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.
Tuesday, October 8, 2013
Dan Monk at WCPO in Cincinnati has a story about Tide Pods. Several companies, most notably Proctor & Gamble (maker of "Tide"), have made a single-load laundry package, designed to enhance the convenience of washing clothes. Many of them are designed with colorful swirls. Unfortunately, children seem to be attracted to the product and put it in their mouths. There have been approximately 13,000 reports of such occurrences documented by poison control centers in the last 2 years. The American Association of Poison Control Centers states there have been over 6,700 such poisoning cases involving children under 5 in the first 8 months of 2013. P&G has been responsive by making the containers opaque and more difficult to open; additionally, they launched a public safety campaign.
A Chicago grandmother, however, argues those precautions do not help prevent many accidents based on the use of this particular product. Because of the product's convenience, many people take the package with them in their laundry baskets, allowing children access. She started a Change.org petition asking P&G to individually wrap Tide Pods and change the warning label about what to do if a child does ingest a Pod. She says she is not interested in suing, but only wants to enhance the safety of the product. If someone were to sue, there is an obvious contributory/comparative negligence issue, and she acknowledges it. She says she used to say it is the care giver's responsibility to keep the product away from children, but she was in the room when her grandson put the Pod in his mouth. She states, "If you blink for a second, the baby can get it in their mouth."
Tuesday, April 9, 2013
Victor Schwartz, Phil Goldberg and Cary Silverman (Shook Hardy & Bacon) recently published Warning: Shifting Liability to Manufacturers of Brand-Name Medicines When the Harm Was Allegedly Caused by Generic Drug Has Severe Side Effects in Fordham Law Review. The abstract provides:
Can a product manufacturer be subject to liability for a competitor’s product? American tort law has always said, “No.” It does not matter if the products are identical. Companies are not to be their competitors’ keepers.
Nevertheless, over the past few years, three courts have overturned this fundamental of tort law, holding that a manufacturer of a brand-name prescription drug can be subject to liability even when a plaintiff alleges that he or she was harmed by a generic drug made by the brand-name manufacturer’s competitor. Most courts, including four federal courts of appeal and dozens of federal district and state trial courts, have rejected this expansion of tort law.
This debate has intensified since 2011, when the Supreme Court of the United States held that all duty to warn claims against manufacturers of generic drugs are preempted by federal drug. The personal injury bar is hoping that courts will give competitor liability theories a new look, particularly when courts find that there is no other path for users of generic drugs to sue.
This Article explains the reasons courts should continue resisting any temptation to change state tort law to allow for competitor liability: (1) it is driven by a search for pockets for paying claims in violation of fundamental tort law principles; (2) the overwhelming majority of courts have continued rejecting competitor liability, even since the Supreme Court ruling; and (3) shifting liability to manufacturers of brand-name drugs could have significant adverse legal and health care consequences.
Monday, April 8, 2013
The National Law Journal reports that consumers have filed economic loss claims against Ford based on the risk of sudden unintended acceleration. The national class action has been filed in federal court in West Virginia. Unsurprisingly, the claims exclude potential personal injury or wrongful death claims. Rather, the claims sound in contract and include Magnuson-Moss, state warranty, consumer protection and unfair trade practices claims. The full article is behind a free registration wall.
I have written about these risk-based claims in Against Liability for Private Risk-Exposure.
Friday, April 5, 2013
Daniel Cummins: "A Maze of Uncertainty: PA Products Liability Law Remains in a Confusing State of Flux"
As of the writing of this article in January of 2013, confusion is reigning in the Commonwealth of Pennsylvania on the uncertain issue of whether the Restatement (Second) of Torts or the different analysis set forth in the Restatement (Third) of Torts should be utilized in Pennsylvania products liability cases. This uncertainty is the result of an ever-growing split of authority not only between the Pennsylvania state and federal courts, but also among, and even within, the different federal district courts across the Commonwealth.
