How to Ensure That You Receive FULL and JUST Compensation For Cancer Caused by Zantac (Ranitidine) N-nitrosodimethylamine, or NDMA Exposure
The multi-national pharmaceutical company Sanofi-Aventis faces numerous lawsuits claiming the company never warned consumers about the possibility of developing cancer from taking Zantac. The generic name for Zantac is ranitidine. Scientific analysis of Zantac and other ranitidine-based drugs detected extremely high levels of N-nitrosodimethylamine (NDMA), a chemical compound considered a probable human carcinogen.
Our cancer lawsuit attorneys opened an investigation to determine whether any person who took Zantac and now is suffering from particular types of cancer has a legal right to file a claim for compensation. Filing a lawsuit against the companies who produced Zantac and other ranitidine medication manufacturers could help pay for medical expenses associated with cancer treatment, lost wages, and physical pain, along with psychological and emotional suffering.
NDMA has been linked to liver cancer, stomach cancer, kidney cancer, and bladder cancer. NDMA is included in the nitrosamine family of chemical compounds. Other nitrosamines are specific to smoking tobacco products and have been linked to lung cancer, tongue cancer, esophageal cancer, pancreatic cancer, and colon cancer.
Sanofi-Aventis Recalled Zantac
The U.S. Food and Drug Administration (FDA) opened an investigation into the potential damages NDMA could cause to the cells of a human being. Even though the possible effects are under investigation, Sanofi-Aventis voluntarily recalled its over-the-counter Zantac tablets after independent testing detected substantial amounts of NDMA. The FDA conducted its own testing and also concluded the levels of NDMA in Zantac were high. The FDA did not immediately declare the levels of NDMA it found to be extremely dangerous. Additionally, the FDA did not caution people who use Zantac to stop taking their medication, despite their findings.
National drugstore chains CVS and Walgreens pulled Zantac and all other ranitidine medications off their shelves after learning about the test results. CVS and Walgreens will continue to sell other over-the-counter heartburn medications that are ranitidine-free, such as Pepcid and Tagamet.
Sanofi-Aventis is not the only maker of ranitidine drugs to announce a recall. Apotex Corp. and Novartis’ Sandoz subsidiary have recalled their ranitidine-based heartburn medications as well. Apotex Corp. and Sandoz recalled their ranitidine heartburn medicines approximately one month before Sanofi-Aventis announced its recall campaign.
FDA Calls for All Ranitidine Products (Zantac) Removed From the Market
FDA Advises Consumers, Patients and Health Care Professionals After New FDA Studies Show Risk to Public Health
April 01, 2020 (FDA News Release) – Today, the United States Food and Drug Administration (FDA) announced that it is requesting that manufacturers of all over-the-counter (OTC) and prescription Ranitidine (commonly sold under the brand name Zantac) drugs withdraw these medications from the market immediately. This is the latest action taken by the FDA to protect consumers from medicines that contain the contaminant N-Nitrosodimethylamine (NDMA), a known carcinogen.
Have you been prescribed Zantac or taken over-the-counter Zantac (Ranitidine)?
Parker Waichman LLP is offering a free consultation to patients and the family of loved ones who were injured or developed cancer as a result of consuming contaminated Zantac (Ranitidine). Our law firm is available to speak with you or your loved one 24/7. Contact Parker Waichman LLP today by calling 1-800-YOURLAWYER (1-800-968-7529), or by visiting our website to start a live chat, or fill out our Contact Form.
What is Zantac designed to do
Zantac is a histamine-2 blocker. Zantac prevents the accumulation of stomach acid by blocking the histamine-2 molecules released during digestion. Zantac provides relief from stomach ailments related to excess accumulation of stomach acids such as gastroesophageal reflux disease, hrtburn, and stomach ulcers.
Millions of people suffer from chronic stomach ailments, which they treat by using ranitidine-based medications. People who used Zantac and other ranitidine-containing medicines to treat chronic digestive difficulties are at the greatest risk of developing cancer from the NDMA found in these medications.
