PA Supreme Court Issues Important Strict Liability Decision

Pennsylvania has long been a jurisdiction which followed unique, sometimes archaic, rules regarding strict product liability. The state Supreme Court recently issued a significant ruling on product liability law in the Commonwealth, perhaps not surprisingly forging its own path going forward. See Tincher et al. v. Omega Flex Inc., No.17 MAP 2013 (Pa. 11/19/14). Disclosure: your humble blogger assisted in one of the amicus briefs.

The decision came in a complex 130 page opinion; in sum, the opinion gives both plaintiff and defendants some of what they sought, and neither side of the bar all. The Court offered a lengthy survey of the history of tort law in Pennsylvania, as a foundation for its key holdings:

1. declined to adopt the Third Restatement treatment of product defect, opting to maintain a strict liability doctrine rooted in the now half-century old Second Restatement, with a nod to incremental future changes in the common law model.  There was clearly a process-based component to the reasoning, as the Chief Justice noted: “It is difficult to imagine a modern court simply adopting something so broad-based and legislative in character as an outside organization’s Restatement of the Law, even if it is the product of an esteemed organization.”

2. unanimously (believe it or not) overruled the infamous Azzarello v. Black Brothers Company, 391 A.2d 1020 (Pa. 1978), case and its unfair and unworkable attempts to distinguish between strict liability and negligence.

In the underlying case, the defendant was hit with a $1 million jury verdict in connection with allegation about defective steel tubing. According to the plaintiffs, the product had been affected by a lightning strike, and caused their house to burn down.

The defendant's appeal argued in part for the adoption of the Third Restatement, under which a plaintiff alleging a design defect must show that the manufacturer could and should have adopted a reasonable alternative design. Of course, that makes compete sense. Other tests of defect (such as consumer expectations) are amorphous and often unworkable.  And Pennsylvania's traditional standard is so pro-plaintiff as to make a manufacturer the virtual insurer of its products -- which the Second Restatement rejects. That is why two justices wrote in support of the adoption of the Third Restatement.

But all six justices ruling on the case agreed to reject the Azzarello decision, which in practice had juries ruling on the defectiveness of products without any consideration of their risks and utilities. So, in essence, Pennsylvania juries received no guidance on when the product is “safe for its intended use.”  New jury instructions will replace the Azzarello question which asked whether the product lacked any element necessary to make it safe. New jury instructions should be fashioned to be applicable to a particular case.   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 defect 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 trial court may choose its own wording as long as the jury charge properly explains the meaning of defective condition. The court thus referenced a two prong standard that allows liability under either consumer expectation or risk-utility tests for defect.  Neither is perfect, and neither will be universally applicable, so plaintiff's choice of a preferred test can be challenged by defense motion practice. The Court recognized, for example, that the consumer expectation test fails at both ends of the spectrum, on obvious dangers and on complex products with dangers that are vague or outside the ordinary consumer’s contemplation.  The Court left for another day the issues regarding manufacturing and warning claims and the interplay with affirmative defenses, and the intended use doctrine.

The overturned precedent also impacted the evidence that was admissible when,as often happened, plaintiffs dropped their negligence count before trial. Going forward, the admissibility of the evidence — even if it arguably implicates negligence concepts — will be decided by trial judges on an incremental basis. Rejection of Azzarello will also mean that judges will no longer do the preliminary risk-utility calculus for the challenged product. Removing risk-utility balancing from the jury turned out to be problematic, as separating risk-utility from the condition of the product is incompatible with basic principles of strict liability.  Risk-utility thus is properly a jury question.

 

Expert May Be Needed on Design Defect, Even Under Consumer Expectations Test

Back when we taught Products Liability in law school, one of the topics that always got significant attention and discussion from the bright-eyed students was how to define "defect." The panoply of tests for defective or unreasonably dangerous products never failed to excite discussion, particularly the role of consumer expectations in product assessment.

That same topic is the focus of an interesting recent decision in the Seventh Circuit. See Show v. Ford Motor Co., Nos. 10-2428 and 10-2637 (7th Cir.,  9/19/11).

Plaintiffs were involved in a motor vehicle accident in a 1993 Ford Explorer;  they sued Ford, alleging design defect. In products liability cases in which the plaintiff alleges a design defect, Illinois (whose law supplied the substantive rules) permits the claim to be established in either
of two ways. First, the plaintiff may introduce evidence that the product failed to perform as safely as an ordinary consumer would  expect when used in an intended or reasonably foreseeable manner. This has come to be known as the consumer expectation test. Second, the plaintiff may introduce evidence that the product’s design proximately caused his injury, when the benefits of the challenged design do not outweigh the risk of danger inherent in such design. This test, which adds the balancing of risks and benefits to the alternative design and feasibility inquiries, has come to be known as the risk-utility or risk-benefit test.

Here, plaintiffs proceeded under the first prong, and offered no expert opinion. Ford moved for summary judgment in light of the absence of expert testimony. Plaintiffs conceded that testimony by an engineer or other design expert was essential when a claim rests on the risk-utility approach. But, they argued that jurors, as consumers, can find in their own experience all of the necessary opinions under the consumer expectation test. The district court sided with the defense, and plaintiffs appealed.

The court first discussed a very interesting preliminary question. The parties assumed, as did the lower court, that state law in this diversity case determined whether expert testimony was essential. The assumption rested on a belief that the quality of proof is part of the claim’s substantive elements, which in turn depend on state law under the Erie doctrine even when substantive doctrine is implemented through federal evidentiary rules.  However, there was a question whether Illinois treats the risk-utility and consumer expectations approaches as distinct substantive law doctrines, or merely as procedural aspects of the general question: is the product unreasonably dangerous. Perhaps the two tests are not theories of liability; they could be considered methods of proof by which a plaintiff may demonstrate that the element of unreasonable dangerousness is met.  If the consumer expectation test is not an independent theory of liability, perhaps federal rather than state law determines whether expert evidence is essential on it. Federal law often requires expert evidence about consumers' knowledge and behavior, because jurors are supposed to decide on the basis of the record rather than their own intuitions and assumptions. If federal courts require expert evidence, rather than relying solely on jurors' experience, in trademark and credit suits, for example, why not in product defect cases, asked the court?  But the court decided to bypass the question, in light of the parties' positions below. 

