Introduction

Ozempic, a brand name for the drug semaglutide, has become the center of legal attention due to lawsuits claiming severe side effects, including gastroparesis, ileus, and intestinal blockage. Manufactured by Novo Nordisk, Ozempic was initially developed as a diabetes therapy but gained popularity for weight management. However, recent allegations suggest that the drug’s manufacturers failed to adequately warn users of the potential risks associated with its use.

Emergence of Lawsuits

The first Ozempic lawsuit was filed on August 2, 2023. Subsequently, a federal panel consolidated at least 55 lawsuits into a multidistrict litigation (MDL) in the Eastern District of Pennsylvania on February 2, 2024. These lawsuits primarily claim that Ozempic and other GLP-1 receptor agonists (RAs) led to severe gastrointestinal injuries, sparking a legal battle that is still in its early stages.

Key Players in Lawsuits

The initial lawsuit was filed by Jaclyn Bjorklund, who took Ozempic and included the drug Mounjaro (tirzepatide) and its manufacturer, Eli Lilly, as defendants. As of February 2024, there have been no global settlements or jury trials, and Ozempic lawsuits are actively being pursued, with lawyers accepting personal injury cases related to gastroparesis, ileus, and intestinal blockage.

Legal Proceedings and Timeline

February 2024

• At least 55 lawsuits were combined into an MDL in the Eastern District of Pennsylvania.
• Plaintiff’s lawyers anticipated the number of lawsuits to potentially grow to as many as 10,000.

January 2024

• The FDA announced an evaluation of reports of hair loss, suicidal thoughts, and aspiration under sedation and anesthesia among people taking Ozempic and similar diabetes and weight loss medications.
• Reports of possible side effects were received through the FDA Adverse Event Reporting System database.

December 2023

• Judge James Cain, Jr. denied Novo Nordisk’s attempt to dismiss Jaclyn Bjorklund’s case, allowing claims such as failure to warn to proceed.
• Plaintiff lawyers filed a motion to consolidate Ozempic cases in Louisiana District Court.

November 2023

• Canadians filed a proposed class action lawsuit, alleging Novo Nordisk’s failure to adequately warn about potential complications, including gastroparesis, linked to Ozempic.

September 2023

• The FDA added warnings for intestinal blockage, intestinal obstruction, and ileus to Ozempic’s warning label.

August 2023

• Jaclyn Bjorklund filed one of the initial lawsuits related to Ozempic and Mounjaro for gastroparesis.
• Novo Nordisk filed a motion to dismiss Bjorklund’s lawsuit in Louisiana federal court.

July 2023

• The American Society of Health-System Pharmacists (ASHP) noted a shortage of Ozempic and Wegovy, another semaglutide, due to increased demand.

August 2022

• Seven Novo Nordisk lawsuits were centralized in multidistrict litigation in Delaware against generic drug makers for patent infringement.
• Lawyers began accepting Ozempic gallbladder lawsuits after scientists linked Ozempic to a higher risk of gallbladder disease and gallstones.

Injuries Named in Lawsuits

The primary injury claimed in recent Ozempic lawsuits is gastroparesis, a severe disorder causing food to move too slowly through the stomach to the small intestine. This condition may result in nausea, vomiting, abdominal bloating, pain, severe dehydration, acid reflux, malnutrition, and weight loss. Undigested food may remain in the stomach, leading to further complications.

In September 2023, the FDA added warnings for intestinal blockage, intestinal obstruction, and ileus, a condition causing the intestines to stop working properly. These warnings have become crucial aspects of the lawsuits, with plaintiffs seeking compensation for the loss of quality of life, medical bills, and other damages.

Other GLP-1 Agonists in Lawsuits

Ozempic lawsuits have implications beyond this specific drug, extending to other GLP-1 agonists. Drugs such as Mounjaro, Rybelsus, Saxenda, and Wegovy are being investigated for similar claims related to gastroparesis, ileus, and intestinal blockage. The legal scrutiny extends to the entire class of GLP-1 agonists, suggesting potential commonalities in the alleged adverse effects.

