Novo Nordisk and Eli Lilly are facing scores of personal injury claims in a multidistrict litigation in Philadelphia federal court for allegedly failing to warn patients about side effects of their blockbuster diabetes and weight loss drugs. Since the MDL was established in February, at least 1,221 complaints have been filed by people who say they endured severe side effects, such as gastroparesis, intestinal obstruction and other digestive problems, after being prescribed GLP-1 drugs to treat diabetes or aid weight loss.
Patients also accuse the companies of not warning doctors about potential problems associated with Novo Nordisk's Ozempic, Wegovy and Rybelsus as well as Eli Lilly's Trulicity and Mounjaro.
Novo Nordisk - which has its U.S. headquarters in Plainsboro - and Indianapolis-based Eli Lilly deny the allegations. In court filings, both have said gastrointestinal issues are well known side effects and printed on the product labels.
Since the legal grounds for all cases were similar, the U.S. Judicial Panel on Multidistrict Litigation agreed to plaintiff attorneys' request to consolidate the suits and send them to the U.S. District Court in the Eastern District of Pennsylvania. At the time, there were about a dozen cases pending in the Keystone State.
Existing filings and future complaints over side effects are now part of the MDL, which is being presided over by U.S. District Judge Karen Martson. Marston's rulings will apply to all cases, helping the court streamline procedures, as well as reducing the burden on plaintiffs and defendants.
In a statement Novo Nordisk said it believes the allegations in the lawsuits are without merit and will "vigorously defend" itself against the claims.
"Patient safety is a top priority at Novo Nordisk, and we stand behind the overall safety and efficacy of all of our GLP-1 RA [receptor agonists] medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional," the company said.
"The known risks and benefits of semaglutide and liraglutide medicines are described in their FDA [U.S. Food and Drug Administration]-approved product labeling. GLP-1 medicines have been used to treat type 2 diabetes for more than 19 years, and for the treatment of obesity for almost 10 years. This includes Novo Nordisk GLP-1 products such as semaglutide and liraglutide that have been on the market for more than 13 years," Novo Nordisk said.
"The safety profile of our GLP-1 RAs is well established in robust clinical development programs and large real-world evidence studies with cumulative exposure to semaglutide alone, including post-marketing use, of over 22 million patient-years," the company added.
"Lilly believes it is critical that only sound science makes its way into the courtroom.," a company spokesperson told NJBIZ. "We are pleased that the Court agreed with our request to accelerate resolution of key medical, scientific, and regulatory issues. As explained in our prior legal papers, Lilly does not believe these lawsuits have merit, and we are vigorously defending against these claims."
As GLP-1 therapies, these drugs control blood sugar levels and help people eat less, which makes them highly effective treatments for both Type 2 diabetes and obesity.
Studies have also suggested these semaglutide medications can reduce the risk of heart attack, stroke and chronic disease. Other recent research has pointed to other new and surprising potential uses for GLP-1s, such as fertility boosters and addiction treatments.
Between 2018 and 2023, prescriptions rose fortyfold due to a combination of social media and celebrity buzz over the benefits. As of May 2024, 6% of U.S. adults - an estimated 15.5 million people - report having used injectable diabetes medicine to reduce weight, according to a Gallup poll.
Last year, Eli Lilly became the world's most valuable pharmaceutical company, recording $34.124 billion in revenue - a nearly 20% increase from 2022. The growth was largely due to the success of its diabetes and weight loss drugs.
At Novo Nordisk, sales of Ozempic, Wegovy and Rybelsus have made the Danish drugmaker one of the most valuable companies by market capitalization in Europe. Of the $34 billion in revenue Novo Nordisk recorded in 2023, Ozempic and Wegovy made up over half of those sales.
NJBIZ recently spoke with legal experts about the status of the litigation, as well as possible effects in areas like public trust and the market for GLP-1 drugs.
Michael Galpern, a partner and chair of the mass tort and class action groups at Javerbaum Wurgaft Hicks Kahn Wikstrom & Sinins PC, believes this case is especially noteworthy because of "the sheer magnitude of people who've been exposed to these GLP-1 drugs."
