INVOKANA^® CLASS ACTION SETTLEMENT

SETTLEMENT APPROVAL OF INVOKANA^® INVOKAMET^® INVOKAMET XR^® CLASS ACTION

Claims Bar Deadline is August 14, 2023, 11:59 PM EST

To complete and submit a Claim Form, click **here** to file a Claim in the online Claims Administration Portal OR the blue Claims Portal button in the top menu bar

For a PDF copy of the Claim Form, click **here** or go to the Documents section of this website.

Estate of Raymond Duck v Janssen Inc. et al., Ontario Superior Court of Justice (London) Court File No. CV-18-00000570-00CP; Ronald Allen Fiddler v Janssen Inc. et al., Court of King’s Bench for Saskatchewan (Regina) Court File No. QBG-RG- 02809-2015; and Steven Varnai and Joanne Giroux v Janssen Inc. et al., Superior Court of Quebec (District of Montreal – Class Actions) Court File No. 500-06-000906-186.

James Boyd of Siskinds LLP, E.F. Anthony Merchant K.C. of Merchant Law Group, and Chloé Faucher-Lafrance of Siskinds Desmeules, Avocats announce that a Canada-wide settlement has been reached in three class actions relating to the prescription drugs Invokana^®, Invokamet^®, and Invokamet XR^®. Invokana^® (canagliflozin) is a prescription medication indicated to lower blood sugar in adults with type 2 diabetes. Invokana^® is also available in combination with metformin, under the brand name Invokamet^®.

The Proceedings raised various allegations against the Defendants and sought damages on behalf of Canadians for harm and injuries which were allegedly related to the use of Invokana^®, Invokamet^®, and Invokamet XR^®. The Defendants deny all allegations and deny any wrongdoing or liability.

The Settlement of the Proceedings has been approved by the Courts.

The Settlement provides for the payment of $1,500,000 which will be used to pay approved claims, the related claims of the Provincial Health Insurers, the costs of notice and administering the settlement, and Class Counsel legal fees, disbursements, and applicable taxes. 10% of the Settlement Amount will be allocated to a Provincial Health Care Recovery Fund and subject to any amounts payable to the Fonds d’aide aux actions collective.

The Settlement applies to:

1. all persons resident in Canada as on or before the dates between June 15 and 21, 2022 who were prescribed Invokana^®, Invokamet^®, and/or Invokamet XR^® in Canada at any time on or before the dates between June 15 and 21, 2022; and
2. all persons who by virtue of a personal relationship to one or more of such persons described in (i) above have claims for common law or statutory damages.

You may also be eligible for compensation if you experienced the relevant medical conditions listed above within three (3) months after the corresponding dates above if (i) you started using Invokana^®, Invokamet^®, or Invokamet XR^® at least 30 days before said dates, and (ii) you used it continuously from that date to the time of the medical condition, without having either attended your prescribing physician or had your prescription renewed.

Class Members who satisfy the eligibility criteria set out in the Compensation Protocol may be entitled to benefits that will be calculated in accordance with the points system detailed in the Compensation Protocol. Please see Compensation Protocol section of this website.

Compensation will also be paid to eligible Class Members estates.

Until all claims have been adjudicated it will not be possible to determine the exact value of the compensation that may be paid to eligible claimants.

Claimant Eligibility

To be eligible to receive a settlement payment pursuant to the Settlement Agreement, a Settling Claimant must:

1. be, or if acting in a representative capacity, be representing the interest of a Canadian resident; and
2. provide Injury Evidence for at least one Eligible Injury; and
3. provide Prescription Evidence of `use of an Invokana Product at the time of, or prior to, such Eligible Injury; and
4. In the event that the Eligible Injury(s) occurred within 3 months after the addition of relevant warning language to a Dear Health Care Professional Letter or Product Monograph (for acute kidney injury claims, after January 25, 2016; for diabetic ketoacidosis claims, after May 31, 2016; and for limb loss claims, after September 6, 2017), provide evidence that the Settling Claimant (i) started using an Invokana Product at least 30 days before the date of the Eligible Injury and (ii) continuously used an Invokana Product from such date to the time of the Eligible Injury without having either attended his or her prescribing physician or had their prescription renewed otherwise. This evidence may be established by way of medical or pharmacy records, or by way of Declaration; and
5. properly complete, execute and submit a Claim Form to the Claims Administrator by the Claim Deadline.

