market share theory of liability made it more difficult for future DES plaintiffs to recover damages.
Lilly howled that disaster would overtake the drug industry, causing severe detriment to the nation’s health care system. As Lilly’s attorney, Russell H. Beatie, Jr. said succinctly: “Eli Lilly is like any other company ladies and gentlemen. I would be a dummy to stand up here and say it is not in business to make money. It is in business to make money, of course it is.”
Another use for a synthetic estrogen was for another non-disease, treatment of menopause — a natural condition. The road for menopausal treatment is more like a street lined with gold leading up to the door of the pharmaceutical companies. The drug industry has quite a number of elaborate ways to entice us to buy its products. One is to enlist the help of doctors in boosting their products. Another way is through direct-to-consumer advertising. The pharmaceutical industry spent more than $4 billion to get your attention for this non-disease.
Menopause is described in medical literature as “the death of the woman in the woman.” How did it happen that a natural occurrence in life drives us to the doctor’s office in such numbers?
Western medicine has viewed menopause as a medical crisis that had the potential of causing a variety of diseases, from diarrhea to diabetes. The crisis was at first deemed greatest for women who had acted indiscreetly in the past. Such indiscretions included getting too much education, having too much sex, attempting to use birth control, or even being insufficiently devoted to husband and children.
By the middle of the twentieth century, doctors switched from looking upon menopause as the cause of disease and began to think of it as a disease itself – a deficiency disease, like diabetes. This gave them the exclusive right to diagnose menopause and to treat its symptoms with another hormone which women were said to be lacking.
Estrogen was first prescribed for menopausal symptoms in the 1930’s which could be taken as a pill, administered via injection, applied directly to the vagina as a cream, or even taken as a “pleasant-tasting cordial” – 14% alcohol! But in 1947, an alarming report revealed that estrogen therapy could seriously disturb the endometria, thickening the uterine tissue and caused cancer.
By 1966, however warnings had not been disseminated and in Feminine Forever, gynecologist Dr. Robert Wilson trumpeted estrogen therapy as an “elixir of youth” to protect women from the “living decay” of menopause. He declared that estrogen could cure nervousness, crying spells, memory loss, chronic indigestion, aching joints, neuroses, and even suicidal thoughts. In addition to making his book a best-seller, these claims also fueled skyrocketing sales of estrogen, from $20 million before 1966 to $83 million in 1975. Not surprisingly, Wilson had received money from the drug companies for conducting his so-called “research.”
In 1975 an article in the New England Journal of Medicine firmly announced what the 1947 study had suspected – women who took estrogen were about 5 to 14 times more likely to develop cancer of the endometrial lining than women who never used the drug. Further, the longer a woman remained on estrogen therapy, the greater her cancer risk. Finally, in 1976, after lobbying by the women’s health movement, the FDA passed a regulation that every estrogen drug had to have a patient package insert describing its health risks. The medical and pharmaceutical lobby opposed this regulation vigorously, arguing interference with the physician-patient relationship. One doctor went so far as to say that seeing such a package insert might be too emotionally upsetting for women seeking estrogen treatment. However, women seemed to heed the warnings about the dangers of estrogen and when sales decreased by 40%, and the incidence of endometrial cancer fell by about 27% nationwide.
Another example of a totally useless, ineffective and dangerous drug is Parlodel manufactured by Sandoz Pharmaceuticals which was used as a lactation suppressant. No woman needs a lactation suppressant. It is easy to control breast milk without taking another untested, dangerous drug. As to general causation in the Parlodel litigation Dr. Kenneth Kulig, a medical toxicologist and emergency physician, testified that Parlodel could cause strokes, seizures and heart attacks. Dr. Kulig further asserted that the pharmalogical properties of Parlodel as reported in epidemiological studies, clinical studies, case reports and animal studies were sufficient to establish causation. Sandoz agreed that there were no double blind-controlled studies and statistically valid tests that could disprove the injuries caused by Parlodel.
