The lawsuit could challenge the trust in Ozempic and other popular weight loss drugs

The makers of the most popular weight loss drugs are being challenged in court.

A federal court in Philadelphia will soon evaluate claims against the makers of Ozempic, Wegovy and similar products.

Dozens of patients who suffered gastrointestinal problems after taking these drugs filed lawsuits alleging that the companies failed to properly warn patients of the risks.

Weight loss drugs are among the most successful products sold in the US, with prescriptions increasing fortyfold from 2018 to 2023. Scientific studies have supported their safety and efficacy, and doctors prescribe them for a variety of reasons, including reducing risk of heart attack and other cardiovascular events.

Over the past few years, celebrities and word of mouth have made these drugs go viral on social media. More than 15 million Americans reported using these drugs as of May 2024.

So what do patient claims about the risks associated with weight loss drugs mean for the future of these products? I am a professor of health law who studies pharmaceutical drug regulation and access to drugs, and I have followed legal developments closely. Regardless of how the trial turns out, I think it could have a huge impact on public confidence and the weight loss drug market.

Drugs: Ozempic, Wegovy, Rybelsus, Trulicity and Mounjaro

Several types of medications fall under the umbrella of “weight loss drugs.” The five drugs at issue in the lawsuit belong to the same class: GLP-1 agonists or analogs, short for glucagon-like peptide-1 receptor agonists. GLP-1 agonist drugs help manage blood sugar levels. They were originally approved for the treatment of type 2 diabetes.

These drugs make people feel full. Doctors began prescribing them for weight management even before the FDA approved them for that purpose. This is a practice known as off-label prescribing. Off-label prescribing is legal and accounts for more than 20% of prescription activity in the United States.

Companies: Eli Lilly and Novo Nordisk

The Danish company Novo Nordisk produces Ozempic, Wegovy and Rybelsus. The American company Eli Lilly produces Trulicity and Mounjaro.

In 2023, Eli Lilly became the most valuable pharmaceutical company in the world. Trulicity and Mounjaro sales played a big role in making this happen. For example, in 2023, Mounjaro’s sales exceeded $1 billion per quarter. Eli Lilly and analysts predict that the company’s weight loss drug revenue will grow significantly between 2024 and 2030.

Analysts expect sales of weight loss drugs to reach $150 billion annually by the early 2030s.

Novo Nordisk has also come up with an idea for weight loss drugs. Its sales of Ozempic, Wegovy and Rybelsus have made it the most valuable company by market capitalization in Europe. It is currently more valuable than the likes of Tesla and Visa and has been described by one reporter as “the single company that supports” the entire Danish economy.

lawsuit

The lawsuit consolidates dozens of lawsuits filed by patients who received one of these five drugs. They were consolidated in part because the legal bases for all these cases were similar. The trial is taking place in Pennsylvania because that was the state with the most pending legal actions. Also, Novo Nordisk’s US headquarters is located nearby in New Jersey.

The patients in the lawsuit each received one of the drugs described above. All had gastrointestinal or related problems. These include intestinal obstructions and gastroparesis, a slowing or stopping of the movement of food through the stomach.

Medically, patients claim that these drugs increase the risk of gastrointestinal injuries. Legally, they claim the companies failed to properly warn patients of the risks. The lawsuit also raises the question of whether the companies made incomplete or misleading representations about these drugs. The companies have signaled they will contest the claims.

implications

We won’t know the outcome of the case for a while. But this lawsuit will have immediate consequences.

First, it draws attention to the dangers associated with these popular drugs. Recent studies have shown that the use of GLP-1 agonists is associated with higher rates of gastroparesis, intestinal obstruction, and pancreatitis. These problems, and many others, including an increased risk of certain tumors, are listed as potential side effects by both the companies and the FDA.

The lawsuit is likely to remind people that no drug is without risk and that patients should be aware of these risks before and during treatment.

Second, while these drugs pose risks, the FDA has reviewed the best available scientific evidence, performed a benefit-risk analysis, and determined that the benefits are worth the risk.

For the past decade, however, the FDA’s credibility has been under attack. Conspiracy theories about the agency abound on social media. The FDA is often the target of baseless accusations that it approves harmful drugs and suppresses good ones.

A major legal challenge to weight loss drugs could contribute to the continued erosion of confidence in the FDA itself. And in an age of misinformation, conspiracy theorists can use the lawsuit to suggest inappropriately that these or all FDA-approved drugs are bad or unsafe.

Finally, less confidence in weight loss drugs may eventually lead to a drop in demand. In the past, lawsuits and misinformation have caused sales to decline, which in turn has prompted manufacturers to stop producing some drugs. This was the case with a Lyme disease vaccine that was approved by the FDA in 1998 and discontinued in 2002 due to low sales. Since then, Lyme disease vaccines for dogs have been brought to market, but humans still can’t get one.

While sales of weight loss drugs are currently stratospheric, sometimes a seemingly isolated event, such as a lawsuit, can set long-term effects in motion.

Ana Santos Rutschman is a professor of law at Villanova Law School.