How the Healthcare System Fails Women
A Call for Changes in Research and TreatmentDepo-Provera, commonly known as the Depo shot or DMPA, is a contraceptive injection containing medroxyprogesterone acetate, a form of the hormone progestin. Historically valued for its safety, convenience, and privacy, it has been a popular choice in birth control.
However, recent research has linked Depo-Provera to an increased risk of brain tumors. Lawsuits against the manufacturer allege that the company failed to adequately warn doctors and patients of these risks, rushing the drug to market without sufficient studies.
Following these findings, Pfizer responded: “We are aware of the potential risks associated with long-term progestogen use and are working with regulatory agencies to update product labels and patient information with appropriate language.” Unfortunately, for many affected patients, this acknowledgment comes too late.
Depo-Provera is not the first contraceptive linked to cancer, nor is it likely to be the last. Many drugs, medical devices, and consumer products have caused significant harm to women over the years.
In this blog post, we explore this troubling trend and the ways the healthcare industry has often failed women—from inadequate research to unfair treatment by medical professionals. By raising awareness and fighting for justice, we hope to move toward a safer, more equitable future.
History of Defective Products
A review of major mass tort litigations in the U.S. highlights a troubling trend: women have been disproportionately harmed by defective drugs, medical devices, and consumer products. From contraceptives and pain management to cosmetic surgery, labor & delivery, and everyday beauty products, failures in healthcare, science, and regulation have impacted nearly every aspect of women’s health and wellness. Below, we detail a few significant cases, some of which our team of attorneys have worked on personally, as well as some research that has yet to result in litigation.
Contraceptives
Essure was a permanent birth control device implanted in a woman’s fallopian tubes to prevent pregnancy. Thousands of reports detailed severe side effects and device failures, such as fracture, breakage, and unintended migration. Additionally, patients reported ectopic pregnancies, pregnancy loss, and even fatalities. After many years, the manufacturer finally ceased distribution in 2018.10
Norplant, a contraceptive implant, faced lawsuits over insertion-related problems like infections and scarring, as well as systemic side effects like stroke and blindness, although serious claims were largely dismissed. Complications with insertion and removal often required surgery under anesthesia, prompting women to seek early removal. Eventually, the manufacturer ceased its distribution in 2002 due to legal issues and declining sales.21
Paragard, a non-hormonal IUD, has been associated with 50,088 complications reported to the FDA, including 17 fatalities since 1989. Reports include severe issues such as device expulsion, migration, uterine perforation, and adverse events like ovarian cysts and uterine rupture.
Our managing Partner, Buffy Martines, serves on the nationwide Plaintiffs’ Steering Committee in MDL No. 2974, In re: Paragard IUD Products Liability Litigation, and is actively working to bring these cases to trial.
Other Pharmaceutical Drugs
Prempro, an HRT drug for menopause symptoms, was widely prescribed to over six million women until a 2002 NIH study linked it to elevated risks of breast cancer, heart attacks, and strokes. Lawsuits led to substantial settlements for women affected by these severe side effects.[18,19]
Fenfluramine and dexfenfluramine, known as Fen-Phen, were withdrawn from the market in 1997 after data linked them to heart valve defects in up to one-third of patients. Ultimately, around six million Americans, mostly women and not all obese, used the drugs before their withdrawal.12
All three of LPM’s founding partners took part in a case involving the wrongful death of a mother who developed primary pulmonary hypertension due to Fen-Phen. The verdict awarded over $1 billion, a record-setting single-plaintiff award at the time.
DES, a synthetic estrogen, was prescribed to pregnant women for decades despite studies indicating its ineffectiveness. Tragically, prenatal DES exposure was later linked to clear cell adenocarcinoma, birth defects, and developmental issues. Although its use in pregnancy was discontinued in the U.S. in 1971, its legacy has left lasting health implications.8
Medical Devices and Products
In the early 1990s, silicone breast implants began to be linked to health risks including cancer, connective tissue diseases, and autoimmune disorders, leading to the FDA banning them.22
Two of LPM’s founding partners, Rick Laminack and Tom Pirtle, achieved groundbreaking victories in these cases and went on to successfully represent tens of thousands of women nationwide and secure hundreds of millions of dollars in settlements.
