St. Jude Under Fire for Faulty Device

Story first appeared in The New York Times.

As St. Jude Medical defends itself against reports of deaths and injuries linked to problems with an implanted heart device, it finds itself in familiar territory. Since 2005, two competitors, Medtronic and Guidant, have faced similar scrutiny about critical flaws in their products.  This could result possible medical malpractice claims coming to light in the near future.

But St. Jude is distinguishing itself with what doctors and others say is a rare response — a scorched-earth defense of its policies and products. The company’s chief executive has led that charge, accusing Medtronic of trying to undercut St. Jude to gain business. He and other company executives have also gone after a prominent researcher, contending he made crucial errors and showed bias in a study critical of a St. Jude heart device component at the center of the safety issue.

The mode of attack, however, may be backfiring. On Tuesday, the medical journal that published the report challenged by St. Jude said it had rejected the company’s request to retract it. And interviews suggest that some of the comments are upsetting some doctors essential to St. Jude’s success — specialists who implant heart devices.

On Wednesday, St. Jude shares climbed 70 cents to close at $39.23, but were still down more than 11 percent since March 30. The scope of the problem involving the component, a wire or lead that connects a defibrillator to a patient’s heart, is still unfolding. The lead, a model called the Riata, has been implanted in about 128,000 patients worldwide.

Electrical wires within the Riata lead are breaking through the insulation and causing unintended shocks in some patients. An even greater concern is that the wires may fail when needed to deliver a lifesaving jolt to restore a failing heart to normal beating. Minneapolis Medical Malpractice Lawyers view this as negligence, based on the fact that the company is aware of the device shortcomings.

The company stopped selling the Riata in late 2010. But the intensity of St. Jude’s response appears to reflect a high-stakes effort to protect 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; thus far, it has a good safety record, but data is only a few years old.

It is little wonder, given the importance of the Durata to St. Jude’s future, that company officials would aggressively defend it. Still, their argumentative manner appears to run the risk of alienating physicians.

For example, in comments to Wall Street analysts in January, he described as a “nonevent” a recent meeting of leading device experts in Minneapolis who had gathered to better understand the safety problems posed by the Riata and how to address the lead’s risks in patients. Doctors are grappling with the issue of whether it is more dangerous to remove the lead if it is failing, or leave it in.

In his comments, St. Jude's chief executive seemed to minimize the meeting’s value, describing it as lightly attended. He added that he also saw it as a sales opportunity for St. Jude, claiming that many doctors in attendance used competitors’ products.

One expert who attended the meeting, said that St. Jude executives might better serve the company’s interests by focusing on patients and their safety. He and other doctors have complained that St. Jude was slow to respond to the Riata problem and initially tried to play it down.


Another expert, said she doubted the suggestion that the meeting was filled with physicians who did not use the company’s devices. However, the expert, who serves on the St. Jude medical advisory board, said she thought the company had been open in dealing with the Riata issue.

In a telephone interview Tuesday, St. Jude's chief executive said his public comments were not intended to be strident but added that he felt it was critical for him to correct mistaken information about St. Jude’s products.

He also said that his remarks about the Minneapolis meeting reflected his view that the safety issues surrounding the Riata had already been addressed by a professional group representing heart device experts. But St. Jude officials may also have been mindful of another issue: in a poll taken of experts at the beginning of the Minneapolis gathering, two-thirds of those who responded said they would reduce the number of newer Durata leads they implanted or not use them for now.

This is not the first time he and the company have taken a combative position: in 2009, St. Jude quit the industry trade group AdvaMed because he argued that the group’s stance on health care reform was placing some device makers like St. Jude at a disadvantage to others.

Some Wall Street analysts said the St. Jude chief executive was acting appropriately in his recent comments, by addressing concerns about the Riata lead without overreacting and scaring investors in the process. While still others feel he is acting rashly.


He said the company had sent him an e-mail contesting his report, then forwarded it to competing analysts. On Wall Street people are still trying to digest this level of aggression.

St. Jude, however, show no signs of backing off. On Tuesday, rather than react in a news release to the decision by the medical journal to deny its request to retract an article, St. Jude apparently shifted to Plan B.

It announced that it had posted data on the Internet intended to show that the researcher with whom it has clashed had made critical mistakes. In response, the opposing doctor said he stood by his report and that the difference between his findings and St. Jude’s reflected methodological, rather than substantive, differences.

Some doctors said that they were tired of the sideshow, and that what they wanted from St. Jude was information about how to deal with patients who have disintegrating Riata leads.

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