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Janssen Pharmaceuticals and Johnson & Johnson knew or should have known that side effects of the diabetes drug Invokana could result in the development of diabetic ketoacidosis, according to allegations raised in a recently-filed product liability lawsuit.
Late last month, Kathleen and William Ciccotti filed a complaint (PDF) against the drug manufacturers in the U.S. District Court for the District of New Jersey, indicating that the diabetes drug caused Kathleen Ciccotti to suffer diabetic ketoacidosis, which is a dangerous medical emergency involving the buildup of acid levels in the blood.
According to the lawsuit, Ciccotti was prescribed Invokana in September 2014. However, she was hospitalized in January 2016 due to diabetic ketoacidosis, which resulted in severe pain and substantial expenses for medical care and treatment.
The complaint indicates that the drug makers failed to provide adequate warnings for the medical community and patients about the link between diabetic ketoacidosis and Invokana, as well as other health risks associated with the controversial new-generation diabetes drug, which was just introduced in March 2013.
“Kathleen Ciccotti’s injuries 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,” the lawsuit states. “The conduct and the product defects were substantial factor in bringing about Plaintiff’s injuries.”
Nearly 1,000 other similar Invokana lawsuits have been filed at the federal level in the U.S. District Court for the District of New Jersey, where they are currently centralized for coordinated pretrial proceedings, as part of a federal multidistrict litigation (MDL) before U.S. District Judge Brian R. Martinotti.
Given common questions of fact and law raised in claims brought on behalf of individual nationwide, the federal litigation is centralized to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.
Invokana (canagliflozin) was the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class now include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.
As more and more diabetics have switched to Invokana since it hit the market in 2013, a steady stream of serious health concerns have emerged from post-marketing adverse event reports, leading the FDA to require several warning label updates over the past few years.
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
More recently, in May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other SGLT2 inhibitors claim is a unique risk with Invokana, not seen with their competing drugs.
As part of the coordinated pretrial proceedings in the federal court system, it is expected that a small group of “bellwether” cases will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
Following any bellwether trials, if Invokana settlements or another resolution for the cases is not found, Ciccotti’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.