One of the debates in tort reform is whether there should be agency preemption of lawsuits. Proponents argue that government agencies are charged with studying the products, and promulgating rules, regulations and requirements. Therefore, where manufacturers meet those standards, there should be no space for liability to consumers for product failure.  Additional arguments suggest that the money saved from court administration should instead facilitate improving agency research and function. However, dangerous product failures, such as the all-metal hip implant, highlight many counter-arguments. One such counter-argument is that agencies simply are not equipped to handle the knowledge, research, and development required to provide comprehensive standards and monitoring for the variety of products on the market. For example, the F.D.A. oversees food, prescription drugs, medical devices, tobacco, cosmetics, and veterinary medicine. Another argument claims that lawsuits provide valuable knowledge to manufacturers and agencies, through the relevant discovery, facts, and evidence involved in a case. Furthermore, a lawsuit provides a means for recovery to injured consumers. Additional considerations must also include the consequences of lawsuits on the access, price, and availability, of products, as well as the line drawn as to whether a product is risky enough to enough people to warrant these consequences. Certainly, there are advantages and disadvantages to both sides of the preemption argument. Ultimately, at present, tort law has not embraced agency preemption.

Medical devices add another wrinkle to the process. Surgeons and other medical professionals are involved in offering, recommending and installing all-metal hip replacements. The implications on medical malpractice and the learned intermediary doctrine¹, implicate surgeons’ judgment when it comes to products that are available and have passed standards, yet are the subject of complaints. Some surgeons have stopped using all-metal hips altogether, as there are other models available that combine plastic with metal. However, some all-metal models have not been the source of complaints. Ultimately, these questions come down to whose cost-benefit analysis consumers will rely on, and who we will hold accountable if these decisions prove to be unsatisfying.

1The learned intermediary doctrine provides that a manufacturer can be shielded from liability for failure to warn where the manufacturer adequately warned a learned intermediary, such as a prescribing physician, who is responsible for warning the patient.

Who is Liable?

There are many theories of liability under which some combination of the medical professionals involved can be held liable.  Technicians may still be liable under a general negligence theory.    Hospitals can be found liable under agency or vicarious liability for the actions of its employees (or apparent employees) and under theories of corporate negligence, which recognize duties such as oversight and adoption of “adequate rules and policies.” See Thompson v. Nason Hospital, 591 A.2d 703.  Furthermore, physicians and nurses have reporting and oversight responsibilities which they may breach especially often where they are involved in reading X-ray scans.

One party that is probably less likely to be liable is the manufacturer.  In order to hold the manufacturer liable in such a case, plaintiffs would have to plead a design defect.  The majority of jurisdictions use a risk-utility analysis—essentially a two-prong balancing test requiring the plaintiff show that a reasonable alternative design would have reduced the plaintiff’s harm and that the defendant’s failure to adopt the reasonable alternative design has rendered the product unsafe. (See Restatement (Third) of Torts: Products Liability § 2(b))  Some courts use a consumer expectation test, where the point is to determine whether the product meets consumers expectations, however, even this standard might prove difficult in an area where consumers probably do not have very evolved or technical expectations.  Furthermore, the Restatement Third advocates an even higher standard for medical devices.  Section 6(c) articulates the standard, “A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its therapeutic benefits that reasonable healthcare providers, knowing of such foreseeable risks and benefits, would not prescribe the drug or medical device for any class of patients.” Id at §6(c).  Such a standard requires a plaintiff so show that the product is essentially of no benefit to any class of patients.  Thus, it would prove difficult to hold manufacturers liable for medical devices that have such wide spread acceptance, use, and benefit.

Preventative Solutions

As the article points out, legislative and institutional solutions are warranted.  State licensing requirements, regulation, and certification of technicians would undoubtedly reduce instances of lack of knowledge and dangerous use of the complicated technology.  Hospital policies that require continuing education, certification, and oversight would likewise contribute to more professional and knowledgeable employees.  Many of these suggestions are part of the Constancy, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy (CARE) bill, a bill that would institute standards, certification, and education requirements for technicians and other imaging and radiation specialists. However, this bill has become a casualty to the political process.  Unfortunately, this gap in both liability and legislation leaves us uncertain as to whose responsibility it is to fill it.