Incomplete or Late Claim Forms – Claims Bar Deadline is August 14, 2023, 11:59 PM EST

Claims that are not properly and timely submitted to the Claims Administrator by the relevant Claim Deadline will be denied by the Claims Administrator. For greater clarity, the failure to meet the relevant Claim Deadline with the required evidence will result in rejection of the claim.

1. a diagnosis of acute kidney injury or acute renal failure occurring on or before April 25, 2016;
2. a diagnosis of diabetic ketoacidosis occurring on or before August 31, 2016; or
3. amputation of a lower limb (i.e. leg, foot, or toe(s)) occurring on or before December 6, 2017.

proof, by way of medical records, which may include contemporaneous physician or hospital records supplemented by a letter from the physician providing any needed clarification of the contents of the records, of each Eligible Injury claimed.

1. Establish proof of Invokana Product prescription for treatment of a diagnosis of diabetes through medical records or documentation from the prescribing or treating physician;
2. Establish proof of prescription for an Invokana Product(s), namely:
   1. contemporaneous medical and/or pharmacy records demonstrating consumption of an Invokana Product;
   2. contemporaneous insurance benefit records demonstrating coverage for an Invokana Product; or
   3. documentation from the prescribing or treating physician confirming consumption of an Invokana Product;
3. Establish the requisite length of time of Invokana Product usage for each Eligible Injury claimed, as follows:
   1. 7 days of continuous usage, including within 48 hours prior to the event, for a diagnosis of acute kidney injury or acute renal failure;
   2. 7 days of continuous usage, including within 48 hours prior to the event, for a diagnosis of diabetic ketoacidosis;
   3. 30 days of continuous usage, including within 30 days of the procedure, for amputation of a lower limb;

Proof of usage to be established with contemporaneous medical and/or pharmacy records, or contemporaneous insurance benefit records, or documentation from the prescribing or treating physician. Absent clear evidence to the contrary, it will be presumed that the Invokana Product prescription was filled and taken in accordance with the prescription.

The Provincial Health Insurers will be paid from the Health Care Recovery Fund in aggregate for each jurisdiction in a manner proportionate to the number of Approved Claimants from each jurisdiction.

Settling Claimant Notification and Claim Appeals

(a) Notification
The Claims Administrator shall notify each Settling Claimant by way of a letter sent via email, if available, or through first class regular mail as to the approval or rejection of his or her claim and the points awarded to the Settling Claimant.

(b) Appeals
Settling Claimants will be granted a 30-day period from the date notice was sent to appeal the rejection and/or classification of their claims. Appeals will be reviewed and assessed by the Referee. Appeals will be made in writing to the Referee, supported only by the documentation provided to the Claims Administrator. Following the outcome on appeal, there shall be no right of further appeal or review. Costs of $150.00 will be payable by the Class Member in respect of an unsuccessful appeal.

Approved Claimant means a Settling Claimant that the Claims Administrator determines is eligible for compensation under the Compensation Protocol.

Claim Form means the claim form developed by the Claims Administrator in consultation with Class Counsel and approved by the Court.

More details of who is a Class Member is set out in the Notice, Documents and Definitions sections of this website.

If there is a conflict between the provisions of the Notice and the Settlement Agreement, the terms of the Settlement Agreement shall prevail.

If there is a conflict between the provisions of the Order and the Settlement Agreement, the terms of the Order shall prevail.