Thursday, April 7, 2016
Jill Lens has posted to SSRN Product Recalls: Why is Tort Law Deferring to Agency Inaction?. The abstract provides:
Tort law currently recognizes liability related to a product recall in only narrow circumstances. Liability is possible if the manufacturer acts unreasonably in an agency-ordered recall or in a voluntary recall, which is likely the result of agency encouragement. What this narrow standard leaves out is possible liability for a manufacturer’s choice to simply not recall. But courts agree that only government agencies are equipped to evaluate the reasonableness of a recall and to determine if one is justified. Thus, if an agency never effects a product recall, tort liability is not possible.
A few commentators have applauded or criticized the narrow standard for liability. But this Article is the first to thoroughly question the standard in light of its real basis—deference to administrative agencies. The Article contrasts this complete deference on recall orders to the very limited deference courts give to agency determinations in traditional defect claims, modern post-sale warning claims, and within decisions to punish the manufacturer by imposing punitive damages. The Article also questions the wisdom of complete deference to an agency’s inaction in not ordering a recall and the legal validity of such deference based on its inconsistency with negligence per se principles. Last, the Article argues that there is nothing special about product recalls deserving of such special deference.
Thursday, January 28, 2016
Anita Bernstein has posted Voluntary Recalls to SSRN. The abstract provides:
The voluntary recall of a defective product, whereby a manufacturer or seller encourages purchasers to return a defective item, looks like a much happier phenomenon than what it fends off: injury for the buyer, liability for the seller, burdens on regulators. Acknowledging these advantages, this Article reviews other aspects of the voluntary-recall fix. First, the term recall has no consistent definition or usage in the United States Code and the Code of Federal Regulations. Second, product recalls are not really voluntary: sellers and buyers alike do not make informed, uncoerced choices to participate in this remedy. The Article concludes with two sets of recommendations to reform the law of product recalls, the first modest and the second ambitious.
Friday, December 11, 2015
Barbara Peters has published The Warnings Compendium (available at Amazon). Topics include:
Designing warnings, deciding when to warn, adequacy, ambiguity, location, conspicuity, attention getting, signal words, color, permanency, cradle-to-grave, audience, intermediaries, complexity, effectiveness, repetition, neurobiology, continuing duty, channels to warn, and legal doctrines affecting warnings.
Friday, November 13, 2015
Last week, I reported that open-heart surgery patients at York Hospital may have been exposed to bacteria that could lead to infections. This week, Penn State Hershey Medical Center announced that its open-heart surgery patients may have also been exposed to bacteria. This appears to be developing into potential products liability cases, perhaps all over the world:
The infections have been linked to heater-cooler devices that are part of the process of controlling patients' body temperature during open heart surgery. A department of health spokeswoman said heater-coolers are used in all open heart surgeries.
Pennlive has the story, including pictures of the device in question.
Tuesday, November 10, 2015
Tuesday, October 20, 2015
Thursday, October 8, 2015
Volvo announced it will accept "full liability" for accidents when one of its self-driving cars is operating in autonomous driving mode. The move would simplify liability issues and perhaps reduce legal barriers to autonomous vehicles. Automobile has the story.
Thanks to Adam Scales for the tip.
Tuesday, September 22, 2015
In Florida last week, a jury hit RJ Reynolds with $14.7M in compensatory damages and $20M in punies for the death of an Air Force sergeant in another of the Engle progeny cases. The jury deliberated only a few hours. ABA Journal has the story.
Monday, August 31, 2015
Twelve U.S. House members are sponsoring the Innocent Sellers Fairness Act (H.R. 1199), designed to remove liability for product injuries from sellers and keep it on manufacturers.
The bill would make it so that no seller of any product would be liable for damages, except in the following cases:
- The seller was the manufacturer of the product;
- The seller participated in the design of the product;
- The seller participated in the installation of the product;
- The seller altered, modified or expressly warranted the product in a manner not authorized by the manufacturer;
- The seller had actual knowledge of the defect in the product as a result of a recall from the manufacturer or governmental entity authorized to make such recall or actual inspection at the time the seller sold the product to the claimant;
- The seller had actual knowledge of the defect in the product at the time the seller supplied the product;
- The seller intentionally altered or modified a product warranty, warning or instruction from the manufacturer in a way not authorized by the manufacturer; and
- The seller knowingly made a false representation about an aspect of the product not authorized by the manufacturer.
A version of the bill has been in the House since 2007, but the number of sponsors has risen recently. U.S.Glass News Network has details.
Monday, August 17, 2015
George Conk has posted one of his older pieces to SSRN: Compared to What? Instructing the Jury on Product Defect Under the Products Liability Act and the Restatement (Third) of Torts: Products Liability. The abstract provides:
Products liability litigation relating to mechanical devices has centered on the concept of design defect, specifically, the unreasonable failure of a manufacturer to take advantage of current design capabilities that would reduce or even eliminate a product's potential dangers. The Restatement (Third) of Torts: Products Liability (Restatement (Third)), promulgated by the American Law Institute in 1997, places the focus of design-defect litigation on proof of the existence of an alternative, safer design for a product, which demonstrates that the product was not designed to be reasonably safe.
The Restatement rejects the long-dominant consumer expectations test of defect and asserts that the risk-utility analysis everywhere relied up must specify that the plaintiff prove as a fact that there was available a safer alternative design which, if omitted, renders the product not reasonably safe.
