Class Actions

St. Jude Defibrillator Class Action —

This class action is brought on behalf of every person resident in Canada that has been implanted with one of several specific models of the St. Jude Defibrillator (ICD).

Case Overview

This class action is brought on behalf of every person resident in Canada that has been implanted with one of the following of models St. Jude Defibrillator (ICD), manufactured between January 2010 and May 23, 2015:

  1. Fortify;
  2. Fortify Assura;
  3. Quadra Assura;
  4. Quadra Assura MP;
  5. Unify;
  6. Unify Assura; and,
  7. Unify Quadra. (the Patient Class)

For a full list of devices, please refer to the Long-Form Notice.

There are approximately 8,900 Patients in Canada who were implanted with one of the affected devices.

The action is also brought on behalf of the dependents of the Patient Class who may have compensable claims under provincial legislation. View the Amended Amended Statement of Claim.

The claim relates to the recall of these ICDs because the batteries may form lithium clusters causing a rapid discharge of the battery, which may cause injury or death of the Patients. The claim alleges that the defendants were negligent in the research, development, design and testing, manufacturing, and post-market monitoring and surveillance of these ICDs, and that the defendants were negligent in the representations that they made to the regulators about the design of the ICDs, including after they became aware of the potential defect in the ICD battery.

Health Canada issued a safety alert on October 15, 2016 warning of the risk of early battery depletion in these ICDs manufactured before May 23, 2015. In the USA, the FDA issued a recall of the devices.

The claim alleges that St. Jude Medical, Inc. knew of the potential for early battery depletion in the ICDs prior to December 2014, when an article was published warning of the problem. It conducted at least 42 product analyses of failed ICDs between 2011 and 2014, which showed evidence of lithium cluster bridging having caused the battery to drain prematurely. Nonetheless, it continued to manufacture ICDs with the potentially defective batteries until May, 2015, and continued to sell the ICDs with the potentially defective batteries up until the date of the warning and recall in October 2016.

On April 12, 2017, the US Food & Drug Administration (FDA) issued a warning letter to St. Jude Medical, Inc. advising that its inspection had revealed that “these devices are adulterated within the meaning of section 501(h) of the [Federal Food, Drug and Cosmetic] Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the current good manufacturing practice requirements of the Quality System (Q) regulation…”. The letter says that St. Jude underreported the incidences of failure due to premature battery depletion. Review the full text of the letter.

Status of the Action

On April 23, 2019, Justice Perell of the Ontario Superior Court of Justice certified this action as a class proceeding, on consent and for settlement purposes, only.

The Plaintiffs have entered into a Settlement Agreement with the Defendants.  Before it is effective, the court must approve the Settlement Agreement as being fair and reasonable and in the best interests of the Class.  If approved, the Settlement will resolve all the claims asserted against the Defendants in this class action.  The Defendants continue to deny any liability to the Class.

A settlement approval and counsel fee approval hearing is scheduled for August 1, 2019 at 10:00 am at Osgoode Hall, 130 Queen Street West, Toronto, Ontario.

More information is available under Updates.

Further updates will be posted as the case progresses. You may also review the case updates on the website of our co-counsel, Howie, Sacks & Henry LLP at: http://www.hshlawyers.com/expertise/mass-tort-litigation/st-jude-defibrillatorpacemaker/

Do you have a St. Jude ICD, and would you like to speak with a member of our Team?

If you or a loved one had or have a St. Jude ICD, and would like to speak to a member of our team, you may complete our online form and we will respond to your inquiry, typically within one business day. Or you can contact us at:

reception@waddellphillips.ca

(t) 647-261-4486
(f) 416-477-1657

36 Toronto St., Suite 1120, Toronto, ON, M5C 2C5, attn.: St. Jude Defibrillator Class Action

Case Overview

This class action is brought on behalf of every person resident in Canada that has been implanted with one of the following of models St. Jude Defibrillator (ICD), manufactured between January 2010 and May 23, 2015:

  1. Fortify;
  2. Fortify Assura;
  3. Quadra Assura;
  4. Quadra Assura MP;
  5. Unify;
  6. Unify Assura; and,
  7. Unify Quadra. (the Patient Class)

For a full list of devices, please refer to the Long-Form Notice.

There are approximately 8,900 Patients in Canada who were implanted with one of the affected devices.

The action is also brought on behalf of the dependents of the Patient Class who may have compensable claims under provincial legislation. View the Amended Amended Statement of Claim.

The claim relates to the recall of these ICDs because the batteries may form lithium clusters causing a rapid discharge of the battery, which may cause injury or death of the Patients. The claim alleges that the defendants were negligent in the research, development, design and testing, manufacturing, and post-market monitoring and surveillance of these ICDs, and that the defendants were negligent in the representations that they made to the regulators about the design of the ICDs, including after they became aware of the potential defect in the ICD battery.

Health Canada issued a safety alert on October 15, 2016 warning of the risk of early battery depletion in these ICDs manufactured before May 23, 2015. In the USA, the FDA issued a recall of the devices.