Also, because "the fact that the GLP-1 manufacturers did include statements about the main injury, which this causes gastroparesis, which is like a slowing or paralyzing of the digestive track. And that can cause anything from stomachache to vomiting to nausea to extreme weight loss to dehydration and death and a bunch of other associated problems," Galpern said.
"Although they mention it, the allegations in this case center around that the manufacturers knew about the risk and they downplayed it," he said. "There's a big difference between mentioning a problem and warning of a problem. There's also a big difference between warning of a problem and warning of a problem correctly. Manufacturers have to accurately warn of the risks and the realistic changes of the risk, as opposed to downplaying it as a theoretical outcome."
Galpern said, "There's hundreds of thousands of incidents out there where somebody talked their family doctor into writing an Ozempic script or somebody got it through the internet. There's millions of people getting it and they're not morbidly obese or diabetic. They needed to lose 10 pounds for a wedding ... There are a million reasons as to why people want to take off weight. I get that.
"But everybody who's taking any drug, at least in theory, must do a cost benefit analysis. Do the risks outweigh the benefit or do the benefits outweigh the risk? And if you're 10 or 15 pounds overweight and you're not in any health crisis, should you be taking a drug that could literally kill you or make the remainder of your life a living hell?" he said.
The issue of "correct use versus misuse of the drug" will be a "central sub-theme" of the MDL, Galpern believes.
But everybody who's taking any drug, at least in theory, must do a cost benefit analysis. Do the risks outweigh the benefit or do the benefits outweigh the risk?
- Michael Galpern, Javerbaum Wurgaft Hicks Kahn Wikstrom & Sinins PC
That means, there needs to be a "careful evaluation" of claimants, "including a close examination of his or her entire records, medical records, hospital records, pharmacy records, credit card statements, insurance, explanation of benefits to prove what drug was taken, how often it was taken or refilled," he said.
A person's social history can also be a factor, including potential alcohol and drug use, Galpern also noted.
Adam Crews, an assistant professor at Rutgers Law School in Camden, said, "With drugs as popular as these, it's only a matter of time until someone finds something to sue about. What's interesting is that there seems to be this focus in this litigation on one very particular gastrointestinal disorder that the plaintiffs allege that they're suffering from. And what's interesting about that is in fact, Novo Nordisk and the FDA have made it quite plain that gastrointestinal adverse reactions are a risk with using this drug.
"I don't know if I've ever specifically identified the exact gastrointestinal disorder that the plaintiffs here are complaining about, but certainly it has been known for a while that adverse gastrointestinal reactions were a possibility for people taking this drug," Crews said.
"I don't want to suggest that I think that there's no merit to any of these plaintiff's claims, but I was very much surprised that the rallying point for all the plaintiffs is this focus on one particular gastric disorder when gastrointestinal adverse reactions are such a prominent part about what is known both at the FDA and information made available by the manufacturers here to be a risk that patients face," he said.
After demand for GLP-1 drugs surpassed supply, consumers turned to compounding pharmacies for off-brand versions of the popular medications. Many physicians also reportedly shifted to off-label prescriptions.
Crews said, "If you had a situation where someone was lawfully prescribed an off-label use of a drug and that off-label use was recommended to them because some adverse risk had been withheld from the public, I think they would still very much have a solid tort claim there."
He went on to say, "The problem here is ... the FDA has made very clear that gastrointestinal reactions are a possibility. And so, if you're a doctor and you're aware of that FDA guidance and aware of the gastrointestinal warnings coming from the manufacturers like Novo Nordisk, it's sort of incumbent on the doctor to do that cost benefit analysis and weigh whether or not to recommend this for off-label use given the potential for the risk.
"And that does seem to be one of the big defenses that the defendants here are leaning on this idea of what's called the learned intermediary doctrine, where what matters is how much information did the doctor who was prescribing this stuff have, because that's sort of the key when we're testing whether the warnings were sufficient," Crews said.
He added, "In general, I think the best course of action for these plaintiffs is to try and attack what information the manufacturers like Novo Nordisk have put out there. And to make their claim that the doctors they were relying on weren't equipped with enough information themselves to make informed decisions about whether to recommend off-label use."
The litigation comes as Novo Nordisk and Eli Lilly continue to battle against copycat versions of their drugs for weight loss and diabetes. Under federal law, compounding pharmacies are permitted by the FDA to prepare compounded versions of medications currently listed in short supply.