By concretizing the relevant design-defect considerations, we will be better able both to hold the designer to the ideal of prudence and to avoid the uncritical sympathy for the injured that courts have long seen as a danger of unclear limitations on liability. In case after case, courts uphold verdicts rooted in risk-utility proof and argument - on the balance of costs and benefits of improving the safety of a product's design - without inquiring closely into how to formulate the balance properly. The New Jersey Products Liability Act states that it is a complete defense if: "At the time the product left the control of the manufacturer, there was not a practical and technically feasible alternative design that would have prevented the harm without substantially impairing the reasonably anticipated or intended function of the product."
Tuesday, July 14, 2015
At JD Supra, Chris Jones of Sands Anderson in Virginia discusses some of the considerations, which include the expansion of products liability into automobile accident cases and the potential need for a post-sale duty to warn in jurisdictions that have not adopted it.
Thursday, May 14, 2015
Aaron Twerski & James Henderson have posted to SSRN Drug Design Liability: Farewell to Comment K. The abstract provides:
Half a century ago the reporter for the Second Restatement of Torts, William Prosser, drafted Comment k to § 402A, defining the liability of drug companies for defective prescription products. Prosser’s attempt to shelter drugs from design defect liability has confused courts and commentators alike. Courts at first interpreted Comment k to immunize drug manufactures from design-based liability; more recently, a growing number have begun to interpret the Comment to allow such actions. However, there is wide disagreement regarding the conditions under which courts should permit drug design claims. Courts have articulated no fewer than eight different tests, all relying on Comment k. This article examines the historical origins of Comment k and explains why it has confused so many judges and academics. The authors argue that the tests adopted by courts in reliance on Comment k are seriously flawed. In its stead, the article advocates that a drug manufacturer should held liable for defective drug design only when the drug is not fit for use by any class of patients. All other drug-related claims should be based on findings that the drug either contained a manufacturing defect or was marketed with inadequate warnings.
Monday, May 11, 2015
From Friday's Genie Industries v. Matak:
In this case, the users of an aerial lift supporting a worker 40' in the air attempted to move
the machine. Signs on the machine and instructions in the user manual warned of the obvious danger:
the machine would tip over and the worker would fall to the ground. And that is what happened. So
obvious was the danger that although over 100,000 lifts of the same general model have been sold
all over the world, the jury was provided with evidence of only three similar accidents involving
similar AWP lifts over the past decade—none of which involved the intentional destabilization
of a fully-extended 40' lift. The lift cannot be said in any sense to be unreasonably dangerous.
Deborah LaFetra, of Pacific Legal Foundation, comments here.
Monday, May 4, 2015
Last year, the Alabama Supreme Court let stand its holding that name-brand manufacturers can be liable for misrepresentations or failures to warn in regard to generic drugs they did not manufacture or distribute. (Coverage here) Now the legislature has sent a bill to the governor that would overturn the result. The bill passed the Senate 32-9 and the House 86-14. Legal Newsline has the story.
Tuesday, April 14, 2015
Richard Epstein & Ryan Abbott have posted to SSRN FDA Involvement in Off-Label Use: Debate between Richard Epstein and Ryan Abbott. The abstract provides:
Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug's label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.
Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.
For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company's unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.
As a result of this recent litigation, many have questioned the FDA's current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.
Monday, April 6, 2015
The focus of the trial was a rear-mounted gas tank. The verdict comes nearly two years after Chrysler agreed to a scaled-back recall of some older-model Jeeps with rear-mounted tanks. The New York Times has the story.
Thanks to Susan Raeker-Jordan (Widener) for the tip.
Monday, March 30, 2015
Last week, Florida adopted new model jury instructions for products cases. On design defects, there is a split in Florida circuits between the consumer expectations and risk-utility tests; the instructions do not resolve the split. Newsome Melton's website has more details here.
Tuesday, March 17, 2015
Richard Ausness (Kentucky) has posted to SSRN 'Danger is My Business': The Right to Manufacture Unsafe Products. The abstract provides:
While no one would dispute that safety is a desirable objective, it may not always be an absolute priority. Rather, in some cases, other societal interests such as personal autonomy, consumer choice, product cost, and performance may trump legitimate safety goals. This is reflected in some of the doctrines and defenses that have evolved to protect the producers of unsafe products against tort liability. Some of these doctrines, such as those determining liability for the producers of optional safety equipment, inherently dangerous products, products with obvious hazards, and prescription drugs and medical devices, are part of the law of products liability. Other doctrines, such as the regulatory compliance defense and the contract specification defense, are aspects of the broader law of torts. Finally, a few of these doctrines, such as federal preemption and the government contractor defense, are rooted in principles of federal supremacy.
Wednesday, February 11, 2015
In Watts v. Medicis Pharmaceutical Corp., an intermediate appellate court in Arizona reversed the dismissal of plaintiff's complaint, holding that the Uniform Contribution Among Tortfeasors Act abrogates the learned intermediary doctrine. The opinion is here: Download AMANDA WATTS, an adultindividual, PlaintiffAppellant, v. MEDICIS PHARMACEUTICAL CORPORATION. Thanks to Bob Bohrer (Cal Western) for the tip.
Wednesday, December 31, 2014