The Norplant Backlash

Wyeth-Ayerst Laboratories used to revel in stories like Stephen Heartwell's. When the company introduced the contraceptive Norplant to the U.S. market in 1991, the nine community clinics Heartwell runs in the Dallas area were swamped with calls. Soon there were lists of 200 women waiting to have the device--a set of matchstick-size capsules--implanted in their upper arms. Two years later, the clinics were implanting 30 devices a week. But Heartwell's tale brings no joy to Wyeth-Ayerst these days. His clinics now remove Norplant from more than 20 women a week--and virtually no one is asking for it. "Many women have heard that Norplant is harmful," he says. "They're afraid to keep using it."

Who wouldn't be? For the past 18 months, former Norplant users have been complaining of 40-pound weight gains, monthlong menstrual periods and removals that cause pain, scars and infections. Lawsuits against Wyeth-Ayerst have exploded and, nationwide, Norplant sales have fallen from 800 a day to just 60. During Norplant's first three years on the market, fewer than 20 out of 800,000 users filed legal complaints, but 50,000 women have now lined up to sue the company. The lawyers say they're merely responding to the needs of women who were harmed by a faulty product. But the company accuses the lawyers of trying to cash in on a fabricated health crisis. And medical experts fear the legal assault could eliminate an excellent method of birth control. "There's no question it's safe," says Dr. Robert Hatcher of Emory University. "It's the lowest-dose contraceptive we've ever had."

No one claims that Norplant is free of side effects. Any hormonal contraceptive can cause headaches, nausea, acne and unusual hair growth. And because Norplant capsules contain progestin but no estrogen (which most oral contraceptives use to regulate menstruation), most users experience irregular bleeding. But menstrual disturbances are an accepted feature of other progestin-only contraceptives. The only side effects unique to Norplant are surgical ones. While extracting the device is usually simple, one removal in five takes an hour or more, and one in four is painful.

Wyeth-Ayerst has always listed Nor-plant's potential drawbacks in its literature. The current package insert even mentions such unsubstantiated problems as strokes, heart attacks and autoimmune diseases. But plaintiffs' lawyers say the company's warnings haven't been stark enough. Besides downplaying progestin's established side effects, they say, Wyeth failed at first to warn of conditions like "pseudotumor cerebri," an unexplained rise in intracranial pressure that some users have experienced. "The warnings were abominable and the overpromotion was fraudulent," says Roger Brosnahan, a Minneapolis lawyer representing several hundred plaintiffs.

Many medical experts agree that the company should have done more to educate doctors and consumers about surgical complications. But they scoff at the claim that Norplant is dangerous. Recent studies from the World Health Organization and from Columbia University's School of Public Health have found that more than nine in 10 users are satisfied. And the FDA recently found "no basis for questioning the safety and effectiveness of Norplant" when it's used as directed.

Wyeth-Ayerst vows to fight as many lawsuits as the plaintiffs' attorneys want to file. But if the legal onslaught continues, the company may find that the only way to avoid being pecked to death is to abandon the product and offer a global settlement, as several breast-implant makers did in 1993. The impasse raises questions about who will regulate medical products. "Is it going to be scientists and the FDA?" asks Andrew Davidson of the Columbia School of Public Health, "or is it going to be lawyers?" The threat of lawsuits has long stifled contraceptive research; Norplant was the first new product to reach the U.S. market since the '60s. Whether it survives the current assault or not, the clear lesson for other would-be innovators is: don't bother.

Nearly 1 million U.S women have tried it since 1991

The average $600 cost is covered by Medicaid

Irregular menstrual bleeding, or no periods at all

Mood swings

Weight gains of more than 40 pounds

Infections at the implant site; difficulty removing the device

Pseudotumor cerebri, an increase in intracranial blood pressure