Nigro, Laura; Scott, Eleanor; Leigh-Dodds, Gemma; Birchall, Ebony --- "Women's health justice: The unique role of the class action mechanism" [2022] PrecedentAULA 5; (2022) 168 Precedent 12

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WOMEN’S HEALTH JUSTICE

THE UNIQUE ROLE OF THE CLASS ACTION MECHANISM

By Laura Nigro, Eleanor Scott, Gemma Leigh-Dodds and Dr Ebony Birchall

There is increasing societal awareness of the injustices suffered by women when engaging with the medical system,^[1] supported by a major area of emerging research which is exposing how implicit and explicit biases against women lead to poor medical outcomes.

Gender bias in the fields of medicine, science and technology can be found in a range of aspects. These include the management of clinical trials, the difference in responses to patient complaints based on the patient’s gender, the design of medical devices and products, the funding allocated to gender-specific illness, and the failure to include or properly consider relevant sex differences in research.

Recently a series of class actions that focus on women’s health issues have been litigated. Class actions are contributing to growing societal awareness of women’s health injustices and, importantly, are playing a unique role by providing a way for women to access justice and redress.

This article outlines the emerging research, which has uncovered injustices in women’s health, and reviews several Australian class actions which have highlighted and remedied women’s health injustices. The Essure case is an example of a women’s health injustice that is now the focus of a class action.

WOMEN’S HEALTH INJUSTICE

The long history of medicine is as much a social history as it is a history of clinical and scientific study: traditionally, medicine has reflected harmful gender norms and power discrepancies.^[2] Aristotle first described the female body as simply the opposite of the male, chronicling the female reproductive organs as the male ‘turn’d outside in’.^[3] Thus women were, from the outset, medically marked by their difference, and ‘defined as faulty, defective, deficient’^[4] in comparison with the male sex. Further, as writer Elinor Cleghorn has identified, ‘the discrimination women encounter as medical patients is magnified when they are Black, Asian, Indigenous, Latinx, or ethnically diverse; when their access to health services is restricted; and when they don’t identify with the gender norms medicine ascribes to biological womanhood’.^[5] Public health researchers have considered how our modern healthcare system has been one designed by men, for men.^[6]

Discrepancies in funding for women’s health and medical research is one cause of poor medical outcomes and health injustice. For example, UK figures show that while one in three women suffer from a gynaecological or reproductive health issue, in 2014 less than 2.5 per cent of publicly funded research was dedicated to this issue.^[7]

The lack of women’s participation, or consideration of women’s experience, in research, may ultimately lead either to delayed diagnosis or to misdiagnosis altogether. For example, although women and men both experience chest pain as a key symptom of a heart attack, women are more likely to experience other, less publicly understood or communicated symptoms, such as nausea and jaw pain.^[8] These issues have contributed to the ‘hysteria’ discourse, where women are stigmatised as ‘difficult’ when regular treatments do not work and, as a result, find their concerns dismissed as not serious.^[9] As legal practitioners, we have heard of corroborating experiences from women whose concerns were dismissed by their doctors or the medical profession for years, or who were told to take over-the-counter pain relief when their underlying health conditions were far more serious.

Gender imbalances in clinical trials of devices and drugs also pose significant problems for the proper analysis and evaluation of potential risks to women. Historically, women have not been recruited into clinical trials as frequently as men and were excluded from early clinical studies of most pharmaceutical drugs. In 1977, after the thalidomide disaster, the US Food and Drug Administration (FDA) recommended that women of childbearing age be excluded from research studies to protect vulnerable populations, in particular foetuses.^[10] British academic Anita Holdcroft noted that this approach resulted in there being scant research into the effects of drugs on women, including potential adverse reactions.^[11]

In the late 1990s, the FDA reviewed and changed its requirements to mandate that manufacturers provide evidence of how their drug is safe for, and affected by, attributes of sex, race and age, and scientists are also now required to account for the role of sex as a variable in their studies.^[12]

