Birth control has been a revolutionary development for women’s reproductive health and autonomy. However, some forms of birth control have also come with serious risks, leading to a wave of lawsuits against manufacturers over the years. From the notorious Dalkon Shield in the 1980s to the more recent Depo-Provera litigation (related to the product’s increased risk of causing brain and spinal cord tumors), the legal landscape surrounding birth control devices and drugs has been fraught with controversy.
Let's take a closer look at some of the most significant cases.
Dalkon Shield: "The Largest Tort Liability Case Since Asbestos"
The Dalkon Shield, an intrauterine device (IUD) introduced in the 1970s, became infamous for its role in causing severe injuries, including infections, infertility, and even death in some cases. The device’s design allowed bacteria to travel into the uterus, leading to catastrophic infections for many women. The resulting litigation spanned decades, with the manufacturer, A.H. Robins Company, eventually filing for bankruptcy. By the 1990s, the Dalkon Shield case was regarded as one of the largest mass tort cases since the asbestos litigation, setting a precedent for future birth control-related lawsuits.
Essure: $1.6 Billion Settlement in 2022
Essure was marketed as a permanent, non-surgical sterilization device. However, after years of complaints about severe side effects—including chronic pain, perforation of the uterus and fallopian tubes, and device migration—Bayer, the manufacturer, faced thousands of lawsuits. The company ultimately settled these claims in 2022 for $1.6 billion. Despite being pulled from the market in 2018, the impact of Essure continues to haunt the women who used it and suffered lasting injuries.
Implanon and Nexplanon: Issues with Migration and Insertion
Implanon, a birth control implant, faced lawsuits in 2015 after reports that the device migrated from its insertion site, leading to unintended pregnancies and other complications. Nexplanon, its successor, is still in use, but lawsuits continue to emerge, with claims relating to improper insertion, migration, and related injuries surfacing as recently as 2022. While Nexplanon is seen as an improvement over Implanon, it hasn’t escaped legal scrutiny.
Mirena IUD: Ongoing Legal Challenges
Mirena, another IUD manufactured by Bayer, has also been the subject of significant litigation. Women reported severe side effects, including device migration, perforation of organs, and hormonal imbalances. As of 2023, early trials for Mirena lawsuits are still ongoing, and the final outcomes remain to be seen. Like Essure, Mirena has been criticized for the lasting harm it has caused many users.
Norplant IUD: Mass Settlements for Tens of Thousands of Women
Introduced in the early 1990s, Norplant was a hormonal birth control implant that faced a slew of lawsuits due to side effects such as migraines, depression, and scarring from the insertion. In 1999, the manufacturer agreed to settle claims from over 36,000 women, marking another major legal defeat for the birth control industry.
NuvaRing® Vaginal Rings: A Costly Legal Battle
NuvaRing, a vaginal contraceptive ring, became the subject of lawsuits due to increased risks of blood clots, strokes, and heart attacks. In 2014, Merck, the manufacturer, agreed to a settlement of over $100 million to resolve thousands of claims, another in a long line of costly legal battles over birth control products.
Yaz®/Yasmin® Birth Control Pills: Bayer’s $1.69 Billion Payout
Perhaps one of the most publicized cases involved the oral contraceptives Yaz and Yasmin. These pills were linked to an increased risk of blood clots, strokes, and heart attacks, especially in younger women. By 2014, Bayer had paid out over $1.69 billion to settle thousands of lawsuits related to these dangerous side effects. This marked one of the largest settlements for an oral contraceptive in history.
Paragard IUD: Litigation Continues
The Paragard IUD has also faced mounting lawsuits. Many women have reported device breakage during removal, leading to severe complications such as organ damage and emergency surgeries. Although Paragard remains on the market, the ongoing litigation could result in significant settlements for affected women in the years to come.
Loestrin 24 FE Birth Control Pills: Antitrust and Injury Claims
The makers of Loestrin 24 FE faced both injury-related lawsuits and antitrust litigation, accusing the manufacturers of delaying the release of generic versions of the drug. This case highlights not only the health risks of certain birth control products but also the larger corporate tactics that affect consumers.
Depo-Provera: The Most Recent Legal Battle
Depo-Provera, a contraceptive injection, has become the most recent focus of birth control litigation. In early 2024, research revealed that prolonged use of Pfizer’s Depo-Provera was associated with an increased risk of brain and spinal cord tumors (meningiomas). When the research was announced, Pfizer stated, “We are aware of this potential risk.” In October 2024, The Women’s Health Litigation Team at Anapol Weiss, a leading law firm in personal injury and mass torts litigation, filed a lawsuit against Pfizer on behalf of a woman who used Depo-Provera for a prolonged period and developed a brain tumor. Tracy Finken Magnotta, one of the leading attorneys on the case, said, "Our client’s life has been forever altered, and we will fight to ensure that those responsible are brought to justice." Anapol Weiss is preparing additional lawsuits on behalf of other women who developed meningiomas after using Depo-Provera for a prolonged period.
As more women come forward with their claims, this case could follow in the footsteps of previous birth control lawsuits, with the potential for significant settlements and corporate accountability.
The Impact of Birth Control Litigation
These lawsuits underscore the ongoing tension between the benefits and risks of contraceptive devices and drugs. While birth control has played a crucial role in empowering women to take control of their reproductive health, the litigation history reveals that manufacturers have often failed to prioritize safety, leading to devastating consequences for many women. The birth control industry has faced billions in settlements, and the legal battles are far from over as new devices and drugs continue to be introduced into the market.
As more women advocate for transparency and accountability in the pharmaceutical industry, the future of birth control litigation will likely remain a crucial aspect of reproductive healthcare policy.