It’s been a mere five years since Johnson & Johnson launched their blockbuster diabetes drug Invokana. In that time, it has climbed into the top-ten most prescribed medications for diabetes, with billions of dollars in sales.
Unfortunately, Invokana has also been tied to a fair bit of controversy.
On at least four occasions, the FDA has warned the public of Invokana’s health dangers. The agency has disclosed thousands of reports of serious adverse effects from patients. And now, J&J has admitted to shareholders that the amount of Invokana lawsuits has risen to over 1,100 cases.
J&J Discusses Invokana in Annual Report
On February 16th Johnson & Johnson filed their 2017 Annual Report to Shareholders with the U.S. Securities & Exchange Commission. In it, the company discusses current liabilities and pending litigation.
Among the many pending legal actions filed against J&J alleging damages from its products are 1,100 lawsuits against subsidiary Janssen Pharmaceuticals for personal injury from the drug Invokana as of the end of 2017.
According to the annual statement, “The number of pending product liability lawsuits continues to increase, and the company continues to receive information with respect to potential costs”.
J&J also admitted that Invokana claims have now been filed in a federal multidistrict litigation court in New Jersey, state courts in California, New Jersey and Pennsylvania, as well as an Invokana class action lawsuit in Canada.
Finally, the annual report states that J&J has established an “accrual” account for the Invokana lawsuits. In accounting terms, this is an account for expenses where the company does not yet know the full cost.
JPML Reports 4% Rise in Invokana Lawsuits
At nearly the same time the Johnson & Johnson Annual Report was released, the Judicial Panel on Multidistrict Litigation published its latest report of pending MDL dockets.
For Invokana, which has consolidated most of its pending cases in MDL 2750 in the New Jersey District Court, the panel noted that 1,029 lawsuits alleging personal injury have been filed as of February 15, 2018.
This represents a 3.8% jump in the number of Invokana claims compared to the report of December 15th, in a time when many expected the filing of cases to begin to slow. Of course, as indicated in J&J’s annual report, this doesn’t even include the cases filed in state courts.
FDA AERS Tracks Invokana Side Effects
Lastly, and perhaps most importantly, is the raw data from the FDA’s Adverse Event Reporting System on Invokana, otherwise known as Canagliflozin. This database tracks a number of different complications reported by the manufacturer, patients or doctors for prescription drugs.
And, while many experts say the FAERS data may only represent a fraction of the actual number of patient side effects, it can be valuable in identifying health risks and the need for more patient warnings.
As of the writing of this article, the FDA showed 2,974 reports of ketoacidosis or blood-related acidosis in patients taking Invokana.
The database contained 1,482 reports of patients suffering kidney damage, disease or failure while using Invokana.
Hundreds of patients have suffered amputation of a toe, foot or lower leg while taking the drug. Finally, 74 Invokana patients have died.
What is important to note from these numbers is that, while they may not show all the complications that have occurred, they still include nearly 5,000 patients. This means nearly 4,000 Invokana users who’ve been injured don’t know of or haven’t joined the pending lawsuits, and could miss out on compensation for their loss.
DrugNews will continue to follow the latest FDA and litigation news for the most prescribed medications. For more information on your drug, or to speak directly with a lawyer, contact us today.
Pending MDL Dockets by District. JPML. (February 15, 2018). Retrieved from www.jpml.uscourts.gov
Johnson & Johnson 2017 Annual Report Form 10-K. SEC. (February 16, 2018). Retrieved from www.sec.gov
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