Ozempic Lawsuit Updates & News | September 2024
ConsumerShield
Reviewed By Adam Ramirez, J.D.
Editor
The Ozempic lawsuit has become a prominent issue in media coverage, drawing attention for the considerable compensations and settlements linked to these cases. Key recent developments include:
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The defendants are pushing for a swift ruling on the cross-cutting issues, seeking to resolve them without engaging in full discovery. In response, plaintiffs' attorneys are urging the court to reject this expedited approach, emphasizing that comprehensive discovery is essential before addressing general causation.
Plaintiffs argue that prematurely deciding on general causation, without fully examining all relevant evidence, would be inappropriate. They emphasize the importance of applying the Bradford Hill criteria, a widely recognized framework for evaluating whether a factor, such as Ozempic, is causally linked to conditions like gastroparesis. These criteria, they argue, are vital to ensure a sound assessment of the potential causal relationship.
The plaintiffs insist that only a full investigation of the evidence will provide an accurate and robust evaluation of general causation. They caution that restricting discovery to narrowly defined categories could leave out critical data, leading to a potentially incomplete or skewed analysis. Therefore, they are advocating for a thorough pre-trial discovery process, urging the court not to streamline the case at the expense of its integrity.
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Following the court's recent order on key “cross-cutting” issues, the defendants wasted no time, swiftly sending a letter to Judge Marston to push for early discovery on general causation. Their successful effort shifts the initial focus to two crucial aspects: the reliability of gastroparesis diagnostic tests and the adequacy of the manufacturers' warning labels.
Confident in their strategy, the defendants aim to accelerate the case's resolution. However, while they are eager to advance these issues, the ultimate success of their approach remains uncertain.
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The court has granted the defendants' request for early discovery, honing in on two pivotal issues: the reliability of gastroparesis diagnostic methods and the sufficiency of the manufacturers' warning labels. These key points could significantly influence the direction of the case. The court will examine whether gastroparesis can be accurately diagnosed without objective testing and if the FDA-approved warning labels comply with federal standards, potentially preempting state law claims.
Additionally, further briefings have been requested on general causation, specifically evaluating whether GLP-1 receptor agonists are linked to the alleged injuries. A decision on this front has been deferred, pending more evidence. A detailed discovery and motion schedule will be determined after the next status conference on September 16, 2024.
Although this ruling presents new challenges for the plaintiffs, their legal team remains confident in overcoming these hurdles.
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A Kentucky woman has filed a lawsuit against Eli Lilly and Company, alleging severe injuries caused by the diabetes medications Mounjaro and Trulicity. The plaintiff claims these drugs led to her developing gastroparesis, a chronic condition that impairs stomach function.
The lawsuit accuses Eli Lilly of failing to properly warn consumers and healthcare providers about the risks, particularly the potential for gastroparesis. The plaintiff's claims include inadequate warning, fraudulent concealment, and negligent misrepresentation. She argues that if she had been fully informed, she would have avoided using these medications.
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The Court has appointed retired Judge Lawrence F. Stengel as the Special Discovery Master to manage and oversee the discovery process between the parties and third parties involved in this case.
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A New Hampshire resident with Type 2 diabetes filed an Ozempic lawsuit this week. She used the medication from June 2022 to September 2023 and was later diagnosed with gastroparesis, a condition that paralyzes stomach muscles, impairing digestion. The plaintiff alleges that Novo Nordisk failed to provide adequate warnings about the risks of Ozempic, resulting in severe and permanent injuries, pain, and emotional distress. The lawsuit was filed directly in the MDL.
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A status conference is scheduled for August 8, 2024, in the GLP-1 RA Products Liability Litigation. The following topics are expected to be addressed:
- Progress on Electronic Plaintiff Fact Sheets (e-PFS): The court will likely inquire about the development and implementation status of the e-PFS system.
- Discovery Phase Update: Parties will provide an overview of the current stage of discovery, including any significant developments or challenges.
- Stayed Cases: The court will seek updates on cases that have been temporarily halted and discuss potential next steps.
- Science Day Planning: Logistics and arrangements for the upcoming Science Day will be finalized.
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The GLP-1 RA Products Liability Litigation, often referred to as the Ozempic class action, has experienced a significant surge in active cases. The number of active lawsuits within the MDL jumped from 111 in July 2024 to 346 in August 2024, representing a staggering 200% increase in just one month.
