Zantac (Ranitidine) Lawsuit News and Updates
The latest lawsuit and trial news for Zantac and Ranitidine.
Zantac Lawsuit Update: What's with all the secrets?
June 9, 2020
Author: Jeremy Fietz
On June 1, 2020, coinciding with the opening of Discovery in the cases (please see last update for explanation), Judge Rosenberg issued PreTrial Order #25 and #26. These deal, in advance, with how both sides will treat the “special” documents and information that will be exchanged over the next 18 months. At least, that’s the theory. In reality, it is the defendants (the giant pharmaceutical companies) that are the ones that always claim that they shouldn’t have to turn over their records and documents or answer questions. Remember, it is the Plaintiffs’ side (our side) that has the burden of proof. In other words, we have to prove that the defendant’s drug is bad, that the defendant failed in their obligation to produce a safe product, failed in their obligation to warn the public of any dangers associated with their product etc. So it is Plaintiffs’ (our) side that is the one trying to gather the information in the Discovery phase of the case. In the case of a drug like Zantac, that has been on the market for decades, there are potentially millions of pages of records that could shed light on what the pharmaceutical companies did (or didn’t do) to test Zantac, what they knew about the instability of the Zantac molecule, what they knew or should have known about how Zantac can break down in the human body to create the cancer causing molecule NDMA (read our FAQ for more information about NDMA). In almost all drug cases, the company knew more than they told the public. In almost all drug cases, the big pharma put profits ahead of people. But the burden to uncover the truth is on the Plaintiffs’ (our) side during this 18 month discovery phase. So what does this have to do with secrets? Well the law protects companies from having to share certain information. If the company’s legal department created a document, that might be protected by the doctrines of attorney client privilege or attorney work product. Obviously, the big pharmaceutical company is not going to help us prove they are were bad, so they routinely do everything they can to pretend that documents and information fall into categories of secrets they don’t have to share.
The Judge in this case, though is making sure there is some accountability when the defense asserts “secret” protection (privilege). When the defense asserts that they should not have to produce a document, they will have to create what is called a “Privilege Log” and produce that. That document will state in more general terms what the document is so that our side can determine if we want to test or challenge the claim to privilege. In the case of a dispute, often the Judge will examine the document and decide whether the defendant is truly entitled to keep it a secret.
The other way big pharma protects itself is by claiming trade secret confidentiality. In that regard, the defendant will claim that most of its internal documents (even those not protected by privilege) are nonetheless important to the way it does business and therefore should not be shared with the world (trade secrets). So when the defendant produces the millions of pages of records it will claim “confidentiality” to most if not all of what they produce so that it doesn’t end up on the nightly news. The Plaintiffs’ (our) side has to abide by the Court’s rules in making sure that the documents do not leak to the outside world (that they are only used inside the case/litigation. The Court sets up a system to remove the confidentiality designation but in most cases very little is done in this regard because there is so much work to be done, our side is usually just happy to finally get the documents.
These tools the defense uses, are not usually enough to stop us from proving the case but they are used to by the companies to keep as much a secret as possible and to hide the truth from the American people. We, at TheLawFirm.com, would like to see reform in this area of law as we believe that the transparency of these kinds of legal proceedings would give the public a greater sense of justice being done and perhaps… perhaps even help change the nature of these drug companies for the better.
Here is a complete copy of PreTrial Orders #25 and #26 and we hope this explanation has been helpful to you.
PreTrial Order # 25 - Work Product and Privilege
PreTrial Order # 26 - Confidentiality
If you or a loved one has been diagnosed with cancer after at least one year of regular use of Zantac, please call us at TheLawFirm.com. We’ll give you a free case evaluation and help you if we can. Check back frequently for more Zantac Litigation Updates.