Even after re-approval in 2006, FDA studies revealed ongoing concerns, with research linking silicone implants to autoimmune disorders and cancers.
TVM, a net-like implant for pelvic organ prolapse, has led to numerous reports of severe side effects like pain, organ prolapse, and infection. Beginning in 2009, thousands of lawsuits were filed against various TVM manufacturers alleging that they were negligent in their design, testing, and marketing of the devices and failed to warn healthcare providers and patients about the potential risks and complications associated with their use. While the FDA began issuing warnings about possible complications in 2008, they did not reclassify the tool as “high risk” until 2016.
Our team at LPM was highly involved in the mass tort litigation that ensued, helping hundreds of women receive compensation from the device manufacturers.
Approved in the early 90s, laparoscopic power morcellators are surgical tools used to break down tissue during minimally invasive surgeries. Tragically, they can also spread cancerous tissue in the abdomen, leading to aggressive cancer in some women. Despite FDA awareness, a warning wasn’t issued until 2014, and subsequent lawsuits led to several device versions being withdrawn from the market.14
Beauty & Hygiene Products
A recent study conducted by the National Institutes of Health (NIH) has highlighted the elevated risk of uterine cancer among women who have used chemical hair straighteners. This risk is particularly significant for Black and Hispanic women who tend to use these products more frequently. In cases of frequent use, the risk of uterine cancer may be more than double that of women who have not used such products.15
We are proud to have one of our founding partners, Buffy Martines, at the forefront of this litigation. As a member of the Plaintiff's Steering Committee of this multidistrict litigation (MDL), Buffy is among the select group of attorneys leading and overseeing this important case.
This litigation is ongoing. If you suspect that your use of hair straighteners has contributed to your uterine cancer diagnosis, you may have a valid legal claim for compensation. Please reach out to us for a confidential consultation to explore your options.
Research has detected trace amounts of 16 metals, including toxic ones like lead, in tampons from various brands. Further research is needed to determine if these metals may leach from tampons and pose health risks, especially considering the long-term exposure many women face. Although the FDA classifies tampons as medical devices, it lacks rigorous chemical testing requirements.[20,24]
Benzene, a carcinogen, has been detected in several popular dry shampoos, leading to recalls and lawsuits. The settlement involving the Batiste brand underscored the need for higher safety standards, particularly in personal care products that are widely used by women daily.
How the Healthcare Industry Fails Women
Inadequate Research & Trials
The overarching goal of the U.S. investment in biomedical research is to improve the health and well-being of the entire U.S. population, but a lack of female representation in research severely undermines the ability to apply research findings to the general public.4
Women, who consume a higher percentage of pharmaceutical drugs than men in the U.S., face nearly double the risk of developing adverse drug reactions, according to the FDA. Despite this risk, studies rarely address how medications impact women specifically, and women have often been excluded or underrepresented in drug trials altogether.13
Key Milestones in Gender Representation in Clinical Trials
In response to the discovery that morning sickness medications caused birth defects, the FDA banned women of childbearing age from participating in early-stage clinical trials, effectively reducing female representation in drug research.
The National Institutes of Health Revitalization Act mandated the inclusion of women in clinical trials. However, the mandate only applied to NIH-funded studies, many of which continued to analyze data without considering gender differences, diminishing the impact of including female participants.
The FDA began examining gender equality in clinical trials. Despite efforts to correct this imbalance, by 2001, two-thirds of trials continued to exclude women entirely. According to DrugWatch, “91 percent of studies found evidence that gender made a difference in drug metabolism or adverse reaction rates, yet scientists often failed to analyze results by gender.”
