Suits connecting Zantac indigestion medicine to cancer failed in nationwide litigation at federal court in Florida, so 583 refugee plaintiffs started over by filing suits in three Illinois counties.
Their claims survived summary judgment in Florida because they had registered as potential plaintiffs rather than suing and paying fees.
Most of the Illinois plaintiffs reside in other states and those in Illinois reside in 38 counties, yet they all sued in Cook, Madison, or St. Clair counties.
Their lawyers, including former Third Circuit Chief Judge Ann Callis, petitioned the Illinois Supreme Court to consolidate all complaints in Madison County.
Instead the justices consolidated complaints in Cook County for pretrial proceedings.
Illinois plaintiffs rely on science that U.S. District Judge Robin Rosenberg of West Palm Beach rejected in December.
Rosenberg didn’t find one scientist who connected Zantac to cancer other than plaintiffs’ experts.
She called it “situational science.”
Rosenberg filled 341 pages with flaws she found.
Her opinion has no bearing on Illinois cases, according to plaintiffs.
They argued at the Supreme Court that Illinois and federal courts follow different rules for evaluating experts.
They pointed out that plaintiffs in Rosenberg’s court filed an appeal notice.
Miller Zois injury firm of Maryland states online that prospects for success on appeal are low and those who are in the multi district litigation are in a tough spot.
“If you are not, and you have a new claim or a claim pending in state court, you are in a much stronger spot,” the firm states.
“State court judges have minds of their own and they won’t mindlessly follow the opinion of a single judge,” it continues.
If Rosenberg reached a correct conclusion, then makers and sellers of Zantac didn’t need to pull it from shelves and switch its active ingredient from ranitidine to famotidine four years ago.
Glaxo Smith Kline developed Zantac and patented it for prescription in 1983.
In 1993, a joint venture of Glaxo Smith Kline and Warner-Lambert began selling a Zantac product over the counter.
In 1998, they decided Glaxo Smith Kline would control prescription Zantac and Warner-Lambert would control Zantac over the counter.
Pfizer bought Warner-Lambert in 2000.
In 2006, Pfizer transferred its rights to Boehringer Ingelheim.
In 2017, Boehringer Ingelheim sold its rights to Sanofi.
Zantac reached $1 billion in sales before any other prescription drug.
In 2019, online pharmacy Valisure of Connecticut sent a recall petition to the U.S. Food and Drug Administration stating ratinidine degraded into nitrosodimethylamine, a carcinogen.
The agency asked makers and sellers to recall Zantac and they did so voluntarily.
Lawsuits soon followed in state and federal courts.
Multi-district judges in Washington consolidated about 2,500 federal cases and assigned them to Rosenberg for pretrial proceedings.
She adopted a joint proposal of plaintiffs and defendants to create a registry of possible claimants, and about 150,000 persons signed up.
Plaintiffs prepared a master complaint naming 187 defendants.
They stated they would prove cancer of bladder, breast, colorectal, esophagus, gastric, kidney, liver, lung, pancreas and prostate.
Rosenberg dismissed all four distributors, all 36 retailers, and all 71 generic manufacturers.
That left no defendants except Glaxo Smith Kline, Boehringer Ingelheim, Pfizer, Sanofi, and Chattem Inc.
Plaintiffs retained Emery Pharma chief executive Ramin Najafi as a chemistry expert and ten expert epidemiologists.
They chose not to rely on the Valisure report that caused the recall and reformulation.
In December 2021 and January 2022, they advised Rosenberg they would not pursue claims of breast, kidney, colorectal, prostate or lung cancer.
Instead, persons on the registry with those cancers began suing in Madison, St. Clair and Cook counties.
Presiding Judge James Flannery of Cook County’s law division ordered consolidation of cases in his court and assigned Associate Judge Daniel Trevino for pretrial proceedings.
In a Madison County case, plaintiffs Joseph Bayer and Gwendolyn Culverson asked Circuit Judge Sarah Smith for joint trial.
Smith denied the motion and set trial for Bayer last August and Culverson this February.
Bayer dismissed his claims three weeks before trial.
According to defendants, he abandoned his claims.
Last October, defendants moved to consolidate Madison and St. Clair cases in Cook County.
They claimed 127 plaintiffs resided in Cook County, 12 in St. Clair, and eight in Madison.
Then plaintiffs moved to consolidate in Madison County, stating Smith had the most advanced case.
They stated transfer might deprive Culverson of a February trial and avoiding trial was likely the reason for wishing to go to Cook County.
The justices chose Cook County.
On Dec. 6, Rosenberg granted summary judgment.
She found Valisure had to heat ranitidine to 266 degrees to degrade it to a carcinogen.
She added that they mixed it with so much salt that the salt would have caused death.
Rosenberg found the first lawsuits were simultaneous with Valisure’s petition.
She also found the food and drug administration couldn’t get the same results as Valisure.
Rosenberg wrote that chemist Najafi found levels of nitrosodometyhlamine “far, far higher than those found by any governmental body in the world.”
She wrote that he found it at the same level as the food and drug administration before plaintiffs retained him.
She noted that no scientist outside the litigation concluded that ranitidine causes cancer.
Rosenberg found experts lacked documentation of tests and substantiation of analytical leaps.
She found they lacked statistically significant data and internally consistent, objective standards for even handed evaluation of data.
“This order is over 300 pages because the court has endeavored to carefully explain each reason why the plaintiffs’ experts have utilized unreliable methodologies to reach their conclusion,” she wrote.
Rosenberg found the question of causation isn’t satisfied simply because an infinitesimal risk is more than zero risk.
She found analysts often identified peaks on chromatographs with manual integration instead of algorithms.
“Manual integration is a powerful manipulation tool,” she wrote.
“Plaintiffs don’t maintain that the rate of error for any of Emery Pharma’s testing is known or even capable of being determined,” she continued.
Najafi’s method for manual integration was to delegate decisions to the judgment and discretion of individual analysts.
Rosenberg wrote that he left sample selections to analysts.
She said a notebook he produced wouldn’t permit an independent scientist to track the progression of a study or replicate a study.
She found it didn’t appear to be organized in any logical way.
Rosenberg added that no document showing why its preliminary values were changed to final values.
Najafi testified his assistants understood the manual better than he did but they weren’t disclosed as experts.
Rosenberg wrote that he conducted novel experiments that didn’t follow peer reviewed designs.
She found fault with five experts who opined that digestion could degrade ranitidine.
She wrote that one let subjects eat what they wanted and two administered other drugs.
She added that experts tested rats, monkeys, ducks, frogs, trout, and guppies but failed to explain a valid connection to humans.
Rosenberg found that experts relied on studies that didn’t support their conclusions.
She found signs of confounding that arises when a factor not accounted for wholly or partially explains an apparent association.
She also found heartburn sufferers are associated with obesity, smoking, alcohol, fat, and certain medical conditions, all associated with a risk of cancer.
Rosenberg wrote that “no widespread acceptance in the scientific community of an observable, statistically significant association between ranitidine and cancer.”
Back in Illinois, on Dec. 13, Jason Zweig of Chicago filed a motion in Cook County to remand Culverson’s case to Smith for trial.
Trevino responded that the decision belonged with the Supreme Court.
Zweig filed a motion there and the justices denied it.
This March, dozens of plaintiffs filed Zantac suits in Madison and St. Clair counties.
As of April 21 no one had consolidated those in Trevino’s court.
This article was first published in Madison Record.