In Looney v. Sandoz the first plaintiff in this litigation came to me because his twenty-one year old wife was given Parlodel solely for the purpose of drying up her breast milk. When she brought her new baby home, she complained bitterly of migraine headaches. Gary Looney, her husband, took her to three hospitals in San Francisco. At each hospital she was told to go home and take an aspirin. She died the next day. Gary Looney was then left at age 22 to deal with a newborn baby and a 2 ½ year old child. The case was settled by Sandoz for $1.5 million dollars. There were several subsequent cases where Sandoz continued to deny responsibility for the severe injuries women suffered from a totally useless drug.
Chorionic Villus Sampling (CVS) was and remains a dangerous prenatal test that is given at around 10-11 weeks of pregnancy instead of amniocentesis. According to the CDC the procedure results in a six-fold increase in limb reductions. My first client, Cynthia Kernatz, had a child born without fingers after her doctor performed the procedure. Cynthia was never informed of any dangers with the test. I had several of these cases. I went to Philadelphia to meet with the inventor. He informed me that the test was perfect and the administration of the test done by doctors was the cause of the limb reductions. None of the mothers of the children were ever informed of any risks.
Another aspect of medicalization is female castration which is still the goldmine of American gynecology. After C-sections, it is the most performed non-obstetric operation in the U.S. at the rate of about 1,643 per day. Sex organs have been removed from more than 22 million U.S. women. Doctors at an OB/GYN conference agreed that “no ovary is good enough to leave in, and no testicle is bad enough to take out”.
In Saudi Arabia a gynecologist may perform only one hysterectomy a year, usually due to a life-threatening event such as an obstetric hemorrhage. In Somalia, uterus removal is viewed as so rare and abhorrent that in 2004 the family of a hysterectomy patient dispatched gunmen to threaten her doctor. They argued that she was as good as dead without a womb, and demanded 50 camels – the usual Somali compensation offered upon a woman’s death. The doctor, who was fined $2,000, promised that in the future he would consult patients’ families before performing such operations.
In the U.S., 45.1% or more of women ages 65 and under in the U.S. report having undergone a hysterectomy. Rates vary by state; in New York the rate is 13.3% with 3.2% in the 44 and under group. Mississippi has the highest rate at 57.1%. No wonder hysterectomies are often called “Mississippi appendectomies.”
Approximately 1 in 2 American women will have a hysterectomy by the time she is 70. More than 400,000 hysterectomies are performed for uterine fibroids, which is a benign condition. Even by conservative estimates, 9 out of 10 American hysterectomies are elective procedures. In addition, surgical removal of the ovaries is done in about 75% of women who have hysterectomies, with no medical justification.
Further, Medicare and Medicaid statistics reveal that the more body parts a doctor removes, the more money the doctor and the hospital receive. The rate of reimbursement for treatments for uterine fibroids from Medicare and Medicaid were as follows:
1. Total hysterectomy $5,200
2. Vaginal hysterectomy, including removal of fallopian tubes and/or ovaries $5,140
3. Abdominal myomectemy $5,132
4. Vaginal hysterectomy $5,051
5. Vaginal myomectemy $1,746
This provides zero incentive to doctors to change their ways. Meanwhile, the increasing number of women physicians has been ineffectual in curtailing the contrast in attitudes towards women’s and men’s reproductive organs.
Breasts are a symbol of a woman’s self-worth. In the U.S. the Society of Plastic and Reconstructive Surgeons issued a memo to the FDA:
“There is a substantial and enlarging body of medical information and opinion to the effect that theses deformities (small breasts) are really a disease, that left uncorrected, result in a total lack of well-being.”
I was Chair of the Foreign Plaintiffs Subcommittee and a member of the Plaintiffs’ six-person Settlement Committee, and throughout the MDL-926 settlement discussions the plaintiff’s bar and the MDL Judge both agreed “no money should go to the foreigns.” I appealed the settlement to the 11th Circuit, resulting in a 25 million dollar fund for foreign plaintiffs.