Zantac Lawsuit Update: Litigation Timeline
June 8, 2020
Author: Jeremy Fietz
On May 28, 2020, the Judge that is in charge of managing what will be many thousands of Zantac cancer cases in the United States continued in her effort to put systems in place to most efficiently move the cases forward. Judge Robin Rosenberg was appointed by the Judicial Counsel on Multidistrict Litigation to lead, manage, and resolve MDL 2924 (In Re. Zantac). For more information on what an MDL is how to make a claim, please see TheLawFirm.com’s FAQ. On with the update.
In PreTrial Order #24, Judge Rosenberg sets forth a general timeline of events.
Discovery opens now (June 2020) and lasts for approximately 18 months. “Discovery” is the phase of a case in which the parties are allowed to ask questions both in written form as well as live cross-examination (depositions). In addition, this phase permits the Plaintiffs to demand documents from Sanofi and other defendants so that we may learn what the drug companies knew about the cancer risk, when they knew it, and why they did not warn the public themselves. During this period
After the 18 month discovery period both sides will hone their medical and scientific arguments and research because after the period is over, the Court will hold “Daubert” hearings. A “Daubert” hearing is one in which the Defendant tries to convince the Court that there is not enough scientific evidence to establish that the drug causes cancer. The Plaintiff must prove that there is at least some legitimate evidence that shows the connection or else the Judge will end the litigation. Essentially, the Judge is like a gatekeeper – he or she does not decide who has better arguments, just whether or not there is enough science behind the case that the decision should be up to a jury.
Next will be “bellwether” trials. A “bellwether” trial is on in which a handful of cases are selected by the Court (with input from both sides) to go to trial. These are real cases involving real people and while their outcomes are not binding on the thousands of other plaintiffs still waiting for justice, they are looked upon as “instructive” or as “examples” of how juries see these cases. The trials proceed and both sides put their best case forward. If the defendant wins the bellwether cases by convincing juries that Zantac does not cause cancer then the prospects of a fair settlement will go down. On the other hand if our side wins the bellwether cases big, then the settlement values of the cases go up. Usually, there is some good and some bad and a settlement of the litigation is reached after a handful of bellwether cases are finished.
As we always tell our clients, pharmaceutical mass tort litigation like this takes time. The good news is, Judge Rosenberg appears to want to move it along as quickly as is possible and we expect that this litigation will not take as long as others we have been involved with.
Here is a complete copy of PreTrial Order #24 and we hope this explanation has been helpful to you.
If you or a loved one has been diagnosed with cancer after at least one year of regular use of Zantac, please call us at TheLawFirm.com. We’ll give you a free case evaluation and help you if we can. Check back frequently for more Zantac Litigation Updates.
Zantac Update: Scientific Information regarding zantac and cancer
May 26, 2020
Author: Jeremy Fietz
FDA Launches Zantac (TM) / Ranitidine Cancer FAQ Website and Confirms Zantac Molecule Unstable
Given the overwhelming use of ranitidine (Zantac) throughout the United States, the recall has prompted considerable concern amongst users. In response, the FDA has published an “FAQ” to deal with the most common questions people ask the FDA. You may find the Official FDA Zantac cancer FAQ.
Some of the leading scientists that have blown the whistle on Zantac theorize that the high levels of the cancer-causing NDMA chemical are a by product of the ranitidine (Zantac) molecule’s exposure to heat inside the body during the digestive process. While the FDA has not yet confirmed this theory, the official FDA position on NDMA in Zantac is revealing. The FDA has stated that:
“tests also show NDMA levels increase in some ranitidine products when the drug is exposed to higher than room temperatures. Based on these findings, FDA has determined that many currently marketed ranitidine products could expose consumers to unacceptable health risks. ”
Room temperature is considered to be around 70 degrees Fahrenheit (depending on your mood). The human body’s average temperature is 98.6 degrees Fahrenheit. In other words, the temperature that the unstable ranitidine molecule is exposed to in the human body is more than 25 degrees higher than the stable “shelf temperature” of the drug.
