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Products Liability

 Las Vegas Products Liability Attorneys                    WHAT IS PRODUCTS LIABILITY LAW?                   

In a product liability setting, you are going to find one of three defects:

1.         Manufacturing Defect: Circumstances in which the claim is for one unit or a small number of units of an otherwise adequately designed product line that has become defective typically due to one of two things:

            1.         The raw materials that comprised the product are defective (MacPherson); or
           

            2.         There is some flaw in the quality control process;

                                    a)         There is a problem with the actual assembly of the product; or

                                    b)         There is a problem because of insufficient testing of the product
                                                after it is manufactured (Zahn).

2.         Design Defect: The stakes are much higher. The plaintiff is arguing that:

            1.         The entire product line is defective typically due to a failure to comply with state-of-the-art technology; or

            2.         There was a failure to incorporate a reasonable alternative design. Section 2,
                        subparagraph (b) of the Third Restatement (page 56 in supplement).

3.         Warning Defects: Based upon state-of-the-art information and science at the time of manufacture, did the defendant have a duty to warn?

            1.         Failure to Warn Claim: If they had a duty to warn and they did not provide a
                        warning; or

            2.         Inadequate Warning Claim: They had a duty to warn and they provided a
                       
warning, but for some reason the warning inadequately conveyed the magnitude
                        of the known risk.  

Defense attorneys in virtually every product liability case will somehow attempt to get the plaintiff’s conduct into the case as a defense: misuse of a product, comparative fault principals, proximate cause, assumption of the risk, and the sophisticated user defense that based upon your subjective knowledge, a different standard should apply to you. I cannot over-emphasize how important plaintiff’s conduct often is as a defense to a product liability claim.

Federal Preemption: The Supremacy Clause (Article VI, cl. 2 ) tells us that federal law is the supreme law of the land. If there is a conflict between state law and federal law and that conflict cannot be resolved, the doctrine of federal preemption will preempt the State law claim. This is important in the product liability realm because there is a number of federal statutes that pertain to product liability that have preemption provisions: Medical Device Act (Lohr v. Medtronic). FIFRA regulates the warnings on pesticides and insecticides – has an express preemption provision. NHSTA tells automobile manufacturers what kind of restraint systems they have to put in has a preemption provision. The Cigarette Act has a preemption provision.

Las Vegas Personal Injury Attorney

Las Vegas Injury Attorney Paul Adras understands Nevada products liability and products liability law. Attorney Paul J. Adras has a scientific background and expert knowledge.  Las Vegas products liability attorney Paul Adras earned his bachelor’s degree in biological sciences with a minor in chemistry before going to law school. His skills and knowledge of products liability law will help you prevail in court. Call Attorney Adras today at: 702 489-2264

More About Federal Preemption  

What makes preemption so dramatic and so different is you can have a client that has been catastrophically injured and there’s no issue about liability, but if there is a federal statute that regulated that field, it may very well preempt what would otherwise be a blockbuster case – it’s a threshold defense. If federal preemption is found to apply, you never get the opportunity to argue the merits of the case.

Sales vs. Services dichotomy: We know that for purposes of strict liability, we need a seller of a product. Two critical terms of art: Seller and Product. Most times it will be obvious we have a seller. In the case of tainted blood, is the hospital a seller of blood to whom strict liability should apply? No. Can you sue a physician for a faulty knee replacement in strict liability as a seller? The answer tends to be no. We will discuss who will qualify as a seller.  

Special issues in automotive litigation: crashworthiness. One of the most complex types of products liability cases. If you have a product liability involving an automobile, fundamentally you have one of two fact patterns:

1.         A defect in the automobile caused an accident to happen Brakes don’t work, accelerator   sticks, etc.

2.         Crashworthiness. The allegation is not that the defect caused the accident; instead you are arguing the defect enhanced the injury. These are often called second-collision cases. The first collision is when you hit the tree; the second collision is the internal collision when your body strikes the dashboard. In the crashworthiness cases you are alleging that the automobile was defective for not being crashworthy. Plaintiff’s conduct: should it matter that plaintiff’s conduct contributed to the happening of an accident? Should that impact crashworthiness? Should your comparative fault be measured visa vie crashworthiness?

FIRST THEORY OF RECOVERY: NEGLIGENCE

The development of theories in products liability is very interesting. The way that you learn tort law is you are led to believe that strict liability is this grand and majestic thing. We have a tendency to back away from negligence a bit thinking that strict liability is all the rage. Negligence based theories remain the heart and soul of product liability litigation. Most products liability cases at some level, conjure up notions of the defendant’s fault or conduct. In fact, it is the relatively rare case in which there is true strict liability.

“More plaintiffs would prefer to present their respective cases to a jury on a negligence, theory rather than on a strict liability basis. Negligence is “hot” and strict liability is “cold.”  It is easier to prevail by showing that the defendant did something wrong than that there is something technically defective about the product.”

Las Vega juries seem to be more receptive to plaintiff’s causes of action that sound in negligence – where you can show the jury fault on the part of the manufacturer. Some of the Vioxx cases have been multi-million dollar verdicts. Why? Because juries have been sitting there listening to testimony about what corporate people knew the dangers of Vioxx – it’s a negligence based case. In order to ever get to punitive damages as a practical matter, unless you find a lot of dirt you’re never going to get past compensatory damages in a products liability claim.

Many judges have stated that the basis of strict liability in design and warning cases is similar – if not identical – to negligence liability.

Jurors respond more favorably to plaintiffs – in terms of both the likelihood of success and verdict size – whose claims are based on negligence rather than strict liability.  

PRIVITY OBSTACLE

MacPherson v. Buick Motor Co. 

NY, 1916, J. Cardozo

The Foundation:

From 1842 onward thanks to Winterbottom v. Wright, unless you were in privity with the direct upstream entity, you could not sue beyond in a chain of distribution in a products liability case. Without privity, you could go no further than the immediate upstream entity.  

There were a couple of exceptions to the privity bar:

1.         Imminently dangerous to the life or health of man kind; and

2.         An article known to be imminently dangerous to life or limb

The case law surrounding those exceptions tended to limit the abolition of privity to things like poisons, explosives and the like. Privity was not an obstacle if you were injured by one of those products. Unless you fit into one of those categories, you could not get upstream to the manufacturer. 

There is no question MacPherson has privity with Close Bros. and they would be liable to him, but they don’t have “deep pockets.” Their liability is more illusory than real.

The attorney for Buick, William Van Dyke, is really arguing this case to keep it out of the exception of an article known to be imminently dangerous to life or limb. Van Dyke’s argument is a historical argument: An automobile should be distinguished from things like poisons and explosives – it does not lend itself to the privity exception.

“The question to be determined is whether the defendant owed a duty of care and vigilance to any one but the immediate purchaser.”

“Subtle distinctions are drawn by the defendant between things inherently dangerous and things imminently dangerous, but the case does not turn upon these verbal niceties.”

Cardozo to some degree tailors his opinion in response to Van Dyke’s argument therefore rejecting it.

“…Irrespective of contract, the manufacturer of this thing of danger is under a duty to make it carefully. If he is negligent, where danger is to be foreseen, a liability will follow. We have put aside the notion that the duty to safeguard life and limb, when the consequences of negligence may be foreseen, grows out of contract and nothing else. We have put the source of the obligation where it ought to be.  We have put its source in the law.”  

Cardozo does away with privity of contract and what does he cite? The law. Gone are the days of the stagecoach.  Irrespective of contract, a duty arises in law, in equity, in fairness that a duty extends not only to the immediate party, with whom you are in privity but to foreseeable downstream entities as well, i.e. the consuming public.

“We think the defendant was not absolved from a duty of inspection because it bought the wheels from a reputable manufacturer.”

Manufacturer responsible for defective materials and components – an important issue in products liability cases. The manufacturer of the finished product cannot delegate its duty to a component part manufacturer. This is a great example of a non-delegable duty.

“We think that the defendant was not absolved from a duty of inspection because it bought the wheels from a reputable manufacturer. It was responsible for the finished product.” 

Either Buick is negligent for not inspecting the wheel or Buick, in the modern context, would be strictly liable for a component part.

“The obligation to inspect must vary with the nature of the thing to be inspected. The more probable the danger, the greater need of caution.”

In a modern case, you sue Close Bros., you sue Buick and you might sue Imperial Wheel as well. If the plaintiff for whatever reason chooses not to sue Imperial Wheel, if Buick is found liable, they can start an action for contribution against Imperial Wheel. 

This case and the next two cases are manufacturing defect cases where negligence works. In practice, manufacturing defect cases are often the cases where you really need strict liability in its purest form. For example, in today’s world of sophisticated products, it will often be impossible to unearth a latent defect without totally disassembling the product. We don’t expect a retailer of a product to disassemble it to try to find a latent defect. Very often in manufacturing defect cases by their very nature an inspection will not reveal a defect and therefore there really is not a breach of a duty of reasonable care. Today, many manufacturing defect cases will require you to use the strict liability formula.

MANUFACTURING PROCESS: FABRICATION AND QUALITY CONTROL

 Jenkins v. General Motors Corp.

US Court of Appeals, 5th Cir, 1971

There’s an accident and an allegation of a bolt falling out and the car goes off the road.

Negating Other Possible Causes

Jenkins’ witnesses, including the trooper who investigated the accident scene, established that there was no evidence of excessive speed, of use of alcohol, or improper driving. One of the ways in which you often prove a manufacturing defect case involving an automobile is to negate other possible causes of the accident. The plaintiff has a theory of how this accident happened – there was a manufacturing defect, and it caused him to go off the road. You support that contention by rebutting or negating other possible explanations. As you rebut or negate all of those other possible explanations for why the accident happened, you are making it more probable than not that the defect proximately caused the accident.

If you take a products liability case, be prepared to spend a hell of a lot of money putting it together. As a practical matter, it is hard to imagine a products liability case that you can get to a jury without expert testimony. Lay person testimony is not going to suffice in these cases. The question becomes, how many experts are you going to need?

Equiponderant: Being of the same weight, could go either way.

Beware of the expert who is a “professional” witness! “Professional expert witnesses are troublesome.” You do need to know who the best experts are. Be careful of those who do just forensic work and not any independent research. If they have abandoned their practices or professional base, you run the risk of the jury being polluted by the “professional expert.”

Expertise" In evaluating a manufacturer’s conduct, note that manufacturers are “held to the skill of an expert in that business and to an expert’s knowledge of the arts, materials, and processes. Thus manufacturers must keep reasonably abreast of the scientific knowledge and discoveries touching their products and of techniques and devices used by practical people in their trade.

Constructive knowledge. When we are talking about a negligence based standard of reasonable care, you are to assume that if there was information available to make a product safer – if that information existed and a manufacturer failed to use it, they had constructive knowledge of it even if they did not have actual knowledge.

For the reasonable care standard, you should hold a manufacturer to be an expert in the field who either has actual or constructive knowledge of all of the state-of-the-art information.

Physicians are not held to that same standard. The standard is the reasonable mediocre doctor – not the best doctor. There is no such thing in products liability; we hold manufacturers to be experts in their fields.  

Ford Motor Co. v. Zahn

US Court of Appeals, 8th Cir, 1959

Having a cigarette which is inadvertently dropped on the floor of the car, as the plaintiff reaches down, the driver slams on the brakes and plaintiff’s head hits the dashboard and gets his eye caught on the jagged edge of a defective ashtray and later loses the eye.

The defendant admitted that they did not test every product, instead, they did sample or spot testing. The defendant’s argument was this is the wrong harm – we do not have to anticipate or foresee the unusual occurrence and resulting injury to the plaintiff. We anticipate that you cut your finger or clothing snagged. They are basically saying, because the anticipated harm in this case was negligible, all that we had a duty to do was what we did – spot checking. They are defending their testing procedures by saying that the foreseeable range of harm in this circumstance is negligible.

The Third Restatement section on physical and bodily harm has a suggested limitation on liability: In a negligence case, liability should be limited to those harms whose risks made the actor’s conduct tortious.

Example: Give a child a gun and they shoot someone, you are negligent. If he drops the gun and hurts toe, the harm does not match the foul; therefore, not negligent.

This notion of limiting liability to those harms, whose risks made the actor’s conduct tortious at least arguably, is a more concrete way to limit negligence liability.   

Caputzal v. Lindsay Co.

Supreme Court of NJ, 1966

After a water softener is installed, plaintiff drinks coffee with discolored water and upon recognition of that fact has a heart attack.

The court rejects the plaintiff’s case and says there are two ways we can reject this claim: The Front Door (duty) or The Back Door (causation). In Palsgraf, Cardozo rejects Mrs. Palsgraf’s claim at the front door. Andrews said not only did they have a duty but once they set that stream of events in motion, we go all the way to causation.

Here, the court says the first way is through duty: “The question is whether liability therefore should be imposed on a manufacturer, seller or installer…with respect to other types of distant consequences.”

