Lawsuits Against Invokana Diabetes Medication Progressing

Dozens of lawsuits against Janssen Pharmaceuticals have been consolidated in New Jersey federal court, according to an order issued Dec. 7. The claims argue that the company did not properly test its Invokana diabetes drug or warn consumers about risks.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) found that lawsuits against the drug company, which is a subsidiary of Johnson & Johnson, involve shared allegations and factual questions that would make consolidation more efficient.

“The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage,” the panel said in its order. “The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.”

Invokana and Invokamet are SGLT2 inhibitors used to treat Type 2 diabetes by preventing the kidneys from reabsorbing glucose into the bloodstream. That excess glucose is flushed out of the body through urination.

Last week’s order involves 55 cases related to Invokana and its sister drug Invokamet. Eighteen cases from other district courts were consolidated with 37 pending actions already pending in New Jersey. The 18 other actions came from districts in states, such as California, Georgia, Illinois, Kentucky, Minnesota, and Virginia. Another 44 cases are expected to be filed in New Jersey federal court.

Panel Decides Consolidation More Efficient and Convenient

Along with deciding that the cases against Invokana all share similar claims and factual questions, the JPML chose consolidation to improve the efficiency and convenience of litigation.

The panel wrote that Janssen Pharmaceuticals is headquartered in New Jersey and many of the witnesses and relevant documents are likely to be found in the state, adding “centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.”

The multidistrict litigation (MDL) has been assigned to U.S. District Judge Brian R. Martinotti, another reason why the panel issued an order for consolidation.

“Finally, centralization in the District of New Jersey allows us to assign the litigation to Judge Brian R. Martinotti, an able and experienced jurist who has not had the opportunity to preside over an MDL,” the panel said. “Judge Martinotti already is presiding over the constituent and tag-along actions pending in the district, and we are confident that he will steer this litigation on a prudent course.”

But the panel decided against adding cases to the MDL that dealt with diabetes drugs marketed and distributed by other companies. At least 20 similar lawsuits have been filed against the companies behind Farxiga and Jardiance.

“Centralizing competing defendants in the same MDL may unnecessarily complicate case management, due to the need to protect trade secret and confidential information,” the panel said.

Adding multiple defendants to the MDL may also result in prolonged pretrial proceedings because of the need for separate discovery and motion tracks, the panel added.

Lawsuits Involve Claims Janssen Knew Risks

In their brief to the court, plaintiffs allege that Janssen Pharmaceuticals knew of a significant risk of kidney damage to those who ingested Invokana but failed to warn the public or medical community of such severe risks.

“To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived Plaintiff, her health care professionals, the medical community, and the general public as to the health risks and consequences of the use of the Invokana,” the brief said.

The U.S. Food and Drug Administration (FDA) first approved Invokana in 2013, but between March 2013 and October 2015, the FDA received 101 confirmed reports of acute kidney injury related to SGLT2 inhibitors like Invokana. This prompted the FDA to add the warning of a ketoacidosis risk to SGLT2 inhibitors in 2015.

Despite claims that Janssen Pharmaceuticals knew of the risks and Invokana has caused serious side effects, the company continues to stand by the safety of its drug.

“Invokana is the No. 1 prescribed SGLT2 inhibitor in the United States and is an important medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes,” a spokesperson for Janssen told Law360 in a statement. “With real world experience that includes more than nine million prescriptions to date, we are confident in the overall safety profile of Invokana.”

The Invokana MDL is now assigned to Judge Martinotti for pretrial proceedings.