The FDA has recently acknowledged that it is continuing to examine the root cause of how NDMA is formed by the ranitidine drug but some scientists believe that the problem is fundamental to the ranitidine molecule itself. It is, according to them, simply an inherently unstable molecule - meaning that it easily breaks into sub compounds when the molecule is “excited”. When the ranitidine molecule breaks, its component parts can form the cancer-causing NDMA molecule. All molecules vibrate or move faster under warmer temperatures and it is believed by many that this heat related vibration is what causes the ranitidine molecule to break apart and form the dangerous NDMA molecule.
Studies are ongoing and we will update as the science becomes more clear and these working theories become more widely proven and accepted.
Zantac Lawsuit News Update: Information regarding the zantac cancer lawsuits
May 18, 2020
Author: Jeremy Fietz
First, if this is your first time checking up on the status of the Zantac litigation there are a few background things you need to know:
1) The Zantac litigation has been consolidated into a Multi District Litigation by the US Federal Courts. This means that no matter what Federal Court your case is filed in, it will most likely end up transferred to the Zantac MDL for handling there… for now.
2) The Zantac MDL was assigned to Federal Court Judge Robin Rosenberg, in the Southern District of Florida and is known as MDL 2924. Here is a link to the Zantac Official MDL Webpage of the Federal District Court:
3) Defective drug cases are generally assigned to an MDL system so that the cases can be managed together by one Judge (instead of by hundreds of different judges all over the country managing the cases in hundreds of different ways). If you have a case, it is still your case. Individual case. But they are managed together for efficiency and according to systems that have been proven for years to resolve these kinds of lawsuits.
4) You can check back with us here at TheLawFirm.com for updates on important rulings, orders, and when the time comes (settlement details).
Now, on with the update: despite a slight slow down in the legal world due to Covid19, for the most part, pharmaceutical litigation goes on and the Court process does not stop. The most recent ruling of Judge Rosenberg in the Zantac MDL was to appoint a Leadership Structure to the management of the litigation.
It is expected that this litigation may take several years (as virtually all pharmaceutical mass torts do) and there WILL be literally thousands of cases filed before all is said and done. Remember, Zantac has been one of the most widely used and prescribed pharmaceutical products in history and since its use cancer rates have gone up dramatically and have affected many thousands of individuals and families.
TheLawFirm.com is proud to be working directly with, and have its clients represented by, lawyers that were recognized by the Court to act in a leadership role in the Zantac litigation. What does this mean? In our over 20 years of representing people in pharmaceutical litigation, we have found that often the clients that are working with the lawyers in leadership are settled sooner or for more compensation than those that are not. Fair? Maybe not, but that’s the reality - so call us first.
We are at the beginning of this litigation. The defendants, including the “inventor” of Zantac, the giant French pharmaceutical company Sanofi, have declared that they will fight the case. That is always how these cases begin. There is a lot to do. Literally millions of documents will have to be reviewed to find out what the drug companies knew and when they knew it. Dozens of depositions will be taken of drug company executives to find out what they were hiding about what they knew (it happens all the time).
The Court has issued 21 “Pretrial Orders” already. These are orders that must be followed by the lawyers and their clients as the cases progress. By the end it is expected that there will be hundreds of orders by Judge Rosenberg - likely leading to a resolution of the litigation as a whole and settlement of the thousands of individual cases. Many of these orders are routine administrative management-type orders. Some will affect the cases more significantly. Stay in contact with your lawyer to make sure they know how to get a hold of you as more and more “action” happens on your case.
Zantac Lawsuit News Update: FDA requests removal of all heartburn drug Ranitidine (Zantac™) Products from the market - advises consumers to immediately stop taking
April 2, 2020
Author: Daniel Gala
On April 1, 2020, the U.S. Food and Drug administration issued an immediate request to all consumers, patients, health care professionals, pharmacies, and hospitals, to stop the sale of the heart burn medication ranitidine (Zantac™), citing the ongoing FDA investigation into its potential cancer risk.
