Dr Kevin R Campbell, MD, FACC
Over the last year, St Jude Medical was involved in a major acquisition deal—one that amounted to nearly 25 billion dollars—with Abbott. The timing of the deal was difficult for St Jude as the company was in the middle of two major product safety issues during the period that the stock price was being negotiated. Certainly, any major flaws in their devices would have been costly to both shareholders as well as the St Jude Medical executive team as it may have significantly devalued the company prior to the close of the deal. In the last week, we have all learned some disturbing facts–about what the company knew and when they knew it—from publicly available FDA documents. The New York Times also published an investigative report and summarized the events of the last year on Friday of last week.
What Were the Product Safety Issues?
Without going into detail (you can find these on my published links that are embedded within the article), SJM had first navigated a major lead recall issue in the prior years and was now dealing with two new product related safety issues.
(1) First there was an issue with premature and sudden battery failure—that resulted in patient deaths—due to the formation of crystals within the battery itself (bridging cathode and anode) that ultimately led to premature energy depletion. The company initially reported that the analysis of these failed batteries were inconclusive and that the deposits may or may not have been the culprit. It is speculated that the company began to receive reports concerning the formation of battery crystals as early as 2011.
(2) There was also an issue with the security of data from the remote follow up devices—cyber security experts claimed that St Jude Devices were uniquely vulnerable. A third party analysis was brought to the attention of SJM management. The company vehemently denied any security vulnerabilities, yet only days after the Abbott acquisition, a “security patch” was delivered remotely to all patients with active monitors.
The deal ultimately closed as planned in January 2017—and according to public records, key players from St Jude Medical made a great deal of money once the deal closed….But some patients with SJM devices were dying.
I Think I (and other thousands of other doctors) May Have “Been Had”
I initially wrote about my concerns surrounding the management of significant ICD battery issues as well as other concerns over the online cyber security of the St Jude Medical home monitoring system known as Merlin at home. After publishing these pieces I was able to speak with Dr Mark Carlson from St Jude Medical and wrote a follow up piece based on the story (and timeline of events) he shared with me. The description of events from the SJM perspective seemed to make sense at the time.
Now, the truth is beginning to emerge. It appears that the company knew of a death related to the battery issue and did not share the information with the medical advisory board. St Jude Medical continued to sell these devices and—unknowingly—physicians such as myself—continued to implant them. While St Jude Medical was aware of the potential issue in 2014 and changed the manufacturing process in 2015–they did not reveal the issue to implanting cardiologists until October of 2016. In fact, these devices remained in circulation and at least seven of these defective devices were still implanted, even after the recall.
As a physician, it is my job to provide proven treatments for my patients. During the time that these faulty devices were being supplied to us by St Jude Medical, our patients trusted us to do our best for them, and we trusted our device makers to provide us with the very best technology available. Now it is estimated that nearly 200K patients have these recalled devices. At this point, most experts—including the FDA—believe that the risk of replacing these devices appears to outweigh the benefit so most recommend that we closely monitor these patients and their devices. Unfortunately, St Jude Medical is not alone. Years ago, Guidant—now Boston Scientific—was found to be guilty of allowing devices that they knew were faulty to be sold and implanted into patients. These events make one wonder…What else has been covered up over the years by the medical device industry?
So, Did St Jude Medical and Others Place Profits Before Patients? Sure Sounds Like It to Me…
At this point—in my opinion–there has been no real accountability in the medical device industry. Those that profited in the Guidant debacle years ago have long since retired to lives of sizable wealth without a thought to the thousands of patients they harmed. The patients that were intentionally put at risk through omission and deception—all in the name of a stock price–are long gone. While Guidant was fined a significant amount of money, those in leadership positions within that company at the time of the infractions, had long “cashed out” their stock options.
In the case of St Jude Medical—now Abbott—it appears to be business as usual. The only reason we are hearing more today is because the FDA finally looked closely at the timeline of events and the available data and have begun to find significant irregularities in the way in which the company handled safety issues over the last several years. Based on the letter issued last week from the FDA these problems must be addressed in the next 15 days. But does that really matter? Those at the top continue to accumulate wealth and physicians, patients and families are left to deal with the fallout of corporate greed.
It is time that we hold industry accountable for their actions. As a physician and patient advocate, I can no longer sit by and watch this happen. I, along with many of my colleagues, implanted devices in 2015 that had potential flaws—known only to St Jude Medical. I am angry—I feel betrayed by the company and I hope that the FDA and Congress will begin to look closely at these types of business practices. We must not allow ANY medical device company to put the price of a stock or the quarterly profits ahead of patient safety.
It is time for a change. If more regulation is needed, then so be it. Medicine is a noble profession—and the manufacturing of medical devices SHOULD be a noble mission as well.
Photo taken by Dr Kevin Campbell at FDA campus, June 2016