Fifty-five lawsuits related to diabetes drug Invokana have been consolidated in a New Jersey federal court, according to a Dec. 7 order issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML).

The panel approved a request from plaintiffs to centralize the cases against Janssen Pharmaceuticals, the maker of Invokana and its sister drug Invokamet, into the U.S. District Court for the District of New Jersey. This consolidates 18 actions from districts in states like California, Georgia, and Illinois with 37 other cases already pending in New Jersey.

Plaintiffs in the suits claim that the subsidiary of Johnson & Johnson knew about a link between Invokana and serious side effects like ketoacidosis and kidney damage but failed to warn consumers and the medical community of the risks.

The panel said that all the cases against Janssen have enough in common to combine them into multidistrict litigation (MDL).

“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, which contains the active ingredient canagliflozin, is a class of Type 2 diabetes drugs called SGLT2 inhibitors first approved by the U.S. Food and Drug Administration (FDA) in 2013. The medication works by inhibiting a carrier that helps sugar get reabsorbed into the bloodstream. The excess sugar is then flushed out of the body.

Consolidation Allows Efficient and Convenient Litigation

The JPML listed several reasons why they approved the request for consolidation in a New Jersey federal court.

“Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings on Daubert issues and other pretrial matters, and conserve the resources of the parties, their counsel, and the judiciary,” the panel said.

The panel added that New Jersey is a convenient location to consolidate the litigation because it is where Janssen is headquartered and where many witnesses and relevant documents are likely to be found.

“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 wrote. “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.”

The main dispute concerning consolidation was whether to include cases involving SGLT2 inhibitors besides Invokana and Invokamet. AstraZeneca and Bristol-Myers Squibb — the companies behind Farxiga — and Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — the companies behind Jardiance — face similar lawsuits.

The panel decided against adding other defendants because it would complicate the case due to the need to protect trade secrets and confidential information.

“In addition, a multi-defendant MDL may prolong pretrial proceedings, because of, inter alia, the possible need for separate discovery and motion tracks, as well as the need for additional bellwether trials,” the panel added.

Janssen Stands By the Safety of Invokana

In an October brief, Janssen agreed with the decision to consolidate the cases but disagreed with the claims presented by plaintiffs.

“While Janssen disagrees with Plaintiff’s characterization of the facts, it agrees that there are common issues meeting the standards for pretrial consolidation,” according to the brief.

Plaintiffs contend that Janssen knew that the diabetes drug caused kidney failure and a buildup of acid in the blood called diabetic ketoacidosis. The FDA received 101 confirmed reports of kidney failure in patients taking SGLT2 inhibitors like Invokana over a two-year period. A warning that SGLT2 inhibitors carry a risk of ketoacidosis was added to labels of Invokana and similar drugs by the FDA in 2015.

Janssen spokeswoman Kaitlin Meiser told Law360 that Invokana is an important medicine in the treatment of diabetes and has demonstrated a positive safety profile that includes more than nine million prescriptions.

“As the MDL process moves forward, we will continue to vigorously defend against the allegations made in these lawsuits,” Meiser added.

The MDL will next enter pretrial proceedings before Judge Martinotti in New Jersey federal court.