Attorneys Submit Petition for Consolidation
The largest group of Zantac lawsuits filed in California state court allege the drug's manufacturers have known about the link between ranitidine and cancer since the early 1980s but did not warn the public because full disclosure of the dangers would have jeopardized sales. Attorneys say this failure to warn has created an epidemic of cancer.
June 8, 2020 – Alameda County, California – – Baum Hedlund Aristei & Goldman and the Moore Law Group have filed lawsuits on behalf of 40 cancer victims and their families alleging the manufacturers of Zantac (ranitidine) have known since the early 1980s that ingestion of the widely-used heartburn medication leads to the production of “staggering amounts” of a potent carcinogen. Attorneys R. Brent Wisner of Baum Hedlund and Jennifer Moore of the Moore Law Group spearheaded the trials in the Roundup litigation, and they intend to repeat that success here for their 7,600+ clients.
The complaints allege the manufacturers caused severe injuries to each of the plaintiffs by manufacturing defective and dangerous drugs that have no business being in a human body, conducted rigged studies to conceal the Zantac-NDMA link to the FDA and lack labels that properly warn consumers of the dangers associated with Zantac (ranitidine) use.
Among the plaintiffs is Hanna Carbajal, a California mother who alleges that her ingestion of brand name Zantac while pregnant—the first prescription drug in history to reach $1 billion in sales—caused her 8-year-old son to develop testicular cancer at the age of five.
The other plaintiffs allege exposure to brand-name and/or generic over-the-counter (OTC) Zantac (ranitidine) caused them to develop bladder cancer, kidney cancer, prostate cancer, testicular cancer, and thyroid cancer.
The defendants named in each complaint vary based on the drug (or drugs) the plaintiffs ingested. Some of the plaintiffs took generic over-the-counter (“OTC”) Zantac, others took prescription Zantac, and some took a combination of prescription and generic versions of the drug. GlaxoSmithKline (GSK), the company responsible for designing and developing Zantac, is named in every complaint. The complaints collectively list six manufacturer defendants:
- GlaxoSmithKline, LLC, of Philadelphia, PA
- Boehringer Ingelheim Pharmaceuticals, Inc. of Ridgefield, CT
- Boehringer Ingelheim USA Corporation of Ridgefield, CT
- Pfizer, Inc. of New York, NY
- Sanofi US Services Inc. of Bridgewater, NJ
- Sanofi-Aventis U.S., LLC of Bridgewater, NJ
The complaints allege seven causes of action and seek punitive damages against the manufacturer defendants:
Count I: Strict Products Liability – Failure to Warn
Count II: Strict Products Liability – Manufacturing Defect
Count III: Negligence – Failure to Warn
Count IV: Negligent Product Design
Count V: Negligent Manufacturing
Count VI: Negligent Misrepresentation
Count VII: Negligence
Attorneys R. Brent Wisner, Michael L. Baum, Pedram Esfandiary, and Adam M. Foster from Baum Hedlund Aristei & Goldman, and Jennifer Moore, Andie B. Camden, and Ashton R. Smith from the Moore Law Group, filed the complaints in Alameda County Superior Court on behalf of 40 plaintiffs, the first group of Zantac cancer victims yet to be filed in California state court.
The legal team also submitted a petition today to formally consolidate the cases in a Judicial Council Coordinated Proceeding (JCCP).
A JCCP is similar to a federal multidistrict litigation (MDL); both provide unified management for the pretrial and trial phases of consolidated cases. In the federal Zantac MDL (In Re: Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924, 20-MD-2924), U.S. District Court for the Southern District of Florida, plaintiffs have already filed at least 230 complaints, and many thousands more are preparing to file cases in federal court and courts throughout the country.
Ms. Moore and Mr. Wisner both participated in forming the MDL in January 2020 and now, here in California, seek to create the same type of coordinated proceeding. Mr. Wisner explains, “We did the same thing during the Roundup litigation. We created both an MDL and JCCP. And, while Ms. Moore took the lead in trying the first federal case in the MDL, I took the lead in state court. Together, we were able to obtain over $2.4 billion in verdicts. We plan to dwarf that here in this Zantac litigation.” Ms. Moore agrees, “Coordinating these two important proceedings is the first step in putting pressure on these defendants to come to the negotiating table and do right by our clients. I am looking forward to getting a case to trial in California state court as soon as possible.”
Details about the Allegations, the Plaintiffs and the Legal Team
Zantac History and NDMA Controversy
Zantac (ranitidine) was originally discovered and developed by scientist John Bradshaw on behalf of GSK in 1976. The drug gained approval from the U.S. Food and Drug Administration (FDA) in 1983 and quickly became one of GSK’s most successful products. Since the 1990s, several companies, including Pfizer, Boehringer Ingelheim, and Sanofi (and their respective subsidiaries) have controlled the generic rights to sell OTC ranitidine. According to GSK’s 2019 annual report, the drugmaker “discontinued making and selling prescription Zantac tablets in 2017 … in the U.S.”
