JAMES, III v. UNITED STATES OF AMERICA
2:19-cv-04627
| E.D. Pa. | Apr 2, 2020Background
- Plaintiff Paul James was injured at a VA hospital when a Siemens Symbia Evo imaging machine crushed his feet after his feet hung over the machine’s edge during an imaging study.
- James alleges the machine was defectively designed (no guard/sensor/kill switch or other safety features), defectively manufactured (warming cabinet and component parts), and inadequately labeled/warned (no instructions, size/height requirements, or conspicuous warnings).
- James sued the United States and Siemens, asserting strict liability (design, manufacturing, failure-to-warn) and breach of implied warranties of merchantability and fitness for a particular purpose.
- Siemens moved to dismiss, arguing Pennsylvania law immunizes medical-device manufacturers from strict liability and implied-warranty claims, and alternatively that the complaint fails to plead required elements.
- The Court applied Twombly/Iqbal pleading standards and Pennsylvania substantive law (including Restatement §402A and Pennsylvania precedent) and denied Siemens’ motion as to strict-liability design and failure-to-warn claims and the implied warranty of merchantability, but dismissed the manufacturing-defect and implied-fitness claims (with leave to amend).
Issues
| Issue | Plaintiff's Argument (James) | Defendant's Argument (Siemens) | Held |
|---|---|---|---|
| Whether Pennsylvania law bars strict-liability claims against medical-device manufacturers | Medical devices (like Symbia Evo) are subject to §402A strict liability for design, manufacturing, and failure-to-warn defects | Pennsylvania precedent (Hahn, Creazzo) and Comment k exempt prescription drugs/medical devices from strict liability | Court: Hahn/Creazzo do not create a blanket bar; courts should not broadly extend Comment k without careful record; decline to immunize all medical-device manufacturers here |
| Whether James pleaded a strict-liability design-defect claim | Alleged absence of guards/sensors/kill switch made the machine unreasonably dangerous | Argues pleading insufficient or precluded by Comment k/precedent | Court: Complaint plausibly alleges an unreasonably dangerous design; design-defect claim survives |
| Whether James pleaded a strict-liability failure-to-warn claim | Siemens failed to warn about foot-crushing risk for tall patients (no size/height warnings or instructions) causing James’s injury | Argues inadequate pleading and that Comment k precludes strict-liability failure-to-warn | Court: Allegations suffice to plausibly show inadequate warnings that made the product unreasonably dangerous and caused injury; claim survives |
| Whether James pleaded a strict-liability manufacturing-defect claim | Asserts components/warming cabinet were manufactured defectively | Allegations are conclusory; no factual allegation of malfunction or component breakdown | Court: Dismissed manufacturing-defect claim as implausible (no factual support); leave to amend granted |
| Whether James pleaded implied warranty of merchantability and fitness claims | Asserts implied warranty claims parallel strict-liability defects and seeks merchantability and fitness remedies | Siemens contends implied-warranty claims disallowed for medical devices or insufficiently pleaded | Court: Implied warranty of merchantability survives (parallels viable strict-liability claims); implied warranty of fitness for a particular purpose dismissed (no allegation of a special purpose known to Siemens) — leave to amend allowed |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility standard for pleadings)
- Ashcroft v. Iqbal, 556 U.S. 662 (application of Twombly plausibility framework)
- Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) (Pennsylvania follows Restatement §402A; caution against broad judicial exemptions)
- Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (Comment k and prescription-drug failure-to-warn context)
- Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006) (applied Comment k to implanted medical device on the facts)
- Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) (limits on extrapolating Hahn; critiques truncated analysis of Comment k)
- Phillips v. A-Best Prods. Co., 665 A.2d 1167 (Pa. 1995) (elements of strict products liability: design, manufacturing, failure-to-warn)