Norplant Birth Control Lawsuit: 1999 Settlement and Market Withdrawal

The Norplant birth control lawsuits were a mass of product-liability claims brought in the 1990s by roughly 50,000 American women against distributor Wyeth-Ayerst Laboratories, alleging the company had not adequately warned them about painful side effects and difficult removal procedures. After Wyeth won every case that reached a jury and defeated thousands of claims on legal grounds, its parent company, American Home Products, agreed in August 1999 to pay about $1,500 to each of more than 36,000 women who had sued. The company admitted no wrongdoing and called it a business decision.¹

What Women Alleged

Norplant was a set of six matchstick-sized silicone capsules containing the progestin levonorgestrel, inserted under the skin of the upper arm to prevent pregnancy for up to five years. The FDA approved it in December 1990, and it reached the U.S. market in February 1991. Demand was immediate: about one million American women had chosen Norplant by early 1993, and roughly 20 percent of them eventually asked to have it taken out early.²³

Women who later sued reported a wide range of adverse effects: irregular and prolonged menstrual bleeding, severe headaches, depression, anxiety, weight gain, nausea, dizziness, acne, and ovarian cysts. Some also described numbness and pain in the arm, skin discoloration, and enlarged ovaries.⁴⁵

Removal was the sharper grievance. Wyeth-Ayerst had described the extraction as a simple outpatient procedure of about 20 minutes, but many women found it far longer and more painful. Capsules migrated within the arm. Scar tissue formed around them. One plaintiff described a removal that ran more than 90 minutes, and others said doctors “continuously poked, pushed, pulled and yanked” to get the rods out.⁶ Some women needed general anesthesia, some needed multiple surgeries, and many were left with permanent scarring.

The lawsuits rested on two main theories. Wyeth-Ayerst had failed to warn women and their doctors about the true severity of side effects and removal difficulties, plaintiffs argued, and it had failed to test the device adequately before selling it.⁴ Some suits also alleged that Norplant was marketed to low-income women who could not afford removal.⁵

The first suit was filed in Chicago in March 1994. By August 1997, about 50,000 women had sued. Roughly 2,800 lawsuits covering some 30,000 women were pending in federal court in Beaumont, Texas, where the Judicial Panel on Multidistrict Litigation had consolidated the federal cases as MDL 1038 before Judge Richard Schell in December 1994. Another third of the suits were spread across state courts in Texas, Illinois, and Indiana.²⁷

Why the Manufacturer Kept Winning

The plaintiffs lost the legal argument that mattered most. In August 1996, Judge Schell denied class certification as premature and ordered bellwether trials of five plaintiffs at a time to test the claims. State courts in Illinois, Pennsylvania, and New Jersey also refused to certify classes.⁷²

The first bellwether trial ended in February 1997 with summary judgment for Wyeth. The pivot was the learned intermediary doctrine, the rule that a prescription drug manufacturer satisfies its duty to warn by informing the prescribing physician, not the patient directly. Because Judge Schell found Wyeth had adequately warned doctors about Norplant’s risks, the company was not liable to individual users.²

Plaintiffs appealed. They argued the doctrine should not apply because Wyeth marketed Norplant directly to consumers and because FDA regulations required specific patient warnings. On January 29, 1999, the Fifth Circuit rejected both arguments and affirmed. The learned intermediary doctrine, the court held, defined the scope of the manufacturer’s duty to warn and could not be sidestepped through other legal theories.⁸

By the numbers, Wyeth’s record at trial was near-perfect. The company won three jury verdicts and 20 pretrial judgments, and more than 14,000 claims were dismissed before the settlement.⁹ One jury did find for a plaintiff. Emilia Medrano was awarded $15,000 for mental anguish and $20,000 in additional damages, but the Texas Court of Appeals reversed, applying the learned intermediary doctrine and finding she had not proven Norplant caused her injuries.¹⁰

