The Duty of Product Manufacturers and Those Who Modify Products

The Duty of Product Manufacturers and Those Who Modify ProductsPennsylvania and New Jersey Law on Manufacturer Duty, Post-Sale Modification, the Consumer-Industrial Distinction, and the Limits of Government Oversight

Posted By Brian E. Fritz, Esquire | Fritz and Bianculli, LLC | Philadelphia, PA

Introduction

Understanding the duty of a product manufacturer begins with the question of who bears legal responsibility when a defective or modified product injures a person. The analysis runs along several parallel tracks. The original manufacturer that designed and built the product carries the primary duty. Sellers and others in the chain of distribution carry related duties. Companies and individuals who modify the product after it leaves the manufacturer’s hands assume their own duty for what they have changed. And there is one further point that most people do not understand and that this article addresses at length: with limited and important exceptions, no government agency reviews and approves a product for safety before it reaches the American market. The fact that a product is on the shelves of a retail store, on the listings of a major online platform, or in the catalog of an industrial equipment supplier does not mean that any government body has determined the product to be safe. The duty to design, test, manufacture, and warn so that the product is not unreasonably dangerous belongs to the manufacturer.

This article addresses the framework through which Pennsylvania and New Jersey law allocates these duties. It defines what a product is for purposes of the law, distinguishes between consumer products and industrial products at the outset because that distinction shapes the entire duty inquiry, examines the manufacturer’s core duty under the law of both states, addresses at length the regulatory landscape and what it does and does not do, develops the duty assumed by those who modify products after they leave the manufacturer, and illustrates the analysis through four anonymized case studies drawn from the firm’s files. A forthcoming companion article in this series will address the categories of product liability cases—design defect, manufacturing defect, failure to warn, post-sale duty to warn, and breach of warranty—in doctrinal depth. This article is the duty piece. It establishes who owes what and why, and it sets the framework within which the categories of cases will be developed.

The article should be read alongside the foundational Tier 2 pillar on duty in this series, which addresses the broader sources of duty in Pennsylvania and New Jersey tort law, and alongside the Tier 3 companion articles on assumption of duty under Restatement §§ 323 and 324A, on negligent entrustment, and on negligent hiring, supervision, and retention. Each of those articles addresses doctrines that operate alongside product liability law in cases involving modified or defective products supplied for use in industrial settings.

Part One: What Is a Product, and Why the Distinction Between Consumer and Industrial Products Matters at the Outset

A. Defining a Product

A product, for purposes of the legal duties addressed in this article, is any tangible item that has been manufactured, distributed, and placed into the stream of commerce for use by a buyer. The category extends across the full range of items the modern economy produces. It includes consumer appliances bought in retail stores or through online platforms; tools and equipment sold to homeowners and tradespeople; vehicles and recreational equipment; electronic devices and household goods; medical devices and pharmaceuticals; food products; and the much broader universe of industrial equipment—production line machinery, cranes and material-handling systems, fabrication and processing equipment, construction equipment, and the components and subsystems incorporated into all of the above. The legal framework that governs the manufacturer’s duty applies across this entire range.

The application of that framework, however, looks meaningfully different depending on whether the product is sold to ordinary consumers for household or personal use or sold to industrial buyers for use by trained workers in commercial or manufacturing settings. The reason for the difference is not that the manufacturer’s duty changes in its core nature—the duty to design, manufacture, and warn safely is the same—but that several legal doctrines calibrate how that duty is applied based on the foreseeable identity of the user and the foreseeable conditions of use. The consumer-industrial distinction therefore belongs at the outset of the duty discussion, not as a sidebar.

B. Consumer Products in Plain Terms

A consumer product, as the term is used in this article, is an item sold to the general public for personal, family, or household use. Consumer products include household appliances, hand tools, lawn and garden equipment, furniture, electronics, kitchen and bath products, recreational equipment, personal-care items, children’s products, and the wide range of goods sold through retail stores and through online retail platforms to ordinary consumers. The foreseeable buyer is a member of the general public, and the foreseeable user is presumed to be a layperson without specialized training in the product’s hazards. The manufacturer’s duty of safe design and adequate warning is shaped by that presumption: the design must accommodate the realities of consumer use, including foreseeable misuse and use by people who are not technically trained, and the warnings must communicate the relevant risks in language and through means that an ordinary consumer can understand and act upon.

C. Industrial Products in Plain Terms

An industrial product, as the term is used in this article, is equipment or machinery sold to a business for use in commercial, industrial, or manufacturing operations. Industrial products include production-line machinery, cranes and lifting equipment, forklifts and other material-handling equipment, fabrication and assembly machinery, processing and packaging equipment, and the components and subsystems incorporated into industrial installations. The foreseeable buyer is a commercial entity—a manufacturer, a contractor, an industrial operator—and the foreseeable users are workers operating the equipment as part of their employment. The manufacturer’s duty in industrial product cases is shaped by these realities: the design must be safe for use in the demanding conditions of an industrial workplace, and the warnings and instructional materials must adequately inform the workers who will operate the equipment about its hazards and safe operating procedures. Several doctrines, addressed in Part Five below, recognize that industrial buyers and trained workers may have access to information and training that consumer buyers do not, and they calibrate the manufacturer’s warning duty accordingly.

D. Why This Distinction Belongs at the Outset

Throughout the duty analysis that follows, the law repeatedly turns on who the foreseeable user is, what training and knowledge that user is presumed to have, and what design choices and warnings are necessary to make the product safe for that user. A heated foot bath sold to consumers and a high-tonnage industrial press sold to a manufacturing facility are governed by the same core duty—design, manufacture, and warn so that the product is not unreasonably dangerous when used as the manufacturer should foresee it will be used—but the application of that duty looks very different in each case. Identifying the category of product at the outset frames the inquiry that follows.

