A woman from Florida alleges Johnson & Johnson’s Invokana diabetes drug caused her severe and permanent injuries, including multiple lower limb amputations.

Plaintiff Joyce A. filed this Invokana lawsuit after discovering the FDA recently issued a warning stating that Invokana and other canagliflozin based medications could increase the risk of lower limb amputations.

She opted to join a growing multidistrict litigation (MDL), consisting of similar Invokana and Invokamet lawsuits alleging the type-2 diabetes medication had failed in its purpose of preventing serious diabetic complications, which forced most of them to undergo at least one lower limb amputation.

According to her Invokana lawsuit, Joyce was prescribed the medication in April 2015 to help manage her blood sugar levels and followed prescription instructions.

When used with diet and exercise, the Invokana diabetes drug was supposed to help Joyce live a normal life without the risk of serious diabetic complications. However, Joyce says she soon developed serious health problems related to type-2 diabetes.

Overview of Invokana Lawsuit

According to the Invokana lawsuit, Joyce reportedly developed a painful diabetic ulcer on her right foot in June 2015 but doctors kept her on the Invokana prescription.

Joyce says she had a prior history of amputations, but was still prescribed the Invokana diabetes drug. Invokana’s warning label allegedly failed to mention any possible risk of amputation nor did it state that patients with a prior history of amputations could face an increased risk.

She claims the warning label also failed to inform prescribing physicians of the alleged correlation between the drug and amputation. The FDA warning advising physicians to switch at risk patients to a different type-2 diabetes treatment drug was unknown.

Based on this information, Joyce says she continued to take Invokana, and her diabetic foot ulcer alegedly tripled in size in just a few weeks. Not long after, on Sept. 29, 2015, Joyce says she underwent a procedure that removed one or more bones connecting the toes to the foot to try and alleviate the pain she was in, but the significant pain still persisted.

Later medical tests allegedly confirmed another wound surrounding her metatarsal stump had reached all the way to her bone and was causing significant swelling throughout her right foot and ankle. The Invokana lawsuit states that Joyce eventually developed an infection in the right foot, and underwent a second amputation surgery to remove the extremity on Nov. 19, 2015.

However, Joyce says she had to undergo a third procedure a few days later – a below the knee amputation of her right leg on Nov. 23, 2015, to prevent the infection from spreading. This has left Joyce a double amputee, which has greatly diminished her quality of life.

Diabetic Amputation Risk

Diabetic amputations sometimes become necessary when blood flow to the lower extremities become compromised due to neuropathy and health issues like peripheral artery disease (PAD). Any condition that causes the blood vessels to narrow could increase the risk of diabetic amputations, infection, and ulcers.

The FDA released a drug safety notice that Invokana and other canagliflozin medications could increase the risk of this on May 16, 2017, after reviewing the results of the CANVAS and CANVAS-R studies.

Even though these complications can be devastating to patients, Johnson & Johnson and subsidiary Janssen Pharmaceuticals allegedly failed to warn against this correlation. Joyce’s Invokana lawsuit is joining MDL No. 2750, and is seeking multiple damages including negligence and failure to warn.

Her Invokana Lawsuit is Case No. 3:19-cv-06167, in the U.S. District Court of New Jersey.