Lawsuit Alleges Amputation, Life-Threatening Complications from Invokana

A Mississippi man has filed a federal lawsuit against Janssen Pharmaceuticals that alleges that the defendant’s negligence caused him to suffer from severe, permanent medical complications. Jim Dedeaux was prescribed Invokana by his physician, a diabetes medication manufactured by the defendant. He took it as prescribed, assuming from the information provided to him that the medication was safe and effective for diabetics.

Plaintiff’s life-threatening medical complications

However, at some point after using Invokana, the plaintiff was forced to undergo the amputation of his right foot and right leg. He asserts that the drug’s side effects caused this complication, which has resulted in permanent, life-altering disability.

Dedeaux further alleges that Invokana was responsible for other medical complications he suffered, including diabetic ketoacidosis, sepsis, and acute kidney failure—all of which have the potential to result in death. The plaintiff demands compensation for his past and future medical bills, as well as other compensatory and punitive damages.

Invokana

Invokana (canagliflozin) first became available in March 2013. At the time, it introduced a new class of diabetes drugs. These are SGLT2 inhibitors, which work by affecting the normal function of the kidneys.

In the years following its release, the FDA received a significant number of adverse event reports regarding the drug. The increased scrutiny led to the FDA requiring the manufacturer to add new warnings to Invokana regarding the risk of diabetic ketoacidosis. The risk of diabetic ketoacidosis had not previously been communicated to patients on the label.

The following year, the FDA required another warning label update, this time regarding the risk of kidney problems. And in May 2017, the FDA alerted the public as to the risk of leg and foot amputation among Invokana patients.

Invokana legislation

Throughout the time in which the FDA was issuing safety alerts for Invokana, additional patients affected by complications were filing lawsuits in federal courts around the country. To date, almost 1,000 federal lawsuits have been filed against the makers of Invokana. Each of them raises allegations similar to those found in the Dedeaux complaint, including claims that the defendants did not adequately research the drug’s safety, and did not provide sufficient safety warnings to doctor and patients.

As is common when a significant number of lawsuits filed against a common defendant raise similar allegations, the Invokana lawsuits filed in federal courts were centralized into a multidistrict litigation (MDL). This mass litigation is currently proceeding in the U.S. District Court for the District of New Jersey. Judge Brian Martinotti and Judge Lois Goodman are presiding. The MDL is currently going through the discovery process to uncover evidence pertaining to the case.

Once discovery is completed, a handful of bellwether cases will be selected. These are the initial cases to go to trial, and they serve as a means for all parties to gauge juror reactions to testimony and physical evidence. It’s common for MDL lawsuits to go through settlement negotiations at around this point, but if any cases aren’t settled, they will be remanded to their home districts for individual trials.

Additional resources:

1. Invokana, https://www.invokana.com/
2. U.S. District Court, Invokana Litigation, http://www.njd.uscourts.gov/invokana-litigation