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)
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
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?