Lawyers from Baum Hedlund Aristei & Goldman filed Zantac cancer lawsuits in Delaware State Court on behalf of more than 7,000 claimants throughout the country who allege the popular heartburn medication causes cancer. The filing of 88 complaints on behalf of 7,291 claimants is one of the largest on behalf of Zantac cancer victims this year.
Zantac attorneys R. Brent Wisner, Michael L. Baum, Adam M. Foster, and Helen E. Tokar completed the filing in the Superior Court for the State of Delaware for personal injury and wrongful death claimants in all 50 states, Puerto Rico, Guam, and France. Example case number: N22C-09-161. The complaints name the following defendants, all of which are incorporated in Delaware:
- GlaxoSmithKline LLC (GSK): Originally developed Zantac (ranitidine) in 1976. The U.S. Food and Drug Administration (FDA) granted approval to GSK to sell prescription Zantac in 1983 and it quickly became one of GSK’s most successful products. Due to GSK’s marketing strategy, which emphasized safety, Zantac reached over $1 billion in sales. GSK controlled the New Drug Application (NDA) for prescription Zantac between 1983 and 2009.
- Pfizer Inc.: Entered into a joint venture with GSK to develop an over-the-counter (OTC) version of Zantac in 1993. Generic versions of Zantac became available in 1997. After the joint venture with GSK dissolved in 1998, Pfizer retained the rights to sell OTC Zantac domestically and retained ownership over the Zantac trademark. Pfizer retained full rights to OTC Zantac in the U.S. from 2000 until 2006, when it transferred all assets pertaining to its Zantac OTC line, including the rights to sell and market any formulation of OTC Zantac, to Boehringer Ingelheim.
- Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim USA Corporation: Purchased the rights of OTC Zantac in 2006. The company sold the OTC Zantac rights to Sanofi in 2016, though the company continued to manufacture the finished OTC Zantac product for Sanofi until October 2019.
- Sanofi US Services Inc. and Sanofi-Aventis U.S. LLC: Purchased the rights of OTC Zantac in 2016 and currently retains that control and responsibility and manufactured and distributed the drug in the U.S.
- Patheon Manufacturing Services LLC: Engaged in the manufacture, distribution, and selling of OTC Zantac on behalf of Pfizer, Boehringer Ingelheim, and Sanofi from 1995 until the drug was withdrawn from the market.
The allegations against the defendants include:
- Count I: Strict Liability – Failure to Warn
- Count II: Strict Liability – Manufacturing Defect
- Count III: Negligence – Failure to Warn
- Count IV: Negligent Product Design
- Count V: Negligent Manufacturing
- Count VI: Negligent Misrepresentation
The plaintiffs allegedly ingested various forms of prescription and/or OTC ranitidine products, and, as a result developed cancer. The complaints, which seek punitive damages against the defendants, allege Zantac causes the following types of cancer:
- Bladder cancer – 553 cases
- Breast cancer – 1,940 cases
- Colorectal / intestinal cancer – 2,472 cases
- Esophageal cancer – 290 cases
- Gastric cancer / stomach cancer – 200 cases
- Liver cancer – 188 cases
- Lung cancer – 119 cases
- Pancreatic cancer – 210 cases
- Prostate cancer – 1,319 cases
Cases by state / country of residence (all US citizens):
- Alabama: 227
- Alaska: 12
- Arizona: 165
- Arkansas: 124
- Colorado: 81
- Connecticut: 54
- Delaware: 27
- District of Columbia: 7
- Florida: 624
- Georgia: 378
- Hawaii: 6
- Idaho: 41
- Illinois: 269
- Indiana: 151
- Iowa: 75
- Kansas: 64
- Louisiana: 194
- Maine: 27
- Maryland: 112
- Massachusetts: 134
- Michigan: 216
- Minnesota: 88
- Mississippi: 162
- Missouri: 202
- Montana: 17
- Nebraska: 31
- Nevada: 82
- New Hampshire: 14
- New Jersey: 148
- New Mexico: 57
- New York: 333
- North Carolina: 352
- North Dakota: 9
- Ohio: 429
- Oklahoma: 152
- Oregon: 68
- Pennsylvania: 296
- Rhode Island: 11
- South Carolina: 220
- South Dakota: 11
- Tennessee: 157
- Texas: 747
- Utah: 53
- Vermont: 9
- Virginia: 150
- Washington: 117
- West Virginia: 112
- Wisconsin: 113
- Wyoming: 9
- Puerto Rico: 19
- France: 1
- Guam: 1
Zantac Cancer Lawsuit Claimants Allege Ranitidine Leads to NDMA Exposure
In 2019, independent laboratory testing found Zantac 150 tablets taken under biologically relevant conditions, contain a cancer-causing substance called N-Nitrosodimethylamine (NDMA) at levels ranging between 245 and 3,100 times higher than the FDA’s allowable limit.
In 2020, following a series of manufacturer-initiated Zantac recalls and an FDA market withdrawal request, all ranitidine-containing products were removed from the market. Since the FDA’s market withdrawal for Zantac, many thousands of Americans have filed lawsuits alleging exposure to Zantac caused them or a loved one to develop cancer.
Attorneys for the plaintiffs say the NDMA in Zantac and its generic versions is not caused by any direct contamination. The ranitidine molecule itself, the complaints allege, contains the constituent molecules to form NDMA. Ranitidine leads to NDMA exposure by:
- The formation of NDMA in the human stomach: When the ranitidine molecule is exposed to the acidic environment of the stomach, particularly when accompanied by nitrites (a chemical commonly found in heartburn-inducing foods), the Nitroso molecule (0=N) and the DMA molecule (H3C-NCH3) break off and reform as NDMA.
- The formation of NDMA due to an enzymatic reaction throughout the human body: NDMA can also form outside the stomach. Laboratory testing found that an enzyme called DDAH (most commonly found in the kidneys and brain, but also found in the bladder, colon, intestine, liver, prostate, and stomach) interacts with ranitidine to produce dangerous levels of NDMA.
- The formation of NDMA due to heat and time: Early studies, including one conducted by GSK in the early 1980s, demonstrated that NDMA formed when ranitidine was exposed to heat. In 2020, an FDA-certified lab that conducted testing on ranitidine found “NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.”
Drug Makers Knew That Zantac Could Degrade into Potent Carcinogen But Failed to Warn Consumers
According to the complaints, the defendants knew that Zantac and generic ranitidine could degrade into a potent human carcinogen, NDMA, in the regular course of transport and storage, and within the human body, but failed to take any action to prevent consumers from being exposed. Instead, the complaints allege Zantac’s manufacturers made billions selling a product they knew posed an unreasonable risk to consumers. If the drug makers had disclosed and disseminated the cancer risks associated with Zantac and OTC ranitidine products, the plaintiffs could have avoided the risk of developing cancer by using several alternatives that do not pose the same risk.
“We’ve had some really interesting discovery in the last six months showing that they knew about this problem and were negligent in the way they did things,” Wisner said in an August interview with Bloomberg. Wisner, who Bloomberg writes, “has shown a knack for winning,” says he is looking forward to taking cases to trial. In 2018 and 2019, he served as co-lead counsel and defeated agrichemical giant Monsanto (now Bayer) in two cancer trials that culminated in over $2.3 billion in jury verdicts.
According to Wisner, he believes the defendants in the Zantac litigation “deliberately misled consumers because they knew that full disclosure of Zantac’s risks would limit the amount of money they could make selling the drugs.”
“They knew that concealing the truth would protect profits. Their deception led to an epidemic of cancer in this country, and we intend to hold them accountable.”