In September of 2019, pharmacy and testing laboratory Valisure filed a Citizen Petition calling for the recall of all ranitidine-containing products due to exceedingly high levels of N- Nitrosodimethylamine (NDMA), a potent carcinogen found during testing of ranitidine pills. The U.S. Food and Drug Administration and European regulators started reviewing the safety of ranitidine with a specific focus on the presence of NDMA.
Discovered as a bi-product in manufacturing rocket fuel, NDMA is only used to induce tumors in animals as part of laboratory experiments. NDMA’s only function is to cause cancer, and according to the complaints, the NDMA in ranitidine is not caused by any direct contamination. Rather, the ranitidine molecule itself contains the constituent molecules to form NDMA.
Valisure’s finding and Citizen Petition triggered a cascade of recalls by ranitidine manufacturers and retailers. In January of 2020, research laboratory Emery Pharma submitted another Citizen Petition to the FDA, showing that NDMA accumulates in ranitidine at unsafe rates when exposed to heat levels that would occur during transport and storage. According to Emery Pharma’s Citizen Petition, ranitidine is a time-and temperature-sensitive pharmaceutical product that develops NDMA when exposed to heat, a common occurrence during shipping, handling, and storage. In addition to warning about this condition, Emery Pharma requested agency directives to manufacturers and distributors to ship ranitidine medications in temperature-controlled vehicles.
In response, on April 1, 2020, the FDA requested drug manufacturers to withdraw all Zantac and generic ranitidine drugs from the market effective immediately after determining that levels of NDMA in some ranitidine medications “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…”
The FDA, in effect, issued a public statement requesting the immediate removal of all ranitidine medications from the market due to the risk to public health:
“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” Based upon its own testing and evaluation, the FDA concluded that “NDMA levels increase in ranitidine even under normal storage conditions and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.”
According to the complaints, the FDA’s testing of ranitidine confirms that NDMA levels increase in the drug even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures to which ranitidine may be exposed during distribution and handling by consumers.
Zantac Manufacturers Have Known Since the Early 1980s That Ranitidine Ingestion Leads to the Formation of NDMA
In 1981, research published in The Lancet found that ranitidine turned into mutagenic N-nitroso compounds (of which NDMA is one) in human gastric fluid when accompanied by nitrites (a chemical commonly found in heartburn-inducing foods). Based on the findings, one of the researchers cautioned that, in the context of ranitidine ingestion, “it would seem prudent to … suggest a diet low in nitrates and nitrites, by asking patients not to take these at times close to (or with) meals[.]”
According to the complaints, GSK knew about this study and “attempted to discredit it.”
Other early studies, including one conducted by GSK in the early 1980s, demonstrated that NDMA formed when ranitidine was exposed to heat. In the study, which was presented to the FDA, GSK remarkably admitted that ranitidine use caused the proliferation of bacteria in the human stomach that are known to convert nitrates to nitrites, which leads to elevated levels of nitrite in the stomach environment. GSK acknowledged this could increase the risk of developing NDMA and, in turn, cancer, but then dismissed this risk because people were only expected to use ranitidine-containing products for a short-term period:
“Ranitidine is recommended only for short-term use and carcinogenic risk, if any, should thus be minimized.”
After numerous studies raised concerns over the link between Zantac and the formation of NDMA, GSK published a clinical study in 1987 specifically investigating gastric contents in human patients and N-nitroso compounds. While the study indicated that there were no elevated levels of N-nitroso compounds (of which NDMA is one), the complaints allege it was intentionally “rigged to fail,” and “designed to mask any potential cancer risk.”
“[I]n the testing it did do, GSK refused to test gastric samples that contained ranitidine in them out of concern that samples with ranitidine would contain ‘high concentrations of N-nitroso compounds being recorded’,” the complaints read. “So, GSK did not test for NDMA in any gastric fluid that contained ranitidine.”
“It appears GSK’s clinical study was rigged and purposely failed to investigate the connection between ranitidine ingestion and the formation of NDMA, which was the well-established at the time,” said Jennifer Moore, attorney for the plaintiffs. “The FDA never would have approved the drug if GSK had tested it properly.”
