NORPLANT AND THE DAMAGE DONE
Most of the time the twins were asleep in bed and Laura was doing the dinner dishes or straightening up the house when the throbbing started, a relentless thudding in her head that made her stomach churn and forced her eyes shut. "Have you ever gotten a headache from eating ice cream?" she asks. "Multiply that times about 80. I'd get to the bathroom and puke until I had the dry heaves. More than once my husband had to pick me off the bathroom floor and walk me or carry me to bed. He'd give me the medicine I took for migraines. Before I had the Norplant, I was the kind of person who never even had to take an aspirin for a headache."
The migraines came and went, but the menstrual bleeding was almost constant. During one seven-month stretch, "I had just 11 days off from my period. Sometimes I had profuse bleeding. I had a diminished sex drive. I had this loss of appetite but kept gaining weight, like about 40 pounds. My hair was coming out in handfuls," she continues, listing the particulars of her "three years in hell" in a clipped, businesslike fashion, lest she linger over the memory and lose her composure. "A typical day for me would be to get up and concentrate real hard on getting everything that needed to be done done, to make it to the end of the day. I wanted to sleep all the time, but sometimes I couldn't sleep at all."
At first, Laura and her family and friends thought she was suffering from postpartum depression. She had given birth to twins, her first two children, on Valentine's Day in 1991. Knowing she didn't want more kids in the near future but not ready to rule out the possibility altogether, she seemed an ideal candidate for Norplant, a form of birth control that had been approved for commercial use by the FDA just two months earlier. Norplant consists of six thin capsules the size of cardboard matchsticks that are surgically implanted on the underside of a woman's upper arm. The capsules slowly release a synthetic hormone designed to prevent the release of eggs from a woman's ovaries and to thicken the mucus in her cervix. It's supposed to prevent pregnancy for a five-year period. After hearing about Norplant from her doctor and reading the information he provided her about the product and its potential side effects, Laura agreed to have it inserted in March 1991. "I thought, great. I'm going to be busy with the twins and I don't have to take the Pill, and it's not going to have any more unusual side effects than the Pill, which I had taken before," she says.
In fact, Laura was so assured of the safety of Norplant that she didn't even think of it as a potential source of her myriad problems until years later. "I thought it was me, that I was having a really hard time with being a parent," she says with a trace of bitterness. At her mother's urging, she went to a psychiatrist, who saw how overwhelmed she was and prescribed Prozac, which she stopped taking after three weeks.
"It got to the point where she thought she was losing her mind," says Kim, Laura's best friend since childhood. "At first she was always angry and then she became distant with me. Finally I told her I was really concerned for her--that she was heading down a road she wasn't going to return from, one that didn't have anything to do with motherhood, and that I thought it might have something to do with that Norplant."
Laura's husband had recently begun voicing the same suspicions. "I suddenly realized I had been confined to something that wasn't myself," Laura says. "Because my hair was so thin, I wore it short; I had always had long hair. These cysts kept appearing on my face; it took me four plastic surgeries to get rid of them. I've never had cysts before or since. I've always been happy and artistic, but I had lost the ability to express myself, to do any painting or to just sing to myself. I was overwhelmed because I couldn't be all of myself. And I realized that I had to have it taken out."
She finally had the capsules removed in 1994. "I was a whole new woman inside of a week," she says. "I told my husband it was like looking through a shroud for three years, and then it came off. I love my kids so much, and I truly regret I was not the best parent I could be over those three years. They teach me how to be a good mom sometimes; I didn't pick up on that before. I'm thinking about when my sons caught their first fish. It was a big moment for them and for me too. On the Norplant I probably would have missed that feeling. I have this wonderful life," she says, starting to cry, "and I didn't even know it was there."
Thousands of women across the country have told similar stories about their experience with Norplant. They describe episodes of prolonged bleeding, splitting headaches, abrupt mood swings, extraordinary weight gain, hair loss, and acne allegedly caused by the drug. In addition, some doctors have had difficulty locating and removing all of the capsules when women have asked to have them taken out. Hundreds of lawsuits have been filed against manufacturer Wyeth-Ayerst Laboratories.
