Evidence of other similar acts can be devastatingly effective. It’s easier for us to believe somebody did something wrong on a specific occasion if we hear they have a prior history of doing the same thing. Federal Rule of Evidence 404(b) addresses this issue, and it is one that comes up in both civil and criminal cases. Most states have reasonably well developed case law about when the jury can hear about other similar acts. The admissibility of the prior events usually comes down to whether the prior events are sufficiently similar to the one giving rise to the case. We discussed how the admissibility of prior medical device problems was sorted out in an IVC filter case last week.
This week we take a look at Dreger v. KLS Martin, LP, 2023 WL 532012 (S.D. Ohio Jan. 27, 2023), a decision resolving a knock-down discovery fight over claimed similar occurrence evidence. It is unusually long and thorough for a discovery-related decision. Dreger was a product liability case arising from surgical procedures involving a rib plate and associated screws sold by the defendant, with claims for, inter alia, manufacturing defect, design defect, failure to warn, and “failure to conform to representation.” The plaintiff in the case went way overboard with discovery demands, seeking not only medical device reports (MDRs) about the device model at issue, but also all MDRs and other incident reports for similar devices that the defendant sold over a 17 year period, and also MDRs in the possession of the defendant’s separate European parent. The defendant offered only the MDR for the plaintiff’s own incident. The parties then filed motions to compel, for a protective order, and seeking sanctions.
The court held that similar incidents involving the same model are relevant and discoverable. As for other models, the plaintiff must identify pertinent similar characteristics. The plaintiff submitted an expert affidavit to the effect that other rib plates were similar to the one actually used on the plaintiff because they were made out of titanium, used similar screws that were similarly countersunk, and were designed to hold broken bone ends together until they healed. But the court thought the plaintiff expert’s affidavit operated at too high a level of generality, while the defense expert affidavit pointed out how the various rib plates involved in the various instances of prior alleged failures were “of different types and thicknesses, were designed for different purposes, were manufactured using different methods, and were applied to three completely different parts of the bodies of three different patients who had three different surgical procedures to address three different medical issues.” The court held that the differences pointed out by the defendant outweighed any similarities and denied discovery. The claimed similarities were speculative. Accordingly, the Dreger court granted the defendant’s motion for a protective order and denied the plaintiff’s motion to compel. This result is right and is unsurprising. A huge problem with similar acts evidence is that such evidence inevitably drags in a lot of evidence and arguments over differences and similarities. How can the jury not get confused? Trying a product liability case is hard enough; trying one that includes a couple of mini-trials about other products and injuries is messy and unfair.
The other discovery disputes resulted in the usual mixed bag of rulings, though we’d guess that the defendant emerged slightly happier than the plaintiff. For example, the plaintiff hounded the defense for MDRs submitted to the FDA other than those publicly available on the Manufacturer and User facility Device Experience (MAUDE) database, but the defendant said it did not have any, so such discovery was denied.
The plaintiff sought discovery from the defendant over FDA-required “corrective and preventative action” (CAPA) materials, but the plaintiff appeared to have misunderstood the CAPA obligations of the defendant, which was an initial distributor for a foreign entity. The defendant was a repackager/relabeler, and any CAPA entry would relate to those functions, not the sort of product defect items for which the plaintiff was hunting. There was no there there.
Not everything went the defendant’s way. The defendant might have been a repackager for CAPA purposes, but it was a manufacturer “for the limited purpose of medical device reporting.” We understand that distinction about as well as we understand Calculus limit equations, the lyrics to the Beach Boys’ classic song, “Surf’s Up,” or Birkin bags. For now, let’s keep it simple: a manufacturer’s internal product complaint files are not protected from discovery by the FDCA.
Finally, the court denied the plaintiff’s request for discovery from the defendant’s foreign parent. The plaintiff argued that common ownership, plus the defendant’s acting as its parent’s agent for purposes of medical device reporting in the United States, meant that the defendant necessarily had control over the parent’s documents and should therefore produce them in this litigation. But the defendant’s president furnished an affidavit establishing that the parent company had no financial interest in the transaction at issue in the case, and the defendant had no contractual or other right to compel production of the parent’s documents. The plaintiff contended that this affidavit was at odds with some prior representations on the corporate web site, but the Dreger court was more impressed with sworn statements as opposed to the internet wayback machine. The court denied the plaintiff’s motion to compel and denied the plaintiff’s motion for sanctions.
The Dreger court’s discovery rulings are, for the most part, refreshing. Essentially, the court told the plaintiff to litigate a case against the defendant it actually sued and maintain focus on the product actually used. The court rejected the usual plaintiff frolics and detours.