Brent Wisner, a California attorney who has represented plaintiffs in complaints challenging the safety of OTC heartburn remedy Zantac made with ranitidine and other drugs would rather have a different career.
“Corporate actors have been shown to take advantage of the system, and defaulting to ‘well, we’ll just let the tort lawyers figure it out after the fact’ is really not a good policy,” Wisner said. “I don’t want my job to exist. I wish it didn’t.”
Instead, Wisner suggested the US Food and Drug Administration “should be focusing on slowing down and making sure they get it right.”
“Because at the end of the day, getting it right is more important than making sure drug companies can make more money,” he said. “That shouldn’t be the priority.”
“I think the framework has to shift from ‘we need to protect industry so they can sell their drugs’ to ‘we need to protect consumers,’ and if that means industry has to eat it for an extra year while it gets approval, then they should,” Wisner added. “I think that would help improve consumer confidence.”
Wisner, a managing partner and senior trial attorney in Wisner Baum LLP in Los Angeles, recently spoke with Pink Sheet sister publication HBW Insight about changes he’d recommend to FDA regulations for developing and manufacturing Rx and OTC drugs that would improve product safety and reduce the potential for complaints for damages.
Wisner and Jennifer A. Moore, founder of Moore Law Group PLLC in Louisville, KY, in October expect to begin jury selection for a trial in California state court for a complaint against Boehringer Ingelheim alleging harm from its Rx ranitidine drug. They also are preparing for a trial for a complaint against Thermo Fisher Scientific’s Patheon Manufacturing Services LLC division, a contract manufacturer of ranitidine formulations.
‘Self-Certified By The Company’
Wisner said US policy not requiring manufacturers have their drug products tested by independent, third-party businesses could be a primary reason for postmarketing problems.
“No one requires the FDA be perfect, but I think one of the things that people don’t realize, and this is something that when I found this out disturbed me, there is no independent testing done on drugs,” he said. “You go and buy a drug, whether or not it has the amount of drug in it, has other stuff in it, all of that is self-certified by the company to the extent they even look.”
Wisner said his firm’s trial wins and in settlements for ranitidine and other pharmaceutical ingredients or finished product complaints show third-party testing should be required.
“We’ve done testing and found out that … no one tests it right,” he said.
The FDA relies on manufacturers’ test results to assure their drug products are safe and effective.
“What they do is they predefine the tests that make it appropriate and then do those tests,” Wisner said. “The FDA doesn’t really care.”
“They’re just, ‘oh, you say you’re going to do it? Fine, we trust you.’ And that’s wrong,” he added. “There needs to be independent testing, it needs to be certified, and there’s some groups that are trying to do things to help get in front of that. But, unless you have it from a regulatory perspective, it’s almost impossible to avoid.”
Impurities also are a potential problem resulting from current pharmaceutical manufacturing regulation.
“They have been relying heavily on the fact that looking was too difficult,” Wisner said. “Now that it’s getting cheaper and easier and quicker to do, their failure to look is causing people to get exposed to stuff they shouldn’t be.”
“What ends up happening is it gets found out later, 10 years after the fact, and then lawyers like me show up and sue everybody and say, ‘This isn’t right, and, yeah, we fix it for this problem, and maybe get some money for the people that were hurt that we could find,’” he added.
“But that’s $1 short and a day late,” Wisner said. “I’d rather get in front of it before I get a case, because I’d rather not have to do that case.”
‘Regulator With Gun To Their Head’
The introduction of a user fee program for the FDA’s OTC monograph system and deadlines for its review of proposals for changes added to the agency’s “getting it done on time” pressure for nonprescription, as well as Rx drugs.
“This move toward making the FDA go quicker so that drug companies can make more money is exactly the mindset,” Wisner said. “Instead of slowing things down, they’re speeding it up and then they’re tying the FDA budget to getting it done on time. Come on, you can’t have a regulator with a gun to their head. That’s preposterous.”
He said making more drugs available OTC helps expand consumer access to self-care remedies, but refuted that the goal should be reached by supporting the FDA’s application and proposal reviews with user fees compelling review deadlines.