The Impact of Limited Oversight on Medical Device Approval
Beyond drug trials, the lack of government oversight for medical device approvals has introduced additional risks for women. Most medical devices enter the U.S. market through the FDA’s 510(k) process, which permits approval without clinical trials if a device is deemed “substantially equivalent” to an existing product.23
Women have been disproportionately affected by this lenient approval process. Research highlights that sex-based biological differences—such as hormones, anatomical variations, inflammatory responses, and physical functions—are rarely factored into device testing, leaving women at heightened risk of complications.17 For example, the insertion of medical devices like IUDs, breast implants, and transvaginal mesh has led to a host of adverse reactions in women, underscoring the dangers of applying a one-size-fits-all approach to medical device approval.
Treatment of Women Patients by Medical Professionals
The exclusion of women from clinical research is not merely an oversight but stems from a long history of biases and misogynistic beliefs about women’s bodies—a legacy that still affects healthcare today. Although it may seem antiquated to exclude women from trials due to “biologically erratic” hormones, this mentality endures subtly in modern medical practice.7 Many women report feeling dismissed or disregarded when seeking medical attention, reflecting systemic biases that can endanger their health.
Historical records show that women’s pain has often been attributed to psychological or emotional causes, disregarding physical explanations for their symptoms.3 This perspective has contributed to pervasive treatment disparities, leading to inadequate care and poor outcomes for women in the healthcare system today.
Key Disparities in Women’s Medical Treatment
The Journal of the American Heart Association reports that women presenting with chest pain in emergency departments wait 29 percent longer than men to be evaluated for potential heart attacks.2 These delays can be life-threatening, particularly in acute situations like cardiovascular emergencies.
When middle-aged women report symptoms of heart disease, including chest pain, they are twice as likely to receive a mental illness diagnosis compared to men with identical symptoms.16 This tendency to attribute physical symptoms to psychological causes undermines women’s access to timely, appropriate treatment.
In an analysis of 981 emergency room visits, women presenting with acute abdominal pain were found to be up to 25 percent less likely than men to receive powerful opioid painkillers.6 This disparity leaves women in unnecessary pain and delays intervention, possibly worsening their medical condition.
A 2019 study revealed that in 72 percent of cases, women experience longer wait times for a medical diagnosis than men.25 Such delays contribute to worse prognoses and diminished quality of life for women whose symptoms remain unaddressed for extended periods.
Research shows that women of color—especially Black women—face even greater barriers to receiving adequate care.5 They are disproportionately more likely to encounter:
-
- Disregarded or dismissed pain reports
- Misdiagnoses
- Delays or outright failures in receiving necessary treatments and medications
These disparities are particularly dangerous when systemic racism intersects with gender bias, compounding the negative effects on women’s health outcomes.
When misogynistic and racist biases pervade the healthcare system, they contribute to delayed diagnoses, inadequate pain management, and reduced access to care, with profound and often life-threatening consequences for women.
Exploitation of Women as Consumers
The systemic disregard for women’s health in medical research, product regulation, and patient care is further compounded by the exploitation of women as consumers. Women control more than 80 percent of healthcare spending decisions in the U.S., and while they suffer from systemic neglect in medical contexts, they are simultaneously targeted by aggressive pharmaceutical marketing campaigns that capitalize on this spending power.
In the United States, the marketing of pharmaceutical drugs and medical devices has been the subject of ethical debate for decades. Yet despite ongoing concerns, pharmaceutical companies have only increased their direct-to-consumer advertising budgets—spending billions more over the past 20 years. By 2013, nine of the ten largest pharmaceutical companies were investing more in sales, overhead, and marketing than in research and development.9
Studies reveal that much of this advertising targets women, especially for commonly prescribed medications such as antidepressants1. This marketing approach encourages women to seek specific medications from their doctors, but they often receive inadequate information from both pharmaceutical companies and medical professionals11, leaving them unable to make fully informed decisions about their treatment options. By prioritizing profits over transparency, these campaigns exploit women’s healthcare decision-making role and contribute to a cycle that values consumer behavior over patient safety and well-being.
A Vision for the Future of Women’s Health
We envision a future where women’s health is no longer an afterthought but a priority in every phase of drug and medical device development—from ideation to implementation. Achieving this vision requires a comprehensive approach that acknowledges women’s unique health needs and strives for transparency and accountability in the healthcare industry.
