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Last Reviewed / Modified On 23 Feb 2016.


Defect in Design – the feasibility of alternative designs and consumer expectations

Manufacturers and sellers have a duty to make and/or market a product which is expected to and does reach the user or consumer without substantial change in the condition in which it is sold free from a “defective condition unreasonably dangerous to the consumer or [the consumer’s] property.” Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) (citing Restatement (Second) of Torts §402A (1)). To demonstrate a breach of duty in a strict liability matter, a plaintiff must prove that a seller (manufacturer or distributor) placed on the market a product in a “defective condition.” The “cause of action in strict products liability requires proof, in the alternative, either of the ordinary consumer’s expectations or of the risk utility of a product.” Id.

Under the “Consumer Expectations Standard,” a product is defective if, upon normal use, the product is “dangerous beyond the reasonable consumer’s contemplations.” Stated another way, the danger must be “unknowable and unacceptable to the average or ordinary consumer.” Among the factors relevant to considering a reasonable consumer’s expectations are the nature of the product, the identity of the user, the product’s intended use and intended user, and any express or implied representations by the manufacturer or seller. Id.

Under the “Risk-Utility Standard,” a product is defective if “a ‘reasonable person’ would conclude that the probability and seriousness of harm caused by the product outweigh the burden or costs of taking precautions.” In other words, “a seller’s precautions to advert the danger should anticipate and reflect the type and magnitude of the risk posed by the sale and use of the product.” In Tincher, the Court identified, but fell short of endorsing, a number of factors that may be relevant to the risk-utility analysis, including the usefulness and desirability of the product, safety aspects of the product, the availability of a substitute product, the manufacturer’s ability to eliminate the unsafe condition, the user’s ability to avoid the danger, the user’s anticipated awareness of the danger, and the feasibility of the manufacturer spreading the loss. Id.

In negligence actions, a plaintiff must show that the defendant had a duty to conform to a certain standard of conduct, breached that duty, such breach caused the injury in question, and actual injury or damages. Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003). Whether defendant owed a duty requires consideration of five factors: “(1) the relationship between the parties; (2) the social utility of the [defendant’s] conduct; (3) the nature of the risk imposed and foreseeability of the harm incurred; (4) the consequences of imposing a duty upon the [defendant]; and (5) the overall public interest in the proposed solution.” Id. (citing Althaus v. Cohen, 756 A.2d 1166 (Pa. 2000)). A manufacturer must foresee and guard against a given risk if it is one which a reasonable manufacturer would anticipate as likely enough to be taken into account. Lambert v. PBI Industries, 366 A.2d 944 (Pa. Super. 1976). See also Dambacher by Dambacher v. Mallis, 485 A.2d 408 (Pa. Super. 1984) (liability for “failing to act as a reasonable man would have acted”).

Misuse of Products

Pennsylvania recognizes several defenses to strict liability actions, including the defense of misuse. See Gaudio v. Ford Motor Co., 976 A.2d 524, 540-41 (Pa. Super. Ct. 2009). While evidence of a plaintiff's own negligence is not generally admissible, evidence of a plaintiff's misuse of a product "is admissible to the extent that is relates to the issue of causation." Id. "To establish misuse of the product, the defendant must show that the use was unforeseeable or outrageous." Id. at 541. "Highly reckless conduct is akin to evidence of misuse and requires the defendant to prove that the use was so extraordinary and unforeseeable as to constitute a superseding cause." Id. at 541. "Conduct is highly reckless when the plaintiff knew or had reason to know of facts which created a high degree of risk of physical harm to himself and that he deliberately acted, or failed to act, in conscious disregard of that risk." Reott v. Asia Trend, Inc., 7 A.3d 830, 836 (Pa. Super Ct. 2010) aff'd, 55 A.3d 1088 (Pa. 2012).

Unanticipated, Unforeseeable, or Unintended Use of Products

In strict liability actions, “a manufacturer can be deemed liable only for harm that occurs in connection with a product’s intended use by an intended user; the general rule is that there is no strict liability in Pennsylvania relative to non-intended uses even where foreseeable by a manufacturer.” Dep’t of Gen. Services v. U.S. Mineral Prods., 898 A.2d 590, 600 (Pa. 2006). See also Nelson v. Airco Welders Supply, 2014 PA Super 286, at 21-23 (2014). This holding was based on the rationale (adopted in Azzarello) that negligence concepts have no place in strict liability actions, and therefore “foreseeability” should not be a basis for imposing liability. Id. at 602-3. Now that Azzarello has been overruled and Tincher has rejected the rigid separation between negligence principles and strict liability claims, the courts may elect to revisit this issue.

