Join me today at 1:15pm I will be LIVE discussing the latest with St Jude Medical and a recall that is the result of 2 patient deaths.
Dr Kevin R. Campbell
Chief Medical Correspondent Bold.Global
This past week, St Jude Medical announced a major recall of nearly 400,000 implantable cardioverter -defibrillator (ICD) devices due to a risk for premature battery depletion. ICDs are devices that are used in patients who are at risk for sudden cardiac death. In some cases, patients are dependent on these devices for life—they have no viable heart rhythm without them. In addition, ICDs have been shown to reduce risk for sudden death by nearly 30% in patients with severely weakened heart muscles. In this particular recall, the company reported (after the FDA acted) that in certain models of ICDs that were manufactured up until 2015, the battery can fail suddenly and prematurely due to a defect in the lithium battery’s construction. In the report, St Jude admitted that there had been 2 deaths from battery failures and nearly 50 other significant incidences of device failures that did not result in death. While recalls of medical devices are not uncommon what is most concerning about this particular situation is the fact that St Jude Medical knew that something was wrong in 2014—when the first death occurred.
What is the Issue with the Current Recall?
According to St Jude Medical, the current problem with the battery has occurred when deposits from the lithium battery build up around the positive and negative poles of the battery—thus causing a short and premature battery depletion. While most normal lithium ICD batteries allow for a 3-month window once the elective replacement indicator (ERI) is triggered, a subset of these recalled batteries apparently no longer function within 24 hours of the ERI alert. The FDA estimates that nearly 400K patients are affected. Just as in similar cases, the FDA is not recommending immediate replacement of these devices but very close in person and remote follow up. If the device does trigger an ERI alert, immediate replacement is warranted.
How Long Have They Known?
It appears that St Jude Medical knew that there was an issue with these devices as early as 2014 when the first death was reported due to premature battery depletion. When a device company is presented with a device failure, prompt analysis is performed. While it is completely understandable to not create a panic over a few reports (until a pattern of malfunction is confirmed) it is troubling that the company did not communicate any of this information to large volume physician implanters. The company changed manufacturing practices in 2015 but only now went public with the information to doctors and patients. They did report failures to the FDA as required by law—and only now went public with the information once an FDA determined threshold of device failures was reached and triggered a federally mandated alert and recall.
Why Would The Company Not Alert Physicians and Patients Earlier?
In my opinion, it all comes down to one word—profits. St Jude Medical, a publicly traded company, must answer to stockholders first. During the time of the initial reports and the change in manufacturing, St Jude was in the midst of a $25 billion dollar acquisition deal with Abbott Laboratories. Senior leadership at St Jude Medical stood to make a great deal of money (along with stockholders) with the completed sale of the company. I suspect that the PR nightmare of a large-scale significant recall could have potentially “killed the deal” or substantially lowered the sale price. I am certain that senior leadership at St Jude Medical was well aware of issues with the battery after the first death in 2014. Fortunately, there have only been two deaths thus far—but with nearly 400K devices affected, experts estimate that roughly 2K devices will short circuit and require emergency replacement. This estimate was based on previous reports of lithium battery deposit rates published in the medical literature. If physicians had known about the potential issue early on, it is likely that the number of potentially defective devices in service would be far fewer.
St Jude Medical is Not Alone
Nearly all device manufacturers in the US have had major recalls in the last several years. Medtronic had a major flaw in a popular ICD lead resulting in tens of thousands of lead fractures requiring surgery to replace; Boston Scientific (formerly Guidant) had numerous recalls of leads, devices and other advisories in the mid and late 2000s; St Jude Medical also has had a major ICD lead recall in the previous 5 years. Only Biotronik (a German company) has not had any significant recalls in the last 5 years. Cover ups and minimizing impacts to patients, physicians and the press has been the norm in the industry for years.
What Happens Next?
I suspect that St Jude Medical’s acquisition by Abbott Laboratories will proceed as planned and this event will be unlikely to affect stock price or investor interest. The senior leadership at St Jude will continue to accumulate wealth. Unfortunately, the only losers in this scenario are patients—the very people medical device industry leaders claim to “serve”. Ideally, St Jude Medical should have communicated concerns to physicians so that these physicians could make informed decisions about whether or not to use the product. Clearly they did not do this as nearly 400K of the potentially defective devices were implanted. Healthcare reform is broken. We are allowing pharmaceutical companies and medical device companies to operate without adequate oversight—profits are put ahead of patient safety. While the FDA has very good criteria in place for notifying patients and physicians when significant adverse events occur, it is unfortunate that there must be deaths before recalls and advisories are initiated.
Watch the full video here, below.
Dr Kevin Campbell, MD, FACC is chief medical correspondent for Bold.global. Dr. Campbell is an internationally recognized Cardiologist who specializes in the diagnosis and treatment of heart rhythm disorders. Dr. Campbell is the Medical Expert for WNCN and appears weekly on the CBS morning news and also makes frequent appearances nationally on Fox News, CBS, and HLN.
In an effort to maintain journalistic accuracy I wanted to add a few comments to my article published yesterday based on new information:
1. The acquisition talks between SJM and Abbott Laboratories did not begin until December 2015, not 2014/mid 2015 as I initially reported. This is reported to be documented in an SEC filing. The sale of the company was announced in April 2016.
2. In an effort to provide more clarity on the price/value of SJM, The stock deal at the time of the acquisition was announced at a price of $85 a share. The price in 2014 was roughly $81 a share and in December 2015 the price was $61 a share.
3. In the interest of full disclosure, I have received consulting fees from all of the mentioned manufacturers including Medtronic, St Jude Medical, Biotronik and Boston Scientific in the past 10 years.
Hmmmmm, just opened a letter that’s been sitting around for a week or two….Seems like have one of these. A week or so ago the device area felt icy cold for about 30 seconds, then seconds later again for 30 seconds. Is this a warning sign of battery depletion? I’ll be calling my dr in the morning. I’m very surprised I wasn’t called by now.
It’s unbelievable companies can get away with this.