Ovarian Cancer and “Tainted Talc”: What Treating Physicians Need to Know

Introduction

On July 12, 2018, a St. Louis City jury sent shock waves across the world, awarding 22 plaintiffs $550 million in compensatory damages and $4.14 billion in punitive damages in a lawsuit against Johnson & Johnson over claims its talcum powder products caused ovarian cancer in women who used the company’s products for years.¹

This case signals a change in the litigation surrounding talc product-induced ovarian cancer in Missouri by placing the blame on potential “contaminants” of talc, rather than the talc itself.

This recent verdict marked a change from previous talcum product cases in St. Louis by focusing on claims that ovarian cancer was caused by exposure to asbestos allegedly found in Johnson & Johnson’s talcum powder, compared to claims that the cancer was caused by the talc. Further, the July 2018 verdict was the first multi-plaintiff talcum powder litigation decided in the United States. To date, evidence presented in the state court trials included company documents that suggested Johnson & Johnson may have been aware of the potential link between talcum powder contaminants and ovarian cancer since the 1970s.

The purpose of this article is to give an overview of the current medical knowledge as to the causes of ovarian cancer, outline the current state and strategies of talc-related ovarian cancer litigation in Missouri, and identify practical challenges facing medical professionals as a result of this ongoing litigation.

Ovarian Cancer & Risk Factors

The American Cancer Society predicts that there will be approximately 22,240 new cases of ovarian cancer diagnoses and approximately 14,070 ovarian cancer deaths annually in the United States.² The most reliable predictors of ovarian cancer are a familial history of breast or ovarian cancer and mutations in certain BRCA1 and BRCA2 genes, suggesting that the disease has a strong genetic component.³ Increased incidence of ovarian cancer is associated with women who are over 55 years old, have never given birth to children, or have taken hormone replacement therapy for over ten years.⁴

While several factors predicting ovarian cancer risk have been identified, no factors have been proven to cause ovarian cancer, although talc has long been considered a potential causative agent for this disease.⁵ However, the scientific and medical communities have not reached an agreement as to whether talc usage does or does not cause ovarian cancer. The U.S. Center for Disease Control and Prevention does not list talc as an ovarian cancer risk,⁶ while the International Agency for Research on Cancer, part of the World Health Organization, classifies the genital use of talc-based body powder as “possibly carcinogenic to humans.”⁷

There is a body of evidence that talc product use may be associated with an increased incidence of ovarian cancer, but that evidence relies on women’s memories about their past use of talc products.⁸ In these studies, ovarian cancer patients remembered using talc products more often than ovarian cancer-free women, or more ovarian cancer patients remembered using talc products than ovarian cancer-free women.⁹ The scientific rigor of these retrospective studies has been criticized and other research casts doubt on their reliability.¹⁰ These studies often failed to distinguish which type of cosmetic product was used (dusting powder, baby powder, talc, bath talc), the exact composition of the cosmetic product, or the brand of the cosmetic product.¹¹ Nor did the studies address whether asbestos was a component of the cosmetic product investigated.¹²

Perhaps more telling, there seem to be no experimental studies providing scientific evidence that talc causes ovarian cancer.¹³ This less-than-compelling scientific record may be part of the reason for the recent shift in litigation strategy: from blaming ovarian cancer on talcum products to blaming ovarian cancer on a specific compound sometimes found in coexistence with talc—asbestos.¹⁴

Neither talc nor asbestos has been shown to cause ovarian cancer.¹⁵ However, asbestos is a compound that is well-known to cause lung cancer and mesothelioma.¹⁶ It is known to be a potent carcinogen and in recent litigation, juries have been persuaded that it is carcinogenic enough to cause ovarian carcinoma.¹⁷

Talc Litigation in Missouri

While the first talc trial was in 2013 in South Dakota,¹⁸ Missouri became a hot spot for such filings after the first verdict by a U.S. jury to award damages over such claims was ordered in the Circuit Court of the City of St. Louis in February 2016.¹⁹ Since the February 2016 verdict, there have been several other high profile talc trials in St. Louis City, most recently with the first multi-plaintiff verdict in July 2018. As of February 2019, Johnson & Johnson is facing roughly 13,000 lawsuits over talc in the United States, most of which have been consolidated in federal court in New Jersey, where the company is headquartered.²⁰ About 700 of these lawsuits have been filed in St. Louis City.²¹ Because of these strategic filings by plaintiffs’ counsel, St. Louis City has consistently been ranked as one of the most “plaintiff friendly” venues in the country.²² The American Tort Reform Foundation complained that plaintiffs’ lawyers’ ability to “introduce junk science in the city’s talc litigation” helped to explain St. Louis city’s popularity as a place to file these lawsuits.²³

Many of the unsuccessful lawsuits against Johnson & Johnson lacked persuasive explanations of the biological mechanisms by which talc is exposed to ovaries and by which talc causes ovarian cancer.²⁴ In the Ingham case, a new theory prevailed. Here, specific components of Johnson & Johnson’s talcum powder products were identified and called out as cancer-causing agents: the talc itself, as well as “other carcinogens, including asbestos, asbestiform fibers, and arsenic.”²⁵ Instead of solely relying on talc as the cancer-causing culprit, the litigants offered the theory that the talc was “tainted” with known carcinogens.

