Weekly Mass Torts Bulletin 2024-May-28

Using Talcum Powder Around Genitals Linked to Ovarian Cancer

Johnson & Johnson is grappling with over 50,000 lawsuits related to its Baby Powder and Shower-to-Shower products, which are alleged to have caused ovarian cancer in women who used the talc-based powders around their genitals.

Recently, a significant new study from the National Institutes of Health (NIH) has added weight to these claims, finding that the use of genital talcum powder is associated with a 17% increased risk of ovarian cancer. The study, however, did not find any connection between talcum powder use and uterine or breast cancer.

Previous studies have suggested a link between talcum powder and ovarian cancer, but questions about the quality of the data have prevented a definitive conclusion. Despite the growing body of evidence, Johnson & Johnson has been fighting these lawsuits for nearly a decade. The company has faced several large damage awards from juries who found that Johnson & Johnson either knew or should have known about the risks of talcum powder but continued to market it to adult women without warning them.

Instead of settling out of court, Johnson & Johnson has tried to handle the litigation through the U.S. bankruptcy system. The company transferred all its liability to a subsidiary, which then declared bankruptcy to seek protection. This strategy has been rejected twice by the courts, but Johnson & Johnson recently proposed a new $6.5 billion settlement offer, which the plaintiffs’ lawyers have rejected.

The NIH study reviewed data from The Sister Study, which included 50,884 women who had sisters with breast cancer. The study, conducted between 2003 and 2009, investigated the association between the use of genital talcum powder and the incidence of ovarian cancer, as well as breast and uterine cancers. Among the participants, 41-65% douched, and 35-56% used genital talc. The researchers found a positive association between genital talc use and ovarian cancer, indicating a 17% increase in risk. While there was also a small association noted between douching and ovarian cancer, neither practice was linked to an increased risk of breast or uterine cancers.

The study's findings support prior research published in medical journals. For instance, a 2019 study in the Journal of Occupational and Environmental Medicine found talc in the tissue of nine out of ten ovarian cancer patients who had used Johnson & Johnson products. Another study from the same year reported a statistically significant 9% increased risk of ovarian cancer among talcum powder users. Despite this, Johnson & Johnson has consistently disputed these findings, asserting that their talc-based products do not cause ovarian cancer.

Due to the large number of similar cases, pretrial proceedings for the talcum powder litigation were centralized in 2016 under a U.S. District Judge in New Jersey. However, delays ensued when Johnson & Johnson's bankruptcy attempts slowed the process, and the judge overseeing the case retired. A new judge has since taken over, and preparations for bellwether trials are underway.

These bellwether trials, set to begin on December 30, 2024, aim to establish how juries might respond to evidence and influence potential settlement values. Earlier this year, the new judge allowed Johnson & Johnson to hold Daubert hearings to challenge the admissibility of the plaintiffs’ expert witnesses, despite a previous judge’s decision to allow the testimonies. The plaintiffs requested reconsideration, but the judge upheld the ruling on April 30, 2024, and issued an amended scheduling order for the first trial.

Johnson & Johnson then sought to delay the litigation further by requesting extensions for defense expert deadlines. However, the judge issued a text order on May 20, 2024, rejecting this request, emphasizing adherence to the established schedule. The judge reminded the parties that no extensions for Daubert or dispositive motion schedules would be entertained.

The outcomes of these bellwether trials, while not directly binding on other cases, are expected to significantly influence the settlement negotiations. If juries continue to award substantial damages, it could pressure Johnson & Johnson to agree to higher settlements to avoid the time and expense of individual trials. This new NIH study adds to the mounting evidence and is likely to bolster the plaintiffs’ claims as they prepare for these pivotal trials.

GSK Hid Zantac Cancer Risks for Decades, Lawsuit Alleges

GlaxoSmithKline (GSK) is facing a whistleblower lawsuit brought by Valisure, an independent testing laboratory, which uncovered high levels of a cancer-causing chemical in Zantac in 2019.

This discovery led to a massive recall and tens of thousands of Zantac-related cancer lawsuits against the drug's various manufacturers. Zantac, known generically as ranitidine, was widely used by millions of Americans before the U.S. Food and Drug Administration (FDA) pulled it from the market in late 2019. The removal followed revelations that ranitidine is inherently unstable and can produce high levels of N-Nitrosodimethylamine (NDMA), a potent carcinogen.

Valisure, which regularly examines popular consumer products for chemical risks, first exposed the problem. Their investigations have also found benzene in aerosol sprays, sparking lawsuits against several sunscreen, deodorant, and other product manufacturers.

Following the Zantac recall, over 80,000 lawsuits were filed across the U.S. against manufacturers like GlaxoSmithKline, Boehringer Ingelheim, Pfizer, and Sanofi. Plaintiffs, many of whom were diagnosed with cancers such as bladder, liver, pancreatic, and stomach cancer, claimed these injuries were linked to their use of Zantac or its generic versions.

The initial whistleblower lawsuit against GlaxoSmithKline was filed in 2019 under seal but was publicly released in May 2023 after the U.S. government chose not to intervene. Valisure’s lawsuit alleges that GlaxoSmithKline was aware for decades of the cancer risks posed by NDMA generated from Zantac use but deliberately concealed this information from federal regulators and the medical community. This, Valisure claims, violated false claims act laws by the federal government and 25 states.

According to one study, GlaxoSmithKline, then operating as Glaxo, detected NDMA in Zantac as early as 1982 but did not inform the FDA of these findings until Valisure’s 2019 investigation. The lawsuit further alleges that when the FDA demanded GSK disclose all data concerning NDMA, GSK withheld this data and instead fabricated a study to mislead the FDA and independent researchers, thus ensuring ranitidine’s approval by falsifying information.

GSK has disputed the validity of Valisure’s testing methods but has nonetheless made settlements in several cases just before trials were set to begin. Recently, however, GSK allowed a claim by a woman diagnosed with colorectal cancer to proceed to trial in Illinois state court. This trial is being closely observed to understand how juries might respond to evidence concerning Zantac's cancer risks, which will be critical for thousands of similar claims.

For several years, Zantac litigation was centralized in the federal court system, with all lawsuits consolidated under a judge in the U.S. District Court for the Southern District of Florida for coordinated pretrial proceedings. However, in 2022, the judge issued a controversial ruling excluding all plaintiffs’ expert witnesses from testifying at trial under federal evidentiary rules. This decision left federal plaintiffs without means to prove that Zantac caused their cancers, resulting in the dismissal of all federal Zantac lawsuits. Appeals have been filed to challenge this ruling.

Meanwhile, the federal court’s ruling did not affect lawsuits in state courts in Illinois, Delaware, and other jurisdictions, where different standards for expert witness testimony apply. In these courts, large settlement agreements have been reached by Pfizer and Sanofi, aiming to resolve their portions of the litigation without undergoing numerous jury trials, which could result in unpredictable and costly outcomes. Pfizer recently announced it intends to pay up to $250 million to settle about 10,000 Zantac lawsuits in state courts. Similarly, Sanofi has agreed to settle 4,000 Zantac cancer lawsuits for over $100 million.

The majority of unresolved Zantac lawsuits now involve claims against GlaxoSmithKline and Boehringer Ingelheim, who have yet to reach comprehensive settlement agreements. The outcome of ongoing and future trials, particularly the Illinois state court case, will likely influence the resolution of these remaining claims.