Zantac^® (Ranitidine) Litigation Tracker

The public only learned of the potential contamination of Zantac and generic ranitidine products in September 2019, so the litigation is still in its early stages. But even so, hundreds of Zantac (ranitidine) lawsuits are already pending across the country.

Updates

December 2022

On December 6, 2022, more than two months after the Daubert hearings and after supplemental briefing and testimony, Judge Rosenberg issued a 341-page Opinion and Order granting the Defendants’ motions to exclude the Plaintiffs’ proposed expert testimony. Based on that ruling, the Court also granted the defense motions for summary judgment and dismissed the cases.

In essence, the Judge ruled that the plaintiffs’ proposed expert testimony was not reliable enough to be admissible in court to support the plaintiffs’ positions on the critical issue of general causation, which the Court framed as: “Does the scientific evidence reliably demonstrate that ranitidine is capable of causing a Designated Cancer at the highest realistic exposure level any plaintiff may have experienced?”

Without the proposed expert testimony, the MDL plaintiffs had insufficient admissible evidence to show that the ranitidine in Zantac could have caused the plaintiffs’ cancers. Therefore, the cases could not proceed.

Zantac (Ranitidine) Multi-District Litigation

By early 2020, fifteen lawsuits were pending in nine district courts against the original manufacturer of Zantac (Boehringer Ingelheim Pharmaceuticals, Inc.), the manufacturers and distributors of Zantac OTC—Sanofi-Aventis U.S. LLC and related companies—and at least one manufacturer of generic ranitidine. The cases claimed that ranitidine (the active ingredient in Zantac) can break down to form the cancer-causing chemical N-Nitrosodimethylamine (NDMA). They further claimed that the defendants knew or should have known that their products exposed consumers to NDMA but concealed that danger from the public.

The first fifteen cases included nine personal injury claims asserting the NDMA consumed while taking Zantac had caused cancer. The other cases sought certification as class actions and were brought on behalf of potential classes of consumers and third-party payors who had paid for Zantac and were seeking refunds and other economic damages. By the time the Judicial Panel on Multidistrict Litigation (JPML) ruled on five plaintiffs’ motions to create an MDL, at least 126 similar “tag-along” cases were pending in 21 federal districts.

On February 6, 2020, the JPML centralized the federal ranitidine cases for discovery and pretrial purposes. The order transferred those cases to the U.S. District Court for the Southern District of Florida and assigned the MDL to Judge Robin L. Rosenberg:

• In Re: Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924, Case 9:20-md-02924-RLR (S. D. Fla.)

More than fifty defendants are currently involved in the Zantac MDL, including Boehringer Ingelheim, GlaxoSmithKline LLC, Pfizer Inc., Sanofi-Aventis, various Sanofi subsidiaries (including Sanofi US Services, Inc. and Chattem, Inc), and numerous generic ranitidine manufacturers as well as wholesalers, distributors, and retailers of Zantac and other ranitidine products. Unsurprisingly, given the vast quantity of Zantac and other ranitidine products sold in the United States, the litigation grew rapidly. By June 2022, the MDL had grown to include more than 2,100 active cases, and well over 150,000 potential claimants had registered claims.

Due to the COVID-19  pandemic, Judge Rosenberg delayed the initial status conference scheduled for March 20, 2020; it was held remotely on May 12, 2020 with everyone attending by telephone or videoconference. (Remote courtroom appearances continued to be the rule well into 2022. Pandemic-related logistics may have delayed, and certainly has complicated the litigation.)

For the rest of the year, from the summer through the fall and into the winter of 2020, Judge Rosenberg worked with the parties and the parties worked to develop the administrative procedures for the MDL and the procedures to control fact discovery. One of the early steps was an initial census of cases including personal injury or medical monitoring claims, and there have been many efforts to further refine and improve the amount and types of information collected about the plaintiffs and their cases through the census. To promote efficiency and reduce delays, Judge Rosenberg established procedures allowing every U.S. plaintiff with a ranitidine-related personal injury claim to file their case directly in the MDL.