Part Two: The Manufacturer’s Duty

A. The Foundational Duty

A manufacturer that places a product into the stream of commerce owes a duty to design, manufacture, and warn about the product so that it is not unreasonably dangerous when used as the manufacturer reasonably should foresee it will be used. This duty runs not only to the immediate purchaser of the product but to all foreseeable users of the product and to bystanders who may be exposed to its hazards. The duty has three principal components.¹ The first is a duty of safe design—the obligation to design the product so that, when manufactured to specification and used as foreseeably intended, it does not create unreasonable risks of physical harm. The second is a duty of careful manufacture—the obligation to produce each unit of the product in conformity with its intended design, free of departures from specification that introduce hazards. The third is a duty of adequate warning—the obligation to inform foreseeable users of the product’s risks, of the precautions necessary for safe use, and of the conditions under which use should be avoided. Each of these components carries its own body of doctrine and gives rise to its own category of product liability case, addressed in greater depth in the forthcoming companion article in this series.

B. Pennsylvania’s Framework After Tincher

Pennsylvania has long recognized strict products liability as articulated in Restatement (Second) of Torts § 402A, which provides that one who sells a product in a defective condition unreasonably dangerous to the user or consumer is subject to liability for the resulting physical harm.² For decades, Pennsylvania applied § 402A through the analytical framework established in Azzarello v. Black Bros. Co., a 1978 decision of the Pennsylvania Supreme Court that imposed certain rigidities on how the doctrine was administered, particularly in the relationship between the trial court’s threshold determinations and the jury’s factfinding. In 2014, the Pennsylvania Supreme Court substantially reset the analytical framework in Tincher v. Omega Flex, Inc..³ Under Tincher, a Pennsylvania plaintiff may prove that a product is in a defective condition unreasonably dangerous through either of two complementary tests: a consumer expectations test, which asks whether the product is dangerous beyond what an ordinary consumer would expect when using the product in a foreseeable manner, or a risk-utility test, which weighs the magnitude of the risk created by the product’s design against the burden of the design alternatives that would have reduced or eliminated the risk. The choice between the tests, and the case generally, is for the jury. Negligence remains an independent and parallel theory of liability against the manufacturer, available alongside strict liability and frequently pleaded together with it.

C. New Jersey’s Framework Under the Products Liability Act

New Jersey codified its product liability law in the Products Liability Act of 1987, N.J.S.A. 2A:58C-1 et seq., which provides a single statutory framework governing claims for harm caused by a product.⁴ The PLA establishes the elements a plaintiff must prove for design defect, manufacturing defect, and failure-to-warn claims; defines what constitutes a defective condition; and provides certain defenses. The PLA largely subsumes the prior common-law product liability doctrines in New Jersey and channels the analysis through its statutory provisions. The core duty of the manufacturer—to produce a product that is not in a defective condition under the standards the PLA establishes—remains the foundation of the analysis, as it does in Pennsylvania. The doctrinal frameworks of the two states differ in their structure and in certain particulars, and the differences are important to the litigation of specific cases. They will be addressed in greater depth in the forthcoming companion article that develops the categories of product liability cases.

D. The Duty Extends Through the Chain of Distribution

Both Pennsylvania and New Jersey impose product liability duties not only on the original manufacturer of the product but on others in the chain of distribution. Wholesalers, distributors, and sellers—including online retailers that function as sellers of the products they offer to the public—may also be liable for harm caused by defective products. The policy rationale for chain-of-distribution liability is straightforward: parties along the distribution chain are in a position to demand safer products from manufacturers, to remove unsafe products from circulation, and to put commercial pressure on manufacturers to design and produce safely. Sellers in the chain are not insurers of every product they sell, but they bear duties commensurate with their role in placing the product before the buying public.⁵

Alongside strict liability and negligence, breach of warranty supplies a parallel theory of recovery against sellers. Express warranties—specific representations the seller makes about the product—and the implied warranty of merchantability—the implicit warranty that goods sold by a merchant are fit for the ordinary purposes for which they are used—both create independent bases for liability when a product fails to perform as warranted and causes injury. Warranty law is a substantial body of doctrine in its own right and will receive its own treatment in the forthcoming companion article.

Part Three: The Critical Truth About Government Oversight—“On the Market” Does Not Mean “Approved as Safe”

The single most consequential misunderstanding that members of the public bring to product cases is the belief that products on the American market have been reviewed and approved for safety by some government agency before they were sold. With limited and important exceptions, that belief is mistaken. The regulatory landscape is far more limited than most people assume, and the manufacturer’s duty to test, design, and warn safely is overwhelmingly the manufacturer’s own duty—not a duty discharged by satisfying a government approval process. This part addresses each of the principal regulatory agencies that members of the public most often associate with product safety, defines what each agency is and what it does, and identifies the limits of its oversight.

A. The Consumer Product Safety Commission

The Consumer Product Safety Commission, or CPSC, is a federal agency created by the Consumer Product Safety Act of 1972 with authority over the safety of consumer products. The CPSC develops and enforces some mandatory product safety standards, can require recalls of products it determines to be unsafe, and operates a public reporting database where consumers and others can report incidents involving consumer products. The agency conducts investigations, issues warnings, and works with manufacturers and retailers to remove dangerous products from circulation.

What the CPSC does not do is review and approve consumer products before they are sold. The agency operates fundamentally on a reactive model. It addresses safety problems that have come to its attention—through reported incidents, complaints, injury data, news reporting, or trends identified in surveillance of the marketplace. A consumer product on a store shelf or on a major online platform has not been pre-approved by the CPSC. It is on the market because the manufacturer placed it there and represented, by the act of placing it there, that the product is safe for its intended use. The CPSC may eventually act if the product turns out to cause widespread harm and the harm comes to the agency’s attention. By the time it does, the product has often been on the market for years and has caused substantial injury.

B. The Food and Drug Administration

The Food and Drug Administration, or FDA, is a federal agency with authority over the safety of food, prescription and over-the-counter drugs, medical devices, biological products, cosmetics, and certain related products. Its regulatory model varies significantly across these categories, and the differences matter to the duty analysis.

