St. Jude Is Rebuffed Over Report On Device - New York Times

In a setback for St. Jude Medical, a medical journal late Monday rejected the company’s request that it retract a published report that found that 20 deaths were linked to failures of a heart device component made by the company.

St. Jude’s stock opened lower before gaining 0.8 percent, or 29 cents a share, to $39.20 early Tuesday after a 5 percent decline on Monday. The stock has tumbled in the last week amid reports involving other failures of the same component, a lead, or cable, connecting a defibrillator to a patient’s heart.

St. Jude, which is one of the country’s biggest medical device producers, did not dispute the deaths had occurred. But on Friday, the company accused the author of the report, Dr. Robert Hauser of Minneapolis, of making critical errors in the research and showing a bias against St. Jude by failing to properly account for deaths involving a similar component made by a competitor, Medtronic.

The company also asked the medical journal that had published the report, HeartRhythm, to retract it. However, the journal’s editor, Dr. Douglas P. Zipes, said in an interview late Monday that the publication had looked at St. Jude’s complaint and did not plan to pull back the article, which had undergone review by experts associated with the journal before its online publication two weeks ago.

Dr. Zipes said that the data St. Jude released Friday to refute Dr. Hauser’s report had not been independently reviewed to determine its accuracy. He said he had offered the company an opportunity to submit its data to the journal for review, but planned to publish Dr. Hauser’s article in the next print edition of HeartRhythm.

“I understand industry’s pain, but I will not abrogate the rules and regulations that have served us so well,” Dr. Zipes said, referring to the peer review process.

He said that Dr. Hauser has agreed to make some changes to his article before its print publication involving what he called “inflection” but added that “the bulk of the manuscript stays as is.”

St. Jude, based in St. Paul, had no immediate response on Tuesday to the rejection of its request. Dr. Zipes said he had informed the company of his decision Monday.

The controversy involves a lead that St. Jude once widely sold. Wires within the cables are working their way through the insulation surrounding them and are causing, in some cases, electrical problems, including shocks at inappropriate times. The company says its newer leads are not affected by the same problem.

Dr. Hauser’s research involved the same older leads but a different issue with potentially fatal consequences. He reported that the insulation surrounding the leads could wear away, causing a short-circuit when a defibrillator fired an electrical jolt needed to restore a failing heart to normal beating.

Dr. Hauser’s report was based on his review of a publicly available device safety database run by the Food and Drug Administration. His analysis showed that the number of reported deaths involving the St. Jude lead were significantly higher than similar reports involving a lead made by Medtronic.

Medtronic has disputed St. Jude’s claims about the number of deaths attributable to its device.

St. Jude issued a news release Tuesday that did not directly address the journal’s decision to reject its request for a retraction.

Instead, the company announced that it had publicly posted 377 reports of deaths of patients who had used the Medtronic defibrillator lead, which is called the Quattro, not 62 deaths as Dr. Hauser’s report stated.

However, a spot review of those reports showed that some of them do not contain an allegation that a patient’s death was associated with the failure of a Quattro lead. Under federal rules, medical device companies must submit a death report whether or not they contain an allegation of device involvement.

Dr. Hauser said that in compiling his data he set aside those reports in which there was not an allegation of possible device involvement in a patient death.