Investigation Launched Against Johnson & Johnson over Neurovascular Events
On January 8, 2025, Johnson & Johnson (J&J) (NYSE: JNJ) issued a press release announcing that they had temporarily paused the U.S. External Evaluation and all U.S. VARIPULSE™ cases while they investigate the root cause of four reported neurovascular events in the U.S. External Evaluation. Levi & Korsinsky, a law firm based in New York, NY, has commenced an investigation into potential securities laws violations concerning this matter.
Background on the U.S. External Evaluation and VARIPULSE™
The U.S. External Evaluation is a study designed to evaluate the safety and efficacy of the J&J’s neurovascular device, the CONCERTO™ Stent System, in the treatment of intracranial large vessel occlusion. The VARIPULSE™ trial is a randomized, controlled, multicenter study that was designed to evaluate the safety and efficacy of the CONCERTO™ Stent System in the treatment of intracranial large vessel occlusion.
Details of the Reported Neurovascular Events
According to J&J’s press release, the four reported neurovascular events occurred between October 2024 and December 2024. Two of these events were stroke-related, while the other two were TIA (transient ischemic attack) events. All four events occurred in patients who received the CONCERTO™ Stent System as part of the U.S. External Evaluation study.
Impact on Johnson & Johnson
Johnson & Johnson’s stock price dropped significantly following the announcement of the paused studies and the investigation by Levi & Korsinsky. The company’s stock price closed at $161.23 on January 7, 2025, but by January 11, 2025, it had dropped to $150.64. The company’s market capitalization also decreased by over $20 billion in the same time period.
Impact on Consumers and the Medical Community
The pause in the U.S. External Evaluation and all U.S. VARIPULSE™ cases could delay the availability of the CONCERTO™ Stent System for the treatment of intracranial large vessel occlusion. This could potentially impact patients who could benefit from the device, as well as healthcare providers who were planning to use it in their practice.
Investigations and Regulatory Response
In addition to the investigation by Levi & Korsinsky, the U.S. Food and Drug Administration (FDA) has also initiated an investigation into the reported neurovascular events. Johnson & Johnson has stated that they are cooperating fully with both the FDA and Levi & Korsinsky in their investigations.
Conclusion
The reported neurovascular events and the resulting investigations and pauses in studies could have significant implications for Johnson & Johnson, consumers, and the medical community. The company’s stock price has dropped, and the availability of their CONCERTO™ Stent System for the treatment of intracranial large vessel occlusion could be delayed. It is important for investors, consumers, and healthcare providers to stay informed about any developments in this situation.
- Johnson & Johnson announced the temporary pause of U.S. External Evaluation and all U.S. VARIPULSE™ cases due to four reported neurovascular events.
- Levi & Korsinsky has commenced an investigation into potential securities laws violations.
- The U.S. Food and Drug Administration (FDA) has also initiated an investigation.
- The reported neurovascular events could delay the availability of the CONCERTO™ Stent System.
- Johnson & Johnson’s stock price has dropped significantly.