In the prescription drug and medical device categories, the FDA operates a substantive pre-market approval process. A new prescription drug must demonstrate safety and efficacy through controlled clinical trials and submitted data before the FDA will approve it for marketing. Higher-risk medical devices undergo a similar approval process, and lower-risk devices clear the market through other regulatory pathways including premarket notification. This pre-market regulatory review is meaningfully more rigorous than the regimes addressed elsewhere in this article, and it represents the principal example of true governmental pre-market oversight in American consumer product regulation.

FDA approval, however, is not absolution. An FDA-approved drug or device that turns out to cause foreseeable harm the manufacturer failed to disclose, that was manufactured defectively, or whose risks were inadequately warned against in labeling, remains the basis for a product liability claim. Many serious problems with approved drugs and medical devices emerge only after years of use in the broader population—effects that did not appear in the limited population enrolled in pre-market clinical trials, interactions with other medications that were not studied, problems with manufacturing quality that arise after approval, and risks the manufacturer knew or should have known about but did not adequately disclose to the FDA or to physicians and patients. The FDA itself maintains adverse event reporting systems precisely because pre-market approval is not the end of the regulatory inquiry. FDA approval is regulatory permission to market the product; it is not a determination that the product is incapable of causing harm or that the manufacturer has fully discharged the duties that product liability law imposes.

In the food category, the FDA’s oversight is substantially more limited than the public generally appreciates. The agency shares jurisdiction over food safety with the United States Department of Agriculture, which regulates meat, poultry, and processed eggs, while the FDA covers most other food categories. The FDA operates principally through inspection of food production facilities (at frequencies that vary by risk category), through post-market surveillance, and through response to outbreaks of foodborne illness. The reality of food safety in the United States is that contamination events—listeria outbreaks in produce, soft cheeses, or processed foods; E. coli outbreaks in ground beef or leafy greens; salmonella outbreaks in eggs, peanut products, or poultry—typically come to public attention only after people have been sickened, sometimes seriously. By the time the agency identifies the source of the contamination and announces a recall, the contaminated product has often already moved through the distribution chain into homes, restaurants, schools, and hospitals. The FDA’s role in this process is largely investigative and remedial. It does not, in any comprehensive sense, prevent food contamination at the source. The duty to produce safe and uncontaminated food belongs to the food producer, and the food producer’s discharge of that duty is not displaced by the existence of FDA oversight.

C. The National Highway Traffic Safety Administration

The National Highway Traffic Safety Administration, or NHTSA, is the federal agency with authority over motor vehicle safety. It establishes and enforces the Federal Motor Vehicle Safety Standards (FMVSS), which set minimum performance requirements for vehicles and certain vehicle equipment in areas such as crashworthiness, occupant protection, lighting, brakes, and tires. NHTSA conducts post-market investigations of vehicle defects, oversees manufacturer recalls, and operates the public-facing safety reporting and recall information systems.

What NHTSA does not do is pre-approve vehicles for sale. The agency operates on a self-certification model: vehicle manufacturers certify that their vehicles comply with the applicable FMVSS, and the vehicles enter the market on the strength of that self-certification. NHTSA’s principal mode of operation is post-market—investigating consumer complaints, conducting safety defect investigations when patterns of failures emerge, and ordering or overseeing recalls when defects are identified. As with the CPSC, the regulatory presence is fundamentally reactive. The vehicle on the dealership lot has not been pre-approved by a government agency for safety. It is on the lot because the manufacturer certified that it meets the applicable standards and placed it there.

D. OSHA and the General Duty Clause

The federal Occupational Safety and Health Administration, or OSHA, is a federal agency with authority over workplace safety. It issues mandatory workplace safety standards—the 29 C.F.R. Part 1910 general industry standards and the 29 C.F.R. Part 1926 construction standards, among others—that establish detailed requirements for the safe operation of workplaces, the use of equipment, the handling of hazardous materials, and the protection of workers. OSHA conducts workplace inspections, issues citations for violations, and assesses civil penalties. The General Duty Clause of the Occupational Safety and Health Act of 1970, codified at 29 U.S.C. § 654(a)(1), supplies a backstop requiring every employer to furnish a workplace free from recognized hazards causing or likely to cause death or serious physical harm.⁶

What OSHA does not do is regulate the design or manufacture of industrial equipment before that equipment is sold. OSHA regulates how equipment is used in the workplace, not how it is built. An industrial machine that meets no OSHA standard, that lacks safety features OSHA workplace standards would expect to be present, or that is otherwise unsafe by design can lawfully be sold by its manufacturer to an industrial buyer. Once the buyer-employer puts the machine into service in a workplace, the buyer-employer becomes responsible for using it in compliance with OSHA’s workplace safety requirements—which may require the buyer-employer to add guards, modify controls, develop safe operating procedures, train workers, and otherwise compensate for design deficiencies in the equipment. OSHA’s presence in the regulatory landscape does not put a regulator at the equipment manufacturer’s plant before the equipment ships, and it does not relieve the manufacturer of the duty to design and produce equipment that is not unreasonably dangerous when used as foreseeable industrial buyers will use it.

E. ANSI, ASTM, and Voluntary Consensus Standards

Members of the public sometimes encounter references to ANSI standards or ASTM standards in product literature and assume these are government regulations. They are not. The American National Standards Institute, or ANSI, is a private nonprofit organization that coordinates the development of voluntary consensus standards in the United States. ASTM International, formerly the American Society for Testing and Materials, is one of the largest standards-developing organizations operating under the ANSI framework. Standards developed under ANSI accreditation, including those developed by ASTM and by industry-specific standards organizations, bring together representatives of industry, academia, regulators, and end users to draft technical standards covering equipment design, materials, testing methods, performance characteristics, and safety features.