Prior to Azzarello, Pennsylvania courts held that a manufacturer or supplier of a product is entitled to assume that the product will only be used in its usual and intended manner. The manufacturer or supplier is not required to insure against any extraordinary risks which may result because of an abnormal or unusual use of the product. Bartkewich v. Billinger, 247 A.2d 603 (Pa. 1968). However, the “abnormal” use of a product precluded a finding of “defect” only if it was not reasonable foreseeable by the seller. Burch v. Sears, Roebuck and Co., 467 A.2d 615, 619 (Pa. Super. Ct. 1983). See also Sheldon v. West Vend Equipment Corp., 718 F.2d 603 (3d Cir. 1983) (intended use includes all those which are reasonably foreseeable); Greiner v. Volkswagenwerk Aktiengeselleschaft, 540 F.2d 85 (3d Cir. 1976) (noting that comment h to section 402A says that a product is not defective when it is safe for normal handling). Placing one’s hand into operating machine constitutes an abnormal, unforeseeable use, but placing one’s hand into machinery that appears to have stopped operating could be sufficiently foreseeable. Compare Bartkewich v. Billinger, 247 A.2d 603 (Pa. 1968); with Schell v. AMF, Inc., 567 F.2d 1259, 1262 (3d Cir. 1977). In addition to precluding a finding of defect, an issue of causation is raised “when the plaintiff’s action is so reckless that the plaintiff would have been injured despite the curing of any alleged defect, or is so extraordinary and unforeseeable as to constitute a superseding cause.” Burch, supra, at 619. With Azzarello overruled, foreseeability may once again dictate whether a use was intended, and consequently, whether a product was defective.

Alteration of Products

Generally, the view in Pennsylvania "product liability cases is that a manufacturer or seller of a defective product is liable for harm caused thereby where the product is expected to and does reach the user or consumer without substantial change in the condition in which it is sold." Sweitzer v. Dempster Sys., a Div. of Carrier Corp., 539 A.2d 880, 882 (Pa. Super. Ct. 1988). However, where a product reaches the consumer after having undergone a substantial change, whether the change was foreseeable or expected becomes an important consideration in determining liability. Id.

Pennsylvania Suggested Standard Civil Jury Instruction Section 16.120 states as follow:

A seller is responsible only for defects that exist at the time the product leaves his or her control. The seller is not liable for defective conditions created by substantial changes in the product occurring after the product has been sold.

[There is, however, an important qualification to this rule. If you do find that defective conditions were created by substantial changes in the product occurring after it was sold, that finding would not, in itself, relieve the seller of liability. Rather, the seller would still be liable, in that circumstance, unless you also find that the changes were ones that could not reasonably have been foreseen or expected by the seller. That is because a seller's responsibility, under our law, extends to all dangers that result from foreseeable changes to the product.]

Unavoidably Unsafe Products

Relying on comment k to Section 402A of the Restatement (Second), the Pennsylvania Supreme Court has held that manufacturers of pharmaceuticals cannot be held strictly liable for consequences arising from the use of their products. Hahn v. Richter, 673 A.2d 888 (Pa. 1996). See also Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). In Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006), the Superior Court affirmed the dismissal of strict liability claims against a medical device manufacturer, finding “no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.” Plaintiff in Creazzo had argued that comment k should not apply because the text of comment k does not mention medical devices, but the Superior Court rejected that argument.

With respect to negligence claims, the Pennsylvania Supreme Court has allowed claims against pharmaceutical manufacturers based on a failure to provide adequate warnings. Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971). See also Hahn, supra. More recently, the Pennsylvania Supreme Court allowed negligence claims based on an alleged failure to exercise ordinary care in the design, research, development, manufacture, sale, testing and distribution of the pharmaceutical at issue. Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). The Lance decision was based in part on the “very distinct treatment of strict-liability versus negligence theory required under the foundational Pennsylvania decision in Azzarello.” Id. at 452-53. Azzarello has since been overruled.

Duty to Warn - Dangerous or Obviously Unsafe Conditions

"A product may be deemed defective if it lacks adequate warnings or instructions necessary for safe use of the product." Fletcher v. Raymond Corp., 623 A.2d 845, 848 (Pa. Super. Ct. 1993). "The duty to warn, however, does not require a manufacturer to educate and instruct a novice in the principles of the product's operation." Id. Nor, does that duty "require that a manufacturer warn of obvious dangers which are generally known and recognized." Id. Manufacturers may assume that consumers "possess the common knowledge of the community." Id. at 845. Whether a risk is "well known" may be important in determining whether a danger was obvious sufficient to absolve a manufacturer of its duty to warn. Id. at 848.

