Toronto, April 30, 2019
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:
- Fortify Assura;
- Quadra Assura;
- Quadra Assura MP;
- Unify Assura; and,
- 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.
Waddell Phillips Professional Corporation at: https://waddellphillips.ca/class-actions/st-jude-defibrillator-class-action/.
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