The claim alleges that St. Jude Medical, Inc. knew of the potential for early battery depletion in the ICDs prior to December 2014, when an article was published warning of the problem. It conducted at least 42 product analyses of failed ICDs between 2011 and 2014, which showed evidence of lithium cluster bridging having caused the battery to drain prematurely. Nonetheless, it continued to manufacture ICDs with the potentially defective batteries until May, 2015, and continued to sell the ICDs with the potentially defective batteries up until the date of the warning and recall in October 2016.

On April 12, 2017, the US Food & Drug Administration (FDA) issued a warning letter to St. Jude Medical, Inc. advising that its inspection had revealed that “these devices are adulterated within the meaning of section 501(h) of the [Federal Food, Drug and Cosmetic] Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the current good manufacturing practice requirements of the Quality System (Q) regulation…”. The letter says that St. Jude underreported the incidences of failure due to premature battery depletion. Review the full text of the letter.

Status of the Action

On April 23, 2019, Justice Perell of the Ontario Superior Court of Justice certified this action as a class proceeding, on consent and for settlement purposes, only.

The Plaintiffs have entered into a Settlement Agreement with the Defendants.  Before it is effective, the court must approve the Settlement Agreement as being fair and reasonable and in the best interests of the Class.  If approved, the Settlement will resolve all the claims asserted against the Defendants in this class action.  The Defendants continue to deny any liability to the Class.

A settlement approval and counsel fee approval hearing is scheduled for August 1, 2019 at 10:00 am at Osgoode Hall, 130 Queen Street West, Toronto, Ontario.

More information is available under Updates.

Further updates will be posted as the case progresses. You may also review the case updates on the website of our co-counsel, Howie, Sacks & Henry LLP at: http://www.hshlawyers.com/expertise/mass-tort-litigation/st-jude-defibrillatorpacemaker/

Do you have a St. Jude ICD, and would you like to speak with a member of our Team?

If you or a loved one had or have a St. Jude ICD, and would like to speak to a member of our team, you may complete our online form and we will respond to your inquiry, typically within one business day. Or you can contact us at:

reception@waddellphillips.ca

(t) 647-261-4486
(f) 416-477-1657

36 Toronto St., Suite 1120, Toronto, ON, M5C 2C5, attn.: St. Jude Defibrillator Class Action

The Action has been Certified as a Class Proceeding

This action was certified as a class action on April 23, 2019 with the consent of the Defendants, solely for the purpose of effecting a settlement of the action.

To learn more about how the certification order may affect your rights as a Class Member, you should review the Long Form Notice, or you may contact Class Counsel through our online portal or by telephone.

If you do not want to be included in the class action, you must exclude yourself by Opting Out by no later than Friday, July 19, 2019.  An opt out form can be downloaded here.  Do not complete this form if you wish to be in the class and participate in the settlement.

The Parties have Entered into a Settlement Agreement

The Plaintiffs have entered into a Settlement Agreement with the Defendants.  Before it is effective, the court must approve the Settlement Agreement as being fair and reasonable and in the best interests of the Class.  If approved, the Settlement will resolve all the claims asserted against the Defendants in this class action.  The Defendants continue to deny any liability to the Class.

A hearing to approve the Settlement Agreement will be held on August 1, 2019 at 10:00 am at Osgoode Hall, 130 Queen Street West, Toronto, Ontario. Class members are welcome to attend the hearing.

A Short-Form Notice advising Class members of the certification order and the motion for settlement approval is being sent out by mail to all class members for whom St. Jude has records.

You can learn more about the proposed Settlement and how it will affect the class members by reading the Long-Form Notice.

Under the terms of the Settlement, the Defendants will pay $5,000,000 CAD in full and final settlement of all claims. Class members will need to complete and submit claim forms (to be made available after the settlement is approved) in order to claim a share of the settlement.

In general, the Settlement calls for payments to Eligible Explant Claimants of approximately $10,000, more or less, plus additional compensation for complications arising from the surgery.  Other members of the Class will receive up to either $100 or $500 depending upon when they were implanted with an affected defibrillator.  Class members may also be reimbursed for out of pocket expenses of up to $500.

The terms for the distribution of the settlement funds, including proposed shares for different class members, can be found at Schedule G of the Settlement Agreement.

Class Counsel will also be asking to have their legal fees approved

At the settlement approval hearing, Class Counsel will also seek to have their legal fees approved of up to $1,300,000, plus disbursements and taxes, and approval of an honorarium of $5,000 each for the representative plaintiffs, to be paid from the Settlement Fund.  Class Counsel have been working under a contingency fee agreement, and have not been paid since the action was commenced.

How to Exclude Yourself from the Action and Settlement

Class members who do not want to participate in the class action and the settlement may opt-out of the class action by no later than July 19, 2019 at 11:59 pm EST. An opt-out form must be completed and sent to the claims administrator at the office listed on the form prior to this time.

How to Object to the Settlement

If you wish to remain in the class action, but object to the terms of the Settlement Agreement, you may send your written objection to the attention of Class Counsel by no later than Monday, July 29, 2019.  They will file your objection with the court.  You may also attend at the settlement approval hearing and make submissions to the court in person.

Further updates will be posted as the case progresses. You may also review the case updates on the website of our co-counsel, Howie, Sacks & Henry LLP at: http://www.hshlawyers.com/expertise/mass-tort-litigation/st-jude-defibrillatorpacemaker/

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