STORY FROM: Drugs & Medical Devices

Joint Stabilization Device Maker Need Not Turn Over 510(k) Info, Kan. Federal Judge Says

WICHITA, Kan. — A Kansas federal judge has refused to make public certain documents the manufacturer of a joint preservation device submitted to the FDA during the 510(k) approval process, ruling that they constitute trade secrets and confidential commercial or financial information.

In a Sept. 18 order, Magistrate Judge Gwynne E. Birzer said Orthopedic Sciences Inc. is not required to turn over the documents in a lawsuit accusing it of participating in a scheme to improperly bill patients and their insurers for medically unnecessary joint preservation surgeries that involved its Titanium Hip Tool Locking Plate Bone Graft Stabilization System.

Charles ...

Associated Law Firms
Edgar Law Firm
Foulston Siefkin
Peterson & Associates
The Health Law Partners

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