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Cardiologist Proves to be Thorn in St. Jude’s Side for ICD Leads

Noted cardiologist Robert Hauser can't seem to stop giving St. Jude Medical palpitations. The embattled medical device manufacturer has spent the majority of 2012 in damage-control mode as it publicly dealt with the fallout from the recall of its Riata implantable cardioverter-defibrillator (ICD)  leads, the subsequent skepticism cast on its Durata leads, and the recent blow from FDA ordering the company to conduct studies on the Riata, Durata, and other leads. Yet despite the steady stream of bad luck and controversy, it appears that Hauser's outspoken criticism of St. Jude's ICD leads is at the heart of St. Jude's most significant PR woes, and it's starting to raise some eyebrows.

Since the recall landed St. Jude's faulty lead under the microscope, Hauser, a researcher and cardiologist at the Minneapolis Heart Institute, has led the charge against the medical device maker's Riata product while fueling fears about some of the company's related products, notably the newer Durata lead. In February, for instance, Hauser penned a perspective piece for the New England Journal of Medicine that held the Riata up as a representation of flaws in postmarket surveillance.

And so began a contentious relationship between the two that has endured throughout 2012. But the highlight of this war of words--or lowlight, depending on your view--occurred in a rapid-fire series of events stemming from a damaging study by Hauser published by Heart Rhythm titled, "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibillator Leads." Upon publication of the study, St. Jude demanded a retraction of the manuscript and strongly criticized the cardiologist's methods and findings; the request was denied. The company continued to publicly and aggressively question Hauser's study, which ultimately led to widespread criticism of St. Jude's handling of the whole situation.

In the wake of what the New York Times dubbed a scorched-earth defense,' St. Jude laid relatively low, staying out of the spotlight while striving to preserve and protect the reputation of its Durata lead.

But the Hauser-St. Jude feud resurfaced this past week. On the heels of FDA's surprising edict ordering St. Jude to conduct studies on several of its leads, including the Riata and the Durata, and recommending that Riata patients receive x-rays, the company saw its stock slide by 4%. Adding to this new wave of bad press, Hauser and his colleagues released a new study in the journal EP Europace that questioned the safety of the company's prized Durata lead.

Using data collected from the MAUDE database, Hauser and his colleagues claimed that Optim, a silicone-polyurethane copolymer that coats the company's Durata lead as well as the Riata ST lead, did not prevent lead abrasions as intended or promoted. In "Failure of a novel silicone-polyurethane copolymer (Optim) to prevent implantable cardioverter-defibrillator lead insulation abrasions," the researchers conclude: "Riata ST Optim and Durata ICD leads have failed due to insulation abrasions. Optim did not prevent these abrasions, which developed less than or equal to four years after implant. Studies are needed to determine the incidence of these failures and their clinical implications." The problems identified were not the same issues encountered with the recalled Riata lead, however.

Hauser has been actively making the rounds to promote his study during the past week, speaking with a number of media outlets and opining about St. Jude's leads. "How good is this Optim insulation, which St. Jude said protects against outside-in abrasions?" he said, according to the Minneapolis Star Tribune. "It turns out, there are a lot of abrasions." Hauser additionally told the New York Times, "There is no need to use this lead until we have more confidence in its performance." He also announced plans for a multicenter study to further investigate the rate of abrasion in Optim-coated leads.

A reputable researcher in the field and respected cardiologist, Hauser is likely pursuing the investigation with the best interest of patients in mind and with sound methodologies. But this whole situation is beginning to seem a bit...personal.

"You mean to say they don't love me? " MedCity News reported that Hauser joked when asked about the situation, adding that the company didn't send him a valentine this year. "I really don't care. That's not why I do this."

And it's true that he shouldn't pull any punches when examining legitimate safety issues and exposing defects or flaws that put patients at risk. But his media exposure, tone of some public comments, and strong focus specifically on St. Jude's products comes off as a bit biased against the company, regardless of whether there is any or not.

Back in April at the height of the Heart Rhythm brouhaha between St. Jude, Hauser, and Medtronic, for example, we took a reader poll on which party's public image was suffering the most. The majority vote of 44% indicated that all three parties, including Hauser, weren't doing themselves any favors in the public court of opinion. And in June, I received an interesting email from a former defibrillator lead designer that speculated that Hauser, former president of CPI, could hold a grudge against the former competitor or may simply enjoy publishing articles and getting media attention. While these assessments are purely opinion based and not grounded in any fact, the truth remains that this contentious interaction between Hauser and St. Jude is beginning to raise eyebrows. And that's not a good sign.

It will be interesting to see how this latest round of research and accusations plays out between the two. But in the meantime, I'll leave you with an interesting point brought up by the reader from whom I received the Hauser email in June. "We said years ago that the reliability [in ICDs] is as good as it will ever be and will only go down from here, and we were right," he wrote. "The most interesting question to ask is: How good is good enough and how bad is still ok? This seems like a simple question, but it has deep ramifications for design, build, and use of defib leads, and is a very difficult question to answer. It involves technical risk, business risk, and reputation risk, and is very difficult to wrap your arms around. Of course, at some point the FDA and the legal system gets involved, but often too little and way too late." --Shana Leonard

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