The Zantac MDL Summarized
A multi-district litigation (MDL) proceeding for Zantac claims was initiated in federal court in the Southern District of Florida on February 6, 2020 in West Palm Beach. Pre-existing federal cases from around the country have been consolidated in the MDL, and future federal cases will be consolidated there as well. At the time of the initial MDL consolidation in February 6, 2020, there were approximately 140 pending lawsuits across the country, including in California, Colorado, Connecticut, Florida, Illinois, New Jersey, and New York. Following the April 1, 2020 decision by the FDA to remove all Zantac/ranitidine products from the market, the number of lawsuits is expected to increase over the next several months into the thousands.
The purpose of consolidating cases into an MDL is to effectively manage and streamline the resolution of high volumes of cases, and the MDL process is often used to handle mass-tort lawsuits against drug manufacturers. The federal law which authorizes the MDL process is 28 USC § 1401, which authorizes the consolidation of cases involving common questions of fact. Here, the issue of the dangers of Zantac and the failures of the drug manufacturers in selling a dangerous product present common questions of fact for all Zantac cases. Other drug/chemical MDL matters current pending in the country include the Xarelto MDL (Louisiana), the Roundup weed killer MDL (California), and the Johnson & Johnson talcum powder MDL (New Jersey).
The presiding judge over the Zantac MDL is United States District Judge Robin L. Rosenberg. Judge Rosenberg was nominated to the bench by President Obama, and was confirmed as a federal judge in 2014. She is a graduate of Duke University School of Law in 1989. Before her nomination to the federal bench, Judge Rosenberg was a Florida state court judge for 7 years in Palm Beach, and before that Judge Rosenberg was in private practice in Palm Beach. This is the first MDL that Judge Rosenberg has handled.
The Zantac MDL website, along with all orders issued to date, can be found here.
The primary defendants in the Zantac MDL currently are the drug companies Pfizer, Boehringer, Sanofi, Chattem, and GlaxoSmithKline.
As of April 2020, there have been 18 orders issued outlining the process for the Zantac MDL. It is still relatively early in the administrative process. The processes and procedures for filing claims, registering claims, obtaining medical records, conducting discovery, and similar issues are currently being decided by the Court with input from the interested parties. To assist the court, Judge Rosenberg has appointed Professor Jamie Dodge of Emory Law School to assist with establishing practices and procedures for the MDL process. Professor Dodge is the founding director of Emory’s Institute for Complex Litigation and Mass Claims.
The Zantac MDL court has ordered filed and unfiled claims to be added to a claim registry, so that all involved parties have an understanding of how many claims there are and why types of injuries have been suffered. The Court has issued deadlines for adding claims to the registry. When new claims are retained by law firms, they will generally have a period of time to add that claim to the MDL registry. Once a claim has been properly added to the MDL registry, the statute of limitations for filing an individual lawsuit for that claim will be “tolled.” This is a key advantage to adding claims as soon as possible to the MDL registry.
The forms for registering claims into the MDL registry have been issued following a collaborative process with all parties. There are approximately 6 pages of questions regarding symptoms and Zantac use that the court has ordered be filled out by all filed and non-filed claimants. The questionnaire asks injured claimants for their states of residence, whether the Zantac used was prescription or over the counter, whether the use was generic (ranitidine) versus Zantac, when the Zantac use started, when it stopped, the injuries suffered (13 cancers are listed as examples), whether death has occurred, the date of diagnosis of cancer, what type of proof of physical injury exists (medical records, doctor letters, etc.), what type of proof of use of Zantac exists (medical record, prescription, receipts, letter from client explaining use, etc.), family information, personal information, marital status, and other basic information.
One of the biggest components of establishing a strong Zantac claim is proving the drug was used, proving how long it was used, and proving the medical issues that have resulted. Proving these things typically requires the collection of medical records and prescriptions. The process of collecting medical records from health care providers, organizing them, evaluating them, and filing them can be time consuming and expensive. The Zantac MDL is currently evaluating the proper processes and procedures for obtaining and sharing medical records. Oftentimes, a claimant may be incapacitated or deceased. In those cases, the claimant may not have someone authorized to sign forms allowing their medical records to be obtained. Judge Rosenberg has approved a process whereby the lawyers representing incapacitated or deceased claimants will be allowed to personally sign the forms allowing medical providers to release their client’s medical information.
Types of Claims Being Brought in Zantac MDL
The Zantac MDL covers claims for personal injury, economic loss, and the need for medical monitoring as a result of having ingested Zantac and/or ranitidine. The specific claims that can be asserted include design defect claims, failure to warn claims, negligence claims, breach of express warranty claims, and breach of implied warranty claims.
Before 1997, Zantac had a patent, and only GlaxoSmithKline had the right to manufacture Zantac and its active drug ranitidine. In 1997, the patent expired, and competitors began manufacturing generic versions of the drug ranitidine.
In 2011, the U.S. Supreme Court ruled in PLIVA v. Mensing that manufacturers of generic versions of drugs generally cannot be sued for the harm caused by their drugs or from a failure to warn, because federal law requires generic drugs to carry the same label as the brand label.
However, the Mensing decision does not mean that users of generic versions of drugs have no claims. Some states allow the brand-name manufacturer (i.e., the companies that manufactured Zantac) to be sued by users of the generic drug (i.e., users of generic ranitidine) under the theory that the makers of the brand-name are responsible for the inadequate warnings provided by the generic manufacturers, and violated a duty of care in providing warnings that generic manufacturers are required to adopt. The theory of allowing generic users of drugs to sue the brand-name manufacturer is referred to as innovator liability. The states that have recognized innovator liability claims by generic users against the manufacturers of the brand-name of drugs are California, Massachusetts, Illinois, and Vermont. Most other states have not yet recognized innovator liability claims.
Zantac and ranitidine design defect claims are based on the fact that the drug manufacturers designed, manufactured, packaged, labeled, distributed, sold, advertised, and marketed the drugs in an unsafe, defective, and inherently dangerous manner. These claims are based on the fact that the drug manufacturers knew or had reason to know that Zantac products were defective and dangerous. These defect claims are also based on the fact that the dangers presented by Zantac (cancer) far outweigh the benefits of the product, especially considering the availability of alternative products.
Failure to warn claims are based on the fact that manufacturers of Zantac had a duty to warn the public of the risks of using the drug, and they failed to do so. These failure to warn claims are also based on the fact that—had proper warnings been given—the public would not have used the products.
Negligence claims are based on the fact that the manufacturers of Zantac registered, researched, manufactured, distributed, marketed, and sold Zantac without exercising reasonable care, and instead were focused on profits. The failure to use reasonable care includes inadequate pre-market and post-market testing, failing to disclosing the results of trial and tests and studies, failure to conduct additional studies to determine the safety of Zantac, failure to properly and design the drug, failure to provide adequate instructions and guidelines and safety precautions, failure to disclose risks, suppressing and downplaying evidence of risks, downplaying the prevalence of cancers and other side effects, declining to make changes to how Zantac was manufactured and advertised, and continuing to advertise and market Zantac after knowing of the risks.
Breach of warranty claims are based on the fact that the manufacturers of Zantac represented and warranted through labels, publications, advertisements, written materials, and other communications that Zantac products were reasonably safe, effective, fit, and proper for their intended use. These warranties included incomplete warnings and instructions. These claims are also based on the fact that the public and users of Zantac relied on the misrepresentations and omissions of the manufacturers of Zantac, and used and continued to use Zantac.
The types of damages available for dangerous drugs can include pain, suffering, mental anguish, medical bills, and lost wages as a result of not being able to work. Other types of damages may be available. There is also the potential for medical monitoring. Medical monitoring is when the drug company agrees to pay for continued medical evaluations of currently-healthy persons into the future to watch for the onset of cancers.
Which Defendants Will Be Held Responsible
Each of the manufacturers and sellers of Zantac, as well as those that manufacture and sell generic ranitidine, face exposure. Each of the manufacturers are expected to deny their product is dangerous, to deny that they did anything wrong, and deny that they are liable for any damages.
Prescription Zantac was originally developed by GlaxoSmithKline, and the FDA granted approval in 1983. In 2020, the FDA revoked approval and demanded that all Zantac and ranitidine products be removed from the market due to cancer risks. Thus, there have been over 3 decades of dangerous Zantac use, which the drug companies have profited heavily from.
Pfizer began manufacturing and marketing an over-the-counter version of Zantac in 2004. Boehringer Ingelheim also obtained the rights to manufacture Zantac in 2006. Sanofi obtained the rights to manufacture Zantac in 2017. There are more than 20 manufacturers of generic ranitidine, including American Health Packaging, Amneal, Apotex, Appco, Aurobindo, Denton Pharma, Dr. Reddy’s, Glenmark, GSMS, Lannett, Mylan, Novitium, Perrigo, Precision Does, and Sandoz.
Companies sued for dangerous drugs often threaten that they will not have enough money to pay claims, and often threaten bankruptcy. The drug companies involved in Zantac are highly capitalized, and it is expected that there will be adequate resources to pay claims. For example, Pfizer’s total stock is worth more than $200 billion. Sanofi’s is worth more than $60 billion. Boehringer’s is more than $20 billion.
Although the market capitalization of the drug companies involved is promising and suggests they may have adequate funds to pay claims, that is never guaranteed. Market forces can dramatically alter the financial fortunes of all companies. For that reason, it is generally a wise idea to assert a claim as soon as possible. If a drug company that is liable for Zantac does start to experience financial difficulty, the earlier claims may be given a preference as to when they are paid and in what amounts.
How Long Will The MDL Process Take
It is difficult to predict how long the MDL process will take and how long it will take for claims to be paid. Claims are resolved at different times, depending on the type of claim and the severity of the injuries. It is expected that there will be thousands of claims brought. Typically, the drug companies will attempt to settle large groups of similar claims at the same time. Other times, specific cases need to be handled individually given their unique factors. Most MDL processes take several years to resolve (which is true for nearly all types of lawsuits). Although the legal process can take time, it is worth the wait and a necessary part of the process of obtaining just compensation.