As a result, the FDA is “sending letters to all manufacturers of rantidine requesting that they withdraw their products form the market,” and “advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have.”
The FDA cites continued investigation into the enormous public health hazard posed by ranitidine [Zantac™].
Given the enormous amount of ranitidine (Zantac™) that has been consumed in the United States in the past 30 years, this has the potential to be discovered as the greatest cancer-causing chemical exposure since asbestos.
For further information about ranitidine (Zantac™) and cancers watch and read more at TheLawFirm.com.
The FDA news release may be found here on the FDA’s website:
TheLawFirm.com is a consumer law firm helping families across America. Our team of top lawyers and paralegals has handled many of the major drug recall cases since the 1990s. Fen/phen, Rezulin, Baycol, Vioxx, we’ve handled them all. Our legal team has decades of knowledge, experience, and a track record of success. We have dedicated our careers to helping victims of the greedy pharmaceutical companies. Call us now for a free case evaluation.
Zantac Lawsuit News Update: Zantac MDL Passes 200 Cases As Court Adjusts Due To Coronavirus
March 30, 2020
Author: Daniel Gala
Despite the court having recently cancelled a key in-person conference due to social-distancing measures implemented in response to the ongoing coronavirus pandemic, multidistrict litigation (MDL) over the heartburn medication Zantac—known generically as ranitidine—continues to expand, growing to nearly 215 total cases as of March 28, according to the MDL docket. Meanwhile, despite the limits on in-person meetings, the court is looking for ways to continue pretrial proceedings, including by making use of videoconferencing.
“In light of the ongoing developments with the spread of COVID-19 (coronavirus), the Court cancels the Initial Conference and will not schedule plaintiffs’ leadership presentations for March 19, 2020,” a March 13 pretrial order signed by United States District Judge Robin L. Rosenberg said. “The Court will issue an order rescheduling the Initial Conference and leadership presentations at a time as soon as practicable that accounts for the health and safety of all participants.”
Established in February 2020, the Zantac MDL has centralized federal products liability lawsuits filed against the makers of Zantac and generic ranitidine in the wake of revelations that the drugs can break down into carcinogenic compounds when digested in the human body.
In September 2019, the United States Food and Drug Administration (FDA) announced that it had "learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”
NMDA is the same substance found to have contaminated generic forms of the blood-pressure medication valsartan and related drugs, prompting widespread recalls of those drugs, as well. However, whereas it is believed that the NDMA found in valsartan and other angiotensin II receptor blockers (ARBs) including losartan and irbesartan is the result of problems in the manufacturing process, plaintiffs suing over Zantac argue that the ability of ranitidine to transform into NDMA and other hazardous compounds once in the human body is intrinsic to the drug itself.
Now, as the MDL court rushes to accommodate social-distancing measures while continuing to usher the litigation along, new cases continue to join despite coronavirus concerns overwhelming the national consciousness. Given the popularity of Zantac and its generic alternatives—and the decades these drugs have spent on the market—some observers anticipate that the MDL ultimately will grow to include many thousands of cases.
In an effort to ensure that social-distancing measures do not completely bring the nascent Zantac MDL to a halt before it even has gotten underway in earnest, Judge Rosenberg issued on March 20 a pretrial order updating the parties on the fluid and highly unpredictable situation.
“As the Court continues to monitor the health crisis and act in accordance with national, local and court directives and guidance, the Court is not in a position currently to give any greater specificity as to when and how the conference and interviews will occur,” the March 20 order said. “But the parties should be assured that the Court is working diligently to ensure that, at the soonest feasible time, the Court will give clear direction to the parties on these and other matters governing the case.”
Because the relatively young MDL had not even selected members to permanent leadership positions before the coronavirus response made it ill-advised to conduct in-person meetings, Judge Rosenberg also authorized the MDL’s provisional leadership groups to continue their work in an effort to keep the litigation moving ahead.
