St. Jude demands retraction of Riata lead study

St. Jude Medical ($STJ) is fighting back after some bad publicity over faulty leads. The company's first target: Dr. Robert Hauser of the Minneapolis Heart Institute.

St. Jude issued a lengthy statement April 6, demanding a retraction of Hauser's study manuscript--published online March 26 in the HeartRhythm journal--for allegedly making it seem as if the company's Riata defibrillator lead caused more deaths than Medtronic's ($MDT) Quattro Secure offerings. Based on a search of the FDA's MAUDE database, Hauser's study concluded that of 133 deaths, 22 were caused by malfunction of the Riata or Riata ST leads (short circuits), and just 5 stemmed from failure of the Quattro Secure. (Hauser, by the way, has become a strong advocate of increased regulatory scrutiny of device implants to boost their safety.)

"Dr. Hauser's research substantially undercounted total deaths in the MAUDE database for Quattro Secure," St. Jude alleges, thereby resulting in "substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead." St. Jude stopped selling the Riata leads in December 2010 over safety concerns. After a follow-up study identified further problems, the FDA issued a Class I recall, the most serious action possible.

Hauser looked at situations in which the protective lead coating wore away, creating a chance for a short circuit when the device ramps up for action, according to The New York Times' follow-up coverage of the issue. St. Jude acknowledged at least 20 patient deaths in these scenarios, but said the death rate was similar to other devices and not unique to the Riata wires, according to the story. Meanwhile, St. Jude CEO Daniel Starks told the NYT that the company has "been more transparent" than its competitors in disclosing lead problems. The article also notes that St. Jude executives have claimed that data filed with the FDA database suggest more problems than Medtronic's data, because St. Jude reports more product details than its competitor.

Separately, St. Jude executives are also accusing Medtronic of trying to smear the reputation of the company's new Durata lead by claiming that it is prone to problems similar to those plaguing the Riata leads, according to the NYT story. Medtronic spokesman Christopher Garland denied the allegations and is quoted by the NYT as saying St. Jude was making "false" claims. Hauser responded in the article that he wasn't surprised by St. Jude's reaction, and said the company has "been very contentious" about his study.

Perhaps St. Jude is feeling under siege. The company's stock took a major hit late last week after St. Jude announced that it had stopped selling its QuickSite and QuickFlex left ventricular leads for cardiac resynchronization therapy devices after acknowledging at least 39 cases of worn insulation.

- here's St. Jude's demand for a retraction
- read the NYT coverage (subs. req.)
- consider Forbes' blog item
- check out the study abstract
- watch the recent CBS "Sunday Morning" story on Dr. Hauser