Originally Published MDDI March 2005
Product Development Insight
Factoring the Law into Medical Device Design
Although product litigation is unavoidable, certain steps during the design process can reduce a manufacturer's risk.
Rubin and Rudman LLP
Medical device manufacturers, more than those in almost any other industry, often face product-liability litigation. Mishaps often occur, and when they do, the resulting injury or death is typically followed by a damage claim and a lawsuit. Such risks cannot be avoided, but they can be reduced. This article focuses on steps during the design process that manufacturers should take to reduce risk and defend themselves against product-liability lawsuits alleging a design defect. These steps entail integrating product-liability legal principles into the device-design stage of medical device product development.
The principles of product-liability law and the perceived defenses that manufacturers rely on in design-defect product-liability cases are discussed. This article examines product liability from the standpoint of preventive law and, in particular, addresses the following questions:
• Why will most medical device manufacturers face a product-liability lawsuit?
• In these lawsuits, what are the governing legal principles that determine the outcome?
• How can a company's internal communications during the design process sink your case in court?
• Why can the manufacturer not rely on the perceived defenses of FDA approval, meeting “industry standards,” and liability insurance?
The regulatory system that oversees the process is itself an excellent example of prevention at work. FDA procedures are designed to detect existing and potential problems and to track the manufacturer's resolutions of such problems as they are detected. It is important to note that although standards and regulations govern the release of a device into the market, they are not the ones that a judge and jury apply in the courtroom. In court, manufacturers face another standard— the law of product liability and design defects.
The law books are filled with cases alleging defective design of equipment that plaintiffs claim caused injury or death. The indexes of these law reports list hundreds of medical devices, from a simple surgical screw to complex x-ray and MRI equipment.
Yet, during the design process, while meeting premarket FDA, ISO, and European standards, most manufacturers fail to address the legal risks at the other end of the cycle.1 Today, good engineering and FDA approval are not enough to ensure maximum protection against product-liability claims.
A Legal Look at Design
The notion of introducing the product-liability preventive law process to designers and engineers is not new. For example, writing about product design in general, James T. O'Reilly wrote:
The role of lawyers in accident reduction will involve effective communication to the designers of tomorrow's consumer products...lawyers should be heard inside the design studio as products are created or modified.... The [legal] counsel for a manufacturer or importer should attempt education for each level of product design.... Attorneys who deal with both regulators and liability juries have a role in explaining to designers the aspects of the product that would present a “defect,” and would thus be subject to negative consequences for the designer and the designer's employer.2
O'Reilly's suggestions to non-U.S. manufacturers selling into U.S. markets are equally pertinent to American manufacturers: “Lawyers need to become safety advocates outside the courtroom, and lawyers should be heard inside the design studio as products are created or modified.” And further, “The role of lawyers in accident reduction will involve effective communication to the designers of tomorrow's consumer products.” O'Reilly “encourages counsel to educate manufacturers and importers about the integration of the safety protective systems and to make product designers more aware of interplay between the common law and regulatory methods of product ‘defect' determination.”
Another legal scholar, focusing on medical device design, made the following comment about the role of product-liability law:
The law should encourage product designers to ask not only how to make a product, but also whether to make it, and why. The designer should consider the full range of design considerations.... The process of selecting a design should be informed by the knowledge that the designer someday may have to justify the particular balance it chose between risk and utility. Such thoughtful consideration of the need to justify design choices ultimately will result in better, safer products.3
The Statistical Certainty of Landing in Court
I firmly believe in this harsh reality: Sooner or later, practically every medical device used in the U.S. market will be tested in a product-liability lawsuit. As our society moves inexorably toward a more technological practice of medicine, the sheer number of devices and procedures creates the inevitability of this chain: You conceive and design your complex product; you test, gain required approvals, and manufacture it; and then it moves on to the customer. Many devices are used by medical professionals in often-difficult and tense life, health, and safety situations. In this complex chain of events, something will go awry, and a patient will be injured or die in a procedure involving a product. A lawsuit will allege medical malpractice against doctors, nurses, and hospitals. Invariably, it will assert a product-liability claim against the manufacturer of the device, and the manufacturer will have to defend itself before a jury.