Turning to the consumer expectations issue, the court felt that plaintiffs’ argument that jurors should be able to rely on their own expectations as consumers reflected a belief that “expectations” are all that matters. Yet because the consumer expectations approach is just a means of getting at some of the issues that bear on the question whether a product is unreasonably dangerous, it is impossible to dispense with expert knowledge, concluded the panel.  The design defect is tied up in the issue of causation. Did the design decisions that went into the 1993 Ford Explorer even contribute to the rollover? Causation is a question about physics, and design options are the province of engineers. Jurors own cars, but people own lots of products without being able to explain (or even understand) the principles behind their construction and operation.  Unguided intuitions will not solve the equations. Without an expert’s assistance the decision would depend on speculation, which cannot establish causation—an issue on which plaintiffs bear both the burden of production and the risk of non-persuasion.

Because consumer expectations are just one factor in the inquiry whether a product is unreasonably dangerous, a jury unassisted by expert testimony would have to rely on speculation. The record here did not show whether 1993 Explorers were unduly (or unexpectedly) dangerous, because the record (absent an expert) lacked evidence about many issues, such as: (a) under what circumstances they roll over; (b) under what circumstances consumers expect them to do so whether it would be possible to reduce the rollover rate; and (d) whether a different and safer design would have averted this particular accident. All of these are subjects on which plaintiffs bear the burden of proof. There are other issues too, such as whether the precautions needed to curtail the rate of rollovers would be cost-justified.

The absence of expert evidence on these subjects was fatal to plaintiffs’ suit.

 

Proof of Feasible Alternative Design Does Not Prove Defect

Readers know that most jurisdictions require that a plaintiff alleging a design defect in a product must produce sufficient evidence of a feasible alternative design that would have avoided the plaintiff's injury had it been adopted.  But a Texas appeals court reminded us recently that evidence of a safer alternative design, while necessary, is not sufficient to show a design defect. Zavala v. Burlington Northern Santa Fe Corp., No. 08-10-00169-CV (Tex. App., 8th Dist., 8/24/11).

Plaintiff filed suit against the railroad, alleging personal injuries sustained while attempting to open an allegedly defective railcar hopper door to unload sugar. Defendant filed a motion for summary judgment, which the trial court granted, and Zavala appealed.

Plaintiff alleged a manufacturing defect, but he could not identify the exact car which injured him or pinpoint any specific defect on that car. He did not see the hopper car again, but he identified the opening mechanism on a BNSF model 450 car as the “same or substantially similar hopper loading mechanism I was injured on.”  The court concluded that since he could not identify the specific car which caused his injuries, he must show more than a scintilla of evidence that all BNSF model 450 cars possess a manufacturing defect. That he could not do.

The court then turned to the alleged design defect. The defect was the alleged unreasonably
dangerous condition of the hopper car opening mechanism. Texas courts apply a risk-utility analysis to design defects that requires consideration of the following factors: (1) the utility of the product to the user and to the public as a whole weighed against the gravity and likelihood of injury from its use; (2) the availability of a substitute product design which would meet the same need and not be unsafe or unreasonably expensive; (3) the manufacturer’s ability to eliminate the unsafe character of the product without seriously impairing its usefulness or significantly increasing its costs; (4) the user’s anticipated awareness of the dangers inherent in the product and their avoidability because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions; and (5) the expectations of the ordinary consumer.  The risk-utility analysis operates in the context of the product’s intended use and its intended users.

The court of appeals reasoned that global assertions that all model 450 doors were defective because they were all hard to open does not create more than a mere suspicion of a defect. It refused to hold that a hard-to-open door is necessarily a malfunction, or that circumstantial proof of a hard-to-open door suffices to demonstrate a design defect.

Plaintiff pointed to his expert evidence of an alleged feasible alternative design for the hopper door. Although evidence of an alternative safer design may assist in proving a design defect, proof of an alleged safer alternative design is not enough to sustain a defective design claim, concluded the court of appeals. See also Hernandez v. Tokai Corp., 2 S.W.3d 251, 256 (Tex. 1999)(proof of an alternative safer design does not negate the common law requirement that the alleged defect renders the product unreasonably dangerous).  A design defect claim arises if a safer alternative design existed and there is a defect that was a producing cause of the personal injury, property damage, or death for which the claimant seeks recovery.

Here, plaintiff failed to produce sufficient evidence to create an issue of fact on defect, even if he did have evidence of a feasible alternative design.  In essence, the court recognized that there can be more than one non-defective way to design a product. There may be different pluses and minuses in each design, and the existence of an alternative does not render all other alternatives necessarily defective.

 

State Court Upholds Questionable Bystander Liability Claim

The Montana Supreme Court recently upheld the imposition of liability on a bat manufacturer for allegedly failing to warn about the dangers of aluminum bats. Patch v. Hillerich & Bradsby Co., d/b/a Louisville Slugger, No. DA 10-0051 (Mont. 7/21/11).  Bad facts made bad law here. 

Many people consider "The Natural" to be one of the greatest sports movies of all time, and those that think deep thoughts have asserted that the screenplay  (presumably not the 1952 book too?) was based in part on the story of Sir Percival from the Arthurian myths, with the broken bat "Wonderboy" taking the part of the knight's broken sword.  Had Roy Hobbs used an aluminum bat, that aspect of the story would have been lost. Since their introduction in the early 1970's, aluminum bats have become quite popular in youth and amateur adult baseball and softball markets. The new bats are often touted as having a wider sweet spot, more power, better feel, or higher performance. It is pretty much accepted that balls come off metal bats faster than they do from wood bats, but this aspect of performance has fueled an ongoing metal/wood issue in some circles.

While pitching in an American Legion baseball game on July 25, 2003, the eighteen year-old plaintiff was struck in the head by a batted ball that was hit using H&B’s model CB-13 aluminum bat. Tragically, plaintiff died from his injuries. In 2006, Brandon’s parents sued H&B, claiming H&B’s model CB-13 aluminum bat was in a defective condition because of the alleged enhanced risks associated with its use: It increased the velocity speed of a batted ball when it left the bat, thus decreasing infielders’ reaction times, which allegedly resulted in a greater number of high energy batted balls in the infield.

The matter was tried in October, 2009, and the design defect and failure to warn claims were submitted to the jury, which concluded that the model CB-13 aluminum bat was not designed defectively, but determined the bat was in a defective condition due to H&B’s failure to warn of the enhanced risks associated with its use. They awarded plaintiffs an $850,000 verdict on their failure to warn claim. Defendant appealed.

