Product Liability Litigation Research Articles

Product Liability Litigation and Innovation: Evidence from Medical Devices

Product Liability Litigation and Innovation: Evidence from Medical Devices

Product Liability Litigation and Innovation: Evidence from Medical Devices

Product Liability Litigation and Innovation: Evidence from Medical Devices

Will Products Liability Litigation Help Protect IoT Users from Cyber-Physical Attacks?

Will Products Liability Litigation Help Protect IoT Users from Cyber-Physical Attacks?

Mental Capacity and Tolling the Statute of Limitations

In In re Mirapex Products Liability Litigation , 912 F.3d 1129 (8th Cir. 2019), Marc Mancini appealed the decision of the District Court for the District of Minnesota that granted summary judgment. The district court found that the facts did not support his claims that the statute of limitations on

Tobacco Litigation, E-Cigarettes, and the Cigarette Endgame

Among his many contributions to the field of public health law, Professor Richard Daynard is perhaps best known for (a) advancing the idea that affirmative litigation, particularly against the tobacco industry, can serve as an effective public health tool, (b) introducing the discussion of an “endgame,” in which the commercial sale of cigarettes—the most deadly form of tobacco use—is phased out. This article unites these two topics and analyzes the potential for affirmative litigation to hasten the end of commercial cigarette sales. In recent years, the major tobacco companies have suggested that they support moving towards a “smoke-free world,” with non-combustible nicotine products such as e-cigarettes gradually replacing more harmful cigarette smoking. Though this rhetoric is deeply cynical—these same companies continue to spend heavily to promote their cigarette brands—it may nonetheless create a window of opportunity for litigants. Past litigation against tobacco companies has foundered on the absence of a “reasonable alternative design” for cigarettes. Today, the tobacco companies’ own statements can be used to show the availability of such alternatives. More importantly, now-public documents from the tobacco industry’s archives help establish the case for treating e-cigarettes as a “reasonable alternative design” for cigarettes. These documents show that the major tobacco companies developed the essential components of e-cigarette technology decades ago, but they chose not to commercialize these products because they feared they would prove to be viable alternatives to cigarettes. This article reviews how the introduction of e-cigarettes may reinvigorate products liability litigation against the manufacturers of conventional cigarettes. Building on the work of Professor Daynard, it also considers how these lawsuits, even if ultimately unsuccessful in court, might nonetheless benefit public health by pressuring the tobacco industry to live up to its public statements and by catalyzing legislative efforts to phase out the sale of cigarettes.

Autonomous Vehicles, Technological Progress, and the Scope Problem in Products Liability

Abstract Autonomous vehicles are widely expected to save tens of thousands of lives each year by making car crashes attributable to human error – currently the overwhelming majority of fatal crashes – a thing of the past. How the legal system should attribute responsibility for the (hopefully few) crashes autonomous vehicles cause is an open and hotly debated question. Most tort scholars approach this question by asking what liability rule is most likely to achieve the desired policy outcome: promoting the adoption of this lifesaving technology without destroying manufacturers’ incentives to optimize it. This approach has led to a wide range of proposals, many of which suggest replacing standard rules of products liability with some new system crafted specifically for autonomous vehicles and creating immunity or absolute liability or something in between. But, I argue, the relative safety of autonomous vehicles should not be relevant in determining whether and in what ways manufacturers are held liable for their crashes. The history of products liability litigation over motor vehicle design shows that the tort system has been hesitant to indulge in such comparisons, as it generally declines both to impose liability on older, more dangerous cars simply because they lack the latest safety features and to grant immunity to newer, safer cars simply because of their superior aggregate performance. These are instances in which products liability law fails to promote efficient outcomes and instead provides redress for those who have been wronged by defective products. Applying these ideas to the four fatalities that have so far been caused by autonomous vehicles suggests that just as conventional vehicles should not be considered defective in relying on a human driver, autonomous vehicles should not be immune when their defects cause injury.

