Who Is Impacted by this Case
Anyone who has used Zantac on a regular basis for any extended period of time would be impacted by this. Individuals who have also been diagnosed with cancer should check for eligibility. Zantac is one of the most common drugs used to treat heartburn. And, with an estimated 60 million Americans suffering symptoms of heartburn each month, you can gather that there could be a large number of plaintiffs in cases against Zantac’s producers.
When was Zantac Introduced
The generic drug ranitidine and Zantac were both introduced in the United states in 1981 as a prescription and over the counter drugs. When the drug was first introduced it was aggressively promoted to both doctors and the general public and Zantac went on to become one of the best-selling drugs in pharmaceutical history.
Why Has Zantac Been Recalled
The FDA along with two other private labs using FDA approved testing has found that over time the chemical NDMA rises in the drug ranitidine (the main drug used in Zantac) to dangerous levels that are not safe for the human body. One study in 2019 saw the FDA, and its European counterparts, cite “unacceptable” levels of NDMA in Zantac. Voluntary removals of the drug were overseen in the United States in 2019, but the FDA doubled down on its call for withdrawal in April 2020.
How To Fight Back Against Zantac
To see if you or a loved one qualify to fight against Zantac, start by taking a free evaluation to check eligibility for compensation.
The popular antacid drug Zantac's main ingredient ranitidine has been found to contain very high levels of a cancer-causing chemical called N-Nitrosodimethylamine (NDMA). In addition there is now evidence suggesting that while the big pharma companies who make Zantac were making unprecedented profits (it was the first drug to ever generate a billion dollars in annual sales) the companies became aware that there was a link to cancer and hid it from consumers for years.
Big pharmaceutical companies like GlaxoSmithKline (GSK), Sanofi, and Boehringer Ingelheim are all aware that they could be facing a mass of expensive lawsuits from people who have used their Zantac products and subsequently developed cancer.
In September 2019, the U.S. Food and Drug Administration first issued a public safety warning about possible cancer risks from Zantac after it became aware of results from an independent laboratory that found high levels of NDMA in ranitidine. At the time, the agency said it did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines. However now after conducting its own research and evaluation similar results were found by the FDA and in April the agency ordered the drug to be removed from the market completely.
N-Nitrosodimethylamine ("NDMA") is a chemical that is usually created as a byproduct of either a natural chemical process in nature or of a manufacturing process. It can be found in small traces in many products and foods around the world. The U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the World Health Organization (WHO) all classify NDMA as a cancer-causing chemical yet NDMA in low doses is not considered dangerous (The FDA has set the acceptable daily intake of NDMA at 96 nanograms). However in high dosages, such as the ones recently found in Zantac, the chemical is considered very dangerous to the human body.
There have been many studies over the last 30 years showing a link between NDMA and cancer. The International Agency for Cancer Research (IARC) unit of the World Health Organization reviewed all studies and warns that NDMA is considered a carcinogenic (cancer causing) in humans. The agency found that NDMA is “carcinogenic in all animal species tested” and noted that the metabolism of NDMA by humans and animals is similar.
Exposure to NDMA in ranitidine has been linked to a number of cancers including Stomach cancer, Colon or Intestinal cancer, Kidney cancer, Breast Cancer, Liver Cancer, Bladder cancer, Liver cancer, Prostate cancer, Lung Cancer, Brain cancer, Pancreatic cancer, Prostate cancer, and Rectal cancer.
What Are The Dangers?
The major risks of cancer and NDMA have to do with the levels of the chemical found in the drug. Both the FDA and other third party labs using FDA approved testing found NDMA levels in ranitidine to be “alarming high”. The testing done by independent pharmacy Valisure’s lab found the levels to be more than 3,000 times higher than the FDA recommended daily dose.
The FDA has agreed that the levels of NDMA in Zantac and other ranitidine products increase over time to an unacceptable level for daily intake yet the FDA calls the high NDMA levels found in Zantac an “impurity”. The agency says that NDMA was present in both the finished drug product samples and the active pharmaceutical ingredients (APIs). But two other independent labs using FDA approved testing does not show this. According to their tests NDMA is not added instead it is formed as a by-product of the chemical process that happens when the drug sits out. Emery Pharma testing shows that NDMA can increase during storage, especially if the drug is exposed to high heat and even while it remains in the package. In addition the Valisure testing results show that NDMA is actually formed in the body upon consumption. In September 2019 they sent a citizen petition to the FDA warning of their findings.
New Research Discoveries
A Stanford University research study from 2016 further supports the results made by Valisure. Urine samples were tested from adults 24 hours before and after ingestion of a standard dose of 150 mg of ranitidine. The results found that levels of NDMA in the urine increased 400-fold, from 110 ng to 47,600 ng. These levels, the researchers believe, show there has been a large underestimation of the actual NDMA exposure in the body, since only a small fraction of the NDMA is actually excreted in the urine.
Clearly more investigation and transparency is needed by the FDA and other governing bodies into the cancer risks of NDMA in ranitidine drugs. Yet based on the knowledge currently available there is enough evidence to show that NDMA levels in Zantac are not safe.
There are potentially millions of people affected by this product. This case has such a high reach because Zantac was a very popular and easily accessible drug. Millions of Americans have been using Zantac and its generic equivalents daily for years to reduce acid reflux. It has been available both over the counter and by prescription.
However those diagnosed with specific types of cancer that are closely linked to NDMA will have a more direct impact.