“GSK admitted decades ago that Zantac could react with nitrite in the stomach to form NDMA, and that long-term use of Zantac could lead to elevated levels of nitrite in the human stomach,” stated R. Brent Wisner. “It’s unconscionable that this didn’t stop them from telling millions of people through advertising to take Zantac when consuming foods containing high levels of nitrates, like hotdogs and pepperoni pizza. Their failure to tell the FDA, the medical community, and their consumers about the true risks associated with this drug has created an epidemic of cancer.”
GSK and Other Manufacturers Disregarded Scientific Evidence Linking Ranitidine to Cancer, Never Reported Safety Data to FDA
Manufacturers of an approved drug are required to submit an annual report to the FDA containing, among other things, new information regarding the drug’s safety. Since the early 1980s numerous animal and epidemiological studies have found the ingestion of ranitidine can lead to the production of NDMA.
In 2016, researchers at Stanford University conducted an experiment in which they measured NDMA in the urine of healthy individuals over the course of 24 hours, administered one dose of ranitidine, and then measured the NDMA in the urine of the same individuals for another 24 hours. On average, the level of NDMA increased by 400 times, to approximately 47,000 nanograms. According to the study, unsafe levels of NDMA are formed in the human body as a result of ranitidine ingestion. The scientists further explained that humans do not typically excrete NDMA in their urine, so that the observed 47,000 nanograms likely only captured 1/100 of the actual NDMA levels in the human body.
Despite regulations requiring drugmakers to submit “copies of unpublished reports and summaries of published reports of new toxicological findings in animal studies and in vitro studies (e.g., mutagenicity) conducted by, or otherwise obtained by, the [manufacturer] concerning the ingredients in the drug product,” the defendants ignored the regulations, disregarded the scientific evidence, and did not report to the FDA significant new information affecting the safety of ranitidine drugs, according to the allegations.
Punitive Damages Sought for “Conscious Disregard” of Plaintiffs’ Rights
The 40 plaintiffs allege the manufacturers of Zantac and generic ranitidine knew they could profit by convincing consumers that ranitidine was harmless to humans, and that full disclosure of the drug’s true risks would have limited the amount of money they could generate. According to the complaints, the defendants accomplished this through a misleading label, a comprehensive scheme of selective misleading research and testing, false advertising, and deceptive omissions. As a result of the defendants’ conscious disregard for their rights, the plaintiffs have requested punitive damages against the drug manufacturers.
The Zantac Plaintiffs
The plaintiffs are all California residents aged 8 to 67 years. A number of plaintiffs granted permission to be mentioned in this press release:
- Grag Amelino, El Segundo
- Michael Caratti, Fair Oaks
- Hanna Carbajal, Valley Springs
- Brian Elias, Covina
- Marc Friedland, Palmdale
- James Goetz, Redondo Beach
- David Harbaugh, Pasadena
- Christopher Ives, Sonora
- Marc Mitchell, Santa Rosa
- Mark Morrison, Napa
- Albert Muesse, Stanton
- James Newton, Vallejo
- Dwight Norman Sr., Stockton
- Lynn Smith, Milpitas
- Brian Wilbur, El Cajon
The cases were manually filed on May 11, but due to delays brought on by the COVID-19 pandemic, the court was unable to issue case numbers until the second and third weeks of May. Case numbers:
RG20061276, RG20061309, RG20061342, RG20061365, RG20061371, RG20061398, RG20061402, RG20061406, RG20061430, RG20061439, RG20061448, RG20061460, RG20061466, RG20061472, RG20061519, RG20061524, RG20061529, RG20061536, RG20061561, RG20061567, , RG20061576, RG20061592, RG20061597, RG20061599, RG20061603, RG20061631, RG20061644, RG20061652, RG20061667, RG20061681, RG20061688, RG20061705, RG20061712, RG20061726, RG20061739, RG20061766, RG20061771, RG20061782, RG20061791, RG20061977
Zantac Cancer Plaintiff: Hanna Carbajal on Behalf of Her Minor Son
Hanna Carbajal took OTC Zantac while she was pregnant with her son between 2010 and 2011. For many years, Zantac and its generic equivalents have been marketed to pregnant women as a safe treatment for heartburn. Prior to the FDA’s April 2020 market withdrawal request, the agency considered the drug as Category B, safe to take during pregnancy.
However, prevailing scientific evidence has found that exposure to ranitidine (and the attendant NDMA) can cause testicular cancer. NDMA is, itself, a very small molecule. This allows it to freely pass through all areas of the body, including the blood-brain and placental barrier. This is particularly concerning as ranitidine has been marketed safe for pregnant women and young children for years, including prior to and during the time Ms. Carbajal ingested the drug.
According to the complaint, as a direct result of being exposed to carcinogenic ranitidine-containing drugs in utero, Ms. Carbajal’s minor son was diagnosed with testicular cancer. Had the defendants warned Ms. Carbajal or any of the plaintiffs that ranitidine could lead to the production of NDMA or cancer, they never would have taken the medication.