The Texas state litigation was also disrupted by lawyer misconduct disputes. In early 1998, a Hidalgo County trial covering about 4,500 consolidated claims ended in mistrial after one plaintiffs’ attorney accused another of telling a client to lie about being examined by an expert witness. In May 1998, two prominent plaintiffs’ lawyers were disqualified from state Norplant cases in an unrelated disciplinary matter because they had hired a legal assistant who had previously worked for the defense, leaving about 3,000 women in four Texas counties without attorneys. A Brownsville trial that September ended with a defense verdict after two hours of jury deliberation.¹¹

The 1999 Settlement

American Home Products chose to settle anyway. In August 1999, the company offered $1,500 to each of the more than 36,000 women who had sued before March 1, 1999, with a total estimated payout of $50 million to $54 million. It admitted no wrongdoing.¹¹² Joseph M. Mahady, president of Wyeth-Ayerst North America, said, “Our legal success has come at a steep price because lawsuits are time-consuming, expensive and have a chilling effect on research.”⁹

The offer was voluntary. Women who thought $1,500 was too little could reject it and keep litigating. Certain categories of injury, including scarring from removal, were not covered.¹ About 32,000 plaintiffs accepted. Roughly 2,960 either rejected the offer or did not respond.¹³

What Happened to Women Who Refused the Settlement

The holdouts did not fare better. On August 14, 2002, Judge Schell granted partial summary judgment to Wyeth and dismissed most of the roughly 3,000 remaining claims. He again applied the learned intermediary doctrine and found the plaintiffs had produced no evidence linking Norplant to conditions such as fibromyalgia or rheumatoid arthritis, and no evidence that different warning labels would have changed how physicians prescribed the device. Only 10 individual cases survived that ruling.¹³

Norplant’s Withdrawal From the Market

The litigation and the media coverage around it wrecked the product commercially. Insertions peaked at about 800 per day in early 1994 and had fallen to 60 per day by April 1995. Family planning clinics reported a surge in removal requests and a steep drop in new insertions. By 1996, annual U.S. sales were $3.7 million and insertions were down 90 percent from their peak.³⁴²

Wyeth suspended U.S. distribution in 2000 over efficacy concerns that later proved unfounded, then permanently withdrew Norplant from the American market in July 2002, citing “business reasons.” Worldwide production ended in 2008.¹⁴¹⁵ Defenders of the device argued that many removal complications came from inadequate physician training rather than defects in the product itself; about 28,000 professionals had completed Wyeth’s training program, but many doctors who inserted Norplant had not.⁴

A Separate Controversy Over Coercion

Norplant was also at the center of a distinct public debate that was not part of the product-liability suits. Between 1991 and 1993, legislators in more than a dozen states introduced bills to condition welfare benefits on Norplant use, offer financial incentives to women on public assistance to use it, or mandate it for women convicted of drug use or child abuse. In several states, judges offered women convicted of child abuse a choice between Norplant and jail.¹⁶ Those cases raised constitutional and civil rights questions rather than product-liability claims, and they were fought on different legal ground from the personal-injury litigation that produced the 1999 settlement.

1
Baltimore Sun. Norplant Maker Agrees to Settle
2
National Academies Press. Norplant Contraceptive Products Liability Litigation
3
University of New Mexico Family Planning. From Breakthrough to Bust: The Brief Life of Norplant
4
Los Angeles Times. Norplant Lawsuits Allege Severe Side Effects
5
Roanoke Times. Norplant Lawsuit Filed Against Wyeth-Ayerst
6
The Spokesman-Review. Norplant Put Her Through Hell
7
FindLaw. In Re Norplant Contraceptive Products Liability Litigation
8
vLex. In Re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374
9
Feminist Majority Foundation. Norplant Manufacturer Makes Settlement Offer
10
FindLaw. Wyeth-Ayerst Laboratories Company v. Medrano
11
Manhattan Institute. Products Liability and the Threat to Contraception
12
The Ledger. Norplant Maker to Pay $50M to Settle Claims
13
Law.com. Norplant Litigation Concludes
14
Los Angeles Times. Norplant Permanently Withdrawn From U.S. Market
15
GLOWM. Implantable Contraception
16
ACLU. Norplant: A New Contraceptive With the Potential for Abuse