The Food and Drug Administration, which investigates and monitors reports of asbestos contamination in consumer products, commissioned a survey in 2009–2010 to screen for asbestos in raw material talc, commercial talc, baby powders, and talc-containing cosmetics. It reported that no asbestos was detected in any of the samples.²⁶

There are allegations that Johnson & Johnson routinely performed certain quality assurance tests on its source talc.²⁷ An internal memo in 1969 referred to tests reporting that some of their talc samples tested positive for trace amounts of asbestos.²⁸ Tests performed between 1970–2000 yielded results that indicate that some samples might have contained trace elements.²⁹ It is unclear whether Johnson & Johnson’s testing definitively established that those trace elements were asbestos or some other non-carcinogenic agent.³⁰ Johnson & Johnson chose not to share the information with the public.³¹

The Ingham court was persuaded that Johnson & Johnson knew or should have known that the talc it purchased to make its baby powder might have been contaminated with carcinogens such as asbestos. This seems to be the first successful ovarian cancer lawsuit that relied on the theory that Johnson & Johnson’s source talc material might have been contaminated with traces of asbestos or other cancer-causing compound.³²

In view of these recent developments, the Department of Justice has subpoenaed Johnson & Johnson for internal company documents about its knowledge of asbestos risks in its talc products.³³ It is hoped that the presence or absence of asbestos in Johnson & Johnson’s source talc will be definitively settled. But for now, it simply is unclear whether Johnson & Johnson’s talc products may or may not have contained asbestos.

But even if asbestos is confirmed to have been in Johnson & Johnson’s source talc, there is still the unresolved question as to whether or not asbestos causes ovarian cancer, and whether asbestos would cause ovarian cancer when present in trace amounts in genital talc products.³⁴

The litigation outcomes have been mixed, but the awards have been large enough to induce Imerys Talc America Inc., which supplies talc to Johnson & Johnson, to file for bankruptcy to end the lawsuits alleging that Imerys’s talc caused ovarian cancer or mesothelioma.³⁵ Johnson & Johnson remains committed to fighting the ongoing litigation in Missouri after the Ingham verdict, explaining “every verdict against Johnson & Johnson in this court that has gone through the appeals process has been reversed.”³⁶

Treating Physicians & Causation Theory

The debate in the scientific and medical community as to whether talc usage may cause ovarian cancer has impacted the litigation strategy and role of expert testimony in talc trials to date. When it was noted in the Ingham lawsuit that, during the course of their patients’ treatment, none of the plaintiffs’ treating physicians concluded that talcum powder products caused their patients’ ovarian cancer, the plaintiffs filed a motion to exclude testimony on causation from plaintiffs’ own treating physicians.³⁷

Missouri courts now follow the Daubert standard for the admission of expert testimony.³⁸ Under this standard, a witness who is qualified as an expert by knowledge, skill, experience, training or education may testify in the form of an opinion or otherwise if: (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principals and methods to the facts of the case.³⁹

Following this standard, the Ingham plaintiffs argued that their own treating physicians should be excluded from providing testimony on causation, as plaintiffs’ treating physicians either testified they were not experts in the causal relationship between talc and ovarian cancer, or that they did not have an opinion as to whether their patient’s cancer was caused by exposure to talcum powder.⁴⁰ Plaintiffs further argued that treating physicians who stated that they had no opinion about the cause of their patients’ ovarian cancer should be excluded from testifying about topics related to causation, as such testimony would not be helpful to the trier of fact.⁴¹

In opposition, Johnson & Johnson reasoned that outside of known causes of ovarian cancer such as certain genetic factors, it is not possible to identify the cause of an individual patient’s cancer within the present state of scientific knowledge, acknowledging that plaintiffs’ treating physicians deposed in Ingham generally testified they had not formed opinions about the specific cause of their patient’s ovarian cancer.⁴² Johnson & Johnson argued against plaintiffs’ attempt to attribute treating physicians’ non-position on causation to an alleged lack of expertise, even though understanding the risk factors for and causes of ovarian cancer is part of any treating physician’s training, background and experience.⁴³

In the end, the physicians who expressed opinions about causation in this case were allowed to testify about that subject at trial, while the physicians who hadn’t expressed opinions on causation were not allowed to testify about that subject at trial.⁴⁴

The role of expert testimony was crucial in the outcome, as the Ingham court relied on the paid expert causation testimony of Drs. Dean Felsher and David Egilman, neither board-certified in gynecology or oncology at the time of trial,⁴⁵ to conclude plaintiffs’ ovarian cancer was a result from plaintiffs’ exposure to talcum powder.⁴⁶

Ongoing Liability Issues for Treating Physicians

In future talc litigation, it is likely that treating physicians will be called upon as either an expert witness for litigants or as a fact witness for their patients, or both.

As physicians evaluate patients diagnosed with ovarian cancer, it may be prudent to identify which factors should be assessed as causing or contributing to the disease. It may also be prudent to develop protocols to ensure such factors are uniformly assessed for all affected patients.

As scientific and medical views about the causative factors of ovarian cancer evolve, such protocols can be updated and those revisions documented as needed.

Thus, in the future, when a patient becomes a litigant, she can present to the court facts that were recorded by her treating physician, and the principles and methods her treating physician used to memorialize those facts. Whether the treating physician is asked to supply an opinion or a factual record, the court is more likely to be satisfied that the physician’s record is reliable and suitable for the court’s consideration when shown that the record was generated in a manner consistent with Missouri standards for expert testimony.

Conclusion

As attorneys, we have focused on the legal issues relating to talc products as potential causative agents for ovarian cancer, but this litigation will likely affect the medical practices of many physicians.

The ongoing cases may reshape attitudes about what is considered a cancer-causing agent and what isn’t, what a physician’s best practices are when a common household item is classified as “maybe” containing cancer-causing agents, and how to answer patients’ questions when they ask their doctor to assess the risks posed by their past use of certain products.

At the very least, the physicians of ovarian cancer patients should be prepared for patients’ questions about causation when the cancer is initially diagnosed, and for lawyers’ questions about causation many years later.

For more specific information about the legal ramifications of these practices, you should consult with a licensed attorney who specializes in healthcare-related litigation issues.