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Sorin Denies Family’s Claim It Hid Heart Valve Info From FDA

Law360 (April 12, 2018, 10:29 PM EDT) -- Sorin Group USA Inc. began working with federal regulators to reinforce its prosthetic heart valves six months before doctors discovered one of the devices had rapidly deteriorated in a young woman, the manufacturer said Thursday in a court filing denying having withheld information from the U.S. Food and Drug Administration.

The LivaNova subsidiary responded to a lawsuit in Massachusetts federal court from the family of Allison Plourde, who died after doctors attempted to remove her decrepit Sorin valve in early 2014. At the time, Sorin argued, a...
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