Norplant on Trial

During 1993, the first year their ads competed, Depo Provera ads appeared in dozens of magazines, from Newsweek to Modern Bride, People to Rolling Stone. While Depo manufacturer Upjohn tried to attract "sexually active" younger women, the Norplant ads aimed for affluent and professional women looking for convenience.

The contrast between the two companies was sharpest when Upjohn selected Maureen McCormick -- a.k.a. Marcia from the campy "Brady Bunch" TV series -- to tour the country promoting Depo. It seems like savvy marketing; the college crowd that saw the Depo ads or heard McCormick probably had access to clinics where the 3-month shot could be obtained.

Instead of seeking to appeal to the nostalgic and hip, the Wyeth-Ayerst advertisements for Norplant featured a dignified photo of a woman in a business suit, along with an explanation of the method. Again, smart marketing: Norplant ads targeted upscale women who could afford the $365 implants, plus another $150 - 300 for the medical worker to insert and later remove the capsules.

Norplant found a ready market; by the end of 1993, more than 800,000 women in this country had the "six sticks" in their arms. Wyeth-Ayerst enjoyed more than $141 million in Norplant sales that year, and with each set of implants costing roughly $30 for manufacturing, royalties to the Population Council, and marketing, each of those sets had a jaw-dropping 1,000 percent markup. For Norplant, the future looked rosy, indeed.

And then the lawyers descended.

There are two views of what began in 1994, after women with silicone breast implants won a staggering $4 billion settlement against manufacturer Dow Corning. Ashby and other Norplant advocates feel that the small army of trial lawyers working on the breast implant case simply moved on to Norplant -- a hoarde of barbarians storming one castle after another. "In the first three years, we had fewer than 20 lawsuits," says Ashby. "Now there's more than 500."

Ashby says that many of these lawsuits are nearly identical, and court papers filed on the same day in different parts of the nation even contain the same typographical errors. She also criticizes advertisements of 1-800 telephone numbers and TV commercials that encourage women with Norplant to join the suit. "They say, if you have a headache, gain weight, anything, you can sue us," she says. What's the alleged health risk in these suits? "At one point it was because the capsules were made out of silicone, like the breast implants. But the amount of silicone [in a Norplant capsule] is insignificant compared [to a breast implant]."

But lawyers suing Wyeth-Ayerst and its parent company American Home Products claim the company is exaggerating and playing the role of victim. "It's unfortunate they say this," says Seattle lawyer Ted Willhite. "Our allegation is that the product is inherently unsafe, and that women were not adequately told about side effects."

Nor should it be surprising that many of the same lawyers and doctors involved with breast implant suits are now fighting Norplant, Willhite says. In the course of the earlier case, immense amount of data were collected from women around the country, particularly on immunological damage. Because of that experience, these lawyers say, a new medical and legal specialty has emerged -- a network of doctors and lawyers nationwide that naturally would be looking at similar risks to women's health.

But regardless of whether the intentions behind the pending class action are noble or greedy, the bad publicity had its effect. Women began avoiding Norplant. More than 800 women daily had the implants in 1992; by last year, it had dropped more than tenfold, to about 50 per day.

There was more bad news for the company: a growing number of women who already had the implants were demanding removal. An easy task -- assuming that a medical worker is available who is thoroughly trained in Norplant removal, and that the woman isn't among the 6 percent that had the capsules inserted too deeply or developed complications, such as migration of the capsules or scar tissue buildup. And besides those variables, there was another obstacle for many women: affording the $100+ for removal.

That cost obstacle seemed solved when the non-profit "Norplant Foundation" was created last March. Funded by Wyeth-Ayerst, it offers free removals to any very low-income women -- as long as they first sign a "certificate" releasing the Foundation of any liability from "certain risks and dangers" in having Norplant removed. To be reimbursed by the Foundation, the clinician extracting the capsules has to sign a statement that the woman agreed to these conditions before the procedure -- and that the worker also released the Foundation from any liability should the removal be fumbled.

Ashby and other Norplant supporters interviewed -- and they appear to be the majority in the medical community -- raise this spectre often: if the courts allow this class action lawsuit to proceed and Norplant is put on trial, the future of birth control research in the United States is doomed. Frequently mentioned is the bankrupcy of Dow Corning after the $4 billion breast implant settlement.

And by great good fortune, also in the early spring of 1995, a bill was introduced by Representative Henry Hyde (R - Illinois) that would help shield Wyeth-Ayerst from exactly such a lawsuit. What became "The Common Sense Product Liability Act Of 1996" limited the amount that could be awarded for injuries, especially punitive damages for pain and suffering. In the final version of the bill were 50 references specifically to implanted materials.

While that reference applied to the silicone breast implants as well as Norplant, testimony to Congress left no question that Norplant supporters had the "six sticks" in mind.

In a May 1, 1995 letter read into the Congressional Record, presidents and directors of five family planning or contraceptive research groups supported the legislation, noting that Norplant especially was unfairly targeted:

...Norplant, one of the most significant contraceptive developments of the past 20 yeas in the United States, was approved by the FDA in 1990. It is now the target of numerous cookie cutter, mass-produced class action lawsuits fueled by sensationalism and slick advertising directed at women. Despite the fact that Norplant continues to be supported by the medical community -- as recently as a March 1995 endorsement by the American Society for Reproductive Medicine -- many women have been driven by unwarranted fears away from a safe and effective contraceptive product.

Punitive damages are meant to punish willful, flagrant, malicious or grossly illegal behavior. A company that has compiled in good faith with the FDA's regulations cannot be guilty of such behavior and should not be threatened with punitive damages. Nor should juries be permitted to second- guess the expert judgment of the FDA on whether the benefits of a drug outweigh the risks.

"There's no perfect method of contraception," she says. "Women must weigh the benefits that most fit her profile." But what about the class action complaint that these women weren't given adequate information about potential health risks? "This is a problem in general. Read any patient insert [pamphlet]; what would you understand if you just had a 6th grade education?"

Asked if there was any connection between her organization and Wyeth-Ayerst, Wysocki concedes they currently take some funding for Norplant training, and received "a substantial amount of money" from the company in the past. They receive no donations directly from Depo manufacturer Upjohn, but both companies have sponsored events for the organization.

Wyeth-Ayerst spokeswoman Ashby says this is not uncommon. "Most organizations get funding of some kind from a company. Every group takes money from industry." Ashby declined to say how much support the company gives family planning organizations. Ashby also would not say if Wyeth-Ayerst asked for these groups to come forward in support of the Product Liability Act, adding that the question "borders on insulting."

Despite heavy industry support, the Product Liability Act passed in the Senate only by about twenty votes, and less than 100 in the gung-ho House of Representatives. President Clinton vetoed the bill just last Thursday (May 2nd), citing its anti-consumer slant.