Johnson & Johnson’s Janssen Pharmaceuticals is trying to dismiss allegations that its popular type-2 diabetes drug Invokana caused a man to develop a life threatening condition, ketoacidosis.

The drug company challenged several of the plaintiff’s claims including failure to warn, strict liability, breach of warranty, and design defects.

Plaintiff Arthur P. filed the Invokana side effects lawsuit back in December in the Philadelphia County Court of Common Pleas. Arthur alleges he began taking Invokana in November 2014 and developed ketoacidosis, a life-threatening condition that caused him to  be hospitalized in February 2015.

Arthur currently resides in Texas but claims he took Invokana in Philadelphia when he was living in Delaware.

Ketoacidosis is a condition in which too much acid builds up in the blood. If left untreated, it can lead to diabetic coma and death. The condition is generally seen in patients with type 1 diabetes who develop high blood sugar. However, type 2 diabetics taking Invokana may be at risk for developing ketoacidosis without registering high blood sugar levels.

Arthur’s design defect claim alleges Invokana’s risks outweigh its benefits. His lawsuit also claims that Janssen was aware of the risks Invokana posed but failed to adequately warn the public, nor did the company conduct enough studies to ensure the drug’s safety in patients.

The Invokana side effects lawsuit also accuses the drug company of not notifying the FDA about the risks associated with the type 2 diabetes drug.

Invokana Side Effect Claims Challenged

Janssen has stated that it would aggressively fight back against Arthur’s claims and issued a response last month that strict liability did not apply under Delaware or Pennsylvania law, and that Arthur’s claims for breach of warranty are without merit. Therefore, the drug company argued, the Invokana side effects lawsuit should be tossed.

“First, courts should identify what action the plaintiff’s state-law claim would require the defendant to take,” the drug maker argued. “Second, courts should determine whether there is a federal law or regulation that prevents the defendant from taking that action independently, meaning without a federal agency’s “special permission and assistance.”

Additionally, the pharmaceutical giant added that Arthur lacks standing in regards to his breach of warranty claims involving Invokana’s safety.

“To the extent plaintiff alleges that the prescribing information for Invokana contained such a warranty, he is simply mistaken,” the company said. “The prescribing information — which the court may judicially notice — does not contain an unqualified statement that Invokana is ‘safe and effective.’”

Further, Janssen stated the entire case should be dismissed on grounds that the lawsuit lacks overall specificity by targeting Johnson & Johnson, Janssen, and Janssen Research & Development LLC.

“Plaintiff repeatedly refers to the collective ‘defendants’ throughout his complaint without identifying the allegedly wrongful conduct of any individual defendant,” the dismissal motion said.

Invokana is already linked with cardiovascular and kidney failure, among other adverse Invokana side effects. Diabetic ketoacidosis is something new, in that it normally affects individuals with type 1 diabetes. The fact that it has begun to emerge in patients with type 2 diabetes is enough of a concern for the FDA to mandate a warning on all diabetes medication in this drug class.

The Invokana Ketoacidosis lawsuit is Case No. 151200653, in the Philadelphia County Court of Common Pleas.