MAY 29, 1996
Elizabeth Brackett of WTTW-Chicago reports on problems a number of women have experienced using the Norplant birth control device.
ELIZABETH BRACKETT: There's a small room in a Chicago law office that's crammed from floor to ceiling with file folders. Inside each one is a story of suffering, a story of a woman who says she's had problems or worse with this. It's called Norplant, and it's a birth control system that was hailed as a breakthrough when it was approved by the Food & Drug Administration five years ago. Now it's in deep legal trouble and may disappear from the American market. Some say it's a good product unfairly hounded by overzealous lawyers. Not this woman--she's one of the plaintiffs.
PAM SKOWRONSKI: I wouldn't do it again if I had, you know, the chance. I think I would, uh, either abstain from having sex till I decided to have another child or, umm, probably just be sick and be on the pill and deal with those complications because that was nothing compared to what I went through when I had the Norplant put in.
ELIZABETH BRACKETT: But as Pamela Skowronski really a victim of Norplant? For every user like Pamela, there are others like Terry Stoica.
TERRY STOICA: I'm still very happy that I chose the method. It's been, umm, good birth control for me. I think the side effects for me have been an irritation, rather than something serious.
ELIZABETH BRACKETT: No one thought Norplant would be this controversial when it was still in the lab. Population control groups had spent years searching for a new and more effective contraceptive, and Norplant seemed to fill the bill. It had been extensively tested both inside and outside the United States. The U.S. distributor, Wyeth-Ayerst, even produced patient videos explaining how Norplant worked. Six small capsules containing the synthetic hormone levonorgestrel are inserted under the skin in a minor surgical procedure. As long as the capsules are in, the hormone continues to enter the body preventing pregnancy. They can be removed surgically any time a woman wants, but left alone, they work unattended for five years. Small wonder that real patients praised Norplant in the company's videos.
WOMAN: (Wyeth-Ayerst Video) Once I heard about the Norplant and what it can do for you, I said, gee, that sounds great.
SECOND WOMAN: (Wyeth-Ayerst Video) It's a peace of mind that I've never experienced with any other kind of birth control.
ELIZABETH BRACKETT: But Jewel Klein's clients tell a different story. She represents Skowronski and thousands of other plaintiffs who tell tales of difficult removals which left ugly bruises and scars, along with serious side effects, ranging from lengthy, painful menstrual periods to excessive weight gains.
JEWEL KLEIN, Plaintiff Lawyer: We're suing because they put out this product, they said it was the greatest thing since sliced bread, they marketed it that way, and our clients were fooled. They didn't get what they bargained for, and many of our clients have really lost a year or two out of their life until they got the poison out of their system.
DR. MARC DEITCH, Medical Director, Wyeth-Ayerst: I'm the senior most person, senior person in the company responsible for drug safety. I have not seen anything that is unexpected that is related to Norplant.
ELIZABETH BRACKETT: Wyeth-Ayerst is convinced it's being targeted by litigators looking for new products to attack after the silicone breast implant controversy. The company points out that many lawyers actively advertised for clients. Dr. Marc Deitch, medical director at Wyeth-Ayerst, says women were clearly warned of well known side effects from using any progestin-only drug.
DR. MARC DEITCH: Well, you have one of the best studied progestins and best studied methods of contraception that we have. Prior to introducing Norplant, um, we, we certainly knew what the side effects were, and one thing we knew was really important when we introduced the product was that counseling would be very important. Not every contraceptive method is the right choice for every woman, and that way women would understand that--what they could expect and when physicians and other health care providers spent the time to explain to women what the side effects were and what they could expect, they could make a good choice. When you look at the over--almost 1 million women that have used Norplant, you find an extremely high level of satisfaction.
ELIZABETH BRACKETT: The company's promotional literature was clear about the side effects, and so were the videos.
WOMAN: (Wyeth-Ayerst Video) Changes in menstruation are to be expected with this system. They may include prolonged menstrual bleeding, bleeding or spotting between periods, no bleeding for several months, or any combination of these. As you just heard, the pattern differs from woman to woman. It's impossible to predict what you might experience.
