Wednesday, May 22, 2019
Yesterday, in Merck Sharpe & Dohme v. Albrecht, the Court held that judges, not juries, should decide whether FDA actions preempt state tort suit alleging failure to warn. The opinion explained that Wyeth v. Levine's "clear evidence" standard contemplates an irreconcilable conflict between federal and state law, rather than a heightened standard of evidentiary proof:
This point of procedural clarity has enormous strategic value for products-liability defendants because it confirms that courts may conclusively rule on the pre-emption defense as early as a pre-answer motion, though the factual complexity of FDA communications likely will push the issue in many drug-pre-emption cases to summary judgment.
Elizabeth McCuskey at SCOTUSblog has details.
Wednesday, May 8, 2019
Mary Davis has posted to SSRN Time For a Fresh Look at Strict Liability for Pharmaceuticals. The abstract provides:
Over the ensuing 50 years from the promulgation of § 402A, products liability in general has seen a retrenchment from strict liability. The Restatement (Third) of Torts: Products Liability openly adopted negligence principles for design and warning claims, and created an entirely new provision to protect pharmaceutical manufacturers even more robust than 402A's comment k. Regarding pharmaceutical liability, the trend away from any liability at all has been remarkable. In the face of this legal history, and in spite of it, this Article proposes taking a fresh look at strict liability for pharmaceutical injuries. What has changed since the adoption of the Products Liability Restatement, which endorsed a virtual immunity from liability for pharmaceuticals? Such a suggestion is likely to be met with cries of “absolute liability” and concern for a chilling effect on innovation for much needed therapeutic treatments. There are three primary reasons this Article proposes a reassessment for strict tort liability in this context. First, the expansive federal preemption doctrine that the United States Supreme Court has fashioned in the last decade defeats almost all state tort liability for pharmaceuticals, particularly for generic pharmaceuticals which comprise over 85 percent of the prescriptions in this country. Second, both the pre-marketing approval process and the post-marketing risk assessment regulatory structures fundamentally cannot adequately identify, communicate, and reduce adverse drug events and, consequently, those events are increasing and likely to continue to do so. Third, the structure of pharmaceutical marketing, increasingly unregulated, has influenced prescribing practices in ways that compound the likelihood and severity of adverse drug events.
These trends in pharmaceutical marketing practices, coupled with the systemic limitations on information-gathering and response in the regulatory system, has created a demand for pharmaceuticals that increases the likelihood of adverse drug events with no meaningful mechanism to identify and reduce the risks presented. While the legal landscape has become barren to the use of tort liability to compensate for the inevitable risk of adverse drug effects, the medical care landscape has become more fertile for those side effects to occur. The convergence of these trends supports a reevaluation of the use of strict, non-fault liability on producers of pharmaceuticals for the harms their products cause.
Tuesday, April 16, 2019
Heidi Li Feldman has posted to SSRN Why the Latest Ruling in the Sandy Hook Shooting Litigation Matters. The abstract provides:
On March 19, 2019 the Connecticut Supreme Court officially released its opinion in Soto v. Bushmaster Firearms International, LLC. Because the decision greenlights civil discovery and trial for the Sandy Hook plaintiffs seeking compensation from the maker, distributor, and retailer of the gun used by the shooter, the ruling received much attention in the popular press. It is, however, very easy to get the wrong impression about the significance of the Connecticut Supreme Court’s decision and the avenues it creates for both the plaintiffs and the defendants in the litigation. The decision is both more and less significant than it seems at first glance. It opens a serious pathway to liability under the PLCAA and creates a strategic dilemma for the defendant as to whether to appeal or go to trial. Yet the PLCAA remains a bar to most types of civil action to which other product makers and sellers are subject. In the absence of comprehensive congressional regulation, it will remain difficult to require or motivate gun makers to enhance the safety of firearms design and distribution.
Monday, April 15, 2019
Last week, all models of Fisher-Price's Rock 'N Roll Play Sleepers (approximately 5 million units) were recalled. Since the product debuted in 2009, it is reported that over 30 infants have died using the product. Days before the recall, the American Academy of Pediatrics urged it upon the CPSC and Fisher-Price. WaPo has the story.