Grady’s Theory, Roughly
While Grady’s paper is an explanation of the role of compliance error in the economic theory of negligence, a central concern is the role of technology in generating liability for its negligent use.  The article seeks to explain why negligent accidents still occur in a regime which has a well-established and well-accepted theory of negligence – the Learned Hand formula – which prescribes precautions to take to avoid liability.

Grady’s answer lies in the concept of compliance error, whereby courts hold defendants liable for every missed instance of an efficient precaution – that is a precaution prescribed by the Learned Hand formula.  Courts in most cases require 100% compliance, and therefore impose strict liability for the use of the precaution.  Hence, Grady identifies a “pocket of strict liability.”  He writes, “In reality the pocket of strict liability comes from making people liable when they have not achieved perfect consistency.  Actors are found negligent for committing efficient ‘compliance errors.’  Economically, this is a form of strict liability because it is a liability that attaches to social-wealth maximizing behavior.” Id. at 987-8.  Technology establishes the precaution for which courts have required perfect compliance in order to escape liability for negligence.  A short example may clarify the distinction: a commercial airline installs a radar system by which it should escape negligence, but the airplane crashes into another airplane. Is this a failure to take the required precaution? Or is it a momentary failure to monitor the precaution (radar screen)? The former is a negligent failure; the latter, a compliance error.

The Technology Life Cycle
Grady emphasizes, “Far from indicating flaws in the system, this is a normal and usual relationship when technology progresses…the paramount purpose of the negligence system is to regulate compliance error in the use of technology.  It is therefore natural that advances in technology tend to increase the number of claims.” Id at 912.  Certainly, technology has redefined the role of the law in the regulation of human and industry behavior.  One such aspect of this role is the requirement and regulation of technology to enhance safety, such as the radar discussed above.  However, Grady also identifies a further natural evolution, that of technology itself.  He writes,

“There is a technology life cycle.  Think of the introduction of the airplane.  In the beginning, res ipsa cases were weak because the technology was so ambitious that the rate of unavoidable accident was high relative to the rate of compliance error.  Then radar was invented, reducing the rate of unavoidable accident, but creating an entirely new opportunity for compliance error when the pilot failed to check the monitor.  In this second stage, technology increased the number of negligence claims and the strength of res ipsa claims.  In the last stage res ipsa cases again weaken as the computer-monitored radar reduces the rate of compliance error more than it reduces the rate of unavoidable accident.  At present, most technological advance seems to occur in the second stage in which res ipsa cases become stronger.” Id. at 911.

Here is where we see the marked difference between 1994 and 2010, the emergence of the third stage of technology.  Grady’s notion of the third stage of technology seems to be one where technology is monitoring the technology, reducing the rate of human compliance error.  Take for example the car Google recently tested on the roads of San Francisco – the car that drives itself.  Such an innovation would replace the potential for compliance error as technology, capable of 100% compliance, replaces human involvement.  However, as the New York Times article points out, there are various legal issues associated with a car that drives itself.  One of which is, who bears the fault of an accident?  I think such fault/causation issues would lead to product liability claims, not just because of the role of the product in the activity, but also because of the deeper pockets of the manufacturers.

Furthermore, I would suggest that the replacement of negligence claims with product liability claims is an inherent feature in the evolution of technology to the third stage.  This would probably be a preferable regime, as manufacturers are often the parties better able to spread costs, improve products, and inform consumers.  On the issue of technological development and liability, I think Grady got it right: stage 3 technology will be the era of improved safety, innovation, and less negligence liability. Instead, liability will be moved up the chain of distribution to the manufacturers, and the realm of product liability will take over.