Invokana Wrongful Death Lawsuit Filed Over Ketoacidosis, Kidney Damage, Heart Attack And Stroke

According to allegations raised in a recently filed wrongful death lawsuit, Invokana side effects caused a woman to suffer diabetic ketoacidosis, severe kidney damage, a heart attack, and a stroke, all of which eventually contributed to her death.

The complaint (PDF) was filed in the U.S. District Court for the Middle District of Louisiana on May 10, following the death of Ide Mae Jones Jackson on February 6, 2016.

The family alleges that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary knew or should have known about the risks associated with Invokana, yet withheld information from consumers and the medical community when they introduced and began aggressively marketing their new-generation diabetes drug in 2013.

Jackson began taking Invokana in February 2015, and used the diabetes drug until her death a year later. After she began using the drug, Jackson suffered diabetic ketoacidosis, severe kidney damage, a heart attack and a stroke. When she began using the drug, neither she nor her doctors were warned that Invokana was linked to these potential health risks, according to the lawsuit.

“The development of the injuries at issue herein were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” according to the complaint. “This conduct and the product defects complained of herein were substantial factors in bringing about and exacerbating Ida Jackson’s injuries and the damage to Ida Jackson’s family and children.”

The case joins a growing number of Invokana lawsuits filed in recent months over problems associated with the diabetes drug, which has only been on the market for three years. The complaints indicate that the drug makers placed their desire for profits before consumers safety by failing to adequately research the medication before it was introduced and aggressively marketed as a superior diabetes treatment.

Invokana Risks

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Amid aggressive marketing by the drug maker following approval, the medication was quickly adopted by the medical community, but a steady stream of potential safety risks with Invokana have emerged over the past few years.

Only two years after the drug was introduced in the United States, the FDA launched an investigation into a link between Invokana and ketoacidosis in May 2015, after identifying at least 20 reports of individuals being hospitalized due to acid problems with the drug or other members of the SGLT2 inhibitor class of diabetes medications.

Following a safety review, the FDA ultimately required Johnson & Johnson to add new Invokana warnings about ketoacidosis in December 2015, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In September 2015, the FDA required new Invokana bone fracture warnings, indicating that the drug may also lead to decreased bone density.

A detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, which was conducted by the Institute of Safe Medication Practices (ISMP), identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors.

Invokana and other members of this new-generation diabetes treatments work in a unique way, by impacting the normal function of the kidneys. However, investigators identified reports of kidney failure and other problems that they suspected were caused by the medication. Other members of the SGLT2 inhibitor class of diabetes drugs include Invokamet, Farxiga, Xigduo, Jardiance and Glyxambi.