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A woman suffering from kidney failure has filed a lawsuit alleging her injuries were caused by the side effects of Invokana, a new-generation diabetes drug that has been linked to a number of serious health concerns.
The complaint (PDF) was filed by Geanie Jackson in the U.S. District Court for the District of New Jersey on December 12, indicating that Johnson & Johnson, it’s Janssen Pharmaceuticals subsidiary, and Mitsubishi Tanabe Pharma Corp. failed to adequately warn doctors and consumers about the risk of kidney damage and kidney failure that may be caused by side effects of their diabetes drug.
Jackson indicates that she was first prescribed Invokana in June 2013, which was just months after the medication was approved as the first member of a new class of diabetes treatments known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.
The medication works in a different way from other diabetes drugs, impacting the normal kidney functions to increase the amount of sugar excreted in the urine. Amid aggressive marketing by the manufacturers, it has quickly grown to become a blockbuster drug. However, as more individuals have switched to the drug, a steady stream of serious side effects have emerged.
Jackson indicates that she agreed to use Invokana in an effort to reduce her blood sugar. However, instead, she alleges that the diabetes drug side effects caused her to develop kidney failure, indicating that the medical problems could have been avoided if warnings had been provided by the manufacturers.
“Defendants knew of the significant risk of severe kidney damage caused by ingestion of Invokana. However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity such risks,” the lawsuit states. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived Plaintiff, Plaintiff’s health care professionals, the medical community, and the general public as to the health risks and consequences of the use of the Invokana.”
The case joins a growing number of similar Invokana lawsuits filed in recent months, including claims by other individuals who developed diabetic ketoacidosis, kidney failure, heart attacks and other injuries.
In May 2015, the Institute for Safe Medication Practices (ISMP) conducted a detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, and identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors, raising questions about whether the benefits provided by the medication justify the risk.
In June 2016, the FDA required the drug makers to add new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
In addition to kidney failure, Invokana diabetic ketoacidosis problems can cause low blood sugar, low potassium levels that can interfere with the functioning of the heart, muscles and nervous system, and can also cause swelling of the brain. If left untreated, ketoacidosis can result in loss of consciousness and even death.
In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new diabetic ketoacidosis warnings to their medications, 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.
As Invokana injury lawyers continue to review and file claims for individuals nationwide, it is widely expected that hundreds, if not thousands, of additional lawsuits may be filed in the coming months and years.