Today’s installment of Boesen Barks! is going to be nothing short of special. We have the honor of interviewing the best boy, Demon! Here is what he had to say.
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.
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.
I am a Labrador/Weimaraner mix!
I am 2 years old! My birthday is 07/10. I would love to celebrate with some dog-friendly ice cream.
Yes. All food! Right now, I really am enjoying steak and chicken. My family spoils me!
My favorite toy is this stuffed animal that my family has to hide from me. They hide my toy because I have gotten used to ripping holes into him due to my fascination with tug of war! I also have another favorite toy, my tennis ball. I am good at getting the ball. Giving the ball back? That is another situation. I want my family to throw the ball but keep the ball in my mouth. See the issue?
Honestly? Not really. I enjoy lounging around at home but if I have to go to the park, I would rather be the only dog there. I just like my space!
Sure! But I am wondering if I could possibly get a treat for sitting this long. I like chicken jerky.
I would like to be able to speak! So I can tell my family what I want when I want. And to tell my mom I love her. She’s the best.
Goofy! Or Pluto. Both are great. I would smile soooooooo big! My family loves my smile.
Sure! But wait, you’re not a dog? All this time I thought you were! Just a funny-looking one.
I always get treats when I’m here! And lots of lovings and scratches. My family does the same at home so it feels like I am at home here too!
You are! And my mom, the rest of the family, the people in the office, the mailman, my bird sibling, the person who just walked by the house the other day….
I would describe my perfect day to start off waking up on my mom’s bed, eating a big breakfast, and snuggling all day with her. Then dinner of course and I also eat some of her dinner too. So, every day is my perfect day!
I do have a job! Professional sniffer and digger. Someone has to do it!
I dunno. All I can say is that my job as a professional digger requires me to hide many things. Socks are one of them. Socks are evil, don’t you know?
I am! I’m a good boy! Can I get a treat now?
Metformin ER (Extended Release) is a popular Diabetes medication that is currently in the process of being recalled due to higher than FDA acceptable levels of NDMA, a cancer-causing impurity.
According to the FDA website, a statement made in December 2019, by Janet Woodcock, M.D., who is the director of the FDA’s Center for Drug Evaluation and Research, was documented. In the statement, Dr. Woodcock reported “.. impurities found in (the) Diabetes drug outside of the U.S.”. In regards to Dr. Woodcock’s statement, she also reported that the FDA was investigating the “.. presence of genotoxic impurities, called nitrosamines, in some types of drugs.” In the investigation, that lasted for over a year and a half, it was found that some drugs were found to contain small amounts of those nitrosamines like N-Nitrosodimethylamine (or NDMA, the carcinogenic substance found in Metformin). In the statement, Dr. Woodcock says that the medication, Metformin, was within the acceptable amount for the United States but there would be testing done to reach a conclusion. On May 28th, 2020, the FDA had a press release, alerting patients and health care professionals about the NDMA findings in certain Metformin Extended-Release products. Fortunately, a short time later, pharmaceutical companies began to voluntarily recall their batches of Metformin ER. It is important to note that with further FDA testing, there isn’t any shown NDMA in Metformin Immediate Release (IR), which is the most commonly prescribed type of Metformin.
N-Nitrosodimethylamine, or NDMA for short, is a common and naturally occurring contaminant found in water and foods like cured or grilled meats, dairy products, and vegetables. It is also a probable human carcinogen when taken in large quantities or over a long period of time. This is not the first time medication has been recalled due to NDMA. Medications like Zantac and Losartan have been recalled as well for their quantities of NDMA present.
According to the FDA’s website, there have been a total of 16 laboratories that have voluntarily recalled the extended-release Metformin. Most recently, in January of 2021, Nostrum Laboratories recalled the medication.
If you or a loved one have been taking Metformin ER, please consult with your doctor right away to find a safer alternative. It is important to note that it can be dangerous for patients with Diabetes to suddenly stop taking Metformin without first talking to their doctor. According to the FDA, it is recommended to continue the use of Metformin until a safer choice is provided because stopping “cold turkey” can worsen actualized symptoms.
It is imperative to be knowledgeable when it comes to women’s health and, in particular, women’s reproductive health. Here at Boesen Law, a law firm of nearly 50% women, we strive to maintain knowledge in regards to women’s overall and reproductive health.
The Paragard IUD is a small T-shaped contraceptive that is implanted inside a woman’s uterus to prevent pregnancy. The device is made from flexible plastic and is wrapped in copper, the active ingredient for this specific contraceptive. According to the official website for the Paragard, (www.paragard.com), the contraceptive is “.. 100% hormone-free” and is “..over 99% effective at preventing pregnancy”. In addition, the website claims that the Paragard has a lifespan of 10 years and a patient can have the Paragard in for as little or as long as they like up to the 10-year mark.
There are several possible side effects of Paragard. Here is a list of a few:
Ectopic pregnancies are pregnancies not in the uterus. It is a medical emergency that often requires surgery. Ectopic pregnancies can cause internal bleeding, infertility, and even death.
