Thinking (Re)Productively – Lawsuits against Mirena®: Potential impact on public health

Antoinette A. Danvers, Gretchen S. Stuart, Amy G. Bryant

Introduction

Patient requests for removal of the levonorgestrel-releasing intrauterine system (Mirena^®) have recently increased in our clinic. Patients report being frightened by television or internet publicity (e.g., “call 1-800-BAD-DRUG”). These patient requests and reports prompted us to investigate current and past litigation surrounding intrauterine contraception (IUC). Widespread use of IUC may set the stage for another epidemic of lawsuits against this safe and effective contraceptive method.¹ In this commentary, we explore the historical and current litigation environment for Mirena®, the impact of the media on women’s perceptions of contraceptive devices, and the negative impact inappropriate litigation can have on women’s health.

Litigation environment

The success of litigation against the Dalkon shield led to a dramatic reduction in IUC use among women in the United States, even among women using safe and effective IUCs. The Dalkon Shield became available in 1970, at a time when Food and Drug Administration (FDA) approval was not required for distribution of medical devices, and there were little to no safety data available.^{2, 3} The Dalkon Shield caused infection and infertility in many users due to the polyfilament strings that acted as a vector for bacteria from the vagina to uterus.² Mass litigation against manufacturers of the Dalkon Shield held the manufacturers liable for damages caused to the women who used the device. The manufacturers paid millions in compensatory and punitive damages and the device was ultimately removed from the market.²

The appropriate removal of the Dalkon Shield, however, led to frivolous litigation against other IUCs.^{2, 4, 5} The Copper-7 (Cu-7) and Tatum-T (TCu200) were safe and effective contraceptives⁶ that also became targets of litigation, leading to their removal from the market.^{4, 7} The Cu-7 and TCu200, both copper IUCs, were among five different IUCs available in the early 1980s when the prevalence of IUC use was about 7.1%.⁸ The manufacturers of these two devices became the defendants in several lawsuits for injuries related to IUC use. Twenty-four went to trial. The manufacturers lost 5 cases including one claim that the Cu-7 caused infertility in one woman.³ Due to the increasing costs of litigation and inability to secure liability insurance, manufacturers could no longer afford to market IUCs.⁴ Consequently, two other IUCs, Lippes Loop^® and Saf-T-coil^® were also removed from the market.⁴ When only one IUC, Progestasert^®, was left on the market, IUC use in the United States declined to 2%.⁸ This last IUC was pulled from the market in 1988.9

The Norplant® levonorgestrel contraceptive implant, another safe, effective, and popular contraceptive method, was also withdrawn due to high costs of mass litigation. Unlike the Dalkon Shield, research conducted by the Population Council demonstrated the safety of Norplant^® prior to its availability in the United States.^{2, 3} Norplant^® had been safely used by women in forty-four countries³ and users were satisfied with the contraceptive device.^{10, 11} Despite patient satisfaction, in 1995 a surge of lawsuits against Norplant® occurred due to active recruitment of plaintiffs using television and newspaper advertisements.² The lawsuits were initially an extension of ongoing lawsuits claiming that the silicone casing used in the implants caused joint and muscle pain, infection and scarring.^{2, 3} Later claims involved alleged side effects of the implant, such as depression, headaches and mood changes.² Four cases went to trial, one ruled in favor of the plaintiff for failure of the manufacturers to warn about side effects.² Despite the fact that most of the cases were unsuccessful in court, the number of pending litigation compelled the manufacturers of Norplant^® to offer a $500 million settlement to the remaining 36,000 plaintiffs.² The Norplant^® litigation raised concerns that all manufacturers of contraceptive devices could become targets of product liability litigation. Even if claims are unfounded and dismissed in court, large-scale litigation can force manufacturers to make large settlements and withdraw the contraceptive from the market.

Mirena^® is the newest target for mass litigation. Solicitations for plaintiffs request women to contact one of several law firms if they have experienced any of a long list of conditions. Some of these conditions are fictitious (“migration”), and some are known side effects and complications of IUC use (Table 1). For instance, women are solicited for complications such as uterine perforation, expulsion and pregnancy. Perforation of the uterus during IUC insertion occurs with approximately 0.06–0.5% of insertions.¹² Other known risks include a 0.8–5.5% risk of expulsion and a 0.2–1.1% risk of contraceptive failure over 5 years.¹² The manufacturer is being accused of neglecting to inform plaintiffs of these risks, when in fact these risks are clearly stated in the manufacturer’s insert for prescribers and patients.¹³

Mirena^® lawsuit websites list side effects such as irregular bleeding, pain, and breast tenderness, as grounds for litigation. Various infectious complications are also listed, including pelvic inflammatory disease, abscess, and peritonitis, despite the fact that infection due to IUCs is limited to the first 21 days after insertion.¹⁴ All medications and devices have the potential to cause harm to some individuals. A discussion of common side effects and risks is part of the counseling prior to initiating any contraceptive method.