Hospitals and clinicians—as well as medical device manufacturers—should continue to provide adequate warnings and obtain the patient's informed consent and release forms. However, one example shows that even warnings and consent may not provide the desired protection. The case involved Abiomed's artificial heart. Although the plaintiff's claims were based on inadequate warning rather than a design defect, the case still serves to illustrate the failure of even heroic precautions by the manufacturer. If the lawsuits being filed are any indication, most people believe that whenever there is a death or injury in a medical setting, someone must be to blame, and there must be a legal remedy against that someone.
The Abiomed case involved a coronary-disease patient facing certain death who opted for an experimental artificial heart. The manufacturer took many precautions with the patient, including providing the patient with a 13-page informational document and having him sign a patient- release form. The company also provided a patient ombudsman to ensure that the patient understood all the risks involved. With the agreement of his wife, the patient had the artificial heart implanted on November 5, 2001.
The man survived the surgery, and the artificial heart appeared to work well. He lived, with difficulties and complications, for almost 10 months, but after suffering a stroke, he died on August 26, 2002. On October 16, 2002, his widow sued Abiomed. Abiomed eventually settled the case with a payment to the plaintiff of $125,000.
This case confirms my conclusion that when that inevitable mishap occurs, it's also inevitable that you will be sued. All manufacturers should take the precautions that Abiomed did. However, such precautions don't provide perfect protection.
Product-Liability Design Defects: Applicable Law
For the purpose of this article, the product-liability law in the United States is neatly stated in the 1998 publication of the American Law Institute's Restatement of the Law, Torts, Products Liability. Its publication was the first time that an entire volume (380 pages) was devoted to just the product-liability segment of tort law.4 Section 2(b), dealing with design defects, is the most pertinent to the problems discussed in this article.
A product is defective when...it is defective in design.... A product is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller...and the omission of the alternative design renders the product not reasonably safe…
As the law developed in the state and federal courts, an injured plaintiff had to prove that there was an alternative design available (whether or not in actual use) that was safer than the defendant's device.
Lawyers view the law as providing a risk-utility test, which asks whether the utility of the product's design outweighs the risks associated with that design—a balancing act of sorts. The lawyer's task in stating the law, however, is infinitely simpler than the designer's task in applying the rules when designing a medical device. Some design choices and judgments can be excruciatingly challenging.
For some device designs, balancing risk and utility requires a manufacturer to effectively make a trade-off between possible safety features and risks to the patient without those safety features. For example, a particular design may be safer, but it may also be less effective than an alternative design. Extreme cases at the ends of the judgment spectrum are simple. For example, when the safer device is so ineffective as to be nearly useless for most patients, it's not a practicable alternative. The more difficult situations are those in which the safety and effectiveness metrics are almost evenly balanced.
Sometimes, the task of making the risk-utility balancing judgment can be passed along to the attending physician or even to the patient. First, the manufacturer provides full disclosure and warnings to the physician, who makes the initial decision whether to use a device. The physician can pass these disclosures on to the patient and get an informed consent or patient release. Recalling Abiomed's experience, however, even a patient's release may not absolve a manufacturer of responsibility. These difficult and often-complex decision points obviously carry a substantial risk of later legal challenge.
Where to Look for the Safer Alternative
Internal Files. A safer alternative to a design can come from a manufacturer's own internal files. For example, a company's complaint files might contain user complaints that relate to safety. These files might also include suggestions from engineers for a feasible and economical, safer design that the company rejected. Such evidence could prove damaging in a product-
liability lawsuit. It would show that there was a safer alternative that the manufacturer knew of but rejected, thus providing the substance of the plaintiff's complaint. It is important to remember that in a lawsuit each side can require the other to produce documents for examination, including computer hard drives. Therefore, the internal e-mails and memoranda (including even some deleted materials) exchanged by design engineers during the sensitive development phase of a medical instrument can be retrieved from computer hard drives and used as evidence in the lawsuit.
