NORPLANT AND THE DAMAGE DONE

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.

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