Union Sues FDA over Censored Report on Heart Defibrillator

Friday, February 15, 2013
FDA Commissioner Peggy Hamburg

Officials with the Food and Drug Administration (FDA) have refused to explain why they heavily redacted a report on heart defibrillators, prompting a labor union to sue the agency.


Unite Here, representing more than a quarter of a million workers in the hotel, food service, laundry, warehouse, and casino gaming industries, filed a lawsuit in federal court after the FDA refused to fully comply with the union’s Freedom of Information Act request.


The union wants to know what the FDA’s inspector general said in an internal report about defibrillator devices manufactured and sold by St. Jude Medical (SJM).


When labor officials received a copy of the report, “almost every portion” of the document had portions blacked out to avoid embarrassing the manufacturer and the agency, according to the lawsuit.


Thousands of patients, including union members, have had the devices implanted.


It was reported last year that defective wires made by SJM to connect defibrillators caused at least 20 patient deaths due to short-circuiting, according to an article by Dr. Robert G. Hauser published in the cardiology journal Heart Rhythm.


The company stopped selling the devices in December 2010 due to safety concerns, but more than 79,000 people in the U.S. and 49,000 abroad still have the implants, the Associated Press reported.

-Noel Brinkerhoff


To Learn More:

Union Says FDA Is Hiding Document (by Elizabeth Warmerdam, Courthouse News Service)

Study Links St. Jude Heart Wires To 20-Plus Deaths (by Matthew Perrone, Associated Press)

Patients Not Allowed Access to Data Collected by Implants in their Bodies (by Noel Brinkerhoff, AllGov)


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