Status of Zantac Litigation
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On December 6, 2022, Judge Rosenberg dismissed the more than 2,450 Zantac lawsuits in the MDL after granting the defendant’s Daubert motions. According to the court, the animal studies are “too dissimilar to the facts presented in [the] litigation.” The next step for the plaintiffs will be an appeal to the 11th Circuit.
If the appeal is successful, it will only benefit plaintiffs who filed a lawsuit. The more than 150,000 plaintiffs who registered claims would only benefit if they file lawsuits.
In Pretrial Order #80, Judge Rosenberg ordered claimants who still wish to file a lawsuit to do so separately and pay the full filing fee. The court will not accept multi-plaintiff complaints, and any cases that have been bundled will be severed. The court also tolled the statute of limitations to “on or about April 5, 2023,” and anticipates that more than 50,000 new cases may be filed.
The U.S. District Court for the Southern District of Florida issued Pretrial Order #69 on November 19, 2021, in MDL-2924, In re: Zantac (Ranitidine) Products Liability Litigation (the “Zantac litigation”). The order addresses the selection of plaintiffs whose cases may proceed to bellwether trials. It sets out steps for the parties to follow until the court rules on any Daubert motions. Once the court has issued those rulings, another order will likely follow that establishes procedures leading up to the bellwether trials.
Judge Robin L. Rosenberg of the Southern District of Florida is overseeing the case for the U.S. Judicial Panel on Multidistrict Litigation. As of September 15, 2022, there are 2,047 actions pending in the MDL. It also includes more than 150,000 claimants who have registered claims. Both the plaintiffs and claimants have used Census Plus Forms (CPFs) to provide information to Litigation Management, Inc. (LMI), which maintains a database of that information.
Watch our full interview with Brent Wisner or read the transcript here.
September 2022 Zantac Litigation Update
Pretrial Order #79 states that in January 2022, Plaintiffs’ Leadership Counsel identified the five designated cancers — from more than 100 injuries in the Registry — they will litigate in the MDL.
The bellwether selection process will also be limited to the five designated cancers, specifically:
- Bladder
- Liver
- Pancreatic
- Stomach
- Esophageal
Bellwether Case Criteria
- The plaintiff must be a Florida resident.
- The Census Plus Forms must not be deficient.
- Each plaintiff must allege that they have suffered at least one designated cancer as a result of taking brand-name ranitidine.
- The plaintiff must not present citizenship issues that would call into question federal jurisdiction.
The bellwether trial schedule has yet to be announced.
In July, the judge dismissed the cases against generic manufacturers stating that a federal law preventing generic makers and distributors from changing FDA-approved labels preempts the claims against them.
Types of Cancer to be Included in Zantac Trial Narrowed Down
According to Pretrial Order #69, in January 2021 the Plaintiffs’ Leadership Counsel (PLC) named ten types of cancer that they planned on litigating. They removed two types of cancer, breast and kidney, from that list two days before the court issued Pretrial Order #69. The current list of cancers stands at eight:
Bladder
Colorecta/
intestinal
Esophageal
Gastric
Liver
Lung
Pancreatic
Prostate
Under the Second Amended Pretrial Order #65, issued in June 2021, the PLC has until January 24, 2022, to produce expert reports addressing general causation. The court expects these reports will identify the types of cancer that the plaintiffs will litigate through the Daubert motions. The parties may eventually narrow the list of cancers further.
Selection of Plaintiffs for Bellwether Trial Underway
Pretrial Order #69 sets out the procedure for selecting bellwether cases. It begins with a Bellwether Pool of three thousand or more cases. From this, the parties will determine an Initial Discovery Pool and then a Final Discovery Pool.
Bellwether Cases Will Be Limited to Florida Residents
The parties to the litigation have agreed that all Bellwether plaintiffs should be Florida residents. They cited two main reasons for this:
1
A federal judge presiding over an MDL does not have authority to transfer the venue of a case from another district to themselves, according to Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 34-40 (1998). Limiting the bellwether cases to Florida residents eliminates the need for Lexecon waivers.
