We’re writing a quick-hit post today on a topic that comes up often in medical device litigation, but rarely results in a court order—what happens when the plaintiffs want an “exemplar” medical device? How do they get one and who pays for it?
We’re not talking here about the medical device that was actually used to treat the plaintiff. That one has already been purchased and paid for, and it may still be implanted inside someone’s body. No, we are referring here to brand new devices that have never been used and that the plaintiffs can use for expert consultation, trial exhibits, or anything else that does not involve actually using the exemplar in a human.
The plaintiffs in Ramkelawan v. Globus Medical Inc., No. 5:18-cv-100, 2019 U.S. Dist. LEXIS 67516 (M.D. Fla. Apr. 22, 2019), wanted multiple exemplars, and they wanted them “at cost.” Id. at *9-*13. The district court ruled, however, that there is simply no authority to compel a defendant to sell its products to opposing attorneys at a preferred price. Id. at *12-*13. If the plaintiffs wanted exemplars, they would have to buy them—and pay retail.
The dispute centered around Rule 34, which allows requests “to produce and permit the requesting party . . . to inspect, copy, test, or sample . . . any designated tangible things.” Fed. R. Civ. Proc. 34(a)(1). The rub is that Rule 34 does not address the cost that should be charged.
In Ramkelawan, the defendant device manufacturer did all that it seems a defendant ought to be required to do, plus more. The plaintiffs’ experts had already inspected, measured, photographed and CT scanned certain parts of the subject devices, and they had tested the surface of the subject devices with Fourier Transform Infrared spectrometry. Id. at *10-*11. The defendants offered exemplars for additional inspection on conditions that were perfectly reasonable: The plaintiffs had to pay for them, mark them “not for human use,” pay for transportation, promptly produce any testing reports, and return the exemplars to defendants at the end of the litigation or destroy them. Id. at *11. To the extent the plaintiffs wanted to inspect an “assembly block”—which we assume is used in assembling the devices—the manufacturer agreed to make one available for inspection at its experts’ facility. Id. at *12.
All that was not good enough for the plaintiffs, who wanted a discount. The district court nonetheless denied their motion to compel. Cases involving ordinary products like “ladders and shopping carts” were inapposite to this case, which involved “highly specialized medical devices.” Id. at *12. Further, in the case that the plaintiffs cited, the requesting parties had agreed to pay retail prices. Id. at *12-*13. In the end,
[w]hile the undersigned acknowledges (as Defendants apparently 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.”
Id. at *13. Bank this one away for future reference. The next time plaintiffs’ attorneys wants an exemplar, offer to sell them one at the retail price or make one available for visual inspection. If push comes to shove, Ramkelawan will be helpful.