Autonomous Vehicles, Technological Progress, and the Scope Problem in Products Liability

Autonomous vehicles are widely expected to save tens of thousands of lives each year by making car crashes attributable to human error—currently the overwhelming majority of fatal crashes—a thing of the past. How the legal system should attribute responsibility for the (hopefully few) crashes autonomous vehicles cause is an open and hotly debated question. Most tort scholars approach this question by asking what liability rule is most likely to achieve the desired policy outcome: promoting the adoption of this lifesaving technology without destroying manufacturers’ incentives to optimize it. This approach has led to a wide range of proposals, many of which suggest replacing standard rules of products liability with some new system crafted specifically for autonomous vehicles and creating immunity or absolute liability or something in between. But, I argue, the relative safety of autonomous vehicles should not be relevant in determining whether and in what ways manufacturers are held liable for their crashes. The history of products liability litigation over motor vehicle design shows that the tort system has been hesitant to indulge in such comparisons, as it generally declines both to impose liability on older, more dangerous cars simply because they lack the latest safety features and to grant immunity to newer, safer cars simply because of their superior aggregate performance. These are instances in which products liability law fails to promote efficient outcomes and instead provides redress for those who have been wronged by defective products. Applying these ideas to the four fatalities that have so far been caused by autonomous vehicles suggests that just as conventional vehicles should not be considered defective in relying on a human driver, autonomous vehicles should not be immune when their defects cause injury.

Technological Solutions to Human Error and How They Can Kill You: Understanding the Boeing 737-Max Products Liability Litigation

Technology often promises increased safety in the form of reduction of human errors. However, there is a dynamic relationship between technological solutions to risks and human behavior. The attempt to design out a persistent pattern of accidents caused by human error can lead to a new, perhaps unanticipated, and possibly even more dangerous pattern of accidents caused or exacerbated by the technology. For this reason it is essential that products liability law proceed from a systems approach, not considering product design and user error in isolation. This article argues that a systems approach to accidents involving technologically advanced products, taking into account the relationship between product design and foreseeable carelessness by users, is essential to ensuring that the law of products liability does not have a negative impact on the underlying goals of this area of law, including the promotion of increased user safety, innovation in product design, and the affordability of useful products. The article uses, as a case study, two accidents involving the Boeing 737-Max jetliner. The Max design incorporated a design feature intended to prevent accidents caused by a pernicious observed pattern of human error. When it failed to function as intended, the result was disaster. Should the blame for these accidents be placed on the manufacturer, for flaws in the design of what was intended as a safety feature? Or should the flight crews be blamed for failing to handle a foreseeable glitch that they were trained to deal with? Complex systems involving interactions between machines and human operators pose a challenge to the usual approach of torts and products liability law of focusing on ex ante incentive creation because of the dynamic relationship between, on the one hand, features of the product’s design and information provided by the manufacturer that are sensitive to patterns of foreseeable user error, and, on the other hand, user behavior that is shaped by the product’s design and the information provided by the manufacturer. The doctrinal and theoretical analysis developed in the context of the 737-Max accidents will be important in other emerging technology contexts, such as the liability exposure of manufacturers and drivers of semi-autonomous cars.

Let’s Be Reasonable: The Consumer Expectations Test is Simply Not Viable to Determine Design Defect for Complex Autonomous Vehicle Technology

Although highly automated vehicles (“HAVs”) have potential to reduce deaths and injuries from traffic crashes, product liability litigation for design defects in vehicles incorporating autonomous technology is inevitable. During the early stages of implementation, courts and juries will be forced to grapple with the application of traditional product liability principles to a never before experienced category of highly technical products. Recent decisions limiting the use of the consumer expectations test in cases involving complex products prompted the authors to examine more closely the history behind and the future viability of the consumer expectations test in HAV litigation.

