Parker Waichman files lawsuits on behalf of two below the knee amputees after the FDA concludes that Johnson & Johnson, Co. and Janssen Pharmaceuticals, Inc.’s sodium-glucose co-transporter-2 (SGLT2) inhibitor diabetes treatment drugs Invokana, Invokamet, and Invokamet XR cause an increased risk of amputations of toes, feet and legs. The European Medicines Agency (EMA) also has informed patients about potential increased risk of amputations for patients taking any SGLT2 inhibitors.
Parker Waichman LLP, a national law firm that has long fought to protect the rights of victims injured by allegedly defective drugs and medical devices, announces that it has filed two lawsuits in New Jersey State Court – the Superior Court of New Jersey Law Division, Middlesex County against Johnson & Johnson, Co. (“Johnson & Johnson”) and Janssen Pharmaceuticals, Inc. (“Janssen”) on behalf of two individuals who suffered below the knee amputations attributed to their use of Invokana.
According to the complaint filed on behalf of Robert E. Shook, a 60-year-old resident of Alabama, after beginning treatment with Invokana in January 2015, Mr. Shook was required to undergo left foot and below-knee, left leg amputations on or about December 15, 2015 and January 15, 2016, respectively (Docket No. MID-L-007339-17). Mr. Shook no longer takes Invokana.
The second complaint, filed on behalf of Michael A. Wilkinson, a 53-year-old Iowa resident, alleges that after Mr. Wilkinson began taking Invokana in April 2015, he had to undergo a below-knee, right leg amputation on or about December 14, 2015 as a result of his Invokana use (Docket No. MID-L-007338-17). Mr. Wilkinson also no longer takes Invokana.
Both lawsuits contend that Johnson & Johnson and Janssen concealed, and continue to conceal, their knowledge of Invokana’s unreasonably dangerous risks of lower limb amputations from consumers and the medical community. The lawsuits also allege that as a result of the defective nature of Invokana, in addition to the below-knee leg amputations suffered by Mr. Shook and Mr. Wilkinson, persons who were prescribed and took Invokana risked or suffered additional severe and permanent personal injuries, including amputations, kidney failure, diabetic ketoacidosis, stroke, and heart attack.
In March 2013, the United States Food and Drug Administration (“FDA”) approved Invokana (canagliflozin) for the treatment of type 2 diabetes. In November 2013, the European Medicines Agency (“EMA”) allowed Invokana to be sold in the European Union. Despite its significant risks of injuring users, Invokana has been one of Janssen and Johnson & Johnson’s top selling drugs in recent years, with reported sales of $1.31 billion worldwide in 2015 and $1.41 billion worldwide in 2016.
On February 24, 2017, the EMA issued information “about a potential increased risk of lower limb amputation (mostly affecting the toes) in patients taking the SGLT2 inhibitors canagliflozin [Invokana], dapagliflozin [Farxiga] and empagliflozin [Jardiance] used for type 2 diabetes.” The EMA review of SGLT2 inhibitors was prompted by an increase in lower limb amputations reported for patients taking canagliflozin (Invokana) in two large clinical trials, CANVAS and CANVAS-R, even though the final results of those trials had not yet been made available to the public.
The EMA noted that “[a]n increase in lower limb amputations has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines.”
On May 16, 2017, the FDA issued a Drug Safety Communication confirming an “increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR).” The Drug Safety Communication indicated that “[b]ased on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.” The two clinical trials that the FDA relied on in requiring new warnings to be added to the Invokana drug labels were the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus).
The FDA also announced in the May 16, 2017 Drug Safety Communication that it was “requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.” The “Boxed Warning,” also known as a “Black Box Warning,” was added in the United States to the Invokana label/package insert on July 25, 2017, and states:
WARNING: LOWER LIMB AMPUTATION
See full prescribing information for complete boxed warning.
• In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, INVOKANA has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg (5.1)
• Before initiating, consider factors that may increase the risk of amputation. Monitor patients receiving INVOKANA for infections or ulcers of the lower limbs, and discontinue if these occur. (5.1)
Parker Waichman commends the EMA for notifying patients promptly about the potential for an increased risk of lower limb amputations with the use of any SGLT2 inhibitor before the final CANVAS and CANVAS-R study results were published. Parker Waichman also commends the FDA for their swift and decisive action in requiring a label change after the publication of the final results from these two clinical trials that “showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment.” The FDA also noted that the risk of leg and foot amputations may be even higher for some people, “including those who have peripheral vascular disease, neuropathy (nerve damage), or diabetic foot ulcers (sores), or who have a history of prior amputation.”
“Given what we now know, unfortunately we are seeing an increasing number of people who suffered lower limb amputations after taking Invokana and Invokamet. The seriousness of the injuries and risks associated with these drugs that have finally been released to the public require justice for those who have been wrongly affected and now must struggle with diminished quality of life and disability,” said Jerrold S. Parker, Senior Partner at Parker Waichman. “We urge patients to stay informed about any new information that may be released about any SGLT2 inhibitors used for type 2 diabetes, not just Invokana, and to tell their doctor right away if they notice any wounds or discoloration on their feet or toes.”
Filing an Invokana and/or Invokamet Lawsuit
Parker Waichman has represented clients in pharmaceutical injury lawsuits for decades. If you or someone you know is interested in filing an Invokana/Invokamet lawsuit, please visit Invokana Lawsuit Lawyers, or contact Parker Waichman LLP at the firm’s website at yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).