A BRIEF HISTORY OF INVOKANA LITIGATION
Plaintiff Arthur Portnoff filed suit against Janssen Pharmaceuticals in the Court of Common Pleas in Philadelphia, alleging that his use of Invokana as a treatment for type 2 diabetes had caused his diabetic ketoacidosis. Portnoff further claimed that Janssen had been aware of serious harms associated Invokana but had withheld material information from the FDA and failed to warn patients adequately. Portnoff’s suit came just days after the FDA issued a revised Invokana label that included a new warning about the risk of ketoacidosis. In a prepared statement, a Janssen spokeswoman said, “With real world experience that includes more than five million prescriptions to date, we are confident in the overall safety profile of Invokana.”
A collection of plaintiffs suing Johnson & Johnson and Janssen Pharmaceuticals over acute kidney damage allegedly caused by Invokana issued a request to the Judicial Panel on Multidistrict Litigation (JPML) in Miami asking that the panel consolidate their cases in multidistrict litigation (MDL) to be heard before a federal court in New Jersey. The initial MDL request covered 56 cases in 11 districts. Later in the month, the JPML granted plaintiffs’ request for consolidation.
Immediately following approval of the federal MDL, plaintiffs in 87 Invokana-related cases requested that a Philadelphia County judge combine their cases into a mass tort, arguing that doing so would streamline the judicial process and result in more consistent rulings. In their filings, plaintiffs alleged that sales of Invokana totaled in excess of $1 billion annually.
Defendant Janssen Pharmaceutical filed a motion requesting that over 100 Invokana-related cases that plaintiffs had brought against the company in the Court of Common Pleas of Philadelphia be removed to federal district court in New Jersey as part of the recently approved MDL there.
A Pennsylvania federal court sided with defendants Janssen and Johnson & Johnson when it rejected plaintiffs’ request to return their cases to the Court of Common Pleas in Philadelphia as part of a mass tort action. The move brought the pharmaceutical companies one step closer to their goal of consolidating the Pennsylvania state court cases with the MDL in New Jersey federal court. Following its victory, Johnson & Johnson released a statement that read in part, “With real-world experience that includes more than 10 million prescriptions to date, we are confident in the overall safety profile of Invokana.”
In a case management conference for the Invokana MDL, a federal district court in New Jersey confirmed its expectation that the first trial would begin sometime around September 2018. As of the date of the conference, the 1001 cases involving 902 different complainants had been filed as part of the MDL.
Invokana usage can increase the risk of leg and feet amputations
The U.S. Food and Drug Administration has confirmed that Janssen Pharmaceuticals’ diabetes medications Invokana and Invokamet can increase the risk of patients needing to have their legs or feet amputated and said the drugs will now require black-box warnings. A black box warning is the strongest possible warning. This is a widely prescribed drug for Type 2 diabetes and was approved by the FDA in 2013.
Most of the amputations involved the foot or a toe, with some others involving legs, with some patients needing more than one amputation.
“Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns,” the agency said in a safety communication. “Do not stop taking your diabetes medicine without first talking to your health care professional.”
The amputation warning is in addition to the concerns the medication can cause a condition known as diabetic ketoacidosis, in which the body produces excess blood acids known as ketones. Lawsuits have been filed regarding this issue in both State and Federal court.
If you took Invokana and suffered the horror of needing an amputation, the attorneys at TheLawFirm.com are here to help you.