Ozempic and Wegovy manufacturers accused of downplaying drugs' risks

A new lawsuit accuses the manufacturers, producers and distributors of popular weight-loss drugs Ozempic and Wegovy of knowingly advertising and selling the products despite their ability to cause severe gastrointestinal issues, without properly warning customers of the risks.

The product liability suit contends that the defendants have failed to warn users “about the true risks of their weight loss drugs, Wegovy and Ozempic,” including plaintiff Billie Farley, who claims to have suffered serious injury as a result of the marketing of the drugs and her use of Ozempic.

The suit alleges that, since receiving FDA approval to market Ozempic, the Novo Nordisk defendants have produced, distributed marketed and sold Ozempic without properly warning Farley and/or her prescribing physicians “that Ozempic was associated with and/or could cause severe gastrointestinal issues including gastroparesis, gastroenteritis, and intestinal blockage or obstruction.”

The complaint further alleges the defendants knew of the association between GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues but ignored the association and failed to disclose the information they possessed.

The Dec. 8 complaint was filed in the U.S. District Court for the Eastern District of Pennsylvania by Motley Rice on behalf of Farley, who accuses the defendants of downplaying the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis, as a result of using the drugs.

Farley claims that, three months after taking Ozempic, she began vomiting and experiencing intense abdominal pain, which resulted in her going to the hospital and having a CT scan, which showed she was suffering from a life-threatening bowel injury, which required an extensive, eight-hour surgery.

After being hospitalized for six days afterward, doctors allegedly told Farley that Ozempic was the probable cause of her injuries and instructed her to stop taking the drug. Three days after being released from the hospital, she was back at the hospital for adnominal pain, where she was told her pain was permanent and related to scarring from her surgery.

According to the complaint, Farley hasn’t had a solid bowel movement since her surgery and allegedly never will again. She claims continues to suffer from constant abdominal pain, nausea and vomiting.

The complaint alleges that the Novo Nordisk defendants advertising and promotional efforts of the drugs has lead to their widespread prescription throughout the United States, and that the drugs have become so popular that in order to address shortages, Novo Nordisk has had to limit shipment to the U.S. and pause advertising.

“Defendants knew from their required premarket and post-market research and analytics that Ozempic and Wegovy could cause malnutrition, cyclical vomiting, and gastroparesis, gastroenteritis, and intestinal obstruction/blockage,” said the complaint. “The Novo Nordisk Defendants have repeatedly failed to warn about the known dangerous side effects of Ozempic and Wegovy. This includes gastroparesis, gastroenteritis, intestinal blockage or obstruction, and malnutrition. All of these conditions can, and have, led to hospitalization and/or death in patients across America.”

The complaint contends that thousands of “adverse event reports have been filed by the public with the FDA Adverse Event Reporting System” and that the FDA has a posted alert that both drugs have “potential safety signals for intestinal blockage.”

“According to the FDA Adverse Event Reporting System, Defendants were aware of reports of intestinal obstruction no later than 2019 for Ozempic and/or Wegovy.153 These reports to the FDA also stated that many of these patients reporting intestinal obstruction or blockage were hospitalized.”

“The Prescribing Information for Ozempic discloses warnings, precautions, and adverse reactions associated with Ozempic, but it does not disclose the risk of severe gastrointestinal events, including gastroparesis and gastroenteritis. Instead, it discloses delayed gastric emptying under the “Drug Interactions” heading and notes that Ozempic “may impact absorption of concomitantly administered oral medications.”

Similarly, it claims that the prescribing information for Wegovy discloses warnings and precautions associated with taking the drug, but doesn’t disclose the risk of severe gastrointestinal events, like gastroparesis and gastroenteritis.

“Defendants do not disclose any risks associated with severe gastrointestinal events, including the risk of gastroparesis, gastroenteritis, and intestinal blockage or obstruction within the ‘Important Safety Information’ section of their promotional website,” says the complaint. “None of the Defendants’ additional advertising or promotional materials warned prescription providers or the general public of the risk of severe gastrointestinal events, including gastroparesis, gastroenteritis, or intestinal blockage or obstruction.”

The complaint brings claims for negligence, negligence-failure to warn, design defect, misrepresentation and marketing and violation of Pennsylvania Unfair Trade Practices and Consumer Protection Law 72 P.S. Sect. 201-1.

Related: Ozempic and Wegovy: To cover or not to cover? That is the question

Farley requests a monetary award, including actual or compensatory damages, actual and treble damages, exemplary and punitive damages, pre-judgment and post-judgment interest, and court costs and other litigation expenses.

“We are honored to represent Ms. Farley. Ms. Farley’s complaint sets forth specific details on how we believe Novo Nordisk wrongfully marketed and promoted its weight loss drugs to her detriment. Our client looks forward to her day in Court where she can present the jury with information of the dangers of these weight loss drugs, and the bigger dangers presented by what we consider to be negligent marketing and promotion of these drugs,” said Farley’s counsel of Motley Rice in a joint statement.

Counsel have not yet appeared for the defendants.