As much of the information surrounding Ranitidine is relatively new, cases against Zantac have only just begun. As of March 2020 there are 140 cases with thousands of people filing suits against Zantac, however most legal experts believe that this is only the beginning and expect a huge number of Zantac lawsuits getting filed over the next few years.
It seems that many of the Zantac lawsuits are in the process of being consolidated into class actions and MDLs (multidistrict litigations). This makes it easier for courts to hear cases with a large number of plaintiffs.
Joining a lawsuit would help hold the makers of Zantac accountable for not protecting consumer rights and would push for the strengthening of consumer protections in the future which would include rules for updating labelling on drugs and recalling other drugs with problematic levels of NDMA. In addition it will help those who have suffered harm from the company’s unethical behaviour receive compensation.
It can be difficult to estimate the amount of compensation that could be paid in the Zantac lawsuit. For a start, there are different types of lawsuits being brought against the Big Pharma companies behind the drug. For example there is also a class-action lawsuit on behalf of consumers who have used Zantac. These claimants have not developed cancer but are instead claiming economic damages against companies like GSK and Sanofi for knowingly selling defective products for heartburn treatment. Any compensation in that case would likely be lower to the compensation claimants in the Mass Tort Zantac cancer lawsuits might be rewarded.
A settlement occurs when the defense and plaintiffs agree on a resolution before the end of a trial. Many Mass Tort Zantac lawsuits are being consolidated into a multidistrict litigation in Florida, where a judge will oversee pretrial arguments and discovery for cases across the United States. In this scenario, we could see the first Zantac lawsuit settlements being agreed before the cases go to trial.
As mentioned above, the Zantac cancer lawsuits are still in the early stages. Events like the Covid-19 pandemic may have slowed down the passage of the cases through the courts, but the cases are still going forward at a good pace. In terms of potential Zantac payouts, Big Pharma companies connected to Zantac may choose to offer a settlement instead of going through with a trial . A successful case brought by plaintiffs claiming Zantac caused cancer could result in multi-billion-dollar payouts from pharmaceutical companies.
In February 2020, federal judges approved 15 Zantac lawsuits to be consolidated into a multidistrict litigation to be heard in a Florida court. An MDL is a means of streamlining the process of pretrial proceedings and discovery, allowing lawyers in the Zantac case to share important information and potentially leading to settlements. New Zantac claimants can join the MDL in Florida, but other cases are pending in courts across the United States.
In April 2020, the FDA reasserted its call for the removal of all ranitidine (Zantac) products from the market immediately. The FDA said it was part of “an ongoing investigation” into NDMA in Zantac and other ranitidine medications. In its statement, the FDA reiterated its belief that NDMA found in Zantac is a “probable carcinogen” (cancer-causing product).
In June 2020, it was reported that California law firms aimed to consolidate the claims of 40 Zantac lawsuit claimants. As with the MDL in Florida mentioned above, consolidation of multiple cases helps streamline the process. Moreover, such alignment of multiple cases is seen as beneficial to the claims of individual plaintiffs.
Many Americans are wondering if they have developed cancer due to defective Zantac antacid drugs. However, it is important that any Zantac victims find the right lawyer for their needs and this case. Cases like Zantac are complex, involving different cancers, various medical studies, and defendants (Big Pharma) with unlimited resources. For that reason, you will want to find experienced personal injury lawyers to ensure your case against Zantac brings about the best outcome for you.
Studies are still being carried out as to the cancer-causing properties of NDMA in Zantac. However, the FDA has called NDMA a “probable” carcinogen. And, that has led many to consider if Zantac use was responsible – or partly responsible – for the cancer they, or their loved ones, have developed. The following types of cancers may have particular links to Zantac:
Bladder cancer – A 2004 study showed that ulcer-sufferers taking Zantac, or another antacid, Tagamet, had a heightened risk of developing bladder cancer.
Stomach cancer – Sometimes referred to as gastric cancer, stomach cancer has many subtypes that can form in the digestive tract. Several of these stomach cancers have been linked to NDMA and Zantac.
Kidney cancer – One of the first lawsuits against Zantac producers came from an Ohio woman who developed stage four kidney cancer after taking two Zantc pills per day for 12 years.
Testicular cancer – Some lawyers have claimed that testicular cancer can develop in young boys when their mothers have taken Zantac when pregnant.
Breast cancer – Breast cancer is the most common type of cancer, accounting for 53% of all cancer cases in the United States and 54% of the deaths. While the FDA has yet to cite specific cancers caused by NDMA, breast cancer is often cited in studies.
Anyone with cancer symptoms – even if you were regularly taking Zantac in the past – should not panic. Common cancer symptoms can also be symptoms of other (non-serious) ailments. These could include, but are not limited to, the following: dramatic weight loss, changing bowel movements, blood in the urine or stool, lump(s) in the breast or testicles, discharge of the breast, loss of appetite, and persistent fever. While it’s important not to panic, it’s advisable to contact your doctor if you have any of the symptoms listed above.
It’s quite unusual to get side effects from Zantac or other antacid drugs, but some users have reported stomach and bowel complaints, such as diarrhoea, nausea, constipation and stomach aches. Other reported Zantac/ranitidine side effects include swollen/tender breasts, insomnia, and headaches. As with all ailments, you should contact your doctor if the symptoms persist. Some serious Zantac side effects have been reported such as coughing up yellow/green mucus, darkness in the urine, physical weakness, vision problems, and yellowness of the skin. You should seek medical advice immediately if you develop any of these symptoms.
Take a free evaluation to determine eligibility for taking action. You or a loved one must meet the following criteria:
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