The healthcare industry has revolutionized over the past years. Research and advancements in medical technology have changed many lives of people living with medical conditions because of the introduction of new drugs and medical devices. Pharmaceutical drugs and surgical procedures have changed and saved the lives of many citizens of America. However, despite these benefits, when manufacturers of drugs take shortcuts when designing, manufacturing, and testing drugs, medicines can cause adverse effects on consumers. The heartburn and ulcer preventing medication Zantac are one of these harmful products which the FDA has recalled due to its link to cancer. If you have been injured or suffered economic losses for using Zantac, you need to be compensated for the injuries. At Consumer Alert Now, our commitment is to educate you on harmful medical products in the market. We further offer aid in taking legal action if you or a loved one has suffered injuries or died due to dangerous drugs.
About Zantac
Zantac, also known as ranitidine hydrochloride, is a popular antacid used to reduce the amount of acid produced in the stomach. The drug was released in the U.S. market in 1983. It made pharmaceutical history after becoming one of the best selling drugs three years after being introduced in the market. The reason for hitting high sales was that the manufacturer claimed the drug was safe and harmless. During this time, the drug was sold through prescriptions offered by medical experts. 1996 was the year over the counter sales of the drug began.
Over the years, other generic equivalent or versions of Zantac have increased competition reducing the sales of the drug. Companies like:
- Apotex Corp
- Mylan Labs
- West-ward Pharmaceuticals
- GlaxoSmithKline, and
- Sanis Health Inc. makes the generic versions
These companies try to copy the original brand of Zantac. The generic versions are identical but often sell at a lower price.
Manufacturing and distribution rights have also been transferred a lot with Sanofi currently holding the rights to make and sell the drug in the U.S. The medication continues to be used to treat:
- Erosive esophagitis
- Stomach damage from NSAIDs
- Peptic and stress ulcers
- Heartburn relief
- Dyspepsia
- Upper gastrointestinal bleeding
Discovery of NDMA in Zantac
Most medications on the market have many health benefits. However, some pose a danger to consumers with already some patients experiencing injuries and deaths associated with these drugs. The latest case of a dangerous drug in the market is Zantac. The Food and Drug Administration (FDA) in September 2019 found an impurity called NDMA (N-Nitrosodimethylamine) in Zantac. The contamination is very toxic and has been linked to human carcinogens that cause cancer since the 1970s. Keep in mind that NDMA is not a product used in the manufacture of Zantac. It is a byproduct that results when you ingest Zantac in the body. Due to the reaction with heat and stomach acid, the drug produces molecules of NDMA.
Many consumer products discovered to contain NDMA in the past years have been recalled voluntarily or by the U.S. FDA. Sanofi voluntarily recalled the drug after Valisure (an online pharmacy firm) reported to the FDA that the drug was dangerous because it contained high levels of NDMA in October 2019. In September 2019, FDA conducted lab tests and discovered the impurities, but they were lower compared to those reported by Valisure.
The majority of Zantac drug makers have also voluntarily recalled the drug and suspended the sale of generic equivalents. Some of these companies are Apotex, Sandoz, and GlaxoSmithKline. Patients who are using prescribed Zantac have, however, been advised against stopping Zantac’s use. Instead, they should contact their doctors for alternative medication. If you are looking for a long-term solution for acid reflux, instead of using Zantac, you can rely on Cimetidine or famotidine as an alternative, especially when buying over the counter. Remember, the FDA has not entirely ruled out Zantac because it has not yet found a conclusive result. Those purchasing over the counter are the ones who have been requested to look for alternatives.
Also, apart from relying on medication, you can avoid anything that causes acid reflux, such as:
- Alcohol
- Stress
- High-fat foods
- Unhealthy weight
- Smoking
- Tight clothing
- Chewing gum that is peppermint flavored
- Overeating
If you can keep off these things, you will avoid taking Zantac or its generic versions completely.
