A Florida federal judge presiding over sprawling multidistrict litigation involving the carcinogens found in the heartburn medication Zantac cut more claims from the litigation, holding that design defect claims are barred by federal law.
The judge rejected arguments by consumers and third-party payers that their claims are not preempted because the heartburn drug was misbranded, as the presence of a cancer-causing substance in the drug was not disclosed.
“As with generic drugs, a claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA has approved,” the judge said.
The FDA issued a warning in September 2019 that trace amounts of NDMA were found in Zantac and similar generic drugs. On April 1, they pulled all prescription and over-the-counter drugs featuring ranitidine – the active ingredient in heartburn medications – from the market over concerns that the drug, when stored above room temperature, could produce unacceptable levels of carcinogen.
Since a brand-name manufacturer can strengthen warnings on drug labels without waiting for the FDA’s sign-off – as part of the agency’s changes being effected process – a labeling claim against a branded drug manufacturer isn’t necessarily preempted, the judge said.
“Therefore, the plaintiffs are granted leave to replead design-defect claims against the defendants that are based on the labeling of ranitidine products,” the judge said.
The judge also dismissed state law claims seeking to recoup monetary losses from buying over-the-counter ranitidine, finding the Congress didn’t intend for any state to classify a claim as a product liability claim when the plaintiff was not personally injured.
Veterans are increasingly filing Zantac lawsuits claiming the drug causes cancer, according to lawyers.
The lawsuits claim drug manufacturers knew the active ingredient in Zantac, ranitidine, had the potential to form a toxic chemical called N-Nitrosodimethylamine (NDMA) in a person’s stomach but did not warn the public. NDMA is known to cause cancer in animals and may cause cancer in humans.
The U.S. Food and Drug Administration asked all manufacturers to withdraw Zantac and all ranitidine products from the U.S. market in April 2020 because the drug could expose people to unacceptable levels of NDMA.
According to lawsuits, scientific literature showed that drugs like Zantac containing a substance called dimethylamine (DMA) were more likely to form NDMA when combined with other substances in the body. This information was available before the FDA approved Zantac in 1983, and lawsuits say drug manufacturers failed to warn the public, exposing them to an increased cancer risk.
Many of the veterans who filed Zantac cancer lawsuits took Zantac prescribed at the VA, according to their lawyers. Because veterans are more likely to take acid-reducing medications, they may be at a higher risk of exposure from Zantac.
More than 200 people recently joined together to file a new Zantac class-action lawsuit in the U.S. District Court for the Southern District of Florida. The plaintiffs bring the action on behalf of themselves and all other similarly situated residents of the U.S. or its territories who purchased and/or used Zantac for personal use.
According to the complaint, Zantac manufacturers deceived millions of consumers into “purchasing and ingesting a defective, misbranded, adulterated, and harmful drug” while failing to warn about the potential for that drug to conatin N-nitrosodimethylamine (NDMA), a cancer-causing agent.
Plaintiffs who used the drug between 1983 until April 2020 when the U.S. Food and Drug Administration removed it from the market now face a potential increased risk of developing cancer, which may require them to endure costly medical monitoring, treatments, and/or medications for the rest of their lives.
The FDA set the maximum allowable daily limit of NDMA to 96 nanograms. Tests on Zantac products, however, revealed much higher than allowed amounts of NDMA, prompting the FDA to notify the public of potential danger in September 2019.
The plaintiffs claim they would never have used the medication if they were aware of its potential to contain NDMA. They say that the defendants knew or should have known of the NDMA risk in their products as early studies showed the possibility of conversion into cancerous N-nitroso compounds. Additionally, the plaintiffs state that the defendants long knew that NDMA could be formed, yet failed to take any action to protect consumers.
The plaintiffs are seeking compensatory and punitive damages.
New commission filings have revealed that Sanofi-Aventis US LLC and GlaxoSmithKline LLC are being investigated by the Department of Justice over allegations that the heartburn drug, Zantac, causes cancer. The DOJ and U.S. Attorney’s Office are specifically looking to see if these companies violated the False Claims Act by failing to reveal their knowledge about the presence of NDMA in their product.
The probes began last month. Around the same time, the New Mexico Attorney General lodged a suit against multiple Zantac manufacturers for having violated the False Advertising Act, the Unfair Practices Act, and other laws.
Zantac cases have already been consolidated in Florida, but attorneys for 40 plaintiffs in California are seeking to have cases consolidated there, as well.
Cancers being attributed to Zantac include testicular, bladder, prostate, kidney, and thyroid. The claims also state that makers of the heartburn drug have known about its potential to cause injuries since the 1980s, and that some even worked to shut down those studies.
Zantac manufacturers continue to deny claims that their heartburn drug causes cancer and say that there is no causal link between Zantac and cancer.
Two Zantac cancer lawsuits have been consolidated in the U.S. District Court of Florida, where the Zantac litigation is pending.
The two plaintiffs, one from Pennsylvania and the other from Florida, are both women who claim that regular use of Zantac lead them (or their descendant) to develop cancer.
The Pennsylvania-based plaintiff filed a claim on behalf of a deceased family member’s estate. The descendant was diagnosed with pancreatic cancer in 2018, succumbing to the illness on August 31, 2019.
According to her complaint, the descendent used Zantac regularly and followed the directions regarding drug usage. The plaintiff’s complaint states that the descendant would have not used Zantac if he was aware of the cancer risks associated with Zantac.
The Florida-based plaintiff’s complaint states that she began taking over-the-counter Zantac regularly more than 20 years ago, using both 75 mg and 150 mg does, initially beginning to use the drug to reduce her stomach acid after undergoing an endoscopy. Similar to the Pennsylvania plaintiff’s claim, the Florida plaintiff states that she used the drug as directed on the label. She began with 75 mg doses but transitioned to 150 mg doses after the higher dose became available in the US market. She also noted that she would have not used Zantac if she was aware of the cancer risks associated with the drug.
The Florida plaintiff was diagnosed with stage IIC colon cancer in April 2018. She subsequently underwent an invasive surgery to have a large part of her colon removed. She has since received various cancer treatments, including chemotherapy treatment.
Both pancreatic cancer and colon cancer have been linked to Zantac use.
Both plaintiffs are seeking compensatory damages as well as punitive damages against the manufacturer.
The attorneys representing 40 different Zantac users with cancer are urging the court to consolidate their cases in California. The plaintiffs allege that Sanofi-Aventis US LLC, Pfizer Inc. and other pharmaceutical companies hid the risks of heartburn drug Zantac.
The plaintiffs in the 40 cases filed a petition to have their suits linked in a judicial council coordinated proceeding to consolidate pretrial and trial phases of the cases, which they said would work alongside the existing Zantac multidistrict litigation in Florida.
“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.” Jennifer A. Moore, a representative for the plaintiffs said.
Plaintiffs in the complaints include the mother of an 8-year-old boy who alleges that her use of Zantac while pregnant resulted in her son developing testicular cancer. Other complaints allege the drug also resulted in bladder, kidney, prostate, and thyroid cancer.
Despite knowing the risks associated with taking Zantac, the companies failed to warn its user and advertised the product as medication to take while eating the very foods that would cause that carcinogen, according to the suits.
Furthermore, the lawsuits claim that GlaxoSmithKline LLC, which first created Zantac in the 1970s, worked to discredit studies in the 1980s that showed the drug’s hazardous potential.
A spokesperson for GSK said the company could not comment on the specifics of the litigation, but that they take the issue very seriously as patient safety is their utmost priority.