“This Court is keenly aware of the delicate nature of balancing the interests in moving this case forward, while also ensuring that it has full information in making any decisions relating to the case, including but not limited to the important determination of permanent leadership,” the March 20 order said. “Until such time as permanent leadership is put in place, the Court finds that pursuant to its broad case management authority, particularly in MDL actions, it is in the best interests of the case to allow the Initial Census Team, Practices and Procedures Team and Interim Defense Leadership Team to continue their work and authorizes them to do so, while conferring with other counsel to ensure that all views are considered while progressing with the important matters at hand.”
Judge Rosenberg urged counsel to work together effectively in order to keep the MDL moving along during these unprecedented times.
“The Court depends on counsel more than ever to work together to advance the interests of the case, even when there may be differing view as to how such progress would occur,” the March 20 order said. “Due to the unavoidable need to reschedule the conference and interviews, the Court was unable to meet counsel in person, discuss an agenda and hear from leadership applicants. In lieu of that conference, the Court must now trust that counsel can act in concert with one another and consistent with what direction the Court gives through its written orders.”
New Cases Continue To Join The Zantac MDL
Despite the difficulties presented by the coronavirus response, new cases continue to join the young Zantac MDL at a rapid clip. For example, as of March 28, the plaintiff in one of the most recent cases to join the MDL had filed his complaint only on March 24, showing that new cases continue to be filed amid the ongoing pandemic.
That case is brought by plaintiff Ernest Lee, who alleged in his complaint that he “used over-the-counter brand name Zantac from the 1990’s through 2018” and that he “took it one to three times per day.”
“In 1998, Plaintiff was diagnosed with colorectal cancer,” the complaint said. “Based on prevailing scientific evidence, exposure to Zantac (and the attendant NDMA) causes colorectal cancer in humans. Plaintiff’s colorectal cancer was caused by ingestion of Zantac. Had any Defendants warned Plaintiff that Zantac could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac. Plaintiff did not learn of the link between Plaintiff’s cancer and Zantac explode until 2020, when Plaintiff learned that Zantac contained high levels of NDMA.”
If you or a loved one has been diagnosed with cancer after regularly taking Zantac or generic ranitidine over a period of years, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation with a licensed attorney!
United States District Court Southern District of Florida. (20 March 2020). Pretrial Order #14 Order Authorizing Continuation of Work by Interim Teams. Case 9:20-md-02924-RLR. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (13 March 2020). Pretrial Order #9 Order Cancelling Initial Conference. Case 9:20-md-02924-RLR. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety information - NMDA Found in. Samples of Some Ranitidine Medicines. Medical Product Safety Information
United States District Court Southern District of Florida. (24 March 2020). Complaint. Ernest Lee v. Boehringer Ingelheim Pharmaceuticals, Inc., et al.; Case No. 9:20-cv-80486. MDL 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
Zantac Lawsuit News Update: Zantac Caused Illinois Woman’s Stomach Cancer
March 24, 2020
Author: Daniel Gala
An Illinois woman has sued the makers of the popular heartburn medication Zantac—known generically as ranitidine—alleging that years of regular use of the medication caused her to develop stomach cancer. The lawsuit joins scores of other cases brought by plaintiffs filing similar claims in the aftermath of an announcement by the United States Food and Drug Administration (FDA) revealing that the widely-used drug possesses carcinogenic properties.
The Illinois-based plaintiff alleges that she took Zantac on a near-daily basis for almost two decades before being diagnosed with stomach, or gastric, cancer in 2019, the Legal Examiner reported March 20.
Since the early 1980s, Zantac has been available in prescription and, later, over-the-counter (OTC) forms. However, in June 2019, the online pharmacy Valisure discovered that, once in the body, ranitidine breaks down into carcinogenic compounds.