“Whether a duty exists is ultimately a question of fairness. The inquiry involves a weighing of the relationship of the parties, the nature of the risk, and the public interest in the proposed solution.”

Yes we talk about foreseeability but in real practical terms, this is what duty is all about.

In the instant case it is much too fanciful to say, from the point of view of fairness, that a reasonable manufacturer, seller, or installer of water softeners should be held to recognize that he would create this kind of injury – no duty to foresee these extraordinary circumstances.

Even if we got to proximate cause, the determination of proximate cause is to be based upon logic, common sense, justice, and precedent.

We would expect some type of gastric harm but not a heart attack. Looking back from the harm to the actor’s negligent conduct, it appears to the court highly extraordinary that it should have brought about the harm.


REVIEW

 

Manufacturing defect cases are often one of the most important circumstances for strict liability in tort. The nature of a manufacturing defect of some flaw, quality control issue, or a latent defect in a sealed product will often be very difficult to show a negligence theory. But in a case like MacPherson where a reasonable inspection would have unearthed the defect, the plaintiff is able to get to a jury on a negligence theory. In a lot of circumstances that will not be the case.

 

Caputzal case: Negligence case where we talked about a range of recoverable injury – the right or wrong type of harm. The fright of ingesting discolored water causing a heart attack seems to be outside the realm of foreseeable harms created by the negligence. If we get past duty and breach, we can deny liability by saying the defective water softener was not a proximate cause of the heart attack.

 

Zahn case. The Third Restatement of Torts regarding apportionment of harm and physical harm talks about a negligence case limiting liability to that type of harm that made the actor’s conduct negligent.

 

Note 6, page 59. A manufacturer of a finished product will inevitably be responsible for the negligence of its component part manufacturer. In the modern context, the end product manufacturer is strictly liable for its component part manufacturer but in the MacPherson case, Buick tried to slough off liability to Imperial Wheel. Cardozo was having none of this. This note reiterates Cardozo’s holding – component manufacturers cannot delegate a duty to safeguard products. In a modern context, the manufacturer could implead the component part manufacturer for purposes of contribution.

 

Design Defect Case: The plaintiff is arguing that the entire product line was defective typically because defendant failed to comply with best state-of-the-art technology or best information. It also means that the defendant failed to adopt a reasonable alternative design.

 

Section 2(b) of Restatement (Third) of Torts:

 

A product is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.

 

I don’t know of many jurisdictions today in which a plaintiff’s lawyer trying a design defect case will get to a jury without proof of a reasonable alternative design. It is never enough to simply criticize a preexisting design – you have to critique it and you have to suggest how it could have been better. If you cannot do that, it is very unlikely that you will get past summary judgment.  

 

Metzgar v. Playskool

US Court of Appeals, 3rd Circuit, 1994

 

The child who dies is 15 months old. Recommended age group on the box: 1½ to 5. The kid is slightly younger than the suggested age range for the product. Already you are thinking: misuse. You are also probably thinking: foreseeable misuse. Is it foreseeable that a child slightly younger than the suggested age might use these blocks? What if he has older siblings?

 

He puts the child in the playpen, comes back in five minutes and the child has choked to death. You’ve got a wrongful death case but also when the father qualifies for a beneficiary, one of the arguments that Playskool will make is negligent parental supervision in an attempt to diminish the wrongful death recovery of the father.

 

The district court renders summary judgment against the plaintiff on all counts. We are up on appeal in the Third Circuit.

 

Size and shape of the block satisfied existing federal standards and regulations for risk mitigation and cautionary labeling promulgated and enforced by the Consumer Products Safety Commission and under the Federal Hazardous Substances Act.

 

Compliance with a statutory standard is evidence of due care, but it is not conclusive on the issue. Such a standard is no more than a minimum. Henke: Yes the block complied with the minimum safety standard but virtually every jurisdiction in the country treats compliance with government standards in a products liability case as only some indication of reasonable care – it is not dispositive.

 

A federal statute or regulation may preempt state products liability law, in which case compliance is a complete defense.

 

Carefully distinguish between government standards and regulations which are only minimum standards versus certain statutes that have preemption provisions that will entirely regulate a field and preempt state common law.

 

This drives defense lawyers crazy: Compliance with a government standard is only seen as some indication of reasonable care, but if you flip the tables, failure to comply with a government standard is generally negligence per se.

 

In the last 20 years, no deaths or injuries were reported from the use of this block but in one year studied there were 11 deaths due to aspiration of small toys or toy parts by children.

 

You’re getting a BPL feel in that paragraph – there’s a very slight risk of a catastrophic harm. The Probability or Possibility (P) of harm is low, but if a harm or Loss (L) occurs it is likely to be catastrophic.

 

What would the Burden (B) have been for Playskool to change the design of the block? It appears that a slight modification to the design could virtually eliminate the choking potential without detracting from the block’s utility (Reasonable Alternative Design).

 

Although the block was in technical compliance with the standards, the block only minimally met the required standards. Reversed and remanded.

 

Note 3: Defendant’s in products liability cases routinely make two arguments:

 

1.         They comply with government standards; and

 

2.         The design we used complied with custom in the industry. Your treatment of compliance   with custom, for purposes of negligence, should be the same as your treatment of       compliance with regulations.

 

While industry practice or custom is important evidence of reasonableness, it generally is not conclusive since the industry as a whole may have been derelict in failing to adopt precautionary procedures. State-of-the-art technology is out there and industry fails to adopt it – even if it is cost efficient because of laxness. Often times custom in the industry lags behind prevailing state-of-the-art technology and in recognition of that lag, courts treat compliance with custom the same way they treat compliance with government regulations. A defendant cannot simply rest by arguing that everyone did the same thing.

 

The Learned Hand Formula: The degree of care demanded of a person by an occasion is the resultant of three factors:

 

1.         The likelihood that his conduct will injure others, taken with;

 

2.         The seriousness of the injury if it happens, and balanced against;

 

3.         The interest which he must sacrifice to avoid the risk.

 

When you are analyzing negligence in a products liability case, especially in a design defect case, be mindful of the BPL formula because it’s all about reasonable alternative design.

 

Posner, A Theory of Negligence. Tort law from an economic standpoint attempts to balance the cost of accidents and the cost of prevention. At some point, if it costs the company more to prevent accidents than it does to compensate victims for the happening of those accidents, the negligence regime would suggest that some accidents then should simply happen (Ford Pinto litigation). This does not however take into account the specter of punitive damages. Posner’s essay is only contemplating compensatory damages. Indignation has its roots in inefficiency (i.e., punitive damages). Anger and passion are inefficient. Perhaps the dominant function of the fault system is to generate rules of liability that if followed will bring about, at least approximately, the efficient – the cost justified – level of accidents and safety.

 

Tort reformers’ argument: The specter of liability may drive the product off of the market or drive the manufacturer out of business.

 

The heart and soul of the BPL test is an attempt to generate that kind of economic efficiency.

 

Mesman v. Crane Pro Services

Seventh Circuit, 2005, Posner

 

Because of the deceleration feature – of which he was aware, the operator knew about the lag time of the “down” button. The district judge from the lower court found for the defendant and set aside judgment on an open and obvious danger issue even though the jury assigned 2/3 fault to the employer and 1/3 fault to Konecranes, the re-manufacturer of the crane. No fault to the operator.

 

In design and warning claims, you have to show fault. Whether or not you couch a design or warning claim in negligence or strict liability terms, make no mistake that fault is something you are going to have to show.  

 

BPL Analysis

 

Posner is still citing Carroll Towing and Posner applies BPL beautifully. In this case the risk, which was substantial, of an injury that would be likely to be serious could have been eliminated at little cost simply by removing the cab or taking away the deceleration button – two easy ways to virtually eliminate all the risk and neither one of them is adopted. Classic BPL scenario.

 

Certainly in the heat of the moment, it is foreseeable to press the wrong button; therefore creating a duty to remove the cab or to remove the deceleration feature. The burden in this case is slight versus the catastrophic harm.

 

Negligence Concept

 

In a manufacturing defect case, strict liability will often be necessary. In a design defect, negligence is critical because a failure to adopt a reasonable alternative design will be a breach of reasonable care. Negligence in its purest form is the lynch pin of warning defect cases as well.

 

What we are looking at in a warning defect case is based upon state-of-the-art knowledge at the time the product was manufactured, should the manufacturer have incorporated a warning and they failed to (failure to warn claim) or based upon state-of-the-art knowledge and information the at the time of manufacturer, does the warning that they included adequately convey the magnitude of the known risk and does the warning and/or instructions sufficiently convey all of the appropriate information to the user in terms of how he conducts himself in relationship to the product.

 

In Boyl, it’s the second part of the warning calculus that is problematic. There is plenty of information on how toxic this product is. Was the user adequately informed about the disposal of the product? Negligence in warning cases is all about knowledge and whether a company acted reasonably with that knowledge.  

 

Boyl v. California Chemical Co.

US District Court, OR 1963

 

Plaintiff uses and dumps weed killer onto her lawn. Five days later, the plaintiff unfortunately decides to sunbathe in the same spot where she dumped the excess arsenical weed killer. She suffered acute physical malfunction and her medical treatment extended over 18 months.

 

BPL has little place in a warning defect case. What does it cost a company to put a warning label on a product? And it may help with the utility of the product. Warning Pollution: Too many warnings dilute the efficacy of the ones that matter. There is no burden whatsoever for a company to put a warning language on a product.

 

If analyzing a warning defect claim, stay away of BPL and go with Note 5: this test is generally inapplicable to a warning defect case because a warning will almost always make a product safer and not detract from its utility.

 

There was no warning or protective advice as to the disposal of the fluid. The warning did not indicate long lasting affect of the product.

 

A manufacturer who undertakes to produce and sell to the general public a product with high risk of human harm must provide specification, instruction, and warning so that it is reasonably safe for ordinary persons to use it, not only for the purposes for which it is produced and intended to be used but also all other necessarily incidental and attendant uses (such as storage or disposal) and to give reasonable notice and warning of after or delayed effect or latent or lingering dangers not known or reasonably to be expected by the ordinary user, but which are “foreseeably probable” to the manufacturer with his expertise.

 

Was it foreseeable that a person informed of the danger of contact with Triox would dump out the residue and lie down right in it? That may very well be a jury question.  

 

Reasonable Care: Expert in the field, Constructive knowledge: in a negligence case, you are to hold the manufacturer to the standard of an expert in the field. Assume that the manufacturer has knowledge of all possible risks, knowledge of all RAD’s and constructive knowledge – even if they don’t know of some technological innovation or even if they don’t know about a new side effect – if that knowledge exists, conclude that they know it constructively. Constructive knowledge should be your benchmark especially in the warning and design claims. If that RAD existed, assume they knew about it. If that side effect to a drug existed, i.e. Vioxx, assume that Merck knew about it. Use the expert in the field standard as well as the constructive knowledge standard as a benchmark for reasonable care.  

 

MISREPRESENTATION

 

Baxter v. Ford Motor Co.

Supreme Court of WA, 1932

 

The infamous shatter-proof glass case – especially where there are women and children.

 

The plaintiff loses at the trial court level. The trial court judge would not allow the entry of the representations and catalogs into evidence. How do you try a misrepresentation case if the jury can’t consider the misrepresentations? The case was retried and the plaintiff prevailed.

 

402B Misrepresentation Elements:

 

1.         A misrepresentation very element driven, can be broken down into four species:

               a)  Silence (A failure to speak being a misrepresentation)

               b)  Negligent speech

               c)  Deceit (synonymous with intentional misrepresentation and fraud)

               d)  Innocent misrepresentation (a good faith statement that turns out not be true)

 

2.         of a material fact, something of no consequence –  no harm, no foul

 

3.         made with an intent to induce reliance, a statement is made or not made to reel   the
            person in

 

4.         actual reliance, you got me

 

5.         justifiable* or reasonable reliance, to what extent do you have to be savvy or a dupe?      There is no need for reliance under strict liability.  

 

6.         and damages.

 

*402B Comment j. Justifiable Reliance. It does not apply where the misrepresentation is not known, or there is an indifference to it, and it does not influence the purchase or subsequent conduct.



The reason why 402B is not used more is because if you plead your claim in strict liability, you need not show justifiable or actual reliance. In essence, strict liability in tort implies reliance whereas 402B requires an actual showing of reliance. Why put your client in a position of having to show reliance when reliance is essentially read into strict liability?

 

Hauser v. Squats

Supreme Court of CA, 1975

 

“Golfing Gizmo”

 

The representation: “Completely safe, ball will not hit player.” The plaintiff took a swing and the last thing he remembers was extreme pain and dizziness. After a period of unconsciousness, he suffered brain damage and became an epileptic.

 

This is another thematic issue in these cases: justifiable reliance vs. puffery. The court concluded that the representation statement was worthy of reasonable and justifiable reliance. When the catalog mentions that you’ll be playing like Jack Nicklaus and that golf pros will be watching you admiringly – that is puffery.