Monday, March 25, 2019
Last week the Fourth Circuit heard arguments in an appeal to answer the following question: Is Amazon responsible when a third-party seller's product malfunctions and burns down a buyer's home? Buyer purchased a headlamp from a third-party seller through Amazon. The headlamp, delivered by Amazon, malfunctioned and burned the buyer's house to the ground. The buyer's homeowner's insurer paid the buyer over $300,000 in damages. Insurer then sued Amazon in negligence, breach of warranty, and strict liability to recoup the money.
A Maryland district judge dismissed the claim on the ground that Amazon was not the seller of the headlamp; the court also held Amazon was insulated by the Communications Decency Act, which protects providers from liability for content created by third-parties. The insurer argued that Maryland state law, including its Uniform Commercial Code, defines seller as “a person who sells or contracts to sell goods,” which should include Amazon considering its platform was used in the transaction and the product was warehoused at an Amazon facility. Amazon's attorney claimed that every court that had ruled on this issue sided with Amazon. There is no timetable for a ruling on the case. Courthouse News Service has the story.
Thursday, March 14, 2019
Marijuana laws are undergoing a rapid transformation. Although still criminal at the federal level, 33 states and D.C. have authorized medical marijuana and 10 states and D.C. have authorized it for recreational use. The business incentives are certainly there. Expected revenue from marijuana businesses in 2019 is projected at $13.7B, and will grow to $22.1B in 2022. One problem involves insurance. Commercial general liability, property liability, and products liability policies often provide only $1M per occurrence and $2M in the aggregate. According to a report released yesterday by A.M. Best, that may be insufficient for marijuana businesses. Moreover, because this is an emerging market, insurers are inclined to stick with the limits. Business Insurance has details.
Monday, February 25, 2019
Frank Vandall has posted to SSRN Tincher Unmasked. The abstract provides:
Over 76 years ago, Justice Traynor of the California Supreme Court called for the adoption of strict liability for products liability cases and for the rejection of negligence in such cases. The Supreme Court of Pennsylvania recently agreed in Tincher v. Omega Flex, Inc. Strict liability leads to corporate liability and this results in increased payments to victims and slightly lower profits. Corporations responded to strict liability with a firm embrace of the negligence cause of action, which puts both parties on an equal footing. This results in corporations winning more cases. The PLAC (an association of corporations that file amici briefs defending corporations) argued for negligence in Tincher.
In this paper I argue in favor of strict liability and support the Pennsylvania Supreme Court’s decision in Tincher.
Thursday, January 24, 2019
In 2016, a 13-year-old and 14-year-old were left with a babysitter and three younger children in Mt. Pleasant, PA. The 14-year-old found a gun and it discharged, killing the 13-year-old. The deceased's parents sued:
The Gustafsons’ lawsuit alleged Springfield Armory and Saloom made and sold a 9mm semiautomatic handgun without warnings and safety features, including one that would prevent a gun from firing when the magazine is removed.
The judge dismissed the case, citing the 2005 Protection of Lawful Commerce in Arms Act. Trib Live has the story.
Tuesday, January 8, 2019
The latest issue of the journal "Pharmaceuticals Policy and Law" is devoted to comparative pharmaceutical products liability. Mike Green and I contributed a descriptive piece on U.S. law, and Marshall Shapo did as well. The lineup:
Pharmaceutical Product Liability Systems: Regulatory Models and Challenges, Miquel Martin Casals & Jose Luis Valverde
Some Comparative Remarks on Pharmaceutical Product Liability, Miquel Martin Casals
Pharmaceutical Product Liability in the United States of America, Christopher J. Robinette & Michael D. Green
Some Aspects of Pharmaceutical Product Liability in the United States of America, Marshall S. Shapo
Pharmaceuticals Products Liability in Japan, Fumihiro Nagano & Antonios Karaiskos
Pharmaceuticals Product Liability in Brazil, Rafael Peteffi da Silva
Pharmaceutical Product Liability in France, Zoe Jacquemin
Product Liability for Medicinal Pharmaceuticals in Germany, Ulrich Magnus
Pharmaceutical Products Liability in the United Kingdom, James Goudkamp
Pharmaceutical Products Liability in Poland, Piotr Machnikowski
Pharmaceutical Product Liability in Spain, Josep Sole Feliu
The Development Risk Defence of the EU Product Liability Directive, Bernhard A. Koch
Wednesday, December 19, 2018
The Supreme Court's preemption cases shield generic pharmaceutical manufacturers from liability. In 2013, the FDA proposed a new federal rule that would have allowed liability against manufacturers of generic drugs. Last week, the FDA withdrew that proposal. The Wall Street Journal has details.
