The Michael J. Bilandic Building, Chicago, home of the Illinois First District Appellate Court
CHICAGO - An Illinois state appeals panel has agreed that generic drug makers can’t face lawsuits claiming Zantac causes cancer.
Plaintiff Angela Valadez said she developed colorectal cancer, allegedly as a result of treating heartburn from 1995 to 2014 by taking Zantac and ranitidine, its generic equivalent. She sued Zantac-maker GlaxoSmithKline and Boehringer Engelheim, which made and sold the active ingredient ranitidine, along with retail pharmacies Walgreens and Duane Read and several companies that made generic versions of the medication.
Cook County Circuit Judge Daniel Trevino dismissed all claims against the generic drug makers, what the court described as “nonbrand defendants,” while also dismissing design defect claims against GSK and Boehringer, all on grounds that federal drug labeling rules pre-empted a state lawsuit.
When the remaining counts against GSK and Boehringer proceeded to trial, a Cook County jury ruled against Valadez in May 2024. Then 89 years old, Valadez and her lawyers from the Chicago firm Keller Postman claimed the defendants owed her $640 million.
Valadez also attempted to revive her claims against the generic drug makers, asking the Illinois First District Appellate Court to rule Judge Trevino erred by dismissing those claims.
Justice Mary Rochford wrote the panel’s decision, filed June 27; Justices Thomas Hoffman and Freddrenna Lyle concurred. The order was issued under Supreme Court Rule 23, which may restrict its use as precedent.
Rochford noted the U.S. Food and Drug Administration gave GSK the exclusive right to sell Zantac in 1983, after which Zantac became the first prescription drug to reach $1 billion in sales. The original patent expired in 1997.
“The molecule ranitidine is the active ingredient in both Zantac and its generic forms,” Rochford wrote. “Scientific studies have shown that ranitidine degrades into a cancer-causing molecule called Nnitrosodimethylamine (NDMA), which is part of a carcinogenic group of compounds called Nnitrosamines.”
In September 2019, pharmacy and testing laboratory Valisure filed a citizen petition seeking the recall of all ranitidine products. The FDA responded by requesting a voluntary withdrawal of all such products in April 2020.
Valadez’s litigation is among tens of thousands of nationwide lawsuits filed after the recall. However, in the years since, the FDA and a federal judge have found fault with Valisure's methods. To cause ranitidine to break down into NDMA, for instance, the tests reportedly required subjecting the medication to temperatures as high as 260 degrees Fahrenheit and exposing it to lethal levels of salt in a so-called “artificial stomach.”
According to court documents, Valisure detected no NDMA in ranitidine when testing it under normal human conditions. A Florida federal judge in 2022 dismissed about 50,000 lawsuits after finding Valisure’s methods didn't fit expert witness standards. Judges in Delaware and California disagreed with those conclusions, allowing lawsuits there to proceed.
With respect to the nonbrand defendants, the Illinois appellate panel rejected an argument it lacked jurisdiction over the August 2023 order dismissing the claims against those companies, calling that ruling “a step in the procedural progression toward the jury trial” by means of streamlining parties and issues. The panel also noted “the nonbrand defendants were not named in the caption of the May 23, 2024, judgment, and thus they were not required to be listed in the notice of appeal from that judgment,” Rochford wrote.
On the root issue of Judge Trevino dismissing the nonbrand defendants, the panel agreed with the corporations.
Valadez filed two strict liability claims and one of negligence. Rochford and the other justices agreed “it was impossible for the nonbrand defendants” to both comply with a federal law requiring that generic drugs utilize the same design and warnings and name-brand medications and Illinois state law requirements that formed the basis of Valadez’s lawsuit, which allege the companies had a duty to provide a safer product design and more complete warnings about cancer risks.
Valadez argued the companies had parallel obligations not in conflict with federal law. But the justices noted a 2020 Zantac case in Florida’s Southern District resulted in a rejection of that same argument, specifically noting “no court has adopted plaintiffs’ theory that impossibility pre-emption can be avoided by showing that a drug is both misbranded under federal law and unreasonably dangerous under state tort law.”
Regarding the negligence claim, the justices agreed Judge Trevino improperly decided that claim was pre-empted because it “did not seek to change the labels and design” of products containing ranitidine. However, the justices agreed with the companies that Valadez can’t pursue that claim on appeal because the issue was fundamentally decided in their favor in the jury trial, albeit with respect to GSK and Boehringer.
“Plaintiff’s complaint made the same allegations of negligence against the brand defendants and nonbrand defendants: that the ranitidine-containing products were not stored and transported at appropriate temperature and humidity levels,” Rochford wrote.
Rochford further said that because the jury returned a verdict on favor of the name-brand defendants, “we presume the jury found (Valadez) was more than 50% contributorily negligent for refusing to undergo a colonoscopy in 2010, 2011, 2012, 2013, thereby barring her negligence claim. Plaintiff’s contributory negligence not only defeats her negligence claim against the brand defendants, but it also defeats her identical negligence claim against the nonbrand defendants.”