The situation has now spiraled downward to the point that litigants with cases pending in the Pennsylvania federal court system have to research whether the particular federal district court judge presiding over the case has previously issued a decision on the issue in order to determine which Restatement standard will be applied in that case. While one Pennsylvania federal court judge has politely noted that this area of the law in Pennsylvania is in a “state of flux,” See Sikkelee v. Precision Automotive, Inc., 876 F. Supp. 2d 479, 489 (M.D. Pa. 2012 Jones, J.). another has more aptly described Pennsylvania products liability law as being “a maze of uncertainty.” See Samson v. Crown Equipment, 2:10-CV-0958, 2012 WL 3027989 (W.D. Pa. 2012 Hornak, J.).
Which standard is applied could make or break a case. Although the Restatement (Second) favors strict liability concepts over negligence principles in the products liability context, the Restatement (Third) decreases the impact of concepts such as "intended use" and "intended user" and places a greater emphasis on the negligence principle of "reasonable foreseeability." All of these changes in the Restatement (Third) arguably shift the balance in favor of manufacturer defendants in personal injury cases based upon allegations that a defective product was the cause of the injury.
As noted below, under the current status of Pennsylvania products liability law, whether the case will be governed by the Restatement (Second) of Torts or the Restatement (Third) of Torts depends upon whether the case is in state or federal court, and if the case is in federal court, the answer may further depend upon which particular federal district court judge is presiding over the case.
Tuesday, March 26, 2013
Sunday, March 17, 2013
When the Supreme Court hears oral argument in Mutual Pharmaceutical Co. v. Bartlett, it will embark on its third elaboration of “impossibility preemption” in the prescription-drugs context. This line of cases is reshaping preemption doctrine, and it is doing so with little regard for a basic legal idea: the distinction between a property rule and a liability rule.
The question at issue is whether it is “impossible” for prescription drug manufacturers to comply with both Food & Drug Administration requirements and state tort law. State tort liability for design defect or failure-to-warn is predicated on a judgment that a drug or drug label was not designed safely. But manufacturers generally cannot alter drugs or labels without FDA approval. Thus, manufacturers argue, it is impossible for them to comply with both tort law and FDA requirements.
The Supreme Court implicitly accepted this view in 2009’s Wyeth v. Levine, when it found no impossibility preemption of a failure-to-warn claim against Wyeth. The Court rested this conclusion on the view that, under FDA regulations, Wyeth could have changed its drug’s warning label without prior FDA approval. Wyeth thus could have avoided tort liability while complying with FDA rules.
This analysis was always dubious: labeling changes ultimately require FDA approval, and thus a manufacturer’s power to make unilateral changes is short-lived and mostly hypothetical. But there soon arose a side effect which the majority in Wyeth, led by Justice Stevens, surely neither foresaw nor intended. To the extent that the power to make unilateral changes exists at all, it is enjoyed only by brand-name manufacturers and not by makers of generic drugs.
Thus when, in PLIVA, Inc. v. Mensing, the manufacturer of a generic drug made an impossibility preemption claim, the Court sprang the trap it had set in Wyeth. If impossibility was avoided only to the extent that manufacturers could change their labels, then impossibility must exist with respect to generic drugs.
In Mutual Pharmaceutical Co. v. Bartlett, the Court is being asked to extend this analysis to preempt some suits against generic manufacturers for design defects. And the United States, for its part, appears to ask the Court to feel free to endorse this rule for all design-defect claims, for both generic and brand-name drugs, on the theory that no manufacturer can alter the substance of its drug without FDA approval. What started as a ground for rejecting preemption in Wyeth is now poised to eliminate virtually all tort liability for prescription drug manufacturers, all in the name of “impossibility.”
But if we know one thing about tort law, we know that it is not impossible to comply with it and FDA requirements simultaneously. We know this because drug manufacturers have been complying with both since the passage of the Federal Food, Drug, and Cosmetic Act in 1938.
Moreover, anyone briefed in the most basic attributes of tort liability and FDA regulation can explain why. Tort liability requires manufacturers to pay damages, not to alter their products. A manufacturer may market a drug as approved while paying tort damages. The manufacturer has other options, such as seeking to modify a drug or label, or developing improved products. But it is entirely possible to change nothing and comply with both sets of laws.