ELIZABETH BRACKETT: But no warning prepared Skowronski for what she experienced--severe abdominal pain, a painfully bruised arm when the Norplant was removed, continuous heavy menstrual bleeding after removal, and eight months later a hysterectomy.
ELIZABETH BRACKETT: And do you think that hysterectomy was from the Norplant?
PAM SKOWRONSKI: Umm, I'm not a doctor but from all the, from the time it was--Norplant was put in my arm till I had that hysterectomy nothing but trouble. So I--and women in my family don't have those kind of problems, so--
ELIZABETH BRACKETT: How much did Norplant change your life?
PAM SKOWRONSKI: Real--a lot, a whole lot, just, you know, not being able to have your own choice of having a child again, it's, it's done.
ELIZABETH BRACKETT: But a doctor who was an early supporter of Norplant and has placed it in hundreds of women says there is no evidence linking Norplant to abnormal bleeding or hysterectomies after it has been removed.
DR. KEITH BROWN: Once the implant is removed from the body, that chemical is out of the woman's system within 72 hours, so if bleeding and side effects continue after that period of time and you know that that substance is no longer in that person's body, you tend to think there's another reason for the irregular bleeding.
ELIZABETH BRACKETT: As doctors, lawyers, and users continue to battle over the side effects of Norplant, clinicians and researchers continue to study the effect of Norplant after it has been implanted in millions of women and perhaps more significantly after it has been removed. Dr. Alan Hirsch's patients complained of severe headache, dizziness, and other problems both before and after using Norplant. This led Dr. Hirsch, a psychiatrist and neurologist, to launch a pilot study on the neurological side effects from Norplant. Though the study only involved five women, what he found in their patterns of brain activity was disturbing.
DR. ALAN HIRSCH: What we saw was clear evidence of brain damage, of peripheral nerve damage. Realize that the substance that's in Norplant, levonorgestrel, has been known in the past to induce a variety of different neurological findings, including those things that we found, as well as it appears something that tends to induce formation of meningiomas, which is a form of brain tumor, that can take twenty, thirty years for it to present. So even after the Norplant's removed, this brain tumor has already been induced to form, and it can continue to gradually build up for decades onward.
DR. MARC DEITCH: Well, let me tell you my opinion of Dr. Hirsch's paper. First, I wouldn't call it a study. Uh, characterizing data on five patients is not a study. In reading through this report, which is really just a recitation of some very bizarre tests that he's done that I don't think are very well substantiated, some of which I've never heard of, apparently what this really is, is what the Supreme Court recently called junk science. This is not good science.
DR. ALAN HIRSCH: Five is a very small number, and we really need to do a much larger study, but even so, you know, we see women all day long, and these are very significant findings. If I saw these five women that worked in a single work site all with these problems, I would be calling the Department of Health. These are very significant findings for an otherwise young, healthy woman. You don't expect it.
ELIZABETH BRACKETT: Last August, the FDA renewed its support of Norplant, calling it a safe and effective contraceptive. But Norplant sales have decreased by 90 percent in the last year. Amy Cohen of Planned Parenthood, an organization that has worked hard to expand birth control options, says she fears Norplant could go the way of most intrauterine devices, the contraceptive sponge, or RU-486, methods easily available in other countries but driven or kept off the U.S. market by fear of lawsuits and protests.
AMY COHEN, Planned Parenthood: I am very, very concerned. I think there will be a chilling effect on research and development as lawsuits escalate and as companies see not only their margin, the profit margin disappearing, but seeing their profits disappearing in supporting themselves. And my big fear is that if we continue to see an escalation in the legal battles around this that what the consequences for us, the American public, is going to be is that we're not going to have many choices around family planning at all.
ELIZABETH BRACKETT: American women already have so few options that the most common method of birth control in this country is sterilization. So the drug's future is uncertain as Pamela Skowronski's case and hundreds of others inch their way through the legal system. The only thing that's certain is that they'll have a long time to wait. Wyeth-Ayerst has promised to stand behind Norplant and vigorously contest each and every case.