State of the Art Defenses

In strict liability actions, Pennsylvania courts refuse to admit evidence relating to industry standards or custom or government standards. Lewis v. Coffing Hoist Division, Duff-Norton Company, Inc., 528 A.2d 590 (Pa. 1987) (ASME standards and expert testimony that 90% of similar products were made the same way); Majdic v. Cincinnati Machine Co., 537 A.2d 334 (Pa. Super. Ct. 1988) (ANSI standards and custom in the industry). Courts similarly exclude “state of the art” evidence. Carrecter v. Colson Equipment Co., 499 A.2d 326 (Pa. Super. Ct. 1985) (level of engineering knowledge available). See also Normann v. Johns-Manville Corp., 593 A.2d 890 (Pa. Super. Ct. 1991). These decisions were based explicitly on the Azzarello decision, which has since been overruled.

In negligence actions, government or industry standards are admissible. Arnoldy v. Forklift, L.P., 927 A.2d 257 (Pa. Super. Ct. 2007) (industry standards and regulations); Dallas v. F.M. Oxford, Inc., 552 A.2d 1109 (Pa. Super. Ct. 1989) (custom or practice in the industry, private or governmental regulations). Even in strict liability actions, industry custom is admissible where punitive damages are sought. Nigro v. Remington Arms Company, Inc., 637 A.2d 983 (Pa. Super. Ct. 1994).

Government Contractor Defense

The government contractor defense was first recognized by the United States Supreme Court in Boyle v. United Technologies Corp. See Boyle v. United Technologies Corp., 487 U.S. 500, 512 (1988). "Liability for design defects in military equipment cannot be imposed, pursuant to state law, when (1) the United States approved reasonably precise specifications; (2) the equipment conformed to those specifications; and (3) the supplier warned the United States about the dangers in the use of the equipment that were known to the supplier but not to the United States." Id. While Boyle was a product design defect case, the government contractor defense has also been recognized in failure to warn cases. See Hagen v. Benjamin Foster Co., 739 F. Supp. 2d 770, 783 (E.D. Pa. 2010).

Statutes of Limitation and of Repose

A two-year statute of limitation applies to actions for personal injury or property damage based on negligent or otherwise wrongful conduct, including strict liability claims. See 42 Pa. C.S. § 5524(2) and (7); Romah v. Hygienic Sanitation Co., 705 A.2d 841, 856 (Pa. Super. Ct. 1998). Such claims must be filed within two years of the time when the plaintiff discovers or, with the exercise of reasonable diligence, should have discovered the injury. Pocono Int’l Raceway, Inc. v. Pocono Produce, Inc., 468 A.2d 468 (Pa. 1983). The plaintiff’s lack of knowledge or misunderstanding does not delay the running of the time period, except where the plaintiff, despite have exercised due diligence, could not have known of the injury. Thus, the time limit for bringing suit begins to run when the plaintiff could, through reasonable diligence, have learned of the potential right of recovery, regardless of whether the facts were actually known to the plaintiff at that time. Id.

Pennsylvania law also dictates that “any person lawfully performing or furnishing the design, planning, supervision or observation of construction, or construction of any improvement to real property must be commenced within twelve years after completion of construction of such improvement.” See 42 Pa. C.S. § 5536(a). Pennsylvania’s twelve-year statute of repose applies to actions in which a plaintiff seeks to recover damages for: (1) any deficiency in the design, planning, supervision or observation of construction or construction of the improvement; (2) injury to property, real or personal, arising out of any such deficiency; (3) injury to the person or for wrongful death arising out of any such deficiency; or (4) contribution or indemnity for damages sustained on account of any injury mentioned in paragraph (2) or (3). Id. Where an injury or wrongful death occurs more than ten and within twelve years after completion of the improvement, however, a civil action within the scope of 42 Pa. C.S. § 5536(a) may be commenced within the two-year statute of limitation, but not later than fourteen years after completion of construction of such improvement. See 42 Pa. C.S. § 5536(b)(1). Moreover, the twelve-year statute of repose may not be “asserted by way of defense by any person in actual possession or control, as owner, tenant or otherwise, of such an improvement at the time any deficiency in such an improvement constitutes the proximate cause of the injury or wrongful death for which it is proposed to commence an action or proceeding.” See 42 Pa. C.S. § 5536(b)(2).

A party moving for protection under the statute of repose must show (1) what is supplied is an improvement to real property; (2) more than twelve years have elapsed between the completion of the improvements to the real estate and the injury; and (3) the activity of the moving party must be within the class which is protected by the statute. Noll by Noll v. Harrisburg Area YMCA, 643 A.2d 81, 84 (Pa. 1994). A manufacturer who does nothing more than supply a defective product which later is incorporated into an improvement in real property by others is not covered by the statute. McConnaughey v. Building Components, Inc., 637 A.2d 1331 (Pa. 1994). Where, however, the manufacturer provides individual expertise as part of a larger improvement to real property, it may be covered by the statute. Noll, supra, at 87.

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