 

When companies put products on the market with representations and warranties, in the modern context, the puffery arguments become harder and harder to make.

 

Although the defendants claim they did not intend their statement to cover situations such as the one at bar, subjective intent is irrelevant. The question is not what a seller intended, but what the consumer reasonably believed. The rule “is one of strict liability for physical harm to the consumer, resulting from a misrepresentation of the character or quality of the chattel sold, even though the misrepresentation is an innocent one, and not made fraudulently or negligently.”

 

 

  

EXPRESS WARRANTY

 

UCC § 2-313. Express Warranties by Affirmation, Promise, Description, Sample

 

(1)        Express warranties by the seller are created as follows:

           

            (a)       Any affirmation of fact or promise made by the seller to the buyer which relates
                        to the goods and becomes part of the basis of the bargain
creates an express
                        warranty that the goods shall conform to the affirmation or promise.          

 

402B requires actual reliance. The conceptual similarity here is under express warranty you have to show that the warranty became a basis of the bargain

 

Kolarik v. Cory International Corporation

Supreme Court of IA, 2006

 

Olive pit case

 

This is a classic manufacturing defect case – one unit is no good, you happened to get a bad olive. Almost always these bad food cases fall under the heading of a manufacturing defect case

 

Even though there is a general expectation that the pits are gone, the court declared: “[E]xpress warranties…must be read in terms of their significance in the…trade and relative to what would normally pass in the trade without objection under the contract description.”

 

Given the evidence of how the defendants receive and resell these olives, it is unrealistic to impart to the description “minced pimento stuffed” the meaning that defendants are guaranteeing that the olives in the jar are entirely free of pits or pit fragments.

 

In order for these olives to be merchantable, every now and again an olive still might have a pit, therefore, no breach of an express warranty.

 

The counterpoint is the Lane case (canned chicken) in the notes. “No bones,” no doubt, means to the manufacturer that great care has been used to remove all bones and all pieces of bone, but we think it would mean to a buyer that no bones whatsoever would be found in the product. The judge said with respect to the theories of the defendant, it may be asked, how many bone fragments would be permissible without contradicting the representation that there were no bones? Two bones? Six? Ten?

 

It is axiomatic that breach of express warranty requires no showing of fault and thus is truly “strict” liability. Henke: Most products liability lawsuits are all about fault. You have to show that a defendant has done something wrong. Did they breach a duty of reasonable care? The primary exception to that statement is an express warranty case. If you’ve got an express warranty claim, I can’t agree more with note 3 – it’s not about fault. As long as you can show that the warranty was a basis of the bargain between the manufacturer and your client, and as long as you can interpret the language in favor of your client – if you’ve got an express warranty and its been breached, it’s a slam dunk case – it’s not about fault. 

 

Moreover, you don’t have to show a defect other than a failure to conform to the warrantor’s representations. All you have to show is that you made a promise – a warranty – and you didn't’t keep it.

 

Stang v. Hertz Corp.

Court of Appeals, NM, 1971

 

The potential shortcomings of the express warranty theory

 

Nuns rent a car from Hertz and they suffer a tire blow-out and one of the nuns is killed in the accident.

 

There is no evidence that any of the nuns relied on, or in any way considered, the rental terms before agreeing to the rental. The case is falling apart because the representation of the warranty was not a basis of the bargain. A lot of express warranty claims will fall apart if you cannot show that your client’s purchase in any way depended upon that warranty.

 

Although their express warranty claim failed on the issue of basis of the bargain, the court went on to find strict liability in tort. If we rent a car from Hertz and a tire blows out, most jurisdictions hold that those who are in the business of leasing products will be held strictly liable for injuries.

 

IMPLIED WARRANTY OF MERCHANTABILITY

 

UCC § 2-314. Implied Warranty: Merchantability; Usage of Trade

 

(1)        A warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is a merchant with respect to goods of that kind.

 

(2)        Goods to be merchantable must be at least such as

 

            (c)        are fit for the ordinary purposes for which such goods are used;

 

If you sell a used car to a friend and that car malfunctions, a claim for breach of the implied warranty of merchantability will not succeed because you are not a seller or merchant with respect to those goods.

 

Shoes must have their heels attached so that they will not break off under normal use, but if those shoes are used for mountain climbing, there is no implied warranty that the heels will be fit for this extraordinary purpose.

There is a sense of misuse in (2)(c). Not only do we need a merchant but we need the goods to be used for their reasonably foreseeable purpose.

 

A plaintiff can also succumb to affirmative defenses (booby traps) that the defendant may raise, for instance, warranty disclaimed, notice of breach not timely, assumption of the risk, or statute of limitations.  

 

Yes the UCC giveth, creating theories upon which to bring a products liability claim, but it may taketh away as well. It also indicates that implied warranties are more easily disclaimed than are express warranties.

 

Henningsen v. Bloomfield Motors, Inc.

Supreme Court of NJ, 1960

 

Manufacturing defect case

 

The warranty language: This warranty being expressly in lieu of all other warranties expressed or implied, and all other obligations or liabilities on its part. Its obligation under this warranty being limited to making good at its factory any part or parts thereof which shall, within 90 days after delivery of such vehicle to the original purchaser or before such vehicle as been driven 4000 miles.

 

In essence what the Henningsens have signed is a contract by which they agree that the only damages to which they are entitled, is basically direct economic loss for defective parts within 4000 miles. And they have basically waived their rights to recover any consequential damages for personal injury that might ensue as a result of those defects.

 

The court noted that such attempts at avoiding the obligations that normally attend a sale are not favored, and are strictly construed against the seller.

 

Points to keep in mind:

 

1.         In a contract between a consumer and a commercial entity, already your suspicions should be aroused – the court will strictly construe an attempt like this to limit liability.


2.         The trial court dismissed the negligence count. The defect in this case is a latent defect that would not be discovered with a reasonable inspection. In this case, there is no breach of reasonable care (as opposed to MacPherson). Res ipsa loquitur does not work either because there is no exclusive control and possession of the manufacturer (660 miles from Detroit to Bloomfield). We are not at strict liability yet so the only remedy is breach of implied warranty of merchantability.

3.         J. Francis: “The language gave little and withdrew much.” This is a contract of adhesion. All judges are chancellors and cannot fail to be influenced by any equitable doctrines that are available. Principals of fairness and equity suggest to Justice Francis that they should not be bound by such a sharp deal.  

DISCLAIMERS UNDER THE UCC

UCC § 2-316. Exclusion or Modification of Warranties

(2)        The language must mention merchantability and in case of a writing must be conspicuous.

(3)        (b)        when the buyer before entering into the contract has examined the goods or the sample or model as fully as he desired or has refused to examine the goods there is no implied warranty with regard to defects which an examination ought in the circumstances to have revealed.

Open and Obvious Dangers. If the buyer discovers the defect and uses the goods anyway, or if he unreasonably fails to examine the goods before he uses them, resulting injuries may be found to result from his own action rather than proximately from a breach of warranty. Henke: The implied warranty will not even apply.

Dorman v. International Harvester Co.

Court of Appeals, CA, 1975

 

Our first economic loss case

 

In a case of economic loss only, UCC theories are your exclusive remedy and only theory of liability.

 

The issue of conspicuousness is a question of law. It is for the court to determine whether or not something is sufficiently conspicuous.

 

Section 2-316 seeks to protect the buyer from the situation where the salesman’s “pitch,” advertising, brochures, or large print in the contract, giveth, and the disclaimer clause – in fine print – taketh away.

 

Three ways to attack a disclaimer under 2-316:

 

1.         Failure to be conspicuous;

2.         Being ambiguous Strictly construed against the drafter and;

3.         Unconscionability (See cases below)

 

 

The language of the disclaimer was not sufficiently conspicuous to have negated the implied warranties, particularly where no standard printed warranty was in fact given to Dorman at the time of execution of the contract. The court concluded that the disclaimer was insufficiently conspicuous to inform a reasonable buyer that he was waiving his right to have a quality product.

 

Burden of Pleading and Proof. As an affirmative defense, a disclaimer must be pleaded affirmatively in the defendant’s answer. And the burden is upon the party asserting the disclaimer to establish that it was delivered at the time of sale and constituted an integral part of the transaction.

 

LIMITATIONS UNDER THE UCC

 

UCC § 2-719. Contractual Modification or Limitation of Remedy

 

(3)        Consequential damages may be limited or excluded unless the limitation or exclusion is unconscionable. Limitation of consequential damages for injury to the person in the case of consumer goods is prima facie unconscionable but limitation of damages where the loss is commercial is not.  

 

McCarty v. E.J. Korvette, Inc.

Court of Special Appeals of MD, 1975

 

You want to be clear about the differences between 2-316 and 2-719. 2-316 is all about total disclaimers – disclaiming liability altogether. 2-719 is all about limiting or tailoring the available remedies for a breach.

 

A disclaimer clause is a device used to exclude or limit the seller’s warranties; it attempts to control the seller’s liability, by reducing the number of situations in which the seller can be in breach. An exclusionary clause [limitation of remedies] on the other hand, restricts the remedies available to one or both parties once a breach is established. Assume for example that a new-car buyer sues for breach of warranty, and the seller raises defenses based on disclaimer and exclusionary clauses. The disclaimer defense denies the existence of any cause of action. The exclusionary-clause defense, on the other hand, denies that the buyer is entitled to the remedy he demands – for example, consequential damages.

 

Consumer Goods: Goods used or bought for use primarily for personal, family or household purposes, e.g., family car, etc. Approximately one-half of all products liability cases involve commercial, rather than consumer goods.

 

UCC § 2-302. Unconscionability. If a court finds a limitation of remedy to be unconscionable, this section permits the court in its discretion to refuse to enforce the contract as a whole, if it is permeated by the unconscionability, or to strike any single clause or group of clauses which are so tainted or which are contrary to the essential purpose of the agreement, or to simply limit unconscionable clauses so as to avoid unconscionable results. Thus, any clause purporting to modify or limit remedies in an unconscionable manner is subject to deletion and will not be given effect.  

 

Tire blow-out note case Collins v. Uniroyal, Inc. (NJ 1974): “If it only saves your life once, it’s a bargain.”  The court remarking on the manufacturer’s statement said, “[I]t appears to us patently unconscionable for the manufacturer to be permitted to limit his damages for a breach of warranty proximately resulting in the purchaser’s death to a price refund or a replacement of the tire. Thus the statutory presumption of unconscionability was not here overcome.”  

 

The court, consistent with 2-719(3) found that the limitation of consequential damages to the value of a new tire was prima facie unconscionable.

 

Prima facie unconscionable suggests that there ought to be circumstances where a manufacturer, even in the case of consumer goods, would be able to support a limitation or be overcome. Here’s the crux of the matter: I am not aware of a published decision in which any court has ever upheld this kind of limitation in a case of consumer goods. 2-719 is a limitation that is typically applied in commercial situations. If it’s a case of consumer goods, you can assume it is going to be unconscionable. If you have two commercial entities who want to limit consequential loss, that’s perfectly fine, but if you put together a consumer with consumer goods and a commercial entity, these limitations are not going to fly.

 

Ford Motor Co. v. Moulton

Supreme Court of TN, 1974

 

The differences between 2-316 and 2-319

 

“2-319(3) provides the limitation of consequential damages for injury to the person in case of consumer goods is prima facie unconscionable, but that Section does not control disclaimer of implied warranties. 

 

Subsection (3) recognizes the validity to clauses limiting or excluding consequential damages but makes it clear that they may not operate in an unconscionable manner. The seller is always free to disclaim warranties in a manner provided in 2-316. If you really want to limit your liability, why don’t you disclaim all warranties? Then you won’t have to worry about limiting damages. Don’t fool around with limitations on consequential loss which would be prima facie unconscionable to a consumer. If you really want to protect yourself, just make a disclaimer altogether.

 

If you are representing a plaintiff in a warranty claim and that plaintiff has been subject to broad-based disclaimers, I personally believe there are three avenues of attack:

  

1.         Conspicuousness;

 

2.         Ambiguity A disclaimer should be strictly construed against the drafter and any ambiguity in the language should be construed in favor of the person whom the disclaimer is being made and;  

 

3.         Unconscionability. If conspicuousness and ambiguity don’t work, I think that a lot of  courts are receptive to the third argument that under general unconscionability principals (2-302) the court ought to throw out the disclaimer as being unconscionable. I would limit this to the consumer/commercial entity settings.    

 

If two equally savvy commercial parties want to disclaim things or limit consequential damages it’s a different story.  

 

STRICT LIABILITY IN TORT

 

Escola v. Coca Cola Bottling Co.

Supreme Court of CA, 1944

 

Gibson, the Chief Justice, finds a cause of action under the inference of negligence provided by res ipsa loquitur.

