Every major product liability case has a pivotal moment where the truth should and could have come out earlier. This is usually the moment when someone inside the company was aware of the defect and tried to warn consumers. For the Boston Scientific Accolade pacemaker recall, this moment came way before the FDA made the unilateral decision to issue what is known as a Class I designation. The Accolade pacemaker was meant to be a breakthrough device that would continually regulate heart rhythms with unmatched reliability and precision. However, as soon as the device was launched, something wasn’t right – patients would be admitted into hospitals and the culprit would always be sudden battery failure of the Accolade pacemaker, since they suddenly developed life-threatening arrhythmias. The FDA, after thousands of such emergencies, decided to issue a statement that documented 2,500 severe injuries as well as four deaths linked to the specific battery defect. What the FDA did not reveal, however, was that Boston Scientific through a whistleblower from inside the company had known about this defect, yet chose to do nothing about it.
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Whistleblower and the Boston Scientific Accolade Pacemaker Failure
The whistleblower evidence regarding the defective pacemaker battery came from a key individual:
- Dr. Robert Hauser, a cardiologist who has studied the safety of heart devices for decades criticized the handling of the battery failures by Boston Scientific. Speaking to the Minneapolis Star Tribune, Hauser compared Boston Scientific’s failure to act like a commercial aircraft repeatedly crashing without the airline taking action to ground the entire fleet. He also stated that the chief medical officer delayed issuing a recall on account of the fact that they did not know as a company what was causing the battery failure, calling this stance unacceptable on account of the risk posed towards patients.
Why Whistleblower Claim Blows Product Liability Claims Out the Water
It is important to note that a company has a duty to warn both patients and physicians as soon as they became aware of any defect as regards their device. This breach of duty to warn can be constituted to mean that the company failed said duty and therefore acted with wanton negligence and their actions directly led to the harm suffered by thousands of patients. A whistleblower that is in possession of company communications and memos who was brushed off or whose words were not taken with the gravitas they deserved makes for a much stronger case than just attributing negligence on account of the over 2000 patients that suffered harm since it introduces the intentionality of the negligence.
To this end, the company cannot claim ignorance as they were clearly put on notice. In addition, it opens up the doors for punitive damages, which are meant to punish corporate misconduct, and undermines any defense argument regarding the safety of the device since internal documents prove the opposite.
Best Boston Scientific Accolade Pacemaker Injury Lawyers – Call Us Today!
If you or a loved one were harmed by the faulty battery issue associated with the Boston Scientific Accolade pacemaker and had to have emergency surgery to remove the device or received a letter from Boston Scientific, do not sign or agree to anything whether verbally or documentarily before speaking to us. Our best pacemaker recall attorneys will help compile the evidence needed to file a robust claim so you can sue for a number of damages in order to receive maximum compensation. Need more information? Simply call us NOW at (314) 481-63338 to learn more about your legal options for justice and compensation as they relate to the Boston Scientific Accolade pacemaker recall. Thanks for choosing McCready Law, and we look forward to helping you.