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
Thursday, November 20, 2014
On Wednesday, the Pennsylvania Supreme Court, 4-2, decided to continue using the Restatement (Second) of Torts for products liability cases. Some highlights:
Having considered the common law of Pennsylvania, the provenance of the strict product liability cause of action, the interests and the policy which the strict liability cause of action vindicates, and alternative standards of proof utilized in sister jurisdictions, we conclude that a plaintiff pursuing a cause upon a theory of strict liability in tort must prove that the product is in a “defective condition.” The plaintiff may prove defective condition by showing either that (1) the danger is unknowable and unacceptable to the average or ordinary consumer, or that (2) a reasonable person would conclude that the probability and seriousness of harm caused by the product outweigh the burden or costs of taking precautions. The burden of production and persuasion is by a preponderance of the evidence.
Whether a product is in a defective condition is a question of fact ordinarily submitted for determination to the finder of fact; the question is removed from the jury’s consideration only where it is clear that reasonable minds could not differ on the issue. Thus, the trial court is relegated to its traditional role of determining issues of law, e.g., on dispositive motions, and articulating the law for the jury, premised upon the governing legal theory, the facts adduced at trial and relevant advocacy by the parties.
To the extent relevant here, we decline to adopt the Restatement (Third) of Torts: Products Liability §§ 1 et seq.,albeit appreciation of certain principles contained in that Restatement has certainly informed our consideration of the proper approach to strict liability in Pennsylvania in the post-Azzarello paradigm.
Majority Opinion (Castille): Download DC-_604793-v1-Pa__Supreme_Court_Tincher_majority_opinion
Concurring and Dissenting Opinion (Saylor): Download DC-_604794-v1-Pa__Supreme_Court_concurring_and_dissenting_opinion_pdf
Updated: Law 360: Pa. Tort Revamp Gets High Marks From Both Sides
Liberty Blog: Tort law remains a mess in Pennsylvania
Monday, November 3, 2014
In May v. Air & Liquid Systems Corp., the Court of Special Appeals of Maryland reaffirmed the rule that there is no duty to warn of asbestos-containing replacement parts that defendants did not manufacture or place in the stream of commerce.
JDSupra has coverage here.
Monday, October 6, 2014
The Connecticut Supreme Court has clarified procedural requirements for the malfunction doctrine in products cases. If the plaintiff only pleads specific defects in a product, the malfunction doctrine can't be used as an alternative way to defeat a motion for summary judgment because there was no notice to the defendants and the court. The decision is White v. Mazda Motor of America, Inc., 2014 WL 4548058 (Conn. 2014).
Tuesday, September 30, 2014
In Pennsylvania, a federal split is resolved: manufacturing defect and implied warranty claims are not viable against pharmaceutical and medical device companies. It was already clear that design and warning defect claims were not viable. Thus, under current Pennsylvania law, negligence is the only cause of action plaintiffs have against pharmaceutical and medical device companies. The Legal Intelligencer has the story.
Thursday, September 11, 2014
The first of about 6,000 Pinnacle metal hip poisoning trials is underway, and plaintiff's lawyer Mark Lanier is producing e-mail evidence designed to show Johnson & Johnson knew of the concern as early as 2001. Plaintiff claims that the Pinnacle hip's design is flawed: the metal-on-metal version of the artificial hip produces debris in the body that can cause metal poisoning. Johnson & Johnson reached a $2.5B settlement last year on another line of its artificial hips known as ASRs. Bloomberg has the story (via Conk/Torts Today).
Tuesday, August 26, 2014
The Alabama Supreme Court recently denied rehearing in Weeks v. Wyeth, letting stand a 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. The rationale appears to be the FDA's requirements that the name-brand manufacturer provide the material for the drug label contents. Generic manufacturers are not allowed to alter those contents. Two views of the case, one from Richard Garrett of the Alabama Policy Institute, and the other from Lew Garrison, who represented the plaintiff.
Thursday, July 17, 2014
In Bostic v. Georgia Pacific Corp., the Texas Supreme Court rejected the "any exposure" or "some exposure" theory of causation, and held that a "substantial factor test" applies to causation in asbestos cases.
Debra J. LaFetra at Pacific Legal Foundation has a full write up of the decision.
Monday, July 14, 2014
James Rustad, son of TortsProf Mike Rustad, is a singer/songwriter who focuses on social commentary. Given his father's interest in torts, it's no surprise that some of his songs have a torts theme. Take a listen to his "The Great Inevitably Exploding Ford Pinto." James has his own YouTube channel here.