These are positive steps, but they do not necessarily cure the implicit biases that continue to occur. For instance, Australian academic Katrina Hutchinson has identified that laboratory tests to ensure the safety of medical implants often ignore whether women have a different biological reaction to metals and other materials than men do, or whether gender differences in body movements, such as the motion of the hip when walking, could impact the operation of the device.^[13] Hutchinson argues that poor outcomes experienced by women may be the cumulative consequence of micro instances of bias across the arc of the design, testing and regulation of and treatment with medical products.^[14]

WOMEN’S HEALTH AND THE CLASS ACTIONS REGIME

Class actions have been used in recent years to highlight and remedy women’s health injustices, as they allow groups of seven or more people who have suffered harms or losses arising out of similar circumstances to commence a claim collectively.^[15] As a result, class actions have played a unique role in the growing movement toward women’s health justice.

In the early 1990s, when the Australian class action regime was in its infancy, women who had been harmed as a result of defective silicone breast implants brought a case against pharmaceutical company Dow Corning. After a lengthy legal battle in both the US and Australia, over 3,000 Australian women were compensated for ruptured breast implants and associated injuries.^[16]

Thalidomide was a drug marketed to pregnant women in the late 1950s and early 1960s as a solution to nausea. Thalidomide class actions^[17] were settled in 2013 and, for children who were born with physical abnormalities after their mothers took the drug during pregnancy, provided an avenue for seeking justice for the devastating impacts of poorly tested medication.

Two scathing reports in 2018 and 2019 on former NSW gynaecologist Dr Emil Gayed detailed decades of complaints from his female patients that went unanswered, with patients remaining unprotected despite awareness by medical regulators of the substandard care.^[18] (The article on pp. xx to xx in this edition details issues with Dr Gayed’s treatment of patients and the inadequacy of systemic response. – Ed.)

Following an announcement of a class action investigation against the NSW health system and its regulators for failing to protect the women injured by the rogue doctor,^[19] a negotiated settlement scheme was achieved with the NSW Government.^[20]

In recent years, vaginal mesh and tape implants have caused significant injury and distress for women in Australia. These vaginal medical implant products, fitted to treat incontinence and prolapse, were faulty and caused serious complications for many women, including chronic pain and inflammation, extrusion of the products into the surrounding organs, and psychiatric injury. A class action on behalf of those affected, Gill v Ethicon Sàrl (No 5)^[21] (Gill) was launched by Shine Lawyers against manufacturer Johnson & Johnson on a ‘no win, no fee’ basis in 2012. This is one of only a few class actions to run to final judgment. In a landmark decision delivered in November 2019, Katzmann J found that the products were not fit for purpose, publicly confirming that the severe injuries suffered by the women involved had in fact been caused by the faulty products.^[22] The manufacturer’s appeal was dismissed by the Full Court of the Federal Court in March 2021,^[23] and in November 2021 a special leave application by Johnson & Johnson was rejected by the High Court of Australia. This result is a major success for the women affected by these products, and will inspire other women facing health injustice to speak up. Indeed, there are several further class actions currently before Australian courts in relation to similar mesh products involving other manufacturers. Gill has shone a light on the way the class actions regime can be used effectively to seek justice for large groups of women.

The increasing number of class actions concerning women’s health may be reflective of increasing societal awareness of women’s health injustice and of a broader social shift, where women have increasing confidence in reclaiming their stories and asserting their rights. Class actions have several benefits over individual litigation, including improved access to justice for large groups of women. In cases relating to failed medical regulation, failed medical products or pharmaceuticals, the complex evidence required and the costs involved in running the case often mean that individual litigation is unviable, with the cost of running the litigation likely to be disproportionate to the damages claim available. In this context, class actions provide a unique option for claimants who would not otherwise be able to pursue justice.

The class action mechanism holds another benefit for women in that claimants can choose to participate in a class action in a largely anonymous way: the group of women involved do not need to detail their (often intimate) injuries individually in a public court document or courtroom. Further, class actions are generally structured so that claimants can participate in the litigation without risk of incurring adverse costs. Finally, we have heard from our clients that a class action can also provide women comfort in knowing that they are not alone, but rather are part of a large group of women with shared experience.