FDA Actions and Warnings

The FDA’s involvement in the Ozempic lawsuit is notable. In January 2024, the FDA announced an evaluation of reports indicating hair loss, suicidal thoughts, and aspiration under sedation and anesthesia in individuals taking Ozempic and similar medications. This move followed reports of these potential side effects in the FDA Adverse Event Reporting System.

In September 2023, the FDA added warnings for intestinal blockage, intestinal obstruction, and ileus to Ozempic’s label. These warnings signaled official recognition of the risks associated with the drug, further strengthening the basis of the lawsuits.

Legal Responses and Defense

In response to the lawsuits, Novo Nordisk, the manufacturer of Ozempic, has defended the safety of its products, including all semaglutide variants. The company acknowledges gastrointestinal side effects but downplays their severity, asserting that these side effects are of short duration and are listed on the drug’s warning label. Novo Nordisk’s defense strategy suggests that users were warned of potential side effects before starting the drug.

Injuries Named in Lawsuits

The main injury claimed in recent Ozempic lawsuits is gastroparesis, a severe disorder causing food to move too slowly through the stomach to the small intestine. This condition may result in nausea, vomiting, abdominal bloating, pain, severe dehydration, acid reflux, malnutrition, and weight loss. Undigested food may remain in the stomach, leading to further complications.

In September 2023, the FDA added warnings for intestinal blockage, intestinal obstruction, and ileus, a condition causing the intestines to stop working properly. These warnings have become crucial aspects of the lawsuits, with plaintiffs seeking compensation for the loss of quality of life, medical bills, and other damages.

Other GLP-1 Agonists in Lawsuits

Ozempic lawsuits have implications beyond this specific drug, extending to other GLP-1 agonists. Drugs such as Mounjaro, Rybelsus, Saxenda, and Wegovy are being investigated for similar claims related to gastroparesis, ileus, and intestinal blockage. The legal scrutiny extends to the entire class of GLP-1 agonists, suggesting potential commonalities in the alleged adverse effects.

FDA Actions and Warnings

The FDA’s involvement in the Ozempic lawsuit is notable. In January 2024, the FDA announced an evaluation of reports indicating hair loss, suicidal thoughts, and aspiration under sedation and anesthesia in individuals taking Ozempic and similar medications. This move followed reports of these potential side effects in the FDA Adverse Event Reporting System.

In September 2023, the FDA added warnings for intestinal blockage, intestinal obstruction, and ileus to Ozempic’s label. These warnings signaled official recognition of the risks associated with the drug, further strengthening the basis of the lawsuits.

Legal Responses and Defense

In response to the lawsuits, Novo Nordisk, the manufacturer of Ozempic, has defended the safety of its products, including all semaglutide variants. The company acknowledges gastrointestinal side effects but downplays their severity, asserting that these side effects are of short duration and are listed on the drug’s warning label. Novo Nordisk’s defense strategy suggests that users were warned of potential side effects before starting the drug.

Motions and Counterarguments

The legal proceedings include Judge James Cain, Jr. denying Novo Nordisk’s attempt to dismiss Jaclyn Bjorklund’s case in December 2023, allowing certain claims like failure to warn to proceed. This decision marked a significant development in the legal battle, as it permitted the continuation of claims against the pharmaceutical giant.

Jaclyn Bjorklund’s case combines an Ozempic lawsuit and a Mounjaro lawsuit, alleging gastrointestinal problems after using both drugs. The case details severe vomiting lasting four weeks or more, leading to the loss of teeth. The plaintiff visited the emergency room multiple times, experienced stomach pain, gastrointestinal burning, and vomited whole food only hours after eating.

The legal landscape also involves an unrelated Ozempic patent litigation MDL with seven cases pending. The complexity of these legal actions suggests that the legal battles surrounding Ozempic are multifaceted, involving patent infringement and the alleged failure to warn users of severe side effects.