Fact discovery and expert discovery often overlap in complex cases, and the Zantac MDL is no exception. Fact discovery in the MDL began in late 2020 and ran all the way into early 2022, when the parties also began taking expert discovery, which is continuing in the summer of 2022.

On January 8, 2021, the Plaintiff’s Leadership Counsel (“PLC”)—the group of plaintiff’s lawyers chosen by the Court to lead and coordinate the plaintiffs’ attorneys in the MDL—had identified ten types of cancers that plaintiffs would include in the MDL.  That initial list included: bladder cancer; breast cancer; colorectal cancer; esophageal cancer; gastric (stomach/intestinal) cancer; kidney cancer; liver cancer; lung cancer; pancreatic cancer; and prostate cancer.

After consulting with the parties, Judge Rosenberg scheduled the defendants’ motions to dismiss the plaintiffs’ Amended Complaints to be briefed from late March through May 2021.  The complexity of the issues in the MDL and the many groups of defendants with different legal positions (such as branded drug companies, generic drug companies, wholesalers, retailers, and pharmacies) led to a remarkable ten separate motions to dismiss the plaintiffs’ three Master Amended Complaints. Judge Rosenberg heard argument on those motions over three days of hearings in early June 2021.

On June 30, 2021, Judge Rosenberg issued several orders in which she dismissed some of the claims against some of the defendants. For example, the Court granted defendants’ (branded drug companies) motion to dismiss some of the plaintiffs’ state law claims as preempted by the federal laws regulating drug labelling.  (The doctrine of preemption, in a nutshell, holds that valid federal laws take precedence over state laws on the same subject.) The court also dismissed the claims against the retailers, distributors, and pharmacies, and against the generic drug companies for various reasons.

In November 2021, the PLC removed breast and kidney cancers from the list of cancers to be included in the MDL, narrowing the list of cancers to eight types. 

On November 15, 2021, Judge Rosenberg issued an amended Case Management Order revising the MDL’s pre-trial schedule for expert discovery through the “Daubert” motions in which each side challenges the other side’s expert testimony.  That schedule sets a lengthy period for expert discovery beginning with the defendants’ initial disclosures regarding their experts in early October 2021 and required all expert depositions to be finished by the end of May 2022. The Order envisioned the first round of Daubert motions filed in June 2022, with briefing through the Summer and argument in September 2022. The first bellwether trials would likely be scheduled for nine to twelve months after the court ruled on the Daubert motions.

On November 19, 2021, Judge Rosenberg issued Pre-Trial Order No. 69 establishing the procedures to choose the pool of cases which will be the bellwether trials for the MDL.  

On December 2, 2021, Judge Rosenberg held a “Science Day” hearing. Those hearings allow the parties to educate the court and help it prepare for the scientific evidence it will hear about. The parties presented their views on the relevant science and recommended specific studies for the Judge to review.  In late January 2022, the plaintiffs presented their experts’ reports on general causation, which narrowed the MDL to five types of cancers:

• Bladder cancer,
• Gastric/Stomach cancer,
• Esophageal cancer,
• Liver cancer, and
• Pancreatic cancer.

The MDL has moved past expert discovery and into pre-trial motions. On May 12, 2022, Judge Rosenberg set the schedule (Pre-Trial Order No. 77) for the parties to file motions related to the scientific evidence. These motions include both the “Daubert” motions challenging the opinions of the opposing expert witnesses, and a motion for summary judgment focused on one key topic critical to general causation which applies to all of the cases—whether ranitidine exposure can cause one or more of the five key cancers. Defendants filed their initial motions on June 13, 2022. Briefing will continue through the summer of 2022 and the court has scheduled hearings and oral arguments on each side’s motions on September 20, 2022 (for defense motions) and September 28, 2022 (for plaintiffs’ motions). Judge Rosenberg instructed both sides to keep their schedules open that week because she may schedule more argument time if needed.

Bellwether trials are still expected to begin nine to twelve months after Judge Rosenberg rules on the Daubert motions, if those rulings favor the plaintiffs.