Wyeth has responded aggressively, in essence attempting to recast the issue not as one of product liability but of rampant "litigation abuse" that has placed the company "under siege" by greedy lawyers whose "cookie cutter" lawsuits are orchestrated so that the company either has to settle out of court or endure negative publicity that costs it money. Wyeth says that in the first three years after it was approved by the FDA for the U.S. market, Norplant was used by more than 800,000 women, yet generated fewer than 20 lawsuits alleging that the device caused them injury. Then, on the heels of a billion-dollar settlement over the use of silicone in breast implants, more than 600 lawsuits against Norplant have been filed in the past two years while sales have plummeted from approximately 800 to 100 units per day. Noting that the FDA has repeated its opinion that Norplant is safe, Wyeth says it will contest the lawsuits and assist any health care provider who is sued in connection with the device.
One of the main villains in Wyeth's scenario is Minneapolis attorney Roger Brosnahan of Brosnahan Joseph & Suggs, who is the co-chair of the court-appointed Plaintiffs' Steering Committee, a group of 16 attorneys from around the country who, according to Brosnahan, represent approximately 50,000 women--including more than 1,000 Minnesotans--claiming to have been injured by Norplant.
Brosnahan demurs at some of the class action liability suits pursued in courts in recent years, but says the Norplant litigation is different from, say, the current tobacco litigation, which involves up to 50 companies and 50 years of product use. "We've got one defendant," he says. "We've got one product. We've got one short period of time when the product has been used. We've got one core set of warnings concerning side effects. And we've got one constellation of injuries that covers about 99.5 percent of the women.
"Fortunately, most of those injuries are not permanent. But here's the problem: It takes a tremendous amount of time and expense to bring a case against a drug company, and without permanent injury, an individual woman can't get anyone to represent her because the potential damages are not sufficient. Bringing in a single expert [to testify] might cost as much as she could reasonably expect to recover at a trial. This is one of those rare cases when class action is the proper tool."
Thus far the courts have been reluctant to agree. Federal judges in San Francisco and Chicago have ruled against certifying a nationwide class of Norplant plaintiffs. The most likely setting for a class action trial is in eastern Texas, where a federal judge has taken some preliminary steps toward certification but wants a couple of individual cases to be tried to clarify some of the issues before making his final ruling. Those individual trials are not scheduled to start until the beginning of next year.
"Are [the plaintiffs' attorneys] working together on this? Sure we are," Brosnahan says in response to Wyeth's conspiracy theory. "I am aware that my four-person shop may not be able to stand toe-to-toe with a $43 billion company that is hiring 500 lawyers ready to spend night and day papering the hell out of me. So people in my business form organizations and associations to parcel out the work and share the results and the risks. But where does it start? Do lawyers create side effects? No, it starts with women calling you up saying, 'I understand you do this kind of work; can you help me?' And you go off to a conference someplace and Charlie from L.A. says he's been getting calls about the same thing. Then you say, 'Well, let's see if Joe from Boston has gotten anything like that.' And pretty soon you're in a room together realizing that this goddamn thing is all over the country.
"[Wyeth] would much rather I compete against the guy up the street instead of us working together for the benefit of these women. They would prefer that I can't call a meeting in Dallas, as I did 10 days ago, and get 18 of the best lawyers in the country sitting around a table for five hours planning how to get these guys. Certainly the legal basis is simple and straightforward: negligence and misrepresentation. Failure to warn."
Wyeth spokesperson Audrey Ashby claims that when a woman goes into a health clinic considering the possibility of getting Norplant, there are videotapes and a wealth of written material available detailing potential side effects and informing her about pre-existing medical conditions that would make her an unsuitable candidate for the implants. And the materials supplied by Wyeth do stress that Norplant may cause changes in menstrual bleeding and can lead to headaches, weight gain, and some of the other maladies described by women who have had unpleasant experiences with the product.
In some of the Wyeth literature, the purported risks of Norplant are juxtaposed with those of taking the Pill. After reading about blood clots, heart attacks and strokes, gall bladder disease, liver tumors, and cancer of the reproductive organs, what's described as a headache and some irregular bleeding suddenly doesn't seem so dire, especially when the literature says that "women can expect an altered bleeding pattern to become more regular after nine to 12 months," and that in any case, "the monthly blood loss is usually less than normal menses. In fact, in some studies, patient blood counts have improved." In this context, it may not be surprising that women who have had relatively positive experiences with the Pill--such as Laura--will fail to think much of the Norplant product warnings.