As a result of exposure to ranitidine, Ms. Carbajal’s son has suffered significant injuries, including testicular cancer, that has required surgeries to remove a testicle, chemotherapy, and other treatments to address the physical effects and permanent damage.
Zantac Cancer Plaintiff: Brian Wilbur
Brian Wilbur, a pillar in his community, has spent 37 years in the California school system. For the last 23 years, he has been the school administrator / Director of Extended Curricular Programs at Grossmont Union High School District in El Cajon, California, where he also served for 11 years as a high school principal. Prior to that, he was a teacher for 13 years.
In 2009, Mr. Wilbur was prescribed brand-name Zantac to address stomach issues and later took generic ranitidine.
In 2017, Mr. Wilbur was diagnosed with prostate cancer after taking prescription Zantac and ranitidine for roughly seven years. He was forced to undergo radiation therapy and medication to treat his prostate cancer.
According to Mr. Wilbur’s complaint, an epidemiological study looking at various cancer risks and H2 blockers, including ranitidine, showed that ranitidine consumption increased the risk of prostate, lung, esophageal, pancreatic, and kidney cancer. Of particular note, the study indicated that people under the age of 60 that took ranitidine were five times more likely to contract prostate cancer.
Mr. Wilbur never would have taken ranitidine drugs if the defendants had warned about the known dangers.
Baum Hedlund Aristei & Goldman
Baum Hedlund Aristei & Goldman has resolved thousands of cases across many practice areas and won more than $4 billion in verdicts and settlements over the past 40 years. The firm’s award-winning personal injury attorneys have extensive experience holding large corporations accountable for concealing the dangers of consumer products. The National Law Journal and The Trial Lawyer Magazine awarded the firm’s Roundup cancer legal team (all of whom are working on the Zantac cases) with 2020 Elite Trial Lawyers Mass Tort Law Firm of the Year finalists, 2019 Elite Trial Lawyers Mass Tort Trial Team of the Year winner, and Trial Team of the Year 2019 by The National Trial Lawyers Top 100.
R. Brent Wisner, vice president and shareholder of Baum Hedlund, is the lead trial attorney for the firm’s Zantac cancer litigation and Roundup cancer litigation. He co-led two of the three Roundup cancer trials against Monsanto, obtaining the largest verdict in California in 2019 and the ninth largest verdict in US history with the $2B verdict for the Pilliods. He has won numerous awards and recognition, including 2019 Civil Plaintiff Trial Lawyer of the Year, by the National Trial Lawyers and American Lawyer Media; America’s Most Influential Trial Lawyers by The National Law Journal and Trial Lawyer Magazine and 2019 Winning Litigators, Titans of Industry by The National Law Journal.
In early 2020, U.S. District Court Judge Robin L. Rosenberg, who oversees all Zantac cancer cases litigation in the MDL, appointed Brent to the Practices and Procedures team, a small group of lawyers who helped establish the protocols and methodology for litigating the tens of thousands of Zantac cases expected to be filed. Judge Rosenberg also originally appointed Brent to the Plaintiffs’ Steering Committee and as Co-Chair of the Trial and Bellwether Committee in the MDL, but Brent recently resigned from those positions to focus his efforts on the California litigation. Brent also serves as Co-Chair of the Zantac Litigation Group for American Association For Justice. Since October of 2019, Brent has delivered Zantac presentations both in person and online, for many prestigious national lawyer conferences.
Moore Law Group
The attorneys at Moore Law Group have made a firm commitment to the practice of personal injury law, representing people who have been injured by the carelessness or neglect of corporations, hospitals, or individuals. Led by trial lawyer Jennifer A. Moore, the firm has a track record of success handling complex injury claims.
Jennifer A. Moore, is the founder and owner of Moore Law Group, based in Louisville, Kentucky. She has successfully led numerous class action and complex litigation cases in both state and federal courts. She successfully tried the first MDL Roundup cancer trial, resulting in an $80M verdict against Monsanto. She is admitted to practice in Kentucky and California and has been recognized by Business First as one of Louisville’s Top 40 Under 40 and recently received the University of Kentucky College of Law’s Professional Achievement Award for her work representing cancer victims in the Roundup litigation. Jennifer serves on the Board of Governors for the American Association for Justice (AAJ) and also on AAJ’s National Finance Council, the Section and Litigation Group Leaders Council and Litigation Group Leaders Council. She is a regular speaker at national lawyer conventions and conferences on the Zantac litigation. Along with Mr. Wisner, she serves as co-chair of AAJ’s Zantac Litigation Group.