St. Jude's New Product Looks Like the Old One

Story first appeared in Bloomberg Businessweek.

St. Jude Medical Inc.’s Durata, a wire used to connect life-saving defibrillators to the heart, was linked to a rare and dangerous fraying defect in one patient in a report to U.S. regulators.

A doctor voluntarily reported the case of a so-called externalized wire from April 17 to the Food and Drug Administration, according to a posting on the agency’s Maude safety database. The unidentified doctor didn’t tell St. Paul, Minnesota-based St. Jude, according to the FDA’s posting.

An anonymous report with such specific details is rare and raises questions about the credibility of the information. The FDA agency reviews the information it receives and forwards the details to manufacturers.

There are a number of reasons for the agency to review all reports that come in, including the potential for fraud or the need for additional follow up. All privacy information is stripped out of the reports prior to posting them on the public database.

The person reporting the incident, including a doctor, patient or someone else, can check a box indicating they want to maintain their privacy without commenting specifically on the Durata device.

St. Jude stopped selling an older version of the device known as Riata in December 2010 and recalled it a year later amid reports the wires known as leads could break through the insulation coating and fail to work properly. Durata replaced Riata, and the new product’s insulation coating, called Optim, was designed to prevent the rare defect. No cases of externalized Durata wires have been reported before now.

‘Some’ Failure

All leads are prone to some level of failure and one lead failure does not implicate the entire family of Durata leads. This new report raises questions on whether Durata is truly immune to the same failures that plague Riata and at the very least, will keep up the discussion on whether St. Jude’s smaller diameter leads should be used when other more reliable leads are available.

St. Jude fell 6 percent to $36.24 at the close yesterday New York, the biggest single-day drop since December. The shares have dropped 26 percent in the past 12 months through yesterday.

Seeking Information
The report indicates that it was filed by a physician, but does not provide the device serial number, the name of the physician or the institution, which would enable the FDA to learn more about the circumstances.

There haven’t been any cases of externalized wires on a Durata lead reported to the company.

St. Jude’s declining stock price is an overreaction. Durata’s performance seems to be similar to competitors and its future performance may show a reduction in lead failures. The sharp negative reaction in the stock reflects the fear factor of a product recall that analysts ultimately do not think will materialize.

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St. Jude Device Problems Escalating

Story first appeared in The Wall Street Journal.
A heart-device problem that has plagued St. Jude Medical Inc. shows no signs of relenting, according to data in the company's latest performance report, expected to be published Tuesday.

The rate of a key failure for the company's Riata-series "leads," wires that connect a defibrillator to the heart, increased 17% since the company's last performance report in November. Following that report, the company issued an advisory—regulators called it a recall—over concerns that the electrical wires inside the lead have a tendency to wear through their silicone coating, becoming loose in blood vessels near the heart.

The scope of the problem captured in the report is small, just 0.74% of the 79,000 Riatas in use as of the end of December. But even doctors involved in reviewing it acknowledge that St. Jude's report cards undercount incidents.

The reports are based on complaints filed by doctors, and on products returned to St. Jude for inspection after patients die or have the device removed. They don't account for problems that aren't actively relayed to the company. St. Jude stopped selling the Riata leads at the end of 2010.

Outside researchers have found failure rates as high as 33%, though such reports have focused on small groups of patients. An 87-patient study at Vanderbilt University Medical Center in Tennessee found one-third of patients had wires that eroded through their insulation. A Vanderbilt electrophysiologist and author, said he believed the findings roughly reflected the scope of the problem.

Not all insulation problems result in electrical problems, including sometimes-lethal short circuits. St. Jude's report cards don't specifically show the rate of leads with insulation problems that also result in electrical problems.

The variation in measures of failure rates underscores the problems the industry has faced in finding ways to better track defibrillators, devices that zap dangerously irregular heartbeats back to a normal rhythm. In the wake of several high-profile recalls in recent years, the industry has put efforts in place—for instance, independent medical advisory boards and wireless monitoring systems—to better identify problems. But many older devices, such as the Riata leads, predate those efforts.

St. Jude is increasing its investment in patient registries that could help better understand the performance of the devices and detect early on if there is an issue.

St. Jude also launched a 700-patient study in December that is meant to give doctors a clearer picture of the rate of both conductors breaking through coating and electrical problems.

Problems with the Riata-series leads first appeared in 2010, and the company stopped selling the product that December. St. Jude acknowledged more problems with the device a year later, prompting the recall. A series of medical journal articles ignited new scrutiny this spring.

In the new performance report, the company also included, for the first time, data collected from several patient registries detailing the performance of its newer, Durata-series leads. The company has struggled with a spreading perception among doctors that the problems of Riata could also arise in Durata, which shares certain design elements, even though there is so far no evidence of problems in the newer leads.

Durata is coated in an extra layer of polyurethane that the company says protects it from wires eroding through the silicone, and has other design changes. It is implanted in 145,000 Americans, with few reports of problems. St. Jude used its performance report to highlight a 90% lower rate of erosion problems for Durata leads at five years, compared with Riata, according the registries, which consist of data collected every six months by doctors for more than 10,000 patients.

Doctors who are dealing with the Riata problems in the field are frustrated, in part, because they lack data to know the full scope of the problem.

St. Jude has recommended that doctors monitor patients with Riata devices closely, in some cases using wireless devices. Doctors are also advised, at their discretion, to do extra electrical tests and to screen for wires breaking through their silicone sheaths with X-rays. St. Jude says there is no consensus on whether to replace leads found to be faulty, but it will provide a free Durata for patients whose doctors go that route.


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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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