The FDA does not want people to panic. The agency continues to explore how dangerous taking ranitidine drugs daily would be for patients in the long term. However, the initial results from tests conducted by the FDA on ranitidine medications revealed unacceptable levels of NDMA. The FDA did not disclose what those “unacceptable” levels were. Of note, NDMA may be consumed when eating certain meals, especially meat, and could also be in drinking water as well.
The FDA instructed consumers to change their medication if they were concerned about NDMA consumption. Tagamet, also known by its generic name Cimetidine, and Pepcid, known by its generic name famotidine, are popular choices for people who have stomach problems but want to avoid consuming NDMA. Pepcid and Tagamet may be purchased as over-the-counter medications. The FDA did not mandate a switch from ranitidine to another medication.
A physician is the best source to consult if you have questions or concerns about which stomach aid you should take. A physician can assess your needs and recommend which over-the-counter or prescription medication you should take. Additionally, a frank conversation with your doctor about whether you should use an antacid in the first place is appropriate. Also, you might need help from a pharmacist or health care clinician to convert your current dose of ranitidine to the appropriate dose of Pepcid or Tagamet.
What is NDMA?
NDMA is a contaminant. As a chemical compound, it is found in water, meat, dairy, and even vegetables. The World Health Organization defines NDMA as a B2 carcinogen. A B2 carcinogen probably causes cancer in humans. Ingestion or exposure to substantial amounts of NDMA could cause stomach or colon cancer. Furthermore, NDMA is highly toxic and had deleterious effects on the human liver. Only a small amount of NDMA exposure may cause liver damage.
NDMA no longer has a useful purpose in the U.S. NDMA was once used as rocket fuel. Now, the Environment Protection Agency uses it for research purposes only.
NDMA is the by-product of many manufacturing processes and, as a result, is highly prevalent in our environment. NDMA could be located near pesticide manufacturing plants, rubber and tire production plants, and tanneries.
Even the process we use to purify drinking water could create NDMA as a by-product. The chlorination of both drinking water and wastewater at treatment plants creates NDMA in the water. Thus, we consume NDMA in the water we drink, the vegetables we eat, and the animals we consume.
The concern for the FDA is how muchNDMA is too much. Although the FDA established a maximum level of NDMA that people living in the U.S. can consume daily, the effect of adding NDMA from another source is unknown. The FDA is trying to determine the effects.
Experts know enough about NDMA to understand that people should not be consuming it in their medications. In 2018, the FDA learned that NDMA could be found in certain blood pressure medications. The FDA worked with the pharmaceutical companies who produced those medications to recall them. The recalled blood pressure medications were identified as losartan, valsartan, and irbesartan.
The FDA calculated the odds of one person developing cancer from taking high blood pressure medication contaminated by NDMA. The FDA figured that 8,000 people would need to take valsartan contaminated by NDMA for four years to produce one additional cancer patient. Consequently, the FDA advised people who used losartan, valsartan, and irbesartan to treat high blood pressure to continue to take prescribed medication unless and until their doctor ordered a change of prescriptions.
The FDA’s opinion on the matter is inherently inconsistent. On the one hand, the FDA announced a recall so that people taking high blood pressure pills do not have an increased risk of developing cancer. On the other hand, the FDA has not advised people to switch medications because of the risk and went out of its way to conjure statistical models that downplay the risk of cancer from NDMA consumption.
Ranitidine Production Halted by Company Because of Potential Carcinogen Contamination
Novartis stated that the company’s Sandoz unit has halted the distribution of generic Zantac because of concerns the product might be contaminated with a probable human carcinogen. According to an article appearing in the Pharmacy Times, the FDA has not announced a formal recall of all ranitidine products. Notwithstanding, Novartis decided to withdraw its ranitidine products from circulation.
The company initiated an internal review to determine how their ranitidine became contaminated with NDMA. Novartis said that it would not resume production of ranitidine until the company answers that question and installs safeguards to prevent NDMA contamination in the future.