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An Illinois man has filed a lawsuit against Novo Nordisk and Eli Lilly, alleging that the companies failed to warn about the risks associated with their weight loss drugs, Ozempic and Mounjaro. The plaintiff, who was prescribed Ozempic in October 2022 and later switched to Mounjaro, experienced severe health issues, including ischemic bowel obstruction, which required surgery in June 2023. The lawsuit, initially filed in Illinois, will be transferred to a class action in Pennsylvania, seeking compensation for injuries, medical expenses, and suffering due to the defendants' alleged negligence and deceptive practices.
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A new JAMA Ophthalmology study of 1,687 patients shows that semaglutide (Ozempic) users have a higher risk of nonarteritic ischemic optic neuropathy (NAION), a leading cause of optic nerve blindness after glaucoma. While Ozempic-related NAION cases are rare, we are monitoring this closely and preparing to represent affected individuals in lawsuits. Vision loss is now added to the serious risks of Ozempic, which currently lacks warnings about blindness or gastroparesis on its label.
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The conference will cover:
- Cross-cutting motion letter briefs.
- Disputed provisions in the ESI protocol and 502(d) order.
- Candidates for the discovery special master.
- Status of the time and expense order.
- Status of discovery.
Defendants want to focus on whether Ozempic and other glucagon-like peptide-1 drugs cause specific health issues, which delays litigation by a year. Plaintiffs are willing to look into causation but aim to prepare for trial. Defendants often use this tactic to stall MDLs, but judges consistently reject their requests to bifurcate discovery, as seen in recent cases like Suboxone, Tepezza, and others.
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A recent study discovered a link between semaglutide, a GLP-1 receptor agonist used in medications like Ozempic, and nonarteritic anterior ischemic optic neuropathy (NAION), an eye stroke causing sudden vision loss. Researchers analyzed data from over 16,800 university hospital patients managing diabetes or weight. They found that 8.9% of type 2 diabetic patients on semaglutide experienced NAION, compared to 1.8% using other diabetic medications. Among overweight or obese patients, 6.7% of semaglutide users developed NAION, versus 0.8% on other weight-loss drugs. These findings highlight a significant risk for doctors and patients to consider when selecting treatment options.
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Five new lawsuits were filed within a month in this ongoing litigation, bringing the total to 106. Four lawsuits were filed in June, and one was filed today by an Indiana woman. She took Ozempic for diabetes and weight control and was hospitalized on July 1, 2022, with severe constipation, rectal bleeding, and vomiting. An ultrasound revealed a bowel obstruction, for which she was treated and released, but she still experiences irregular bowel movements. She claims the Ozempic label did not adequately warn of these risks, significantly impacting her life.
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Novo Nordisk is investing $4.1 billion to boost production of Wegovy and Ozempic. This massive investment highlights the company's significant financial resources, which could be used to pay settlements and verdicts. It also underscores the potential damage to Novo Nordisk's reputation and sales if they face a large adverse verdict in these lawsuits.
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A Kansas resident has filed a lawsuit against Ozempic's manufacturer, claiming the medication caused severe health complications, including gastroparesis. The plaintiff, who took Ozempic from 2019 to 2022 for type 2 diabetes, alleges the drug led to persistent vomiting, diarrhea, and abdominal pain, as well as emotional distress. The lawsuit seeks damages for the plaintiff's suffering and medical expenses.
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During a recent hearing, Judge Karen Spencer Marston emphasized her commitment to keeping the Ozempic litigation on track. Although the hearing was uneventful, Judge Marston made a significant decision regarding the scheduling of a "Science Day." While attorneys proposed mid-September, the judge insisted on scheduling it for July.
This decision indicates a desire for expedited progress, which is promising for those seeking early settlements. However, despite this push, the earliest expected trials are still projected for late 2025.
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Judge Karen Spencer Marston, a U.S. District Judge for the Eastern District of Pennsylvania, has been assigned to oversee the Ozempic MDL following Judge Pratter's passing. Nominated by Donald Trump and confirmed in 2019, Judge Marston brings extensive experience in criminal law and litigation from her distinguished career in both public and private sectors. She holds a BA from Davidson College and a JD from Wake Forest University School of Law, and has served as a federal prosecutor and chief of the Narcotics and Organized Crime Section in the U.S. Attorney’s Office for the Eastern District of Pennsylvania.
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In May, twelve new cases were added to the Ozempic class action MDL, matching April's volume. This brings the total number of pending cases to 101, reflecting a slower start than expected.