Specifically, Valisure reported in a petition submitted to the FDA in September 2019 that the ranitidine molecule is by its nature unstable. As it is digested by the human body, ranitidine has the potential to break down into N-nitrosodimethylamine (NDMA), the same probable human carcinogen previously found to have contaminated certain batches of the blood-pressure medication valsartan and the related drugs losartan and irbesartan.
However, unlike contaminated valsartan, which was found to contain an unintended impurity due to flaws in the manufacturing process related to the use of solvents, Zantac (ranitidine) by its very nature has the potential to become NDMA when it is digested by humans.
Despite the FDA’s having made its announcement only as recently as September 2019, knowledge of the association between Zantac (ranitidine) and NDMA dates back years. In 2016, a study with the unsubtle title “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” found that taking ranitidine caused the content of NDMA in a patient’s urine to increase by a factor of 400.
“Following ranitidine intake, the urinary NDMA excreted over 24h increased 400-folds from 100 to 47 600 ng [47,600 nanograms], while total N-nitrosamines increased 5-folds,” the study’s authors summarized. More worrying still, the authors note that “NDMA excretion rates after ranitidine intake equaled or exceeded those observed previously in patients with schistosomiasis, a disease wherein N-nitrsosamines are implicated as the etiological agents for bladder cancer.”
Despite the 2016 study being the first to document the massively increased NDMA levels of individuals who have taken ranitidine, the potential for ranitidine to break down into carcinogenic nitrosamines like NDMA once inside the human body has been known to science for even longer.
As the authors of the 2016 study note, “[P]revious studies have demonstrated that amines [like Zantac, an amine-based pharmaceutical] can form N-nitrosamines when exposed to nitrite at stomach-relevant pH.”
In other words, scientists have known for years that Zantac has the potential to transform into a carcinogenic compound when exposed to conditions like those present in the human stomach, and yet the makers of Zantac and generic ranitidine did nothing to warn doctors, patients, or regulators, instead leaving it to the third-party pharmacy Valisure to alert the FDA years if not decades after the fact.
This history of inaction forms the basis of the dozens of lawsuits like the one filed recently by the woman from Illinois, which allege that the makers of Zantac and generic ranitidine knew or should have known of the serious risk posed to patients but continued to sell the highly profitable drug without warning anyway.
Anticipating a caseload that potentially could run into the thousands, the Judicial Panel on Multidistrict Litigation (JPML) has centralized federal Zantac (ranitidine) lawsuits as multidistrict litigation (MDL) in the Southern District of Florida at West Palm Beach. The number of cases in the Zantac MDL recently passed 150 and is only expected to grow from there.
Have you or a loved one been diagnosed with cancer after years of regularly taking Zantac or generic ranitidine? If so, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation!
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines. Medical Product Safety Information
Zeng, T. et al. (June 2016). Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Carcinogenesis
Luhana, R. (20 March 2020). Illinois Women [sic] Files New Zantac Lawsuit, Claiming Link with Gastric Cancer
Zantac Lawsuit News Update: Zantac MDL Grows To More Than 150 Cases
March 15, 2020
Author: Daniel Gala
Despite being just over one month old, multidistrict litigation (MDL) over the popular heartburn drug Zantac (ranitidine) already is growing, having increased to more than 150 total cases as of March 15, according to the court’s list of member cases.
Established February 6 by order of the Judicial Panel on Multidistrict Litigation (JPML), the Zantac MDL centralized federal lawsuits filed by plaintiffs alleging that they were exposed to a probable human carcinogen present in the over-the-counter medication.
At the time of the JPML’s transfer order, the Zantac MDL contained 141 cases, meaning that about ten cases have joined the nascent litigation within roughly its first month. Given the popularity and widespread availability of Zantac over a period of decades, many observers expect the total number of cases potentially could reach into the thousands.