Reasons for Filing Lawsuits

People have filed Ozempic lawsuits primarily because they took the drug and later suffered from gastroparesis, a severe disorder causing food to move too slowly through the stomach to the small intestine. The symptoms of gastroparesis include nausea, vomiting, abdominal bloating, pain, severe dehydration, acid reflux, malnutrition, and weight loss.

The FDA’s addition of warnings for intestinal blockage, obstruction, and ileus in September 2023 further emphasized the potential severity of the side effects associated with Ozempic. These warnings reflected the acknowledgment of risks by the regulatory authority and added weight to the claims made by those filing lawsuits.

Eligibility and Qualification

Individuals who took Ozempic for weight loss or other indications and experienced severe gastroparesis resulting in vomiting for four weeks or more may qualify to file a lawsuit. Lawyers are accepting cases from those who meet these criteria and have suffered severe gastrointestinal problems.

However, there are specific exclusions, such as individuals who had gastric bypass surgery, gastric banding, or gastric sleeve surgery before taking Ozempic. Additionally, the exclusion of cases for those being treated for cancer highlights the nuanced criteria for eligibility. Potential plaintiffs are encouraged to contact a lawyer promptly for a free case review to determine qualification and preserve the right to file a lawsuit within the limited timeframe.

Damages and Compensation

Damages sought in Ozempic lawsuits depend on the harm and losses suffered by the plaintiffs. While the exact compensation varies, Jaclyn Bjorklund’s case serves as an example. She is seeking compensatory and punitive damages, including medical costs resulting from severe gastrointestinal issues. The injuries she claims include the loss of teeth and internal damage, leading to multiple hospitalizations. Additionally, she seeks compensation for ongoing and future medical costs, pain caused by the alleged actions of Novo Nordisk, and court costs and attorney fees.

The sought-after damages indicate the significant impact of the alleged side effects on the lives of the plaintiffs. The claims extend beyond immediate medical costs to encompass long-term consequences, pain and suffering, and the financial burdens associated with ongoing medical interventions.

Future Implications and Challenges

The future of Ozempic lawsuits is uncertain but holds several potential developments. With the claims consolidated into an MDL, the legal process is streamlined, allowing for more efficient handling of individual claims while also facilitating collective decisions on common issues. The number of lawsuits is expected to grow, providing an evolving landscape for legal professionals involved in these cases.

The longer the legal proceedings take, the more data about potential connections between semaglutide and gastroparesis will become available. Ongoing research and reports released in recent months may influence the direction of future lawsuits. If researchers can establish a link between Ozempic and severe side effects, it could significantly impact the legal landscape and potentially lead to more filings.

One notable factor that may affect the outcome of Ozempic lawsuits is the existence of counterfeit products. Novo Nordisk reported the discovery of a counterfeit Ozempic pen in June 2023. The existence of counterfeit products introduces a layer of complexity, requiring plaintiffs to prove that they were using genuine Ozempic and not a counterfeit version. Additionally, the reliability of adverse event reports may be compromised if counterfeit products become more prevalent.

Conclusion

The Ozempic lawsuits represent a complex legal battle, combining allegations of severe side effects, FDA warnings, and the pharmaceutical company’s defense. The consolidation of lawsuits into an MDL suggests a coordinated effort to address common issues efficiently. The claims of gastroparesis, ileus, and intestinal blockage underscore the potential risks associated with the drug, leading to significant impacts on the lives of those affected.

As the legal proceedings unfold, the outcomes of individual cases and collective decisions in the MDL will shape the future of Ozempic lawsuits. The challenges posed by counterfeit products, ongoing research, and evolving FDA evaluations add layers of complexity to the litigation. For individuals considering or involved in Ozempic lawsuits, choosing experienced legal representation is crucial to navigating the intricate legal landscape and seeking potential compensation for the alleged damages suffered.