During the years that 1 million U.S. women and 1 million foreign women had silicone gel breast implants placed inside their bodies, plastic surgery was the most rapidly growing medical specialty. Between 1965 and 1989, the number of doctors who called themselves plastic surgeons multiplied four times, more than twice the rate of physicians as a whole. In one year, more than 350,000 women and teens had breast implant surgery. Only 57,000 of those were for reconstruction after a mastectomy.
By portraying large-breasted happy women while advertising risk-free surgery, plastic surgeons capitalized on many women’s dissatisfaction with their bodies. The doctors’ marketing strategies fueled the demand for cosmetic breast augmentation. One could argue that by encouraging healthy people to undergo surgery, the doctors violated the medical precept “First do not harm.”
Foreign women had even fewer warnings than women in the U.S. and defective devices were shipped to them. For example, a memo from McGhan Medical Corporation dated 10/22/76 reads as follows:
“Product deviates from specifications due to visible flaws. Request approval to release product for shipment to Mexico.” This was signed by the quality assurance manager, the product director, and the production manager.
In addition to the cases I have mentioned, lawyers often use their legal training and law licenses to effect social change. If women lawyers and activists do not secure and protect the legal rights of their sisters, who will?
In the 1980s I, and my then-client Karen DeCrow, initiated a civil action on behalf of three abortion rights organizations including Abortion Rights Mobilization, Inc., five women’s health clinics, a women’s center, five clergy and fifteen (15) voters against the United States Secretary of the Treasury, the Commissioner of Internal Revenue, and two Catholic church groups to challenge the enforcement of § 501(c)(3) of the Internal Revenue Code which exempted from taxation groups,
“organized and operated exclusively for religious, charitable,…or educational purposes,…no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation…, and which does not participate in, or intervene in (including the publishing or distributing of statements), any political campaign on behalf of any candidate for public office.”
This provision of the Code also provided a double benefit to organizations that were tax-exempt under this provision because it permitted an income, gift or estate tax deduction for contributions to such entities. Although the groups were allowed to lobby, their attempts to influence legislation could not constitute a “substantial part” of their activities. We, the plaintiffs’ lawyers in that case, Abortion Rights Mobilization, Inc. (“ARM”), et al. v. Regan, et al., 544 F.Supp. 471(S.D.N.Y. 1982), sought a declaration from the court that the political activities of the Roman Catholic Church and the inaction by the Secretary and the Commissioner violated the Constitution. Ultimately, the Court found that the voter plaintiffs, the three abortion rights organizations and the members of the clergy had standing to proceed with their action to contest the alleged infringement of their right to participate in the political process on equal terms with all others and free from arbitrary government interference and to assert a challenge against the unconstitutional establishment of religion.
This year alone 1,218 provisions have been introduced relating to reproductive rights. Since 2010 the states have adopted a total of 334 new abortion restrictions constituting 30% of all state enacted abortion restrictions since Roe v. Wade in 1973.
It is depressing to think about the barriers to reproductive justice, the backlash against the gains of the women’s movement, the failure of governmental authorities to enforce laws that guarantee women’s rights and the entrenched traditions and political views that encourage politicians to deny funding for women’s reproductive health and to enact laws designed to prevent the closing of clinics that provide necessary services. The Guttmacher Institute estimates that fifty-seven percent of American women live in states that are openly hostile toward women’s reproductive rights.
State laws to restrict abortion can be characterized as follows: Personhood legislation, Near-Total Abortion Bans; Abortion Bans After Twelve Weeks; Biased Counseling and Mandatory Delays; Counseling Bans and Gag Rules; Insurance Prohibition for Abortion; Refusal to Provide Medical Services; Restrictions on Low-Income Women’s Access to Abortion; Restrictions on Young Women’s Access to Abortion; and Targeted Regulation of Abortion Providers (TRAP).
Fifteen states have near-total criminal bans on abortion that are clearly unconstitutional. Louisiana and Utah enacted the bans in 1991 and 2013, almost three decades after Roe was decided. Mississippi, North Dakota, South Dakota and Louisiana have “trigger” laws that would immediately result in a criminal ban on abortion should Roe be overturned.
In 2011, Ohio became the first state to consider a bill that would ban abortion as soon as a fetal heartbeat could be detected. This “heartbeat” bill, while not technically a near-total ban, would effectively outlaw abortion in most circumstances, with no exceptions for rape, incest, or fetal anomaly because a fetal heartbeat can detected as early as six weeks into a pregnancy. These laws are clearly unconstitutional. In 2013, North Dakota also enacted a “heartbeat” law that would have made abortion illegal as early as six weeks. The District Court ruled the law unconstitutional in April 2014.
In nine of the seventeen states that mandate that women be given counseling before an abortion, providers are required to talk about the long-term mental health consequences for a woman, and she will only be told about the possible negative responses, despite the evidence that many women actually feel relief. In five states, women will be told that having an abortion means they are more likely to get breast cancer despite the fact this has been definitely refuted by the National Cancer Institute. Twelve states require that a women be counseled on the fetus’ ability to feel pain, despite the fact that the American College of Obstetricians and Gynecologists has stated that a fetus is not capable of feeling pain until 27 weeks.
Despite Roe’s prohibiting states from banning abortions in the first trimester, “[twenty] states have unconstitutional and unenforceable bans that could outlaw abortion as early as the twelfth week of pregnancy, with no exception to protect a woman’s health.” Nebraska enacted a pre-viability abortion ban that prohibits access to abortion after twenty weeks, and thirteen states have followed this path. While the original Nebraska ban rests on the claim of fetal pain as its justification, its sponsors readily admit that it was intended as a challenge to Roe v. Wade. In fact, the true intent of these laws has become clearer as several states introduced twenty-week bans that were not predicated on fetal pain. Instead, they ban pre-viability abortion restrictions disregarding Supreme Court precedent.
The arguments made to undermine a woman’s reproductive freedom are not new. As the testimony before Governor Nelson Rockefeller’s Commission on Reproductive Rights demonstrates, the anti-choice movement has always argued fetal pain, life at conception, and morals. While some rights have been chopped away, the Supreme Court has reaffirmed the right to an abortion this year in Whole Women’s Health vs. Hellerstadt et al in an opinion by Justice Breyer.
As the year 2016 comes to a close, the trend of medicalizing women’s biology shows no sign of abating. According to the American College of Obstetricians and Gynecologists, about two-thirds of American women rely on their gynecologists for primary care. Unsafe and questionable methods of contraception are still used. The Mirena intrauterine device promises effective birth control for up to 5 years. During pregnancy, upwards of 20 tests are performed on both mother and unborn child, some of which are more perilous than the conditions they purport to detect. Surgically, women undergo numerous unnecessary C-sections, hysterectomies, oophorectomies, and other procedures.
“Many of the procedures performed on women’s reproductive organs, and medications administered to control them, have been unsupported by empirical evidence. Reproductive technologies penetrate the female genitalia whether medically or surgically…..Finally, women’s doctors decreed that menopausal women are deficient, that women must maintain childbearing levels of hormones rather than progress through the normal stages of life. Each of these interventions has been justified by ‘science’ …. [but] seldom have we examined the reason we ask the ‘scientific’ questions”.
Despite the social progress made by women in recent decades, we have not advanced far enough when it comes to our biology. Clearly, it is not enough for feminist lawyers to fight and win battles for women’s lives on the courthouse steps. We also ask feminist women and men to ensure that the rights we fought so hard to obtain translate into meaningful changes in the lives of women and their families. We must go beyond our offices, outside the courtrooms, and into women’s lives. We have to ask women what they need, what is important to them, and make sure that their voices drive the laws and policies we create.