Case Protective Order: United States of America, Central District of California

Citation: In re: Toyota Motor Corp. Unintended Acceleration Marketing, Sales Practices and Products Liability Litigation, Case Number: 8:10ML2151 JVS (FMOx) Protective Order: Redacted stipulated protective order governing the exchange and handling of source code and source code related material

The Monsanto Papers: Poisoning the scientific well.

Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company's efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate. A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined. The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called academic website as a front for the defense of Monsanto products. The use of third-party academics in the corporate defense of glyhphosate reveals that this practice extends beyond the corruption of medicine and persists in spite of efforts to enforce transparency in industry manipulation.

Insuring the Product Liability Risks of Cannabis

Legal adult-use marijuana is associated with risks that may cause bodily injury and property damage. Many of these risks have been well documented and widely discussed in the media, including theft, fire, motor vehicle accidents and consumption-related injuries. The potential for an increase in the number and value of cannabis-related product liability claims and lawsuits, however, is of particular concern to the cannabis and insurance industries. The production, distribution and sale of an ingestible product that has psychoactive effects – accompanied by a wide range of anticipated labeling and marketing representations – will certainly result in robust product liability litigation.

Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs

Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs

The Role of Medical Literature, Clinical Trials and Experimental Research in Drug Product-Injury Litigation: A Primer with Two Examples

When any type of product has been ordered to be removed from the marketplace by a governmental regulatory body, that action is a powerful indicator that the product has been determined to be unsafe for further use, thereby branding the product as defective and opening up the possibility of product liability litigation. When the product is a drug or medical device, it is especially serious since the possibility of personal injury (acute and/or chronic) or death may occur. Needless to say, in these situations, product injury litigation will almost surely follow. We review the definition and requisite claims needed to establish drug product liability, and the role that the medical literature, clinical trial data, and even experimental research data can play in product (drug)-injury litigation. We show how each of these resources played a significant role in two well-known cases: Fen-Phen and thimerosal. The ultimate goal of such knowledge is to make better informed decisions about drug safety.

Development in Aviation Product Liability and Its Implication to China

The victims of aviation accidents often bring a case to litigation on the account of product defect under the aviation product liability, other than transportation liability, in order to obtain highamount compensation. Aviation product liability has a strong international character, and a combination of both transportation and product liability. In judicial practice, this kind of liability is related to a lot of confusing complexities: legal relationship, legal subject, the principle of liability, exemption of liability, jurisdiction and applicable law. With the background of China's strategy on large aircrafts and growing consumer protection, China should learn from the mature legislation and judicial practice of European and American aviation product liability. The amendment of Civil Aviation Law, legislation of specialized aviation industrial promotion law and the improvement of aviation product liability system will prevent China becoming the third largest target for aviation product liability litigation after the United States and Europe.

Forensic Evaluation of a Hazardous Household Product

Product liability litigation often follows injury to a person, then retention of human factors experts to evaluate causes of the injury. The nature of the investigation may require additional evaluations by other domain experts. This forensic case involved a man who died after using denatured alcohol as a fuel. Forensic analyses indicated that a flame arrestor, plastic fuel container, and adequate warnings most likely would have prevented this fatal incident. In addition, the analyses showed that the product manufacturer failed to guard consumers from the hazards of using the product and failed to warn consumers of the hazards that accompanied use of denatured alcohol.