The key issue was whether a failure to warn claim can be brought by a bystander -- plaintiff was not the consumer nor the user. H&B asserted that only the individual batting (actual user) and the individual who purchased the bat (actual consumer) could assert a failure to warn claim.  The court disagreed, saying this interpretation of the terms user and consumer is somehow contrary to the definition of the terms as contained in the Restatement (Second) of Torts § 402A. This state court’s products liability jurisprudence had recognized that a failure to warn claim may be brought by some persons who are not actual purchasers or users of a product; previous plaintiffs included those who are passively enjoying the benefit of the product, as in the case of passengers in automobiles or airplanes, as well as those who are utilizing it for the purpose of doing work upon it.  "The realities of the game of baseball" supported, said the court, the decision to submit the failure to warn claim to the jury. The bat was deemed an indispensable part of the game. The risk of harm accompanying the bat’s use extends beyond the user, beyond a player who holds the bat in his or her hands. A warning of the bat’s risks to only the batter standing at the plate inadequately communicates the potential risk of harm posed by the bat’s increased exit speed, concluded the court. In this context, all of the players, including plaintiff, were deemed "users or consumers" placed at risk by the increased exit speed caused by H&B’s bat.

Defendant also argued that plaintiff could not establish causation - reading and heeding the warning. The court held that H&B’s argument erroneously assumed that placing a warning directly on the bat is the only method to provide a warning. While placing a warning directly on a product is certainly one method of warning, other methods of warning exist, including, but not limited to, issuing oral warnings and placing warnings in advertisements, posters, and media releases. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 131 (9th Cir. 1968) (“[O]ther means of communication such as advertisements, posters, releases to be read and signed . . . or oral warnings . . . could easily have been undertaken . . . .”). Such warnings, if issued by H&B in this case, said the court, could have communicated to all players the potential risk of harm associated with H&B’s bat’s alleged increased exit speed.

What the court here called a "flexible" approach to causation really eviscerates one of the fundamental elements of the claim. The court allowed the jury to infer without any basis in fact that plaintiff would have heeded a warning had one been given-- apparently because he was deceased, and thus real proof of causation was hard to find. There is no basis to allow a jury simply to express sympathy for a tragic accident victim,as here there was not sufficient proof that the plaintiff would have adjusted his behavior after receiving the warning to avoid the injury. The decision puts this court in a tiny minority of states that recognize some kind of bystander failure to warn liability, which most courts agree is unworkable and contrary to the reality of modern commerce.

The concurrence correctly noted that plaintiff did not articulate specifically what a warning should have contained and what message should have been given. Statements to the effect that the bat would hit balls at unusually fast speeds or unusually far distances are the kind of messages accompanying usual product advertising and are not likely to change a player's/plaintiff's behavior. Moreover, they are precisely the qualities in a bat which baseball teams and players seek out. Plaintiff could not articulate specifically how a warning would have changed the result here, in other words, how the failure to warn caused this accident.

H&B also argued that because plaintiff had been hit by batted balls before, he knew he could be hit and, therefore, assumed the risk when he continued playing baseball. The court explained that assumption of the risk defense in this state is inapplicable as a matter of law without evidence the victim actually knew he or she would suffer serious injury or death, and, knowing that, the victim voluntarily exposed himself or herself to the danger. Lutz v. Natl. Crane Corp., 267 Mont. 368, 379-80, 884 P.2d 455, 461-62 (1994). What the victim actually knew is evaluated using a subjective standard in Montana. Here, said the court, there was no evidence that plaintiff actually knew he would be seriously injured or killed when pitching to a batter using one of H&B’s model CB-13 aluminum bats. He knew he could be hit with a screaming line drive, but not that it could injure him seriously?

Plaintiff's apparent theory, as articulated in closing argument, was that H&B should have
advertised that its bat “could kill.” And the inference which plaintiff asked the jury to draw in order to establish causation was that, following the publishing of a warning “that this bat could kill,” the parents would have prohibited Brandon from playing baseball.  That tells you how unworkable the theory is. This was a terrible accident on a baseball field, the kind of accident that has also occurred with wood bats. The bat was not defective. It was made in accordance with the rules approved for play by baseball's organizing and governing bodies. Bad facts again make bad law.
 


 

Jury Rejects Medical Monitoring Claim in Coal Dust Litigation

A West Virginia jury last week ruled in favor of defendant Massey Energy Co. in a class action accusing the company of exposing plaintiffs from an elementary school to toxic coal dust. Dillon et al. v. Goals Coal Co. et al., No. 05-c-781 (Circuit Ct. Raleigh County, W.Va.).

The plaintiffs first filed suit in 2005, complaining about a coal silo near the Marsh Fork Elementary School in Raleigh County.  Coal dust allegedly drifted from the silo into the school, exposing the plaintiffs, and putting them at increased risk of lung disease.  The court eventually certified a class of about 300.

Plaintiffs sought a medical monitoring program to early detect the alleged effects of the exposure.  In order to sustain a claim for medical monitoring expenses under West Virginia law, the plaintiff must prove that (1) he or she has, relative to the general population, been significantly exposed; (2) to a proven hazardous substance; (3) through the tortious conduct of the defendant; (4) as a proximate result of the exposure, plaintiff has suffered an increased risk of contracting a serious latent disease; (5) the increased risk of disease makes it reasonably necessary for the plaintiff to undergo periodic diagnostic medical examinations different from what would be prescribed in the absence of the exposure; and (6) monitoring procedures exist that make the early detection of a disease possible.  See Bower v. Westinghouse Electric Corp., 522 S.E.2d 424 (W. Va. 1999).

The defense challenged both the significant exposure and increased risk prongs. The jury rejected the medical monitoring claim after a 2 week trial.

State Supreme Court Adopts Risk Utility Test for Defect

The South Carolina Supreme Court last week vacated a $31 million verdict for a minor injured in a Ford Bronco rollover accident.  Branham v. Ford Motor Co., 2010 WL 3219499 (S.C. 8/16/10).  The case raises a number of interesting points for our readers.

This was a product liability action involving a Ford Bronco II.   Hale was driving the vehicle with several children as passengers, including her daughter seated in the front passenger seat.  No one was wearing a seat belt.  Hale admittedly took her eyes off the road and turned to the backseat to ask the children to quiet down. When she took her eyes off the road, the Bronco veered towards the shoulder of the road, and the rear right wheel left the roadway. She responded by over-correcting to the left, which allegedly led the vehicle to roll over.

Plaintiff, the parent of one of the injured passengers, sued. The case against Ford was based on two product liability claims, one a defective seat belt sleeve claim, and the other, a “handling and stability” design defect claim related to the vehicle's alleged tendency to rollover.  The jury returned a verdict of $16,000,000 in actual damages and $15,000,000 in punitive damages.