For the clear majority of women who use Norplant and find it to be a highly effective, long-lasting, hassle-free method of birth control, the wording of Wyeth's warnings are a moot point. But a significant minority--thousands of women--claim that Wyeth misled them by not providing more specific data on the potential frequency and severity of Norplant's side effects. "Saying that there is a chance of irregular bleeding or menstrual changes doesn't give women enough information upon which to make a decision," says Brosnahan's law partner Jane Joseph. "But if you tell women there is a chance they might bleed 20 days a month for an indefinite period of time, or possibly become depressed to the point of requiring prescription medication, or perhaps gain 25 pounds in a period of four months, they have a much better idea of the real potential side effects. That is the crux of our warnings case. Based on the data Wyeth had at the time, they chose to underinform rather than inform the women of the possibility of the experience."
Much of the clinical research associated with Norplant was conducted not by Wyeth, but by an international organization known as The Population Council. In the process of going through discovery proceedings for the upcoming lawsuits, Brosnahan and other lawyers came upon the Population Council's original application for FDA approval of Norplant, which they say included the percentages of people suffering from various side effects during the course of the clinical trials. (Its public release is currently blocked by a confidentiality order issued by a judge in connection to the lawsuits.) Both Brosnahan and Joseph say that if Wyeth had been similarly specific in its warnings and labeling, there would be no Norplant lawsuits today.
"We'll probably be able to get that confidentiality order lifted in about six weeks, and then we'll get about 25 documents released that will allow people to see what this bullshit is all about with Wyeth's PR campaign saying that the lawyers have caused the whole problem," Brosnahan says. He claims Wyeth's own sales figures reveal that while 970,000 Norplants were purchased in this country from 1991 to '95, the product's peak period was actually its second year on the market, in 1992, when it sold approximately 414,000. "The next year  it fell out of bed, dropped by more than 100,000. Yet in depositions with executives from the company, they admit there was no significant litigation until March 1994," Brosnahan says, adding that the executives explain the drop-off as a result of the initial pent-up demand for the product being satisfied during its first two years of availability. That is also the reason given by Wyeth spokeswoman Ashby, who prefers to emphasize that after Norplant sales revenues topped $100 million in both '92 and '93, negative publicity from the lawsuits pushed it well below that mark in '94 and '95.
According to Brosnahan, he also discovered that while Norplant is designed and marketed as a five-year program, a full 38 percent of its users have it removed in two years or less--and that only 12 percent of those people cite the desire to get pregnant as a reason. That may be a low figure, since Medicaid will not pay the $200-$300 removal costs unless it is medically necessary, and women who have changed their mind about getting pregnant may concoct a medical excuse in order to get the procedure subsidized. It is also possible that Brosnahan, a tort lawyer who is prevented by a judge's order of confidentiality from backing up his claims with documentation, is blowing a certain amount of smoke. But by Wyeth's own account, fewer women are getting Norplant inserted.
Removing Norplant, as it turns out, can have complications of its own. One local birth control counselor who has advised women on their contraceptive options for the past 15 years says she had Norplant inserted in August 1993 and that it was "a fantastic method for me, with no side effects." But with a wedding planned for this summer, she decided to get her Norplant removed this spring, an experience that confirmed her suspicion that "physicians are only now getting hit with a lot of removals, and a lot of them have been trained to put in Norplant but not to take it out."
Like a great many people, the woman had switched health plans in the last two or three years, practically guaranteeing that the doctor who removed her Norplant would not be the same person who initially put it in. Aware that the complication rate for this procedure goes up among doctors who have not performed it at least 150 times, she exercised a right she always urges on those she counsels. She specifically asked for the most experienced, conscientious physician--"the one who does all the difficult patients"--to perform the removal. Despite her precautions, the procedure that Wyeth claims should consume just 10-20 minutes actually lasted for nearly two hours. One of the capsules had traveled up her arm and had to be located with ultrasound before it could be removed. She says the procedure was a lot more painful and harrowing than she had expected.
Among the thousands of women being represented by the Plaintiffs' Steering Committee are some who have had problems with the insertion and/or removal of Norplant. Ever since the product was put on the market, Wyeth has had a toll-free number directing consumers to physicians and clinics with surgical and clinical experience in how to deal with it; during the same period, the company has offered free courses and surgical training for eligible health care providers. But at the same time, neither Wyeth nor the FDA has stipulated that the health professionals receive that training as a precondition for working with Norplant. And until recently, claims Joseph, the company did not urge consumers in their literature to question physicians and nurses about their level of experience with the product.
