NORPLANT AND THE DAMAGE DONE

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 [1993] 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.

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