Lee v. Smith & Wesson Corp.: A Products Liability Case Study

Expert opinions are a fundamental strategic component in the field of products liability litigation. The success of a party’s claim or defense often depends upon an expert’s testimony at trial, and the “battle of the experts” forces triers of fact to “‘abdicate their fact-finding obligations’ and, instead, simply adopt the opinions of the expert witnesses whose testimony they find persuasive.” The benefits of an expert’s opinion have prompted considerable manipulation in court—in an effort to avail themselves of the highly persuasive nature of a credible expert’s opinion, litigants have attempted to introduce expert testimony bearing only a tenuous connection to the case at hand. In response, the Federal Rules of Evidence and corresponding U.S. Supreme Court (“Supreme Court” or “Court”) precedent have severely curtailed these abusive litigation tactics, instead forcing trial court judges to assess a proffered expert’s opinion for both relevancy and reliability to ensure that the opinion adequately “fits” the facts of the case.This Note critiques the progression of the admissibility of expert testimony codified by Federal Rule of Evidence 702 (“Rule 702”) and subsequently expanded upon by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc. and its progeny. Part I provides a brief history of the admissibility of expert testimony in federal court. Part II addresses a recent decision made by the Sixth Circuit, Lee v. Smith & Wesson Corp., which extended the admissibility under Rule 702 to include an expert’s opinion that directly contradicts the oral testimony of its own witness. Finally, Part III analyzes the 2-1 decision in Smith & Wesson Corp. and argues against the logic of the majority’s opinion, instead favoring the dissent’s interpretation of Daubert, its progeny, and Rule 702.

Conning the IADC Newsletters

International Association of Defense Counsel committee members prepare newsletters each month that contain a wide range of practical and helpful material. This section of the Defense Counsel Journal is dedicated to highlighting interesting topics covered in recent newsletters so that other readers can benefit from committee specific articles. Protecting Manufacturers from Qui Tam Actions Under the False Claims Act By D. Jeffrey Campbell and Frank Fazio, and Steven S. Vahidi IADC member D. Jeffrey Campbell is the Managing Principal at Porzio, Bromberg & Newman, P.C. in Morristown, New Jersey. Frank Fazio is a principal of Porzio, Bromberg & Newman, P.C., where he focuses his practice in the areas of pharmaceutical marketing and sales compliance, pharmaceutical and medical device product liability and toxic tort litigation. Steven S. Vahidi is an associate of Porzio, Bromberg & Newman, P.C., where he concentrates his practice in the areas of pharmaceutical marketing and sales compliance and product liability litigation. Their article, which originally appeared in the November, 2005 Medical Defense Committee newsletter, focuses on provisions in the False Claims Act that encourage whistleblowers to file lawsuits against their employers on behalf of the United States. The federal government is aggressively pursuing criminal and civil claims against pharmaceutical and medical device manufacturers for practices that violate the False Claims Act (FCA).1 The FCA provides that those who knowingly submit false claims to the government for payment are liable for treble damages, plus civil penalties, as well as possible exclusion from Centers for Medicare and Medicaid Services (CMS) programs. Federal prosecutors are taking advantage of a provision in the FCA that encourages whistleblowers to come forward with evidence of wrongdoing and file civil suits against violators of the FCA on behalf of the United States. Lawsuits filed by such whistleblowers are known as qui tam lawsuits. Under the tarn provision, whistleblowers who file an action on behalf of the United States can receive a portion of favorable settlements or judgments.3 Increasingly, pharmaceutical industry insiders are providing the government with evidence of wrongdoing. Much of the evidence involves illegal tactics to increase sales and market share, including off-label promotion and the use of bribes and kickbacks to induce providers to prescribe the company's products. Submitting claims to CMS for reimbursement of the cost of illegally-promoted products is a violation of the FCA. Qui Tam Prosecutions In October 2005, Swiss Drug maker Serono paid $567 million to settle claims under the FCA for improperly promoting, marketing, and selling its drug Serostim. Serostim, a human-growth hormone, is used to treat AIDS Wasting, a potentially fatal condition involving severe weight loss. Serono admitted that it had improperly marketed the human-growth hormone by supplying doctors with diagnosing software that had not been approved by the FDA. Serono also admitted to offering doctors allexpense paid trips to a medical conference in Cannes, France, in return for their writing new Serostim prescriptions. The Serono settlement is the third-largest FCA health fraud settlement in U.S. history and the largest prescription drug settlement to date.5 The investigation was initiated in Connecticut by a former Serono laboratory employee who filed a tarn claim under the FCA. Four other employees filed similar suits in other states. The five whistleblowers will share an award of approximately $51 million.6 Just in the last year, tarn False Claims Act actions against the medical industry have returned approximately $1 billion to government treasuries. The largest recoveries have come from pharmaceutical manufacturers. For instance, in December 2004, Gambro Healthcare agreed to pay $350 million in penalties for violating the FCA by providing kickbacks to physicians who recommended unneeded tests and services. …

