Patients live across the country, but the lawsuits unfolding in a Philadelphia courtroom tell the same story of being harmed by drugs used to lose weight or control diabetes.
They take drugs like Ozempic, Wegovy or Mounjaro that doctors are increasingly prescribing. Patients then began to experience problems such as vomiting, weakness, constipation and other signs of bolus obstruction.
Now, dozens of these patients are suing drug makers in federal court for failing to adequately warn of the potentially serious side effects of drugs marketed for intractable health problems, such as diabetes and obesity.
These types of medications were created to help people with diabetes control their blood sugar levels. When people take the drug, they feel less hungry and their digestion slows down, leading to weight loss.
Philadelphia is ground zero in a legal battle that could shape the future of these drugs, whose growing popularity has been heralded for the potential to transform everything from the food on grocery shelves to in the fashion clothing market. Celebrities like Oprah have shared how they’ve been using Ozempic to lose weight encouraging others to consider doing the same.
But a growing number of patients say in lawsuits that drugmakers Novo Nordisk (maker of drugs like Ozempic, Wegovy and Rybelsus) and Eli Lilly (Trulicity, Mounjaro and Zepbound) failed to adequately warn them about side effects.
In a lawsuit, a Pennsylvania woman describes how she started Wegovy to lose weight last year. After a few months, she started suffering from stomach cramps and vomiting. I could barely eat or drink. He spent four days in hospital and was diagnosed with gastroparesis, a condition in which the stomach empties too slowly.
Nothing in the ads she saw for the drugs prepared her for the potential risk, she said in the lawsuit. Attempts by The Inquirer to reach her by phone were unsuccessful.
In February, a six-judge federal court consolidated the cases in Philadelphia because the Eastern District of Pennsylvania had the most cases at the time, 13 of 55, and was close to Novo Nordisk’s headquarters in Plainsboro, NJ.
A showdown in the hall will likely be years away. Here’s what you need to know about the drugs and lawsuits that will be discussed in Philadelphia:
The legal arguments
Lawmakers in Washington, DC, are scrutinizing drug prices, but the focus in the Philadelphia courtroom will be drug safety and the companies’ advertising efforts.
The lawsuits accuse the companies of aggressive marketing campaigns that downplay the risks and of targeting women, teenagers and communities of color. They say the drug makers they created a market for their drugs by spending millions of dollars on marketing and promotion that created a media frenzy and a mega seller.
The drug companies had a reason to know about these potential injuries, they were legally required to warn about them, and in our view they failed to warn adequately, said Paul Pennock, an attorney at Morgan & Morgan who represents the people seeking the manufacturers
Novo Nordisk said its drugs, such as Ozempic and Wegovy, are safe and effective when used appropriately.
Novo Nordisk believes the allegations in these lawsuits are without merit, and we intend to vigorously defend against these claims, the company said in a statement.
Eli Lilly did not respond to a request for comment.
Powerful drugs, powerful side effects
A record number of Americans have started taking these types of prescription drugs for weight loss and diabetes in recent years. US doctors wrote more than nine million prescriptions for Ozempic and similar drugs in the last three months of 2022, an analysis by data analytics firm Trilliant Health found.
These medications belong to a class of drugs known as GLP-1 agonists. The Food and Drug Administration first approved GLP-1 agonists for type 2 diabetes in 2005. In 2014, the agency approved a GLP-1 agonist for weight loss. Newer versions of these drugs have received FDA approval since 2017 to treat diabetes (eg, Ozempic, Rybelsus, and Mounjaro) and obesity (Wegovy and Zepbound).
Doctors have also been prescribing approved diabetes drugs for weight loss, Trilliant’s analysis of insurance claims suggests, a practice known as off-label prescribing.
GLP-1 agonists alone are not a cure for diabetes or obesity, said Kunal Shah, a doctor at Rutgers Health who specializes in obesity treatment. Patients using these medications should maintain a healthy diet and exercise under a doctor’s supervision.
Common side effects include nausea, Shah said. Medicines can also rarely cause inflammation of the pancreas, a painful condition that can lead to serious complications.
These are powerful medicines, he said Shah, who is not involved in the litigation. And powerful drugs have powerful side effects.
Why Philly?
When a growing number of people began suing Novo Nordisk and Eli Lilly over their weight-loss drugs, a panel of judges decided the cases were similar enough to be consolidated before a judge.
It’s a common process for product liability litigation that has also led to a billion-dollar settlement between the NFL and retired football players who suffered brain injuries from repeated concussions, a series of cases that they were also litigated in Philadelphia.
Judge Gene EK Pratter will oversee the GLP-1 litigation. Pratter will set ground rules on issues such as evidence and privacy for all cases. And if the parties reach a global agreement to settle cases without a series of trials, Pratter will be called upon to approve or reject it.
The litigation could lead to changes to promote safety, as well as financial compensation for people, said Pennock, the attorney representing some of the people who sued.
We hope that companies will come forward and put a good, strong, clear and unambiguous warning on the labels of these drugs, he said.
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