Invokana Injury – Amputation Lawsuit
Invokana injury lawsuits are mounting in the consolidated multi-district litigation (MDL) in the U.S. District Court, District of New Jersey (MDL 2750), and the first of those trials are expected to begin in September. These initial bellwether cases will give a good indication of how future claims for damages will be resolved by manufacturer Janssen (a subsidiary of Johnson & Johnson), which markets the drug for treatment of Type 2 diabetes.
Since the MDL was created, more than 1,000 cases have been filed within the federal district court, alleging patients prescribed Invokana are at a markedly higher risk of suffering an amputation of a lower extremity (usually a leg or toe).
Case Management Order # 20 in the MDL outlines the first group of bellwether cases – a total of 12, with six chosen by plaintiffs and six by defendants. Half of those plaintiffs who took Invokana developed a condition known as diabetic ketoacidosis, while the other half suffered kidney injuries. The judge overseeing the MDL encouraged both sides to identify claims that are overall representative of future claims. Discovery in those initial cases will be intense, and findings revealed in those discovery actions can be applied to future cases.
Another recent report indicated these lawsuits may be having some impact on Invokana sales, as a Johnson & Johnson’s most recent earnings report (fourth quarter 2017) indicates drug sales fell short of analysts’ expectations, falling 29 percent to $262 million.
What is Invokana?
Canagliflozin (the generic name for the drug) obtained approval from the U.S. Food & Drug Administration in 2013 as a first-of-its-kind drug for treatment of Type 2 diabetes. It’s an SGLT2 inhibitor and it blocks glucose absorption by the kidneys.
As noted by the manufacturer, the intention is to lower one’s blood sugar (A1C) when users take a once daily pill in addition to adopting an improved diet and exercise routine. It’s not intended for weight loss, though some users do report that. It’s also not a blood pressure medicine, though some patients do note lower systolic blood pressure when taking Invokana.
The drug was heralded upon release, but since then has been embroiled in controversy over its safety.
Why is Invokana Dangerous?
The company lists its most common side effects as urinary tract infections, genital yeast infections and changes in urination. But these issues aren’t at the center of the litigation.
As our Salt Lake City Invokana injury attorneys can explain, early clinical trial results indicated those taking the drug were at increased risk for developing cardiovascular (heart) complications within the first month of treatment. Two years after the drug’s release, manufacturers for both Invokana and Invokamet (a sister medication) were updated its label to indicate possible risks of decreased bone density and bone fractures.
In late 2015, the FDA ordered another label update indicating all SGLT2 inhibitor class medications would include warning of higher risk of diabetic ketoacidosis, a serious and potentially life-threatening condition that, if not immediately diagnosed and treated, can result in diabetic coma and death.
In 2016, the drug labels were updated once again to reflect more than 100 reports of acute kidney injury among those taking the medication. Then in May 2017, a Black Box Warning – the highest safety warning there is – was added to both Invokamet and Invokana following clinical trial findings indicating significant risk of amputations of the leg and foot.
Product liability attorneys in Utah continue to closely watch the development of these cases.
Contact the James Esparza Law Group in Salt Lake City, Utah for more information on filing a Invokana injury lawsuit. Call (800) 745-4050.
Additional Resources:
Form 8-K, Current Report Johnson & Johnson, Jan. 23, 2018, U.S. Securities and Exchange Commission
More Blog Entries:
Invokana Black Box Warning – Leg & Foot Amputations, May 19, 2017, Salt Lake City Invokana Injury Attorney Blog