A Competitor's Product. In some cases, a competitive product is available that offers a safer alternative. In one case, the court ruled in favor of the injured plaintiff because the defendant's “product's use provided no benefit beyond those available with the safer, proven alternative...the ECTRA System was unreasonably dangerous and of little added utility compared to available alternatives—in short, defectively designed.”5
In another case, however, the plaintiff was unable to establish that a safer alternative to the defendant's pacemaker atrial lead existed, and the plaintiff lost:
[P]laintiffs provide no evidence that there is a safer, alternative lead design that could have been used.... They merely state than an alternative lead was available...but, identifying an alternative design is not enough to suggest that the alternative is safer.... Plaintiffs must show that the passive lead is safer, which they cannot do since the unrebutted evidence indicates that it is less preferable than an active fixation lead.6
O'Reilly notes, “The legal issue of comparative safety of designs necessitates a sound basis for comparison. What is the safety of our competitor's design? How safe are designs by other vendors of this commodity?”2
Industry Publications. Publications are another source of identifying a safer alternative, even one that may not yet be in actual use. O'Reilly points out, “A product using the reasonable alternative design need not be on the market currently....Choices of design made by competitors in industry will no longer be a horizon for the prudent designer, where safety is concerned.... Products liability trends favor claimants who offer the safer ‘reasonable alternative design,' whether or not such a design is accessible to consumers today.”2
Defenses That Don't Work
FDA Approval. In some cases, federal law can override state product-liability law. The principle is called preemption. Some federal laws in this area provide explicitly—in the wording of the federal statute itself—that FDA decisions will preempt or override conflicting or supplementary state law requirements. But even in the absence of explicit preemption, courts are also free to infer preemption from a statute, i.e., to find implicit preemption. Until late 2002, FDA's position was consistently against implicit preemption. If the statutes' words don't provide for preemption, then, with few exceptions, state tort laws could come into play in medical device product-liability cases.
More recently, however, FDA and the Bush administration moved toward favoring implicit preemption, as illustrated by FDA's amicus brief in a case before the U.S. Third Circuit.7 The basic ruling on preemption is the U.S. Supreme Court's 1996 Lohr decision.9 That decision was split so evenly that the several justices' opinions created uncertainty as to the true holding of the case. The split seen among cases in the federal circuit courts reflects this uncertainty. Some courts have found in favor of federal preemption where defective design is claimed against a device that has gone through FDA's PMA process; others allow state product-liability law to operate. This split on the preemption issue signals that the Supreme Court may well revisit this issue in the future and refine the standards for federal preemption.
O'Reilly concluded, “Federal standards compliance is not enough, as the Third Restatement and the majority of courts have agreed.” Regulatory “compliance...does not immunize the tort defendant from civil liability.”2 FDA's PMA process is aimed at determining that a device is reasonably safe and effective. In certain cases, FDA will comment upon, strongly suggest, or even require labeling modifications; however, the agency does not typically identify specific alterations to design or labeling that would or would not be permitted.
Two competing devices may both be reasonably safe and effective and thus meet FDA standards. But if one is a safer alternative, the other may well be in trouble in the courtroom (except when a court finds federal preemption and disregards state law). The selection and choice of features related to safety are typically not set forth in the FDA approval letter, but rather are left to each manufacturer. And, although there are design standards for certain types of products, neither the Medical Device Act nor the PMA process prescribes design specifications. Consider the observations of a federal district judge in a 2001 case. Focusing on the point of the safer-alternative standard, he says, “FDA review does not appear to entail consideration of alternative designs that might make the device safer.”10
The two authors of the Restatement of the Law of Products Liability also point out that FDA approval is not a defense. They note that some states' tort-reform statutes expressly provide that if a product complies with governmental regulation, the product is presumed to be nondefective. This means that the injured plaintiff, to make a case, must provide enough evidence of defective design to overcome this presumption.11 In those states, this reform statute would control. But in the absence of such a state statute, the restatement adopts a less-decisive role for compliance with governmental regulation. The authors put forth what they view to be the more-traditional common-law rule:
The traditional common law rule is that compliance with a statute or regulation is evidence that a trier of fact may consider in deciding whether a product is defective, but compliance with a statute or regulation is not binding. The Products Restatement adopts the traditional view and rejects the position that compliance with a statute or regulation creates a formal presumption of non-defectiveness. Furthermore, the Products Restatement takes the position that a product that is in violation of a governmental standard is defective per se and that there exists no “justifiable excuse” defense for violating a governmental safety standard.12
This is not mere academic theorizing. The Massachusetts Supreme Judicial Court made this same point in a 1985 decision.13 So where does this leave the device manufacturer? It depends. FDA approval may provide a manufacturer with some protection as to some devices and only in some jurisdictions. And where (i.e., in which jurisdiction) a lawsuit will be is unclear. Reliance on FDA approval thus remains an uncertain defense.
