Zantac (Ranitidine) Lawsuit News and Updates
The latest lawsuit and trial news for Zantac and Ranitidine.
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
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