Bexis has been writing amicus curiae briefs for the Product Liability Advisory Council (“PLAC”) for a long time. He was introduced to PLAC by one of the best lawyers he (or anyone, for that matter) ever met, Edward W. “Neddie” Madeira, Jr., who recently passed away. Fare thee well, Neddie, you are missed.
Back in 1996, Bexis filed a PLAC brief in the Pennsylvania Supreme Court on the relatively obscure subject of the admissibility of absence of prior incidents as relevant to causation and/or defect in a product liability case. The result was Spino v. John S. Tilley Ladder Co., 696 A.2d 1169 (Pa. 1997), which held:
[T]here is little logic in allowing the admission of evidence of prior similar accidents but never admitting their absence. . . . In adopting a rule allowing lack of prior claims evidence subject to the trial court’s discretion, we are careful to note that . . . evidence of the absence of prior claims is admissible as relevant to the issue of causation.
Id. at 1175. The key to admissibility was the soundness of the defendant’s recordkeeping. “[E]vidence of the non-existence of prior claims is admissible” where “the offering party has provided a sufficient foundation − that they would have known about the prior, substantially similar accidents involving the product at issue.” Id. at 1174 (citing, inter alia, Espeaignnette v. Gene Tierney Co., 43 F.3d 1, 9 (1st Cir.1994)).
Negative evidence – lack of prior incidents – is not the kind of thing that comes up in our sandbox very often. In twelve years of blogging we’d cited Spino exactly once, and not for this proposition (Spino also started Bexis on his ultimately successful decades-long effort to overturn a case called Azzarello, that was once the foundation of Pennsylvania product liability law).
But now we have LaPorte v. Vlad, 2020 WL 2840321 (Mass. App. June 1, 2020), in which the impressive manufacturing history of a drug proved decisive in beating a manufacturing defect claim based on – well, not much of anything other than the decedent developed osteomyelitis quite a while (five months, at least) after being injected with the defendant’s drug (Depo-Medrol, an injectable corticosteroid) in the same general area. Id. at *1-2. Of course, there was no direct proof (there rarely is) because “the vials of Depo-Medrol injected into [decedent’s] knee were not recovered.” Id. at *2.
Plaintiff did not let a little thing like no direct evidence at all stand in the way of a lawsuit. Instead, he took a flyer on an expert (named Flyer) who purported to perform a differential etiology that “the only medically reasonable explanation for the Staph A infection [the decedent] suffered after her injection of Depo Medrol is that the Depo Medrol vial was compromised during the manufacturing and/or delivery process.” Id. at *3 (emphasis original). The osteomyelitis allegedly developed from the staph infection. Id.
Plaintiff’s problem was that the defendant only manufactured, but did not deliver, the drug into the hands of the prescribing physician, Vlad the injector. That’s where the absence of prior incidents − Depo-Medrol’s sterling manufacturing history – proved decisive:
Beyond speculation that something might have gone wrong in the manufacturing, nothing in Flyer’s opinion addressed the details of the manufacturing process at [defendant]. The only, and undisputed, evidence regarding the manufacturing process itself was that [defendant’s] records showed that for the relevant period (indeed going back to 1959) all of the vials of Depo-Medrol manufactured by [defendant] had passed all requirements, including those for sterility, before leaving [defendant’s] control.
Id. at *3. Plaintiff’s expert could blather all he wanted about “ruling” things out, but on the record evidence it was impossible to rule in a manufacturer-caused infection source in the first place. “[P]laintiff has failed to come forward with any evidence upon which a reasonable fact finder could rely to conclude that the defect occurred before the product left [defendant’s] control, an essential element of product liability.” Id. (citations and footnote omitted). The omitted footnote is also interesting, because it also relies on the absence of other incidents:
[I]t is undisputed that none of [the medical defendants’] other patients suffered any ill effects from the Depo-Medrol shipped to and used by [them] during the relevant period. . . . [Defendant] has satisfied its burden to demonstrate a lack of evidence that the specific Depo-Medrol prescribed to [decedent] was contaminated when it left [defendant’s] control.
Id. at *3 n.5 (citation and quotation marks omitted).
So the manufacturing defendant won affirmance of summary judgment, on the basis of a well-documented 50-year history of flawless manufacturing. We note that this manufacturing history stands in stark contrast to the thousands of claims – that received nationwide attention − related to contamination of the generic version of Depo-Medrol (methylprednisolone acetate) once produced by the now-defunct New England Compounding Center. To win this kind of motion, concerning this drug, in this venue (Massachusetts was ground zero for the NECC fiasco) is a truly notable accomplishment.
Good work by both the defendant (for over 50 years) and defense counsel, Jennise Stubbs, Dan Rogers, and Sonila Themeli, of Shook, Hardy, and Lisa Oliver White and Peter Kober, of Murphy & Riley, who were nice enough to send Laporte our way.