Plumbers & Pipefitters Local Union 630 Welfare Fund told the appeals court that U.S. District Judge Robin L. Rosenberg erred in dropping state design defect claims from lawsuits against name-brand Zantac makers such as Pfizer Inc. and Sanofi-Aventis U.S. LLC. The union argues there is no issue between the federal and state statutes.
Federal law takes precedence when it conflicts with state law, according to the supremacy clause of the U.S. Constitution. However, the union said that in the case of Zantac, federal and state drug-branding laws seek the same end: accurate and truthful labels on medications.
Plumber’s Union Argument: The Claims are Parallel
The union said: “Here, the state and federal duties do not conflict because they are parallel.”
Judge Rosenberg’s ruling came in a batch of suits that generally accuse Pfizer Inc., Sanofi SA Inc. and GlaxoSmithKline LLC – as well as generics makers, distributors, pharmacies and others in the supply chain – of false advertising, failure to warn, and other claims linked with the discovery of the cancer-causing chemical nitrosodimethylamine (NDMA) in Zantac.
In a Dec. 31, 2020 ruling, Judge Rosenberg said the claims made under state laws against the generic-drug makers and re-packagers are preempted. The judge also ruled that the plaintiffs’ federal warranty claims which rely on those allegations cannot proceed.
The judge did note that the Supreme Court has not clarified whether state design defect claims that parallel the federal misbranding statutes are preempted by federal law.
The plumbers’ union argued that the federal Food Drug and Cosmetics Act – which governs drugs like Zantac – contains no preemption clause; therefore, the idea only applies when state and federal laws conflict.
The union argued that, “Claims are parallel if the federal and state duties are the same, even if the wording to describe the duty differs.”
The union also wants the Eleventh Circuit to overturn Judge Rosenberg’s ruling that it lacks standing to represent class members across multiple states because the claims of injury arise under the laws of multiple states.
The union said it sustained the same legal injury as all class members — overpaying for a worthless drug — and all the state laws in question are similar in requiring refunds.
The union said: “Class representative standing requires no more.”
The FDA issued a warning in September 2019 that it had found trace amounts of the carcinogen NDMA in Zantac and similar generic drugs. On April 1, 2020, the FDA pulled all prescription and over-the-counter drugs featuring ranitidine (the active ingredient in the meds) from the market over concerns that, when stored above room temperature, the drug could produce unacceptable levels of ranitidine.
The FDA has set an allowable daily limit of 96 nanograms of NDMA; however, researchers have found more than 3 million nanograms in a dose of Zantac. NDMA is also found, notably, in red meat, tobacco, and beer.
Plumbers’ Union fights to reinstate Zantac Claims
Zantac was recalled from store shelves by Walgreens, Rite Aid, and CVS in October 2019, after research found a cancer-causing ingredient in Zantac. Wal-Mart later recalled the drug as well, while Novartis halted global distribution of its ranitidine drugs in the same class as Zantac.
America’s biggest drug store chains pulled the popular heartburn medication from shelves after the U.S. FDA said it had found low levels of cancer-causing ranitidine in Zantac samples.
FDA re: Zantac and NDMA
Though the FDA said as recently as Nov. 1, 2019 that levels of NDMA (N-Nitrosodimethylamine) which the agency found in Zantac are not any higher than that found in grilled or smoked meats, the FDA has mostly side-stepped a discussion of how Zantac can become a dangerous carcinogen.
The FDA stated Nov. 1 on its web site: “FDA has determined that the levels of NDMA in ranitidine and nizatidine [Zantac’s active ingredients] are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
Reuters, however, reported that FDA said it found “unacceptable levels” of a cancer-causing impurity in the popular heartburn drug Zantac and its generic versions known chemically as ranitidine.
Valisure does work FDA fails to do
U.S. and European health regulators revealed then that they were reviewing the safety of ranitidine after the online pharmacy Valisure flagged the impurities to regulators. Canada’s health authorities then asked the drug’s makers to halt distribution.
Valisure out tests FDA
The FDA reportedly checked over-the-counter drugs using a low-heat method of testing. FDA said it found much lower levels of the impurity – N-nitrosodimethylamine (NDMA) – than were discovered with a higher temperature test used by Valisure. The difference is that because Zantac reaches extraordinary temperatures in the human gut, the higher-temperature measurements taken by Valisure more closely match real-world conditions of Zantac exposure and breakdown.
NDMA had previously been found in some blood pressure meds such as Valsartan, a branded name from a class of drugs known as angiotensin II receptor blockers, or ARBs. Those potentially cancer-causing impurities are thought to have been introduced by recent changes in the drugs’ manufacturing process.
The FDA said Valisure’s higher temperature testing method generated very high levels of NDMA from the ranitidine drugs. The FDA claimed that method, which Valisure had used for testing ARBs, was not suitable for ranitidine.
Valisure also said at that time that it also suspected its high temperature method resulted in findings of higher NDMA levels. Valisure also said that it did not find NDMA in a body-temperature test of ranitidine it conducted.
Nevertheless, a Valisure analysis conducted in conditions similar to the human stomach generated more than 300,000 nanograms of NDMA. That number is significantly above acceptable levels set even by the FDA, according to a Valisure company spokesman.
Valisure CEO David Light said his company’s analysis shows that even if the pills are not contaminated, the drug is likely to form the impurity in patients’ stomachs after ingestion.
Plaintiff’s attorneys across the country are now filing individual Zantac cancer lawsuits in various state courts against Pfizer and other companies which made or marketed Zantac in its prescription or over-the-counter forms.