GSK: Delaware Supreme Court grants appeal in Zantac cancer lawsuit

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Pharmaceutical giant GlaxoSmithKline (GSK) and rival drugmakers, including Sanofi, Pfizer and Boehringer Ingelheim, have won the right to an appeal hearing in the Delaware Supreme Court over claims that an ingredient in the drug could cause cancer. The drug is currently the subject of more than 70,000 lawsuits pending.

The appeal challenges a lower court judge's earlier approval of the plaintiffs' opportunity to testify as expert witnesses about the alleged cancer link. The drugmakers argued the testimony was not supported by sound scientific methods.

The biggest concern is ranitidine, the active ingredient in Zantac, which could potentially break down into N-nitrosodimethylamine (NDMA), a possible carcinogen, if the drug is stored at higher temperatures or left on the shelf for long periods of time.

However, GSK has consistently denied these allegations and stated that the expert opinions underlying these concerns are not reliable.

The Food and Drug Administration (FDA) recalled Zantac in 2020, with Australia and the European Union also opting for voluntary recalls.

Before the recalls, Zantac was sold by GSK, US pharmaceutical giant Pfizer, French pharmaceutical company Sanofi and Germany-based Boehringer Ingelheim.

Investors react positively to decision

After the appointment was announced, GSK shares rose by more than 3 percent by the close of trading on Tuesday.

GSK said in a press release on Tuesday: “GSK welcomes today’s decision by the Delaware Supreme Court to review the Delaware Superior Court’s decision allowing plaintiff’s expert evidence to be presented at trial.

“The scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of cancer. As of 2019, there are 16 epidemiological studies looking at human data on ranitidine use, including results for more than one million patients using ranitidine, supporting this consensus.

“GSK is committed to defending itself vigorously and conducting this litigation in the best interests of the company and its shareholders. The Delaware litigation will continue in parallel with the Delaware Supreme Court review. In addition to the Delaware Supreme Court review, the company will raise additional defenses in the litigation, including failure to provide proof of use and proof of diagnosis, which the court recently ordered.”

Lack of documentation and unreliable methodology cited in GSK Zantac case

The lack of credible documentation and methodology has been raised several times. A previous lawsuit against Zantac, filed by approximately 50,000 plaintiffs at a pretrial hearing in Florida federal court in December 2022, was dismissed.

US District Judge Robin Rosenberg said in her ruling: “Outside of this trial, there is no scientist who has concluded that ranitidine causes cancer. The plaintiff scientists in this trial systematically used unreliable methods, without documentation of how the experiments were conducted, without justification for analytical jumps, without statistically significant data, and without consistent, objective, scientifically sound standards for unbiased evaluation of the data.”

Hope for an end in sight

Russ Mould, investment director at AJ Bell, said in an email: “Legal issues surrounding the heartburn drug Zantac continue to dominate GSK's news agenda. The saga is full of twists and turns, and investors are trying to guess whether GSK will win or lose tens of thousands of lawsuits alleging that Zantac causes cancer.”

“The market has reacted positively to the news that Delaware's highest court will hear an appeal by GSK and other drugmakers that sold the product. This is a positive step forward for the pharmaceutical giant, but it is far from the end of the story.

“The matter has become a major distraction for GSK management and many investors are hoping that a settlement will be reached and that they can then move on. GSK insists it has done nothing wrong and says there is no evidence that the product causes cancer.”