 

In a case like Henningsen, where the negligence count was dismissed, in the context of modern manufacturing where products make their way half-way across the country, you can feel the problems with res ipsa loquitur. How do you argue that a manufacturer had exclusive control of the instrument when it’s gone half-way around the world?

 

Then Justice Traynor’s concurrence comes along. “In my opinion, it should now be recognized that a manufacturer incurs an absolute liability (Traynor uses “strict liability” in Greenman) when an article that he has placed on the market, knowing that it is to be used without inspection, proves to have a defect that causes injury to human beings.”

 

“Even if there is no negligence, public policy demands that responsibility be fixed wherever it will most effectively reduce the hazards to life and health….”

 

“People who are injured are not prepared for its consequences. The cost of an injury and the loss of time or health may be an overwhelming misfortune to the person injured, and a needless one, for the risk of injury can be insured by the manufacturer and distributed among the public as a cost of doing business.”

 

That is the foundation of our tort system.    

 

“The retailer, even though not equipped to test a product, is under [strict] liability to his customer….and should apply to all products, not just unwholesome foods.”

That principal will be adopted into 402A. I can’t think of any other concurring opinion that is as important as this one.

 

“The consumer no longer has means or skill enough to investigate for himself the soundness of a product, even when it is not contained in a sealed package, and his erstwhile vigilance has been lulled by the steady efforts of manufacturers to build up confidence by advertising and marketing devices such as trademarks.”

 

The general layperson cannot ascertain a latent defect anyway, but even to the extent that they could, because of the bombardment of advertising, they are not inclined to. As a skeptic of the consumer expectations test, we as laypeople, how should the expectations that we bring to a product have any ultimate relevance in terms of whether that product is adequately designed? 

 

 

Greenman v. Yuba Power Products, Inc.

Supreme Court of CA, 1963, Chief Justice Roger Traynor

A classic example of the benefits of strict liability in tort versus a warranty theory

The defendants argue that reasonable notice must be given of a breach of warranty. Traynor says that the notice requirement is not an appropriate one for the court to adopt in actions by injured consumers against manufacturers with whom they have not dealt.

As applied to personal injuries, and notice to a remote seller, it becomes a booby-trap for the unwary. The injured consumer is seldom “steeped in the business practice which justifies the rule.”

Justice Traynor is saying that we need to move away from the warranty theories because of the booby-traps and pitfalls. He takes us into the realms of strict liability.

“A manufacturer is strictly liable in tort when an article he places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being.”

Absolute liability should only apply in products whose risks are so high and whose utility is so low, that as a matter of public policy, if you make that product and someone is injured, you are responsible, period. It is limited to very few products. Traynor substitutes strict for absolute.

"The purpose of such liability is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves.”

“To establish the manufacturer’s liability it was sufficient that plaintiff proved that he was injured while using the Shopsmith in a way it was intended to be used (Suggesting that misuse may negate the strict liability claim) as a result of a defect in design and manufacturer of which plaintiff was not aware (Suggesting that notions of contributory or comparative negligence may temper the strict liability claim) that made the Shopsmith unsafe for its intended use.”

You have this sweeping opinion on strict liability in tort – the bedrock principles that if they put it out there and you get injured they’re going to pay you, but let’s not be so fast. They may not have to pay you if you are misusing the product or if you have knowledge of the danger and you proceed in the face of a known risk. The reason why I want to point out that language is because when we get to Section 402A, I think you are going to see that the ALI really took to heart Traynor’s qualifications at the end of his decision.

Two important terms of art in 402A:

(1)        One who sells; What constitutes a seller of a product for purposes of strict liability? It         will also include retailers, distributors, wholesalers and those who are in the business of        leasing products and renting cars. (Stang case)

Example:  If you go to a breast implanting surgeon and he does numerous implants every week and has a bulk-sale discount with Dow Corning to only do Dow implants.  And that implanting surgeon gives you a defective implant that ruptures, should that surgeon be held strictly liable?  Are they a seller of a product?  Who knows?  The word seller is not always obvious. 

            any product,  Is an animal purchased at Meijer’s considered a product? The third             Restatement says yes.

Example: If you buy a hamster at Meijer and it give you a communicable disease, is Meijer liable?  Yes, pets are products for strict liability treatment. 

Example: Electromagnetic Fields (EMF). Some of the science was a bit dubious but one of the threshold issues was whether or not EMF’s, generated by high tension power lines, constituted a product for purposes of 402A. Some jurisdictions said yes it was a product.

            in a defective condition unreasonably dangerous. That statement has not withstood    the test of time. It’s a dual requirement – you’ve got to show it’s defective and it’s really bad. Most jurisdictions today, in their basic definition of strict liability, when a judge is giving a jury instruction, they’ll say something like – you must find that the product was not reasonably fit, suitable and safe. That’s much more modern language. 

             …to the user or consumer (or to the foreseeable bystander – a bystander would have the  same claim that you would have) or to his property (Indicating that 402A principals apply to both personal injury and property damage).

             (a) If the seller is engaged in the business of selling such a product, The implied             warranty of merchantability only applies to those who are merchants with respect to  those goods. The person who is an occasional seller is not subject to strict liability.

            (b) it is expected to and does reach the user or consumer without substantial change   in the condition in which it is sold A frequent issue is, what happened to that product from the time it left the warehouse to the time you were hurt? (Substantial Alteration Defense). Judge Traynor was talking about misuse toward the end of Greenman, 402A is  talking more about alteration. 

(2)        This rule applies although

            (a) the seller has exercised all possible care in the preparation and sale of his    product The intent of (2)(a) is to distinguish this regime from negligence but this has not    withstood the test of time. We know today that strict liability and negligence have a lot of      similarity. The ALI was trying to suggest that strict liability would be different from   negligence.

            (b) the user or consumer has not bought the product from or entered into any             contractual relation with the seller. Also suggesting that this regime is supposed to be different from warranty theories.

Comment m:

The rule stated in this Section does not require any reliance on the part of the consumer. Why sue under 402B, where you have to show reliance, when you can sue under 402A where right in the terms of the comments of 402A we are told by the ALI that there is no reliance requirement. The rule stated in this Section is not governed by the UCC so it’s not affected by limitations, i.e. 2-719, disclaimers, or notice of breach – none of those apply. Those booby-traps that Traynor spoke about in Greenman are rendered moot in a 402A world. This is the bridge from Henningsen to Greenman and now to Section 402A.

Denny v. Ford Motor Co.

NY Court of Appeals, 1995

The court tackles the question of whether there is any substantive difference between a strict liability claim and a breach of the implied warranty of merchantability. 

Plaintiff was injured when she slammed on the brakes of her Ford Bronco II to avoid hitting a deer, and the vehicle rolled over. She starts a product liability lawsuit under theories of strict liability and breach of the implied warranty of merchantability.

The fundamental question the court wrestles with is, can a jury logically and consistently come to a conclusion in which they reject strict liability in tort but accept breach of implied warranty as a theory. 

In a design defect case you do a risk utility analysis. The court says that the risk-utility test for design defect has a negligence flavor to it. On the other hand, the UCC’s concept of a defective product requires an inquiry only into whether the product in question was “fit for the ordinary purpose for which such goods are used” (2-314 [2][c]).  

The cause of action is one involving true strict liability, since recovery may be had upon a showing that the product was not minimally safe for its expected purpose.

The court is saying that strict liability is really negligence and implied merchantability really is strict liability. The court is saying, if you violate Section 2-314 (2)(c) – If your product is not minimally safe, you can be subject to liability under the UCC whereas under a risk-utility test, it’s a very careful balancing of cost-benefit kind of thing.

Ford argues that this product performed exactly as we would expect it to. The main purpose of this product is for off-road use and the way it is designed is for that purpose.

The plaintiff argued that the product’s ordinary purpose was for routine highway and street driving and it was not fit or safe for that purpose – and the court buys into that. 

“A rational fact-finder could have simultaneously concluded that the Bronco II’s utility as an off-road vehicle outweighed the risk of injury resulting from rollover accidents (a jury could find that the product passes the risk-utility test, therefore no strict liability) and that the vehicle was not safe for the “ordinary purpose” of daily driving for which it was marketed and sold” (it fails under 2-314 [2][c]).  

Denny may be alone in this view. Other courts reason that strict liability in tort “is essentially the liability of implied warranty divested of the contract doctrines of privity, disclaimer, and notice.”

Strict liability and negligence are functionally the same in design cases and in warning cases. You do not need to bother trying to make hair-splitting decisions between the two.

When drafting a products liability complaint, for personal injury, will you include all theories of liability available? Yeah, because that’s how you draft a complaint. But when push comes to shove and you are preparing the case, I personally believe that very few cases will suggest to you strategically to go down the warranty road. Exception: If you have an economic loss case (just a crummy product), most jurisdictions require that you secure a remedy under the UCC.

If strict liability makes a difference it is in the “impure” defect case. Kroger doesn’t have a duty to open a container and find a latent defect but in a food example, they are strictly liable. In a lot of manufacturing defect cases, strict liability truly does make a difference. 

Disclaimers. Another key aspect of warranty law that led to the development of strict liability was the ability to disclaim. Strict liability does not allow for disclaimers. R III of Torts, Products Liability: Disclaimers and limitations of remedies, waivers, and other similar contractual exculpations do not bar or reduce otherwise valid products liability claims against sellers.

 THE DETERRENCE RATIONALE – ACCIDENT PREVENTION

Strict liability in tort creates a more powerful incentive for companies to act responsibly.

First National Bank v. Nor-Am Agricultural Products, Inc.

Court of Appeals of NM, 1975

In 1969, in Alamogordo, New Mexico, the Huckleby’s sat down to a meal of pork from a hog they had raised themselves. A year earlier, the pig had been fed grains that were not meant for consumption (animal or human), but only for planting more grains. They had been treated with the seed disinfectant Panogen-15, which contained methyl mercury.

The children suffered blindness and paralysis from mercury poisoning. 

Allowing injured plaintiffs to proceed on a theory of a manufacturer’s liability, without the necessity of proving negligence, will cause manufacturers to take cautionary steps to prevent the marketing of dangerously defective products.

I fail to think that the prospect of being held strictly liable in tort really impacts corporate behavior – Merck still makes Vioxx. The only thing that may impact corporate behavior is the threat of punitive damages.

THE CONCEPT OF DEFECTIVENESS

 Manufacturing Defect: You allege that one unit or a small number of units of an otherwise adequately designed product line that has become defective typically due to one of two things:

            1.         The raw materials that comprised the product are defective (MacPherson); or    

            2.         There is some flaw in the quality control process;

                                    a)         There is a problem with the actual assembly of the product; or

                                    b)         There is a problem because of insufficient testing of the product
                                                after it is manufactured (Zahn).

R III of Torts §2(a): A product contains a manufacturing defect when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product.

When we buy a product, we expect it to be good. We don’t expect it to hurt us or malfunction, yet intellectually, we have to know on some level that expectation is impossible to achieve. We know that in order for products to be affordable, on some level, they cannot be perfect. Some products are going to go out into the world and people are going to be hurt. Manufacturing defect cases speak to that underlying dilemma: expectations vs. reality.

When you define a manufacturing defect that is sort of the underlying question – how safe is safe enough to pass the legal test?

In a manufacturing defect case, you must show that the flaw existed at the time the product left the manufacturer’s control – that the flaw did not arise after the fact. That is a problem for plaintiffs in these cases time and time again. You’ve got to make sure that the problem was there originally.

Manufacturing defects by their very nature are unintended. Nobody intends to leave a part out of a machine. It’s not intended to be defective. In a design defect claim we are criticizing a conscious decision to make a product in a certain way.

Magnuson v. Kelsey-Hayes Co.

Court of Appeals of MO, 1992

Bystander case

A wheel and tire broke loose from a pick-up truck and struck and severely injured the four year old plaintiff.

The design of the wheel was reasonable but it was defectively manufactured. The steel forming the wheel was dangerously defective and that the wheel contained the defect when the defendants introduced it into commerce. Verdict for plaintiff: $4.75 million.

If you are analyzing a manufacturing defect case, you are going to set forth the definition of the concept, you are going to try and identify which one of these scenarios it is – is it bad raw materials or a quality control problem? You’re then going to talk about how you are going to prove the case:

Since the product may well have been damaged or destroyed in the accident, the crucial issue often is whether the flaw is shown to have resulted from a manufacturing error or from some other cause – such as normal wear and tear; abuse by the user; a mistake by a repair mechanic; or perhaps from the force of the accident itself.

What you are not going to do is talk about tests or analytical concepts – they don’t lend themselves to it. A product went out there, it had an unintended flaw, so let’s talk about how that happened as opposed to tests.

Liability is not based on fault but is truly strict in manufacturing defect cases.

Pouncey v. Ford Motor Co.

US Court of Appeals, 5th Cir., 1972

Appellee was injured while putting antifreeze in his 1966 Ford when the fan blade broke off and struck him in the face causing permanent facial disfigurement.   