Wednesday, December 12, 2018
In 2011, Pennsylvania replaced joint and several liability with a statute referred to as the "Fair Share Act." The statute provided that if an individual defendant was found less than 60 percent liable in a given case, then dollar-amount damages for said defendant would be set at a level proportional to their percentage of liability in that case. A Court of Common Pleas judge in Philadelphia held that the Fair Share Act did not apply to asbestos, despite the lack of an explicit carve-out, because asbestos exposure is not quantifiable. The Superior Court held this was erroneous and now the case is before the Supreme Court of Pennsylvania. The case is Roverano v. Crane, Inc. The Pennsylvania Record has the story.
Tuesday, December 4, 2018
Last month, the Supreme Court of Indiana held that Indiana's statutory defense of misuse is an absolute bar to recovery and not a mere factor in a comparative fault analysis. In dicta, earlier cases had leaned in the other direction. The court issued a caveat:
This is not to say that any allegation on the part of a seller that a plaintiff misused the product will suffice. The misuse defense is qualified by the plain language in the statute. That is, in order to successfully employ misuse as a defense, the seller must show both that the misuse of the product is: 1) the cause of the harm; and 2) not reasonably expected by the seller. If a plaintiff misuses a product but it is not the cause of the harm and/or the misuse can reasonably be expected by the seller, then the misuse would not serve as a complete defense and comparative fault principles would apply.
The case is Campbell Hausfeld/Scott Fetzer Co. v. Johnson, , 109 N.E.3d 953 (Ind. 2018).
Tuesday, October 23, 2018
From the Boston Globe's "Talking Points" earlier this month:
New Jersey’s Supreme Court has dismissed more than 500 lawsuits against the maker of an acne drug that caused some patients to develop a gastrointestinal disease. The court ruled Wednesday that Hoffmann-LaRoche’s warning labels for its Accutane treatment were adequate. Plaintiffs have contended the warnings should have said Accutane ‘‘causes,’’ rather than ‘‘is associated with,’’ inflammatory bowel disease. A trial court had dismissed the suits in 2015, but an appeals court had reinstated most of them. The Supreme Court also ruled the 532 product-liability claims from patients in multiple states were properly consolidated in New Jersey, where Hoffmann-LaRoche has its principal place of business.
— ASSOCIATED PRESS
Monday, October 1, 2018
Abilify, a drug used to treat schizophrenia and bipolar disorder, is the subject of a mass tort suit claiming it leads to destructive behaviors. The drug was brought into the U.S. market by Otsuka America and Bristol-Myers Squibb in 2002. Prior to any warnings in the U.S., European and Canadian warning labels stated that Abilify could unleash "destructive behaviors." On May 3, 2016, the FDA required an addition to Abilify's labels warning of “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.” Complaints allege failure to warn and failure to adequately test the drug. The Daily Beast has the story.
Tuesday, July 10, 2018
Last March, a tragic fire here in Harrisburg killed two girls (a two-year-old and a ten-year-old). The fire allegedly occurred when a LayZBoard hoverboard overheated while it was charging. The families are now suing the manufacturer and seeking more than $500,000 in damages. A further tragedy occurred as a fireman was responding to the call; he was killed when a driver who was high ran a stop sign. The proximate cause implications are exam-worthy. The Tampa Bay Times has details.
