According to a story by The Canadian Press (CP) and carried by CityNews (05/11/17), the Ontario resident had been implanted with a Fortify Assura defibrillator in January, 2014. Such devices are designed to last at least seven years before surgery is required to replace them. In Houle’s case 33 months on – under three years, with more than four years to go – Houle was told by her doctors that her medical device could fail at any time.
Without warning. And with potentially catastrophic results.
That conversation occurred in October, 2016. Five months later, in March of last year, Houle was finally scheduled for replacement surgery and was implanted with a different defibrillator model.
However, for those five months Houle was left “enormously distraught and anxious,” according to CP. The Port Hope resident remained fearful to drive on her own or to travel outside the country for fear of suddenly losing consciousness.
A potential for 8,000 class members in Canada
That wasn’t an idle fear. In Canada, according to CP, there have been in excess of two dozen reports of patients suddenly blacking out after their devices failed. While there were no reported deaths in those particular situations, two European patients died after the batteries in their defective St. Jude Cardiac defibrillators suddenly failed. One of the two victims died just days before a scheduled surgical replacement.
The Canadian class action lawsuit is intended to encompass some 8,000 Canadian patients implanted with the problematic defibrillators manufactured by St. Jude Medical between January 2010 and May 23, 2015. Models include Fortify, Fortify Assura, Fortify Assura MP, Unify, Unify Assura, or Unify Quadra. The problem has to do with lithium cluster formation, which causes the batteries to short-circuit. When this happens, power rapidly depletes and leads to premature failure without warning.
When defibrillators are working properly – including those manufactured by St. Jude – the devices emit a low vibration at regular intervals, a signal to the patient that the device is near the outer window of its life cycle and power is in decline. Once those vibrations begin, the patient has about 90 days – or three months – to get in to see their doctor and arrange for a replacement.
In theory, it works well. Except, when it doesn’t – and that’s when defective St. Jude Cardiac defibrillators with problematic batteries fail without warning, putting the lives of patients in certain jeopardy.
An important aspect of any St. Jude ICD battery lawsuit is the allegation that St. Jude Medical knew about the problems with their ICD batteries for years, but played down the risk and continued to ship them before finally recalling the defective St. Jude Cardiac defibrillators in the fall of 2016.
The FDA famously took St. Jude to task
The preceding was no idle accusation. Such an allegation was made by the very entity that rides shotgun over pharmaceuticals drugs and medical devices – the US Food and Drug Administration. According to The New York Times (04/13/17), the FDA famously issued a warning letter to St. Jude Medical in the spring of last year taking the device maker to task for not doing enough to rectify the situation, among other allegations.
“What bothers me most about this is that the doctors and the patients weren’t told about the potential” for failure, said Dr. Robert G. Hauser, a retired cardiologist who campaigns for improved safety of medical devices, in comments to The New York Times. “And clearly this is for St. Jude’s benefit. They can sell products rather than scrapping it.”
But the FDA itself did not escape Hauser’s wrath. He faulted the regulator for not having investigated St. Jude sooner. “[The FDA] should have been in there years ago, looking at all the raw data in order to determine if the incidence was low enough to allow these devices to be shipped and implanted,” he said.
Health Canada, the Canadian health regulator and the equivalent to the FDA in that country, also issued warnings about the defective St. Jude devices. Houle is joined as the representative plaintiff in the Canadian class action by her husband Roland Houle by way of the Family Law Act for damages suffered as the result of injuries and losses suffered by his wife, according to statements of claim.
St. Jude Medical Inc. and St. Jude Medical Canada are named as co-defendants in the multi-million dollar Canadian class action filed with the Ontario Superior Court.
Abbott acquires the assets, the liabilities and the headaches in purchase
St. Jude was purchased a year ago by Abbott Laboratories. Based in Chicago, Abbott paid US$25 billion to acquire St. Jude. In a statement to CP Abbott said it would be defending its position in the Canadian St. Jude lawsuit. Abbott told The New York Times last April that “we have a strong history and commitment to product safety and quality.”
READ MORE ST JUDE CARDIAC DEFIBRILLATORS LEGAL NEWS
“Obviously, if you have an implanted device and you can have the battery deplete without any warning, it could be a serious problem,” said Miller. In referencing lead plaintiff Houle, Martin says the damages and injuries extend beyond the emotional trauma of fearing her St. Jude defibrillator could fail at any moment. “You are causing someone to have a surgery at an earlier stage and at least an extra surgery,” Miller said.
Allegations are yet to be proven in Court. The case is Houle et al. v. St. Jude Medical Inc. et al., 2017 ONSC 5129, Case No. CV-17-572508 CP in the Ontario Superior Court of Justice.