One of the many issues that individuals with diabetes face is the risk of amputation related to diabetic neuropathy. The loss of sensation in a person’s feet can cause injuries that don’t heal that then become infected. Managing one’s diabetes is important to avoiding these problems.
In recent years there have been advances in medication that help individuals manage their diabetes. What most people probably do not expect is a medication designed to control the disease being a cause of amputations.
However, the law firm of Parker Waichman, LLP has filed a lawsuit in New Jersey alleging exactly that. The lawsuit, filed against Johnson & Johnson and Janssen Pharmaceuticals by two individuals, alleges that the drug makers knew that their Invokana, Invokamet, and Invokamet XR diabetes medications could lead to an increased risk of amputation of toes, feet, and legs, but concealed that risk from consumers and the medical community. As a result, the suit alleges, the two plaintiffs each lost legs below the knee.
The plaintiffs are not alone in this belief. The European Medicines Agency, the group tasked with approving drugs for sale in the European Union, issued a warning in early 2017 that use of these drugs could lead to a significant increase in the risk of amputations. The Food and Drug Administration, the US Agency tasked with approving medications for sale in the United States, issued its own warning in late 2017 following the results of two studies of individuals using these types of medications being published, which showed that using drugs like Invokana resulted in an increased risk of amputation. The FDA now requires packaging for Invokana, Invokamet, and Invokamet XR to carry what’s sometimes called a “Black Box Warning”, which is the strongest warning the FDA issues, and is only used in situations where a drug carries a serious risk of adverse or life-threatening effects.
These drugs can be difference-makers for individuals with diabetes. But anyone choosing to use these drugs should be fully aware of the possible consequences. Unfortunately, individuals who began taking these drugs prior to 2017 were deprived of what could reasonably be considered critical information; namely, that these drugs could increase their chances of amputation.
“Anyone with diabetes knows that amputation is a possible complication,” said Peter Tragos, a partner with Tragos, Sartres, and Tragos, a law firm that represents individuals in dangerous drug matters. “However, deciding to take a medication that could improve your life but that also carries with it the possibility that amputation could be more likely should be made with all the facts. Based on what we know, Johnson & Johnson and Janssen Pharmaceuticals knew all the facts but kept them from the public.”