As Joseph points out, ob/gyn doctors are not likely to be very familiar with the neurovascular properties of the arm, where Norplant is inserted and removed. In its literature, Wyeth states that both insertion and removal can be accomplished in a matter of minutes, yet it can be a deceptively complicated process, particularly if the doctor has little or no experience with the procedures, or is removing a device implanted by somebody else. If the device is inserted too deeply, the capsules are more apt to travel away from the site; a too-shallow implant increases the risk of infection and rejection by the body.
The issue of doctors' lack of expertise with Norplant goes beyond insertions and removals. "Originally, [Wyeth] wanted all the providers to go through a training program to learn about Norplant," says Dr. Marilyn Joseph (no relation to attorney Jane Joseph), medical director of Boynton Health Services on the University of Minnesota campus. "But there was a lot of resistance among the clinicians to have to go through the training, so the company, for PR purposes, abandoned it." Joseph, who has gone through the training and says she "almost tries to dissuade people from using Norplant, because of the bleeding and to make sure they really want it," claims that "many doctors didn't tell their patients anything other than it was an effective form of birth control for five years, and they don't have to worry about any bleeding or anything." There are some Norplant-related lawsuits that seek damages against the physician as well as (or instead of) Wyeth; this is not the case among the largest group of Minnesota plaintiffs, whose attorneys believe, as Jane Joseph puts it, "that the doctors were duped [by Wyeth's claims of safety] as much as the patients."
There is still a chance that there won't be a class action suit certified against Norplant's makers after all, but in the meantime Wyeth is playing the "nuisance litigation" theme to the hilt. And it's having an impact: In Congress and on Main Street, a heavily, if surreptitiously, promoted corporate campaign to restrict product liability and rein in tort lawyers has been gaining momentum for a few years now. The movement is boosted by learned articles in media such as the The New York Times, Newsweek, and Family Planning Perspectives arguing that overregulation and the fear of lawsuits is stalling research and development on innovative new contraceptive products.
That's one way to spin it. But according to a 1993 report by the Program for Appropriate Technology in Health (or PATH), many drug companies view mature markets such as the United States as containing little additional profit potential. Ironically, proven options in this market include products like the Pill and IUDs, which were made safer and more effective as a result of celebrated lawsuits against them. Short of creating an altogether new form of contraception with broad appeal--like the long-heralded promise of a male oral contraceptive--most companies feel that new products would simply prey upon, and thus disrupt, the existing market for already developed, already profitable products.
When they do want to introduce a major new product into the market, they often find nonprofit or public groups to underwrite much of the research, as Wyeth did with the Population Council in the course of developing Norplant. A 1995 Rockefeller Foundation report estimated that pharmaceutical companies were raking in as much as $2.9 billion annually on contraceptive products while spending a paltry $22 million on research. With specific regard to Norplant, which reportedly sells for as little as $23 per unit in some parts of the world, Brosnahan says that Wyeth (which is a division of the multi-billion-dollar American Home Products Corporation) determined it would have a 90 percent gross profit if Norplant sold for $285 per unit four years ago. It currently retails in the United States for $365 per unit, a sum that Wyeth spokeswoman Audrey Ayers defends by saying it still makes Norplant one of the most cost-effective birth control methods available. Unless you're one of the unlucky few for whom the matter of side effects becomes more than a footnote in product literature.
Ryan Peck and Jon Segal contributed research to this story.
Norplant, the Law, and Social Engineering
by Britt Robson
JUST TWO DAYS after Norplant received FDA approval for use in the United States, the Philadelphia Inquirer published an editorial headlined "Poverty and Norplant--Can Contraception Reduce the Underclass?" It advocated the promotion of the device for welfare mothers and other poor women. The editorial writer, Donald Kimelman, acknowledged that he was "perhaps raising the specter of eugenics. But it would be worse to avoid drawing the logical conclusion that foolproof contraception could be invaluable in breaking the cycle of inner city poverty."
Norplant surfaced at a time when the United States was bringing eugenics out of the closet again. The country has a long and dishonorable, if seldom told, history of coercing "undesirable" people not to have children. Historical studies such as Philip Reilly's The Surgical Solution and Allan Chase's The Legacy of Malthus point to more than 60,000 cases of involuntary sterilization between 1907 and 1964. In view of the fact that some states (including Virginia and North Carolina) had sterilization programs that continued into the 1970s, and because sterilizations have also occurred in an illegal, clandestine fashion throughout this century, the actual number is probably much higher.
