Manufacturers of consumer products sometimes value profits over customers’ safety. In these cases, product liability law firms such as Nessler & Associates form class action lawsuits or represent clients in multidistrict litigation (MDL). Class action suits divide one award among many plaintiffs, whereas MDL suits transfer each case to one jurisdiction. This type of legal action allows each plaintiff to recover damages individually.
Glaxo, the company that would eventually become GlaxoSmithKline (GSK), received The United States Food and Drug Administration (FDA) approval for prescription Zantac to treat stomach ulcers in 1983. Five years later, Zantac was the world’s best-selling drug and one of the first to surpass $1 billion in sales.
In a 2019 statement to Scientific American, GSK notes that during the development process, it considered the possibility that the drug could contribute to N-nitrosodiethylamine (NDMA) development. This compound has been linked to many kinds of cancer.
GSK’s patent expired in 1997, allowing other manufacturers to make generic Zantac, also called Zantac Ranitidine or Ranitidine. Pfizer got FDA approval for an over-the-counter version of Zantac in 2004. The following 13 years saw the brand change hands among Johnson & Johnson, Boehringer Ingelheim Pharmaceuticals, and Sanofi, the current brand owner.
More than 15 million people took prescription-strength ranitidine medications annually, and millions more took OTC versions regularly to treat gastroesophageal reflux disease. These people might face an increased risk of many types of adverse reactions.
If you took this popular heartburn drug and later received a cancer diagnosis, let a personal injury lawyer with Nessler & Associates help you hold the pharmaceutical companies responsible for your medical bills and physical injuries. During a complimentary initial consultation, we can examine your laboratory tests and other medical records to learn how your health condition has impacted your life.
Carcinogenic Compound Found in Active Ingredient of Ranitidine
Valisure, an independent pharmaceutical testing company, found NDMA in ranitidine samples manufactured by many companies. Valisure started as a small online pharmacy that did quality control testing on every lot of medication they sold. The company tested brand-name and generic versions of the prescription drug and several versions of over-the-counter medicines.
What is NDMA?
N-nitrosodiethylamine is a naturally occurring compound that exists in minute amounts in food and beverages: industrial processes can also create nitrosodimethylamine NDMA. The Environmental Protection Agency lists it as a semivolatile organic chemical and classifies it as a potent carcinogen. NDMA can be created unintentionally through chemical processes such as water treatment and manufacturing.
NDMA exposure over time can significantly increase your risk of cancer. Harmful ingredients or inadequate cleaning can introduce NDMA into medications. This contamination might include the actual NDMA compound or a combination of precursor compounds.
The FDA lists the safe upper limit of NDMA from close to a million nanograms of ranitidine per day. Valisure’s tests found doses in some products as high as 304,500 nanograms per tablet, which led to their notification of the FDA.
NDMA Concentration Can Increase Over Time
GSK and other manufacturers of prescription and generic versions of ranitidine argue that Valisure’s heating of samples might have created excessive levels of NDMA. However, the FDA developed lab tests exploring how observed levels of NDMA might appear in the human stomach. Many samples produced results outside acceptable limits.
Many pharmaceuticals are exposed to increased heat during storage and transportation. Emery Pharma found that ranitidine exposed to high heat for as little as 5 days developed more than 96 nanograms of NDMA in some samples. Temperatures can be as low as 77℉ and produce the carcinogenic substance, with higher levels observed in medications exposed longer.
Which Products are Affected?
Many companies manufacture ranitidine medicines. Some companies produce over-the-counter versions of generic ranitidine for multiple store brands, while other generic manufacturers produce prescription drugs.
Manufacturers of defective products include:
- Boehringer Ingelheim Pharmaceuticals
- Sanofi SA
- Apotex Corp., which makes medicines for Rite Aid, Walmart, and Walgreens
- Novartis
- Aurobindo Pharma USA
- Sandoz
- Perrigo Company
- Dr. Reddy’s Laboratories
- Lanette Company
- Novitium Pharma
- American Health Packaging
- Amneal
- Golden State Medical Supply
- Precision Dose
NDMA’s apparent link to cancer makes this popular medication a potential public health catastrophe. Instead of attempting to protect the public, most manufacturers are trying to discredit studies and protect their profits. You need an experienced MDL attorney from Nessler & Associates to protect your right to fair compensation.
Cancers Linked to Zantac Use
Researchers have connected ranitidine use to several types of cancers. If you have been diagnosed with cancer, a personal injury attorney can work with medical experts to determine the likelihood of a link between your cancer and your use of ranitidine drugs.
