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In a crucial legal battle, pharmaceutical companies, including GSK, Pfizer, and others, seek to convince a Delaware judge that the evidence put forth by plaintiffs’ lawyers in approximately 72,000 lawsuits linking the discontinued heartburn drug Zantac to cancer lacks scientific support.
Challenging the Science
Mark Cheffo, representing GSK, argued before Judge Vivian Medinilla that the litigation had outpaced the scientific evidence, emphasizing that no reliable studies establish a direct link between Zantac use and cancer. Cheffo pointed out that plaintiffs rely on the claim that Zantac’s active ingredient, ranitidine, can degrade into NDMA, a chemical associated with cancer. However, he asserted that the levels of NDMA in Zantac are comparable to those found in everyday foods and have not been proven to be cancer-causing.
Background and Legal Landscape
In 2019, Zantac sales were halted by some manufacturers and pharmacies following the detection of NDMA in certain pills. Subsequently, a wave of lawsuits emerged from individuals alleging the development of cancer after taking Zantac. Plaintiffs argue that the companies were aware of or should have known about the cancer risk posed by ranitidine and failed to warn consumers adequately.
Judge Vivian Medinilla oversees most of the nearly 80,000 Zantac cases still pending in the United States. Zantac, once the world’s top-selling drug, is at the center of extensive legal scrutiny.
Previous Legal Victories and Ongoing Appeals
In 2022, the drugmakers, including Sanofi and Boehringer Ingelheim, secured a significant victory when a judge dismissed about 50,000 consolidated lawsuits in federal court, citing insufficient scientific support for the claim that Zantac causes cancer. Despite this win, plaintiffs are appealing the ruling.
Medinilla is set to use the same legal standard as the Florida judge to evaluate expert testimony. However, the experts presented in the Delaware cases differ from those excluded in the federal court lawsuits.
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Stakes for the Pharmaceutical Companies
The outcome of the hearing could have profound implications for the pharmaceutical companies. If the judge rules that plaintiffs’ experts cannot testify to Zantac’s cancer-causing potential, it might bring an end to all Delaware cases. Alternatively, the judge could allow testimony for certain cancers but not others, reducing the companies’ potential liability.
Zantac’s Historical Significance
Initially approved in 1983, Zantac became the world’s best-selling medicine in 1988, becoming one of the first drugs to surpass $1 billion in annual sales. Its ownership changed over the years, with GSK, Pfizer, Boehringer Ingelheim, and Sanofi being successive owners. In 2020, the FDA requested the removal of Zantac and its generic versions from the market after detecting NDMA in drug samples.
Financial Fallout and Ongoing Litigation
Concerns about prolonged legal battles and potential financial settlements resulted in a collective market value loss of nearly $40 billion for GSK, Sanofi, Pfizer, and GSK-spinoff Haleon over a week in August 2022. Beyond the Delaware cases, the drugmakers are contending with approximately 4,000 claims in California state court and about 2,000 in various state courts nationwide. The pharmaceutical companies have settled several individual cases in California ahead of trial. Lawyers for the other pharmaceutical companies, reiterating their stance that there is no evidence linking Zantac to cancer, are expected to present their arguments later in the day.
