Novo Nordisk Seeks to Dismiss Lawsuit Over Ozempic Gastrointestinal Side Effects

In response to a failure to warn lawsuit brought by a Louisiana woman who developed painful stomach paralysis, the manufacturer claims Ozempic gastrointestinal side effects were well disclosed to doctors and consumers

Novo Nordisk is calling for the dismissal of a stomach paralysis lawsuit brought by a user of it’s popular Ozempic drug, claiming that the gastrointestinal side effects associated were well known to doctors and plaintiffs, since the drug works by delaying gastric emptying.

The Ozempic lawsuit was filed by Jacklyn Bjorklund in August, alleging that the Novo Nordisk and Eli Lilly failed to warn about the risk of stomach paralysis from Ozempic and Mounjaro, which is a similar diabetes drug that is also widely prescribed off-label for weight loss.

Ozempic (semaglutide) was initially introduced for the treatment of people with Type 2 diabetes. However, amid aggressive advertisements that promoted the weight loss benefits, Ozempic has been increasingly prescribed as a diet drug in recent years, leading the drug maker introduced a higher dose version, known as Wegovy, which is specifically approved for weight loss use.

Mounjaro is part of the same class of medications, but involves the active ingredient tirzepatide, which has been marketed for treatment of type 2 diabetes, and was just recently approved for weight loss under the brand name Zepbound.

Ozempic Stomach Paralysis Side Effects

Although the drugs have been marketed as safe and effective, concerns have emerged in recent months about painful and debilitating gastrointestinal problems from Ozempic, Wegovy and Mounjaro, primarily involving stomach paralysis, also known as gastroparesis, which results from delayed emptying of the stomach.

As a result of the drug maker’s failure to sufficiently disclose the risk, a number of former users are now pursuing Ozempic lawsuits and Mounjaro lawsuits nationwide, each raising similar allegations that they developed painful and debilitating stomach problems, which could have been avoided if false and misleading information had not been provided for users and the medical community.

In response to the lawsuit filed by Bjorklund, which was one of the first brought by a user of Ozempic, Novo Nordisk filed a motion to dismiss (PDF) on November 3, claiming that they sufficiently warned about the gastrointestinal side effects of Ozempic.

While the motion currently applies just to the one claim, a decision on the motion could have wide-ranging impact on other pending claims now being pursued by former users of Ozempic, who have been left with painful and debilitating gastrointestinal complications, sometimes resulting in hospitalization, intestinal obstructions, surgery and other long-term problems.

Drug Maker Claims Gastrointestinal Side Effects of Ozempic Are “Well Known”

Although Bjorkland claims that Novo Nordisk failed to adequately disclose the risk of permanent and long-term injuries linked to stomach paralysis, the drug maker’s motion to dismsis claims that users and the medical community were aware that the drug delayed gastric emptying and may cause gastrointestinal side effects.

“Plaintiff acknowledges in her complaint that ‘gastrointestinal events are well known side effects’ which are extensively discussed in the U.S. Food and Drug Administration approved labeling for both products,” the motion states. “Nonetheless, Plaintiff somehow claims her unidentified physician(s) were not adequately warned of these risks and alleges that both the Novo Nordisk defendants and Lilly violated an ill-defined express warranty.”

Novo Nordisk claims Bjorklund failed to adequately allege failure to warn and breach of express warranty claims in her lawsuit. The manufacturer claims that the delayed gastric emptying is how Ozempic works, which it says was well known to regulators and the medical community.

Eli Lilly filed a similar motion against Bjorklund’s complaint last month, claiming her injuries occurred before she began taking Mounjaro.

Ozempic Gastroparesis Risks

In July, a CNN investigation outlined reports linking Ozempic and stomach paralysis, indicating that researchers have similar problems have been associated with other drugs in the same class in recent years.

In 2017, researchers with the Mayo Clinic conducted a study involving a similar diabetes medication known as Victoza, which found that the drug caused significantly slower digestion in users, taking about 70 minutes for half the food they ate to leave their stomachs, compared to four minutes for people who did not take the drug. However, the study found that people’s bodies tended to adjust over time.

The American Society of Anesthesiologists (ASA) issued a warning about using Ozempic and Wegovy before surgery this summer, indicating that the lack of gastric emptying linked to the drugs could put patients at risk of vomiting and aspiration while under the effects of anesthesia.

It is widely expected that hundreds or thousands of similar claims may be brought in the coming months and years, over similar gastrointestinal risks associated with these medications.