Manufacturer moves to settle Norplant claims
The recent corporate decision to settle lawsuits filed by more than 36,000 U.S. women in connection with use of the Norplant contraceptive implant system will have no effect on the manufacturer’s continued support of the birth control method, say company leaders.
"The Norplant System has been a valuable contraceptive option for more than a million Ameri can women and nearly five million women worldwide, and Wyeth-Ayerst will continue to make it available to doctors and their patients," said Philip de Vane, MD, vice president of clinical affairs and North American medical director for Wyeth-Ayerst Laboratories in Philadelphia.
The settlement, estimated at $50 million, would end five years of litigation involving Norplant. Plaintiffs’ lawyers say the company downplayed such side effects as irregular menstrual bleeding, nausea, headaches, and depression.
Wyeth-Ayerst Laboratories and its parent company, American Home Products Corp. of New York City, have consistently denied wrongdoing and said that the side effects were described in the product’s labeling. The move to settle the lawsuits comes after a string of legal victories on behalf of Norplant, including three jury verdicts, more than 20 summary judgments before trial, and the dismissal of about 14,000 claims.
The agreement to settle the cases was described as "purely a business decision" by Joseph Mahady, president of Wyeth-Ayerst North America.
"Our legal success has come at a steep price because lawsuits are time-consuming, expensive, and have a chilling effect on research," said Mahady. "Now that the courts have found these cases to be without merit, we can turn our attention back to providing contraceptive options for American women."
Affirming the safety of Norplant
The Population Council in New York City, which developed the contraceptive implant system, reiterates its belief that Norplant is safe and effective when used in accordance with the labeling, says council spokeswoman Sandra Waldman. Many studies have supported this statement, she notes.
The federal Food and Drug Administration affirmed the safety of the Norplant System in a 1995 talk paper, Waldman points out. The paper stated, "The agency’s ongoing analysis of adverse reaction reports and postmarketing surveillance studies have found no basis for questioning the safety and effectiveness of Norplant when the product is used as directed in the labeling."1
Plaintiffs, who include about 10,000 Texas residents, have 120 days to accept the terms once they are notified.2 If they refuse, their cases will proceed in court, where American Home Products already has sought to dismiss them. The settlement would give each woman $1,500 if she filed suit before March 1.2
"The amount of the award per patient is small," notes Andrew Kaunitz, MD, professor and assistant chair of the department of OB/GYN at the University of Florida Health Sciences Center in Jacksonville. "Nonetheless, this litigation related to Norplant, a safe, effective, and convenient contraceptive which had a side effect profile well described in package labeling, will make the pharmaceutical industry that much less interested in developing new contraceptive option.
References
1. McLearn D. Norplant update. FDA Talk Paper T95-42. Rockville, MD: Food and Drug Administration; Aug. 17, 1995.
2. Ornstein C. Norplant company agrees to settle suits. Offer to women could top $50 million. Dallas Morning News, August 26, 1999.
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