1. North American Spine Society Discovery Considerations for Spinal Device Manufacturers Facing Litigation Carmel Cosgrave SmithAmundsen LLC

2. Medical Device Litigation 101 The FDA was given power over medical devices in the 1976 Medical Device Amendments to the Food, Drug, & Cosmetic Act, 21 U.S.C. section 360c et seq.

3. Devices are categorized into three classes based upon the amount of risk involved in the use of that device Class I Devices that do not require premarket approval or clearance but must follow general controls dental floss, sponges Class II Devices that are cleared using the 510(k) process catheters, hearing aids Class III Devices that are approved by the Premarket Approval (PMA) process artificial heart Spinal Device Examples Most Pedicle Screws = Class II Artificial disk replacement devices, prosthetic nuclear replacements, and recombinant bone morphogenetic proteins = Class III

4. How the FDA Reviews Devices: Premarket Notification (PMN or 510(k) Process) Allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Any device that reaches market via a 510(k) notification must be "substantially equivalent" to a device on the market ("predicate device"). Pre-market approval (PMA) Higher level a review than 510(k) FDA oversees scientific and regulatory review of device prior to marketing Applies almost exclusively to Class III devices. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of the device.

5. How Classification Affects Lawsuits Pre-emption When a product is approved through a PMA process, pre- emption applies Mitchell v. Collagen Corp., 126 F. 3d 902 (7th Cir. 1997); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001) 510(k) review process is the clearest exception to preemption MDA does not preempt common law suits for medical devices that are marketed under the 510(k) process. Medtronic v. Lohr, 116, S. Ct. 2240 (1996) Riegel v. Medtronic, 552 U.S. 312 (2008) affirmed the doctrine of pre-emption protection only for those medical devices reaching U.S. markets via PMA and preserved the previous Lohr v. Medtronic decision's lack of preemption protection for those medical devices marketed via the generally more abbreviated 510(k) clearance mechanism

6. Medical Device Litigation Today Medical device manufacturers face an increasingly hostile and uncertain legal environment Industry is under seemingly constant pressure from liability cases and unfavorable media exposure Manufacturers have to be mindful not only of the threat of unfavorable verdicts BUT also the threat of failing to comply with the duties under the state and federal discovery rules

7. Medical Device Litigation Today Areas were a lawsuit could arise: Patent Trademark Product Liability Product Liability Contract Employment Regulatory

8. Anatomy of a Lawsuit Pleadings Complaint Answer or Dispositive Motion Discovery Obtain Evidence Interrogatories Requests for Production Requests for Admissions Depositions Trial Ongoing assessment of resolution through settlement

9. Avoiding the Pitfalls of Discovery

10. Discovery: Why You Should Care Discovery is essential to litigation Involves any material which is calculated to lead to admissible evidence A good discovery strategy is indispensable to the successful defense of a medical device products liability suit. Discovery narrows the issues relevant time period for discovery of documents events occurring prior to and during the plaintiff’s use. Gives the defense information about its case Strengths and weaknesses Knowledge of the documents in your files Identification of witnesses and shaping defense themes

11. Discovery: Why You Should Really Care Grange Mut. Cas. Co. v. Mack $8,830,983.69 Qualcomm Inc. v. Broadcom Corp. $8,568,633.24 Green v. Blitz U.S.A, Inc. $250,000 in civil contempt sanctions provide a copy of the court’s Order detailing sanctions “to every Plaintiff in every lawsuit against it, for the past two years. file a copy of the court’s Order with its first pleading or in every new lawsuit it participates in for next five years

12. Discovery violation cases and sanctions are trending upward Defendants were sanctioned for e-discovery violations nearly three times more often than plaintiffs the most common misconduct was failure to preserve electronic evidence, followed by failure to produce and delay in production. Duke Law Journal, Vol. 60:789, 2012

13. Burdens on Manufacturers Production of voluminous documents Protection of trade secrets and intellectual and other proprietary property Cost and time associated with demands on employees Production of documents in “Native Format” Typically, files must be produced in the manner in which they are maintained in the regular course of business, OR a more targeted production can be made, in which defense counsel selects the responsive documents and produces them in response to individual requests. Maintaining HIPAA/HITECH Compliance Federal regulations prohibit releasing personal identifying information related to adverse event reports.