It is possible for the IUD to be attached to the wall of the uterus. This just may make removal harder to do. Sometimes, surgery may be needed.
The Paragard can sometimes go through the wall of the uterus. If this occurs, one is not protected from pregnancy. After perforation, the Paragard may move outside the uterus and can cause scarring, infection, damage to organs, pain, or infertility. Perforation risks are increased for breastfeeding women.
There is a risk of the Paragard partially or completely falling out of the uterus. It is rare (only happening in about 2 out of 100 women). One is not protected from pregnancy if this occurs.
Menstruation may be heavier and longer with spotting in between. Please call your healthcare provider if bleeding remains heavier and longer.
There are some reports of more severe risks when using the copper-wired Paragard. Below is a list of those risks:
Within the first couple of days after the Paragard is placed, a life-threatening infection can occur. If one develops severe pain or fever shortly after the IUD is placed, please call your healthcare provider immediately. Antibiotics are usually prescribed for treatment but this infection can lead to other conditions that will be mentioned next.
This inflammatory disease starts off as an infection. It usually occurs within the first 20 days of the Paragard being placed. It is an infection that occurs in the uterus. Please be aware that PID and Endometritis are usually sexually transmitted meaning one and their partner are at a higher risk during intercourse. Fortunately, this can be treated with antibiotics as well; however, the diseases can cause problems such as infertility, ectopic pregnancy, and chronic pelvic pain. Some cases might require surgery and in rare occasions, PID can cause death.
There are more risks to keep in mind if you are considering using the Paragard. If you or someone you know has had the Paragard placed, had to have it removed, and had the contraceptive break apart upon said removal, call us here at Boesen Law (303) 999-9999. We are more than happy to provide you with a free consultation in regards to the Paragard.
I have been with Boesen Law since August 3, 2020.
My favorite memory with Boesen Law so far is a white elephant exchange just before the holidays. It was a gag gift with a picture of Mr. Boesen’s face instead of a flag on the top of a wooden dowel.
I was drawn to the legal field because of my own attorney. My attorney was helping me with custody of my daughters and was always there with an objective opinion while still being kind. He was brilliant and honest. I knew from then 2002, that I wanted to help people with the same type of objectivity and kindness.
My favorite part of the job is walking with people through some of the hardest times in their lives and seeing them make it out the other side a stronger and more determined person.
This is a tough question, I’m not sure. I would hope they would say I am fiercely loyal and accepting of people for who they are.
I love to read, mostly biographies. Learning about different types of people and their struggles along with how they grew from those struggles is fascinating to me.
My favorite food is Nachos.
My favorite movie is the Expendables.
My favorite quote is from Gandhi “Live as if you will die tomorrow, learn as if you will live forever.”
I don’t necessarily have a hero, but I do admire in one way or another every individual I have ever met or talked to. Everyone is so different and has such different stories, I believe they should all be admired for who they are or who they are trying to become.
Over the next five years, I intend to finish the Ph.D. I am working on and attend and complete law school. I’m not sure if I want to become an attorney after I’m done, but who knows.
I enjoy shopping with my kiddos (not sure if retail therapy is a hobby)
I’m not sure, I’ve experienced so many wonderful things during my career it’s hard to pick one. I would have to say one of my prouder moments throughout my career is hearing my team tell me they trust me.
One piece of advice I would tell my younger self would be to be an active listener.
I would like to extend my vocabulary, understanding, and diction.
Today’s installment of Boesen Barks! is going to be nothing short of special. We have the honor of interviewing the best boy, Demon! Here is what he had to say. 1. What kind of dog are you? I am a Peekapoo 2. Where does your name come from? My name, Demon, comes from the…Read More
This week, we have the pleasure of interviewing Arti, our residential bad (but good) boy! Here is what he had to say. 1. What kind of dog are you? I am Arti. I thinks I am a mix of Chow for sure, pure awesomeness, and a bit of a bonehead. 2. How old are…Read More
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…Read More
I never thought I would need an attorney but after a work related injury I found myself struggling to make sense of the paperwork. To protect myself and my career I had to find help. Jon offered an expert opinion, made sense of the paperwork, protected my livelihood and pension and gave me peace of…
I would recommend Boesen Law to anyone that needs a serious solution to an overwhelming situation. I had just walked out of a head on car collision with extensive injuries, and Steve took over the stress of getting my bills paid. The other motorist was under insured and I had challenges all along the way,…
When I received the call that my 17 year old daughter had been in a terrible automobile accident and was going into emergency surgery for severe brain trauma, I went into survival mode, not knowing what the outcome would be. I frantically made phone calls as I rushed to the hospital. Mr. Jon Boesen was…
Boesen Law is exemplary in providing sound and reliable legal advice, excellent customer service, and respect for the clients they serve. I am confident that my legal matter will be resolved in my favor due to the legal expertise demonstrated by Jon Boesen.