Vollrath v. DePuy Synthes Business Entities, 3:19-cv-01577

Background

Plaintiff Jurgen Vollrath (pro se) received a DePuy S‑ROM modular hip implant (stem/sleeve/head) in December 2010; the femoral stem fractured in September 2017.
Vollrath sued DePuy/Johnson & Johnson alleging negligence, strict products liability (design, manufacturing, failure to warn), breach of warranty, willful concealment/fraud, and IIED; he voluntarily dismissed fraud/concealment and IIED at oral argument.
Defendants moved to exclude plaintiff’s two experts (structural engineer Christopher Higgins and metallurgist Dan Danks) under Federal Rule of Evidence 702 and for summary judgment.
Higgins opined that larger offsets increase stresses and can harm fatigue life; Danks concluded the implant failed by fatigue. Both limited their opinions to engineering/metallurgy and did not opine on medical/device regulatory compliance or whether the design was defective.
The court denied the Daubert challenge (experts admissible on their limited topics) but granted summary judgment for defendants because plaintiff lacked evidence to raise genuine disputes on negligence (no proof of FDA noncompliance), design/manufacturing defect (no consumer‑expectation or comparator evidence, and experts would not opine the device was defectively designed), failure to warn (no evidence additional warnings would have made the product safe), and breach of warranty.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of experts under FRE 702	Higgins and Danks offer engineering/metallurgical opinions about stresses and fatigue that are relevant to cause of failure	Experts lack medical/device expertise and thus cannot raise a genuine issue on defect/causation	Court denied exclusion; experts admissible on their limited engineering/metallurgical topics (Daubert not satisfied grounds for exclusion)
Negligence based on alleged failure to obtain FDA approval / regulatory noncompliance	DePuy modified S‑ROM without proper FDA approval; that noncompliance establishes breach of care or negligence per se	Buckman preempts fraud‑on‑FDA claims; defendants argue no private right and no evidence of regulatory violation	Court found no evidence that Defendants failed to obtain FDA approval and experts offered no regulatory opinions; negligence claim fails for lack of proof
Design defect (strict liability)	Engineering and metallurgical testimony (offset → higher stress; fatigue failure) supports that design was unreasonably dangerous	Evidence shows no admissible proof that design was defective or that ordinary consumer expectations were frustrated; defendants point to plaintiff’s activity as causal	Court held plaintiff did not present sufficient evidence under Oregon’s consumer‑expectations/risk‑utility framework; summary judgment for defendants
Manufacturing defect	The implant’s early failure (under 7 years vs. expected 20+) shows this unit was mismanufactured	No comparator parts, no circumstantial evidence of mismanufacture; failure alone insufficient without more	Court held mere failure without comparison or other evidence insufficient to survive summary judgment
Failure to warn	Warnings did not disclose fretting/corrosion risk or regulatory status; additional warnings would have made device safe	Surgeon was apprised of risks; no evidence extra warnings would have prevented harm or made device safe	Court held plaintiff produced no particularized evidence that inadequate warnings caused harm or that warnings would have cured defect; claim fails
Breach of warranty	Implied warranty that device was fit for intended purpose; device failed prematurely	No evidence device was defective or unfit	Court concluded warranty claim fails for lack of evidence of defect

Key Cases Cited

Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (trial court is gatekeeper; admissibility focuses on relevance and reliability, not correctness)
Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311 (9th Cir. 1995) (discusses application of Daubert in Ninth Circuit)
Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187 (9th Cir. 2007) (metallurgist testimony admissible on failure analysis; admissibility distinct from summary judgment causation proof)
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (FDCA enforcement is federal; private fraud‑on‑the‑FDA claims are preempted)
McCathern v. Toyota Motor Corp., 332 Or. 59 (Or. 2001) (Oregon adopts consumer‑expectations test and requires sufficient evidence for jury to assess product dangerousness)
Axen v. Am. Home Prod. Corp., 158 Or. App. 292 (Or. Ct. App. 1999) (Oregon recognizes that evidence of regulatory violation can inform negligence standard of care)