STORY FROM: Drugs & Medical Devices

Identities of Foreign Adverse Event Reporters Protected, Fla. Appeals Court Rules in Hip Replacement Action

WEST PALM BEACH, Fla. — Reports of foreign adverse events associated with Howmedica Osteonics Corp.’s recalled hip replacement devices must be redacted to conceal the identities of the voluntary reporters, a Florida appellate court has ruled.

On Jan. 25, the Florida Court of Appeal, 4th District, held that nothing in 21 C.F.R. § 20.63, which protects the identities of voluntary reporters, indicates that the regulation is only applicable to domestic reporters; therefore it can be extended to foreign voluntary reporters.

HOC sought certiorari review from the Broward County (Fla.) Circuit Court’s order that denied its request to redact identifying ...

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Freedland Harwin Valori
Kopelowitz Ostrow Ferguson Weiselberg Gilbert
Shook Hardy & Bacon
Wicker Smith O'Hara McCoy & Ford

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