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Attorneys involved in Zantac litigation may be divided on the significance of the U.S. Food and Drug Administration's decision calling on drugmakers to pull the heartburn medication from the market, but all agree the move highlights what appears to be a growing unease over its safety.

The FDA announced it was asking manufacturers to withdraw all prescription and over-the-counter Zantac from the market over concerns that a potentially carcinogenic molecule in the drug may build up over time if the medication is stored above room temperature. Many retailers already had removed Zantac from store shelves.

The FDA move is part of an ongoing investigation into the molecule N-Nitrosodimethylamine, or NDMA, which is a component in the drug, according to a news release issued Wednesday.

"We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured," said Janet Woodcock, director at the FDA's Center for Drug Evaluation and Research.

Litigation over the drug was brewing for several months before the FDA announcement. About 150 lawsuits raising both personal injury and economic loss claims were consolidated in February into multidistrict litigation before U.S. District Judge Robin Rosenberg in the Southern District of Florida.

Although some attorneys said the FDA's move likely would not have a significant impact on how the lawsuits proceed, one of the leading attorneys in the litigation said the regulator's decision could be a "game-changer."

Brent Wisner, a Los Angeles partner in Baum, Hedlund, Aristei & Goldman, said the FDA had been "protective" of the drug and dismissive of claims about its potential risks. That support could have provided powerful ammunition in the defense arsenal, but that firepower has been removed by the FDA action.

"It takes the FDA out of the equation, out of the litigation, and it really strengthens the plaintiff's case," he said.

FDA concerns about the way NDMA builds up in the medication while it sits on the shelves also could  significantly impact the litigation, because now it potentially widens the scope of possible defendants to any store that stocked the drug, Wisner added.

"The reason for its removal is what is so powerful. It's not that there's a new way of manufacturing it. … The FDA is removing the molecule from the market because it is inherently unsafe," he said. "These companies are now all on the hook, and all have exposure. I think the number of potential defendants in this litigation is going to increase dramatically."

Plaintiffs attorneys are predicting the litigation will be enormous since the drug went on the market in  1983 and attracted millions of customers. With such a large pool of plaintiffs, Wisner said having a significant number of defendants will be key to ensuring a successful result for such a large group.

"I think it's a real game-changer," he said. "It's going to dramatically increase the size and scope."

So far, the litigation has focused on four drugmakers, two of which had recalled the drug. In early October, GlaxoSmithKline recalled prescription Zantac and a few days later Sanofi announced its voluntary recall of over-the-counter Zantac. Earlier that month, preliminary tests by the FDA showed "unacceptable levels" of NDMA in some samples of ranitidine, the generic name for Zantac.

Not all attorneys, however, agreed about the significance of the FDA move.

Jason Zweig of Hagens Berman Sobol Shapiro, a leading attorney in the litigation and is pursing both economic loss class actions and personal injury cases now in the MDL, said the FDA move is likely to get significant media attention, which could lead to new case filings.

However, in terms of strengthening the claims, the Chicago and New York partner said he felt it was only a matter of time before the FDA decided to pull the drug from the market.

"The only surprise for me was the amount of time it took the FDA to get there," he said. "We've had zero doubts that this drug would be pulled off the market."

The science linking Zantac and the carcinogenic molecule has been clear, so even without the FDA's recent move, causation would be solid, Zweig said.

"It's just validation of what we've been saying all along," he said. "This is just an inherently unstable drug, and it has no business being in the marketplace."

Kline & Specter attorney Shanin Specter, who has led several personal injury drug mass torts, agreed  the litigation will be most significantly dictated by the science. Specter, who is based in Philadelphia, said his firm has several clients who took Zantac and later developed cancer and is evaluating their cases. The firm is closely watching drug studies being conducted by Sloan Kettering and others, and those findings, more than anything from the FDA, will drive the MDL.

"The FDA's direction is important, sure, but in the context of the voluntary withdrawal from the market by many pharmaceutical companies and the withdrawal of Zantac from the store shelves by many retailers, it is just one more indication that there's a lack of confidence in the safety of the product," Specter said. "We need to see some hard science here in order the satisfy judges and juries about the causative relationship between ingestion of Zantac and a variety of cancers."

Sanofi spokesman Nicolas Kressmann noted the company's voluntary recall but said it stood behind the science showing the drug is safe.

"We take this issue seriously and continue to work closely with the FDA to evaluate any potential safety risks associated with Zantac," Kressmann said. "At Sanofi, we stand by the longstanding science that supports the safety of Zantac OTC products, which have been used by consumers for over two decades."

Sanofi is a French company with U.S. operations headquartered in Bridgewater, New Jersey.

U.K.-based GlaxoSmithKline did not return a message seeking comment by deadline.

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