The State-of-the-Art Defense. The threshold quest is for definition: what is meant by state-of-the-art? This question is explored by legal scholars Boyd and Ingberman.14 They describe at least two possible, but conflicting, definitions of state-of-the-art, opting for the one which “equates state-of-the-art with more exceptional safety: being at the forefront of technical advancement or capability.” They agree with the Iowa Supreme Court that a “distinction exists between custom and state-of-the-art; custom refers to what was being done in the industry, state-of-the-art refers to what feasibly could have been done.”15 They conclude (citing cases) that the more “commonly applied alternative definition of state-of-the-art holds the defendant to a more stringent test than conformance with industry custom.” These conclusions come awfully close to the safer alternative standard.
In The Politics of the Products Liability Restatement, the chief authors conclude that even if no other manufacturer had adopted the safer design, the less-safe but more popular design would still be considered defective: The fact that “everybody's doing it” is no defense for defective designs that cause harm.12
The conclusion for today's medical device manufacturer? You would do well not to rely merely on what others in the industry are doing. This has become the weakest of all views of what a state-of-the-art defense means. Rather, in this context, the safer alternative means an alternative that is effective, feasible, and within the reasonable capability of industry to deliver, given the current level of technical advancement or capability. Indeed, O'Reilly suggests that manufacturers' legal counsel educate its designers about “the demise of industry custom as a defense to liability” and suggests “explaining the reasonable alternative design issues.”12
Liability Insurance Is Not Always the Answer. Manufacturers rely on product-liability insurance to pay legal expenses and damage awards if a claim leads to a jury verdict against the company. However, having liability insurance doesn't mean manufacturers can neglect legal risks. Excess claims mean higher premiums, and eventually the insurer may refuse to renew products altogether. It is critical to take action to prevent such claims and to take early steps to successfully defend the company in court.16
Using Numbers to Identify the Safer Alternative
A Concept from Pharmaceuticals. Applying product-liability rules to the design process generically is not simple. Each device presents its own special challenges to the design process. It is interesting to look at the pharmaceutical industry's concept of dosage levels and apply it to medical device manufacturers. This illustration oversimplifies a complex and nuanced problem; however, the focus here is on those devices that emit a measurable magnitude (dose) of a force or energy to achieve a therapeutic result.
Certain pharmaceuticals are considered poisons, yet in small or minute quantities, they are therapeutically useful.17 Similarly, some medical devices (e.g., x-ray and MRI equipment) emit radiation, but above certain dosage levels (or intensity), this energy becomes potentially harmful. Assuming that medical or engineering professionals could identify the lowest dosage level at which radiation produced the desired therapeutic effect, it would appear that such level would then, in a court of law, be considered the safer alternative. And if the defendant manufacturer chose a higher dosage and the patient suffered injury, then the existence of this other, lower effective dosage could result in the manufacturer losing its case in court.
Since dosage levels are also established with reference to the particular patient's age, condition, weight, etc., any generic dosage set by the manufacturer is only a starting point for the prescribing clinician to determine what is proper for a particular patient. It is this starting point that serves as a simplistic example of seeking the target safest alternative.
Dosages: Medical Device Examples. Phototherapy is the use of light to treat a medical condition or seasonal affective disorder. Ultraviolet light therapy improves eczema symptoms in some people, yet excessive sun exposure from naturally occurring ultraviolet rays can damage skin with sunburn, making the eczema patient's condition worse and, after prolonged exposure in some cases, can cause skin cancer.18
Electroconvulsive therapy has been used for treating schizophrenia.19 But when used at a dosage that is too aggressive, patients suffer undesirable symptoms, including incontinence, profound disorientation, and pronounced memory loss and, in some cases, death.
A Dosage Design Issue: The Portable Defibrillator. Defibrillators use a pulse of electrical energy to restore the heartbeat of a person suffering from cardiac arrest. Portable defibrillators are becoming more common in public places, including on airplanes and in homes of high-risk patients. In many cases, the lowest dosage that provides the desired therapeutic effect is, in the context of a product-liability lawsuit, the safer alternative.
