Lexiscan is a pharmaceutical drug used to diagnose coronary artery disease (CAD). It is a vasodilator, which means it widens blood vessels. This allows blood to flow more easily to the heart, which can help doctors to detect blockages in the arteries.
In 2013, the U.S. Food and Drug Administration (FDA) issued a warning about Lexiscan and a similar drug, Adenoscan, noting there was a “rare but serious risk of heart attack and death.” The FDA ordered the manufacturers of these drugs to change their labels to reflect these risks.
As a result of the FDA’s warning, several lawsuits were filed against Astellas Pharma Inc., the manufacturer of Lexiscan. The lawsuits allege that Astellas failed to adequately warn doctors and patients about the risks of the drug.
In 2018, Astellas reached a $190 million settlement with the U.S. government to resolve allegations that the company had illegally marketed Lexiscan for unapproved uses. The settlement did not resolve the private lawsuits against Astellas.
The private lawsuits against Astellas are ongoing. In 2023, a federal judge in Florida ruled that Astellas could not be held liable for heart attacks that occurred after patients were given Lexiscan during stress tests. However, the judge allowed the lawsuits to proceed on other claims, such as that Astellas failed to adequately warn doctors about the drug’s risks.
The Lexiscan lawsuits are complex and it is too early to say how they will ultimately be resolved. However, the lawsuits have already raised important questions about the safety of Lexiscan and the role of pharmaceutical companies in warning doctors and patients about the risks of their drugs.
