Ozempic (semaglutide) is approved by the U.S. Food and Drug Administration for Type 2 diabetes. Some studies and patient reports have linked the drug to gastroparesis, also known as stomach paralysis. This can cause digestive tract blockages and severe vomiting. It may lead to hospitalization or, in some cases, death.
In September 2023, the FDA added a warning for intestinal blockages, or ileus, to Ozempic’s label.
People who suffered from severe vomiting, gastroparesis or intestinal blockages have been filing Ozempic, Wegovy and Mounjaro lawsuits against manufacturers Novo Nordisk and Eli Lilly. Law firms are also investigating Trulicity, Saxenda and Rybelsus for similar claims.
Trial attorney and pharmaceutical litigation expert Jonathan Sedgh is one of the award-winning attorneys at the national law firm Morgan & Morgan, which filed the first Ozempic lawsuit. In this Q&A, Sedgh explains why people are filing Ozempic lawsuits, the status of Ozempic litigation and who qualifies to file a claim.
Q: What is Ozempic?
Ozempic is a medication that was approved by the FDA in 2017 to treat Type 2 diabetes. It’s a prefilled pen administered by patients at home by doing an injection under the skin, typically in their stomach, thigh or upper arm.
Q: Why are people filing lawsuits against Novo Nordisk and Eli Lilly?
People are alleging that Novo Nordisk and Eli Lilly failed to properly warn patients and their doctors about certain Ozempic side effects and risks of the drugs. We’re alleging that the Defendants knew or should have known that these drugs could cause what’s called gastroparesis, ileus and intestinal blockages, and they failed to properly warn the American population about it.
Q: In addition to Ozempic, are there other similar drugs you are pursuing lawsuits for?
We’re pursuing cases related to Ozempic, Mounjaro, Wegovy, Rybelsus and Saxenda. These are drugs that have semaglutide, tirzepatide and liraglutide as active ingredients. Out of all these drugs, Wegovy is the only medication that is approved for weight loss. All the other medications are only approved for type 2 diabetes.
But there are doctors who prescribe these drugs for weight loss off-label. They are allowed to do this to treat patients with type 2 diabetes and some patients who need to lose weight who don’t have diabetes if they believe that the drugs can help them.
We’re filing lawsuits against these drugmakers for failing to properly warn people of the risk of gastroparesis, ileus and intestinal blockages.
Q: How many people do you estimate are being affected by gastrointestinal side effects of these drugs?
It might be too early to tell since we’ve just started pursuing these cases over the last few months. But I wouldn’t be surprised if this ended up being a litigation where there were tens of thousands of people who are going to pursue lawsuits against Novo Nordisk and Eli Lilly.
Q: What are the injuries claimed in Ozempic and Mounjaro lawsuits?
Gastroparesis is the main injury, but we are also investigating cases from people who suffered an ileus or intestinal blockage. Some individuals may not have a formal diagnosis of gastroparesis because you must do some diagnostic testing with a GI doctor. But some people also refer to gastroparesis as stomach paralysis or a frozen stomach.
In essence, it’s whenever your stomach stops working. And one of the symptoms of this is persistent vomiting. So, we’re looking for individuals who have been vomiting for at least a month or longer. You don’t necessarily have to have a formal diagnosis of gastroparesis, but we’re willing to investigate the cases where people have been vomiting for more than four weeks and have been hospitalized due to this.
Sometimes you need to get an IV because you’re dehydrated because of all the vomiting. But it’s ironic because the way these drugs work is by slowing down the digestive tract so people feel full longer. And that’s what gastroparesis is on “steroids.” It seems like the drug is causing some sort of permanency in the process of slowing down the digestive tract.
We definitely have a broad spectrum of clients at this point. We have individuals who were taking the drug for a few months, and after they stopped taking the drug, they stopped vomiting. We have people who stopped taking the drug and continued to vomit for a few months after they stopped taking the drug. And we do have people who stopped taking the drug and a year later are still vomiting.
Q: What kind of warnings are currently on these drug labels?
At the time we first started pursuing this litigation, Mounjaro was probably the only label that listed something related to gastroparesis, but it is in no way adequate. The rest of the medications do not mention anything in the Warning section about vomiting, gastroparesis, stomach being frozen or stomach paralysis. We believe that they should have at least told the FDA or suggested to the FDA that there should be some sort of warning there. It wasn’t until September 2023 that the FDA required a warning for ileus and intestinal blockage for these drugs.
Q: What type of science is there that links these drugs to these side effects?
There are some publicly available clinical trials, observational studies and case reports showing an association between gastroparesis or persistent vomiting and Ozempic and these types of drugs.
Ultimately, through litigation, we’re going to be able to get any evidence the drug companies may have had, such as pharmacovigilance or clinical trial studies. The goal is to be able to investigate further and determine what the company knew or should have known when they were applying for approval from the FDA.
For example, I’ve seen some reports that showed on average 50% of individuals who had GI issues or were complaining about GI issues were removed from some studies. We want to question the reliability or quality of these studies and what these companies said to the FDA. Again, these are all allegations and they have yet to be proven, but that is what we are seeing.
Q: Where are these cases in the litigation process?
The first case filed in the country back in August was on behalf of Ms. Bjorklund, filed in the Western District of Louisiana. We have had a conference with the Judge and are moving forward with discovery. We have since filed about another dozen cases in many jurisdictions.
Ultimately, I would envision these cases going through the multidistrict litigation route, where there will be a petition probably by the end of the year to consolidate these cases in front of one federal judge.
There are probably a dozen firms right now that we’re coordinating with or have been asking how they can help. So, I think we’re going to see an uptick in case filings across the country, which will ultimately lead to the MDL.
Q: If people believe they were injured by Ozempic or another one of these drugs, how do they know if they qualify for a lawsuit?
If you’ve been vomiting for more than a few weeks, it’s worth giving us a call. We could hear your story just to see what the facts are in your case. Sometimes there are nuances, so if somebody has a few ER visits but was only vomiting for two or three weeks, that’s something we would look at.
So, the best thing to do is pick up the phone and give us a call or sign up online for a free consultation. You don’t need to commit to anything. Just tell us your story, and we’ll ask you a few basic questions. We may ultimately decide to pursue your case for further investigation. We’ll get a copy of your medical records and see if the facts line up with the science that we’re pursuing.
You should call sooner rather than later because there is a time limit to file your case, and it varies by state. There are also some states where the statute of limitations starts ticking when you were injured or your symptoms started and not when you discovered your injury was associated with these medications.
Q: How many cases are you investigating currently, and what kind of experience does the firm have with this type of litigation?
We’ve received over 40,000 inquiries from individuals to date. These are people who are calling in, asking us questions and telling us their stories. But ultimately, we’ve retained over 14,000 clients out of that 40,000. So, they’re the ones that fit our criteria. We’re pursuing and investigating on behalf of those 14,000 but the number is growing every single day.
When it comes to our experience at Morgan & Morgan, we have a mass tort department that encompasses about 300 people, including lawyers and paralegals. And we’ve been in leadership committees across the entire spectrum of multidistrict litigation. We currently have about 12 lawyers who have different leadership positions. I don’t think there’s another firm in the country that could say they have 12 different people in leadership positions.
We have the resources and are America’s largest personal injury law firm. We’ve handled diabetes cases. We’ve handled GI cases. We’ve handled cancer cases. So, we’re in the best position to pursue these types of cases.
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