2
Witnesses with information relevant to plaintiffs and claimants in Florida are within the Southern District’s subpoena jurisdiction.
In Pretrial Order #69, Judge Rosenberg cites multiple authorities stating that bellwether cases should be “representative of the cases in the MDL as a whole.” At a hearing held on October 25, 2021, she brought this up with the parties. She states in the order that the parties offered further reasons for limiting the bellwether pool to Florida cases. They informed her that they reviewed reports prepared by LMI analyzing information in the claimant database. The parties stated these reports show that plaintiffs and claimants in Florida represent the entire MDL “in terms of demographics and product usage.”
Criteria for Inclusion in the Bellwether Pool
The court identified four initial criteria for bellwether cases in Pretrial Order #69:
A report that the court received from LMI stated that, in early November 2021, more than 4,000 plaintiffs and claimants in the database met all four of these criteria.
Selection of the Bellwether Pool
Pretrial Order #69 directs at least 75% of eligible plaintiffs and claimants to provide a certification, in a form attached to the order, to the PLC no later than December 9, 2021. The certification states that if the plaintiff or claimant is selected for the “Initial Discovery Pool,” they will not bring claims against any defendants that would destroy diversity jurisdiction in the case.
The plaintiffs and claimants who respond by the deadline will be part of the Bellwether Pool. If the PLC has not received certifications from 75% of the eligible plaintiffs and claimants by December 9, the court states that it may modify these procedures. It may also “conduct an inquiry as to why” too few plaintiffs and claimants responded.
The plaintiffs and claimants who respond by the deadline will be part of the Bellwether Pool. If the PLC has not received certifications from 75% of the eligible plaintiffs and claimants by December 9, the court states that it may modify these procedures. It may also “conduct an inquiry as to why” too few plaintiffs and claimants responded.
Selection of the Initial Discovery Pool
The parties will use the Microsoft Randomizer app on December 10, 2021, to select members of the Bellwether Pool for each type of cancer. The number of cases for each type of cancer will be the greater of either:
85% of the total number of cases of that type of cancer in the Bellwether Pool; or 25%
Assuming that the number of cancers in the litigation does not change by December 10, this will result in an Initial Discovery Pool of at least two hundred plaintiffs and claimants.
Pretrial Order #69 requires a minimum of twenty-five cases for each type of cancer in the Initial Discovery Pool. If the number for a type of cancer drops below twenty-five, such as if a plaintiff drops out of the litigation, the order directs the parties to use Microsoft Randomizer to select a replacement plaintiff or claimant from the Bellwether Pool.
The plaintiffs and claimants selected for the Initial Discovery Pool must file a “Short Form Complaint” by December 16, based on the requirements established by Amended Pretrial Order #31. That order provides a list of fifteen items to include, such as the plaintiff’s or claimant’s name, the approximate dates they used the medication, whether the medication was obtained in an over-the-counter or prescription form, the injuries allegedly caused by the medication, and the approximate date those injuries were diagnosed. If a plaintiff or claimant is added to the Initial Discovery Pool later, they will have six days to file a complaint.
Pretrial Order #69 requires a minimum of twenty-five cases for each type of cancer in the Initial Discovery Pool. If the number for a type of cancer drops below twenty-five, such as if a plaintiff drops out of the litigation, the order directs the parties to use Microsoft Randomizer to select a replacement plaintiff or claimant from the Bellwether Pool.
The plaintiffs and claimants selected for the Initial Discovery Pool must file a “Short Form Complaint” by December 16, based on the requirements established by Amended Pretrial Order #31. That order provides a list of fifteen items to include, such as the plaintiff’s or claimant’s name, the approximate dates they used the medication, whether the medication was obtained in an over-the-counter or prescription form, the injuries allegedly caused by the medication, and the approximate date those injuries were diagnosed. If a plaintiff or claimant is added to the Initial Discovery Pool later, they will have six days to file a complaint.
