Johnson & Johnson continues to face legal challenges over Invokana. In addition to slowing U.S. sales, the Type 2 diabetes drug continues to be the subject of a growing product liability litigation involving diabetic ketoacidosis and other side effects allegedly associated with its use.
According to Johnson & Johnson’s most recent earnings report, U.S. sales of Invokana fell by $50 million (16.8%) during the first quarter of 2017, to $270 million. However, sales were up 32% in international markets, to $37 million.
Invokana Side Effects
Brought to market in March 2013, Invokana was the first SGLT2 inhibitor approved in the U.S. to treat Type 2 diabetes. Johnson & Johnson also markets a sister diabetes medication called Invokamet, which also contains metformin. These drugs work by preventing the absorption of glucose by the kidneys, resulting in its elimination from the body via urine.
Since Invokana’s approval, SGLT 2 inhibitors have been the subject of several of U.S. Food & Drug Administration (FDA) safety alerts:
- September 2015: The agency announced that the labels for Invokana and Invokamet would be updated to include information about a possible increased risk of bone fractures.
- December 2015: New warnings about diabetic ketoacidosis and serious urinary tract infections were added to the labels of all SGLT2 inhibitors, including Invokana and Invokamet.
- May 2016: The FDA announced it was investigating a possible link between Invokana, Invokamet and an increased risk of lower limb amputations (mostly involving the toes).
- June 2016. Kidney warnings already included on the labels of Invokana, Invokamet, Farxiga and Xigduo XR were strengthened after the drugs were linked to more than 100 reports of acute kidney injury.
More than 230 Invokana lawsuits have been centralized in federal multidistrict litigation now underway in the U.S. District Court, District of New Jersey. All of the pending cases were filed by people who allegedly developed diabetic ketoacidosis, kidney damage and other serious complications due to treatment with Invokana or Invokamet.
US District Judge Brian R. Martinotti will convene “Science Day” on May 21. This event will give the parties the opportunity to inform the Court of the medical and scientific issues central to Invokana and Invokamet lawsuits in a non-adversarial and off-the-record setting.
The Court has also indicated its intention to begin bellwether trials in September 2018. These trials will act as test cases, and could provide insight into how juries might decide similar Invokamet and Invokana lawsuits in the future.
Sandy A. Liebhard, a founding partner at Bernstein Liebhard LLP, has represented plaintiffs in complex litigation for more than 20 years. As an author for RXInuryHelp.com, Mr. Liebhard has written extensively on the litigation involving proton pump inhibitors (Nexium, Prilosec, PrevAcid, etc.) and kidney injuries; Risperdal and gynecomastia; the Bair Hugger forced-air warming blanket; talcum powder and ovarian cancer; transvaginal mesh; power morcellators; defective hip implants; and more.