This conclusion appears to be applicable to the portable defibrillator industry because of the way defibrillator manufacturers have aligned and differentiated themselves. Complexities such as a particular patient's resistance to a particular electric current level, repetitive defibrillation shocks, and other factors are part of the design. As the science in this dynamic field continues to develop, these considerations may well come into play in the courtroom when a patient, suffering from side effects that could have been avoided, claims that there was a safer alternative to the defendant's defibrillation device.
Some manufacturers continue to sell the older, so-called monophasic, high-energy systems. Others have shifted to newer biphasic, low-energy systems. The joules of energy produced by the monophasic system are higher than the number produced by the biphasic system. Is one of these the safer alternative under product-liability law? And should device designers factor the answer into their drawing-board decisions?
From a litigator's point of view, professional literature provides evidence as well as an array of potential expert witnesses to testify in a product-liability lawsuit as to which device is the safer alternative. In the case of defibrillators, for example, medical literature seems to indicate that the higher-energy (monophasic) defibrillations are riskier than the newer, biphasic alternative. Monophasic defibrillations, it is said, have been “shown to result in more postshock cardiac dysfunction...a higher incidence of myocardial depression and bradyarrhythias.” By contrast, the biphasic technology showed results “possibly indicating less cardiac injury.” The report continues, stating that “the cardiac dysfunction that follows such a series of higher-energy shocks may diminish the long-term survival prospects of the typical cardiac arrest victim.” And here is another comparison between less and more: “Biphasic truncated pulses have been shown to limit mechanical dysfunction after shock compared with monophasic pulses. Biphasic waveforms may help heal the cell membrane after shock.”20
A study in 2001 reported in Chest concludes: “Lower-energy biphasic waveform shocks were as effective as conventional higher-energy monophasic waveform shocks for restoration of spontaneous circulation after 10 minutes of untreated VF.21 Significantly better postresuscitation myocardial function was observed after biphasic waveform defibrillation.”
Other clinicians have confirmed these observations. For example, “much lower energies of biphasic waveforms are as effective and less damaging than conventional higher-energy monophasic waveforms for defibrillation, restoration of spontaneous circulation, and post-CPR survival.” Lowering defibrillation is as effective as high-energy, “but yields significantly better postresuscitation myocardial function.22
This analysis may be simplistic. It omits technical details and makes the assumption that the lower-energy biphasic system is adequate to produce the desired therapeutic effect on the patient. However, it serves to illustrate a suitable approach for medical device designers. If design engineers were to consult with product-liability lawyers, based on the cited authorities, they should conclude that biphasic is the safer alternative. And under current tort-law standards, a plaintiff resuscitated but injured by the older, monophasic technology, could point to this literature and statistical data to prove to a jury a defective-design case of product liability against the manufacturer of the older monophasic technology. A plaintiff could point to the newer biphasic, lower-energy defibrillator as a safer alternative. And it may well be that even within the newer biphasic waveforms, less is more. When therapeutic effect is equal, low-energy biphasic waveforms appear to provide a safer alternative than a higher-energy biphasic waveform.
A Safety-Design Issue: The Sleep Apnea Machine. Sleep apnea is a potentially life-threatening condition in which regular breathing stops hundreds of times each night. One treatment uses a medical device to push air through a mask worn during sleep. This device, run by an electric-powered compressor motor, is designed to maintain continuous positive airway pressure (CPAP).
What happens if there is a power outage and the patient suffering from this potentially life-threatening condition is left to breathe on his or her own? Cursory research indicates that of the different CPAP systems available, one system provides for a shutdown. The system includes audible-visual alarms (presumably to wake the patient) and an optional battery backup (presumably to continue the system's operation without interruption). This system is, in my view, the safer alternative. A patient who is injured or dies due to a power outage and equipment shutdown from one of the other manufacturers' machines could develop a prima facie case of product liability against the manufacturer and a medical malpractice case against the clinician who prescribed the machine that did not have the alarm or the backup battery.