The trial court had dismissed the strict liability claim regarding the seat belt on the basis that the sleeve was not defective as a matter of law. But the negligence claim shared with the strict liability claim the element that the product be in a dangerous condition unreasonably dangerous. The trial court should thus have dismissed it too, the supreme court said.

The court also found that the closing argument of Branham's counsel was designed to and likely did inflame and prejudice the jury. The closing argument relied heavily on inadmissible evidence to pump up the punitives claim in requesting that the jury punish Ford.  This closing argument invited the jury to base its verdict on passion rather than reason, and the supreme court found that it denied Ford a fair trial.

But the more interesting part of the case related to Ford's two-fold argument that: (1) Branham failed to prove a reasonable alternative design pursuant to the risk-utility test; and (2) South Carolina law requires a risk-utility test in design defect cases to the exclusion of the consumer expectations test. 

The court found that plaintiff had produced sufficient evidence of a feasible alternative design to get to a jury.  But, while the consumer expectations test may fit well in manufacturing defect cases, the court agreed with Ford that the test is ill-suited in design defect cases. It thus held that the exclusive test in a products liability design case is the risk-utility test, with its requirement of showing a feasible alternative design.

The very nature of feasible alternative design evidence entails the manufacturer's decision to employ one design over another. This weighing of costs and benefits attendant to that decision is the essence of the risk-utility test.  The court noted that this approach is in accord with the current Restatement (Third) of Torts.  The court noted that the Third Restatement effectively moved away from the consumer expectations test for design defects, and towards a risk-utility test.  While the feasible alternative design inquiry is the core of the risk-utility balancing test in design defect cases, the court went out of its way to note that a jury question is NOT created merely because a product can be made safer. There is a longstanding principle that a product is not in a defective condition unreasonably dangerous merely because it “can be made more safe.” 

 The court sent the case back for a new trial.

Medical Monitoring Class Actions Rejected in Beryllium Cases

The Third Circuit has affirmed the dismissal of two putative class actions that sought medical monitoring for workers and neighbors of factories using beryllium. Sheridan, et al.  v. NGK Metals Corp., et al., 2010 WL 2246392 (3d Cir. June 7, 2010). 

Readers may recall that previously we posted on the district court's dismissal of the claims against one of the defendants, an engineering firm that, according to the plaintiffs’ Amended Complaint, was involved with testing, sampling, analyzing, and monitoring the air quality and levels of beryllium at one plant involved in the cases. The Third Circuit affirmed.  Boiled down to its core, plaintiffs’ Amended Complaint contended that the engineering firm breached its duty of reasonable care by failing to warn members of the community surrounding one of the plants at issue about the alleged beryllium emissions from the facility. But there was no legal duty to warn.  In order for the engineers to have negligently failed to warn plaintiffs of harmful beryllium exposures, they must have undertaken the responsibility of making that warning. Plaintiffs never alleged that the firm negligently performed the tasks it actually undertook—that is, testing, analyzing, and monitoring the levels of beryllium, and reporting those tests to the owner and operator of the facility. 

Also of note for readers is the remainder of the court's analysis regarding other defendants, which focused on one of the elements of medical monitoring.

Some background.  Plaintiffs in each case filed a putative class action lawsuit against multiple defendants, alleging negligence in connection with beryllium exposure, and seeking a medical monitoring trust fund based on their alleged increased risk of developing chronic beryllium disease int he future. In the first action, (the “Anthony action”), the District Court granted defendants’ joint motion for summary judgment. In the second (the “Zimmerman action”), the District Court addressed three separate legal issues— medical monitoring under Pennsylvania law, claim preclusion of the claims of one named plaintiff, Sheridan, and third-party liability—and issued final orders in favor of defendants. Although the cases presented similar legal issues, they arose out of different locations and distinct facts. However, plaintiffs’ lawyers, many of the expert witnesses, and one defendant, were the same in each case. The Third Circuit did not consolidate the two separate appeals, but resolved them in one opinion.

Inhaling beryllium particles can lead to scarring of the lungs, a condition known as chronic beryllium disease.  CBD occurs when the immune system mounts an attack against beryllium particles that have entered the body. The lung sacs become inflamed and fill with large numbers of white blood cells that accumulate wherever the beryllium particles are found. The cells form balls around the particles called granulomas. Eventually, the lungs become scarred and lose their ability to transfer oxygen to the blood stream.

The dose-response picture is a bit unusual. Mere exposure itself appears to be insufficient because only persons who have a particular genetic “marker”—the Human Leukocyte Antigen (HLA)-DPB1 allele—can potentially recognize beryllium in the lungs as an antigen. This reaction is called beryllium sensitization (“BeS”). The parties did not dispute that BeS is a necessary precursor to CBD. BeS by itself causes no abnormal lung function and requires no treatment (i.e., it is asymptomatic).  The experts debated how many people have the marker with estimates ranging from below 10% to 40% of the population. The most common test for sensitization is the beryllium lymphocyte proliferation test (“BeLPT”), which is not a test for the genetic marker, but a reasonably accurate test for sensitization according to the experts.

Readers know that one of the typical elements of a medical monitoring claim is proof of a significantly increased risk (of contracting the latent disease for which plaintiff seeks medical monitoring). Plaintiffs' expert testimony was that all individuals exposed to beryllium at above background levels are at a significantly increased risk and require medical monitoring. They  declared that there is a direct relationship between the level of exposure and risk, and that CBD is not qualitatively different from any other environmental exposure disease.  Defendants' expert opined that given class rep Anthony’s negative result in the test to show whether he had become sensitized, and the fact that only a small percentage of the population can become sensitized, Anthony was not at a significantly increased risk of developing CBD.

In the other class action, the parties stipulated that class rep Zimmerman was not beryllium sensitized. Plaintiff experts argued, however, that anyone who has lived in the area surrounding the plant in question was at a significantly increased risk given the levels of beryllium in the
ambient air and documented cases of CBD in the community. They made a quantitative risk assessment based on collected exposure data, concluding that the risk of contracting CBD to the members of the proposed class represented by Zimmerman was 3 per 10,000, and for those
individuals who have lived near the plant for at least ten years, the risk allegedly increased to 1 per 500.

