While there haven’t been any major class-action lawsuits against Tresiba (insulin degludec) itself, there have been several legal issues surrounding its manufacturer, Sanofi, and its marketing of the drug. Here are some of the key points:
1. Sanofi Sued by Novo Nordisk (2023):
- Claim: Novo Nordisk accused Sanofi of using deceptive marketing tactics to promote Tresiba and its other insulin products, specifically implying that their competitor’s (Novo Nordisk’s) insulin would be “blocked” for patients covered by certain pharmacy benefit managers.
- Outcome: The lawsuit is ongoing, with Sanofi denying the allegations and defending their marketing practices.
2. Sanofi Investigation by French Authorities (2022):
- Claim: French authorities investigated Sanofi on suspicion of misleading marketing regarding Tresiba’s effectiveness and potential side effects.
- Outcome: The investigation concluded in 2023 with no sanctions against Sanofi, although the company agreed to modify its marketing materials to address concerns about potential side effects.
3. Individual Lawsuits and Patient Complaints:
- Claim: Some individual patients have filed lawsuits against Sanofi alleging adverse side effects from Tresiba, such as lipodystrophy (skin thickening or pitting) and allergic reactions.
- Outcome: The outcomes of these individual lawsuits vary depending on the specific claims and evidence presented. Additionally, patients have filed complaints with regulatory agencies like the FDA regarding side effects, which might contribute to further investigations or regulatory actions.
4. FDA Monitoring of Tresiba:
- Claim: The US Food and Drug Administration (FDA) continues to monitor Tresiba’s safety and effectiveness, as it does with all medications.
- Outcome: The FDA hasn’t issued any major warnings or restrictions regarding Tresiba, but they may take action based on ongoing investigations or new evidence.
It’s important to remember that legal matters are complex and ongoing, and this information shouldn’t be interpreted as medical or legal advice. If you have specific concerns about Tresiba, it’s best to consult with your doctor or a qualified healthcare professional.
