Leading British drug companies, together with other pharmaceutical groups are urging an US judge to rule that the evidence plaintiffs’ attorneys want to use to support their 72,000 lawsuits alleging that discontinued heartburn drug Zantac causes cancer is not supported by science.
Mark Cheffo told the Delaware Superior Court in Wilmington Judge Vivian Medinilla that this litigation was “a case where lawyers and lawsuits got ahead of science — way, far ahead of science” at the beginning of a 3-day hearing. Cheffo said that no reliable studies have linked Zantac to cancer.
GSK shares, Britain’s 2nd largest drugs company, as well as other global drug manufacturers that sold Zantac, fell dramatically 18 months ago due to concerns over potential multi-billion-pound liability resulting from a wave lawsuits.
GSK is focusing on improving the productivity of their drug pipelines under Dame Emma Walmsley’s leadership as group chief executive.
GSK’s defense received a boost when, in December 2022 in Florida, about 50,000 cases of alleged fraud were dismissed in a federal court pre-trial hearing. GSK reached an agreement in October with a California state judge in relation to a few cases.
Delaware has the largest number of unresolved cases, with 72,000 filed claims. Many of these cases are related to cancers for which Florida plaintiffs chose not to pursue.
City analysts believe a decision on admissibility in Delaware can be made within 6 months. Jefferies analysts told their clients that they thought GSK was likely to reach a settlement for its liability in the first half this year, which is estimated at up to $3 billion or $4 billion. All parties would prefer to avoid uncertainty and future costs.
Shore Capital stated: “We believe that a worst case scenario, of up to $30 billion for Zantac litigation, is reflected currently in the share prices and any further clarity would support a material increase in the price.”
Ranitidine (marketed as Zantac) helped fund GSK’s global expansion. It was one of the world’s first blockbuster prescription drugs, with annual sales exceeding $1 billion.
This drug is used to treat heartburn by reducing the amount of stomach acid that is produced. The drug was first released by GSK as a prescription medication in the 1980s. It wasn’t until later that the rights for the over-the counter product in America were purchased by other companies.
The US Food and Drug Administration approved the over-the-counter form, developed by a partnership between GSK and Warner-Lambert in 1995. Pfizer purchased the rights to Zantac in 2000. They were later acquired by Boehringer Ingelheim and Sanofi. After being contacted by regulatory agencies, GSK in 2019 suspended all Zantac dose forms to all markets while tests and investigations were conducted. In 2020, the FDA requested that all manufacturers of Zantac withdraw their products from the market.
GSK’s spokesperson said, “We are confident in our position. We will continue to vigorously represent ourselves on the basis of facts and science.” There have been 15 peer reviewed epidemiological studies since 2019 on the effects of using ranitidine on humans. These studies reflect the scientific consensus of the fact that there are no reliable or consistent evidences that runningitidine can increase the risk of any type of cancer.
GSK will argue in Delaware that the court should follow federal MDL (multidistrict litigation) court’s Daubert comprehensive ruling, which, based upon the scientific evidence, effectively dismisses all cases and claims relating to the federal case’s five designated carcinomas. Delaware state courts use the Daubert standard for determining admissibility of expert testimony, just like federal courts.
The Delaware court will also examine the admissibility evidence concerning five more cancers. All of these should be rejected according to the standards established by the MDL Court, especially since the MDL Plaintiffs had previously abandoned their claims due to lack of scientific proof.
GSK shares traded around £18 until the sale brought them to £13 by September 2022. The shares fell by 23 1/2p or 1.5 percent to close Monday at £15.40.