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In the ongoing multidistrict litigation (MDL), defendants Novo Nordisk and Eli Lilly have disputed plaintiffs' allegations linking GLP-1RA medications to severe gastrointestinal conditions like gastroparesis. The defendants argue that no conclusive evidence exists to connect these drugs to the reported issues, suggesting diabetes, which many plaintiffs have, could also cause these conditions. Additionally, the plaintiffs accuse the companies of misleading marketing strategies, particularly concerning the promotion of drugs like Ozempic for uses not specifically approved by the FDA. The court will examine whether the drug companies' marketing misrepresented the severity and risks of side effects.
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Novo Nordisk has allocated $11 million towards promoting Ozempic for weight loss, specifically covering travel and dining for doctors. This strategy included sponsoring 12,000 physicians with 457,000 meals and travel to destinations such as Honolulu, Paris, London, and Orlando.
Critics argue that these funds could have been more effectively used for researching the drug's potential severe side effects and long-term health implications, including stomach paralysis and other digestive issues. This expenditure may also challenge Novo Nordisk's ability to claim financial constraints in covering settlements or judgments related to patient injuries caused by the medication.
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During the first hearing of the Ozempic lawsuit MDL in the Eastern District of Pennsylvania, Judge Pratter emphasized the importance of efficiency and clear communication among all parties. She discouraged any unnecessary delays and requested focused progress in the litigation, which consolidates 72 lawsuits with potential to include over 20,000 cases. The lawsuits allege that GLP-1 receptor agonists like Ozempic and others increase the risk of severe gastrointestinal issues, including stomach paralysis. Some plaintiffs report severe side effects requiring emergency or surgical interventions. The legal proceedings also address claims that patients were not sufficiently warned about the risks of using these medications off-label for weight loss.
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Judge Gene E.K. Pratter is set to define key aspects of the Ozempic lawsuit, including discovery timelines and case eligibility, ahead of a landmark trial. The first status conference is scheduled for March 14, 2024.
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- MDL Formation: Federal Ozempic lawsuits and related medications consolidated into an MDL.
- Inclusion of Similar Drugs: Wegovy, Mounjaro, Rybelsus, and Trulicity included.
- Jurisdiction Chosen: Eastern District of Pennsylvania selected, close to Novo Nordisk’s New Jersey headquarters.
- Major Drug Manufacturers Involved: Novo Nordisk and Eli Lilly initially objected, proposed alternative jurisdictions.
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- MDL Approval: Judicial Panel on Multidistrict Litigation (JPML) approves consolidation of Ozempic lawsuits into an MDL.
- Streamlined Process: Centralization aims to enhance pre-trial efficiency, including evidence gathering and discovery.
- Impact on Plaintiffs: Expected to accelerate settlement processes for those affected by Ozempic side effects.
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- Case Filed: Sandra Linney from Bonneville County, Idaho files a lawsuit against Novo Nordisk in the U.S. District Court for the District of Idaho.
- Complaint Focus: Alleges inadequate safety labeling by Novo Nordisk on Ozempic, failing to adequately warn of severe gastrointestinal risks.
- Company's Potential Response: Novo Nordisk expected to deny liability and possibly move to dismiss the case.
- Growing Legal Pressure: The increase in Ozempic lawsuits may prompt the U.S. Judicial Panel on Multidistrict Litigation to consider consolidating these cases for more efficient pretrial proceedings.
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- Initial Lawsuit: A lawsuit filed in Louisiana at the end of 2023 accuses diabetes drugs like Ozempic and Mounjaro of causing severe health issues, including extreme vomiting and tooth loss.
- Request for MDL: Plaintiffs, including the Louisiana complainant, seek to form a Multi-District Litigation (MDL) for all federal cases involving Ozempic and related drugs.
- Drug Makers' Stance: Initially, both Novo Nordisk (Ozempic's maker) and Eli Lilly & Co. (Mounjaro's maker) were reluctant to submit to jurisdiction in Louisiana, but Novo Nordisk now supports the MDL idea, suggesting either Louisiana or California as suitable venues.
- Eli Lilly’s Objection: Eli Lilly opposes being included in the Ozempic MDL, citing the relatively fewer lawsuits against Mounjaro. They propose Indiana or North Carolina as possible venues if an MDL for Mounjaro is considered.
