Timeline

August 2024

Ongoing Lawsuit Acceptance

The lawsuits involving GLP-1 drugs are still ongoing. New cases are being accepted as the litigation continues to evolve.

July 2024

New Study on Semaglutide

Harvard Medical School published a study linking semaglutide use to an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition that can lead to sudden vision loss.

May 2024

Passing of Judge Gene E. K. Pratter

Judge Gene E. K. Pratter, overseeing the Ozempic and Mounjaro MDLs (multidistrict litigation), passed away unexpectedly. The MDLs were reassigned, which led to delays in the litigation process.

February 2024

Consolidation of Lawsuits

A total of 55 lawsuits alleging severe gastrointestinal injuries from GLP-1 drugs, including Ozempic, Wegovy, and Mounjaro, were consolidated into a federal MDL in the Eastern District of Pennsylvania.

January 2024

FDA Review of Adverse Effects

The U.S. Food and Drug Administration (FDA) reviewed reports of suicidal thoughts or actions in patients using GLP-1 drugs. The FDA’s preliminary evaluation did not find evidence linking these medications to suicidal thoughts or actions.

December 2023

Key Case Ruling

Judge James Cain, Jr. rejected Novo Nordisk’s attempt to dismiss the first case, allowing failure to warn claims to proceed.

September 2023

FDA Updates Warning Labels

The FDA updated the warning labels for Ozempic to include risks of intestinal blockage, obstruction, and ileus, following reports of more than a dozen cases. This update came after 18 cases of ileus were reported to the FDA, with a total of over 8,500 reports of gastrointestinal issues related to drugs like Ozempic and Wegovy. Ileus was mentioned in 33 cases, including two deaths. This labeling update matched the existing warnings for other GLP-1 drugs and receptor agonists.

August 2023

First Lawsuit Filed Claiming Gastrointestinal Issues

The first lawsuit is filed alleging severe gastrointestinal injuries from Ozempic and Mounjaro. This lawsuit marked a significant legal challenge related to the side effects of these drugs, leading to summonses issued to Novo Nordisk and Eli Lilly.

July 2023

Rising Demand and Drug Shortages

The American Society of Health-System Pharmacists (ASHP) reported shortages of Ozempic and Wegovy due to heightened demand.

August 2022

Initial Lawsuits and Emerging Risks

  • Seven lawsuits were centralized into a multi-district litigation (MDL) in Delaware concerning patent infringement related to Ozempic (semaglutide). This litigation focused on protecting Novo Nordisk’s patents against generic drug makers.
  • A research letter published in JAMA Internal Medicine linked Ozempic to an increased risk of gallbladder disease and gallstones, prompting related lawsuits alleging inadequate warnings.

May 2022

FDA Approves Mounjaro for Blood Sugar Control in Type 2 Diabetes

The FDA approved Eli Lilly’s Mounjaro (tirzepatide) for managing blood sugar levels in Type 2 diabetes patients.

June 2021

FDA Approves Wegovy for Chronic Weight Management

The FDA approved Wegovy (semaglutide) for chronic weight management in adults with obesity or overweight, who also have weight-related medical problems. Wegovy is also approved for use in children aged 12 years and older.

September 2019

FDA Approves Rybelsus for Oral Treatment of Type 2 Diabetes

The FDA approved Rybelsus (oral semaglutide) for the treatment of Type 2 diabetes in adults. Rybelsus is a tablet form of semaglutide, allowing patients to take the medication orally rather than through injections.

December 2017

FDA Approves Ozempic for Type 2 Diabetes and Cardiovascular Risk Reduction

The FDA approved Novo Nordisk’s Ozempic (semaglutide) for the treatment of Type 2 diabetes in adults. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with Type 2 diabetes and known heart disease

December 2014

FDA Approves Saxenda for Chronic Weight Management

The FDA approved Saxenda (liraglutide) for chronic weight management in adults and children aged 12 years and older with obesity or overweight. Saxenda is also indicated for use in addition to diet and exercise.

September 2014

FDA Approves Trulicity for Type 2 Diabetes Management

The FDA approved Trulicity (dulaglutide) for the treatment of Type 2 diabetes in adults. Trulicity is a once-weekly injection that helps to control blood sugar levels and may also reduce the risk of major cardiovascular events in patients with Type 2 diabetes and known heart disease.