Thirteen pharmaceutical companies are facing a raft of civil lawsuits in B.C. Supreme Court after multiple allegations were brought forward claiming the gastrointestinal drug Zantac could lead to several forms of cancer or other ailments.
Zantac is a drug used to treat issues such as acid indigestion, heartburn, sour stomach and gastroesophageal reflux disease.
Lawyer Tyler Dennis said another 20 claims are pending.
He said they are being pursued one at a time rather than in a class action, because in the latter, plaintiffs often receive only pennies on the dollar at the end of the case.
Notices of civil claim filed in B.C. Supreme Court starting July 15 allege Zantac contains active ingredient ranitidine hydrochloride, which, when ingested, produces a known carcinogen called N-Nitrosodimethylamine (NDMA).
Health Canada directed companies to stop distributing ranitidine drugs in September 2019 as an interim, precautionary measure while it assessed the risk of NDMA found in some drugs.
“Since then, companies have recalled products from the Canadian market because they contained or potentially contained NDMA above acceptable levels,” Health Canada said in August 2020.
On April 1, 2020, the U.S. Food and Drug Administration requested the drug be withdrawn from the market, saying NDMA is a probable human carcinogen.
The defendants
The 13 defendants in the case include: Glaxosmithkline Inc., Pfizer Canada SRI, Johnson & Johnson Inc., Sanofi Consumer Health Inc., Sanofi-Aventis Canada Inc., Sanofi Pasteur Limited, Chattem (Canada) Inc., Boehringer Ingelheim (Canada) Ltd., Apotex Inc., Pro Doc Ltée, Sandoz Canada Inc., Sanis Health Inc. and Sivem Pharmaceuticals ULC.
According to the claims, the defendants were individually and/or collectively responsible for “designing, manufacturing, assembling, processing, labelling, packaging, modifying, advertising, import and/or sale of Zantac.”
The claims also allege the defendants sold Zantac to distributors and retailers, directly to physicians and hospitals, and to the general public.
In the case of Apotex, the company produced a generic version of the drug sold in Walmart and other stores, the claims said.
The claim alleges the defendants “knew or ought to have known” that their products contained, were contaminated by or would produce NDMA.
The plaintiffs’ claims
Some of the plaintiffs said they used Zantac for decades to treat heartburn and other common ailments.
Plaintiff Edith Louise Karacsonyi alleged she used the drug between 2008 and 2019 to treat acid reflux and gallstones, but that the drug contributed to the development of a kind of kidney cancer.
Fay Elizabeth Karp alleges her use of Zantac between 1990 and 2019 for heartburn and gastroesophageal reflux disease contributed to invasive urothelial carcinoma, a bladder cancer.
In Kenneth Roy Kelly's case, he alleges using Zantac to treat heartburn over a decade caused or contributed to his development of metastatic colon cancer.
Kenneth Alan Kirschner, meanwhile, alleged his use of Zantac for heartburn and acid reflux caused or contributed to his developing urothelial carcinoma.
Cindy Letain claims she used it for heartburn and acid reflux and that it caused or contributed to the plaintiff’s development of endometrial adenocarcinoma.
The claims say the defendants were negligent in marketing Zantac.
“Post-market information received and collected by the defendants should have lead the defendants to issue post-sale warnings about Zantac, or to recall Zantac sooner than they did,” the suits said.
Defendants’ responses
Pfizer Canada spokesperson Sophie Morin said while the company has sympathy for the plaintiffs, it believes the claims are without merit.
“The company believes that the full evidentiary record will show that its Zantac product was not responsible for the plaintiffs' alleged injuries,” Morin said. “Pfizer, which has not sold a Zantac product in more than 15 years and did so only for a limited period of time, will continue to defend itself vigorously in these cases.”
Spokesperson Merry Garbutt said Boehringer Ingelheim Canada has never held any licence for the sale or marketing of Zantac or ranitidine in Canada and has never been involved with the product.
Further, she said the company is not aware of any claims filed against it this week in B.C. Supreme Court.
“The company has not been served with any such claims. Boehringer Ingelheim Canada is aware of one lawsuit filed against it in the British Columbia Supreme Court regarding Zantac (ranitidine) on Sept. 3, 2021,” Garbutt said. “That lawsuit has been permanently stayed by the court.”
Sanofi spokesperson Lori Bogdanis said scientific evidence doesn’t support the plaintiffs’ claims that Zantac causes cancer.
She said while Sanofi swiftly and voluntarily withdrew over-the-counter Zantac from the market in 2019 after obtaining test results showing that some of its ranitidine products may contain a contaminant called NDMA, it did so out of an abundance of caution and to allow evaluations to continue.
“People are routinely exposed to small amounts of NDMA every day, including through drinking water and common foods,” Bogdanis said. “There is no evidence of even a minimal cancer risk from real-world use of Zantac as a result of any NDMA contamination.”
Bogdanis said Sanofi began marketing Zantac in 2017 based on its more than 30-year track record of providing patients safe and effective heartburn relief.
“Sanofi stands by the safety of the medicine today,” Bogdanis said. “Given that Sanofi acted responsibly at all times and the lack of scientific support for plaintiffs’ claims, Sanofi is fully confident in its defences to the litigation.”
Other companies did not respond to Glacier Media’s request for comment by deadline.