J&J Continues to Face Invokana Ketoacidosis Lawsuits
Lawsuits continue to be filed against Johnson & Johnson alleging that the type 2 diabetes drug Invokana caused ketoacidosis, a condition where the blood is too acidic. Plaintiffs allege that J&J failed to warn patients and the medical community about the risks. At the same, sales of Invokana are currently on the decline in the United States.
Parker Waichman LLP has decades of experience representing clients in product liability and personal injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing an Invokana ketoacidosis lawsuit.
J&J’s most recent earnings report shows that Invokana sales decreased by $50 million in the United States, 16.8 percent during the first quarter of 2017. Sales totaled about $270 million for the quarter. Internationally, however, sales increased 32 percent to $37 million.
Invokana ketoacidosis lawsuits have been consolidated into a federal multidistrict litigation in the U.S. District Court, District of New Jersey. Plaintiffs allege ketoacidosis, kidney damage and other serious complications allegedly due to Invokana or Invokamet. U.S. District Judge Brian R. Martinotti is overseeing the litigation. “Science Day” will be held on May 21st, giving both sides to present medical and scientific issues to the court. Bellwether trials are expected to begin in September 2018.
The MDL contains over 230 Invokana lawsuits.
According to court records, one plaintiff is a Pennsylvania woman who started taking Invokana in November 2014. The lawsuit states that she experienced nausea, vomiting and dehydration in March 2015, allegedly due to Invokana side effects. Her doctors diagnosed her with diabetic ketoacidosis. Her lawsuit alleges that she could have avoided this condition and subsequent adverse events if the drug makers adequately warned of this risk.
FDA Warns of Ketoacidosis with Invokana, Other SGLT2 Inhibitors
The U.S. Food and Drug Administration (FDA) updated the warning on Invokana and other SGLT2 inhibitors to disclose the risk of ketoacidosis in 2015. The label update affected Farxiga, Jardiance, and three combination products that include an SGLT inhibitor with metformin: Invokamet, Xigduo XR and Glyxambi.
Regulators said patients taking these drugs should be aware of symptoms of ketoacidosis, which may include:
• Difficulty breathing
• Abdominal pain
• Unusual fatigue or sleepiness
Regulators identified 20 cases of ketoacidosis associated with the use of an SGLT2 inhibitor between March 2013 and June 2014. All patients required hospitalization.
The FDA said patients should not stop taking their medications without first consulting their physician.
Diabetes is a condition where the body cannot utilize sugar properly for energy, causing sugar levels to rise outside of the cell. When body cannot break down sugar for energy, it resorts to fat for energy instead. This results in the production of ketone bodies, which accumulate in the blood and make it more acidic. SGLT inhibitors work by stimulating the kidneys to remove blood from the sugar through the urine, lowering blood sugar.
Diabetic ketoacidosis (DKA) more commonly occurs in patients with type 1 diabetes, where the body does not produce enough insulin, the hormone responsible for telling cells to uptake glucose.
Patients with type 2 diabetes typically have insulin resistance, where the body no longer responds to insulin appropriately.
FDA states that “DKA, a subset of ketoacidosis or ketosis in diabetic patients, is a type of acidosis that usually develops when insulin levels are too low or during prolonged fasting. DKA most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels.”
“The FAERS cases were not typical for DKA because most of the patients had type 2 diabetes and their blood sugar levels, when reported, were only slightly increased compared to typical cases of DKA. Factors identified in some reports as having potentially triggered the ketoacidosis included major illness, reduced food and fluid intake, and reduced insulin dose.”
In June 2016, the FDA also updated warnings on Invokana and similar drugs regarding acute kidney injury. In patients with acute kidney injury, the kidneys suddenly stop working. This may cause a dangerous accumulation of waste products. Patients with acute kidney injury may experience decreased urine or swelling in the legs or feet.
The FDA identified 101 reports of acute kidney injury between March 2013 and October 2015.
Filing an Invokana Ketoacidosis Lawsuit
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in filing an Invokana lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).