PHILADELPHIA – Another lawsuit from an out-of-state plaintiff joins others in targeting Johnson & Johnson’s Invokana medication for Type 2 diabetes, alleging the company failed to warn him that the drug put him at increased risk for the gangrene he sustained from taking it.
Daniel Stromme of Missoula, Mont., filed suit in the Philadelphia County Court of Common Pleas on Jan. 30 versus Janssen Pharmaceuticals, Inc. in Horsham and Janssen Research & Development, LLC in Raritan, N.J.
“Daniel Stromme was prescribed and has taken the prescription drug Invokana as prescribed by his doctor. As a result, Mr. Stromme suffers from severe and life-threatening injuries; specifically, Fournier’s gangrene and subsequent hospitalization and medical treatment,” Stromme’s lawsuit reads.
The lawsuit says 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.
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 their knowledge of data indicating that Invokana use is associated with and/or causally related to Fournier’s gangrene, defendants promoted and marketed Invokana as safe and effective for persons such as Plaintiff throughout the United States, including in Pennsylvania and Philadelphia,” the suit states.
According to the litigation, Stromme was prescribed the drug in March 2016.
“Plaintiff began taking Invokana on or about March 4, 2016. He took it consistently and as prescribed by his doctor. As a direct and/or proximate result of his ingestion of Invokana, plaintiff was hospitalized and suffered extensive, debilitating injuries, including, but not limited to, Fournier’s gangrene,” the suit states.
“Plaintiff was admitted to the emergency room on Feb. 17, 2017. He presented with a left groin and perineal abscess. During his hospitalization, plaintiff received extensive medical care and treatment. Specifically, plaintiff underwent an incision and drainage of the abscess of the left groin and perineum, as well as excisional wound debridement involving skin, subcutaneous tissue, fat, and some of the musculature around the left groin area.”
On Aug. 29, 2018, the FDA required that a new warning about the risk of Fournier’s gangrene be added to the labeling for Invokana and other SGLT2 inhibitors, because the FDA observed that cases of Fournier’s gangrene had been reported in patients taking SGLT2 inhibitors.
“From March 2013 to May 2018, the FDA identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor such as Invokana. By comparison, only 6 cases of Fournier’s gangrene were identified by the FDA in a review of other antidiabetic drug classes over a period exceeding three decades. The FDA noted that additional cases of Fournier’s gangrene likely existed,” the suit says.
Janssen 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,” the company 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 and unjust enrichment, the plaintiff is seeking a trial by jury along with damages, jointly and severally, in excess of $50,000, plus interest, costs, punitive damages, treble damages and such other relief this Court deems just and proper.
The plaintiff is represented by Eric H. Weitz of The Weitz Firm in Philadelphia, plus Jason C. Webster and Michael M. Gallagher of The Webster Law Firm, in Houston, Texas.
The defendants are represented by Brian T. Feeney, Gregory T. Sturges and George Jeffrey Farrell of Greenberg Traurig, also in Philadelphia.
Philadelphia County Court of Common Pleas cases 190102947
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at firstname.lastname@example.org