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

Patients live all over the country, but the cases playing out in a Philadelphia courtroom tell the same story of being harmed by drugs used to lose weight or control diabetes.

They took medications such as Ozempic, Wegovy, or Mounjaro that doctors continue to prescribe. Then the patients began to have problems such as vomiting, weakness, constipation and other symptoms of intestinal obstruction.

Now, many of these patients are suing drug manufacturers in federal courts for not providing adequate warning of potentially dangerous side effects from drugs marketed for health problems, such as diabetes. and obesity.

These types of medications are designed to help people with diabetes control their blood sugar levels. When people take the medicine, they feel less hungry and their digestion slows down, which results in weight loss.

Philadelphia has no legal battle to shape the future of such drugs, whose growing popularity has been heralded for their potential to change everything from the food on grocery shelves to in the fashion clothing market. People like Oprah have mentioned how they have been using Ozempic for weight loss encouraging others to consider doing so.

But a growing number of patients say in lawsuits that drugmakers Novo Nordisk (maker of drugs including Ozempic, Wegovy, and Rybelsus) and Eli Lilly (Trulicity, Mounjaro, and Zepbound) failed to warn them about enough with the side effects.

In one case, a Pennsylvania woman describes how she started Wegovy for weight loss last year. After a few months, she started having stomach pains and vomiting. He could neither eat nor drink. He spent four days in the hospital and was diagnosed with gastroparesis, a condition in which the intestines empty water very slowly.

Nothing in the ads he saw for the medication warned him of potential harm, he said in the lawsuit. Efforts by The Inquirer to reach him by phone were unsuccessful.

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

It is possible that the court’s deliberations have been going on for years. Here’s what you need to know about drugs, and the charges that will be filed in Philadelphia:

Legal disputes

Lawmakers in Washington, DC, are monitoring drug prices, but the focus of the Philadelphia court will be drug safety and the companies’ advertising efforts.

The lawsuits accuse the companies of aggressive marketing campaigns that downplay the risks, and target women, youth and communities of color. They say drug manufacturers they created a market for their drug by spending millions of dollars on “advertising and promotion” which caused a “media frenzy and a mega seller.”

“The drug companies had a reason to know about these potential dangers, they were bound by law to warn them, and in our opinion they did not enough warning,” said Paul Pennock, a Morgan & Morgan attorney who represents the plaintiffs.

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

“Novo Nordisk believes that the allegations in these cases are without merit, and we intend to vigorously defend ourselves against these allegations,” the company said in a statement.

Eli Lilly did not respond to a request for comment.

Strong medicine, strong side effects

A record number of Americans have started taking this type of prescription drug for weight loss and diabetes in recent years. US doctors wrote more than nine million prescriptions for Ozempic and similar medicines in the last three months of 2022, an analysis from data analysis company Trilliant Health found.

These drugs belong to a group 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. New types of these drugs have received FDA approval since 2017 to treat diabetes (for example, Ozempic, Rybelsus, and Mounjaro) and obesity (Wegovy and Zepbound).

Doctors also have been prescribing approved diabetes medications for weight loss, a Trilliant review of insurance records 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 the treatment of obesity. Patients using these medications need to maintain a healthy diet and exercise under a doctor’s supervision.

Common side effects include nausea, Shah said. Medicines can also sometimes cause inflammation of the pancreas, a painful condition that can lead to serious complications.

“This is a powerful drug,” it said Shah, who is not involved in the case. And strong drugs have strong 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 that the cases were similar enough to may be joined before a single judge.

This is standard practice for product liability cases that have also resulted in multibillion-dollar settlements between the NFL and retired football players who suffered brain injuries from repeated concussions, a series of lawsuits which were also prosecuted in Philadelphia.

Judge Gene EK Pratter will preside over the GLP-1 lawsuit. Pratter will set ground rules on issues such as evidence and confidentiality for all cases. And if the parties reach a global settlement to settle the cases without a series of lawsuits, Pratter will be called upon to accept or reject it.

The lawsuits could lead to changes to promote protections, as well as financial compensation for individuals, said Pennock, a lawyer representing some of the plaintiffs.

“We hope that the companies will come forward and give a good and solid and clear and clear warning on the names of these drugs,” he said.