Least Severe Side Effects of Zantac
The known side effects of these drugs are:
- Fatigue
- Headache
- Dizziness
- Constipation
- Impotence
- Diarrhea
- Vomiting
- Nausea
- Rash
- Loss of appetite
If you are taking Zantac, the foregoing are some of the side effects that you are likely to experience.
Medical Conditions Associated with NDMA Exposure
There is fear that the people who have been using Zantac for long have been exposed to NDMA, which is associated with liver damage. The concerns are founded because the drug further causes cancer in the human digestive system. These cancers include:
- Stomach Cancer
When discovered at an early stage, stomach cancer is treatable. The leading cause of this type of cancer is acid reflux. Smoking, poor diet, and obesity are other causes of the illness. You will know you have stomach cancer if you experience the following symptoms:
- Weight loss
- Nausea and vomiting
- Feeling bloated after meals
- Persistent heartburn
- Fatigue
- Stomach pain
When the disease is diagnosed at a late stage, treatment is almost impossible. But if diagnosed early, the patient can undergo a surgical procedure to remove the stomach. Chemotherapy and radiation are other treatment options.
- Bladder Cancer
Cases of bladder cancer are rare. Of all cancer diagnoses nationwide annually, bladder cancer accounts for only 5% of these cases. Some of the precursors of cancer include family history, smoking, protracted bladder infection, and industrial chemical exposure. This type of cancer is also treatable, and if it is left untreated, cancer might spread to other body organs. The symptoms for the diseases include:
- Blood in the urine
- Difficulty urinating
- Pain during urination
- Fatigue
- Weight loss
Just like stomach cancer, bladder cancer can be treated through chemotherapy, radiation, and surgery.
- Esophageal Cancer
The esophagus is a tissue connecting the trachea and the stomach. The tissue is made of mucous membranes that break down food before it gets to the stomach. When you take Zantac or ranitidine before reaching the stomach, it reacts with the acid and heat in the esophagus during digestion resulting in the production of NDMA. Continued use of the drug exposes the throat to human carcinogens that lead to the growth of cancer in the tissues of the throat. The symptoms of this type of cancer manifest themselves at late stages, making the diseases untreatable. By the time it is discovered, it is found to have spread to other body organs.
The things that increase the risk of contracting this form of cancer are smoking, age, poor nutrition, gender, excessive alcohol consumption, environmental exposure, and dangerous drugs like Zantac.
The symptoms of the disease include:
- Weight loss
- Loss of blood through coughing
- Untreatable heartburn
- Difficulty and pain when swallowing anything
- Chest pain
Esophageal cancer requires treatment at early stages hence the need for frequent screening. When discovered in the early stages, the disease can be treated through surgery, radio, or chemotherapy, and stent.
- Pancreatic Cancer
The pancreas is a gland in the body that produces pancreatic juice, which aids in digestion and regulation of blood sugar. Continued use of Zantac causes the pancreas to produce enzymes that are highly associated with diseases, including cancer. People at a high risk of developing this disease are those with obesity, pancreatitis, diabetes, genetic predisposition, and genetic syndromes. The frequent symptoms of the disease are:
- Fatigue
- Depression
- Loss of appetite
- Weight loss
- Upper abdominal pain
- Jaundice
- Bowel obstruction
Treating pancreatic cancer is dependent on how far the disease has spread and the location of cancer. Doctors can provide treatment through surgical procedures to remove the tumor or pancreas, chemotherapy, radiation therapy, and palliative care.
Other cancers associated with NDMA include:
- Lung
- Kidney
- Liver
- Colorectal
- Nasal
- Multiple myelomas
- Leukemia
Those experiencing any of these conditions, and can link it to Zantac, should reach out to Consumer Alert Now because they qualify as plaintiffs.
Other Drugs that are Contaminated with NMDA
Apart from Zantac, there are other drugs that have been recalled for containing NMDA contamination. The contamination has been found in blood pressure drugs containing Losartan and Valsartan. The contamination is, however, due to poor manufacture by generic companies.