Both legitimate and illegitimate companies have tried to fill the gaps in GLP-1 availability by making copies of their active ingredients - semaglutide and tirzepatide - at a much lower price than the branded drugs.
Over the past year and a half, Novo Nordisk and Eli Lilly have sued more than three dozen medical spas, weight-loss clinics, compounding pharmacies and online sellers to stop them from selling products claiming to contain the active ingredients in their drugs.
Given the availability of compounded versions of the drugs, attorneys will need to do their due diligence in determining if potential plaintiffs were using the branded medication. "Certainly, I guess it's possible that people will sort of have fallen through the cracks ... And maybe they don't know that they were using maybe a copycat version of the drug and so conveyed the wrong information by accident to their attorney," Crews said.
"My read of the current status of this litigation is that this is not where the defendants have chosen to focus their fire just yet. It looks like they think they've got some pretty good defenses in their pocket where they will not necessarily need to get into those individualized determinations of figuring out who exactly was using their drug," Crews said. "They might be able to cut the legs out from all of this for other broader reasons."
Commenting on the venue where the MDL was assigned, Crews said, "An interesting thing about this region, of course, is there are a lot of pharmaceutical companies who are headquartered in the general area. New Jersey has a big pharmaceutical presence."
"It wouldn't surprise me if the Eastern District of Pennsylvania sees more pharmaceutical litigation than your typical federal district court just because of the concentration of pharmaceutical companies there," he said. "So, it's possible that some benefits here might be greater familiarity with pharmaceuticals, products, litigation, more ease of working with this type of science and more familiarity with the underlying tort law principles that apply here."
"And to the extent that we've managed to situate these cases in a place where we can leverage some of that experience and exposure to the pharmaceutical industry, that will, I think, benefit both parties in terms of being able to sort of streamline this case without getting bogged down in educating your judge about some of the fundamentals," he said.
After reviewing the latest updates in the case, Galpern believes "there's a significant chance of plaintiffs collecting in the future" because "this was a widespread problem."
Crews anticipates that there could be a "pretty quick resolution."
"The district court has been ruling in favor of the defendants on some important procedural steps, including focusing the early stages of discovery here on some key issues that might potentially resolve all of these cases in one swoop," he said. "As I look at how the district court is structuring this litigation, it does look to me like the judge is interested in this idea of a learned intermediary doctrine defense, this idea that what matters for the adequacy of the warning is the information that doctors had rather than the information end consumers had. And that seems to be a defense that the defendants want to push pretty hard."
Crews went on say, "It would not surprise me if the defendants were in a position very early next year to tee up an early motion for summary judgement trying to raise that defense and stamp out these types of claims altogether."
"I don't know that that will be successful, but certainly if I were the defendants, I would feel really good about how the judge has structured this case so far to try to get at key issues that might really prevent this from dragging on forever," he added.
The legal challenge is expected to have several implications, including greater attention to the side effects associated with GLP-1 medication. It could also remind individuals that no drug is free of risk and patients need to be aware of potential outcomes.
Crews said, "Because this drug is so popular and this litigation has the potential to be so high profile, we certainly do have a risk that average American consumers will be concerned about the health effects of taking this drug in ways that will change their behavior. Maybe they'll become less likely to want to pursue using something like Ozempic."
"It's not unheard of that pharmaceutical litigation can result in people becoming very wary of particular drugs. My recollection is that there was a vaccine for Lyme disease that underwent a lot of the similar type of products liability litigation and there's not really a Lyme disease vaccine on the market anymore because demand plummeted because people kind of got afraid of it. So, I do think there's an effect on consumer behavior," he said.
Because this drug is so popular and this litigation has the potential to be so high profile, we certainly do have a risk that average American consumers will be concerned about the health effects of taking this drug in ways that will change their behavior.
- Adam Crews, assistant professor, Rutgers Law School
Crews - who spent three years as appellate counsel at the Federal Communications Commission - thinks there could potentially be an effect on "perceptions of the FDA."
"A big issue in this case is going to be the extent to which the FDA was requiring adequate warnings and disclosures. And we're already at a point where I think many Americans are increasingly skeptical of institutions of expertise of medical adjacent agencies after some of the things that happened with covid," he said.