Becoming Masters of the Universe: The How To's of Multi-Jurisdictional Product Liability Litigation

IN an increasingly globalized and connected world, purely locally made products are becoming increasingly rare. These days, most products are developed in a synergetic process where component parts are sourced from a variety of countries, and products are assembled or manufactured elsewhere and sold around the world. This presents a web of unique legal, practical and strategic challenges for product liability litigation, as the potential harm caused by a defective product is not quarantined within convenient jurisdictional boundaries. This brings a variety of risks to potential defendants as parties, courts and rules (of law and process) seek to overcome traditional jurisdictional constraints and effectively and fairly manage resulting litigation.In any given matter, the question of how defendants can best address the challenges of multi-jurisdictional product liability proceedings requires a nuanced understanding of the relevant laws in each jurisdiction in play, as well as an appreciation for the ways in which those laws may be implemented (or not) and may complement or clash with one another. This article explores some of these issues, with a focus on practical measures which can be taken to prevent, prepare for and conduct international multi-jurisdictional product liability litigation. These measures provide a framework for minimizing the financial, reputational and other risks facing companies that are exposed to large-scale, international litigation, which can be tailored depending on the various jurisdictions in play at the relevant time.I. Duplicative ProceedingsA. Risks Associated with Duplicative ProceedingsThere is a large scope for duplicity of proceedings in multi-jurisdictional litigation. As US District Court judge David F. Levi, Chair of the Advisory Committee on Civil Rules, recently explained:overlapping and duplicating class actions in federal and state court create serious problems that: (a) threaten the resolution and setdement of such actions on terms that are fair to class members, (b) defeat appropriate judicial supervision, (c) waste judicial resources, (d) lead to forum shopping, (e) burden litigants with the expenses and burdens of multiple litigation of the same issues, and (f) place conscientious counsel at a potential disadvantage.1This problem also exists in Australia and Canada, where different state and federal jurisdictions have their own unique procedural requirements,2 * as well as within Europe.1All this said, the relatively superficial differences that exist within the various courts and frameworks of the United States, Canada or Australia, or within Europe or the E.U. arguably pale in comparison to fundamental divergences between the representative regimes in the United States and, for example, France. While globalization has mitigated distances between states and led to a sharing of legal principles between nations, this trend has not manifested in any sort of harmonized legal procedure. Corporate defendants can be subject to perpetual proceedings being launched around the world in respect of a single product.The Vioxx litigation provides a good clear example of this. Merck Sharpe & Dohme (Merck) was sued throughout the United States and Canada over the antiinflammatory drug Vioxx, and also faced a Federal Court claim in Australia. Because of jurisdictional differences within the United States and Canada, there were 16 class actions filed against Merck in the United States in relation to Vioxx, and separate proceedings brought in the Canadian provincial courts of Ontario and Saskatchewan.4Unsurprisingly, this multiplicity of proceedings led to Merck incurring con1 siderable unnecessary expense, and to add uncertainty, Merck was variously successful and unsuccessful as each piece of litigation played out (in the United States alone, Merck successfully defended 11 of the 16 class actions).This also meant that in the United States alone, Merck was forced to create a $950 million settlement fund in light of the constant stream of litigation and difficulties with predicting not only outcomes, but even interlocutory procedural developments (because of different courts approaching issues differently). …

Study on Aviation Product Liability Litigation：a Perspective of Legislative and Judicial Practice in the United States

Study on Aviation Product Liability Litigation：a Perspective of Legislative and Judicial Practice in the United States