Lessons From a Court Decision on Exemplar Medical Device in Discovery

Legal consequences abound at every corner in healthcare. Each month this blog discusses examples of what those consequences can be.


I recently came across an interesting court decision about getting an exemplar of an implanted medical device. While the topic is a little off the beaten path for health information management (HIM), the decision still holds lessons for HIM professionals that might face similar situations when working on discovery at their organization.

The device is an artificial disc implanted into the spine of the plaintiff in Ramkelawan v. Globus Medicals Inc., Case No: 5:18-cv-100-Oc-JSM-PRI (M.D. Fl. Apr. 22, 2019). He seeks damages for personal injuries allegedly incurred after the implantation. (The plaintiff’s wife, who brought related claims, is also a plaintiff).

The plaintiffs moved to compel the defendants to produce exemplars of, among other things, the device that was implanted. The defendants had allowed the plaintiffs’ experts to inspect exemplars and to perform a non-destructive test of one. The defendants had also offered to allow the plaintiffs to inspect one exemplar at the office of the defendants’ expert and had offered other exemplars for sale at the price of $10,000. The plaintiffs described the price as “astronomical” and asked the court to order that exemplars be provided at cost.

The court began its analysis by review of Federal Rule of Civil Procedure 34(a)(1), which governs discovery of tangible things. The court noted that Rule 34(a)(1) does not address the cost to be charged for production of a tangible thing or an exemplar. It then denied the plaintiffs’ motion:

“There appears to be no dispute that Defendants are willing to produce exemplars for inspection as contemplated by Rule 34.

What Plaintiffs are specifically requesting in the instant motion, however, is not an inspection, but that Defendants be compelled to produce the exemplars ‘at cost’ and with ‘reasonable transport costs.” *** Plaintiffs offer no persuasive authority in support of this request. The cases cited by Plaintiffs in support of their motion, Cannioto v. Louisville Ladder, Inc. Case. No. 8:09-cv-1892-JSM-YBM ***, and Whynot v. Publix Supermarket, Inc., Case No. 2013-CA-007898-0, are easily distinguishable from this case, as they involve fairly ordinary products (ladders and shopping carts), as opposed to highly specialized medical devices. *** Further, in the cases cited by Plaintiffs, the plaintiffs agreed to pay the retail price of the exemplar product. While the undersigned acknowledges (as Defendants apparently also do) that Rule 34 contemplates that Defendants make the subject device or exemplars available for inspection, there is simply no basis or authority for the Court to require Defendants to provide the exemplars for purchase at Plaintiffs’ preferred price, or ‘at cost.’”

Ramkelawan is different. There are circumstances under which courts have ordered cost-shifting or cost-sharing between parties related to the costs of discovery. This is done as an exercise of a judge’s discretion in circumstances where, for example, electronically stored information (ESI) is found to be “not reasonably accessible because of undue burden or cost” (Rule 26(b)(2)(B)). However, these orders are rare because of what is known as the “American Rule,” a proposition that each side bears its own litigation costs. Costs can also be awarded at the end of litigation to prevailing (“winning”) parties.

What all this means is that, as a general proposition, parties pay their own way through discovery. If a party wants a sample of a tangible thing from an adversary (rather than an inspection of the thing), the requesting party should not look to the court to order production of the sample “at cost,” unless the thing is a “fairly ordinary product.”

This comes back to a lesson for HIM professionals: Assuming that you are asked to review and/or compile significant volumes of ESI for ultimate production in discovery and the cost of doing so (in terms of time, money, or diversion of resources) is high, bring that to the attention of your attorney so they might argue that the cost should be shifting to or shared with the requesting party.

 

**Editor’s Note: The views expressed in this column are those of the author alone and should not be interpreted otherwise or as legal advice.

Ron Hedges, JD, is a former US Magistrate Judge in the District of New Jersey and is a writer, lecturer, and consultant on topics related to, among other things, electronic information. He is a Senior Counsel with Dentons US LLP.

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