Report: Postmarketing Regulatory Troubles at St. Jude Depress Share Value

Posted 13 April 2012 | By Alexander Gaffney, RAC 

The regulatory issues faced by St. Jude as a result of unfavorable reports concerning the safety of its Riata defibrillator leads-as well as the company's cessation of sales for its Quicksite and QuickFlex defibrillator leads-are causing more than just publicity problems for the company, reports Reuters.

The regulatory issues are "raising concerns on Wall Street that doctors will curb use of the company's products, weakening its position in the $6.5 billion global market for implantable defibrillators," writes Reuters. "St Jude shares have fallen more than 9 percent since the start of last week, compared with a 2 percent decline in the S&P Health Care Equipment index."

The company is currently engaged in an aggressive public relations battle against the medical journal Heart Rythym over a peer-reviewed article published by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation. Hauser's article concludes defibrillator leads manufactured by St. Jude were responsible for more deaths than were leads manufactured by Medtronic.

While the situation has escalated sharply in the last week, leading to the possibility that the US Food and Drug Administration will institute additional surveillance measures on medical devices, investors seem to be betting against St. Jude, reports Reuters.

Doctors, too, seem skittish, said Reuters, fearful of similar devices manufactured using the same design "backbone."

Read more:

Reuters - Analysis: Heart device troubles cloud St Jude's outlook

Regulatory Focus - As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

Regulatory Focus - Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

Cardiobrief - After an Unprecedented Request for a Retraction, A Close Look at the Data

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