14. Discovery Recommendations It is important to be knowledgeable throughout the lawsuit Designate a contact person for purpose of coordination with counsel May be different from in-house counsel Person should be familiar with how information flows throughout company Because…

15. Discovery Recommendations Counsel will typically need assistance with: Document production Assessing scope of production Date ranges, models, revisions, types of information available Inspection of records Follow up questions Supplemental production Producing documents in a native or accessible format Electronic or hardcopy Identifying key personnel for interviews Preparation of witnesses for deposition Ensuring manufacturer is compliant with any litigation hold

16. Discovery Recommendations Protecting valuable information Copyrights Trade Secrets Patents Design information not relevant to lawsuit Discovery provides broad access to information which might be relevant at trial It is better practice to have an understanding of what information is at issue early in the case Hard to “un-ring the bell” when non-relevant but potentially harmful information is inadvertently disclosed

17. Discovery Tools Protective Order Court issued Opportunity for parties to discuss and agree on scope of relevancy in the case In the event confidential information must be disclosed Forces the receiving party to maintain and secure confidential information

18. Discovery Tools Protective Order Continued Inspection and testing of the medical device Differing views can easily arise over proposed testing Protective order allows manufacturer to have say in how the testing is conducted Opportunity for expert or consultant input ASTM standards compliance

19. Discovery Tools Discovery motions as a sword and shield Motions to compel Depositions of Plaintiff's witnesses Motions to bar What should be discoverable Pre-suit testing Different models

20. Discovery Recommendations 30(b)(6) witness deposition A powerful discovery tool Used to investigate areas of inquiry of a corporate entity Requires company to educate and produce an appropriate representative whose testimony will be binding on the company Powerful but limited Party seeking to examine witness must first inform the company of the areas of inquiry the party seeks to investigate Different from a typical fact witness deposition and allows company additional time for prep If the notice is too broad, there is ground to quash the notice Notices seeking information on a party’s search efforts to find documents responsive to discovery requests is not allowed Coleman v. General Elec. Co., 1995 U.S. Dist. LEXIS 8186 Am. Nat’l Red Cross v. Travelers Indem. Co., 896 F. Supp. 8

21. Discovery Recommendations 30(b)(6) continued… Selecting the Appropriate Representative Not limited to producing a single representative to testify May produce such number of persons as to satisfy the request. States v. Taylor, 166 F.R.D. 356, 360 Examining party cannot demand or specify a particular officer Producing party can select a desired witness BUT witness must be familiar with topics on which they are proffered Former employees can be proffered BUT, testimony is still binding on entity Courts take 30(b)(6) notices very seriously Unprepared witness may lead to sanctions Some courts have viewed “I don’t know” answers as unacceptable

22. Other Discovery Tools to Consider Request for preservation Does Plaintiff have possession or control of the medical device? How is the device handled? Storage Temperature Biological material? Unilateral inspection or testing?

23. Other Discovery Tools to Consider Claiming privilege and privilege logs Work product, attorney/client, other New case: Coito v. Superior Court, 54 Cal. 4th 480 (2012) recorded witness statements by investigators hired by counsel entitled to qualified work product protection and may be entitled to absolute protection if the disclosure would reflect “an attorney’s impressions, conclusions, opinions, or legal research or theories.” Privilege logs required and also helpful in the process of analyzing information subject to disclosure

24. Other Discovery Tools to Consider Independent or Defense medical examination of Plaintiff Assesses the extent of Plaintiff's injures Generally, must have good cause as to why exam will aid discovery Think carefully Potential to backfire Defense witness may become plaintiff’s best witness

25. For more information and questions, please contact: Carmel Cosgrave Direct Dial: 312-894-3228 E-mail: ccosgrave@salawus.comccosgrave@salawus.com Colin Gainer Direct Dial: 312-894-3331 E-mail: cgainer@salawus.comcgainer@salawus.com