These standards are voluntary unless they have been incorporated by reference into a binding government regulation. A manufacturer’s compliance with the applicable ANSI or ASTM standard for the equipment is evidence that the manufacturer exercised reasonable care; the manufacturer’s noncompliance with such a standard is evidence of negligence and of unreasonable danger. Neither compliance nor noncompliance is conclusive—they are pieces of evidence the jury weighs in evaluating the manufacturer’s discharge of its duty.⁷ The point for present purposes is that ANSI and ASTM standards are industry self-regulation, not government oversight, and the existence of an applicable standard does not place a government regulator between the manufacturer and the public.

F. The Bottom Line

For most products on the American market, no government agency reviews and approves the product before it is sold. The fact that a product is on the market—on a retail shelf, on a major online platform, in an industrial supplier’s catalog—does not mean any government body has determined the product to be safe. Even where regulatory regimes exist, they are largely reactive (CPSC, NHTSA), regulate the workplace use of equipment rather than its design (OSHA), or address only certain categories of products (FDA for drugs and devices, with substantially more limited reach for food). The duty to design, test, manufacture, and warn so that the product is not unreasonably dangerous belongs to the manufacturer. When the manufacturer fails that duty, the consequences fall on the people the product injures, and the regulatory landscape is no defense.

Part Four: The Industrial Setting—Sophisticated User and Sophisticated Intermediary Doctrines

A. The Doctrines in Plain Terms

In industrial product cases, the law recognizes that the foreseeable user of the product is often a trained worker employed by an industrial buyer that is itself knowledgeable about the equipment and its hazards. Two related doctrines, recognized in both Pennsylvania and New Jersey, calibrate the manufacturer’s warning duty in light of these realities. The sophisticated user doctrine recognizes that some end users of industrial products are themselves experienced and knowledgeable about the equipment’s hazards—a journeyman with years of experience operating a particular category of equipment, for example—and that warnings to such users may be calibrated accordingly.⁸ The sophisticated intermediary doctrine recognizes that a manufacturer’s warning to an industrial buyer who is itself sophisticated about the product’s hazards, and who has the practical means to convey hazard information to its workforce through training and operating procedures, may in some circumstances satisfy the manufacturer’s warning duty even though the manufacturer did not separately warn the end user.⁹

B. What These Doctrines Do Not Do

The sophisticated user and sophisticated intermediary doctrines do not eliminate the manufacturer’s duty. They calibrate one component of the duty—the duty to warn—in specific circumstances where the law recognizes that the warning function may be discharged through means other than direct warnings to the end user. The doctrines do not relieve the manufacturer of the duty to design and manufacture a non-defective product. A manufacturer cannot supply industrial equipment with hidden hazards, omit warnings, and then point to the industrial buyer’s sophistication as a defense. The doctrines apply only where the buyer or user in fact has the relevant knowledge, where the manufacturer’s reliance on the buyer’s sophistication is reasonable in the circumstances, and where the warning that would have been conveyed through the intermediary would have been adequate to inform the end user. Manufacturers attempting to invoke these doctrines must establish each element, and Pennsylvania and New Jersey courts evaluate the inquiry carefully on the facts of each case.

C. Why This Matters in Practice

In nearly every industrial product case, the manufacturer argues that the sophisticated buyer or sophisticated user should have known the hazard and that the manufacturer’s responsibility is correspondingly reduced or eliminated. Plaintiff’s counsel must understand the doctrines and their limits to address the defense effectively. In particular, counsel must be prepared to demonstrate where the manufacturer’s duty was independent of and unaffected by whatever knowledge the buyer or user is presumed to have had—where, for example, the hazard was not actually known to the industry, where the manufacturer failed to convey hazard information to the buyer at all, where the buyer lacked the practical means to convey the warning to the affected workers, or where the design defect at issue is one for which no warning could have made the product reasonably safe.

Part Five: The Modifier’s Duty—When Someone Changes the Product After It Leaves the Manufacturer

A. The Basic Principle

When a person or company modifies a product after it leaves the manufacturer’s hands, the modifier assumes a duty of care for what the modification has done. The principle reaches a wide range of conduct. It includes the removal or defeat of safety guards that the manufacturer designed into the product. It includes the bypass or disabling of interlocks and other engineered safety controls—the systems that prevent a machine from operating under unsafe conditions. It includes the reprogramming of programmable logic controllers (PLCs) so that the machine no longer enforces the safety logic the manufacturer built into the system. It includes retrofitting equipment with new components that change how it functions. It includes any other change that alters the product’s safety characteristics. Whatever the form of the modification, the modifier becomes responsible for the modification, and depending on the nature and significance of the change, the modifier may bear primary liability for harm the modification causes.

A programmable logic controller, or PLC, is the small industrial computer that controls a modern machine’s automated functions. The PLC tells the machine when to start, when to stop, what speed to run at, and—critically—when it is permitted to operate at all. In a properly designed industrial machine, the PLC enforces the safety logic the manufacturer built into the system: it refuses to allow the machine to operate while a safety guard door is open, it stops the machine if an emergency stop is activated, it requires that energy isolation procedures be followed before service can begin. The PLC is the brain of the machine, and the safety logic the PLC enforces is one of the principal engineered safety features in modern industrial equipment. When a modifier rewires a PLC to ignore safety inputs—to operate the machine even when interlocks are absent, to permit operation that the manufacturer’s design would have prevented—the modification defeats the engineered safety design at its core.

B. The “Substantial Change” Doctrine and Its Limits

Pennsylvania and New Jersey both recognize the principle, derived from Restatement (Second) of Torts § 402A and the case law applying and interpreting it, that a substantial change to a product after it leaves the manufacturer’s control may shift liability to the entity responsible for the change.¹⁰ Manufacturers sometimes invoke the substantial change doctrine as a defense, asserting that the modification—not the original product—was the cause of the harm. The doctrine has real application: a fundamental alteration of a product, of a kind the manufacturer could not have foreseen, may indeed cut off the original manufacturer’s liability and place responsibility on the modifier.