The Third Circuit noted that the intermediate appellate court in Pennsylvania had addressed analogous medical monitoring claims in Pohl v. NGK Metals Corp., 936 A.2d 43 (Pa. Super. Ct. 2007). The Pennsylvania Superior Court concluded there that the record provided no support for plaintiffs’ contention that they were sensitized to beryllium and thus that they faced a significantly increased risk of contracting CBD. Plaintiffs in federal court contended that Pohl was neither controlling nor persuasive, because it was a fact-specific decision in which the state court dismissed the three plaintiffs’ claims based on their individual failure of proof.

The court of appeals, however, concluded that the state court drew a line along the exposure-to-disease continuum -- at sensitization. The Third Circuit held that unlike its role in interpreting federal law, it may not "act like a judicial pioneer" in a diversity case. Contrary to both Anthony’s and Zimmerman’s contentions, Pohl was not based only on a simple lack of proof; it was based on plaintiffs’ failure to meet the requisite threshold for establishing significantly increased risk due to (1) the undisputed facts about beryllium exposure, BeS, and CBD, and (2) plaintiffs’ inability to demonstrate a significant increase in risk of disease before sensitization. Although the disparate data on how many people have the marker shows the gaping holes in the current state of scientific research, as well as the substantial factual disagreements between scientists, it was not material to this appeal. The parties stipulated that Anthony had not developed BeS, and there was no proof that he has the genetic marker associated with CBD. This background data did not prove his individual significantly increased risk.

As to the Zimmerman class (all persons who resided within a one-mile radius of the Reading Plant for at least six months during the time period between 1950 and 2000), the court noted that plaintiffs tried to make a different showing, including by presenting data on specific exposure levels around the Reading Plant and the number of documented cases of CBD in the community there. From Zimmerman’s perspective, exposure to beryllium is analogous to exposure to other toxins, such as asbestos and PCBs. Defendants contended CBD’s immunological nature distinguishes beryllium from other toxins, which do not invoke an allergic response in only a subset of susceptible persons and instead have a more linear exposure-to-disease relationship.

The state of the art is that only a small subset of an exposed population (those who carry the genetic marker) is at risk of developing CBD; the relationship between beryllium exposure and CBD is relatively non-linear, making generalized risk assessments inappropriate. Thus, there was a failure of proof on the risk element, given the current state of scientific knowledge on the
relationship between beryllium exposure and disease. Plaintiff failed to present sufficient evidence that as a proximate result of the exposure, he had a significantly increased risk of contracting
CBD.

The failure of the class reps to show they could meet a necessary element of the claim meant that the class actions could not proceed. (Sheridan's claim was barred.)

Safe Chemicals Bill Introduced in Senate

Sen. Frank R. Lautenberg, D-N.J., chair of the Senate Subcommittee on Superfund, Toxics
and Environmental Health, introduced this week the "Safe Chemicals Act of 2010," which would
amend the the Toxic Substances Control Act of 1976.

Over the last several months, Congress has held a series of hearings focusing on chemical safety and possible ways to modernize TSCA. Chemical business leaders, public officials, scientists, doctors, academics, and liberal environmental organizations have expressed support for varied methods of reforms to the principal toxic substance law. The “Safe Chemicals Act of 2010” comports with the reform principles laid out by the Obama Administration and groups such as the Safer Chemicals Healthy Families Coalition, and purports to address issues with TSCA identified by the GAO.

The bill (summarized here) is supposed to:

  • provide EPA with sufficient information to judge a chemical’s safety, by requiring manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing. EPA will have full authority to request additional information needed to determine the safety of a chemical.
  • Prioritize chemicals by having EPA categorize chemicals based on risk, and focus resources on evaluating those most likely to cause harm.
  • Place a new burden of proof on chemical manufacturers to prove the safety of their chemicals, including all foreseeable uses, before the chemical may enter the market or continue to be used.
  • Create more access to chemical information, by establishing a public database to catalog the information submitted by chemical manufacturers and the EPA’s safety determinations. The EPA will impose requirements to ensure the information collected is "reliable."
  • Promote innovation and development of green chemistry, through grant programs and research centers to foster the development of safe chemical alternatives, and bring some new chemicals onto the market using an expedited review process.


     

It is clear that safety must be the primary goal of chemical regulatory reform, and the scientific and technological advances made since the passage of TSCA should allow industry and the regulatory agency to achieve a high degree of safety.  Certainly,  the need to prioritize chemicals for evaluation, a proper risk-based approach to EPA safety reviews, and a reduction in animal testing, are all aspects that should generate bi-partisan support. However, the bill’s proposed decision-making standard may be both legally and technically impossible to meet. Readers know how the articulation and application of the burden of proof can be outcome determinative. It is impossible to prove that something is "safe,” if one means risk-free. Every substance, even water, is hazardous to health at some levels in some exposure contexts. It would be devastating for our economy if this bill was merely a back-door attempt to make the so-called precautionary principle the law in this country, as it is in Europe. It is simply scientifically false that every chemical that is dangerous at high doses is also hazardous at low doses;  it is patently false that every chemical that causes effects in lab animals will also cause those effects in human beings.

And the proposed changes to the new chemicals program could very well hamper innovation in new products, processes, and technologies. In addition, the bill undermines business certainty by appearing to allow states to adopt their own regulations and create a lack of regulatory uniformity for chemicals and the products that use them.

Congressmen Henry Waxman and Robert Rush have proposed a "discussion draft" on the House side, and that may afford an opportunity for a transparent and meaningful discussion by all key stakeholder groups to ensure that TSCA reforms are based on sound science and protect the safety of all consumers, while promoting jobs and innovation.  In these uncertain economic times, the last thing needed is another expensive government program that risks doing more harm than good.

 

Senate Hearing on TSCA Reform Featured Industry Experts

The Senate Subcommittee on Superfund, Toxics, and Environmental Health convened a hearing last week with leaders of businesses that manufacture or use chemicals to hear their business views on reforming U.S. chemical safety law. The hearing was the third in a series of oversight hearings leading up to the possible introduction of legislation to reform the Toxic Substances Control Act (TSCA). 

Entitled "Business Perspectives on Reforming U.S. Chemical Safety Laws," the hearing featured testimony from Charlie Drevna, President of the National Petrochemical and Refiners Association.  His remarks addressed the call from some observers for a European-style replacement regulatory regime. The European Union has started to implement new legislation – Registration, Evaluation and Authorization of Chemicals (REACH), but many of the perceptions of REACH are incorrect. For example, rather than relieving the government of the burden of chemical safety, REACH only increases the burden on industry while it does not reduce the burden on government. No government authority is going to receive a chemical dossier from industry and take it at face value. Furthermore, REACH places so much burden on industry that small- and medium-sized chemical manufacturers are already facing significant difficulties complying with the program. REACH, contrary to some commentary, is unlikely to spur innovation in safer chemicals. Innovation is a function of spending on research and development and ease of entry into the marketplace. Toxicity and other laboratory testing is considered part of research and development and typically comes out of R&D budgets. That leaves less money for new, and often safer, product development. REACH is a regulatory concept that has never been attempted anywhere in the world, at any time. Authorities in Europe have already been inundated with so much information that they simply cannot keep up.
 

