GSK notches Zantac win in Illinois, appeals high-stakes setback in Delaware

11 Jun 2024
www.fiercepharma.com
Drug ApprovalPatent InfringementPriority Review
GSK notches Zantac win in Illinois, appeals high-stakes setback in Delaware
Preview
Source: FiercePharma
GSK on Monday reiterated its stance that “there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.”
As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer.
Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday, GSK said in an online statement.
GSK did not settle Kasza’s claim and stressed that it did not pay her anything for her voluntary dismissal, according to the company's statement. The drugmaker said it will continue to “vigorously defend itself” in the ongoing litigation.
The company reiterated its stance that “there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.”
Ranitidine is the former main ingredient in Zantac, which quality assurance lab Valisure first linked to the possible carcinogen N-nitrosodimethylamine (NDMA) back in 2019.
The FDA ultimately called for a complete purge of the original Zantac formulation from the U.S. market in April 2020.
GSK is the original developer of Zantac and gained approval for the med back in 1983, turning it into a blockbuster and the world’s bestselling drug by 1988. When the drug lost patent exclusivity in 1997, Pfizer, Sanofi, Boehringer Ingelheim and others began selling generic versions until the FDA’s 2020 ranitidine kibosh.
Earlier this month, a Delaware judge allowed more than 75,000 lawsuits against various drugmakers to proceed when she ruled that juries in the state can hear expert analyses of the potential health risks caused by Zantac.
At the time, ODDO BHF analysts claimed GSK could face potential exposure worth $2 billion if the company were to settle the tens of thousands of claims it faces.
Despite the legal setback in Delaware, GSK has been able to win or parry various other Zantac claims in recent months. In late May, a Chicago jury sided with GSK and Boehringer when it rejected the claim of Angela Valadez that the heartburn drug had led to her colon cancer.
In February, GSK settled two separate Zantac personal injury lawsuits in California. Prior to that, GSK in October said it had resolved another four cases in the Golden State, one of which was set to go to trial in November.
Sanofi, for its part, agreed to settle approximately 4,000 personal injury claims related to Zantac in early April, while Pfizer charted a similar move to knock out some 10,000 lawsuits in several U.S. state courts in May.
Apart from the Kasza case, GSK was set to face another jury trial in Illinois this month from a plaintiff claiming Zantac caused his prostate cancer, plus another prostate cancer personal injury claim from a plaintiff in Illinois in July, according to the company's first-quarter earnings release.
As for the Delaware decision, GSK on Monday added that it plans to appeal the so-called Daubert ruling, which allows for plaintiff expert testimony as part of the Zantac litigation in the state. Pfizer, Sanofi and Boehringer joined GSK in filing the application to the Delaware Supreme Court against what the companies deemed an “inconsistent” application of the standard.
The Delaware Supreme Court is expected to issue a decision on whether to grant the drugmakers’ request for interlocutory review “sometime later this year,” GSK said.
Editor's note: This story was updated with additional detail on GSK's decision to appeal the recent Daubert ruling in Delaware.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.