Cancers of the Digestive System
Multiple studies have examined the links between ranitidine and NDMA and cancer and NDMA. One study showed abundant evidence that NDMA-contaminated ranitidine causes digestive system cancers in humans and animals. These human carcinogen cancers include:
- Colon cancer
- Small intestinal cancer
- Stomach cancer
- Liver cancer
- Pancreatic cancer
- Pharyngeal cancer
- Esophageal cancer
Other Cancers
NDMA exposure can cause other forms of cancer, including:
- Bladder cancer
- Breast cancer
- Testicular cancer
- Prostate cancer
- Thyroid cancer
- Leukemia
- Multiple myeloma
- Lung cancer
- Kidney cancer
If you’ve received a cancer diagnosis after taking a ranitidine product, consult an attorney with Nessler & Associates to discuss your case. You may be entitled to significant financial compensation.
NDMA Can Damage Organs in Other Ways
NDMA can cause organ damage beyond cancer. A Centers for Disease Control and Prevention document lists various problems NDMA has caused in human and animal studies. For ethical reasons, many of these studies cannot be conducted in humans. Potential issues cited in the CDC paper and the EPA paper include:
- Liver damage
- Blood vessels
- Immune dysfunction
- Developmental issues in fetuses, including miscarriage and mortality at birth
- Decreased iron-binding capacity in the blood
FDA’s Role
Valisure asked the FDA to pull ranitidine products off the market in the summer of 2019. On September 13, the FDA issued a statement alerting patients and prescribers that ranitidine may contain unsafe levels of NDMA.
On April 1, 2020, the FDA asked manufacturers and retailers to pull ranitidine products from the market after conducting its own tests. That letter classifies ranitidine as a risk to public health.
The FDA works to prevent consumers from taking dangerous drugs. The cancer risk presented by ranitidine prompted the FDA to ask manufacturers to recall prescription and over-the-counter medications voluntarily.
What an Illinois Product Liability Lawyer Can Do
A lawyer with the personal injury law firm of Nessler & Associates can examine your potential claim and provide accurate feedback on your chances of success. If you decide to proceed, we can calculate your damages, investigate the manufacturers of the heartburn medications you took, and represent you in multidistrict litigation.
Calculate Damages
You should receive compensation for economic and non-economic damages related to your health condition. We can use your medical records and receipts to calculate your monetary losses. We determine intangible losses after discussing how your condition impacts your daily life.
Economic damages include:
- Medical costs, including physical therapy
- Lost wages
- Loss of future income
- Out-of-pocket expenses such as medication and assistive devices
Noneconomic dama
- Loss of enjoyment of life
- Loss of consortium
- Pain and suffering
- Mental anguish
- Decreased life expectancy
- Reduced quality of life
If the discovery process shows that the company knew about the dangerous levels of NDMA and failed to warn consumers or correct the problem, your lawyer can seek punitive damages.
Investigate the Drug Manufacturers
Your legal team can work with the other attorneys in the MDL to investigate the pharmaceutical manufacturers that produced the medications you took during discovery. This process might involve subpoenas for internal communications and lab tests. It will likely include depositions with past and current employees to determine what the company knew about potential risks and when they knew it.
One benefit of the multidistrict litigation process is the consolidation of the discovery process, which saves plaintiffs money and time.
Representation in the MDL
Mass tort actions like MDLs arise from product liability cases in which thousands or millions of people have been affected by a defective drug or other product. The courts use aggregate litigation to keep their dockets from becoming congested with thousands of similar, time-consuming individual lawsuits.
One federal judge oversees the pretrial process and appoints a team of lawyers from the plaintiffs’ representatives to lead a combined discovery and pretrial process. Attorneys from both sides will select a few representative cases for bellwether trials. The results of these trials will guide your lawyer in future settlement negotiations.
Consult a Nessler & Associates Product Liability Attorney
The law firm of Nessler & Associates employs dedicated personal injury attorneys that handle product liability cases. We protect the rights of people who negligent pharmaceutical manufacturers have injured. Our Zantac cancer lawsuit attorneys will help you get the maximum compensation you deserve.
Our cancer lawsuit attorneys work on a contingency fee basis. This payment structure means you don’t pay unless you win. It offers a no-risk way to access legal representation that will fight aggressively on your behalf.
If you have developed cancer due to unacceptable levels of NDMA in your acid reflux medication, call Nessler & Associates at (800) 727-8010 for a no-obligation, free consultation, and case evaluation. Discover how we can help you get compensation for your medical expenses and emotional pain.