Dr. Neil C. Hawkins, Vice President, EH&S and Sustainability  for The Dow Chemical Company testified that an ideal chemical safety program would base its decisions on a consistent scientific
evaluation of both hazard and potential exposure (an evaluation of risk), using a weight-of-evidence approach. A weight-of-evidence approach requires critical evaluation of the entire body of available data for consistency and biological plausibility. Studies conducted and funded by industry are necessary and valuable contributions to the understanding of potential public health and environmental effects related to the manufacture and use of its products. Industry scientists have expert knowledge of the chemicals they manufacture, especially as this relates to the development and interpretation of the science needed to comply with governmental requirements around
the world. Research should be judged on the basis of scientific merit, without regard for funding source or where the studies are conducted (e.g. academia, government, or industry). 

Also testifying was Linda Fisher, Vice President, Safety Health and the Environment for DuPont.  She stressed in her remarks that as the agency contemplates exposure reductions it is important that the EPA be required to take into account the societal benefits from the use of chemicals and the time and complexity of bringing substitutes to market. Congress should avoid presumptive bans or rigid phase-out schedules. Bans and deadlines for phase-outs or substitution that fail to account for the realities of transitioning to new ingredients, receiving needed customer and regulatory approvals, or modifying manufacturing facilities, are counter-productive. Such actions could lead to unnecessarily disrupting markets, reduce public access to valued products, and cede markets to global competitors.

The issue of confidential business information, or CBI, also needs attention. The ability to preserve legitimate CBI and prevent piracy of intellectual property is critical to U.S. competitiveness and innovation. If companies simply give innovation away there is little reason to innovate.  Intergovernmental sharing of CBI data with proper protections, whether between state and federal governments or nation to nation, should be facilitated.


 

Senate Holds Hearing on TSCA Issues

The Senate Committee on Environment and Public Works' Subcommittee on Superfund, Toxics and Environmental Health held a hearing earlier this month entitled, "Current Science on Public Exposures to Toxic Chemicals."   Readers from the chemical and energy industries in particular will want to take note of the discussion.

Chairman Lautenberg (D.N.J.) opined that  TSCA fails to give EPA the tools it needs to protect against unsafe chemicals.He claimed that in three decades EPA has tested only 200 of the more than 80,000 chemicals in the products people use every day. He mentioned unnamed "studies" that allegedly have found that as much as five percent of cancers, ten percent of neuro-behavioral disorders and 30 percent of asthma cases in children are associated with hazardous chemicals. That is why, he said, he will soon introduce a bill that will overhaul our nation’s chemical laws, with the "simple goal" to force chemical makers to prove that their products are safe before they end up in a store. 

This bill would fall into place with the ideas of other proponents of radical reform and supporters of the so-called precautionary principle.  Common sense would suggest that principles for any regulatory or statutory changes to TSCA should be based on the best available science, including risk assessment; must include cost-benefit considerations; must protect proprietary information; and must prioritize reviews for existing chemicals. Senator Lautenberg's notion would encourage litigation, allow for activist rather than government enforcement, and would compel unnecessary product substitution that will further damage our weak economy.  Indeed, it would harm small and medium-sized companies and could harm innovation.

Other witnesses at the hearing included Steve Owens, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances Environmental Protection Agency;  Dr. Henry Falk  of the CDC; and Dr. Linda Birnbaum, Director  of the National Institutes of Environmental Health Sciences.

A number of witnesses also talked about bio-monitoring, the concept to potentially identify the concentration of chemicals actually taken up by the human body and the metabolic fate of those chemicals; to identify susceptible populations or particular at-risk groups (e.g. genetic polymorphisms) for chemical toxicity; and to inform discussions regarding levels of exposure consistent with no adverse effects (thresholds). However, bio-monitoring cannot eliminate potential confounders or alternative explanations for identified associations between chemical exposure and disease.  Any environmental chemical will be present to some extent in those who ingest, inhale or otherwise are exposed to it. Thus, the rabble-rousing about  “neurotoxins”, “endocrine disruptors”, or other “harmful chemicals” is essentially meaningless, without specific relationship to dose, exposure timing, and comparison to appropriate control populations. Our ability to measure substances at very low concentrations has outstripped our ability to determine causation.

Unfortunately, bio-monitoring has been abused as a tool. The practical problem with overstating exposure-disease associations is seen every day by medical professionals who evaluate people who are fearful of being “poisoned” by the latest chemical touted in a study as the cause of the same disease blamed on another compound just the month before, noted witness Dr. Charles McKay.

EPA Releases First Chemical Action Plan

The Environmental Protection Agency recently issued its first Chemical Action Plan (CAP).  The plan deals with  phthalates, which are found in some food packaging and cosmetics.  But anyone in the chemical industry should take notice, as this CAP comes as part of EPA’s efforts to enhance the existing chemicals program under the Toxic Substances Control Act. EPA has identified an initial list of widely recognized chemicals, including phthalates, for action plan development based on one or more of the following factors: their presence in humans; persistent, bioaccumulative, and toxic  characteristics; use in consumer products; or production volume.

Although many in industry support  EPA’s effort to update agency actions for prioritized chemicals under TSCA, there is much to question in this effort so far, including the fact that the initial set of chemicals seem to have been selected based on their current “high-profile” nature. EPA should prioritize chemicals for the CAP program based on scientific criteria that reflect available hazard, use, and exposure information.  Despite the new Administration's campaign promises, there has been little transparency, and in fact great uncertainty, over the scientific basis for the selection of these chemicals.  Unfortunately, the CAP process to date provides no evidence of a systematic, science-based approach to chemicals management.

A large body of scientific data already exists about phthalates, and these products have been subject to numerous government safety assessments.  Bio-monitoring data shows that exposure to phthalates in the general public are below safety limits established by the EPA and the European Union. In assessing potential future restrictions on certain phthalates, EPA plans to weigh the relative toxicity and feasibility of phthalate substitutes. Identification of safer and affordable non-phthalate substitutes will be an important consideration in any action that would restrict the use
of these chemicals.  EPA intends to conduct a Design for the Environment and Green Chemistry alternatives assessment by 2012. The information developed could be used to encourage industry to move away from phthalates in a non-regulatory setting to expand risk management effects beyond whatever regulatory action might be taken under TSCA, or could be used as input to a regulatory action. 

