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For the first time in two years, we write from the confines of our office in downtown Philadelphia.  While we loved the full-time “work from home” regime, we have fondly re-embraced the near-forgotten view from our 30th-floor window, along with our Dancing Barney doll, our RBG action figure, and our solar-powered effigy of Queen Elizabeth II (she pivots her wrist in a perfect royal wave when she’s placed in the sun).  And especially the many framed photos of two- and four-legged beloveds, including the treasured Drug and Device Law Little Rescue Dog we lost during the pandemic.  We hope all of you are similarly seeing your worlds slip back toward pre-apocalyptic “normalcy.”

From these new/old surroundings, we are pleased to report on an interesting case that reaches a great result notwithstanding some atypical reasoning.  In Vollrath v. Depuy Synthes Business Entities, et al., 2022 WL 326781 (D. Ore. Feb. 3, 2022), the plaintiff alleged that he was injured when the defendants’ modular hip implant fractured seven years after it was implanted in him.  He asserted a claim for negligence, a claim for breach of implied warranty, and strict liability claims for design defect, manufacturing defect, and failure to warn.  He disclosed two experts (rare for a pro se plaintiff):  a structural engineer and a metallurgist/tribologist.  The defendants moved for exclusion of both experts and for summary judgment.

Motion to Exclude Experts

The defendants argued that the experts failed to satisfy all four elements of F.R.E 702 – that they were not qualified, their testimony was not based on sufficient facts or data, their methodologies were not reliable, and they did not reliably apply their methodologies to the facts of the case.

The structural engineer “calculate[d] the stresses that would be produced on the stem of the prosthesis under different offset dimensions,” and the metallurgist offered an opinion about the nature of the fracture; specifically, that it was a fatigue fracture. Vollrath, 2022 WL 326781 at *3-4.  Both testified that they were not offering the opinion that the hip implant was a defective device, and neither had a medical background nor any experience in “orthopedics, biomaterials, anatomy, or physiology.”  But, the court emphasized, that did not mean that the opinions the experts offered were not admissible.  As the court explained, “Defendants . . . advance no argument that these two experts are unqualified in their respective fields, that their reports lack the rigor or methodology that those fields require, or that their proposed testimony is irrelevant or unhelpful.”  Id. at *4.  Instead, the defendants’ “sole argument in support of excluding [the experts]” was that “because the experts [were] not medical experts—or medical device—experts . . . , their testimony does not present a genuine issue of medical fact.”  Id. (emphasis in original).

But, the court concluded, that was not the relevant inquiry under F.R.E. 702; to the contrary, “expert testimony need not guarantee that a plaintiff prevail in order to be admissible.”  Id. at *5.  Because the defendants “challenged the admissibility of [the plaintiff’s] experts only on the grounds that it [did] not guarantee that [the plaintiff would] prevail on his claims,” the court “reject[ed] the challenge” and denied the defendants’ Rule 702 motions.  Id. at *5 (citation omitted).

Summary Judgment

But that did not end the inquiry.  Having held that both experts’ opinions were admissible, the court was tasked with determining whether those opinions enabled the plaintiff to escape summary judgment on any of his claims.  And, for reasons echoing the defendants Rule 702 arguments, the court held that the experts’ opinions did not permit any of the plaintiff’s claims to survive summary judgment.  We will take them one by one.


In his negligence claim, the plaintiff asserted that, in violation of FDA regulations, the defendants did not seek FDA approval when the modified the modular hip.  The defendants argued that this claim was preempted by Buckman – that only the federal government was authorized to file suit for noncompliance” with FDA regulations.  But, the court pointed out, the plaintiff did not bring a “fraud on the FDA” claim in the nature of the claim Buckman held to be preempted.  Instead, he argued that “the defendants’ failure to seek FDA approval for certain modifications” to the artificial hip “[gave rise to a state law negligence claim” – a negligence per se claim – showing that the defendants breached the standard of care.”  Id. at *6.

The court noted that federal courts applying Oregon law had held that Buckman didn’t necessarily foreclose this sort of parallel state law negligence claim.  But, the court held, it did not need to “address whether [the plaintiff’s] claims [were] the type the Supreme Court considered to be preempted in Buckman or could support a negligence per se claim under Oregon law,” id., because the plaintiff had produced no evidence to support his claim that the defendants had not complied with FDA regulations – both experts testified that they had reviewed no regulatory materials and were not offering opinions about regulatory/approval issues.  And so, “[i]n light of the absence of any evidence to support [the plaintiff’s] assertion that Defendants failed to obtain proper FDA approval” for the version of the mechanical hip implanted in the plaintiff, the negligence claim could not survive summary judgment.  Id. at *7.

Strict Liability:  Design Defect

The court first considered the design defect claim.   The court explained that, under Oregon’s consumer expectation test, a defective product is one that is “dangerous to an extent beyond that which the ordinary consumer would have expected.” Id. at *8.  While this ordinarily is a fact question to be determined by the jury, the trial court must first “ensure that the evidence is sufficient for the jury to make a determination about what ordinary consumers expect.”  Id.  This evidence can include “advertising and other representations by the defendant about how a product can be used and will perform,” and may include risk-utility balancing – proving that a practicable and feasible design alternative was available.”  Id.  (We admit some confusion about the apparent conflation of tests here, but we will allow the end to justify the means.)  Here, neither of the plaintiff’s experts offered the opinion that the modular hip was defective.  The plaintiff contended that, nevertheless, the experts’ opinions could explain why the device failed and lead a jury to the conclusion that the hip was defectively designed.  The court held that this evidence, coupled with the plaintiff’s own subjective expectation about the longevity of the artificial hip, was not sufficient to satisfy the requirements of the consumer expectation test.  Summary judgment for the defendant on the design defect claim.

Strict Liability: Failure to Warn and Manufacturing Defect

The court granted summary judgment on the manufacturing defect claim because the plaintiff had not adduced evidence that his mechanical hip differed from similar hips manufactured by the defendant – his only evidence of a “manufacturing defect” was the evidence that the hip failed.  Next, the court turned to the failure-to-warn claim, and this discussion was curious.  There was no mention of the learned intermediary doctrine (probably due to Oregon’s unusual strict liability regime) and no discussion about warnings causation.  Instead, the court explained that, under Oregon law, “a plaintiff alleging failure to warn must show that the manufacturer of a product had reason to anticipate danger from the product’s use and that a warning would have made the product safe.”  Id. at *10.  The plaintiff alleged that the defendant should have warned physicians and patients that the product was prone to failure (hence “defectively designed”) and that the defendant had not properly sought FDA approval (and, hence, was “negligent”).  Because the court had already held that there was no evidence to support the design defect claim or the negligence claim, it held that the plaintiff could not pursue the derivative failure-to-warn claims.  Again, we’ll take it, though the failure-to-warn analysis is not what we have come to expect.

Breach of Implied Warranty

Finally, the court granted summary judgment on the warranty claim because there was no evidence that the modular hip was “defective or unfit for the purpose required, such that any implied warranty might have been breached.” Id. at *11.

Vollrath fascinates us.  We think it is a little cattywampus, disposing of the design defect claim then using that holding as a springboard to grant summary judgment on the warnings and warranty claims without applying the usual analysis to those claims.  But the bottom line is a victory the defendant deserved under any analysis, and we’ll take a defense win, even dressed in unusual clothing.  Have a great weekend, and stay safe out there.