The court had a jaded view of the case: “Not surprisingly, Ford’s expert witnesses took a different view of the facts.”

Alabama courts have freely permitted juries to infer manufacturer negligence from circumstantial evidence where there is in the record direct evidence of an actual defect in the product.”

Ford itself offered no evidence as to the quality control procedures actually employed with regard to the radiator fans produced in 1966. A jury could infer from this evidence negligence on the part of Ford in marketing a defective radiator fan which could reasonably have been expected to produce injury or damage. Reasonable people could differ on why the blade fractured.

A lot of manufacturing defect cases will be proved by circumstantial evidence because many times the actual evidence has been destroyed by the accident, spoliation, etc. 


MANUFACTURING DEFECTS (CONTINUED)

Proving the Case

The difficult thing about manufacturing defect cases is often how you prove the case. How do you prove the defect existed at the time it the manufacturer’s control as opposed to something happening to the product after it was out in the world?

Intellectually we know that products cannot be perfect. The amount of money a company would have to spend to even aspire to make perfect products would be so cost prohibitive that we would never be able to afford the product. Emotionally, when we buy a product we expect it to perform. If it fails to perform and we are injured, we expect a remedy. It’s heart vs. head.

The concept of defect is not self-defining when a product contains a flaw. Since all products are flawed at some technological level, the decision must still be made as to when a flaw emerges as a defect.

We struggle, as a matter of law, when a small imperfection becomes sufficiently significantly a legal defect and that’s often hard to identify. 

These cases tend to fall into one of two categories: Faulty materials or faulty assembly.

Delegation of Duty. Vandermark v. Ford Motor Co. (1964), Justice Traynor. “Since Ford, as the manufacturer of the completed product, cannot delegate its duty to have its cars delivered to the ultimate purchaser free from dangerous defects, it cannot escape liability on the ground that the defect in Vandermark’s car may have been caused by something one of its authorized dealers did or failed to do.” 

That’s as good a law today as it was back in MacPherson. We do not allow manufacturers to delegate the duty to safeguard the product to other entities. They can implead those other entities for purposes of contribution, but in the first instance they are primarily responsible for their finished products.  

Proof – The Malfunction Doctrine. There is no test if you will – it’s all about proof. Occasionally you are going to get direct evidence. In Henningsen (manufacture defect case), maybe we take a deposition and we find out that some guy on the assembly line was drunk and he left a part out of the car. You get direct evidence at a deposition of negligence. It is far more likely that the way in which a manufacturing defect case will be proved is through circumstantial evidence or negating other possibilities.

Ducko v. Chrysler Motors Corp.

Superior Court of PA, 1994

Plaintiff was driving a new 1985 Chrysler Fifth Avenue when the car suddenly jerked to the right and the steering felt like it locked. She attempted to apply the brakes, but they also failed to respond. The car crashed and plaintiff broke her back.

“From this circumstantial evidence, a jury may be permitted to infer that the product was defective at the time of sale.” 

That is about as common a sentence you are likely to see in a manufacturing defect case.

Negate Other Causes

The malfunction theory permits a plaintiff to prove a defect in a product with evidence of the occurrence of a malfunction and with evidence eliminating abnormal use or reasonable, secondary causes for the malfunction. The plaintiff is relieved from demonstrating precisely the defect yet it permits the trier-of-fact to infer one existed from evidence of the malfunction, of the absence of abnormal use and of the absence of reasonable secondary causes. 

Time Element

Where the alleged malfunction occurs shortly after the product has been delivered to the user (this was a new car), the inference that the defect originated with the manufacturer is stronger.

How long has the product been out there? As time goes by and there is more wear and tear on the product, the more difficult your circumstantial evidence case becomes.  

The Coke bottle in Escola had been there only a day. Change that fact pattern and have those bottles sitting around for a couple of weeks, under warm or cold conditions and you have a different case.

Plaintiff need not prove a specific defect, but may establish a prima facie case of defectiveness upon proof of a sudden malfunction, where other plausible causes are absent.

For circumstantial evidence to make out a prima facie case, it must tend to negate other reasonable causes, or there must be an expert opinion that the product was defective. Because liability in a products liability action cannot be based on mere speculation, guess or conjecture, the circumstances shown must justify an inference of probability as distinguished from mere possibility. Where there is an equal probability that an accident occurred for reasons other than a product defect, the plaintiff fails to make a case.

In other words, if it’s 50/50 or your explanation of the cause of the accident is only as good as what else might have happened, you don’t have a claim. The circumstantial case must lead to a probability that the underlying malfunction was a proximate cause of the accident.

PROOF – EXPERT TESTIMONY

You need expert testimony regardless of the type of defect.

Daubert v. Merrell Dow Pharmaceuticals

Supreme Court, 1993, Blackmun

The junk science debate

Bad cases make bad law. Daubert was a bad case. For the Supreme Court to finally take a case on the junk science debate, they took the Bendectin litigation. The allegation in the Bendectin litigation was that Bendectin, which pregnant women took for morning sickness, led to certain types of birth defects, particularly malformed digits or limbs.

Even I would concede that the science supporting a causal relationship between Bendectin and birth defects was dubious. From a plaintiff’s standpoint, you could hardly have picked a less favorable backdrop for the US Supreme Court to make a statement about the admissibility of this kind of science.

The standard in these cases was always the Frye standard. Under Frye (1923), scientific opinions were not admissible unless they had gained general acceptance in the scientific community – the general acceptance standard.

In the intervening years, the Federal Rules of Evidence were drafted, including Sections 702 and 703.

The Frye standard was really a bean counting approach. How many studies had been done and what percentage of those studies support the plaintiff’s position? If it is only a minority of those studies, it is not generally accepted, and it’s not admissible. 

With Daubert, the Court begins a shift away from simple bean counting and suggests to a trial court judge, who is faced with this determination of admissibility, to look instead at how the scientist/expert arrived at his or her determination. What was his or her methodology? Are their conclusions based upon reliable underlying data? Is this the type of methodology that most scientists would use and would find to be valid?

“Thus when a party proffers expert scientific testimony, the trial court has a vital ‘gatekeeping function’ – a threshold obligation to render a preliminary determination of both the (1) reliability (validity – is it a good methodology?) and (2) relevance (fit) of the expert’s reasoning or methodology underlying the testimony proposed.”

In the aftermath of Daubert, a lot of trial judges have taken very seriously the gatekeeping role that Justice Blackmun set forth. 

Daubert Factors:

1.         Testability. Has it been tested, or is it just theoretical?

2.         Error rate. An acceptable known or potential rate of error.

3.         Control Standards. The scientific techniques application was subjected to appropriate standards of control.

4.         Peer Review. Whether subjected to peer review and publication.

5.         General Acceptance. No longer the sole determinate, but this still matters.

Bendectin is a classic example of litigation driven science. When all you have is poking holes in the existing science, as opposed to doing new work that supports your claim, you are on very thin ice. The plaintiff’s experts could not show a causal connection between Bendectin and birth defects. They could only testify that Bendectin was capable of causing birth defects, not that the drug in fact (or more likely than not) caused the plaintiff’s birth defects. 

The Federal Rule of Evidence 702: The Daubert Amendment

1.         Whether experts are “proposing to testify about matters growing naturally and directly out of research they have concluded independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying.” Is the opinion based upon preexisting research of the expert or did this expert have any opinion about this until the litigation began and he was asked to be an expert and put together a theory? Is it preexisting or litigation driven science?

2.         Whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion.

3.         Whether the expert has adequately accounted for obvious alternative explanations. Negating other causes/possibilities.

4.         Whether the expert “is being as careful as he would be in his regular professional work outside his paid litigation consulting.” Forensic work as opposed to their regular work. Is there some suggestion that this expert might have a different standard for his or her forensic work than he or she would have with their patients or with other non-litigation clients? A cynical but realistic factor.

5.         Whether the field of expertise claimed by the expert is known to reach reliable results for the type of opinion the expert would give. For example, an expert is doing animal studies – are animal studies a reasonable underlying methodology by which to arrive at the conclusion that is being offered?  

If you are going to be products liability lawyers or toxic tort lawyers, this is your bread and butter. It is going to be hugely important.

“Abuse of Discretion” standard of review. If a district court judge throws out your expert, and you take that up on appeal, the Joiner case (a Daubert progeny case) does not give you much confidence that the appellate judge is going to reinstate your expert.

Rehnquist’s dissent in Daubert: With all due respect, we are not epidemiologists, toxicologists, or pharmacologists – pick your ologist – we’re not any of them. Rehnquist questions trial court judges having this active gatekeeping function. What about the Seventh Amendment? A right to a jury trial? Access to the court system? To what extent should a trial judge usurp the role of a jury by making this pretrial determination that an expert report is inadmissible as opposed to allowing a jury to asses that expert’s credibility?

Assuming that a trial judge is capable of making a very fact-sensitive determination, I can see the Joiner rationale. Why should an appellate court, who didn't’t see the expert testify, be probing of what really happened?

In Kumho Tire v. Carmichael, the Court ruled that Rule 702 should apply to all expert testimony including engineering testimony of the type ordinarily relied upon in products liability cases involving durable products.      

Rule 104 Hearing (Daubert Hearings)

How this works: You file a lawsuit and file an expert’s report. The defendant receives a copy of the report, says this is junk science and they move to dismiss the report pursuant to Rule 104 or a Daubert Hearing.

The Daubert Hearing and ruling have effectively become virtually as case outcome determinative as a class certification hearing and ruling: once decided, a case either shrivels up and goes away, or becomes more dangerous to try. Practically speaking, they are every bit as case dispositive as a summary judgment hearing.

You are not going to get in front of a jury without an expert and if the judge bounces your report in a Daubert Hearing, it’s all over. If you survive a Daubert Hearing, and your expert report is admissible, the value of your case may have just doubled. Daubert Hearings are a trial within a trial.

Booth v. Black & Decker, Inc.

US District Court, PA, 2001

The expert in this case failed to produce objective evidence on several levels. Mostly, he failed to reproduce the same effect of welding and scoring on a similar toaster, and he did not install the thermal cut-off device on an exemplar toaster which he recommended as a reasonable alternative design.

Net Opinion: An expert’s opinion not really grounded on any underlying methodology or good science. Net Opinion Rule: Net opinions are not admissible.

Q.        Does the expert have to implement or manufacture the RAD if feasible? In this case, the court wanted the expert to produce an example of his RAD on a similar toaster. That seems to be placing an extra high burden upon the plaintiff - not only does he have to suggest a RAD,  but he has to build it also?

A.        I would not think in terms of having to actually construct something. We saw that discussion in Knitz as well. Generally speaking, it will be enough to suggest alternatives. Certainly, if your expert has a viable alternative that they have constructed, all the better. I wouldn't, however, think of it as necessary.

Rudd v. General Motors Corp.

US District Court, AL, 2001

The plaintiff was injured when a fan blade from his pickup truck broke loose and struck him. Plaintiff sued claiming the fan blade had been made of defective metal, based largely on the testimony of his expert.

The judge in this case did not hold a Daubert Hearing. The decision whether to hold a Daubert Hearing is entirely discretionary with the trial court. The judge looked at the expert’s report and read his deposition. The expert testimony satisfied each of the three specific reliability standards of new Rule 702 and was admissible. Defendant’s motion of summary judgment denied. 

FOOD AND DRINK

Kolarik v. Cory International Corp.

Supreme Court of IA, 2006

Consumer Expectation Test

Returning to the olive pit case where the express warranty claim failed.

The theory that carries the day is a negligence theory. The express warranty claim failed because as a practical matter, you cannot ascertain that every one of these olives will have no pit.

Now we have a negligence based claim for failure to warn. The court said that a question of fact did arise as to whether the manufacturer’s failure to give a warning of a possible presence of a pit is an actionable defect. The case is remanded on that issue. What is more important is it introduces us to the Consumer Expectation Test.

Some jurisdictions cling to the “foreign-natural” test – that there is no liability if what is in the foodstuff is a natural byproduct of the food itself – the fish bone, chicken bone, etc. There is no liability for natural byproducts. 

This court rejects the foreign-natural distinction. The test should be what is reasonably expected by the consumer in the food as served, not what might be natural to the ingredients of that food prior to preparation.

Most jurisdictions are moving away from the foreign-natural distinction to a general consumer expectation test.

California and Louisiana limit liability for natural substances. If there is a piece of glass in the food, you’ve got a strict liability claim. If there’s a piece of bone in your fish chowder, you have to show negligence. 

Fried Chicken: The reasonable expectation test should be applied and a jury applying the test could reasonably conclude that a piece of fast food fried chicken is unmerchantable if it contains an inedible item of the chicken’s anatomy.

Oysters: Courts impose a duty to warn of the risk of serious, possibly deadly, infection from contaminated oysters even though the risk is only to persons with suppressed immune systems. A jury might find oyster eater did not reasonably expect contamination that could cause hepatitis.

