Lexiscan, a heart imaging drug, faces ongoing lawsuits alleging inadequate risk warnings by its manufacturer, Astellas, following an FDA warning about potential heart attack and death risks. While a 2023 ruling shielded Astellas from some liability, legal battles continue regarding other claims.
Lexiscan, a vasodilator drug, helps diagnose coronary artery disease (CAD) by enhancing blood flow during imaging. However, shadows of risk emerged in 2013 when the FDA warned about “rare but serious” heart attack and death dangers associated with Lexiscan and its counterpart, Adenoscan. Consequently, the FDA mandated label changes reflecting these risks.
This sparked a wave of lawsuits against Astellas, the manufacturer, alleging:
- Inadequate Risk Warnings: Plaintiffs claim Astellas failed to properly inform doctors and patients about the potential life-threatening risks associated with Lexiscan.
Despite a $190 million settlement with the U.S. government in 2018 regarding illegal marketing practices, the private lawsuits against Astellas persisted.
The Legal Landscape:
The legal terrain surrounding Lexiscan is intricate and evolving:
- 2023 Ruling: A Florida federal judge ruled in Astellas’ favor regarding liability for heart attacks directly following Lexiscan administration during stress tests.
- Ongoing Claims: However, the judge allowed lawsuits pursuing other claims to proceed, including insufficient doctor warnings about Lexiscan’s risks.
Uncertain Resolution:
With legal proceedings still underway, a definitive outcome remains elusive. However, the lawsuits have served as a catalyst for crucial discussions:
- Drug Safety: Heightened awareness of potential Lexiscan risks and the importance of transparent communication about adverse effects.
- Pharmaceutical Responsibility: Scrutiny of pharmaceutical companies’ obligations to accurately inform about drug risks and adhere to legal regulations.
| Complete Date | Case | Citation | Court | Short Summary |
|---|---|---|---|---|
| 2013 | N/A (FDA Warning) | N/A | N/A | FDA warns about rare but serious risks of heart attack and death associated with Lexiscan and Adenoscan. |
| 2018 | United States ex rel. Escobar v. Astellas Pharma Inc. | Not available (settlement) | N/A | Astellas settles with the U.S. government for $190 million regarding illegal marketing practices for Lexiscan. |
| 2023 | Various individual lawsuits against Astellas Pharma Inc. | N/A (ongoing) | U.S. District Court for the Southern District of Florida | Lawsuits allege various claims against Astellas regarding Lexiscan, including inadequate risk warnings. Judge ruled in Astellas’ favor regarding heart attack liability after stress tests but allowed other claims to proceed. |