Based on information released by the United States Food and Drug Administration (FDA), plaintiffs in the Zantac MDL allege that, when in the human body, ranitidine forms enormous amounts of the probable human carcinogen N-nitrosodimethylamine (NDMA).
“N-Nitrosodimethylamine (‘NDMA’) is a potent carcinogen,” explains the complaint of plaintiff Michael Karpal, whose case, filed in late February, is one of the most recent to join the Zantac MDL. “It used to be a chemical byproduct of making rocket fuel in the early 1900s but, today, its only use is to induce tumors in animals as part of laboratory experiments. Its only function is to cause cancer. It has no business being in the human body.”
However, as the lawsuit continues: “Zantac (chemically known as ranitidine), the popular antacid medication used by millions of people every day, leads to the production of staggering amounts of NDMA when it is digested by the human body. The U.S. Food and Drug Administration’s (‘FDA’) allowable daily limit of NDMA is 92 ng (nanograms) and yet, in a single dose of Zantac, researchers are discovering over 3 million ng.”
Zantac MDL Lawsuit “The [FDA’s] allowable daily limit of NDMA is 92 ng (nanograms) and yet, in a singe dose of Zantac, researchers are discovering over 3 million ng.”
That plaintiff, Michael Karpal, alleges that he “took Zantac from approximately January 1, 2004 until approximately December 31, 2019 for about 15 years and, as a result, developed bladder cancer.”
His lawsuit names as defendants several prominent pharmaceutical companies including Boehringer Ingelheim, Sanofi, Chattem, Pfizer, and GlaxoSmithKline.
According to Karpal, Pfizer was the original holder of the New Drug Application (NDA) for over-the-counter (OTC) Zantac (ranitidine), controlling US rights from August 2004 to December 2006. Subsequently, Boehringer Ingelheim held the US rights to OTC Zantac from December 2006 until January 2017, at which time Sanofi took control (an arrangement which continues to date). Chattem, for its part, is a wholly-owned subsidiary of Sanofi and “distributes OTC Zantac for Sanofi.”
GlaxoSmithKline “was the original innovator of the Zantac drug and controlled the NDA for prescription Zantac between 1983 and 2009.” Importantly, “[b]y controlling the Zantac NDA it also directly controlled the labeling for all Zantac products through 2009.”
Karpal’s lawsuit alleges that “GSK’s negligence and misconduct related to Zantac as an innovator directly led to the failure to warn for other OTC versions of Zantac.”
Given the nature of the cases involved, in which the alleged injury can take years if not decades to develop, it could take some time for the Zantac MDL to grow into the many hundreds if not thousands of cases. But, given the millions of individuals who have taken Zantac on a routine basis, it is unfortunately only a matter of time before more cases arise.
If you or a loved one has been diagnosed with cancer after taking Zantac (ranitidine) regularly, contact the team of experienced attorneys at TheLawFirm.com today for a free legal consultation!
United States District Court Southern District of Florida (West Palm Beach). Civil Docket For Case#: 9:20-md-02924-RLR. In Re: Zantac (Ranitidine) Products Liability Litigation
Judicial Panel on Multidistrict Litigation (JPML). (6 February 2020). Transfer Order. Case MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Eastern District of New York. (25 February 2020). Complaint and Demand For Jury Trial. Case 9:20-cv-80423-RLR. Michael Karpal v. Boehringer Ingelheim, et al
Zantac Lawsuit News Update: Zantac MDL Gets Underway In Fla., First Conference Set For March 20
March 13, 2020
Author: Daniel Gala
Multidistrict litigation (MDL) over allegations that the popular heartburn medication ranitidine—sold for years under the brand name Zantac—possesses carcinogenic qualities has taken its first steps in the Southern District of Florida, with the court appointing liaison counsel for both plaintiffs and the defense, while also scheduling the MDL’s first conference for March 20.