Friday, June 8, 2018
F. Patrick Hubbard & Evan Sobocinski have posted to SSRN Crashworthiness: The Collision of Sellers' Responsibility For Product Safety with Comparative Fault. The abstract provides:
Crashworthiness cases often involve the following issue: Should any wrongdoing by the plaintiff in causing the initial collision reduce or bar the plaintiff’s recovery for defective crashworthiness? Jurisdictions disagree on the answer to this issue. This disagreement results in large part from differing positions on two questions. First, should products liability law use duty rules to impose liability in a way that ensures efficient accident cost reduction or should it seek fairness through relatively unstructured jury allocations of liability based on fault? Second, in addressing the first issue, should for-profit corporations be viewed as: (1) “tools” to achieve human goals like efficient reduction of accident costs or (2) “persons” entitled to fair treatment in the same way as humans.
Relying on an analysis of doctrine, history, and policy, this Article argues (1) that for-profit corporations are tools, not persons with moral rights, and (2) because these corporations are not “moral persons”, the concern for efficient reduction of accident costs by internalizing the cost of injuries from product defects to corporations should prevail over a concern for “fairness” to these corporations in allocating accident costs. Therefore, because reducing manufacturers’ liability for crashworthiness also reduces the efficient internalization to manufacturers of the cost of their failure to provide cost-effective safety, the plaintiff’s role in causing the initial accident should be irrelevant to plaintiff’s claim for defective crashworthiness. This concern for internalization also supports the expansion of plaintiff’s rights in other areas of liability for defective vehicle design.
Tuesday, December 19, 2017
Bruce Feldthusen, Mike Green, John Goldberg & Cathy Sharkey have posted to SSRN Product Liability in North America. The abstract provides:
This book chapter provides an overview of the rules governing liability for product-related injuries in the U.S. and Canada, as well as the context in which those rules operate. Included are discussions of the rationales for, and the development of, the U.S. doctrine of strict products liability, and the application of strict products liability and negligence doctrines to hypothetical cases.
Friday, November 3, 2017
Ellen Wertheimer & Mark Rahdert have posted to SSRN The Force Awakens: Tincher, Section 402A and the Third Restatement in Pennsylvania. The abstract provides:
In Tincher v. Omega Flex (2014), the Pennsylvania Supreme Court reached two important decisions regarding Pennsylvania product liability law. First, it overruled an earlier decision, Azzarello v. Black Brothers, Inc., which had mandated a bifurcated process for assessing product defects that required trial judges first to assess whether a product was potentially unreasonably dangerous before submitting the question of whether it was defective to the jury. Second, it rejected efforts by some Justices, federal courts and the defense bar to have the Court adopt the negligence-oriented principles of the American Law Institute’s Third Restatement of Torts: Product Liability. Instead, the Court reaffirmed Pennsylvania’s commitment to the strict product liability principles set in Restatement (Second) Section 402A. This article assesses the implications of the Tincher decision for the future development of product liability law in Pennsylvania and elsewhere. It explains the foundational principles of strict product liability that the decision affirms, discusses the Court’s establishment of a composite consumer expectation and risk-utility test for determining defects in product design, defends the Court’s commitment to modest and incremental common-law adjudication, and discusses the development of jury charges that are faithful to Tincher’s approach. The article also takes issue with attempts by the product liability defense bar to push post-Tincher adjudication toward a negligence-based framework that is inconsistent with the Court’s reaffirmation in Tincher of a doctrine of strict product liability.
This article will be published in Volume 27 of the Widener Law Journal. It is currently in draft form and should not be quoted without the permission of its authors.
Wednesday, September 6, 2017
David Berke, who appears to be a Yale Law student, has posted to SSRN Products Liability in the Sharing Economy. The abstract provides:
This Note undertakes an in-depth review of an important legal problem that has not yet been addressed—the role of products liability in the sharing economy. To date, two foundational questions have not been posed in the sharing economy literature, much less answered. First, what descriptive role, if any, does products liability have in the sharing economy? Second, what role should products liability have in the sharing economy and its regulation, as a normative matter? In Part I, this Note examines a hypothetical sharing economy products liability claim point-by-point and finds that, descriptively, such a claim is conceivably possible but extremely difficult. In Part II, this Note argues against this current state of the law and advocates a more robust role for products liability in the sharing economy.
Friday, May 19, 2017
The latest edition of Marshall Shapo's products liability treatise is available from Elgar. The blurb provides: