Plaintiffs Mitchell B. and his spouse Jessica B. have filed a lawsuit in U.S. District Court against Janssen Research and Development Inc., Johnson and Johnson Inc. and related companies, who are developers and distributors of Invokana. The couple is joining multidistrict litigation (MDL) 2750 with this action against the pharmaceutical giants.

Mitchell B., a type-2 diabetic, alleges he suffered Invokana kidney complications with symptoms such as nausea, vomiting, dizziness and pain in the abdomen. Ultimately, he was diagnosed with diabetic ketoacidosis twice, with two hospitalizations within a four-day period in July 2014.

He had been taking Invokana since April of the same year. As a result of her spouse’s pain and suffering, Jessica B. is adding her own claim for loss of consortium.

Approval and Marketing History of Invokana

Invokana, one of a class of drugs known as sodium glucose cotransporter-2 inhibitors (SGLT-2), was approved for use of glycemic control in type-2 diabetics by the Food and Drug Administration (FDA) on March 29, 2013.

According to the factual allegations part of the couple’s Invokana lawsuit, the label contained no warning about Invokana kidney complications such as ketoacidosis, renal injury or kidney failure.

The plaintiffs say it was not long after the drug’s approval that the defendants began to promote Invokana for uses not approved by the FDA, such as weight loss, blood pressure reduction and cardiovascular health benefits. The aggressive marketing campaign and failure to disclose Invokana kidney complications allegedly led the medication to a top-selling category. It claims more than $1 billion in sales annually.

Invokana Kidney Complications and Other Problems Acknowledged by FDA

According to the lawsuit, between September 2015 and May 2017, the FDA openly acknowledged problems associated with SGLT-2 drugs including Invokana. In September 2015, it was revealed that they have been linked to premature bone loss and fractures.

In October 2015, FDA announced SGLT-2 inhibitors like Invokana had been associated with kidney issues such as ketoacidosis, kidney infections, and urosepsis. In May 2016 and again in May 2017, Invokana and other SGLT-2 medications were identified as an additional risk factor for amputations.

In June 2016, the FDA announced severe renal system impairment, anaphylaxis shock, and angioedema are possible side effects that can come from use of SGLT-2 drugs.

The Plaintiffs Complaints Regarding Invokana Kidney Complications

Mitchell and Jessica B., having allegedly suffered as a result of the actions and omissions of the defendants in this case, are bringing the following complaints against them: Count 1 – Design Defect; Count 2 – Failure to Warn; Count 3 – Negligence; Count 4 – Breach of Implied Warranty; Count 5 – Breach of Express Warranty; Count 6 – Fraudulent Misrepresentation; Count 7 – Loss of Consortium.

The plaintiffs are asking for a trial by jury, compensatory damages that include payment for pain and suffering, loss of wages past and future, all associated medical costs, and all attorney fees and court costs.

They are also asking for the assessment of punitive damages to deter defendants from such negligent and fraudulent activities in the future.

The Invokana Lawsuit is Case No. 3:17-cv-04504-BRM-LHG, in the U.S. District Court for the District of New Jersey.