Florida judge dismisses Zantac cancer claims against GSK, other pharmas
GSK can breathe a little easier after a Florida federal judge dismissed thousands of claims that Zantac and related heartburn products caused cancer, triggering a boost in premarket trading on Wednesday.
Plaintiffs in the sprawling multidistrict litigation (MDL) at first attempted to link popular ranitidine heartburn products to 10 types of cancer, but later withdrew breast, kidney, colorectal, prostate and lung. On Tuesday, Judge Robin Rosenberg tossed the remaining claims in liver, bladder, pancreatic, esophageal, and stomach cancers, upon determining that the allegations were based on “flawed” and “unreliable” evidence.
Pfizer, Boehringer Ingelheim and Sanofi, which owned Zantac rights at various points in time, were also named in the suit, in addition to Thermo Fisher’s Patheon Manufacturing Services.
“Here, there is no scientist outside this litigation who concluded ranitidine causes cancer, and the Plaintiffs’ scientists within this litigation systemically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data,” Rosenberg wrote in an opinion.
Zantac was first approved as a prescription medicine for heartburn in 1983, and after a decade of record sales, GSK began working on an over-the-counter formulation. Several OTC forms were cleared in 1995, and those sales rights later passed through the hands of Pfizer, Boehringer Ingelheim and Sanofi. However, the drug was recalled in 2019 over unacceptably high levels of a potential carcinogen known as NDMA.
Plaintiffs argued that ranitidine can transform into NDMA in the body or on the shelf in high temperatures, and in 2020, regulators requested the recall of all ranitidine products. More than 2,450 plaintiffs filed suits in the MDL, or had cases transferred to the Florida federal court.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” former acting commissioner Janet Woodcock said around the time of the recall. “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
GSK continues to argue that “the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.”
“Yesterday’s ruling reflects the state of that science and ensured that unreliable and litigation-driven science did not enter the federal courtroom,” the company said in a news release.
The recent dismissal does not affect thousands of ongoing cases at the state level, many of which include plaintiffs who exited federal MDL or whose alleged injuries had been dropped, a Sanofi spokesperson told Endpoints News back in September.
GSK said in its announcement on Wednesday that it will “continue to defend itself vigorously, including against all claims brought at the state level.”
The company noted on its Q3 call last month that 70,000 new claims had been filed in the state of Delaware, the majority of which had “not been vetted at this point in time.”