Birth Defects Linked With Zantac Contaminated With N-Nitrosodimethylamine (NDMA)
A Scientific Study Shows a Potential Link Between NDMA and Birth Defects
N-Nitrosodimethylamine (NDMA) is found in many over-the-counter and prescription medications. NMDA has recently been detected in antacid medications like Zantac (ranitidine), high-blood pressure medications like Diovan (valsartan), Cozaar (losartan), and acid blockers like Axid (nizatidine). NMDA is widely understood to be a human carcinogen. However, we encounter NDMA in many of the foods we eat and even the water we drink.
Although the U.S. Food and Drug Administration (FDA) allows the consumption of NDMA to a specified level in some substances, the agency has routinely said that excessive consumption of products containing NDMA is hazardous to human health. Recalls for medication like Zantac were necessary to prevent people from consuming unhealthy quantities of NDMA.
A study from 1995 illustrates the importance of limiting NDMA consumption. The study examined the effect alcohol would have on the fetus after the child’s mother was exposed to NDMA. The study found that there is a greater chance of a woman to pass NDMA and its cancer-causing properties to her fetus after taking alcohol. The scientists concluded that children could develop childhood cancer after the child’s mother consumes anything containing NDMA. Indeed, the researchers believe that alcohol consumption or cigarette smoking, coupled with the transmission of NDMA to the child, could exacerbate the chance that the child could have cancer.
The results of the study should be of grave concern to women who are or might become pregnant. Unwitting consumption of NDMA might cause alleged birth defects, congenital disabilities, cancer, deaths and fetal injury in mothers who took medications, over the counter meds, and generic meds now recalled due to large quantities of NDMA.
The researchers who conducted the NDMA and fetal injury study hypothesized that mothers could expose their unborn children to many harmful chemicals in utero, or in the womb. The scientist humanely used pregnant Patas monkeys as subjects for their experiment. The researchers gave their pregnant subjects a dose of ethyl alcohol and then NDMA 45 minutes later, or not at all depending on which subjects were in the control group. The scientists measured the levels of alcohol and NDMA in both the mother and fetus. The results provide keen insight into the transmission of harmful chemicals from mother to unborn child.
Blood samples were drawn from the fetus and mother, as well as samples of fluid from the placenta, informed the researchers’ analysis. The scientists saw that the level of NDMA in the mother’s liver was lower in the mother than the fetus. The significance of those findings relates to the growth or formation of DNA adducts.
DNA adducts are identified as part of a gene that connects to a harmful substance that could develop into a cancer cell. The researchers expected to find and did find an increase in DNA adducts, or potential cancer-causing bodies, form after they administered the NDMA to their subjects. The studies indicate that the DNA adducts were higher in some fetal structures than their mothers, especially in the placenta and liver of the fetus. The researchers concluded, based on that information, that the mothers did not metabolize NDMA and simply passed the carcinogen onto their child, as evidenced by the increase of DNA adducts in the fetus.
Notwithstanding the above, the study has its limitations. The scientists could use only eight subjects for the test, which was the most humane procedure. The small number of subjects calls into question the significance of the researchers’ findings. However, scientists believe that their study confirms the findings reached by other scientists studying a similar process in other animals. Most importantly, the conclusions drawn from the study prove a solid connection between the food or medication a mother eats that contains NDMA, and that it will be passed on to the unborn child who will cause DNA adducts to form. The formation of DNA adducts could cause the child to develop cancer.
Lawsuits Filed Against Makers of Zantac Because of Potential Carcinogen Contamination
A Quick Look at the Issue
Anyone who used Zantac and has received a diagnosis of cancer in the bladder, colon, rectum, esophagus, throat, nose, kidney, liver, lung, pancreas, prostate, or stomach may have a legal cause of action for damages. Sanofi-Aventis manufacturers Zantac. Plaintiffs who recently filed lawsuits claim that Defendants knew about the potential problems with ranitidine creating NDMA and failed to inform consumers of the associated risks.
What is the Issue With Zantac and Ranitidine?
The FDA has been engaged in an ongoing investigation regarding the N-Nitrosodimethylamine (NDMA) in Zantac and Ranitidine medications as it is a substance that could cause cancer. The FDA states that the N-Nitrosodimethylamine (NDMA) impurity, in certain ranitidine medications, can increase if the medicines are stored in warmer than room temperatures and when stored over some time. The increased level of N-Nitrosodimethylamine (NDMA) can reach levels that are unacceptable levels for this type of impurity. The FDA also stated that no existing or new prescriptions for Zantac or over-the-counter Ranitidine will be made available to consumers in the United States.
N-Nitrosodimethylamine (NDMA) has been identified as a probable carcinogen, according to the FDA. IN 2019, the FDA was informed that an independent drug-testing laboratory discovered traces of NDMA in Ranitidine. Low levels of N-Nitrosodimethylamine (NDMA) are commonly consumed in the diet as the chemical is found in water and some foods. In low concentrations, N-Nitrosodimethylamine (NDMA) is considered to be benign. However, higher levels of exposure could raise the risk of developing cancer in people. The FDA administered its own laboratory testing and also found small traces of N-Nitrosodimethylamine (NDMA) in Ranitid.
The FDA is also warning users who are taking over-the-counter Ranitidine to cease taking any pills or liquid they currently possess, dispose of the medications properly, and not purchase more. The FDA instructed individuals who want to continue treating their medical condition to consider taking other approved over-the-counter products. Patients using prescription Ranitidine should discuss treatment alternatives with their health care professional.
Why did Plaintiffs File Lawsuits Against the Makers of Zantac?
The lawsuits filed by the plaintiffs against Sanofi-Aventis claim that the company knew that consumers who ingested Zantac might develop cancer and did not alert the consuming public. Valisure, an online pharmacy that conducted tests of multiple ranitidine products, including Zantac, told the FDA they found excessive levels of NDMA in all lots tested.
Valisure explained that ranitidine is not a stable compound. The medication’s component parts react together to form NDMA as a by-product. The analysis detected NDMA in excess of 3 million Nanograms per tablet in ranitidine products. The FDA’s daily limit on NDMA consumption is approximately 31,000 times smaller than the discovered amounts.
As noted above, the FDA analyzed ranitidine medications after receiving Valisure’s conclusions and found unacceptable levels of NDMA in samples of ranitidine.
The scientific findings of Valisure and the FDA allow plaintiffs to proceed with lawsuits. Lawsuits allege that Sanofi-Aventis know or should have known that Zantac would yield dangerously high levels of NDMA in a person’s body. The lawsuits further allege that Sanofi-Aventis failed to disclose potential dangers to consumers.
Lawsuits Claim Contaminated Zantac and Ranitidine Caused Their Cancer
People who have taken Zantac or over-the-counter Ranitidine may have a legal cause of action for damages if they have been diagnosis with:
- Liver Cancer
- Lung Cancer
- Cancer to the fetus/baby while in utero at the time Zantac was taken.
- Liver Disease
- Bladder Cancer
- Colon Cancer
- Rectum Cancer
- Esophagus Cancer
- Throat Cancer
- Nose Cancer
- Kidney Cancer
- Pancreas Cancer
- Prostate Cancer
- Stomach Cancer
In complaints filed by plaintiffs, several of the lawsuits allege the makers of Zantac and Ranitidine (Defendants) were aware of the likely problems with Ranitidine forming NDMA and neglected to notify consumers of the associated dangers.
Parker Waichman LLP is currently offering a free consultation to review your case and explain your legal rights. To receive your free consultation, call us 24/7 at 1-800-YOULAWYER (1800-968-7529). You may also start a live chat, or fill out our Contact Form to schedule your free consultation.
What Can I Get If I File a Lawsuit?
A successful litigant could be awarded monetary compensation for damages caused by Zantac consumption. People battling cancers caused by Zantac and NDMA face exorbitant medical expenses and may miss work for an extended length of time. The physical pain a cancer patient must endure is debilitating. Additionally, the mental anguish cancer patients face is exhausting. Cancer patients are in a literal fight for their lives. The day-to-day fight to live exhausts the patient as well as his or her family.
Therefore, a company found liable for manufacturing a defective product, like Zantac, that might cause cancer, could be legally responsible for all medical bills associated with the treatment and care of the patient, repayment of lost wages, compensation for future medical care, and compensation for physical pain and mental anguish.
The company might also be liable to the estate of a cancer patient who suffered a wrongful death.
How Much Does an Attorney Cost to Handle My Zantac Cancer Case?
A case against any company that manufacturers ranitidine will be handled on a contingency fee basis. In other words, your Zantac cancer lawyer has the incentive to win your case, or else your lawyer does not receive any compensation.
What Rights to I have in my Zantac Cancer Lawsuit?
Contact Parker Waichman LLP today to find out more about your rights to compensation for cancers caused by prolonged use of Zantac, including bladder, colorectal, esophageal, throat, nose, kidney, liver, lung, pancreas, prostate, or stomach cancer.
What Damages Could I Receive in a Zantac Cancer Case?
In litigating product liability cases related to Zantac, our attorneys are seeking the highest amount of compensation on behalf of our clients. Though jury awards and settlements can never be guaranteed, our firm aggressively pursues monetary justice for our clients.
Typically, in a product liability case, our attorneys will seek the following forms of damages (monetary compensation) on behalf of our clients:
- Medical costs associated for the treatment of their cancer;
- The costs associated with the medications purchased to date along with those costs necessary in the future;
- Lost earnings/wages;
- Earnings that are expected to be lost in the future;
- Damages for pain and suffering; and
- Damages for emotional and mental distress.
Parker Waichman LLP knows that a cancer diagnosis is devastating news for both victims and their families. Our product liability lawyers want to help ease the stress that has been wrongfully placed on you and your loved ones. Contact us to discuss your claim with a qualified lawyer. We serve clients nationwide and are available to discuss your case day or night.
Are Other Related Medications Affected?
As of April 1, 2020, the FDA has tested, but has not detected any traces of N-Nitrosodimethylamine (NDMA), in cimetidine (Tagamet), famotidine (Pepcid), lansoprazole (Prevacid), esomeprazole (Nexium), or omeprazole (Prilosec).
Due to the COVID-19 pandemic, the U.S. FDA is recommending that consumers and patients dispose of their medicines and not to return the store where the medication was purchased for a refund. The FDA urges health care medical professionals and patients to communicate adverse reactions or quality problems to the agency’s MedWatch Adverse Event Reporting program by completing a report online at www.fda.gov/medwatch/report.htm, or by downloading and completing the form and submitting the form by fax at 1-800-FDA-0178.
Why Choose Parker Waichman LLP for My Zantac Cancer Case?
Parker Waichman LLP has the experience and resources necessary to tackle complex litigation. Through dedicated advocacy, our firm has secured over $2 billion in monetary compensation on behalf of injury victims and their families. While providing outstanding results to our clients, our law firm has also earned notable honors from our peers, receiving the following recognitions (among others):
- Ranking of “5 Dragons” from peer review by Lawdragon
- 8/10 Rating from AVVO
- Listing in the Peer-Reviewed “Best Lawyers” Publication
- “Preeminent Lawyers” AV Peer Review Rating
We invite you to review our firm’s results and receive your free case consultation with one of our attorneys. We urge you to act quickly to begin protecting your legal rights.
Statutes of Limitations to Recover Compensation Are in Place – Do Not Delay!
Statutes of limitation apply to every case in the country, including those related to Zantac. Statutes of limitation set a deadline by which your case must be filed in court. Your Zantac cancer case’s statute of limitations is determined by several factors, including the state where you were diagnosed, the state you live in, the extent and nature of your injuries, and the date on which you were diagnosed.
Contact Parker Waichman LLP Today to Schedule a FREE Case Consultation
Parker Waichman LLP offers completely free case consultations and we are available 24 hours a day to assist you. If you or a loved one was diagnosed with cancer caused by Zantac, contact Parker Waichman LLP today by calling 1-800-YOURLAWYER (1-800-968-7529), or by visiting our website to start a live chat, or fill out our Contact Form.
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