Trichinosis from Pork: It is common knowledge that pork must be cooked. If cooked, a jury might be allowed to decide if the meat was unfit or whether it was properly cooked.

Cloudbirds on Cake: Applying the plain view doctrine (open and obvious danger), no negligence in supplying a cake ornament the same color as the icing. One of the problems in these cases is often the disappearance of the evidence.

Preservation of evidence + proving the defect existed when product left the manufacturer

Shoshone Coca-Cola Bottling Co. v. Dolinski

Supreme Court of NV, 1966

Plaintiff filed a strict liability claim for physical and mental damage arising from drinking Squirt that contained a decomposed mouse. “The moment plaintiff produces evidence tending to show that the mouse was in the bottle while in the defendant’s control, he has, to some degree, negated tampering by others.”

Notes: Litigation in food and drink cases usually focus on three major issues:

1.         Whether the food or drink is wholesome or defective;

2.         Whether the condition of the product in fact caused plaintiff’s damages; and

3.         Whether the product’s condition can be attributed to the defendant.

Disgusting Junk in Food: As in Shoshone, the first two issues are not often seriously contested where the foreign substance in the product is so obviously harmful or offensive that no one could doubt that the product is unwholesome and capable of causing injury, even without medical testimony.

Keeping the Junk: The plaintiff must prove that the junk was really there, and if he swallows or otherwise disposes of it, his lawsuit may well travel the same route. No evidence, no case.

Ordinary Junk: If the object is not necessarily offensive or commonly regarded as repulsive, the plaintiff must establish that the object’s presence rendered the food or beverage unwholesome by contaminating the product. Here, expert testimony normally will be required to establish the plaintiff’s case.

Damages and Mouse heads: After a nursing assistant purchased a barbecue sandwich from a vending machine, heated it in the microwave and took a bite she heard “an awful crunch.” She opened the sandwich and discovered a headless mouse inside. She sued and the jury awarded $10,000 in damages. 

 DESIGN DEFECTS

The plaintiff is arguing that the entire product line was defective typically because defendant failed to comply with best state-of-the-art technology or best information. It also means that the defendant failed to adopt a reasonable alternative design.

Section 2(b) of Restatement (Third) of Torts:

A product is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.

The drafters made it explicit that you must show a reasonable alternative design in a design defect claim. The design defect claim will fail if all you do is criticize. You’ve got to suggest how it could have been better.

If you start losing design defect claims, it’s probably not going to be an isolated incident. If one jury finds that your product line is no good, it is likely that other juries are going to find the same thing.

The defense of design defect claims is extremely vigorous. The expert testimony is ratcheted up ten-fold here because so much rests on the outcome.   

Two analytical tests have emerged for design defect claims: The Consumer Expectation Test and The Risk-Utility Test.

There are about eight states that still use a separate consumer expectation test as the benchmark of liability.

When you buy a product there may be a warranty or no warranty, but there is an implied warranty that the product is merchantable. That warranty comes from the consumer’s expectation. The implied warranty of merchantability is really the theory that articulates or reflects the consumer’s expectations.

Vincer v. Esther Williams All-Aluminum Swimming Pool Co.

Supreme Court of WI, 1975

Two year old plaintiff suffered brain damage when he fell into a swimming pool in which the retractable ladder had been left in the down position. 

This court is clinging to the dual language of 402A: “Even if a product is defective, it must be shown to be unreasonably dangerous to the user or consumer.” In 2007 courts tend to talk about not reasonably fit, suitable, or safe.  

§402A comment i. Comment i explicitly embraced the notion of consumer expectation.

When you are determining whether a product is adequately designed, do not take into account either the plaintiff’s expertise or his abject idiocy. Do not take the subjective lack of wisdom of the plaintiff into account on the threshold determination of whether a product is adequately designed. Instead, use the plaintiff’s subjective knowledge as the court suggests here on comparative fault or perhaps on proximate cause. A plaintiff’s actual knowledge of danger or a plaintiff proceeding in the face of a known risk may act as an intervening and superseding cause of an accident.

Imputed contributory negligence will bar an injured child’s action against a third-party tortfeasor if the child’s parent was guilty of negligent supervision.  

DESIGN DEFECTS (CONTINUED)

 

Analytical Framework: The Consumer Expectation Test

 

A reoccurring issue is when children are harmed and the facts also suggest that there may have been some negligent parental supervision, especially if you have a real small child – 2, 3, or 4 years old. Imputed contributory negligence will bar an injured child’s action against a third-party tortfeasor if the child’s parent was guilty of negligent supervision. 

 

If you are using a consumer expectation test, what if the consumer is an expert or conversely, what if he is an idiot? It is sometimes said that an injured consumer’s special knowledge of the danger is not relevant to the defectiveness issue, but goes instead to his or her contributory negligence (comparative fault) or assumption of the risk. When analyzing the issue of defect, to the extent that you use a consumer expectation test, do not consider expertise on the issue of defect. Whether or not a product is defective is a function of the reasonable consumer’s expectations.

 

If you are analyzing a fact pattern where the user is an expert, use his expertise against him when you get to affirmative defenses, whether it is comparative fault, assumption of the risk, and perhaps even proximate cause. You may also use the person’s expertise maybe as an intervening and superseding cause of the accident – that given his knowledge he should not have done what he did – in essence, his expertise may be something that breaks the chain of causation. Hold back on using the plaintiff’s subjective expertise on the issue of defect. When you are talking about whether something is defective, use a reasonable person standard. If you have expertise, use it later on defenses.

 

Foundations of the Consumer Expectations Test. Cross-reference pages 65-65 in Supplement, notes g and h of Section 2 of the Third Restatement. Under Subsection (2)(b) (definition of a design defect), consumer expectations do not constitute an independent standard for judging the defectiveness of product designs. Henke: The Third Restatement has explicitly rejected consumer expectation as a separate test.

 

At the bottom of the page: Although consumer expectations do not constitute an independent standard for judging the defectiveness of product designs, they may substantially influence or even be ultimately determinative on risk-utility balancing in judging whether the omission of a proposed alternative design renders the product not reasonably safe. 

 

Henke: It no longer is a separate standard. In most cases it will not be determinative of liability but then the statement at the bottom of the page suggests that there still may be a given case where consumer expectations are very close to dispositive. Even though the consumer expectation test has waned, it is still important in a given fact pattern. Only six states have a separate consumer expectations test. Most jurisdictions have adopted the language in comment g that the consumer expectations test should be part of an overall risk-utility test.

 

Unless you are a mechanical engineer or some other kind of expert, with the complexity in today’s world, you come to a product and you expect it to work – and that’s about it. You expect it not to hurt you.  To make my expectation the baseline of whether or not a product is defective imbues in me a whole bunch of knowledge that I cannot even pretend to have. That’s always been a thematic weakness of the consumer expectation test. 

 

Do keep in mind that the place where a true consumer expectation test remains important is in the manufacturing defect bad food cases. Most jurisdictions have adopted a simple consumer expectations test for strict liability in those cases.

 

If writing a memo on a design defect claim (hint, hint) you should indicate to me your recognition that a small handful of jurisdictions retain a separate consumer expectations test as the benchmark for design defect determination; however, the overwhelming majority of jurisdictions and the Third Restatement have incorporated a consumer’s expectations into the overall risk-utility test.

 

Open and Obvious Danger in the Product

 

What if there is something open and obvious to the reasonable consumer? You should incorporate that into your overall risk-utility test. Do not conclude that if there is an open and obvious danger which the reasonable consumer would know about. It is an important consideration in your overall analysis but even the consumer’s appreciation of an open and obvious danger should not necessarily dispose of their claim. It may be a factor but don’t use it in a dispositive fashion.

 

RISK-UTILITY TEST

 

It is the critical and overwhelming majority test for technical design defect cases.

 

Nichols v. Union Underwear Co.

Supreme Court of KY, 1980

 

Four-year-old plaintiff was badly burned while playing with matches when his T-shirt caught on fire. The basis of the suit was strict liability for design defect.

 

In the immediate aftermath of law review articles, Kentucky begins to change their law to adapt to this developing test.  

 

The plaintiff complained that the consumer expectation jury charge should be one of several factors to be considered. The Kentucky court agreed. Instead of having a separate consumer expectation test, a consumer’s expectations will now be one of several factors that the jury will take into account.

 

The concurring opinion gives more guidance with his jury instruction:

 

You will find for the plaintiff if you are satisfied from the evidence that at the time of the manufacture of the cotton and polyester T-shirt the risk of harm from its being accidentally set on fire while being warn by a child outweighed the benefit to the public from its availability in the marketplace. Otherwise, you will find for the defendant.

 

Sperry-New Holland v. Prestige

Supreme Court of MS, 1993

 

Plaintiff was injured when his shirt became stuck in the auger of a combine. This court explicitly adopts the risk-utility test.

 

Footnote 4: Open and obvious danger. Under the risk-utility test, the openness and obviousness of a product’s design is simply a factor to consider in determining whether a product is unreasonably dangerous (defective).

 

When we get to warning defects, an open and obvious danger may be a complete bar to a warning defect claim. Do not use open and obvious danger as a complete bar in a design claim – put it into your overall risk-utility test.

 

Risk-utility test: BPL?

 

If you fail the risk-utility test, you are strictly liable in tort. The conceptual framework for the risk-utility test is of course Learned Hand’s BPL test from Carrol Towing. The risk-utility test is a strict liability construct and yet its conceptual foundation is negligence.

 

Page 248: By substituting “defect” for “negligence” (D for N), the Hand formula converts comfortably to the “strict” products liability task of determining defectiveness. Reformulated, the defectiveness formula looks like this:

B<P x L=D

 

(Accident Prevention) Costs < (Safety) Benefits = Defect

 

A product is defective if the safety benefits exceed the resulting costs. If the defendant fails the test in this context, we conclude that the product was defective.

 

Because the method for ascertaining responsibility is identical in both negligence and strict liability, many courts and commentators have recognized the “functional” equivalence of the two theories of liability in design and warnings cases. The proofs for one are the proofs for the other in a design case and in a warning case. The risk-utility test is the perfect example of that merger. The risk-utility test is a strict liability test but it is clearly a negligence based test. It is a BPL test, but if you fail the test, instead of saying you are negligent here we say, the product was defective. 


RISK-UTILITY FACTORS

 

(1) The usefulness and desirability of the product – its utility to the user and to the public as a whole. How important is this product? Would society be just as well off if it didn't’t exist?

 
(2) The safety aspects of the product – the likelihood that it will cause
injury, and the probable seriousness of the injury. As close as you can get to BPL – the P and the L are right in there.

 

Reasonable Alternative Design

(3) The availability of a substitute product which would meet the same need and not be as unsafe.  3 and 4 are the heart and soul of design defect. It is not enough in a design defect case to simply criticize.  You have to criticize and suggest how it could have been better. If you can’t suggest how it could have been better, I think § 2(b) of the Third Restatement couldn't’t be clearer in terms of the weakness in your case if you can’t do that. 

 
(4) The manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility. Is it technologically feasible to make this product differently? What about the cost? Defendant counters with, it solves the problem but it creates another one. Does the alternative design just correct the old problem or does it unfortunately create other problems? Will the alternative design frustrate the very purpose for which you got the product? Motorcycle and vow bus examples: if catastrophically harmed, the car is deigned for maximum cargo space – no liability. It frustrates the very purpose of what the product is on the market to do. You’ve got to be all over alternative design on an exam (Also seen in crashworthiness).

 

Objective user, not the expert user

 

(5) The user's ability to avoid danger by the exercise of care in the use of the product.  The user in this factor is not the plaintiff. It’s the reasonable, objective, hypothetical user – not the expert or Olympic diver. If the plaintiff is an expert, do not take his expertise into account on the initial question of defect. When analyzing this factor, think about the reasonable user. Save the plaintiff’s expertise for issues of comparative fault or assumption of the risk. Discuss subjective knowledge and abilities in defenses.

 

Consumer Expectations

 

(6) 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. If applicable, talk about consumer’s expectations. Is this a simple product? Are the dangers open and obvious? So the consumer’s expectations are meaningful? The user here is not your client. 

 

(7) The feasibility, on the part of the manufacturer, of spreading the loss by setting the price of the product or carrying liability insurance. Unlikely to require much discussion unless you have financial data, insurance policies, or cost distribution about the company. 

 

The seven risk-utility factors should be used as a jury charge.

 

When you talk about Reasonable Alternative Design, is the alternative design too costly or does the alternative design affect the product in some negative way? Note 3: Propeller guards on motorboats. Between reduced speed and fuel efficiency, the guards increase other risks like trapping limbs. 

 

A reasonable alternative design is a design that probably would have prevented the accident without impairing the utility, usefulness, practicality or desirability of the product.

 

Feasibility Factors. Technological capability, commercial practicability, cost, commercial availability of materials or components, and the likelihood of consumer acceptance. 

