By Emily Cox
A new lawsuit alleges that Johnson & Johnson (J&J) and its Janssen Pharmaceutical unit actively hid Invokana amputation risks to maximize sales and profits at the expense of patients’ lives and limbs.
Michael R. Wilkinson filed the complaint this past week in the Superior Court of New Jersey. He indicates that J&J’s insidious concealment of significant Invokana amputation risks for financial gain resulted in the loss of one of his legs below the knee.
In addition to the Invokana amputation risks, Wilkinson also alleges that the drug makers also withheld information about the substantial risk of heart attacks, strokes, kidney failure, and diabetic ketoacidosis, profiting off the egregious deprivation of countless patients’ rights to make informed decisions regarding their healthcare.
“Defendants knew or willfully and wantonly disregarded the fact that Invokana causes debilitating and potentially lethal side effects… but continued to design, manufacture, market, distribute, sell, and/or promote the drug to maximize sales and profits at the expense of the health and safety of the public… in a conscious, reckless, or negligent disregard of the foreseeable harm caused by Invokana,” the lawsuit states.
According to Wilkinson, he used the popular diabetes drug from April 2015 through May 2017. But, in December 2015, Invokana amputation risks claimed his right leg below the knee. However, because the manufacturers lied about the drug’s safety, Wilkinson was unaware of Invokana’s role in causing his permanently debilitating injuries until Invokana amputation rates recently came to light. New clinical trial findings revealed an extraordinarily high rate of diabetic amputations for Invokana users. Researchers found that the risk of leg and foot amputation was twice as high among those taking the diabetes drug compared to those taking a placebo. For a population already at significant risk for amputations, this revelation was especially troubling.
Invokana Amputation Risks Just One of Its Many Dangerous Side Effects
The FDA approved Invokana (canagliflozin) in March 2013. It was the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. They work by altering normal kidney functions to eliminate excess blood sugar through urination. Other members of the class include Invokamet, Jardiance, Farxiga, Xigduo, and other. However, Invokana has remained the biggest seller in the class due to its aggressive marketing.
As an increasing number of diabetics have switched to Invokana, serious health concerns continue to emerge from post-marketing adverse event reports. Consequently, the FDA has required several warning label updates over the past few years.
In September 2015, the FDA made labeling changes to include warnings about bone density changes and strengthened the warning for increased bone fracture risks for Invokana and Invokamet users. The labeling change further indicates that bone fractures can occur as early as 12 weeks after starting the medications.
That December, the regulatory agency mandated a diabetic ketoacidosis warning for Invokana. The warning indicates that the medication increases the risk for the life-threatening condition. Ketoacidosis typically requires emergency treatment. But, prior to the warning update, Invokana warnings didn’t alert patients about the importance of seeking immediate medical attention if they experienced any symptoms. These include abdominal pain, fatigue, nausea, respiratory problems, and vomiting.
In June 2016, the FDA strengthened label warnings due to high reports of kidney injuries. These strengthened warnings involved Invokana’s kidney risks. The label change warns that the diabetes drug may increase the risk of acute kidney injury and other severe health problems.
Most recently, in May, the FDA issued a mandate for a black box warning regarding Invokana amputation risks. The black box warning is the most serious labeling change within the agency’s power to require.
Invokana Amputation Risks Add New Dimension to Litigation
Since the FDA issued the Invokana amputation risks black box warning, a surge of amputees have joined the fight to hold J&J and Janssen accountable for their “conscious and deliberate disregard for the rights, health and safety of…Invokana users.”
Wilkinson filed his claim in state court. However, more than 1,000 individuals have filed similar Invokana lawsuits in the federal litigation. In December 2016, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal Invokana lawsuits for coordinated pretrial proceedings. As a result, District Judge Brian R. Martinotti is overseeing the entire federal litigation in the District of New Jersey. The JPML centralized the litigation to avoid duplicate discovery and conflicting pretrial rulings that could further impede the litigation’s resolution.
The first Invokana bellwether trial is scheduled for September 2018. The bellwether will help gauge how future juries may respond to allegations that manufacturers hid the drug’s substantial risks. While the bellwether will have no bearing on other lawsuits in the litigation, it may help influence settlement agreements.