Why a legal fight against the manufacturers of Ozempic, Mounjaro, and other diabetes and weight-loss drugs will take place in a Philly courtroom

The patients live all over the country, but the lawsuits that play out in a Philadelphia courtroom tell the same story of being harmed by drugs used to lose weight or manage diabetes.

They took medications such as Ozempic, Wegovy, or Mounjaro that doctors are increasingly prescribing. Then the patients began experiencing problems such as vomiting, weakness, constipation, and other signs of bowel obstruction.

Now, dozens of these patients are suing the drug manufacturers in federal courts for not adequately warning of the potentially serious side effects from 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 medication, they feel less hungry, and their digestion slows down, which results in weight loss.

Philadelphia is ground zero in a legal fight that could shape the future of such drugs, whose growing popularity has been heralded for the potential to transform everything from the food stocked on grocery shelves to the market for fashion apparel. Celebrities such as Oprah Winfrey have shared how they’ve been using such medications to lose weight, and are encouraging others to consider doing the same.

But a growing number of patients say in lawsuits that drugmakers Novo Nordisk (manufacturer of drugs including Ozempic, Wegovy, and Rybelsus) and Eli Lilly (Trulicity and Mounjaro) did not warn them adequately about side effects.

In one lawsuit, a Pennsylvania woman describes how she started Wegovy for weight loss last year. Within months, she began suffering from stomach cramps and vomiting. She could barely eat or drink. She spent four days in a hospital, and was diagnosed with gastroparesis, a condition in which the stomach empties too slowly.

Nothing in the ads that she saw for the medications prepared her for the possible risk, she said in the lawsuit. Attempts by The Inquirer to reach her by phone were unsuccessful.

In February, a six-judge federal panel consolidated the cases in Philadelphia because the Eastern District of Pennsylvania had the most cases at the time, 13 out of 55, and was close to the headquarters of Novo Nordisk in Plainsboro, N.J.

A courtroom showdown likely remains years away. Here is what you need to know about the medications, and the lawsuits that will be argued in Philadelphia:

Lawmakers in Washington, D.C., are scrutinizing the prices of the medications, but the focus in the Philadelphia courtroom will be the safety of the medications and the companies’ advertising efforts.

The lawsuits accuse the companies of aggressive marketing campaigns that minimize the risks, and of targeting women, teens, and communities of color. They say drugmakers created a market for their medications by spending millions of dollars on “marketing and promotion” that created a “media frenzy and mega seller.”

“The drug companies had a reason to know about these potential injuries, were legally bound to warn of them, and in our opinion did not adequately warn,” said Paul Pennock, an attorney with Morgan & Morgan who represents people suing the manufacturers.

Novo Nordisk said its medications, such as Ozempic and Wegovy, are safe and effective when used appropriately.

“Novo Nordisk believes that 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 similarly rejected the claims, saying it clearly warns of digestive side effects.

“These risks were communicated to and widely known by health-care providers,” the company said in a statement.

A record number of Americans have begun taking this type of prescription medication for weight loss and diabetes in recent years. U.S. doctors wrote more than nine million prescriptions for Ozempic and similar medications in the last three months of 2022, an analysis from data-analytic company 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. The newest versions of these medications have received FDA approval since 2017 to treat diabetes (for example, Ozempic, Rybelsus, and Mounjaro) and obesity (Wegovy and Zepbound).

Physicians have also been prescribing the medications approved for diabetes for weight loss, the Trilliant analysis of insurance claims suggests, a practice known as “off-label” prescribing.

GLP-1 agonists alone are not a remedy for diabetes or obesity, said Kunal Shah, a Rutgers Health physician who specializes in the treatment of obesity. Patients using these medications need to maintain a healthy diet and exercise under a physician’s monitoring.

Common side effects include nausea, Shah said. The medications can also on rare occasion cause pancreatic inflammation, a painful condition that can lead to serious complication.

“These are powerful medications,” said Shah, who is not involved in the litigation. “And powerful medications have powerful side effects.”

When a growing number of people began suing Novo Nordisk and Eli Lilly over their weight-loss and diabetes drugs, a panel of judges decided the cases were similar enough to be consolidated in front of one judge.

This a common process for product liability litigation that has also yielded a billion-dollar settlement between the NFL and retired football players who suffered brain injury from repeated concussion, a series of cases that were also litigated in Philadelphia.

U.S. District Judge Gene E. K. 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 sides reach a global settlement to resolve cases without a series of trials, Pratter will be called up to approve or reject it.

Litigation could lead to changes to promote safety, as well as financial compensation for individuals, said Pennock, the lawyer representing some of the people who sued.

“We hope that the companies will come around and put good and solid and clear and unequivocal warning on the labels for these drug,” he said.

Editor’s note: This story was updated with comment by Eli Lilly.