 

Comment : The likely effects of the alternative design on production costs; the effects on product longevity, maintenance, repair, and aesthetics and the range of consumer choice among products are factors that may be taken into account.

 

When we are doing a risk-utility test, are we limiting that test to the parties in the courtroom or can you do a risk-utility test in a more global fashion? Keep your risk-utility test focused on the situation at hand and not an industry. Do not expand it out in some global way.

 

Knitz v. Minster Machine Co.

Court of Appeals of OH, 1987

 

While plaintiff was positioning the foot treadle, the press she was working at activated and severed two of her fingers.

 

The plaintiff’s expert argues several alternative designs and the defendant argues the weakness of each design – each one has its issues.

 

We know that anytime a safety apparatus requires affirmative action the on the part of the user, human nature being what it is, that may be a problem.

 

The plaintiff’s expert comes up with his own reasonable alternative design, but it is not used anywhere in the country, so it probably really isn't’t an alternative design.

 

Nondelegable Duty

 

Instead of a manufacturer integrating the safety device into the product, he leaves it up to the employer to make that determination. That’s not going to fly. Even if a manufacturer offers such a feature as optional equipment, most courts hold that a product sold without such a reasonable, safety-enhancing, inexpensive safety feature renders the product defective and the manufacturer negligent for failing to employ the feature as a standard part of the design. The fact that someone else will install such devices should not immunize him Bexiga v. Havir Mfg. Corp.

 

Exception:

 

What if the manufacturer says, the employer wanted a multi-purpose punch press and they specifically instructed us to not install such and such device because that device would frustrate the multi-purpose options. Courts are split on this issue. Some do entertain the issue if there is going to be a multi-purpose issue. If you have a fact pattern where the manufacturer tries to defend their duty to delegate by saying we received specifications from the employer that they needed the machine in a multi-purpose capacity, you need to acknowledge that some courts have allowed for a delegability there. In most cases you should find that there is no ability to delegate. 

 

Governmental & Industry Regulations:

 

Evidence of compliance with OSHA standards, while not conclusive of nonliability, is relevant and admissible.

 

Prior and Subsequent Acts/Accidents:

 

Evidence of prior accidents is admissible if it shows notice to the manufacturer of the hazardous nature of the product. Even if another accident is substantially similar to the plaintiff’s accident, such evidence must satisfy Evidence Rule 403, which provides that relevant evidence should be excluded if it’s probative value is substantially outweighed by the danger of unfair prejudice, of confusion of the issues, or of misleading the jury.

 

Absolute Liability Model:

 

There are some products that are so dangerous and utility so low that even if they had a reasonable alternative design it is not necessary to prove that one existed e.g., Lawn darts, 150 volt quivering lump baton, and a hand-held cross bow that can penetrate a telephone book from 25 feet away. We’re not saying you can’t make it, but we’re saying as a matter of public policy, that if you chose to make it and it injures someone, you will pay him or her. 

 

Subsequent Remedial Measures:

 

What if after the accident the company redesigns the product – is that admissible? Rule 407: Evidence of subsequent measures is not admissible to prove negligence, culpable conduct, a defect in a product, a defect in a product’s design, or a need for a warning or instruction. If the defendant raises it, maybe you can get it in as a rebuttal.

 

What about a claim based on strict liability? If your claim is not a negligence claim, what then? The rule on its face only applies to negligence. It may be intellectually disingenuous because practically speaking, strict liability and negligence are functionally the same. But as practitioners, take this into account. If a state court will allow the evidence in, go for it.

 

 

 

 

WARNING DEFECTS

 

The third and last type of defect we discuss before we talk about affirmative defenses. I am somewhat biased; the bulk of the asbestos litigation that I worked on was based on a failure to warn. When we are talking about warning defects, we ask ourselves:

 

Whether based upon state-of-the-art information at the time the product was manufactured, did a duty arise on the part of the manufacturer to provide a warning and if so, did they breach that duty by either not providing a warning at all (failure to warn) or perhaps did they breach that duty by providing a warning that for one of many reasons, proved to be inadequate.

 

1.         Failure to Warn Claim: If they had a duty to warn and they did not provide a warning; or

 

2.         Inadequate Warning Claim: They had a duty to warn and they provided a
            warning, but for some reason the warning inadequately conveyed the magnitude
            of the known risk. 

 

So much of the discussion really applies to the second category; whether or not a warning is adequate. Almost always the issue of whether or not a warning is adequate is a question of fact. Very seldom do you see a court take away from the jury the issue of whether or not a warning is adequate. For a court to find as a matter of law that a warning is not adequate is extremely rare.  

 

Injured plaintiffs often reinforce the importance of safety information by making warning defect claims, since proving a warning “defective” is often a much easier (and less expensive) task than successfully attacking a product’s design.

 

In the Knitz case we had experts battling back and forth about all those possible alternative designs. The time and money that goes into a design and defect case can be very substantial – experts, and mechanical engineers testifying about alternative designs and the like – whereas in a warning defect case you may also hire an expert but as a practical matter that amount of time and money it will cost a plaintiff to put together a warning case is a lot less than a design defect case where you are trying to impugn the entire product line. There may be a sense where maybe this is an easier case to show than a design defect. Keep this in mind: It is very common for a warning defect and a design defect to coexist. A lot of products liability lawsuits contain both of those defects. One of your earliest examples is from Torts II in the O’Brien (swimming pool) case. You are injured in a swimming pool accident, you make two claims:

 

1.         The warning on the pool is inadequate; and

 

2.         A design claim – that the bottom of the pool should’ve had a different kind of surface.

 

Analytically both as lawyer and students in this class don’t be at all surprised to see the coexistence of warning and design defect.

 

Warnings Pollution

 

A huge issue. Companies have become so terrified of potential lawsuits that they now put so many warnings on their products that it’s out of control. The legal issue becomes, at what point are there so many warnings, both of things that matter and things that are superfluous? At what point is the user of the product hit with this notion of warnings pollution? What starts to happen here is the abundance of warnings and those warnings that are not all that critical begin to distract the user from those that really matter. The overall message of safety is diluted by extraneous information. It’s a thematic issue in these warning defect cases: When is it too much and when does all this superfluous stuff start to take away from what you really need to know about the product?

 

Personal Autonomy

 

Another reason for requiring warnings and instructions, but one which reflects a more fundamental human value, has surfaced in recent decades. Personal Autonomy: A persons’ right to determine his own fate. The rationale is that the user or consumer is entitled to make his own choice as to whether the product’s utility or benefits justify exposing himself to the risks of harm. One of the things we will question is as a practical matter, how careful are we as consumers and users of products? Yes, theoretically we should be entitled to all pertinent information on how to use a product and what its dangers are, but human nature being what it is, even if we are given that autonomy, in actuality and in fact, how often do we exercise it in a real way?

 

There can be a disconnect between this body of law that we create and the reality of how we act as human beings. At least theoretically much of this law is premised on our expectation and our interest in personal autonomy.

 

Instructions vs. Warnings

 

Under the heading of warning defect we are talking about two categories of information:

 

1.         Instructions in the proper use of the product; and

 

2.         Warnings about the attended dangers inherent in the product.

 

A failure to provide either one, leads to a cause of action. Under a failure to warn heading, keep in mind both the issue of instructions and of the actual warnings about product hazards.  

 

A warning is not considered to be a substitute for a reasonable alternative design. If a substantial danger could have been designed out of a product at little cost, a large majority of courts hold that even an “adequate” warning does not insulate a manufacturer who failed to employ the safer design. A warning is not a Band-Aid.

 

You still see this sometimes. A manufacturer in design defect case basically saying, I put a warning on the product, I didn't’t have to adopt a reasonable alternative design. I made the user aware of the dangers – that ought to be enough.

 

You should not conclude that a warning is a legitimate substitute for a reasonable alternative design. There are very few jurisdictions left that will allow a manufacturer to escape liability by just slapping a warning on a product.

 

Federal Preemption

 

A duty of a manufacturer to warn and instruct is sometimes addressed by Congress. The fact of the matter is Federal Preemption often arises in warning defect cases when Congress has created some statute that allows a federal agency to basically regulate the given field. Federal agencies speaking to what is appropriate in terms of warnings will factor into federal preemption.

 

Lewis v. Sea Ray Boats

Supreme Court of NV, 2003

 

Leo Gasse was killed and Robin Lewis catastrophically injured due to carbon monoxide poisoning during an overnight outing in a Sea Ray boat.

 

What I find most interesting about this case is the stubbornness of the trial judge and the jury instructions issue.  

 

They bring a wrongful death claim and they attack the adequacy of the warnings. The warning emphasizes the carbon monoxide danger that would be emanating from the engine’s exhaust system. It does not suggest any harm to be worried about as to the generator.

 

The plaintiff gives a very nice proposed jury instruction:

 

“A warning must (1) be designed so it can reasonably be expected to catch the attention of the consumer; (2) be comprehensible and give a fair indication of the specific risks involved with the product; and (3) be of an intensity justified by the magnitude of the risk.”

 

Rejecting this jury instruction, twice during deliberation they are sending notes requesting a definition of an “adequate warning” Each time the plaintiff’s lawyer reiterates his request to use the language of the proposed jury instruction and both times the judge said no, the jury needs to use their common sense.

 

“Given that experts testified in this case to the nature and quality of the warnings that were given and their supposed behavioral impact, the jurors were entitled to more specific guidance as to the law governing the duty to warn in connection with consumer products.”

 

When you read this case, it doesn’t come as a surprise to you that the Supreme Court of Nevada sends the case back because the jury instruction gave no instruction whatsoever.

 

When we are talking about the issue of whether a waning is adequate, how specific of the warning need to be? Does it have to only warn generally of risks involved with the use of the product or does a manufacturer have to be more specific about the type of risks involved?

 

You see a discussion of this in Note 3: Burch v. Amsterdam Corp., (1976). Plaintiff was using a mastic adhesive, he forgets to check the pilot light, applies a coat of adhesive, it explodes and he sees his skin peeling from his body. He attacks the warning. The defendant failed to warn of the specific risk of use near fire or flames but they didn't’t talk about pilot lights. The dissent raises a fair point. There is that notion of reducing this to an absurdity. This case is a classic example of the whole problem with warning defect cases – how much is enough but how much becomes too much? At what point does too much information overwhelm the user who throws up hands and doesn’t read anything. Do you put every damn thing in the world that causes a spark? If you take the majority’s decision to the absurd extreme, it might suggest that.

 

Caution: inflammable mixture, do not use near fire or flame. We cannot say as a matter of law that “near” exposed him to this risk. These are the kinds of cases from a defense or a manufacturer’s standpoint that drive you kind of nutty. This leads you to overreact and to provide so much information that even the important stuff becomes diluted.

 

Note 5: Over warning – Warnings Pollution. That is the fear. The Michigan court agrees with Judge Riley: “If a manufacturer had to list all sources of friction, or all sources of sparks, as a means of warning of a flammability hazard, its warning would have to be of epic or encyclopedic proportions because the combination of circumstances or materials that could create a spark would be almost limitless. Excessive warnings on product labels may be counterproductive, causing ‘sensory overload’ which literally drowns crucial information in a sea of mind-numbing detail.”

 

Spilane v. Georgia Pacific Corp. (1995): CAUTION, SLIPPERY WHEN WET. The plaintiff, a roofer, fell off a roof and sued manufacturer for failure to adequately warn. Held: the language failed to convey how appallingly slick the roof surface was. The court drew the analogy: Beware of cat, stay away, which would fail to adequately warn exposure to a cheetah.

 

These cases are extremely fact sensitive. It makes it all the more odd why the trial judge in the Lewis case refused the repeated requests of the jury for additional guidance. It is hard for me to fathom.

 

Warnings Pollution Danger: The inclusion of each extra item dilutes the punch of every other item. Given short attention spans, items crowd each other out; they get lost in fine print.

 

 

 

General Motors v. Saenz (1993)

 

The issue here is prominence. Plaintiffs argued that a warning could have been more prominent. The court said the more instructions and warnings that are printed in one place, the less likely that any of them will be noticed. With each additional thing you put there it becomes less likely that the user perhaps reads any of them or the really important ones.

 

Todd v. Societe BIC

7th Circuit, 1993

 

A 2-year-old was killed in a fire started by a 4-year-old using a BIC lighter. In an action against the manufacturer, plaintiff asserted that BIC should have warned of the specific risks posed to households with young children.

 

Heeding Presumption

 

These are the same parents who avoid the Surgeon General’s warning on the cigarette package and who blow smoke into their kids’ faces. These parents who fail to heed all these other warnings suddenly would have become extremely careful had BIC given them all this other information about the hazards of a lighter. This would have been the moment in their otherwise careless existences when they would have become cautious.

 

This discussion is so important in warning defect cases because so often as a defense lawyer in these cases, you are going to defend a warning defect by basically attacking the credibility of these plaintiffs relative to their general level of care. People who do not pay any attention to these critical health issues, the Surgeon General’s report, the warning on the package, they expose their children to second-hand smoke – they do all of those things but had there been this additional warning on this lighter, suddenly they would have become very careful people.  