This future includes:
Understanding Women’s Health Issues to Create Targeted Solutions
Addressing women’s health requires dedicated resources to understand specific conditions, symptoms, and experiences unique to women. Developing targeted treatments for women’s health issues is essential to providing effective and inclusive care.
Conducting Thorough Research with a Representative Sample of Subjects
Medical research must be diverse and representative, with clinical trials that reflect the population they aim to serve. Comprehensive trials that account for gender differences ensure that new treatments are safe and effective for everyone, especially for women who have been historically underrepresented.
Enforcing Ethical Marketing Practices in the Pharmaceutical Industry
Pharmaceutical companies should be held to rigorous ethical standards, particularly in their marketing practices. Transparency and honesty in advertising allow patients to make decisions based on facts, not persuasion tactics. Regulations should ensure that all consumers, especially women, are fully informed about their treatment options.
Educating and Enabling Women with Information Needed to Make Informed Healthcare Decisions
Women deserve access to clear, evidence-based information to make empowered healthcare choices. Educational resources and trustworthy guidance from medical professionals are essential in helping women navigate their health journeys with confidence and clarity.
Believing Women When They Say Something is Wrong
Listening to women and validating their experiences are fundamental to improving healthcare outcomes. Medical professionals should trust women’s reports of their symptoms and address their concerns with urgency and respect, eliminating gender biases that dismiss or minimize their pain.
Driven by Results
Guided by Experience
We are a mass tort litigation firm that believes a group effort is essential to success, both inside and outside the courtroom. Each of our firm's lawyers contributes their unique skills and experience, collectively forming an exceptional team that offers clients a robust network of support and a wealth of expertise.
Works Cited
- Asadi, Leila K., and Asim A. Shah. “Gender Bias in Antidepressant Direct-To-Consumer Pharmaceutical Advertising.” Comprehensive Psychiatry, vol. 123, May 2023, p. 152384, https://doi.org/10.1016/j.comppsych.2023.152384.
- Banco, Darcy, et al. “Sex and Race Differences in the Evaluation and Treatment of Young Adults Presenting to the Emergency Department with Chest Pain.” Journal of the American Heart Association, vol. 11, no. 10, 4 May 2022, https://doi.org/10.1161/jaha.121.024199.
- Bever, Lindsey. “From Heart Disease to IUDs: How Doctors Dismiss Women’s Pain.” The Washington Post, 13 Dec. 2022, www.washingtonpost.com/wellness/interactive/2022/women-pain-gender-bias-doctors/.
- Bibbins-Domingo, Kirsten, and Alex Helman. Why Diverse Representation in Clinical Research Matters and the Current State of Representation within the Clinical Research Ecosystem. Www.ncbi.nlm.nih.gov, National Academies Press (US), 17 May 2022, www.ncbi.nlm.nih.gov/books/NBK584396/.
- Chambers, Brittany D., et al. “Clinicians’ Perspectives on Racism and Black Women’s Maternal Health.” Women’s Health Reports, vol. 3, no. 1, 1 May 2022, pp. 476–482, www.ncbi.nlm.nih.gov/pmc/articles/PMC9148644/, https://doi.org/10.1089/whr.2021.0148.
- Chen, Esther H, et al. “Gender Disparity in Analgesic Treatment of Emergency Department Patients with Acute Abdominal Pain.” Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine, vol. 15, no. 5, 2008, pp. 414–8, https://doi.org/10.1111/j.1553-2712.2008.00100.x.
- Cleghorn, Elinor. “The Long History of Gender Bias in Medicine.” Time, 17 June 2021, time.com/6074224/gender-medicine-history/.
- “Diethylstilbestrol (DES) and Cancer.” National Cancer Institute, Cancer.gov, 5 Oct. 2011, www.cancer.gov/about-cancer/causes-prevention/risk/hormones/des-fact-sheet#what-is-des.
