FDA Warning
In August 2018, the FDA issued a warning regarding a possible link between SGLT2 inhibitors and Fournier’s gangrene. The warning came after the FDA’s analysis of events from 2013-2018 found several cases of Fournier’s gangrene in patients receiving SGLT2 inhibitors, including Jardiance. This warning served as the initial trigger for various legal actions against the manufacturers of these drugs, including Boehringer Ingelheim and Eli Lilly.
Legal Actions and Lawsuits
Several lawsuits were filed after the FDA warning, primarily focusing on the manufacturers’ alleged failure to properly warn patients and their physicians about the risk of Fournier’s gangrene. Plaintiffs argue that they were not informed about the potential risks and, therefore, could not make a well-informed decision about their treatment.
Latest in the Litigation
As of recent updates, the litigation process is ongoing. Both sides present robust arguments. The defendants maintain that they had adequately communicated all potential risks through their product labeling and deny any negligence in this matter.
On the other hand, plaintiffs insist that the potential risk of developing Fournier’s gangrene was not sufficiently explained, arguing that, had they been aware of these risks, they might have opted for alternative treatments. Courts have yet not reached a definitive conclusion. This case can potentially prompt further scrutiny regarding the responsibility of pharma companies in providing comprehensive safety data on their drugs and may set precedence for laws regulating drug safety information disclosure.
If you or a loved one has suffered an injury from Jardiance, give us a call at the Michael Brady Lynch Firm at 888-585-5970 or brandon@mblynchfirm.com.
Date: August 15, 2023
Author: Brandon Salter
Citations
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2-inhibitors-diabetes
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9450557/
https://www.drugs.com/medical-answers/jardiance-perineum-3552698/#:~:text=Jardiance%20has%20a%20rare%20side,anus%20and%20vulva%20in%20women