“It’s the most pernicious form of deception and lie, because there is some truth to it,” Wisner said. “Yes, there is some truth that, yes, certain drugs we need to get to market. They are important to people’s health, like people should have access, but we cannot do it at the expense of making sure they’re safe and effective.”
Independent Lab Questioned Ranitidine Safety
Lawsuits challenging the safety of ranitidine, a histamine-2 blocker, came after one of the groups testing drug ingredients independently, Valisure LLC, advised the FDA about potential safety problems in 2019. Defendants also have won multiple state court trials challenging the safety of Zantac or of other ranitidine formulations.
Valisure, represented by Wisner and Moore, in 2024 received $70m from GlaxoSmithKline to resolve a whistleblower complaint after raising concerns about a potential link between the use of Zantac, other heartburn remedies and other drugs containing ranitidine and cancer.
The Connecticut laboratory’s testing found ranitidine became unstable post-production and degraded into a human carcinogen, N-nitrosodimethylamine (NDMA).
Although the FDA criticized some of Valisure’s work and found different NDMA levels in separate testing, the US, along with most other countries, asked industry to stop sales of Rx and OTC ranitidine formulations.
In 2020, the FDA asked firms to withdraw the products from the market, but did not pull its approval. The agency requested that industry continue studying the ingredient to improve its stability.
‘Never Once Told FDA’
Wisner and Moore, along with other attorneys in separate complaints, have reached settlements for plaintiffs in complaints against GSK, which developed the ranitidine formulation and previously sold Rx Zantac in the US, and Pfizer, which had Rx rights for the brand from 1998 to 2006.
GSK in 2024 reached settlements estimated at up to $2.2bn for about 80,000 Zantac lawsuits in state courts and for $70m in Valisure’s false claims complaint in federal court.
Also in 2024, Pfizer agreed to pay up to $250m to resolve 10,000 lawsuits filed in state courts.
Sanofi, which held US OTC Zantac rights when ranitidine products were pulled from the market, in 2021 relaunched the brand reformulated with 10mg famotidine as Zantac 360°.
Additional lawsuits have been filed since the French firm in 2024 said it planned to settle all ranitidine complaints.
In May, Sanofi sold a 50% controlling stake in its consumer healthcare business to private equity firm CD&R for about €10bn ($11.3bn) in total cash proceeds. The business is operating as Opella.
“All that’s left is Boehringer and Patheon and we’re going to trial against Boehringer mid-October,” Wisner said. “I don’t know if we’ll resolve it beforehand, but if we don’t, great, we’re going to trial.”
“We’re going to show the jury what we have on them, which is, candidly, a little damning,” he added. “You know, we have some pretty good evidence for them, really knowing that there was a problem, and not taking action.”
The complaint alleges Boehringer’s witnesses testified in depositions that when the firm controlled the brand, multiple studies were published linking ranitidine to NDMA formation.
“One of their internal reviewers actually identified this issue and said, ‘Oh, my God. You know, ranitidine is creating this environmental carcinogen,’” Wisner said. “And despite all that, they never once told the FDA or took any action to investigate or test or do anything to warn consumers. They just kept selling it, making hundreds of millions of dollars a year. Laughing all the way to the bank.”
Litigation against generic manufacturers of OTC and Rx ranitidine formulations is limited after a Florida federal judge across multiple rulings from 2020 to 2022 found that state-law claims against the firms, as well as repackaging firms, retailers and distributors, were pre-empted by federal law. The decisions limited the plaintiffs’ targets in federal court to the brand-name manufacturers.
“Basically, what [the decisions] said was generic makers are photocopy machines,” Wisner said. “They don’t have any control over the warnings, the science of the development of the drug, that’s all done by the brands. Because of that, because we have a generic drug system that helps lower prices of drugs, their only duty is to make the same thing as the brand.”
“You can’t sue them for anything that’s wrong,” he added. “The same doesn’t apply to the brand. If they can, they can make a warning label change. They can do things to affect how consumers understand and appreciate the risks of the product.”
