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An Ohio man has filed a product liability lawsuit against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary, indicating that the drug makers failed to adequately warn that side effects of Invokana may cause him to suffer a heart attack.
The complaint (PDF) was filed by Mitchell Greenbaum in the U.S. District Court for the Northern District of Ohio on August 28, indicating that he suffered a heart attack six months after he switched to Invokana for treatment of his diabetes.
Invokana (canagliflozin) is a new-generation type 2 diabetes treatment, which was introduced in March 2013 as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. The drugs work in a unique way by impacting some normal kidney functions, and have been linked to a number of serious side effects in post-marketing adverse event reports.
Greenbaum is an obstetrician who indicates he began taking Invokana in early 2016. In August of that year, while stopped at a traffic light, he suffered a myocardial infarction, or heart attack. As a result, Greenbaum suffered hypoxia and had to be revived.
According to allegations raised in the lawsuit, Invokana caused the heart attack, and the drug makers withheld information from users and the medical community about the potential risk. The complaint notes that in 2013, when Invokana was first approved, the FDA ordered a study that indicated that there was a significant increase in the risk of heart attacks to Invokana users, but new warnings were never added to the drug’s label.
“Janssen Defendants had a duty to the public and the Plaintiff to manufacture, formulate, design and create a drug which would not adversely increase the risk of cardiac arrest in users, especially given the fact that some users foreseeably may have a prior history of hypertension,” the lawsuit states. “Janssen Defendants failed to recognize the risk of increased clotting and cardiac arrest, or intentionally chose not to recognize said risk, which constitutes both negligence and intentional misconduct.”
Invokana Health Concerns
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 May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other similar diabetes drugs claim is a unique risk with Invokana.
Last month, the latest FDA statement about Invokana was issued, announcing new warnings about the risk of a rare flesh-eating genital infection, known as Fournier’s gangrene, which has resulted in at least one death.
Greenbaum’s claim will be consolidated with other Invokana lawsuits pending in the federal court system, which are currently consolidated for pretrial proceedings before one judge in New Jersey.
Following coordinated discovery and any bellwether trials held to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, if Invokana settlements or another resolution for the claims is not reached, Greenbaum’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.