THE ESSURE CLASS ACTION

Between 1997 and 2018, hundreds of thousands of women worldwide were implanted with Essure, a device which was marketed as a safe, ‘natural’, and ‘hormone-free’ alternative to tubal ligation for women who wanted permanent contraception. The device is a small coil made from several materials including nickel and titanium, which is inserted into each fallopian tube. Essure was designed to intentionally cause inflammation and scar tissue, to generate an occlusion of the tube and the consequent inability to become pregnant.

Tens of thousands of adverse event reports worldwide have alleged that the device caused a range of serious health complications, including chronic pelvic and abdominal pain, irregular menstrual bleeding and cramping, and perforation of the fallopian tubes and other organs. Many women who had the Essure device implanted have undergone hysterectomies or other invasive surgery to remove the device in an attempt to relieve their symptoms.

Thousands of women from around the world who suffered similar symptoms after having the device implanted found each other on Facebook. Women used social media to offer support to other women, to raise awareness about the device, and to launch broader campaigns. Their efforts resulted in significant public reporting on the device,^[24] and eventually even a documentary titled The Bleeding Edge, which was released to Netflix on 21 April 2018. This documentary examined the $400 billion medical device industry and the speed with which devices have been rushed into the market, providing a detailed investigation of the Essure device.

The experiences of women fitted with the Essure device, as represented in public reporting and the documentary, echo many broader gender biases which affect women engaging with the medical system. For example, it took considerable time for the concerns of women to be believed and then acted upon. This was an issue raised in public reporting on the device, with women noting they had voiced their concerns to doctors for several years. Further, women who had been affected by the device reported significant trouble finding appropriate medical assistance for their serious complications.

In Australia, Essure was supplied between 1999 and 2017.^[25] In August 2017, the Therapeutic Goods Administration issued a hazard alert on the device and updated the product labelling to include warnings about potential adverse events and situations where device removal may be necessary.^[26] In the same year, the manufacturer decided to discontinue the distribution of Essure, stating that the withdrawal was due to ‘business reasons’.^[27]

The Essure device has been the focus of litigation across the world. The Australian class action (on behalf of women who had Essure inserted in Australia) is currently before the Supreme Court of Victoria.^[28] While the outcome of the case is still to be determined, the class action is providing an opportunity for this group of women to collectively seek redress. The case alleges the device was defective and that the entities responsible for it were negligent and breached Australian consumer laws. The entities, including the company Bayer Australia Ltd, are defending the claim and deny the allegations.

CONCLUSION

Society is becoming increasingly aware that women face unique challenges when engaging with the medical system. Emerging research shows that gender bias against women in medicine, a reality historically and still the case today, causes poor medical outcomes.

Class actions play an important role in promoting women’s health justice. They give women agency, protection from adverse costs risks and, for most participants, an added layer of privacy. Women involved in class actions also have the comfort of shared experience. Actions of this kind provide the ability to expose widespread health injustices, bring those responsible to account and seek rightful redress.

Laura Nigro, Eleanor Scott, Gemma Leigh-Dodds and Dr Ebony Birchall are lawyers in the class action team at Slater and Gordon Lawyers and have all worked on the Essure class action and other class actions related to women’s health.

EMAIL [e-mail]; [e-mail]; [e-mail]; [e-mail].

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^[1] This article discusses the experience of gender bias in medicine. The literature we have researched and referenced may use the terms ‘women’ and ‘female’ interchangeably and may assume that people who have internal reproductive organs, such as a uterus, are women. We acknowledge that this assumption, and the language we use when referring to patients and their bodies, can also contribute to systemic inequalities patients face when accessing healthcare. For more information, see ‘Redefining anatomical language in healthcare to create safer spaces for all genders’, Monash Biomedicine Discovery Institute with AA Sanchez (17 May 2021) <https://www.monash.edu/discovery-institute/news-and-events/news/2021-articles/redefining-anatomical-language-in-healthcare-to-create-safer-spaces-for-all-genders>’.

^[2] E Cleghorn, ‘Medical Myths About Gender Roles Go Back to Ancient Greece. Women Are Still Paying the Price Today’, Time Magazine (17 June 2021) <https://time.com/6074224/gender-medicine-history/>.