The doctrine, however, has important limits, and those limits frequently determine the outcome of cases involving modified industrial equipment. A modification that was foreseeable to the manufacturer—because it represents a known industry practice, because the manufacturer’s own design facilitated or invited it, or because the manufacturer knew or should have known that buyers were making the change—does not cut off the manufacturer’s liability. The original manufacturer remains in the case. And separately and independently, a modifier that performs a substantial change negligently bears its own direct liability for the consequences of that negligence, whether or not the original manufacturer is also a defendant. The substantial change doctrine is not an on-off switch that allocates liability to one party or the other. It is a doctrine that may, in particular cases, shift the focus of the inquiry toward the modifier without eliminating the original manufacturer’s exposure where the manufacturer’s conduct also contributed to the harm.

C. The Modifier’s Affirmative Duty Under Assumption-of-Duty Principles

Once a company or individual undertakes to modify a product, the modifier has voluntarily undertaken a duty of reasonable care in performing the modification.¹¹ This is the same duty examined in detail in the companion article in this series on assumption of duty under Restatement §§ 323 and 324A. A safety consultant retained to retrofit guards onto a machine has undertaken a duty to perform that retrofit competently. A maintenance organization that modifies machine controls has undertaken a duty to do so in a manner that does not introduce new hazards. A safety director who approves the disabling of interlocks has undertaken a duty for the consequences of the modification he has authorized. The undertaking creates the duty, and the duty is owed not only to the entity that engaged the modifier but to the foreseeable users of the modified product—the workers who will operate it after the modification.

The standard is reasonable care in performing the undertaking. A modifier that designs guards without consulting an engineer, without reviewing applicable industry standards, without testing the design, and with the goal of meeting a price point rather than achieving safety has not exercised reasonable care. A modifier that defeats engineered safety controls without analysis, without alternative safeguards, and without warnings to the workers who will encounter the modified equipment has affirmatively created the unsafe condition that the manufacturer’s design was meant to prevent.

D. Modifications That Defeat Manufacturer-Installed Safety Systems

The most serious modifier-liability cases involve modifications that affirmatively defeat safety systems the manufacturer designed into the product. These modifications are doctrinally significant because they convert a product the manufacturer designed to be safe into one that is, by virtue of the modification, unsafe. The categories recur in serious industrial injury cases. The removal of machine guards in violation of OSHA’s general machine guarding standard, 29 C.F.R. § 1910.212, which requires guards to protect operators from hazards created by point of operation, ingoing nip points, rotating parts, and other moving components.¹² The defeat of guard-door interlocks—the engineered electrical or electronic systems that prevent a machine from operating while a safety door is open—whether through physical bypass, through replacement with non-functioning latches that permit the door to be closed without engaging the safety circuit, or through rewiring of the machine’s PLC so that the absence of the interlock signal no longer prevents operation. The disabling of energy-isolation systems required by OSHA’s lockout/tagout standard, 29 C.F.R. § 1910.147, which requires that energy sources be isolated and locked out before service or maintenance is performed on a machine.¹³ Each of these modifications converts a guarded, safety-controlled machine into one that operates without the safety systems its manufacturer designed. The modifier—whether a corporate safety director who approves the modification, an in-house maintenance organization that performs it, or an outside contractor retained to do it—assumes liability for the resulting unsafe condition.

E. The Interplay With Other Direct-Fault Theories

Modifier liability rarely stands alone in cases that produce serious injuries. A company that approves the modification of a machine to defeat its safety systems is almost always also exposed to negligent supervision, negligent retention, and negligent entrustment claims, addressed in detail in the companion articles in this series. A parent corporation whose decision-makers select unsafe equipment, whose safety director condones unsafe modifications, or whose corporate-level officers control the practices through which equipment is modified across operating subsidiaries may be liable as a separate legal entity from the operating subsidiary that employs the injured worker. The Workers’ Compensation Trap discussion in the companion vicarious liability article addresses the investigative discipline necessary in any serious workplace injury involving a corporate family. The doctrines of product liability, negligent entrustment, negligent hiring/supervision/retention, and vicarious liability work together to map the full universe of potential defendants in cases involving modified industrial equipment, and counsel handling such cases should evaluate each theory independently and plead them together where the facts support them.

Part Six: Sellers in the Chain of Distribution

Both Pennsylvania and New Jersey impose product liability throughout the distribution chain. Manufacturers are the primary target of product liability law, but distributors, wholesalers, and sellers—including online retailers that function as sellers of the products they offer to the public—may also bear liability for harm caused by defective products supplied through them. The policy is to ensure that injured plaintiffs have viable defendants, to put commercial pressure on every link in the distribution chain to demand safer products, and to align the legal incentives so that all parties profiting from the sale of unsafe products bear some share of the responsibility for the harm.

In the modern marketplace, the question of who is a “seller” for purposes of these duties has become more complex with the rise of online retail platforms. Major online retailers function in many cases as sellers of the products they offer through their platforms, and both Pennsylvania and New Jersey law have evolved to recognize that a retailer’s use of an online platform does not automatically remove it from the chain of distribution for product liability purposes. The specifics of when an online retailer is treated as a seller, and the contours of the resulting liability, are developed in greater depth in the case law and would extend beyond the scope of this article. The point for present purposes is that the chain of distribution principle reaches sellers in their many modern forms, and the analysis should not be foreshortened by assumptions about the structure of the modern retail marketplace.

Breach of warranty supplies a parallel theory of recovery against sellers, alongside strict liability and negligence. Express warranties—specific representations a seller makes about the product—and the implied warranty of merchantability—the implicit warranty that goods sold by a merchant are fit for the ordinary purposes for which they are used—both create independent bases for liability when a product fails to perform as warranted and causes injury. Warranty law will be addressed in greater depth in the forthcoming companion article.

Part Seven: A Preview of the Categories of Product Liability Cases

The categories of product liability cases will be addressed in depth in the forthcoming companion article in this series. They are previewed here briefly so that readers of this article can orient themselves to the doctrinal architecture that the next article will develop.

