U.S. Invokana Sales Slide As Injury Lawsuits Mount

By Sandy Liebhard

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.

Invokana Litigation

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.

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Philadelphia Judge Allows Invokana Case to Proceed Against Janssen

invokana-warning kidney-damageJanssen Pharmaceuticals Inc. lost a motion to dismiss a Texas man’s complaint that Invokana gave him diabetic ketoacidosis, allowing his product liability claim to proceed in the Philadelphia Court of Common Pleas.

Janssen, based in Raritan, New Jersey, filed a forum non conveniens motion, which Judge Denis Cohen denied. The company argued that:

  • Plaintiff Matthew Landes took Invokana and suffered his injury in Texas.
  • It would be difficult for Janssen to get witnesses like the plaintiff’s physician to come to Pennsylvania to testify.
  • Invokana was manufactured in Puerto Rico and developed in New Jersey.

In opposition, plaintiff attorneys Scott Levensten and Michael Johnston of the Levensten Law Firm PC in Philadelphia argued successfully that most of the discovery would come from Janssen’s offices in Pennsylvania or New Jersey. The case is Landes v. Janssen Research & Development LLC et al., case number 160300269, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.

Dozens of actions

Nearly 90 cases are pending against Janssen in Philadelphia courts. Invokana won approval from the Food & Drug Administration in 2013, but plaintiffs claim that it can cause a condition known as diabetic ketoacidosis, in which the body produces excess blood acids known as ketones.

Separately, dozens of plaintiffs who suffered kidney damage or ketoacidosis have filed a motion to create new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in federal court in New Jersey.

There are at least 56 actions pending in 11 different judicial districts against defendants Johnson & Johnson of New Brunswick, NJ, Janssen Pharmaceutical Inc. of Titusville, NJ (a J&J subsidiary) and Tanabe of Osaka, Japan.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

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