EPA also intends to lay the groundwork to consider initiating in 2012 rulemaking under TSCA section 6(a) to further regulate phthalates. Readers know how regulatory events can spawn and impact toxic tort litigation.  It should be noted  that an Action Plan is intended to describe the courses of action the Agency plans to pursue in the near term to address its concerns. The Action Plan does not constitute a final Agency determination or other final Agency action.

 

 

 

 

ACS Head Offers Different View of Medical Monitoring

Readers of MassTortDefense involved in the defense of medical monitoring cases will want to follow the ongoing debate occasioned by the New York Times story this week, quoting Dr. Otis Brawley, chief medical officer of the American Cancer Society, admitting that American medicine has over-promised when it comes to medical screening and that the advantages of screening have been “exaggerated.”

Medical monitoring, whether a remedy or cause of action, is a claim for the cost of medical screening for a plaintiff exposed to a toxic substance allegedly because of the defendant’s wrongful conduct and who is accordingly at risk of future disease. Medical monitoring is designed to early detect the disease and thus maximize the chances of a cure or beneficial treatment.

As a an advocacy matter, medical monitoring is presented by plaintiffs with the seemingly unchallengeable notion that early detection saves lives. Plaintiff attorneys rely heavily on juror pre-loads about the importance and benefits of screening; virtually every juror has had a Pap smear, or mammogram, or prostrate test, and they have all been inundated with messages from the American Cancer Society that screening is highly efficacious-- messages that ignore the risks of screening. Defendants fight an uphill battle when they try to get the jury to keep an open mind about the risks and benefits of plaintiffs’ experts' proposed screening program.

Reportedly, the ACS is now working on a message, to put on its Web site early next year, to emphasize that screening for breast, prostate, and other cancers can come with a real risk. Those risks include not only the risks of the screening procedures themselves (such as radiation), but the risks of false positives, and the follow-on risks of over-treating a nodule that would never have developed into life-threatening disease. On the flip side, many researchers point out that the prostate cancer screening test has not been shown to prevent prostate cancer deaths. Similar lack of benefit has been noted with chest x-rays and CT scans for lung cancer. If cancer screening was really as effective as plaintiffs assert, the cancers that once were found late, when they were untreatable or incurable, would now be found earlier, when they could be treated and cured. Thus, a large increase in early cancers found would be accompanied by a decline in late-stage cancers, and an improvement in mortality. That just hasn’t happened for many types of screening.

Whether the issue is the screening tool or the screening itself, plaintiffs should no longer be allowed to base their medical monitoring claims on a widely accepted misconception that all screening is good, and all early detection saves lives.  Defense attorneys may have a juror pool more receptive to the evidence-based argument that plaintiffs must be held to their burden of proof to show that a monitoring procedure exists that makes early detection of the disease possible; the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.
 

 

FDA Issues Strategic Plan For Risk Communication

The U.S. Food and Drug Administration last week issued a Strategic Plan for Risk Communication, outlining the agency’s new efforts to disseminate public health information. The plan lays out a framework for the FDA to provide information about regulated products to health care professionals, patients, and consumers. The purpose of the document is to describe the FDA’s strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment, where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their health and well-being.

The plan defines three key areas – FDA’s science base, its operational capacity, and its policy and processes – in which new strategic actions might help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years.

 They include:

  • Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
  • Producing a research agenda for public dissemination
  • Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
  • Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
  • Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes

The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure their effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations. FDA noted that the public may not understand the context within which FDA makes decisions, for example, about recalls of particular foods or medical products.  By helping the public better understand how it approves and/or recalls products, FDA hopes to complement its premarket review and postmarket actions. In the past, FDA’s communication efforts arguably were largely restricted to overseeing the key vehicle for communicating risk information to the public—the labeling of FDA-regulated products. The process of negotiating with product manufacturers about changes to labeling or decisions to recall a product can be lengthy. Now, as the Internet and emerging technologies both enable and feed the public’s demand for greater transparency and communication frequency, these protracted waiting periods are giving way to communication in real time. Thus, designing a contemporary risk communication strategy is critical, says the plan, to FDA’s efforts to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology.

The plan comes three years after a study by the Institute of Medicine opined that the FDA had fallen short of its task of making sure that the drugs that come to the market are safe for use.  The IOM's recommendations included clarification of the FDA's role in gathering and communicating
additional information on the risks and befits of marketed products.  The FDA then created a new risk communication advisory panel to develop best practices for communicating the risks and benefits to the public.


 

FDA Releases Draft Guidance on Risk Evaluation and Mitigation Strategies

The FDA has released its draft guidance on Risk Evaluation and Mitigation Strategies, or REMS, laying out guidelines for how pharmaceutical companies should follow the plans, and describing the consequences for not doing so. The draft guidance for industry entitled ‘‘Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,’’  follows on the Food and Drug Administration Amendments Act of
2007 (FDAAA) which added new provisions to the Federal Food, Drug, and Cosmetic Act giving FDA the authority to require REMS.

For every drug approved by the FDA, the risks associated with its use are communicated through the labeling/product package insert. The manufacturer or the FDA may determine that a formal ongoing effort may be needed to monitor and manage risk issues, and thus that a Risk Evaluation and Mitigation Strategy is necessary to go beyond traditional product labeling to ensure that the benefits outweigh the risks on an ongoing basis.  FDA may now require REMS for any NDA, ANDA, or BLA, at any stage of the product life-cycle.  REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.  About 60 medicines are currently sold with such plans.

We have posted before about the opportunities and pitfalls in REMS that could have a significant effect on future litigation involving the product. The REMS process may engender “bad documents” (a paper trail that casts the company or its products in a bad light). On the other hand, one of the common claims asserted in product litigation is that a manufacturer was aware of and failed to adequately warn about its product’s risk. As the REMS process is specifically designed to increase the effectiveness of warnings to the health care and patient communities, it may bolster a defense against the assertion that the manufacturer failed to provide adequate warnings.

The new draft guidance describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents, and how to communicate with FDA about a REMS. The draft guidance was issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the format and content of proposed REMS, REMS assessments, and proposed REMS modifications.