A design defect case asserts that the product is dangerous because of how it was designed—that an alternative design was feasible, that the alternative would have reduced or eliminated the risk that caused the harm, and that the manufacturer’s choice of the actual design over the safer alternative made the product unreasonably dangerous. A manufacturing defect case asserts that the particular unit of the product that caused the harm departed from its intended design due to an error in production—that something went wrong on the production line and the unit that injured the plaintiff is not the unit the manufacturer intended to make. A failure-to-warn case asserts that the product carried risks that adequate warnings would have allowed users to avoid or mitigate, that the manufacturer failed to provide adequate warnings, and that adequate warnings would have prevented the harm. A post-sale duty to warn case asserts that the manufacturer learned of dangers after the product was sold and failed to take reasonable steps to warn known users. A breach of warranty case asserts that the seller made representations or implicit promises about the product that the product failed to fulfill, with resulting harm to the buyer or user.

Each of these categories has its own doctrinal structure, its own proof requirements, and its own defenses. The forthcoming article will address each in detail under both Pennsylvania and New Jersey law.

Part Eight: Case Studies

The following four case studies are drawn from the firm’s files and have been anonymized to preserve client confidentiality. Each illustrates a distinct application of the duty principles addressed in this article, and together they cover the range from original manufacturer liability through post-sale modifier liability, from consumer products through industrial equipment, and from single-defendant cases through multi-party corporate-family cases.

Case Study One: PA, Newspaper Collation Machinery, Original Manufacturer Plus Post-Sale Guard Designer

A Pennsylvania matter. The original manufacturer of industrial assembly-line machinery used to collate and organize inserts and pages of newspapers into final form supplied the equipment to a purchaser-employer. The sale contract between the manufacturer and the purchaser-employer represented that the machinery conformed to OSHA standards. The representation was false. The machinery was supplied without guards around areas where moving parts created nip points—the points at which moving components come together in a manner that can trap a worker’s hand, arm, or other body part—exposing operators to the risk of being drawn into the machine. The purchaser-employer was subsequently cited by OSHA in an unrelated inspection for the absence of guarding at these locations. In response to the citation, the purchaser-employer retained a post-market guard designer and manufacturer to retrofit guards onto the machinery.¹⁴

The post-market guard designer was not an engineer. He did not consult an engineer. He did not look at any applicable standards governing machine guarding or safety interlock design. The goal of the retrofit, as he undertook it, was to produce guards within a price range that would secure the sale—to make the work cheap enough to win the engagement, not to make it safe enough to discharge the safety function. The guards he designed and supplied included sliding plexiglass windows installed at the locations where the original machine had no guarding. The plexiglass windows were not interlocked. There was no engineered electrical or electronic system that cut power to the machine when the window was slid open. A worker who slid the window open to clear a jam in the machine was exposed to the still-energized internal moving parts the window was nominally there to guard.

Our client, a worker employed by the purchaser-employer, was operating the machinery when a jam developed. He was unaware that the retrofit guard’s window was not interlocked—the window’s presence and apparent function as a safety guard suggested otherwise. He slid the window open to clear the jam and reached into the machine. The machine started up. His hand and arm were trapped, an artery was pierced, and his arm and hand were rendered irreparably damaged.

The case proceeded successfully against both the original manufacturer and the post-sale guard designer. Against the original manufacturer, the case rested on the original defect—the supply of unguarded machinery, in violation of the express representation in the sale contract that the machinery conformed to OSHA standards, where the absence of guarding at known nip points exposed foreseeable industrial users to the precise category of injury our client suffered. Against the post-sale guard designer, the case rested on the assumption of duty in undertaking the retrofit, breached by the absence of any engineering analysis, the failure to consult or consider any applicable standards, and the price-driven design that omitted the interlocks any reasonable safety analysis would have required. The doctrinal architecture of the case was layered: original-manufacturer product liability for the underlying defect; assumption-of-duty liability against the modifier for the negligent performance of the retrofit; and a recognition that the retrofit, far from curing the original defect, introduced additional hazards by creating the appearance of safety guarding without the function of safety guarding. Cross-reference forward to the companion article on the categories of product liability cases for the design defect and failure-to-warn doctrinal framework, and back to the assumption of duty article for the post-sale designer’s assumed duty.

Case Study Two: PA, Concrete Plant, Pendant-Controlled Crane, Panel Failure, Amputation

A Pennsylvania concrete plant produced prefabricated wall panels for use in construction. The plant was structured as part of a corporate family. The operating subsidiary employed our client and the production workforce. The parent corporation employed the decision-makers with ultimate authority over plant operations, equipment selection, and safety practices. The decision-makers in question were employed by the parent corporation, reported to the parent’s officers, and exercised their authority across the operations of the operating subsidiary.¹⁵

Two failures combined to produce the injury. The first concerned the selection of the overhead crane used to handle the concrete panels. The crane was equipped with a pendant control—a hand-held controller tethered to the crane by a physical electrical cable, requiring the operator to remain physically near the crane and the load as the load is moved. The principal alternative configuration is a remote control, a wireless or radio-frequency controller that allows the operator to stand at a position of his or her choosing, away from the crane and the load, including outside the fall zone in which the load could come down. The parent corporation’s decision-makers selected the pendant control configuration without performing a job safety analysis (JSA), without considering the alternative remote-control configuration, and without conducting any documented safety evaluation of the equipment-selection decision. The pendant control configuration required the operator to be tethered to the load and within the fall zone as the load moved—precisely the exposure the remote control configuration would have eliminated.

The second failure concerned the manufacture of the concrete panels themselves. The panels included connection hardware—fastenings designed to be embedded in the concrete during the casting process to permit the panels to be lifted and handled. Engineered plans specified the placement, embedment, and fastening of this hardware. The plant did not ensure that the panels were being made in accordance with the engineered plans. The connection hardware in the panels was an installation and specification failure attributable to the plant’s failure to follow the engineered plans for panel manufacture.