Information Gathering by the Initial Discovery Pool
From December 15, 2021, through January 22, 2022, people in the Initial Discovery Pool will need to gather medical records about their condition. Pretrial Order #69 states that they must provide LMI with signed authorizations and a list of the following medical providers, if applicable:
- Primary care physician
- Gastroenterologist
- Physician who prescribed ranitidine
- Physician who diagnosed the alleged cancer
- Treating oncologist
From February 1 to April 30, 2022, the members of the Initial Discovery Pool must provide LMI with a signed and notarized “CPF Bellwether Supplement” providing additional information.
Vetting the Initial Discovery Pool
Defendants must notify the LPC of deficiencies in a CPF Bellwether Supplement within five days of receiving it. The plaintiff or claimant will then have two weeks to fix the deficiency. If a plaintiff or claimant fails to correct a deficiency by the deadline, Pretrial Order #69 states that the defendants may move to dismiss their case with prejudice. The defendants then have the option of selecting a substitute from the Bellwether Pool within three days.
The parties have until March 1, 2022, to agree on eligibility criteria for the bellwether cases. At the October 25 hearing, they informed the court that these criteria would most likely relate to mistakes or misstatements, such as “when a Plaintiff asserts that he or she took ranitidine, but pharmacy records indicate that the Plaintiff took a different drug.”
By August 1, 2022, the parties must provide the court with a list of people in the Initial Discovery Pool who do not meet the eligibility criteria. Plaintiffs and claimants who meet the eligibility criteria and who provided all information and documents on time and without deficiencies will be the “Final Discovery Pool.”
The parties have until March 1, 2022, to agree on eligibility criteria for the bellwether cases. At the October 25 hearing, they informed the court that these criteria would most likely relate to mistakes or misstatements, such as “when a Plaintiff asserts that he or she took ranitidine, but pharmacy records indicate that the Plaintiff took a different drug.”
By August 1, 2022, the parties must provide the court with a list of people in the Initial Discovery Pool who do not meet the eligibility criteria. Plaintiffs and claimants who meet the eligibility criteria and who provided all information and documents on time and without deficiencies will be the “Final Discovery Pool.”
Daubert Motions
Both sides in the litigation submitted proposals for how bellwether selection should continue after the court rules on Daubert Motions. The court “decline[d] to adopt a post-Daubert process or schedule at this stage of the litigation.”
Background of Zantac Litigation Until Now
Vetting the Initial Discovery PoolDefendants must notify the LPC of deficiencies in a CPF Bellwether Supplement within five days of receiving it. The plaintiff or claimant will then have two weeks to fix the deficiency. If a plaintiff or claimant fails to correct a deficiency by the deadline, Pretrial Order #69 states that the defendants may move to dismiss their case with prejudice. The defendants then have the option of selecting a substitute from the Bellwether Pool within three days.The parties have until March 1, 2022, to agree on eligibility criteria for the bellwether cases. At the October 25 hearing, they informed the court that these criteria would most likely relate to mistakes or misstatements, such as “when a Plaintiff asserts that he or she took ranitidine, but pharmacy records indicate that the Plaintiff took a different drug.”By August 1, 2022, the parties must provide the court with a list of people in the Initial Discovery Pool who do not meet the eligibility criteria. Plaintiffs and claimants who meet the eligibility criteria and who provided all information and documents on time and without deficiencies will be the “Final Discovery Pool.”DaubertMotionsBoth sides in the litigation submitted proposals for how bellwether selection should continue after the court rules on DaubertMotions. The court “decline[d] to adopt a post-Daubertprocess or schedule at this stage of the litigation.”Background of Zantac Litigation Until NowRanitidine, also known by its brand name Zantac, was one of the most widely prescribed and used medications for acid reflux, heartburn, and various related issues from the early 1980s until its recall by the U.S. Food and Drug Administration (FDA) in 2020. It belongs to a group of drugs known as histamine H2-receptor antagonists or H2 blockers. These drugs provide relief from heartburn and other conditions by reducing the amount of stomach acid produced by the body.