Less invasive and less permanent than vasectomies or tubal ligations, Norplant has breathed fresh life into the prospect of socially prescribed sterilization. A month after the device's approval by the FDA, a California judge gave a woman convicted of child abuse the choice of getting a Norplant or going to jail for two to four years. That same year, 1991, a Texas judge ordered another woman convicted of child abuse to get Norplant as a condition of her sentence. Politicians were a little slower to see the potential; Louisiana gubernatorial candidate David Duke was ahead of the curve in 1991 when he proposed cash payments to welfare mothers who agreed to use Norplant. But in the first half of 1993, 17 legislative measures were introduced in 10 states involving the use of Norplant as a coercive form of birth control for women convicted of child abuse or drug addiction or, in some cases, for any woman on public assistance.
While the use of Norplant as an express tool of social engineering has yet to elicit a court challenge, the ACLU has argued that making a woman "choose" between prison and Norplant violates her fundamental constitutional right to control her own body, particularly since the device cannot be removed without a medical procedure. "Allowing judges and legislators to control the reproduction of some women would legitimize the role of government as an overseer of women's childbearing capacity in general," according to one ACLU paper. As the ACLU puts it, "The incentive plans target women on welfare, and the sentencing tactics have been disproportionately aimed at low-income women of color. These policies are reminiscent of the eugenics movement earlier this century, which targeted low-income, non-English speaking women and women of color for forced sterilization."
The R&D genesis of Norplant gives critics more ammunition. Back in 1974, National Security Council head Henry Kissinger commissioned a study to articulate a worldwide population policy. The resulting report noted that the U.S. comprised just 6 percent of the world's population yet used about a third of its resources, and that one way to avoid increased competition for that lion's share was to restrict local consumption through population control programs. One declassified NSC paper unearthed by the anti-abortion American Life League, entitled "Implications of Worldwide Population Growth for U.S. Security and Overseas Interests," prudently noted that "it is important in style as well as substance to avoid the appearance of coercion." Another NSC document, written two years later, found that, "In some cases, strong direction has involved incentives such as payment to acceptors for sterilization, or disincentives such as giving low priorities in the allocation of housing and schooling to those with larger families. Such direction is the [essence] of an effective program." By 1977, a high-ranking official in the U.S. Agency for International Development (USAID) was quoted as saying that his agency's goal was to sterilize one quarter of the world's women.
Enter Norplant. Wyeth-Ayerst Laboratories, the maker of the device, proudly states in its literature that Norplant has been tested "for over 20 years in 55 countries worldwide." Much of that testing has been carried out by The Population Council, a nonprofit organization founded by international financier John Rockefeller III, with a history of members on its board who are connected to the World Bank, an organization notorious for linking economic monetary policy toward Third World countries with those countries' deference to multinational corporations. A substantial amount of Population Council funding has come from USAID.
During that time there have been periodic media reports of coercive testing of Norplant on Third World women. At a 1990 meeting of the American Public Health Association, Dr. Shayam Thapa claimed that when Norplant was tested in Bangladesh, only one-fourth of the many women who wanted the capsules removed due to negative side effects could find a doctor willing to do so. The BBC television documentary program Horizon reported that the women in Bangladesh were not told their Norplants were part of a clinical trial--in other words, that the women did not give informed consent--and that their complaints of side effects and pleas to have the devices removed were ignored. The television crew filmed records purporting to show that out of 1,300 women involved in the trials, more than 100 were reported as being refused removal of their Norplants. Spokespeople for both Wyeth and the Population Council say that reports of coercion in Bangladesh are sensationalistic and that Norplant was not on clinical trial in Bangladesh.
Meanwhile, back in the United States, a 1993 study by Contraceptive Technology Update found that low-income women were commonly receiving Norplant free of charge through Medicaid, only to find that Medicaid often would not pay for removal when the women complained of side effects. The study found that the women frequently were not informed that they would have to bear the cost of Norplant removal if it was done before the five-year expiration date. Medicaid does pay for removal in cases of medical necessity, but that's not as encompassing as it sounds: One woman in South Dakota gained 65 pounds in 6 months yet was informed there was no medical justification for Medicaid paying for removal of her Norplant.
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