PHILADELPHIA – More lawsuits are alleging that Johnson & Johnson’s diabetes medication, Invokana, gave them an increased risk of suffering amputations – and that the company failed to warn them of that same risk.
Brian Stewart, Timothy Yancer and James Marquez, all of Houston, individually filed suit in the Philadelphia County Court of Common Pleas on Sept. 12 versus Janssen Pharmaceuticals, Inc. in Horsham and Janssen Research & Development, LLC in Raritan, N.J.
“Stewart was prescribed and supplied with, received and has taken the prescription drug Invokana. This action seeks, among other relief, general and special damages and equitable relief due to plaintiff suffering severe and life-threatening injury, amputation of multiple toes on his left foot, and Diabetic Ketoacidosis (DKA),” Stewart’s lawsuit states.
“Yancer was prescribed and supplied with, received and has taken the prescription drug Invokana. This action seeks, among other relief, general and special damages and equitable relief due to plaintiff suffering severe and life-threatening injury, amputation of the second toe on his right foot, and wound and bone debridement of left fifth metatarsal,” Yancer’s lawsuit reads.
“Marquez was prescribed and supplied with, received and has taken the prescription drug Invokana. This action seeks, among other relief, general and special damages and equitable relief due to plaintiff suffering severe and life-threatening injury, amputation of his right leg,” Marquez’s lawsuit says.
The suits state Invokana, which accounts for more than $1 billion in annual sales, is a member of the gliflozin class of pharmaceuticals, also known as sodium-glucose co-transporter 2 (“SGLT2”) inhibitors. Invokana has the highest selectivity for the SGLT1 receptor among SGLT2 inhibitors currently marketed in the United States. SGLT2 inhibitors, including Invokana, are currently approved only for improvement of glycemic control in adults with Type 2 diabetes.
“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,” the suit states.
In May 2012, Janssen R&D submitted a New Drug Application to the FDA for approval to market Invokana in the United States. In March 2013, the FDA approved Invokana as an adjunct to diet and exercise for the improvement of glycemic control in adults with the treatment of Type 2 diabetes.
“Despite defendants’ knowledge of the increased risk of amputation among Invokana users, defendants did not warn patients but instead continued to defend Invokana, misled physicians and the public, and minimized unfavorable findings,” the suit says.
“Defendants failed to adequately warn consumers and physicians about the risks associated with Invokana and the monitoring required to ensure their patients’ safety. Despite defendants’ knowledge of the increased risk of amputation among Invokana users, defendants did not conduct the necessary additional studies to properly evaluate this risk prior to marketing the drug to the general public.”
Each plaintiff allegedly suffered diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of amputation of other body parts, limbs, and/or metatarsals, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions and other losses and damages.
Janssen spokesperson Sarah Freeman previously issued a statement from the company as to the lawsuits brought against it by users of Invokana.
“Invokana (canagliflozin) is an important medicine, used along with diet and exercise, to lower blood sugar in adults with Type 2 diabetes. With real world experience including more than 19 million prescriptions to date, we are confident in its overall safety profile, and will continue to defend against the claims raised in this litigation,” Freeman stated.
For counts of failure to warn (strict liability), negligence, gross negligence, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, fraud, unjust enrichment, violation of the Unfair Trade Practices and Consumer Protection Law, strict liability and breach of warranties, the plaintiffs are seeking trials by jury along with the following relief:
• General damages that will conform to proof at time of trial;
• Special damages in an amount within the jurisdiction of this Court and according to proof at the time of trial;
• Loss of earnings and impaired earning capacity according to proof at the time of trial;
• Medical expenses, past and future, according to proof at the time of trial;
• Past and future mental and emotional distress, according to proof;
• Punitive or exemplary damages according to proof;
• Restitution, disgorgement of profits, and other equitable relief;
• Injunctive relief;
• Attorney’s fees;
• Costs of suit incurred herein;
• Pre-judgment interest as provided by law; and
• Such other and further relief as the Court may deem just and proper.
The plaintiffs are represented by William H. Barfield and Don Worley of McDonald Worley, in Houston, Texas.
The defendants are represented by Brian T. Feeney and Gregory T. Sturges of Greenberg Traurig, in Philadelphia.
Philadelphia County Court of Common Pleas cases 180901313, 180901314 & 180901316
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com