Januvia Legal News Articles & Interviews

Trenton, NJ: The FDA warns of fracture risk with Invokana and Invokamet and more recently of a higher risk for foot and leg amputation. The lawsuit chickens have now come home to roost.

Los Angeles, CA: When Janumet (sitagliptin and metformin combined) was approved by the US Food and Drug Administration (FDA) in 2007, the type 2 diabetes drug was within five years of achieving sales of $1.7 Billion. That year, when Janumet hit blockbuster status by 2012, the parent drug of Janumet – Januvia – earned $4 Billion for manufacturer Merck & Co. Januvia has been associated with Januvia side effects, and has resulted in Januvia cancer lawsuits.

Philadelphia, PA Final results from two independent clinical trials indicate the amputation risk for users of the Type 2 Diabetes drug Canagliflozin, marketed as Invokana, Invokamet, Invokamet XR, are much greater than previously understood.


The FDA was so concerned about the information the studies provided that it moved immediately to ensure consumers are warned about the increased risk of leg and foot amputations through a Boxed Warning label on all Invokana prescriptions.


“I think the fact that the independent clinical trials lead to a situation where the FDA went straight to a black box warning, its highest level of scrutiny, just shows how important and how critical this information is to the public,” says Brian J. McCormick Jr., a Philadelphia attorney from the firm of Ross Feller Casey.


To McCormick, Jr. the studies confirm and add significant weight to the many personal injury claims he and his firm are bringing forward on behalf of diabetic Americans that allege they have been injured as a result of using Invokana to control their Type 2 Diabetes Mellitus.


The studies (CANVAS Canagliflozin Cardiovascular Assessment Study) and the CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) showed, according to a FDA website safety warning (May 2017), that leg and foot amputation occurred about twice as often in patients treated with Canagliflozin compared to patients taking a placebo.


“It is a terrible progression for some of these patients,” says McCormick. “They go in and they have a diabetic foot ulcer and they don’t how bad it is. They have one amputation and then they go back and have another toe removed – and next thing they know they have half their foot removed.”


According to the FDA safety communication on May 15, 2017, “Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.”


“Our firm is investigating both Ketoacidosis cases and we are also investigating amputation cases,” says McCormick. “We have a number of clients we are working with and I think at the end of the day what this new information shows, and will show in court, is that Johnson & Johnson did know that this risk existed and chose not to do anything about it.”


Canagliflozin is licensed for sale in North America by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The drug is designed to be used in combination with diet and exercise to lower blood sugar levels in Type 2 diabetes patients. The drug is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that causes sugar to be eliminated through the urine.


Invokana was first approved for sale by the FDA in March 2015. Within three months the FDA had 100 reports of Ketoacidosis and kidney damage in Invokana users. In May 2015, the FDA ordered the label contain a Ketoacidosis warning. By 2016, the FDA had added possible kidney damage to the Invokana warnings. In May 2017, it added increased risk of amputation.


“Some of these patients are otherwise healthy but for this terrible injury all of a sudden. They have been on this drug for a few months, or perhaps a few years and now they are seeing this Box Warning and putting two and two together,” McCormick says. “All of a sudden this is happening. No one told them about this and it would have changed how they handled their diabetes.”


The Invokana lawsuits have been consolidated in an MDL in New Jersey. The cases are going through case management process with discovery expected at a later date. It will be some time before the cases go to trial.

Boston, MA Results of a new study gave Merck’s diabetes drug Januvia a clean bill of health, particularly regarding Januvia heart issues. But there is still some concern about the drug’s link to acute pancreatitis.

Atlanta, GA If Marti hadn’t researched Januvia after her husband died from pancreatic cancer, she too might also have suffered serious Januvia side effects. “When my doctor prescribed Januvia, I remembered that my husband Don had taken it and there was no way I was going to get Januvia cancer,” says Marti.

Fort Myers, FL Although Claudeth’s father was diabetic, she believes that Januvia killed him. “It wasn’t until after he died that we heard about its link to pancreatitis and Januvia pancreatic cancer. My dad was only 60 years old,” says Claudeth.

La Crosse, WI Robert believes that he wouldn’t be alive today if not for his pharmacist and wife intervening when he was prescribed Januvia during a hospital stay.

San Diego, CA As of November 2014, more than 540 incretin mimetics lawsuits, concerning a class of drugs that includes Januvia, have been filed in the Southern District of California. Claims have been on the rise since the FDA, in March 2013, warned the public that a study had found precancerous changes in the pancreatic cells of Januvia, Byetta and Victoza users.

Stouffville, ON After several months of pain, Marcello was diagnosed with pancreatitis, but after he was told to stop taking Januvia. “My doctor never mentioned Januvia pancreatitis but he did tell me to stop taking it,” says Marcello. Needless to say, Marcello changed doctors and he is furious with the Januvia manufacturer.

New York, NY Product liability claims involving incretin mimetic medications such as Januvia are moving forward in courts nationwide. Plaintiffs allege they developed pancreatic cancer due to their use of these drugs.