In response to the recent controversy surrounding St. Jude Medical’s Riata and Riata ST defibrillator leads, the company has engaged in an unprecedented – some say scorched-earth – effort to protect the reputation of its products. Dr. Edward Schloss, a cardiologist whose career spans nearly two decades, recently told MassDevice.com that he “can’t recall seeing a more contentious and open dispute between medical device companies in my 19 years working in this field.” Other doctors are complaining that St. Jude is spending too much time defending the now-recalled Riata leads, and not doing enough to help doctors treat patients with malfunctioning Riata wires.
Riata and Riata ST. Defibrillator Defects
The Riata and Riata ST defibrillator leads, which are wires that connect implantable defibrillators to a patient’s heart, have raised safety concerns for several years now. St. Jude stopped selling the Riata in late 2010, and warned doctors not to use them because they were poking through their insulation. Such a defect can cause a defibrillator to emit unnecessary shocks to a patient’s heart, and even worse, fail to emit a life-saving electrical impulse to the heart when it’s needed.
In December 2011, the U.S. Food & Drug Administration (FDA) designated St. Jude’s letter to doctors a Class I recall, its most serious type of device recall. St. Jude has advised patients with exposed wires to seek medical advice regarding their removal, and has advised that patients with intact tubing be monitored. Lead extraction can be a dangerous procedure, and according to St. Jude, two patients have died during procedures to remove their Riata wires.
Late last month, a study published by prominent cardiologist Dr. Robert Hauser in the Heart Rhythm journal raised more concerns about the Riata Leads. As we’ve reported previously, the study analyzed 62 lead-related deaths for Medtronic Inc.’s print Quattro Secure and 71 for Riata. Out of those, Hauser determined 22 deaths to “high-voltage” failures caused by insulation defects in Riata Leads, but only 5 to similar Quattro Lead failures. The deaths in Hauser’s study were obtained via a search of the FDA’s Manufacturers and User Facility Device Experience (MAUDE) database.
An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S.
St. Jude’s Response to Heart Rhythm Riata Lead Study
St. Jude has demanded a retraction of the Heart Rhythm study claiming it was biased and inaccurate. St. Jude further claims its own analysis using the same criteria employed by Hauser found 377 reports of deaths involving Quattro Secure wires, while Hauser reported 62. The company’s analysis of Riata lead events in the database found 74 deaths, while Hauser reported 71. St. Jude also criticized Hauser’s use of the MAUDE database for his study, asserting that doing so caused his findings to be biased “against manufacturers that more transparently report on device malfunctions” The company claimed that Medtronic reports the least amount of detail regarding adverse events compared with other companies in the industry.
Over the weekend, St. Jude continued to mount its defense of the Riata, with the company’s CEO, Daniel Starks, asserting in an interview with the Times that its rivals, including Medtronic Inc., had engaged in a “whisper campaign” to discredit its heart devices, and were using the Riata issue to gain market share for their own products.
According to the Times, the efforts put forth by St. Jude appear to be aimed at protecting its newer lead, the Durata, from any suggestion that it might be prone to the same problem. The Durata has an added insulation sheath that St. Jude says should prevent the problem. According to the Times, Durata has a good safety record, but data is only a few years old.
On Tuesday, the editor of Heart Rhythm rejected St. Jude’s request for a retraction. Dr. Douglas P. Zipes, said in an interview with The New York Times that the publication had looked at St. Jude’s complaint and had no plans to retract the article, which had undergone review by experts associated with the journal before its online publication. Zipes also pointed out that the analysis St. Jude released on Friday had not been independently reviewed to determine its accuracy. He has offered the company the opportunity to submit its analysis for review.
The Medical Community’s Reaction
St. Jude’s strong defense of the Riata lead has taken many in the medical community by surprise. According to a newly-published article in The New York Times, it may also be alienating some doctors.
“I don’t think he (Stark) is helping his company,” Dr. Laurence M. Epstein, a heart device expert in Boston who consults for Medtronic and St. Jude, told the Times. “I think that any time you get defensive, it looks bad.”
Some doctors have also complained that St. Jude was slow to respond to the Riata problem and initially tried to play it down.
“I hope that St. Jude is putting as much effort into helping patients with Riata leads as they are into pointing out flaws in studies that identified the failures, Dr. Charles Swerdlow told the Times. The article described Swerdlow, who practices in Los Angeles, as a physician who “consults primarily with Medtronic but has also worked with St. Jude.”
For now, it seems, St. Jude has no intention of backing away from its current strategy. On Tuesday, after learning the Heart Rhythm Journal would not retract Hauser’s study, St. Jude announced that it had posted data on the Internet intending to show Hauser had made mistakes.
According to the Times, some physicians have grown weary of the back and forth. Instead, they want St Jude to offer some guidance on treating patients with disintegrating Riata leads.
“In order to know what to do you have to understand the statistics,” Dr. Epstein told the Times. “We don’t know the risks with this lead.”