## Facts

- Rowan Parkinson underwent coronary angioplasty on May 11, 1999.
- During the procedure, a coronary guidewire designed/manufactured by Advanced Cardiovascular Systems, Inc. (ACS), a Guidant subsidiary, fractured and left a tip segment in Parkinson’s coronary artery.
- Parkinson required emergency bypass surgery and allegedly suffered continuing health problems.
- Plaintiffs alleged the fracture was the type of event that ordinarily does not occur absent negligence or defect and claimed it was the only such event in the treating cardiologist’s experience across more than 650 similar procedures.
- Plaintiffs proceeded largely on circumstantial proof, asserting the physician did not negligently use the device.
- Defendants argued guidewire tip separation can occur without defect or negligence and contended the physician may have caused the fracture by torquing/twisting the wire against resistance.
- Plaintiffs asserted negligence, strict liability (design/manufacturing defect and failure to warn), breach of express and implied warranties, and loss of consortium.
- Defendants moved for summary judgment (and supplemental summary judgment) on all claims, including on grounds of Comment k, the learned intermediary doctrine, lack of defect and causation proof, lack of reliance for express warranty, derivative nature of consortium, and lack of parent-corporation liability for Guidant.

## Issues

1. Whether plaintiffs could rely on circumstantial “malfunction” evidence (res ipsa loquitur–type reasoning) to infer defect/negligence without identifying a specific defect.
2. Whether Comment k to Restatement (Second) of Torts § 402A barred or limited strict-liability and implied-warranty claims for a prescription medical device.
3. Whether the learned intermediary doctrine barred or narrowed failure-to-warn theories, including on causation.
4. Whether genuine disputes of material fact existed on defect, abnormal use/physician misuse, and proximate causation sufficient to defeat summary judgment on negligence and manufacturing-defect theories.
5. Whether Guidant, as a parent corporation, could be held liable absent proof of direct involvement or another recognized basis for parent liability.

## Decision

- The court granted defendants’ motions in part and denied them in part.
- The court held that certain strict-liability theories—particularly design-defect–based strict liability—were limited/barred for the prescription medical device under Comment k principles.
- The court curtailed failure-to-warn theories to the extent plaintiffs lacked evidence that warnings to the physician were inadequate or that different warnings would have changed the physician’s conduct (causation) under the learned intermediary framework.
- The court denied summary judgment on negligence and/or manufacturing-defect theories where plaintiffs’ circumstantial evidence could support an inference of malfunction/defect and where disputes remained over physician misuse and causation.
- The court dismissed or narrowed the express-warranty claim for lack of evidence of reliance on a specific affirmation/representation in selecting or using the guidewire.
- The loss-of-consortium claim survived only to the extent underlying substantive claims survived.
- Claims against Guidant were narrowed or dismissed to the extent plaintiffs failed to show Guidant’s direct involvement beyond the subsidiary’s design/manufacture/sale of the device.

## Legal Principles

- Under Pennsylvania products-liability law, a plaintiff may prove defect via circumstantial “malfunction” evidence when direct proof of a specific defect is unavailable, if the event is of a type not ordinarily occurring absent a defect and reasonable alternative causes (including abnormal use) are sufficiently excluded; competing evidence on these points generally presents a jury question.
- Comment k to Restatement (Second) of Torts § 402A limits strict-liability design-defect (and closely related implied-warranty) theories for certain prescription medical products deemed “unavoidably unsafe” when properly prepared and accompanied by adequate warnings, shifting the focus toward negligence and warning adequacy.
- Under the learned intermediary doctrine for prescription medical products, the manufacturer’s duty to warn runs primarily to the prescribing/operating physician; a warning-based claim requires proof of inadequacy and causation (including evidence the physician would have acted differently with an adequate warning).
- Summary judgment is inappropriate where record evidence permits competing inferences on defect versus misuse and on proximate causation.
- Express-warranty claims generally require proof of reliance on a specific express representation; absent reliance evidence, the claim fails as a matter of law.
- A loss-of-consortium claim is derivative and rises or falls with the viability of the underlying tort claims.
- Parent-corporation liability requires an evidentiary basis beyond ownership status (e.g., direct participation in relevant conduct or another recognized theory).

## Conclusion

The court restricted strict-liability and implied-warranty theories for the prescription guidewire under Comment k and narrowed warning-based claims under the learned intermediary doctrine, but held that plaintiffs’ circumstantial malfunction evidence created triable disputes over defect, misuse, and causation, allowing negligence and/or manufacturing-defect claims (and derivative consortium) to proceed against the manufacturer.


Parkinson v. Guidant Corp., 315 F. Supp. 2d 741 (W.D. Pa. 2004)