Our client was using the crane to lift one of the concrete panels and was walking with the pendant control to move the panel into a storage area. While the panel was suspended and being moved, the fastening hardware ripped out of the panel—a consequence of the manufacturing failure—and the panel released. Because the pendant control configuration tethered our client to the crane and required him to be near the load as he walked it into position, he was within the fall zone when the panel released. The concrete panel struck him. He suffered amputation injuries.

The case proceeded successfully on multiple theories against multiple defendants. Against the manufacturer of the crane, both product liability and negligence: the pendant control configuration’s known under-load exposure for foreseeable industrial use supported a design defect theory, and the absence of warnings about the hazard supported a failure-to-warn theory. Against the parent corporation, direct negligence on two tracks: negligence in the equipment-selection decision made without JSA or safety analysis, and negligence in the failure to ensure that concrete panel manufacture followed the engineered specifications. The parent corporation, as a separate legal entity from our client’s direct employer, was reachable in tort despite the workers’ compensation exclusivity that would otherwise have barred a claim against the operating subsidiary. The companion article in this series on vicarious liability addresses the Workers’ Compensation Trap and the investigative imperative that this kind of multi-entity corporate structure makes essential. The case illustrates the doctrinal payoff: the manufacturer was responsible for the defect in the equipment it sold, and the parent corporation was responsible for the operational decisions and oversight failures that compounded the equipment hazard with the panel manufacturing failure.

Case Study Three: PA, Diabetic Foot Bath, Online Retailer Plus Manufacturer, Burn Injury Leading to Amputation

A Pennsylvania matter. Our client purchased a foot bath from a major online retailer. The product was a consumer product—a heated foot bath designed to provide therapeutic warm-water treatment to the user’s feet. It included no temperature regulator, no thermostatic limit, and no other engineered means of preventing the water from reaching temperatures that could burn the user. The product carried no warnings about temperature settings, no recommendations for safe use, and no warnings about the risk of burns to users with reduced sensation in their feet.¹⁶

Our client had diabetic neuropathy—a condition that impairs sensation in the feet and lower extremities and that is common among the millions of Americans living with diabetes. A person with diabetic neuropathy may be unable to perceive when water has reached an injurious temperature, because the sensory nerves that would normally signal pain and heat are damaged or absent. The condition is so prevalent in the population of foreseeable users of a heated foot bath that any manufacturer of such a product, applying any reasonable analysis of who would actually use the product, would foresee that a meaningful percentage of users would be people with this condition. Our client, lacking the ability to perceive when the water temperature had reached a level that was injuring his feet, and having received no warning to alert him to the risk or to recommend a safe temperature setting, suffered extensive burns to both feet from his use of the product. The injuries ultimately led to the amputation of one foot. Ongoing wound care issues with the other foot have continued.

The case proceeded successfully against both the manufacturer and the online retailer. Both were sellers within the meaning of Pennsylvania and New Jersey product liability frameworks. The retailer’s status as a seller of the product on its platform brought it within the scope of distribution-chain liability under both states’ law. The defect theory was inadequate warnings. The foreseeable population of users included people with diabetic neuropathy. The manufacturer was in the best position to know the risk—to know that a heated water product without a temperature regulator and without warnings would foreseeably injure users who could not perceive the water’s temperature. A warning addressing safe temperature limits and the special risk to users with reduced sensation in their feet would have been technically simple, inexpensive, and effective. Its absence was the breach. The case illustrates several points central to this article: that the absence of any government pre-approval did not relieve the manufacturer of its duty to design and warn safely; that the availability of the product on a major online retail platform was not a substitute for safety review and was not a representation by any government body that the product was safe; and that the foreseeable user population—not just the manufacturer’s marketing target—defines the scope of the manufacturer’s warning duty.

Case Study Four: PA, Parent Corporation, Safety Director, Defeated Interlocks, PLC Rewired, Maintenance Worker Amputation

A Pennsylvania matter. This same matter is addressed in the companion article in this series on negligent hiring, supervision, and retention, where it is examined through the lens of the parent corporation’s negligent hiring of an unqualified safety director and its negligent retention of him in the face of a documented pattern of OSHA citations. It is addressed here through the lens of modifier liability—the affirmative defeat of manufacturer-installed safety systems, undertaken at the direction or with the approval of the parent corporation’s safety director, who reported to and was subject to the performance review of the parent corporation’s CEO and officers.¹⁷

The parent corporation oversaw a safety director who condoned and encouraged the modification of industrial machinery in the corporation’s operating subsidiaries to defeat the manufacturer-installed safety systems. The stated business purpose of the modifications was production throughput—to allow the machines to continue operating without being shut down to address jams, and thus to increase the volume of product the equipment could produce. The modifications were not minor. The interlocks for the guard doors—the engineered electrical safety controls that prevented the machines from operating while a safety door was open—were physically removed altogether and replaced with simple exterior barrel latches. The barrel latches mechanically held the doors closed but had no connection to the machine’s safety circuit; they performed none of the safety function the original interlocks performed.

Because the manufacturer had designed the machines to refuse to operate without intact interlocks—a deliberate design decision intended to ensure that the machines could not run with their guard doors open—the modification required an additional step. The machines’ PLCs had to be rewired so that the machines would no longer recognize that the safety interlocks were absent. The PLC rewiring was the second affirmative modification, and it was the modification that converted the design from one in which the manufacturer’s safety logic prevented operation under unsafe conditions into one in which that logic had been removed. Without the PLC rewiring, the manufacturer’s engineered safety design would have prevented the machines from operating at all once the interlocks were removed. The PLC rewiring was the affirmative engineering act that made the unsafe operating mode available.

