Regulatory Focus™ > News Articles > As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

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

Posted 11 April 2012 | By Alexander Gaffney, RAC 

A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources.

St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," reports Forbes.

On 10 April, HearthRhythm responded, saying despite "some changes" that will be made, "the bulk of the manuscript stays as it is" and will not be retracted, reports Forbes.

St. Jude also released its own figures saying Medtronic's Quattro product likely caused 377 deaths, widening the scope of the spat significantly, reports Mass Device. The implications are likely to raise tensions in Minneapolis, where both companies are based, and for regulators tasked with formulating a response.

Medtronic responded by backing up the journal's findings, saying in a statement to Reuters they found their own analysis to be "consistent with what [the journal] found, and we confirm [its] results."

The US Food and Drug Administration (FDA) is reportedly looking to "unveil a new medical device post-market surveillance program aimed at better tracking potentially faulty devices" that includes a unique device identification (UDI) program that has been stalled at the Office of Management and Budget for months, reports Mass Device in a separate article.

That plan has been supported in the past by Senator Jeff Merkley, who last month released the Ensuring Safe Medical Devices for Patients Act, which would require FDA to release UDI regulations by the end of 2012 and add medical devices to the Sentinel post-marketing surveillance initiative. It is unclear whether FDA's regulations, which have been deemed by OMB to be "significant" in scope, would still be held up at OMB if re-issued.


Read more:

Mass Device - FDA looks to strengthen device surveillance post-Riata | MassDevice.com On Call

Mass Device - St. Jude, firing back, posts 377 Medtronic Quattro lead deaths

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

Forbes - Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper

Fierce Medical Devices - Tough luck, St. Jude: No retraction for you

Fierce Medical Devices - UPDATED: Medtronic backs Hauser's findings on Riata leads

Bloomberg - Heart Rhythm Stands by Study Linking St. Jude's Riata to Deaths

Med Page Today - Journal Editor Nixes Retraction of Study

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

Mass Device - Heart doc on St. Jude, MDT Riata fight: "I can't recall seeing a more contentious" dispute

Regulatory Focus - Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB

Regulatory Focus - Bill Would Address Medical Device Safety By Giving FDA Additional Authority


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