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- EMA Inquiry: The European Medicines Agency is examining a potential link between diabetes and weight-loss medications like Ozempic and Wegovy, and an increased risk of self-harm or suicidal thoughts.
- New Concerns: This investigation adds to existing concerns about Ozempic, such as stomach paralysis, cyclic vomiting syndrome, and gallbladder issues. The possible connection with suicidal tendencies represents a significant new area of concern.
MDL Motion: A group of plaintiffs using Ozempic has filed for the consolidation of all federal cases into a Multi-District Litigation in the Western District of Louisiana. The aim is to centralize related cases for efficient discovery, consistent court rulings, and shared evidence.
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- Court Ruling: Louisiana Federal Judge James Cain, Jr., rejected Novo Nordisk's motion to dismiss a lawsuit filed by Jaclyn Bjorklund.
- Lawsuit Focus: The suit accuses Novo Nordisk of failing to adequately warn about the risk of gastroparesis, or stomach paralysis, associated with the use of their drug, Ozempic.
- Case Advancement: This decision allows Ms. Bjorklund's case to proceed further in the legal process.
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- Objective: Lawyers seek to combine federal lawsuits against Ozempic, Mounjaro, Trulicity, and Wegovy producers into a single Multidistrict Litigation (MDL).
- Claims: The suits allege the drugs cause severe stomach issues, like gastroparesis, without adequate warnings from manufacturers Novo Nordisk and Eli Lilly.
- Current Status: Approximately 20 lawsuits filed in U.S. Federal Courts.
- Proposed Location: Advocates for consolidation suggest the Western District of Louisiana under Judge James Cain.
- FDA Position: No comment on the rising Ozempic lawsuit numbers.
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- Issue: Ozempic users experiencing complications like regurgitation during surgery under anesthesia.
- Warning: The American Society of Anesthesiologists advises against using Ozempic and similar drugs on the day of surgery and seven days prior.
- Cause: Gastroparesis, a side effect of Ozempic, leads to delayed stomach emptying, increasing risks during surgery.
- FDA Response: Updated labels for Ozempic and related drugs to include new warnings about these risks.
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- Study Findings: The Journal of the American Medical Association (JAMA) published a study revealing increased severe gastrointestinal risks in patients using GLP-1 agonist drugs, like Ozempic and Wegovy. These drugs can cause significant stomach pain and delay gastric emptying.
- Drug Use: Initially approved for diabetes, GLP-1 agonists are now frequently prescribed off-label for weight loss.
- Reports: Users of Ozempic and similar drugs report severe stomach and intestinal issues, likely linked to the medication.
- FDA Action: In September, the FDA required warnings on Ozempic labels about the risk of intestinal blockage, including food or fluid getting stuck in the colon.
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- Common Legal Ground: The lawsuits in the Ozempic Multi-District Litigation (MDL) predominantly hinge on the allegation of a failure to warn consumers.
- Plaintiffs' Claims: They argue that Ozempic's manufacturers were aware, or should have been aware, of the drug's potential to cause severe gastroparesis and other digestive problems. Manufacturers did not inform users for possible problems.
- Role of Evidence: Scientific proof will play a crucial role in these legal proceedings.Top of Form
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- Current Lawsuit Count: Seven lawsuits filed against Ozempic for stomach paralysis.
- MDL Creation: A Multi-District Litigation (MDL) is established to manage these and potentially hundreds or thousands more anticipated cases.
- MDL Process: In the MDL, all cases will undergo collective evidence discovery and pre-trial motions, though individual trials will occur if necessary.
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- Plaintiff: Jaclyn Bjorklund filed the first lawsuit concerning stomach paralysis from Ozempic use.
- Medical Issues: She experienced severe gastrointestinal problems, including vomiting and stomach pains, leading to a hospital emergency.
- Condition Explained: Gastroparesis, a condition where stomach muscle contractions slow down or weaken, causing delayed food digestion and health risks.
- Allegation: The lawsuit accuses Novo Nordisk of failing to provide adequate warnings about the risk of stomach paralysis linked to semaglutide drugs (Ozempic and Mounjaro).
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- Findings: Recent evidence indicates that Ozempic, widely used for weight loss, can lead to severe gastrointestinal issues.
- Conditions Identified: Notable conditions linked to Ozempic include stomach paralysis and violent vomiting.
- Risk Factors: The risk is particularly high for those using Ozempic long-term at high dosages recommended for weight loss.
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