Zantac Cancer Lawsuits
Today, the main question about Zantac is not if it causes cancer. It is about how many cases of cancer the drug has caused. Ingesting high amounts of NDMA every day while using the medication increases the risk of contracting various types of cancer. Drugmakers of Zantac are facing lawsuits, and class action lawsuits as victims of the drug seek compensation for exposure to NDMA in the medicine. The plaintiffs argue that the drug makers have all along known the drug was risky and ought to have enlightened consumers and the community in general about NDMA impurities in the drug. By filing a personal lawsuit, you get an opportunity to recover full damages for contracting cancer. Some of the recoverable damages include:
- Pain and suffering
- Medical monitoring
- Medical treatment and expenses
- Cost of unusable drugs
- Loss of past and future earnings
- Temporary or permanent disability
- Past, current and future life enjoyment
- Punitive damages
Product Liability Law
Dangerous drugs cause thousands of injuries annually in America. Product liability laws provide victims of these drugs with the recourse they need to make those responsible for the damages financially liable. Two types of product liability apply to the case of Zantac, which include:
Design Defects
A product that differs from the manufacturer’s original design or intended result is considered defective. Zantac makers and those who designed its generic equivalents are liable for creating a defective product. If you bought Zantac and you have not been diagnosed with cancer, you can still join the lawsuit to hold Sanofi and other makers of the drug responsible for designing a defective product. Those that didn’t suffer injuries but purchased the medication can also join the lawsuit.
When proving liability in dangerous drugs where there are design flaws, you must show that there was an issue of contamination. If there was improper labeling because of a lack of information or misinformation, the manufacturer should still be held liable, notwithstanding whether they knew of the design defects or not.
Marketing Defects
When a product is not labeled correctly, or some safety warnings have been left out or withheld by the maker, then it is deemed to have marketing defects. The manufacturers of Zantac drug marketed the drug as being safe and harmless for treating acid reflux and GERD. The safety warnings were misleading, which is why you should join the lawsuit so long as you used the antacid medication.
Doctors and patients all rely on the drug warning label when purchasing the drug. This information helps them weigh the advantages and disadvantages of the drug to decide on whether to buy or not. When Zantac and generic equivalent makers left out the warning that the medicine can cause cancer, patients and doctors were left in the dark. Thus the need for these drug makers to be held liable.
Keeping this in mind will help you know the type of case you are eligible to file. In cases of injuries sustained by many plaintiffs because of a harmful drug from one manufacturer, you can opt for a multidistrict litigation or class action lawsuit.
Dangerous Drugs Mass Torts
Antacids like Zantac can be of significant benefit to users. However, in some incidences, the reaction of the drug and its side effects can be adverse and even life-threatening. A dangerous drug like Zantac can bring about substantial financial losses, loss of time for work and family, or also result in worsening of the initial medical condition.
Avoiding dangerous drugs in the market is very difficult, especially after a user or consumer sees that the FDA approves the drug. Drug manufacturers conduct clinical tests while the FDA also performs its tests before a drug is released in the market. Even after these tests and trials, specific side effects of the drug might not be noticed. These can cause severe harm to consumers who trust the dangerous drug to be safe. Dangerous drugs consumers are even in more danger because companies that manufacture these drugs like Sanofi are more profit-oriented. Much of their time and focus is on making profits and not focusing on the risks and the adverse side effects of their product. They, therefore, continue marketing and selling drugs that end up causing severe side effects to consumers.
When a drug like Zantac is used nationwide, thousands of people are affected. If you are among those people that suffer harm because of Zantac, you can recover damages for the expenses and suffering endured. To do this, drug manufacturers and in this case, Sanofi have to be held liable through a mass tort lawsuit.