REMS required by the FDA are subject to regulatory inspection and are enforceable under the FDCA as amended by FDAAA.  A drug may be considered misbranded if the responsible person for that drug fails to comply with a requirement of the approved strategy.  Firms that don't follow their plans will face fines of up to $10 million for a continued violation, according to the FDA guidance.
 

Senate Holds Hearing On Medical Device Safety Bill

The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enacted would overturn the Supreme Court's interpretation of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act in Reigel v. Medtronic.  The Supreme Court ruled that the MDA bars state law product liability claims against medical device companies based on alleged defects in products that had received approval through FDA's stringent premarket approval (PMA) process. The PMA process is used only in class III devices—devices FDA deems to be “high risk,” like pacemakers. The devices that are marketed as PMAs represent cutting edge science and are critical to public health.
 

We have posted on this legislation before here at MassTort Defense.  In addition to ignoring the important benefits of a uniform federal standard and the chaos of allowing devices to be regulated by litigation, the bill would would stifle innovation in the medical device industry and result in lost jobs, especially at smaller device companies. Obviously the bill is favored by overzealous trial lawyers and the legislators they support.

Testifying at the hearing were a variety of supporters of the bill, including academics who argued that preemption deprives victims of their right to compensation from the wrongdoers who injured them -- without convincingly responding to the concerns that would be raised by the new regime which allow juries throughout the country not only to impose requirements that are inconsistent with FDA determination, but that differ from one state court to another. The witness panel had no representative from the device industry.

The legislation would take away primary responsibility for device safety from the FDA and put it in the hands of lay jurors who have little to no understanding to the science involved, and who will listen to plaintiff's lawyers arguing about a single alleged injury without regard to the many of patients potentially safely aided by the device. Democratic supporters argued that no matter how diligently and effectively the FDA does its job, it simply cannot "guarantee that no defective, dangerous, and deadly medical device will reach consumers." The notion that any regulatory regime can "guarantee" defect-free products is misguided.  And to think that lay juries will do a better job of balancing product risks and benefits is foolish. Risk is inherent in all medical devices, and small numbers of patient injuries does not mean a device is defective.
 

The Advanced Medical Technology Association (AdvaMed) has urged Congress to reject the legislation, noting it would increase health care costs and decrease patient access to life-saving medical technology.  As the debate is ongoing about health care reform, legislation that will create more litigation, increase health care costs, and render it harder for medical device manufacturers to invest in promising new technology, hardly seems wise.

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State Supreme Court Affirms Summary Judgment Under Risk-Utility Test

The Texas Supreme Court last week upheld summary judgment in a design defect case, finding that under the risk-utility test, the commercial trailer at issue was not defective as a matter of law. See Timpte Industries Inc. v. Gish, Texas, No. 08-0043, (6/5/09).

Readers of MassTortDefense recognize that in a strict products liability claim, the risk-utility test has been the dominant test of "defectiveness" employed by state courts. The opinion offers an interesting example of the potential relevance of an obvious design risk (even in a jurisdiction that has rejected the obvious danger rule), and the interplay of warnings and design issues.

Plaintiff Gish was seriously injured when he fell from the top of a commercial “Super Hopper” trailer into which he was attempting to load fertilizer. He sued Timpte, the manufacturer of the trailer, alleging, among other things, that several features of the trailer were defectively designed, rendering the trailer unreasonably dangerous. The Super Hopper trailer is a standard open-top, twin hopper trailer, which is loaded from above through use of a downspout or other device and is emptied through two openings on its bottom. Once the trailer is loaded, a tarp is rolled over the top
to protect its contents.  A ladder and an observation platform are attached to the front and rear of the trailer to allow the operator to view its contents.

The downspout that was loading fertilizer into the trailer was not lowering properly on the day of the accident.  Gish pulled on a rope to lower it, but that was unsuccessful, so he climbed up the front platform ladder and climbed onto the top rail to work with the downspout. A gust of wind hit him from the back, causing him to fall.

Plaintiff alleged defects in the top two rungs of the ladders attached to the front and rear of the trailer which allowed a person to climb atop the trailer; and a defect as to the top rail of the trailer, which was allegedly too narrow and slippery and contained too many tripping hazards for a person to walk safely along it.

To recover for a products liability claim alleging a design defect, under Texas law, a plaintiff must prove that (1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was a producing cause of the injury for which the plaintiff seeks recovery. To determine whether a product was defectively designed so as to render it unreasonably dangerous, Texas courts have long applied a form of the risk-utility analysis that requires consideration of the following factors: (a) the utility of the product to the user and to the public as a whole weighed against the gravity and likelihood of injury from its use; (b) the availability of a substitute which would meet the same need and not be unsafe or unreasonably expensive; (c) the manufacturer’s ability to eliminate the unsafe character of the product without seriously impairing its usefulness or significantly increasing its costs; (d) the user’s anticipated awareness of the dangers inherent in the product and their avoidability because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions; and (e) the expectations of the ordinary consumer.

The court emphasized that risk-utility analysis does not operate in a vacuum, but rather in the context of the product’s intended use and its intended users. Specifically, while Texas has rejected the “open and obvious danger rule” under which obvious risks are not design defects which must be remedied, the obviousness of the claimed defect is an important consideration in determining whether the product is unreasonably dangerous -- and may even be decisive in a particular case.

Essentially, Gish complained that the trailer’s design failed to prevent him from climbing atop the trailer and then, once he was up there, failed to protect him from the risk of falling. The court found no evidence, however, that the top rail of the trailer was unreasonably dangerous in light of its use and purpose. The risk of falling while trying to balance on a 5 inch wide strip of extruded aluminum nearly ten feet above the ground is an obvious risk that is certainly within the ordinary knowledge common to the community. Timpte warned users to always maintain three-point contact with the trailer, which is impossible for a user standing on the top rail. Had Gish adhered to this warning, his accident would not have happened. Additionally, widening the side walls of the trailer so as to convert the top rail into a safe walkway, as Gish’s expert proposed, would have increased the cost and weight of the trailer while decreasing its utility.

Moreover, Gish’s injury was only remotely related to the ladder’s top two rungs: they allowed him to climb atop the trailer, where he was subsequently injured. Timpte warned users not to use the ladder to climb into the trailer itself, and the obvious nature of the risk of climbing onto the top rail negated  the need for any additional warning. The two top rungs were necessary to maintain the stability of the ladder and provide an emergency handhold in the event someone slips on the ladder. Their utility was high, the court concluded, and Gish's injury was “only remotely related” to those rungs.