Product News and Recalls

Federal officials, doctors concerned over GranuFlo allegations

Health care providers and federal health regulators have voiced concerns, following revelations that the United States’ largest operator of dialysis centers may have concealed reports that one of its products carries a potentially deadly risk.

A New York Times report quotes Steven Silverman, director of compliance for the U.S. Food and Drug Administration’s medical devices division, as saying: “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”

The FDA is investigating the allegations against Fresenius.

In November, 2011, Fresenius sent out an internal memo to its own doctors stating that 941 patients suffered cardiac arrest in the company’s clinics in 2010, and the incidents may be associated with a product called GranuFlo.

Yet Fresenius did not inform other clinics of this concern until March, 2012, and only did so after an anonymous tipster gave the U.S. Food and Drug Administration a copy of the in-house warning.

The New York Times quotes the chief medical officer at a dialysis chain that uses Fresenius products as saying: “If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it.”

The report said dialysis centers throughout the country were checking patients to make sure the GranuFlo product didn’t put them at risk.

You should consult with a doctor before making any change in your medical care. If you or a loved one have suffered injury or death after kidney dialysis, contact Lopez McHugh for a free consultation; we can help determine if GranuFlo was used.

See the story here:

http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0