Any action that causes an infringement of rights or harm, in which the party accountable is held liable, is called a tort. A mass tort, therefore, deals with offensive acts committed against many plaintiffs against the responsible party in a collective agreement. Mass torts are very helpful, especially in this case of Sanofi, which is a large company. If you decide to sue such a company alone, it will drain all your resources, and you might end up losing the case. However, in a mass tort lawsuit, victims of a dangerous drug are allowed to do the following:
- Combine their claim
- Gather similar evidence
- And pool together resources to sue one company
The defendant in mass tort lawsuits is the manufacturer of the dangerous drug. These pharmaceutical companies have some of the best attorneys in the world and have the best expert witnesses. Due to that, they will rarely admit that they are at fault and will do everything in their power to deny you a claim.
Aside from the manufacturer, the doctor who prescribed the dangerous drug can also be held responsible. This will, however, apply only if the physician prescribed the dangerous drug without adequate information about it or when they already know the dangers of the drug but failed to warn you about it.
Establishment of Mass Torts
The lawsuit is established when an attorney requests the court through a petition to centralize multiple lawsuits. The motion is granted when the judge determines that the litigation involves or has the potential to affect numerous plaintiffs, and if the injuries involved can be attributed to one dangerous drug. Once a mass tort has been filed, all the others that proceed will be embodied in the new proceeding. Note that this lawsuit is referred to as a mass tort if it is created in the state court. If it is created in a federal court, it becomes multidistrict litigation.
Zantac Multidistrict Litigation
Multidistrict litigation is a type of legal proceeding that occurs after several lawsuits have been filed in a federal court. The suit is filed by persons who have suffered some injuries or losses because of a company’s conduct. Many people have filed multiple lawsuits against Sanofi. Instead of these cases being heard separately, they care joined before one federal judge. The judge selects a Plaintiff’s Steering Committee (PSC) whose role is to pursue discovery on behalf of the plaintiffs. The reason these cases are investigated is that drugs might have different side effects on consumers hence cannot be put together in a single class.
In the case of Zantac, the role of the committee is to investigate the medication to prove or disprove that the drug is being linked to cancer. The investigation might take years, but it is far much more straightforward because witnesses gave their testimonies once instead of one at a time. To prevent the same witnesses from testifying in all cases against Zantac manufacturers, MDL can consider certain truths facts. So, if experts determine that Zantac is linked to cancer, then that becomes a fact that can be used in personal injury cases and class actions.
Multidistrict litigation is necessary in the case of Zantac because many plaintiffs are making claims against Sanofi and other makers of generic versions of Zantac. The United States Judicial Panel will meet to discuss the issue and determine if to consolidate the cases or not. If they deem it necessary to have the cases consolidated, then everyone who has suffered injuries or harm because of consumption of Zantac and has a claim will have the claim combined in one case, which is heard by a single judge.
The judge in charge of the litigation will throw out cases that don’t seem to have enough evidence. He or she might also dismiss some statements considered as facts preventing them from being used in class actions and individual lawsuits. When the MDL is concluded, cases then go back to their various jurisdictions for court hearings after the judge has grouped common issues for all court procedures.
Differences between Multidistrict Litigation and Class Actions
While in MDL, the court consolidates all the investigations, evidence gathering, and discovery, and the verdict is based on damages and the extent of injuries. In a class action, members share the same decision and settlement. Each member of an MDL is part of a large group, but they are treated individually. In a class action, members are represented by a class representative, meaning they are treated collectively. Also, class actions involve fewer participants than those in MDL.
Find a Product Liability or MDL Attorney near Me
At Consumer Alert Now, we act as watchdogs on behalf of product consumers. We understand that drug manufacturers are supposed to manufacture safe drugs and warn consumers of any risks. Since they don’t always do that, we bridge the gap by educating the public on various dangerous medications like Zantac and their side effects. We also link those who want to file lawsuits for the injuries sustained with experienced attorneys. Contact us today at 800-511-0747 for a free consultation and a review of your case.