Superior Court Judge Vivian Medinilla concluded Friday evening that consumers are not relying on flawed science to support claims that Zantac — owned by different companies at different times — caused various cancers. She also found that disputes over experts’ analyzes of these health risks can be properly argued at trial.
Delaware law shows “deep deference to the role of juries as the ultimate fact finders,” Medinilla said in a 102-page ruling. “Delaware courts are reluctant to intervene in the heart of a technical debate between opposing scientists. » She has not yet set a trial date for any of these cases.
The ruling is a blow to New York-based GSK and Pfizer, which hoped to persuade Medinilla to follow the lead of a federal judge in Florida who rejected cancer evidence as unreliable in 2022. The California judges and of Illinois approved the validity. of much of the same evidence, leading GSK and Pfizer to settle some cases. Yet last month, an Illinois jury rejected a woman’s claim that Zantac caused her colon cancer in the first U.S. case to go to trial.
UK-based GSK said on Saturday it disagreed with Medinilla’s decision and would appeal. “The decision does not mean that the court agrees with the scientific conclusions of the plaintiffs’ experts, and it does not determine liability,” GSK said in a statement.
Pfizer said it was involved in “only a fraction” of the Delaware cases, adding that it still saw no material impact in the Zantac litigation. The company intends to appeal, it said in a statement Saturday.
Former Zantac users have sued the brand-name and generic drugmakers that made the heartburn medication over the years, alleging that the product caused, among other things, breast cancer, stomach and colon.
Link against cancer
The plaintiffs argued that the companies knew that ranitidine — the drug’s active ingredient — converted to NDMA, a potential carcinogen, under certain conditions. In 2020, the U.S. Food and Drug Administration asked companies to remove all ranitidine drugs from the U.S. market after some versions were found to be contaminated with NDMA.
Medinilla cited the FDA recall in its decision to allow consumer experts to testify on studies showing that NDMA can cause cancer and that ranitidine can turn into a carcinogen under certain circumstances. The judge noted that regulators ordered the ranitidine version of Zantac to be removed from the market after concluding that NDMA is a “substance that can cause cancer.”
Companies and consumers will have the opportunity to present their experts before juries, who will ultimately decide on the cancer risks of Zantac, the judge noted. “This dispute presents a classic battle of experts,” Medinilla wrote. Companies “can meet their challenges” in the face of plaintiffs’ scientific evidence during cross-examination at trial, she added.
Zantac entered the U.S. market as a prescription drug in 1983 before morphing into an over-the-counter heartburn treatment in 1995. GSK and Warner Lambert developed it in a joint venture, and the drug was owned by several companies in previous years. Sanofi, which acquired it in 2017.
In addition to GSK and Pfizer, Sanofi and Boehringer Ingelheim GmbH have been sued by consumers. After the federal cases were dismissed, many were refiled in Delaware, where the drug companies’ U.S. units are incorporated.
Lawyers for the companies argued that the Delaware cases relied on the same scientific data rejected in Florida, and the plaintiffs sought to have Medinilla ignore his function of assessing the legitimacy of evidence presented to juries. The consumers’ attorneys countered that they offered different expert witnesses in the Delaware cases who based their opinions on “reliable documents.”
The case is IN RE: Zantac (Ranitidine) Litigation, N22C-09-101 ZAN, Superior Court of Delaware (Wilmington).
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