An explanted medical device is an interesting thing. It was designed and made to reside within the human body, and it was implanted for the purpose of saving or improving life, even if only cosmetically. Sometimes it has to be removed, often by design and under the applicable standards of care. Take for example retrievable vein filters and certain kinds of stents. They go in, and they can come out. Nothing to see here.
We, however, are product liability litigators, so when we encounter an explanted medical device, odds are that it was removed because the patient experienced an alleged complication. This is where we repeat the mantra of medical product liability law—all drugs and medical devices have both benefits and risks. And, when a device comes out and the patient sues, what happens to the device?
That was the subject of a recent case called Dreger v. KLS Martin, L.P., No. 2:20-cv-3814, 2022 U.S. Dist. LEXIS 103088 (S.D. Ohio June 6, 2022), and the district court held that the defendant device seller could perform nondestructive testing on the explanted device at the location of its choosing. In addition—and we think most importantly—unless and until the defendant disclosed the results of the testing as potential evidence, those results were protected attorney work product.
The plaintiff in Dreger alleged a defect in a titanium alloy rib plate that had to be removed, so the Defendant reasonably wanted to test the device. To be clear, we are talking here about non-destructive testing. Destructive testing is different because it can be done only once and cannot be repeated. Because the device (or part of it) has been altered, if not completely destroyed, you have to do it under an agreed or court-ordered protocol so the party holding the device does not gain an unfair advantage. It also goes without saying that altering or destroying potential evidence in litigation without an ironclad agreement is a really bad idea and prohibited.
But back to Dreger, the defendant wanted to inspect the explanted plate at the manufacturer’s world-class laboratory in Germany. The plaintiff objected on the basis that the law did not require inspection in Germany and because the defendant might not give the device back. Even to our jaded ears, these excuses are extremely thin. Id. at *3-*4. Perhaps the law does not require inspection in Germany, but the law surely permits it. Here, the manufacturer’s lab had state-of-the-art equipment and the expert engineers necessary to conduct the proper non-invasive testing. Moreover, the laboratory was subject to regulation by the FDA, and the facility was routinely inspected and approved by the FDA and other regulators. Id. at *3. Under these circumstances, when the plaintiff asked “why Germany,” the defendant and the district court appropriately replied “why not”?
The purported fear that the defendant would not return the device was even less credible. The defendant stipulated that it would return the device, and “in almost 30 years of routine shipments between [the defendant] and [the manufacturer’s lab], no device has ever been lost. Plaintiff’s suggestion that she would be harmed if she did not have the Explanted Device for trial is purely speculative . . . .” Id. at *6.
Finally, the district court rejected the plaintiff’s argument that her expert and/or counsel should be allowed to observe the testing. The authorities that the plaintiff cited dealt with destructive testing, but that’s a different situation that calls for different rules (see above). Moreover, unless and until the defendant elected to use the information from the inspection as evidence, the results of the inspection and testing were protected work product. That includes “the work product generated by the inspection, along with the identities of, and facts known or opinions held by, [the defendant’s] consulting experts. Id. *6-*7.
This last point is the most important. Sure, the device manufacturer had the best lab and all, but ordering the defendant to find a proxy lab in the U.S. might not have been the end of the world. On other hand, an order waiving the work product protection and allowing the plaintiff’s experts and lawyers to peer over the defendant’s shoulders could be downright disruptive. It might even have persuaded the defendant to forego testing altogether. Of course, these things go both ways, and the plaintiff’s expert will be allowed to conduct nondestructive testing without the defendant poking its nose in. But all things considered, we’ll take it.