The combined modifications converted machines the manufacturer had designed to be incapable of operating with open guard doors into machines that could operate with the doors open, the interlocks defeated, and workers exposed to the moving internal parts the guards were originally designed to isolate. Our client was performing maintenance on one of the affected machines. He had opened the machine and believed it to be deenergized for the maintenance operation. Because of the modifications—the removed interlocks, the simple barrel latch in place of an engineered safety control, the rewired PLC that no longer required interlock satisfaction for operation—the machine’s capacity to operate had not been actually defeated by the maintenance procedures the worker reasonably believed to be in place. He reestablished an interior connection during the repair. The machine started. Our client suffered amputation injuries.

The case proceeded successfully against the parent corporation. The modifier liability theory rested on the affirmative defeat of the manufacturer’s safety systems—both the physical removal of the interlocks and the PLC rewiring that made operation possible in their absence—undertaken at the direction or with the approval of the parent corporation’s safety director, who reported to and was subject to the performance review of the parent corporation’s CEO and officers. The parent corporation, as a separate legal entity from the operating subsidiary that employed our client, was reachable in tort. The case is the cleanest illustration in the firm’s files of the modifier-liability principle in its purest form: the manufacturer designed the machine to be safe, the modifier affirmatively converted the machine into an unsafe machine through engineering changes that defeated both the physical safety systems and the safety logic, and the modifier bears direct responsibility for the resulting harm. The cross-reference to the negligent hiring, supervision, and retention article addresses the same matter through the institutional-fault lens; the cross-reference to the negligent entrustment article addresses the related theory that the modified machine was then entrusted to maintenance workers who had no knowledge of the modifications and no means of ensuring the machine was actually safe before they began their work.

Part Nine: Similarly Situated Manufacturers and Modifiers

The four case studies above are illustrative, not exhaustive. The duty principles addressed in this article reach a substantially broader universe of potential defendants in the kinds of cases handled in Philadelphia, South Jersey, and the surrounding region. Original equipment manufacturers across both consumer and industrial categories. Component manufacturers whose components are integrated into larger products and whose component-level defects propagate into harm to the end user. Private-label manufacturers and white-label resellers whose products move through the distribution chain under different names. Online retailers and marketplace platforms functioning as sellers of the products they offer to the public. Distributors and wholesalers along the chain of distribution. Equipment retrofitters and post-market modifiers who undertake to add, remove, or alter safety features or operating characteristics of machines after they leave the manufacturer. In-house engineering and maintenance organizations performing modifications on company equipment. Outside contractors retained to modify or upgrade equipment. Corporate safety directors and engineering leadership whose decisions authorize equipment modifications. Parent corporations whose decision-makers control equipment selection and modification practices across operating subsidiaries. Each of these entities and individuals operates within the framework this article describes, and each may bear duties whose breach supports liability in cases where defective or modified products cause injury.

Conclusion

The duty of a product manufacturer and those who modify products is extensive, they are well-established under Pennsylvania and New Jersey law, and they are not relieved by the regulatory landscape that members of the public commonly assume to be more protective than it actually is. For most products on the American market, no government agency has reviewed and approved the product before sale. Even where regulatory regimes exist—FDA approval for prescription drugs and medical devices, FMVSS self-certification for vehicles, voluntary consensus standards for industrial equipment, OSHA regulation of workplace use of equipment—the manufacturer’s duty to test, design, manufacture, and warn safely is its own. When a downstream company or individual modifies the product, the modifier assumes its own direct duty for what the modification has done, and that duty often becomes the central question in cases involving defeated safety systems, retrofitted guards, and altered control logic. The interplay among original-manufacturer liability, modifier liability, and the related direct-fault theories of negligent entrustment and negligent hiring, supervision, and retention defines the universe of defendants in the most serious industrial product cases.

For attorneys representing seriously injured clients in the Philadelphia metropolitan area and throughout South Jersey, the discipline of evaluating both the original manufacturer’s duty and any modifier’s duty in every product case is essential. So is the discipline of recognizing that the absence of government approval is not a defect in the legal case—it is, in most product categories, simply the regulatory reality, and the manufacturer’s duty fills the space the regulatory regime leaves unoccupied. The forthcoming companion article in this series will develop the categories of product liability cases—design defect, manufacturing defect, failure to warn, post-sale duty to warn, and breach of warranty—within the framework this article has established.

About Brian E. Fritz, Esquire

BRIAN E. FRITZ, ESQUIRE has represented seriously injured clients in Pennsylvania and New Jersey for almost 30 years. He has dedicated his practice to providing hope to the victims of others’ negligence and helping them navigate the challenges they now face. His primary focus includes: construction and premises liability; corporate direct liability for negligence; motor vehicle and trucking accidents; dangerous and defective products; unsafe modification of products and machinery; medical malpractice with an emphasis on birth-related injuries and cerebral palsy; exposing liability caused by disguised and hidden corporate decision-makers; establishing vicarious liability where companies have mislabeled workers as independent contractors; securing third-party liability for catastrophically injured workers whose recoveries would otherwise be limited to workers’ compensation; and providing second opinions to seriously injured clients whose cases were initially rejected on mistaken assumptions.

He is admitted to practice law in the State and Federal Courts of Pennsylvania and New Jersey and has handled cases in other jurisdictions on a pro hac vice basis. Based in Philadelphia, he represents clients throughout Pennsylvania and New Jersey. He is a member of the Board of Directors of the Philadelphia Trial Lawyers Association.

He has been recognized annually by his peer attorneys for inclusion in Super Lawyers and has been named one of the Top 100 Attorneys in Philadelphia in the Super Lawyers rankings. He has annually been selected for inclusion in The Best Lawyers in America. His case results have achieved annual national and state recognition by Best of the Bar, reserved for only the top 100 resolutions in any given year. He has annually received Martindale-Hubbell’s AV Preeminent rating for Legal Ability and Ethical Standards based on voting by peer attorneys and members of the Judiciary (Judicial Edition).

Disclaimer: This article is for educational and informational purposes only and does not constitute legal advice. Every case is unique, and the information presented here should not be relied upon as a substitute for consultation with a qualified attorney. If you have been injured, please contact a licensed personal injury attorney in your jurisdiction to discuss the specific facts and circumstances of your situation.