 

Over Promotion. You should keep in mind that an otherwise adequate warning may be rendered inadequate if the manufacturer so over promotes the product that the over promotion dilutes, if not eclipses, the associated warning. Is there so much aggressive promotion of the product, that basically serves to silence the warning that they’ve given you?

 

1971 Pharmaceutical companies’ detail men minimized the drug’s hazards. A warning that standing alone might be adequate but may become inadequate due to over promotion

 

Olson v. Prosoco, Inc.

Supreme Court of IA, 1994

 

I really agree wholeheartedly with this case. When we were talking about our theories of recovery in the modern liability context, when you have a warning defect claim, or a design defect claim, negligence and strict liability are virtually identical theories of recovery.     

 

In Olson, the Iowa Supreme Court says the plaintiff’s warning defect case is a negligence case. Whether you want to call it negligence or strict liability, the fact of the matter is, as a plaintiff’s lawyer in a warning defect case, you have to show a breach of reasonable care – a negligence standard.

 

In this class and on my final exam, I do not expect you to split hairs and argue to me that there is any discernible difference between the two theories in a warning defect claim. Instead, you should say, that the two theories of have merged in this context and that the essence of the plaintiff’s case and the proofs supporting it are negligence based.  

 

When you are applying this negligence standard to a manufacturer in this context, they are to be deemed an expert in the field. What that means is: As far as what knowledge they had when they made their product and they put a label on it, you should assume they had actual knowledge of dangers as well as constructive knowledge.

 

Example: If a company is making a product and there are scientific studies suggesting that there is an association between this product and some disease or side-effect, if that information exists you should assume that they know about it either actually or constructively because we hold them to be an expert in the field.

 

Use the negligent standard here, but hold the manufacturer to the level of an expert in the field.

 

Merger of Theories

 

Note 5: Tort Reform. Some state legislatures have repealed strict liability in design and warning cases. As practitioners you may very well find yourself in a jurisdiction that statutorily has eliminated strict liability in warning defect claims and even in design defect claims. We have come full circle from Justice Traynor’s opinions in Escola and Greenman. From all of that revolutionary excitement surrounding strict liability in the 1960s, now several decades later we are acknowledging that to a great extent, perhaps strict liability was much ado about nothing. I don’t think about this as a tort reform issue. I don’t think the merger of doctrines harms the plaintiff. I don’t think it makes it harder for the plaintiff to prove his or her case. The fact of the matter is in a warning defect case, you’ve got to show that:

 

1.         The manufacturer had knowledge of the danger; and either

 

2.         Failed to warn you; or

 

3.         Warned you inadequately.

 

It’s a knowledge-based case no matter how you slice it. It’s not a tort reform issue – it’s a reality check issue.

 

 

Warning Methods

 

Meyerhoff v. Michelin Tire Corp.

US District Court, KS, 1994

 

Plaintiff is killed while trying to inflate a truck tire. If these are my experts supporting my claim, I’ve got big trouble

 

Their theory of the case quickly unraveled. No testimony that it would have been feasible for Michelin to put a warning on the tire. The other expert never worked in the tire industry. Their testimony is of no help whatsoever.

 

In this court’s view, a person cannot, after suffering an accident, simply draw up a warning limited to the dangers involved in that accident and argue that warning should have been conveyed by the manufacturer or seller without first also establishing that that warning is adequate and that it actually could have been communicated in the manner proposed.”

 

Daubert again. The court is impugning these experts. The experts lacked the underpinnings of scientific validity demanded by Daubert.

 

Note 4, Page 330: Expert Testimony. Take everything we talked about in Daubert and you can apply it just as readily in this context.  If you are handling a warning defect claim, be prepared to find relevant experts who will testify about whether or not a particular warning is adequate. If you get into that realm, then be prepared for the whole Daubert discussion.

 

1.         Warnings experts are important; and

 

2.         Because of Daubert, more than ever, you’d better make sure you have a good one who     can withstand a pre-trial hearing on the admissibility of their report.

 

Note B, Page 322. Black Letter law: If a product is big enough that the warning could be placed right on it as opposed to sending the user to a pamphlet or to something else, you should assume that if the manufacturer does not place the warning on the product when they can physically, that will most likely be an inadequate warning. To the extent that a warning can be on a product, you have to put it there.  

 

Foreign Language Warnings

 

A jury could reasonably conclude that even the best of written warnings might not be good enough, since the information foreseeably would be needed by persons of limited education, and that the skull and crossbones or other comparable symbols might fairly be required under the circumstances.

 

Campos v. Firestone Tire & Rubber Co.

NJ, 1984, J. Pollock

 

Campos is still a good opinion for some warning defect principals.

 

Campos, a Portuguese immigrant, reaches into the cage on a tire changing machine and gets injured. Plaintiff brings an inadequate warning claim. Campos cannot read the warning, nor can a lot of the other guys at this plant. The plaintiff’s expert testifies that due to the nature of the industry, there should have been pictorial warnings instead of written ones. 

 

Cross-examination of plaintiff’s expert:

 

Set up question from deposition: Is [an adequate warning] better than the pain caused by a prior injury in terms of suppressing his instincts for putting his hands in the cage? Answer: No. No further questions.  

 

Mr. Campos did the exact same thing prior, although he wasn't’t as badly hurt.  

 

This court says the obvious danger is merely one element.  Most jurisdictions have found no duty to warn of obvious dangers or of risks that are generally known. You should indicate both positions here. I think there are enough jurisdictions that treat open and obvious like this court does. There is a significant number of jurisdictions that treat open and obvious as just a part of the analysis on whether there is a duty to warn.

 

You should not apply the risk-utility test to a warning defect. The risk-utility test should be limited to design defect claims.  

 

Firestone admitted that they had the non-delegable duty to warn.

 

“That preexisting knowledge might negate a claim that the absence of a warning was a cause in fact of plaintiff’s injury.” I cannot tell you how many warning cases fall apart on causation Graves case.  Was the inadequate warning a cause in fact?  Probably not – it’s not enough to prove defect.

 

If you are analyzing a warning defect claim you can say negligence and strict liability are functionally equivalent in warning and design cases or you could use Justice Mosk’s theory that the two have converged.  Bottom line:  these cases are all about fault.  What did a company know, when did they know it and is this warning adequate to convey the risks they knew.   

 

Adequacy of Warning

 

If a product is going to be used in a market where much of the using public doesn’t speak English or whatever the circumstance might be, courts increasingly recognize that in those circumstances, if it is foreseeable that the market that uses the product is not going to be conversant in the native tongue, then the manufacturer might very well might have a duty to provide dual language warnings, pictographs or some other universal label.

 

Does a manufacturer have a duty to warn of an open and obvious danger? The answer is in most jurisdictions – no. The open and obvious nature of the danger is only a factor that is to be taken into account in the overall risk-utility analysis. Here, in a warning defect case, the open and obvious nature of the danger is dispositive in many jurisdictions and obviates the need to warn at all. The minority position on this issue is represented in Campos. The New Jersey Supreme Court as well as a handful of other states say, the open and obvious nature of the danger does not eliminate the duty to warn; however, the court goes on to say that the plaintiff’s subjective appreciation of the open and obvious danger is relevant on the issue of causation.

 

Open and obvious does not eliminate the duty to warn, but the plaintiff’s subjective appreciation of the open and obvious nature of the danger is relevant on causation. In essence under the New Jersey approach, open and obvious comes in the back door on causation as opposed to the front door on the threshold issue of duty.

 

A lot of warning defect cases fall apart on causation. Whether it be on cause in fact or proximate cause, I can’t tell you how many of these cases fall apart at that stage.  The warning in this case is inadequate. If half the guys at the plant can’t read it, how can we say with a straight face that it’s adequate? The warning here is defective, but was the inadequate warning a cause in fact or substantial factor in Campos’ injury? No it wasn't’t – there was no nexus between the inadequate warning and what happened to him. What he did was an instinctive reaction, at the spur of the moment under pressure. The fact of the matter is he had a prior accident of the exact same type suggesting that no amount of warning whatsoever would have protected him in this case.

 

The cost. The additional cost of a warning will in most cases have but a slight impact on the risk-utility analysis, since such a cost would generally have little, if any, effect on a product’s utility. You should confine the risk-utility test to design defect analysis. It doesn’t make much sense in a warning defect case. You can always put a warning on a product – it doesn’t make the product more expensive – although you could make the argument of warnings pollution. Putting a warning on a product is not a cost issue, but the manufacturer might be able to argue that the utility of my product may be compromised if there is so much information here, the person is not going to read it all. I supposed you could make some utility arguments in that sense, but generally speaking, don’t get into a risk-utility analysis at all when you are talking about a warning defect, hold that off for design defect claims.

 

Defendant’s counsel also conceded that a duty to warn existed irrespective of the fact that defendant did not manufacture or sell the cage Bexiga (holding a manufacturer responsible for failing to include safety devices on its machine). In most circumstances there is a nondelegable duty warn.  

 

Heeding Presumption. Some courts have helped plaintiffs overcome the burden of proof by positing a rebutable presumption that the warning would have been heeded if given. What the court is saying here is, instead of speculating about what Campos may or may not have done, should he simply be given the presumption that had there been a better warning he would have read it and he would have heeded it. Instead of conjecture on what he may or may not have done, should he get that presumption? If the answer is yes, how would the defendant then rebut that presumption? BIC case – the parents claiming that if there had been more language on that lighter, their little 4-year-old never gets into it, they would have been more careful or cautious. Really? But you smoke and expose them to second-hand smoke. This is the disconnect between claims and reality.

 

Admissibility of Subsequent Warnings. Jurisdictions are split as to which subsequent remedial measures evidence is admissible.

 

LEARNED INTERMEDIARY DOCTRINE

 

In most circumstances a manufacturer of a product has a nondelegable duty to provide a warning directly to the end-user of a product. The Perez decision explores the primary exception to the nondelegable duty rationale and that is the learned intermediary doctrine.

 

For a long time most courts in the nation have allowed pharmaceutical manufacturers to delegate their duty to warn to the prescribing physician who is deemed to be a learned intermediary between the patient and the drug company.

 

§6 of the Restatement (Third) of Torts

 

(d)(1) is a restatement of the learned intermediary doctrine (the principal). (d)(2) is an explicit recognition that the principal will not always apply.

 

(d) A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:

 

            (1)        prescribing and other health-care providers who are in a position to reduce the  risks of harm in accordance with the instructions or warnings; or

 

            (2)        provided to the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

           

Exceptions

 

1.         Mass Immunizations. The most common exception was the mass immunization principal. In that circumstance where there is no expectation of any real dialog with a health-care provider, courts have always required the pharmaceutical company to warn people directly – Send out representatives, take out a full-page ad in the local paper, hand out pamphlets and information to people when they get there that day, etc.

 

2.         Oral Contraceptives. The Massachusetts Supreme Court said that in that particular context the patient who is more active or controls the course treatment than you would otherwise be in most circumstances. In MacDonald v. Ortho, the court believed that that particular dynamic was not the type of passive patient dynamic that should give rise to the exception. The court also went on to say, after getting the birth control prescription most women would not visit the gynecologist again for 6-12 months. The physician would not have as close and continuing relationship and control over that continuing course of treatment. This exception would perhaps apply in any situation where the patient is much more active participant in the process – a patient going to a doctor and saying, this is what I want you to do.

 

3.         Direct to Consumer Advertising. As discussed in Perez.

 

Perez v. Wyeth Laboratories, Inc.

Supreme Court of NJ, 1999

 

This was a case having to do with the Norplant birth control implant device. It is a series of time released capsules that a woman would have implanted into her arm. The litigation arose on an inadequate warning theory.

 

The theory was that the warning didn't’t really provide sufficient information about side effects and about the pain associated with explant. The inadequate warning was brought and the plaintiff’s lawyer argued that this case should be another exception to the learned intermediary doctrine. This exception pivots on the issue of direct to consumer advertising.

 

Direct to consumer advertising: If these companies are going to spend this much money to get us to use these products, they could spend a little more to also directly tell us more about the warnings of side effects and the like. The third exception that comes out of this case is a general one – in this new marketing milieu, if a company uses this amount of direct to consumer advertising circumventing a physician to create a demand for their product, why can’t they come out at us directly to give us good warnings?

 

The decision in Perez is a modern adaptation and a bringing forward of those Henningsen principals. This is not the Normal Rockwell world anymore.  

 

Under the New Jersey Product Liability Act, which Justice O’Hern discusses, FDA approval of the warning language accompanying a drug creates a rebutable presumption of its adequacy. Most jurisdictions have statutes or common law that creates this kind of rebutable presumption.

 

As the dissent points out, the discussion about the FDA approval was really not a part of the record below in this case.

 

Source: Professor Richard C. Henke