Rouviere et al v. Depuy Orthopaedics, Inc. et al

Filing 120

ORDER: IT IS, on this 10th day of June, 2020, ORDERED that the following are the deposition topics as to which an HOC witness or witnesses shall testify: Written materials or warnings that accompanied the MDM (including the Instructions for Use) during the period 2010 to 2017. The packaging, labeling and marketing of the MDM during the period 2010 to 2017. Any recalls initiated regarding the MDM. The history of the perfor mance of the MDM, including any reports of defects, failures or other adverse events. The intended, permitted or foreseeable use of the MDM within any other hip system, device or components, whether manufactured by HOC or any other manufacturer, and whether or not communicated to or authorized by the FDA or any other oversight authority. Any reactions caused by use and/or corrosion of the MDM, including hypersensitivit y, foreign body reaction, metal toxicity and allergic reactions. Any coatings used or considered for use on the MDM. The 510(k) application and approval process for the MDM. Failure rates associated with the MDM. The Design History File for the MDM and the information contained therein. Use of the MDM with components designed, manufactured and sold by other medical device manufacturers. Testing and/or analyses done on the MDM. So Ordered. (Signed by Magistrate Judge Stewart D. Aaron on 6/10/2020) (js)

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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK JODI ROUVIERE and ANDRE ROUVIERE, Plaintiffs, v. DEPUY ORTHOPAEDICS, INC. n/k/a MEDICAL DEVICE BUSINESS SERVICES, INC. and HOWMEDICA OSTEONICS CORPORATION d/b/a STRYKER ORTHOPAEDICS, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) 6/10/2020 Case No. 1:18-cv-04814-AJN-SDA ORDER THIS MATTER having been brought before the Court on a motion by Defendant Howmedica Osteoncis Corp. (“HOC”) for a protective order, and Plaintiffs and HOC having met and conferred as per the Court’s June 3, 2020 Order (ECF No. 116) and having agreed to deposition topics regarding the MDM components (hereinafter “MDM”) implanted into Jodi Rouviere in August 2012, IT IS, on this 10th day of June, 2020, ORDERED that the following are the deposition topics as to which an HOC witness or witnesses shall testify: 1. Written materials or warnings that accompanied the MDM (including the Instructions for Use) during the period 2010 to 2017. 2. The packaging, labeling and marketing of the MDM during the period 2010 to 2017. 3. Any recalls initiated regarding the MDM. 4. The history of the performance of the MDM, including any reports of defects, failures or other adverse events. 5. The intended, permitted or foreseeable use of the MDM within any other hip system, device or components, whether manufactured by HOC or any other manufacturer, and whether or not communicated to or authorized by the FDA or any other oversight authority. 6. Any reactions caused by use and/or corrosion of the MDM, including hypersensitivity, foreign body reaction, metal toxicity and allergic reactions. 7. Any coatings used or considered for use on the MDM. 8. The 510(k) application and approval process for the MDM. 9. Failure rates associated with the MDM. 10. The Design History File for the MDM and the information contained therein. 11. Use of the MDM with components designed, manufactured and sold by other medical device manufacturers. 12. Testing and/or analyses done on the MDM. Dated: June 10, 2020 SO ORDERED: ____________________________ Hon. Stewart D. Aaron, U.S.M.J. 2

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