GSK et al file appeal to Delaware Zantac order

GSK and other drugmakers have lost no time in filing an appeal to a Delaware court’s decision to allow more than 70,000 Zantac-related lawsuits to go ahead.

Just over a week ago, Judge Vivian Medinilla of Delaware Superior Court issued an order ruling that cases claiming Zantac (ranitidine) could cause cancer were “admissible”, sparking a sell-off in GSK shares that wiped billions off its market cap.

Now, the drugmaker and co-defendants, including Pfizer, Sanofi, and Boehringer Ingelheim, have filed an application to elevate the case to the Delaware Supreme Court for an “interlocutory” review – an appeal made before claims are resolved – seeking the dismissal of the lawsuits before they can be heard.

In a statement, GSK acknowledged that this type of review was generally only allowed in exceptional circumstances, but added that it “believes such circumstances are present here.”

GSK and other pharma companies that have sold ranitidine products over the years have so far been fairly successful in fending off the litigation, with wins in the US and Canada, and the Delaware decision was viewed as a major setback to their position.

For its part, GSK has insisted there is “no consistent or reliable evidence that ranitidine increases the risk of any cancer,” adding: “There are 16 epidemiological studies looking at human data regarding the use of ranitidine, including outcomes for more than 1 million patients using ranitidine, supporting this consensus.”

At the heart of the Delaware cases is the interpretation of the Daubert standard, which provides a framework for a trial court judge to assess the reliability and relevance of expert witness testimony.

Judge Medinilla wrote in her opinion that experts fielded to provide evidence by the plaintiffs were “serious scientists”, and it would be improper to dismiss them as “poseurs or witnesses for hire.”

Not so, claims GSK, arguing that the order is inconsistent with how the Daubert standard has previously been applied in both Delaware and federal courts and could have “profound implications” for all companies and businesses incorporated in the state.

If the Superior Court rejects the application to raise it to the Supreme Court, GSK and the other defendants have said they will seek leave to appeal directly to the higher court.

Zantac was originated by GSK and launched by the company in the early 1980s, which sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion over the years.

Sanofi had rights to the OTC version of the drug that was recalled in 2019 over possible contamination with NDMA, and it was also sold in generic form by several other producers.

The appeal has been filed as a separate lawsuit brought by plaintiff Eugenia Kasza was abandoned before it could go to trial in Illinois. GSK said it did not settle Ms Kasza’s claim and has not paid anything in exchange for the voluntary dismissal.

Photo by Jent Jiang on Unsplash