The federal multidistrict litigation overseeing hundreds of products liability lawsuits involving Invokana and Invokamet are moving forward in the U.S. District Court, District of New Jersey. On May 1, 2017, the court has established an initial discovery plan addressing, among other things, bellwether case selection protocol, scheduling and trial dates. The Court had previously indicated that the litigation’s first bellwether trials could begin in September 2018.
There are 288 lawsuits filed in MDL 2750 before US District Judge Brian R. Martinotti in IN RE: Invokana (Canagliflozin) Products Liability Litigation. Plaintiffs who suffered ketoacidosis or kidney damage allegedly related to the use of Invokana or Invokamet. They accuse the drugs’ manufacturers of failing to warn patients about the serious risks potentially associated with the medications.
In an order dated May 5, 2017, the court has barred the filing of multi-plaintiff complaints, apart from those that name a derivative plaintiff, such as a spouse. Multi-plaintiff cases already pending in the litigation as of May 5 are to be severed.
“We are pleased that the Court is moving forward with plans for bellwether trials, as verdicts in these cases could give some insight into how other juries might decide similar lawsuits involving Invokana or Invokamet,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.
FDA Boxed Warning
In related news, the FDA issued a safety alert on May 17 that Invokana and Invokamet have an increased risk of leg and foot amputations.
Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Final results from two clinical trials – 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) – 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. 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.
Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.
Invokana and Invokamet Side Effects
Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor approved by the U.S. Food & Drug Administration (FDA) to treat Type 2 diabetes. The agency approved Invokamet in November 2014. Both drugs lower blood glucose levels by preventing the absorption of sugar by the kidneys, thereby causing it to be eliminated via urine.
The FDA has since issued several safety alerts to warn of side effects potentially associated with the use of Invokana and other SGLT2 inhibitors. In December 2015, for example, the agency announced that the labels for all drugs in this class would be updated to include information about diabetic ketoacidosis, a potentially deadly complication related to the accumulation of toxic acids (ketones) in the bloodstream. The labels were also modified with information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.
In June 2015, the FDA mandated stronger kidney warnings for several SGLT2 inhibitors, including Invokana and Invokamet, after the medications were cited in more than 100 reports of acute kidney injury.