Beard v. Johnson and Johnson, Inc.
41 A.3d 823
| Pa. | 2012Background
- The decedent underwent open gastric bypass surgery using Ethicon endocutter; peri-strips were applied to reinforce the staple line.
- The endocutter used was discarded after one procedure; post-op leaks led to sepsis and death.
- Plaintiff asserted strict-liability design defect; initial theory focused on malfunction, with later proffered design-defect rebuttal by Hetzel.
- Trial court allowed late design-defect evidence as rebuttal; defense sought continuance, which was denied.
- Jury returned $5,000,000 for design defect; verdict rejected malfunction theory.
- Superior Court vacated verdict and remanded to enter judgment for defendants; petition for review followed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Should risk-utility balancing focus on all uses of a multi-use product? | Beard argues risk-utility must consider multi-use design; not limited to open use. | Ethicon contends risk-utility applies to the product's primary use or the specific use in question. | No; risk-utility may weigh multi-use functionality. |
| May a trial court weigh weight/credibility in determining risk-utility on a pre-trial record? | Beard contends de novo, fact-finder credibility matters should guide balancing. | Ethicon argues risk-utility is a legal determination under current law with deference to trial-record findings. | Trial courts may rely on the record; appellate review remains plenary on legal questions. |
| Did the Superior Court properly assess whether the endocutter’s risk-utility analysis should be limited to laparoscopic use? | Beard asserts analysis must cover open surgery as used here, not only laparoscopic. | Ethicon asserts analysis appropriately weighed laparoscopic context and overall product design. | The court refused to limit risk-utility to a single use; multi-use analysis is permissible. |
| Should the court undertake an independent pre-trial risk-utility evaluation of a complex device? | Beard urges pre-trial risk-utility balancing based on record; not required to wait for trial. | Ethicon argues threshold balancing is a legal inquiry under Azzarello and remains appropriate post-trial. | The court did not require independent pre-trial risk-utility evaluation; analysis upheld as presented. |
Key Cases Cited
- Azzarello v. Black Bros. Co., 480 Pa. 547, 391 A.2d 1020 (Pa. 1978) (no-negligence in strict liability framework; threshold risk-utility)
- Schmidt v. Boardman Co., 608 Pa. 327, 11 A.3d 924 (Pa. 2011) (reaffirms risk-utility framework and open-ended factors)
- Dambacher by Dambacher v. Mallis, 336 Pa. Super. 22, 485 A.2d 408 (Pa. Super. 1983) (risk-utility factors for design defect review)
- Berrier v. Simplicity Manufacturing, Inc., 598 Pa. 594, 959 A.2d 900 (Pa. 2008) (discusses disrepair in Pennsylvania design-defect law; Restatement debate)
- Covell v. Bell Sports, Inc., 651 F.3d 357 (3d Cir. 2011) (federal perspective on Restatement Third discussion)
- Schindler v. Sofamor, Inc., Pa. Super. 774 A.2d 765 (Pa. Super. 2001) (risk-utility consideration factors in design-defect cases)
- Fitzpatrick v. Madonna, Pa. Super. 623 A.2d 322 (Pa. Super. 1993) (risk-utility framework and social policy considerations)