^[3] E Cleghorn, ‘Healthcare Has a Race – and Gender – Problem’ (23 June 2021) <https://lithub.com/healthcare-has-a-race-and-gender-problem/>, extracted from E Cleghorn, Unwell Women: Misdiagnosis and Myth in a Man-Made World, Dutton, 2021.

^[4] Ibid.

^[5] Cleghorn, above note 2.

^[6] See for example K Young, J Fisher and M Kirkman, ‘“Do mad people get endo or does endo make you make you mad?”: Clinicians’ discursive constructions of Medicine and women with endometriosis’, Feminism and Psychology, Vol. 29, No. 3, 2019, 337–56.

^[7] K Burrowes, ‘Gender bias in medicine and medical research is still putting women’s health at risk’, The Conversation (8 March 2021) <https://theconversation.com/gender-bias-in-medicine-and-medical-research-is-still-putting-womens-health-at-risk-156495>.

^[8] Ibid.

^[9] G Jackson, ‘The female problem: how male bias in medical trials ruined women’s health’, The Guardian, (14 November 2019) <https://www.theguardian.com/lifeandstyle/2019/nov/13/the-female-problem-male-bias-in-medical-trials>.

^[10] Ibid.

^[11] A Holdcroft, ‘Gender bias in research: how does it affect evidence based medicine?’ Journal of the Royal Society of Medicine, Vol. 100, No. 1, 2007, 2–3 <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761670/>.

^[12] Burrowes, above note 7.

^[13] K Hutchinson, ‘Why women are more likely to have dodgy hip implants or other medical devices’, The Conversation (12 August 2019) <https://theconversation.com/why-women-are-more-likely-to-have-dodgy-hip-implants-or-other-medical-devices-121363>.

^[14] K Hutchinson, ‘Gender Bias in Medical Implant Design and Use: A Type of Moral Aggregation Problem?’ Hypatia, Volume 34, No. 3, 2019, 570–91

<https://doi.org/10.1111/hypa.12483>.

^[15] See Federal Court of Australia Act 1976 (Cth), pt IVA; Supreme Court Act 1986 (Vic), pt 4A; Civil Procedure Act 2005 (NSW), pt 10; Civil Proceedings Act 2011 (Qld), pt 13A.

^[16] Bates v Dow Corning (Australia) Pty Ltd [2005] FCA 927.

^[17] Robbins v Grünenthal & Ors GmbH No S CI 2010 5845 and Rowe v Grünenthal GmbH & Ors No S CI 2011 3527.

^[18] GB Furness SC, Review of processes undertaken by the Medical Council of New South Wales pursuant to Part 8 of the Health Practitioner Regulation National Law (NSW) with respect to Dr Emil Gayed (Final Report, 2018).

^[19] Slater and Gordon Lawyers, ‘NSW health system failed Dr Emil Gayed’s victims’ (Media release, 7 February 2019) <https://www.slatergordon.com.au/media/nsw-health-system-failed-dr-emil-gayeds-victims>.

^[20] Slater and Gordon Lawyers, ‘Redress scheme provides compensation to women injured by rogue former NSW surgeon Emil Gayed’ (Media release, 13 September 2021) <https://www.slatergordon.com.au/media/redress-scheme-provides-compensation-to-women-injured-by-rogue-former-nsw-surgeon-emil-gayed>.

^[21] [2019] FCA 1905 (Gill).

^[22] Ibid.

^[23] Ethicon Sàrl v Gill [2021] FCAFC 29.

^[24] See for example J Block, ‘The battle over Essure’, Washington Post (26 July 2017) <https://www.washingtonpost.com/sf/style/2017/07/26/essure/>.

^[25] Commonwealth Department of Health, Therapeutic Goods Administration, ‘Essure Contraceptive Device’ (Alert, 14 July 2020) <https://www.tga.gov.au/alert/essure-contraceptive-device>.

^[26] Ibid.

^[27] Ibid.

^[28] Turner v Bayer Australia Ltd (ACN 000 138 714) & Ors S ECI 2019 02916.