Medical Device Litigation 30(B)(5) Deposition Form Notice for Ohio Courts

This page is an example of a 30(B)(5) that was used in a medical malpractice case with overlaps with a medical device and "off label" use and promotion.

COURT OF COMMON PLEAS
_____________________, OHIO

Plaintiff
vs.

Defendant

30 (B)(5) NOTICE DIRECTED TO __________________
Plaintiff, pursuant to the Ohio Civil Rules of Procedure 30(B)(5), directs the following Notice to Defendant__________________. Plaintiffs respectfully requests that Defendant choose one or more of its employees, officers, agents, or other persons duly authorized, to testify on its behalf on the following matters at a place and time mutually convenient for all Parties and Counsel.

DEFINITIONS

“Off label” means any use of ______________ that was not approved by the FDA and/or not contained within the approved uses and indications of the package label and instructions for use provided by_____________________________________.

The 30(B)(5) matters include but are not limited to the following:

1. The existence of the documents requested in Plaintiff’s discovery requests;
2. The electronic creation, duplication,  indexing, and/or storage of the documents requested in Plaintiff’s discovery;
3. The method of search for the documents requested;
4. The purchasing and distribution contracts, as well as any negotiations, with _________________________from _____________-present relating to_______________.
5. The review of the pre-market safety data of ______________prior to and immediately after FDA approval;
6. The financial evaluation of future profitability (financial modeling or forecasting) of _____________prior to and immediately after FDA approval;
7. The system, policies and protocol for introducing the _____________to the market and use at _____________;
8. The meetings, program, and coordination with _________________________regarding the launching, introduction, marketing, and use of_______________
9. The system for reporting adverse events to the FDA and compliance with federal regulations;
10. The documentation of adverse events related to ______________.
11. The accounting and income received from surgeries involving the use of _________.
12. All clinical trials performed at ____________________involving the safety and efficacy of ___________;
13. The policies and protocols for monitoring and evaluating the appropriateness of physician uses of medical devices in non-FDA approved;
14. Protocols and guidelines for patient selection in _____________for on label and “off label” surgeries;
15. The known and recognized data regarding the safety and efficacy of “off Label” and non-indicated uses of___________ in____________;
16. Reimbursement rates for surgeries involving _______________________;
17. Protocols and procedures for disseminating FDA warnings, notices, and safety alerts regarding medical devices or pharmaceuticals to physicians or patients;
18. Advertising and promotion of the ____________in local media;
19. Income derived from __________________ in “off-label ” procedures;
20. Policies, protocol and procedures for working with _______________detail personnel;
21. The policies or protocols for the use of newly approved medical devices at _________
22. The policies and protocols for physician’s interaction with medical device companies regarding grants, enrollment fees, gifts, promotional fees, speaker fees, and drafting and authoring industry sponsored journal articles.
23. Informed consent policies;
24. Discipline actions taken against any prior employees for the use of____________ in “off label” procedures.