Tuesday, February 26, 2013
Forbes reports that Pfizer is asking the Alabama Supreme Court to reconsider its decision holding Pfizer liable for failing to warn a consumer who took a generic version of the drug Reglan. The article points out the regulation, not litigation, may answer this one:
Meanwhile, though, the issue may be decided by the FDA. The agency recently disclosed plans to revise its regulations so that generic drugmakers can update product labeling and warn patients about risks associated with their drugs. If the FDA were to make such a change, generic drugmakers could be sued in state courts – if they become aware of evidence of serious side effects, but do not take action to update the product labeling (back story).
Monday, January 28, 2013
The Legal Intelligencer reports that Philadelphia Court of Common Pleas Judge Nitza Alejandro has denied Johnson & Johnson's McNeil-PPC's post-trial motions in a case involving over the counter Children's Motrin. In the case, a jury awarded $10 million to a young girl who suffered Stevens-Johnson syndrome/toxic epidermal necrolysis after taking Children's Motrin. The full story is behind a free registration wall.
Thanks to Lisa Smith-Butler for the alert.
Tuesday, January 15, 2013
Friday, January 11, 2013
Muddling the preemption waters, the Ninth Circuit has ruled that a plaintiff can bring a state law failure to warn claim against a medical device manufacturer. The court found the claim was not preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act. A copy of the opinion is here. The Recorder (via law.com) has more.
Thanks to Lisa Smith-Butler for the alert.
Tuesday, November 27, 2012
On Monday, the Supreme Court of Pennsylvania ruled that, in order to avoid liability, a defendant raising a claim of highly reckless conduct must plead and prove such claim as an affirmative defense. The case, Reott v. Asia Trend, is here.
Thanks to Scott Cooper for the tip.
Tuesday, October 23, 2012
The Sunday Boston Globe contained an article by Jay Fitzgerald on the potential suits from the outbreak of meningitis linked to a Framingham drug compounding pharmacy. Suffolk's Mike Rustad is quoted in the piece.
Saturday, October 6, 2012
Tuesday, September 25, 2012
The Wall Street Journal reports that mass tort filings in the Philadelphia Court of Common Pleas have "skyrocketed from 550 in 2008 to nearly 2,700 last year. The surge left an already busy court system buried in lawsuits and scrambling to repair the damage." The article reports:
Also contributing to the surge of cases: the success of the Complex Litigation Center, a specialized Philadelphia court established in 1992 largely to handle the growing asbestos and pharmaceutical docket. The center adopted techniques that were designed to move cases through quickly, such as setting early trial dates, holding frequent meetings among the lawyers, and consolidating similar cases.
The Complex Litigation Center drew more mass-tort cases to Philadelphia. But until recently, it was largely able to manage its docket. Since 2008, the backlog of asbestos and pharmaceutical cases has shot up from about 2,600 to more than 6,100 through last month. Last year, 88% of the pharmaceutical cases were filed by out-of-state plaintiffs, according to the court.
The mess is now largely Judge Herron's to deal with. Since taking over as the administrative judge late last year, he has put into place several measures designed to reverse the trend—and to send a message to out-of-state lawyers to take their lawsuits to other courts. "Go elsewhere," he says, when asked to describe the message he is hoping to send to out-of-state lawyers. "There are a lot of really wonderful courts in the U.S., and you should make broader use of them."
Friday, August 17, 2012
This week, Amaris Elliott-Engel, of PA Law Weekly, wrote the first of a series of articles on tort law. Her first piece is on the uncertainty in Pennsylvania products law. Twice in the last 3 years, the U.S. Court of Appeals for the Third Circuit has opined that the Pennsylvania Supreme Court would adopt the Restatement Third (Products Liability). However, the state Supreme Court has not directly addressed the issue, although there has been some provocative dicta and one instance in which the justices announced they had improvidently granted allocatur to consider whether section 2 of R3 should replace 402A of R2. Thus, in general, state courts are applying 402A and federal courts are applying R3, though even among federal courts, some apply 402A. As elsewhere, most plaintiffs' lawyers tend to prefer 402A and most defense lawyers tend to prefer R3.
Thanks to Scott Cooper for the tip.