Multiple scientific studies have linkedZantac with N-nitrosodimethylamine (NDMA), a chemical classified as a probable human carcinogen. Lawsuits allege that the drug has been responsible for numerous types of cancer, including the eight that are currently the subject of the MDL. The number of pending lawsuits against Zantac’s manufacturer and others began to increase dramatically in 2019. In anticipation of even more litigation, the Judicial Panel on Multidistrict Litigation created MDL 2924 on February 6, 2020.
The plaintiffs filed a Second Amended Master Personal Injury Complaint on August 2, 2021. The complaint names Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi as defendants. It asserts thirteen causes of action, including multiple products liability and negligence claims, unjust enrichment, loss of consortium, survival actions, and wrongful death.
Multiple scientific studies have linkedZantac with N-nitrosodimethylamine (NDMA), a chemical classified as a probable human carcinogen. Lawsuits allege that the drug has been responsible for numerous types of cancer, including the eight that are currently the subject of the MDL. The number of pending lawsuits against Zantac’s manufacturer and others began to increase dramatically in 2019. In anticipation of even more litigation, the Judicial Panel on Multidistrict Litigation created MDL 2924 on February 6, 2020.
The plaintiffs filed a Second Amended Master Personal Injury Complaint on August 2, 2021. The complaint names Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi as defendants. It asserts thirteen causes of action, including multiple products liability and negligence claims, unjust enrichment, loss of consortium, survival actions, and wrongful death.
NDMA Established as a Well-Known Carcinogen
CarcinogenNDMA is found in small amounts in various food products. It can be a byproduct of cooking foods that contain sodium nitrite. At one time, it was used in the production of rocket fuel. This type of use reportedly stopped when testing of water, soil, and air samples near a manufacturing plant found high levels of the chemical.
Around the time that ranitidine became available to consumers in the early 1980s, scientific evidence suggested that nitrate in the stomach could react with it to form NDMA. Studies in the 2000s found evidence that oxidation of ranitidine could also form NDMA. When tests of municipal water supplies found unusual levels of NDMA in the 2000s, excretion of ranitidine through urination was a suspected source. Studies conducted in the 2000s and 2010s found links between NDMA and cancers of the bladder, liver, kidney, stomach, colon, prostate, and pancreas.
Around the time that ranitidine became available to consumers in the early 1980s, scientific evidence suggested that nitrate in the stomach could react with it to form NDMA. Studies in the 2000s found evidence that oxidation of ranitidine could also form NDMA. When tests of municipal water supplies found unusual levels of NDMA in the 2000s, excretion of ranitidine through urination was a suspected source. Studies conducted in the 2000s and 2010s found links between NDMA and cancers of the bladder, liver, kidney, stomach, colon, prostate, and pancreas.
FDA's Role in Zantac Litigation
A pharmacy called Valisure, which also tests prescription medications for contaminants, filed a citizen petition with the FDA after it detected NDMA contamination in Zantac. The petition requested a recall of all ranitidine-based drugs and an investigation. The FDA launched an investigation into the link between Zantac and NDMA later that month, although it did not request a recall at that time.
Manufacturers of generic ranitidine medications began issuing voluntary recall requests soon after the FDA began its investigation. Laboratory testing eventually showed that levels of NDMA in ranitidine can increase to unsafe levels over time or when the drug is exposed to hot temperatures. The FDA issued a market withdrawal request for Zantac and other ranitidine-based drugs on April 1, 2020.
Manufacturers of generic ranitidine medications began issuing voluntary recall requests soon after the FDA began its investigation. Laboratory testing eventually showed that levels of NDMA in ranitidine can increase to unsafe levels over time or when the drug is exposed to hot temperatures. The FDA issued a market withdrawal request for Zantac and other ranitidine-based drugs on April 1, 2020.
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From December 15, 2021, through January 22, 2022, people in the Initial Discovery Pool will need to gather medical records about their condition. Pretrial Order #69 states that they must provide LMI with signed authorizations and a list of the following medical providers, if applicable:
