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Court Update for Zantac: The Popular Heartburn Medication- Continued

Court Update for Zantac: The Popular Heartburn Medication- Continued

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Court Update for Zantac: The Popular Heartburn Medication- Continued

Boesen Law is committed to providing critical court updates. This week, we continue our report on Zantac, the commonly used heartburn medication, and the suit that has been filed against it. Last week, we reported about the new arguments that Judge Robin L. Rosenberg had rejected from last year. We also discussed the new rulings (and several others) that Judge Rosenberg had made on New Year’s Eve of last year. Click here to read more about last week’s reporting.


We left off last week regarding the three separate master complaints that the Plaintiffs have filed against the defendants. The complaints include a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of the third-party payers. Judge Rosenberg commended the plaintiffs for correctly arguing that some state laws take a drug’s labeling into consideration as part of a design-defect claim.


If we recall the information that was shared last week, Judge Rosenberg rejected arguments stating that the claims and allegations of Zantac being misbranded were “preempted”. Consumers and third-party payers argued that because of excessive levels of nitrosodimethylamine (NDMA), a cancerous substance, Zantac should be labeled as mislabeled. Zantac’s formulation had already been approved by the FDA. To take the drug, update the formulation, and resell the improved medication would require for companies to resubmit the new formulation to the FDA. 

 

According to Judge Rosenberg, he reported that the plaintiffs “.. are granted leave to replead design-defect claims against the defendants that are based on the labeling of ranitidine products”. This means that the plaintiffs can reargue their claims due to the fact that there are now more paths to consider like in this instance, many states require for brand-name manufacturers to strengthen warnings on drug labels without waiting for the FDA to sign off on those reports.


In a statement, the Plaintiffs’ co-lead counsel said that, “Based on today’s orders and the orders issued in late December, Plaintiffs can re-plead all claims against certain groups of Defendants and other claims against all groups of Defendants. These rulings are especially important in light of the 60,000-plus individuals diagnosed with cancer who have already submitted claims to the MDL registry, as well as approximately 1,000 cases filed to date in federal and state courts across the country.”


Along with Judge Rosenberg allowing the plaintiffs to re-plead their case in light of new evidence, he also dismissed state law claims seeking compensation for monetary losses due to buying over-the-counter versions of the Zantac medication. It was found that Congress did not intend for any state to classify a claim as a product liability claim when the Plaintiff, themselves, were not personally injured due to the medication. However, now that the Plaintiff is allowed to replead some of their claims, it is possible that the monetary loss can be brought up again. We will have to see what Judge Rosenberg’s final ruling is.


Boesen Law is covering the updates as they occur. If you have any questions in regards to this case or if you are seeking legal advice and representation, please feel free to contact us at (303) 999-9999. Boesen Law is always available.

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Zantac

Court Update for Zantac: The Popular Heartburn Medication

Court Update for Zantac: The Popular Heartburn Medication

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Court Update for Zantac: The Popular Heartburn Medication

Boesen Law has been closely monitoring the lawsuit involving the popular heartburn medication, Zantac. We monitor medication and pharmaceutical companies because we believe that we can assist people who have been affected by faulty medications and pharmaceutical companies.

We have been made aware of an update regarding the ruling in Zantac’s multidistrict litigation (MDL) involving labeling claims of carcinogens found in the medication has reduced more claims from the litigation. This means that a Florida federal judge presiding over MDL is holding the defect claims to be barred by federal law.

The judge in question is U.S. District Judge, Robin L. Rosenberg. Judge Rosenberg reported that the defect claims against Zantac manufacturers like Pfizer Inc. and Sanofi-Aventis U.S. LLC are preempted by the Federal Food Drug and Cosmetic Act because it is impossible for the companies to change the formulation in Zantac without the approval of the FDA. Judge Rosenberg has this to say,

“ As with generic drugs, a claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA approved.”

This means, not in legal jargon, that the claims being presented in court about Zantac being misbranded (though the FDA has approved the formulation) aren’t valid claims. The companies that make Zantac can’t go in and change the medication’s formulation because the FDA has approved the existing formula. If any changes are made to the current formulation, companies would have to obtain new approval by the FDA.

This new ruling comes after several rulings Judge Rosenberg made on New Year’s Eve. The ruling was that Zantac generic makers, packagers, retailers and distributors were preempted by federal law. What this means is that there were lawsuits, accusing companies such as Pfizer Inc. and Sanofi-Aventis U.S., as well as the above mentioned for false advertising and failure to warn people due to the discovery of nitrosodimethylamine (NDMA) which is a cancer-causing chemical. We have talked about this chemical before in our blog post regarding Metformin, a Diabetes medication that has been recalled due to NDMA. Here is the link if you’d like to read more: https://boesenlaw.com/2021/03/27/popular-diabetes-medication-metformin-recalled-due-carcinogenic-ingredient/

Back in September of 2019, the FDA issued a warning that there were trace amounts of NDMA in Zantac and similar generic drugs. However, in April of 2020, the FDA pulled all prescription and over-the-counter medication that featured ranitidine, the active ingredient found in heartburn medications. It turned out that the medication, when stored above room temperature, could produce an unacceptable amount of NDMA. According to the FDA, the allowable daily limit of NDMA is 96 nanograms but researchers found that in one dose of Zantac, there were more than 3 million nanograms of the carcinogen. It is important to note that NDMA is a naturally occurring chemical that can be found in things such as red meat, tobacco, and beer.

Since February of this year, plaintiffs for this suit have filed three more master complaints which are a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of the third-party payers. We will continue to monitor the lawsuits and update you with more information as soon as we receive it.

If you or someone you know has been affected by Zantac or would like more information about your rights, do not hesitate to call Boesen Law at (303) 999-9999. We are always more than happy to assist and we are always on standby for you.

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Zantac and Cancer Risk

FDA Inquiry and Request

The FDA has requested that all Zantac and other prescription-strength drugs containing ranitidine be removed from shelves as of April 2, 2020. The FDA launched an investigation into the popular heartburn relief drug in September 2019 after it found high levels of a human carcinogen known as N-Nitrosodimethylamine (NDMA). 

What is Zantac?

Zantac is the commercial name for the drug ranitidine. Ranitidine is an H2 blocker that works by decreasing the amount of acid created by the stomach. It is an over-the-counter (OTC) drug approved to prevent and relieve heartburn and a sour stomach. There is also prescription-strength Ranitidine available to treat ulcers and Zollinger-Ellison syndrome and GERD.

What is NDMA?

N-Nitrosodimethylamine or NDMA for short is a yellow oily liquid with a faint odor. It decomposes when exposed to light and gives off toxic nitrogen fumes.

It is primarily used in laboratory research to induce tumors in experimental lab animals. It was formerly used to make rocket fuel but this was stopped after high levels of the chemical were found in air, water, and soil samples near the fuel manufacturing plant. 

Cancer Risk

Zantac or the generic form of the drug ranitidine contains the chemical NDMA. NDMA can enter the body by inhalation, absorption of the skin, and ingestion. Since Zantac and another generic version of it are ingested, it can be linked to the following cancers:

  • Stomach Cancer
  • Colorectal Cancer
  • Bladder Cancer
  • Pancreatic Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Prostate Cancer
  • Leukemia
  • Non-Hodgkin’s lymphoma

Lawsuits

Boesen Law, LLC is investigating claims relating to those who have used Zantac or any other product containing ranitidine and have been diagnosed with cancer.

Please contact us at 720-266-6700 to speak with our legal team.