Issues of Cost. When life-and-death issues are at stake, the law may have little or no tolerance for price-based design decisions, especially if a safer alternative is available at little cost difference. Such cost-benefit analysis would be weighed by a judge and jury in determining whether, under all the circumstances, it would have been reasonable for the manufacturer to have designed its device with a safety mechanism. They would also determine whether the cost to the manufacturer made it unreasonable, and thus the decision to provide for a power-outage contingency was left to the patient or physician.
Device designers and engineers should be aware of the safer-alternative legal standard, because this is the direction that both the product-liability law and design-defect cases are taking. During the design process and certainly before going into production, management should determine whether a safer alternative is available that could be presented in the courtroom. Some specific suggestions include the following:
• Design engineers should monitor research and developments in their own companies and in their industry through literature, conferences, and so on.
• Design engineers must also be aware of the competition. Is a competitor producing a safer alternative? Or does any competing device have a feature that makes it safer?
• It is essential to know what a manufacturer's own files contain about the company's design decisions.
• Management and legal counsel should educate engineers and designers about the discovery process in litigation. Designers should understand, when writing their memos and e-mails, that they may be called upon to produce these documents and to explain them in court. Manufacturers must remain cognizant of the risks of what is said (or not said) in communications and that those communications can (and in some cases must, under law) be retained in a design history file and produced in court. Being prepared reduces the risk of having an old memo hurt a manufacturer's case in a court.
• Things that go wrong with the most sophisticated and complex cutting-edge equipment are often not the elements that make them so advanced and complicated. Rather, it is often the simple mechanical elements that fail.
• Finally, although legal input is surely not useful in all medical device design decisions, engineers should be free to consult a product-liability specialist when making design decisions. The vast majority of product-liability lawyers are litigators. They sue medical device companies, or they defend them in court. Manufacturers should find lawyers who focus on prevention—avoiding defective designs and keeping them from going into production. And remember, in some cases, a product-liability claim can arise to the level of an existential risk. Some claims can threaten the very existence of the manufacturer.
The author thanks his colleague, Kenneth Ross of Minneapolis, for reviewing a draft of this article and providing his suggestions.
The author also thanks Professor James O'Reilly, author of Product Warnings, Defects, and Hazards, for his review of this article.
This article is part of a monograph available on-line from the author at [email protected].
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2. James T O'Reilly, “Dialogue with the Designers: Comparative Influences on Product Design Norms Imposed by Regulators and by the Third Restatement of Products Liability,” Northern Kentucky Law Review 26, no. 3 (1999).
3. George W Conk, “Is There a Design Defect in The Restatement (Third) of Torts, Products Liability?” Yale Law Journal 109, no. 3 (2000): 1087, 1101.
4. The Restatement of the Law, Torts (Third), Products Liability, (Philadelphia: American Law Institute, 1998).
5. Violette v. Smith & Nephew Dyonics Inc., 62 F.3d 8, 13 (1st Cir. 1995).
6. Webster v. Pacesetter Inc., 259 F.Supp 2d 27, 33 (DCt. DC 2003).
8. Horn v. Thoratec Corp. No.02-4597 (3rd Cir.7/20/2004).
9. Medtronic v. Lohr, 518 U.S.470 (1996).
10. Webster v. Pacesetter Inc., 171 F.Supp 2d 1, at 10 (D.D.C. 2001), citing Goodlin v. Medtronic Inc., 167 F3d 1367, at 1369-70 (11th Cir. 1999).
11. Kan. Stat. Anno., Section 60-3304(a).
12. James A Henderson Jr. and Aaron D Twerski, “The Politics of the Products Liability Restatement,” (Symposium on the American Law Institute: Process, Partisanship, and the Restatement of Law) Hofstra Law Review 26 (1998): 667–695.
13. MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 139-140, cert. denied, 474 U.S. 920 (1985).
14. James Boyd and Daniel E. Ingberman, “Should ‘State of the Art' Safety Be a Defense Against Liability?” Resources for the Future, Discussion Paper 96-01, 1995.
15. Chown v. USM Corp., 297 NW2d 218 (Iowa 1980).
16. Kevin Quinley, “Insurance Is Not a Substitute for Good Risk Management,” Devices & Diagnostics Letter, December 8, 2003.
17. EJ Calabrese and LA Baldwin, “Toxicology Rethinks Its Centra
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