Wednesday, June 11, 2014
Victims of a Saturn Ion crash in 2004 are suing GM to reopen a case over the death of one person and serious injuries of another. GM settled the case for $75,000 and argued the driver was 100% to blame. Now lawyers argue the case should be reopened in light of the recall of defective switches in many of GM's cars, including the Ion. The Chicago Tribune has the story.
Tuesday, March 25, 2014
Aaron Twerski (Brooklyn) & James Henderson (Cornell) have posted to SSRN Fixing Failure to Warn. The abstract provides:
Failure to warn remains a doctrine in distress. More than two decades ago, the authors published an article identifying a number of problems with failure-to-warn doctrine in products liability law. In essence, the article criticizes the law traditionally governing products warnings for being little more than an “empty shell,” allowing claims that need only be asserted rhetorically to reach the jury. Afterwards the authors served as Reporters for the Restatement, Third, of Torts: Products Liability, helping to write black-letter rules covering product warnings and a number of other subjects. Working on the Restatement project involved coming to terms with the similarities and differences between defective design and failure to warn. One important difference relates to what a plaintiff must prove to establish a product defect. Regarding design-based liability, American courts generally require plaintiffs to prove that a specifically-identified reasonable alternative design (RAD) was available at the time of commercial distribution of the product. Regarding alleged failures to warn, many courts impose no similar burdens on the plaintiff. In those jurisdictions, the plaintiff need only assert in conclusory fashion that the defendant’s warnings of nonobvious product-related risks were inadequate, without specifying exactly what warning the defendant should have given or proving that a different warning would have done any good. The authors conclude that the same rigor necessary for a plaintiff to make out a prima facie design defect case should be required for alleged failures to warn. Plaintiffs asserting warning claims should be required to specify, by suggesting a reasonable alternative warning (RAW), exactly how the defendant should have effectively communicated product-related risks and to prove how the RAW would have prevented or reduced the plaintiff’s harm. From a broader perspective, too much has been made of the differences between design and warning and not enough has been made of their similarities. This essay aims to set things right.
Wednesday, February 26, 2014
James Henderson (Cornell) & Aaron Twerski (Brooklyn) have posted to SSRN Optional Safety Devices: Delegating Product Design Responsibility to the Market. The abstract provides:
Early in the development of a robust system of products liability law, American courts delegated most of the responsibility for assuring the safety of product designs to the market. Except for designs that failed to perform their intended functions and thus should be said to be dangerously self-defeating, most courts rejected claims that products were legally defective because they could have been designed more safely. As long as the relevant risks were obvious or product sellers supplied adequate warnings of hidden risks, product purchasers, not courts, determined how much design safety was appropriate. And then came the products liability revolution. Spurred by the adoption of strict liability under § 402A of the Restatement (Second) of Torts, courts began in the 1970s to question, and then to reject, the idea that adequately-informed consumers always make sensible decisions regarding product design safety. Thus arrived a new era in American products liability in which courts began independently to review the reasonableness of manufacturers’ product design choices, thereby second-guessing decisions reached in the market. In fairly short order courts abolished the patent danger rule and opened their doors to a broad range of fault-based design defect claims.
Perhaps the most significant exception to the general pattern of courts overriding markets by engaging in broad product design review — a controversial subject upon which this essay focuses — concerns optional safety devices with respect to which purchasers, not courts, often make controlling decisions. The issue of when courts should delegate responsibility for product design safety is complex. What has been lacking to date is a structured approach to this issue. This essay, for the first time, pulls together the various strands of rationale offered by the courts into a coherent approach, concluding with a proposed Restatement section with comments. Work remains to be done in applying the suggested approach to future cases. The authors believe that this essay provides an important starting point for further development.
Monday, February 3, 2014
Monday, January 27, 2014
On January 21, 2014, the Pennsylvania Sureme Court finally* decided Lance v. Wyeth. The court held that drug manufacturers could be liable for negligent design of an FDA approved drug. I believe this is the first jurisdiction to accept this theory. Drug & Device Blog has a thorough analysis of the opinion.
*finally because the case was argued in 2011 and has been pending before the state supreme court for nearly three years.
Friday, November 8, 2013
Nora Freeman Engstrom (Stanford) has posted to SSRN 3-D Printing and Products Liability: Identifying the Obstacles. The abstract provides:
Though just in its infancy, 3-D printing seems poised to transform the goods we buy, the products we use, and the world we inhabit. A question frequently raised about 3-D printing, though, is how product liability law will apply to 3-D-printed goods. Tackling that important and timely question, this Essay applies contemporary product liability law to defective products from home 3-D printers. The analysis reveals that if home 3-D printing really does take off, PL litigation as we know it may well, in large measure, dry up. And if it doesn’t, the technology threatens to unsettle the theoretical justification for product liability law’s development.