Established February 6 by order of the Judicial Panel on Multidistrict Litigation (JPML), the Zantac MDL centralized roughly 140 federal lawsuits filed against the makers of Zantac and generic ranitidine alleging that the ranitidine molecule develops into a probable carcinogen once inside the human body.
United States District Judge Robin L. Rosenberg, presiding over the MDL in the Southern District of Florida, has wasted little time getting the litigation underway, filing the MDL’s first pretrial order on February 14.
In addition to scheduling the MDL’s first conference for March 20, the wide-ranging, 36-page order also covers a host of other topics aimed at getting the litigation moving. For instance, it required that plaintiffs and the defense each submit by March 6 a position statement “indicating their preliminary understanding of the facts involved in the litigation and the critical factual and legal issues”; clarifies methods for proper service among the parties; establishes a standard format for pleadings in the MDL; and instructs the clerk of the court on how to handle the influx of anticipated transferee cases.
The Zantac MDL’s first pretrial order also contained an instruction to all parties not to destroy any evidence that may potentially be relevant to the litigation.
“All parties and their counsel are directed to preserve evidence that may be relevant to this action,” Judge Rosenberg ordered. “The duty extends to documents, data, and tangible things in possession, custody, and control of the parties to this action.”
In subsequent orders, Judge Rosenberg on February 28 appointed a liaison counsel for plaintiffs and on March 9 named defendants’ liaison counsel.
The allegations behind the Zantac MDL arise from a September 2019 announcement by the US Food and Drug Administration (FDA) regarding the presence of a probable carcinogen in the popular heartburn medication, sold generically as ranitidine.
"FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” the FDA’s September 13 statement warned. “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results from laboratory tests.”
A month later, on October 18, Zantac-maker Sanofi announced that, as “a precautionary measure” it was recalling “all Zantac OTC (over-the-counter) in the United States” including “Zantac 150, Zantac 150 Cool Mint, and Zantac 75.”
NDMA is the same probable human carcinogen previously found to have contaminated certain lots of the generic blood-pressure medication valsartan and related drugs, leading years-long recalls that are still ongoing. However, in the case of valsartan, regulators believe they have traced the presence of NDMA back to a change in manufacturing practices having to do with the use of solvents, while evidence shows that the ranitidine molecule in Zantac transforms into NDMA once it has entered the human body.
As one Zantac lawsuit described, “[U]nlike the NDMA present in valsartan, the NDMA associated with this common drug [Zantac] is not an impurity caused by faulty manufacturing processes. Rather, the NDMA is inherent in the drug itself.”
Plaintiffs further allege that the makers of Zantac (ranitidine) have been aware of this fact for decades but, rather than alerting regulators, doctors, and patients, they instead chose to conceal the information in order to protect their cash cow.
Given the popularity of Zantac and generic ranitidine and the many years for which they were available on the market, the Zantac MDL is expected to grow significantly, potentially into the many thousands of cases.
If you or a loved one has developed cancer after years of regularly taking Zantac or generic ranitidine, contact the attorneys at TheLawFirm.com today for a free legal consultation!
Judicial Panel on Multidistrict Litigation (JPML). (Filed 6 February 2020). Transfer Order. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (Entered 14 February 2020). Pretrial Order #1 Setting Initial Conference. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (Entered 28 February 2020). Pretrial Order #5 Order Appointing Plaintiffs’ Liaison Counsel. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States District Court Southern District of Florida. (Entered 9 March 2020). Pretrial Order #7 Order Appointing Defendants’ Liaison Counsel. MDL No. 2924. In Re: Zantac (Ranitidine) Products Liability Litigation
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines. Medical Product Safety Information
Sanofi. (22 October 2019). Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. Company Announcement. United States Food and Drug Administration (FDA). Recalls, Market Withdrawals, & Safety Alerts
United States District Court For The District Of New Jersey. (Filed 25 October 2019). Complaint. George Cravens, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., et al. Case 3:19-cv-19368
Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.
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