The most disturbing claims, however, are those that are unsubstantiated by science. Intrauterine contraception causing “migration,” defined as “tearing of the uterus after proper insertion,” is one of the primary claims that the lawsuits make.¹⁵ This unfounded claim misleads patients into believing there is a high likelihood of developing a problem with their IUC even months to years after initial correct placement.

Impact of the media on women’s perceptions and use of contraceptives

The media convey negative and positive messages about contraception to a wide audience. Contraceptives are particularly vulnerable to media attention due to effects of the “boom and bust” phenomenon.¹⁶ Introduction of new contraceptive devices largely focuses on the benefits leading to an increase or “boom” in sales. When high expectations are not met, a new and negative portrayal leads to a rapid decline or “bust” in sales.¹⁶ When the IUC was first introduced in the popular media, the positive aspects of the method were highlighted, and high uptake ensued.¹⁷ Discontinuation rates then soared as information about problems with the Dalkon Shield became available and women became afraid to use any IUC.¹⁷

Media attention resulting in contraceptive discontinuation has also been observed with the oral contraceptive pill and Norplant^®.^{17, 18} Early media reports about Norplant^® were largely favorable, highlighting its high desirability, safety, and reliability.¹⁸ Newspapers quoted enthusiastic users and physicians. Later, negative headlines about Norplant® dominated, portraying individuals unhappy with the product.¹⁸ Higher rates of pill and IUD discontinuation was observed after news events about FDA warnings around contraceptives.¹⁷ The practice of using mass media can have a profound impact in a very short time frame due to the large numbers of people reached.¹⁶ Today, the effect could be more profound with the added popularity of social media.

In the last 10 years, widespread medico-legal controversies or negative media coverage of IUCs had not occurred until the recent surge in Mirena^® lawsuits. Intrauterine contraceptive use has increased significantly since the marketing of CuT380A in 1988 Mirena® in 2000.¹⁹ The lack of media attention prior to recent litigation may have actually contributed to recent increase in IUCs use.¹

Potential impact on women

Litigation against the Mirena^® hurts women’s health in two major ways: direct decrease in the use of a highly effective contraceptive method, and plummeting interest in contraceptive development. Even if lawsuits are not successful, history shows that many women will still request IUC removals, and avoid IUC placements.⁸

One of the goals of the Healthy People 2020 public health campaign is to reduce the unintended pregnancy rate in the United States by 10%.²⁰ As part of this effort long acting reversible contraceptives like Mirena^® have been promoted because they are among the most effective contraceptives.^{21, 22, 23} Consequently, IUC use is steadily increasing, with 8.5% of contraceptors using an IUC in 2009.²⁴ Removal of Mirena^® from the market would harm women, as they would lose a highly effective method to prevent unplanned pregnancy. Research has shown that women will more likely select a less effective contraceptive method, increasing their risk of unintended pregnancy.²⁵ Complete removal of the IUC from the market could lead to dramatic increases in unintended pregnancies. In the 1970s and 1980s, an estimated 182,000 unintended pregnancies resulted from removal of IUCs.⁸

The loss of Mirena^® would also impact women using it for reasons other than contraception. Mirena^® is recommended as first-line treatment for menorrhagia²⁶ and is as effective as surgical management with endometrial ablation.²⁷ For treatment of endometriosis, Mirena® provides benefits similar to gonadotropin-releasing hormone analogues, but with fewer side effects.²⁸ The Mirena® is also effective for treatment and prevention of endometrial hyperplasia without atypia²⁹ Mirena^® provides an important medical alternative to hysterectomy for women with many common gynecological conditions.

Apart from the direct effect on women’s health, litigation deters contraceptive development, and is the most commonly cited barrier to contraceptive innovation.³⁰ The number of pharmaceutical companies actively pursuing contraceptive research and development decreased from 13 in the 1970s to one by the end of the 1980s.³¹ Pharmaceutical companies’ fear of litigation not only leads to cessation of production, but also to a decline in new contraceptive development, thus limiting future contraceptive options.³⁰

Conclusion

Frivolous lawsuits against contraceptives undermine women’s health, and can cause harm. As former U.S. Attorney General Dick Thornburgh stated, “as the litigation explosion expands in this country, junk science is producing “junk law”…the ultimate victims are the American workers and consumers through the increased costs [and] diminished innovation opportunities”.³²

Physicians should take a proactive role in helping to limit the potentially negative impact of Mirena^® litigations on the use of the IUC. In order to continue providing the best care for patients seeking contraceptive services, clinicians caring for women must:

• Acknowledge the lawsuits and solicitation practices to patients.
• Re-educate patients about the risks and benefits of Mirena® based on scientific evidence.
• Counsel patients thoroughly on expected risks and side effects of the device.
• Ensure safety by obtaining adequate training for placement, following safety protocols when placing the device, and selecting candidates for IUC appropriately.

The Mirena^® has become an important safe and effective contraceptive device. Ensuring that it remains available for our patients is crucial.

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