- Drug Policy 101: Pharmaceutical Marketing Tactics Institute for Health Policy. Kaiser Permanente, 2020.
- Health, Center for Devices and Radiological. “Essure Permanent Birth Control.” FDA, 10 Jan. 2020, www.fda.gov/medical-devices/implants-and-prosthetics/essure-permanent-birth-control.
- James, Julia. “Patient Engagement | Health Affairs Brief.” Healthaffairs.org, 2024, www.healthaffairs.org/content/briefs/patient-engagement.
- Kolata, Gina. “How Fen-Phen, a Diet “Miracle,” Rose and Fell.” The New York Times, 23 Sept. 1997, www.nytimes.com/1997/09/23/science/how-fen-phen-a-diet-miracle-rose-and-fell.html.
- Llamas, Michelle. “How the FDA Let Women Down.” Drugwatch.com, 24 Sept. 2015, www.drugwatch.com/featured/fda-let-women-down/.
- ---. “Power Morcellator Lawsuits | Allegations, MDLs & Settlements.” Drugwatch.com, 24 May 2024, www.drugwatch.com/morcellators/lawsuits/.
- Mackar, Robin. “Hair Straightening Chemicals Associated with Higher Uterine Cancer Risk (Environmental Factor, November 2022).” National Institute of Environmental Health Sciences, Nov. 2022, factor.niehs.nih.gov/2022/11/papers/uterine-cancer.
- Maserejian, Nancy N., et al. “Disparities in Physicians’ Interpretations of Heart Disease Symptoms by Patient Gender: Results of a Video Vignette Factorial Experiment.” Journal of Women’s Health, vol. 18, no. 10, Oct. 2009, pp. 1661–1667, www.ncbi.nlm.nih.gov/pmc/articles/PMC2825679/, https://doi.org/10.1089/jwh.2008.1007.
- Phillips, Susan P., et al. “Medical Devices, Invisible Women, Harmful Consequences.” International Journal of Environmental Research and Public Health, vol. 19, no. 21, 1 Jan. 2022, p. 14524, www.mdpi.com/1660-4601/19/21/14524, https://doi.org/10.3390/ijerph192114524. Accessed 3 Dec. 2022.
- “Prempro Settlements to Result in $1.2B Payments for Breast Cancer: Report.” AboutLawsuits.com, 20 June 2012, www.aboutlawsuits.com/prempro-settlement-payments-breast-cancer-29138/.
- “Prempro: Uses, Dosage & Side Effects.” Drugs.com, 20 Feb. 2024, www.drugs.com/prempro.html.
- Shearston, Jenni A, et al. “Tampons as a Source of Exposure to Metal(Loid)S.” Environment International, vol. 190, no. 108849, 1 June 2024, pp. 108849–108849, https://doi.org/10.1016/j.envint.2024.108849.
- Siegel Watkins, Elizabeth . “From Breakthrough to Bust: The Brief Life of Norplant, the Contraceptive Implant.” Journal of Women’s History, vol. 22, no. 3, 2010, pp. 88–111, https://doi.org/10.1353/jowh.2010.0585.
- “Silicone Breast Implants Linked to Number of Complications, but FDA Critical of Study.” Www.breastcancer.org, 20 Nov. 2022, www.breastcancer.org/research-news/silicone-implants-linked-to-complications.
- Silvestrini, Elaine. “FDA 510(K) Clearance - Dangerous Fast-Track Approval Process.” Drugwatch.com, 5 Sept. 2023, www.drugwatch.com/fda/510k-clearance/.
- Treisman, Rachel. “A Study Found Toxic Metals in Popular Tampon Brands. Here’s What Experts Advise.” NPR, 11 July 2024, www.npr.org/2024/07/11/nx-s1-5036484/tampons-heavy-metals-study.
- Westergaard, David, et al. “Population-Wide Analysis of Differences in Disease Progression Patterns in Men and Women.” Nature Communications, vol. 10, no. 1, 8 Feb. 2019, pp. 1–14, https://doi.org/10.1038/s41467-019-08475-9.