This is a generalization of a question that was raised in the GD debate about the “coffee lawsuit”:
Suppose a company makes a product that conforms to accepted industry and government standards - but could theoretically have been designed safer. Are they liable in the few cases that the product does fail and cause injury?
This could apply to any product. Suppose for example some component of your car fails - it most likely could have been made even better. In fact your bumpers could have been made sturdier etc. etc. If your new house catches fire - it could have been built more fireproof. Is there an implication that the company is responsible for that percentage of people that actually do get injured (or property damaged)?
I believe that drug companies are routinely held liable for harm caused by medicines that were approved by the FDA, even without a showing that the drugs could have been safer.
It depends. A mere showing that something could have been made safer may not give rise to liability. Your Volkswagen could be made safer-a lot safer-but the fact that it doesn’t withstand a crash as well as a Hummer won’t make Volkswgen liable per se. They could also make Porsche convertables more safe by putting in roll bars, but people won’t buy them. My brother worries about me a lot because the design for the door on my 95 Camaro is about as effective as a sheet of paper and if I’m ever T-boned in the driver’s side door i’ll be puddingnik.
It’s also something of a cost benefit analysis, as macabre as that sounds. If you can show that a safer design could have been used at around the same price, then the failure to use the safer design may have been negligent. But the failure to make a car that can withstand the forces of reentry won’t give rise to negligence, since the consumer isn’t going to shell out government-level expenditures for it.
To have a lawsuit you generally need to show not just that a design wasn’t as safe, but that there was either negligence on somebody’s part or that the item was dangerously defective when it left the factory. It’s admittedly a judgment call as to when something is merely not as safe as it could be and when someone is being negligent or something is defective, but that’s what we have juries for.
This can happen because drug manufacturers wihhold information from the FDA or encourage use of the medicines in manners unreviewed by the FDA, but chiefly it happens because the FDA is pretty much limited to reviewing what the manufacturer provides to them. In other words, the medicine doesn’t conform to industry standards or government regulations.
Product liability: Normally, conforming to industry practice shields manufacturers from liability for design defects. However, juries can (and will) find that entire industries are negligent in adhering to certain practices, if the danger is great enough, the cost is little enough, and the utility of the product is little enough.
Drug companies are liable for avoidable design defects. They are NOT liable for disclosed side effects, nor for side effects that could not have been revealed by clinical testing, but if the data at their disposal reveals (or would have revealed under adequate scrutiny) a dangerous side effect which was then not disclosed, then they are liable for the harm caused by that defect.
I thought adherence to indusrty standards was a defense in rebutting a claim of negligence, but was no defense in a strict liability case based on a design defect (although I admit my real world experience in the matter is zip, all my knowledge of the matter comes from book larnin’).
An extremely complicated question but the replies above are pretty on-target. My thoughts:
On specific industry standards and customs:
Of course, laws vary among jurisdiction but I do believe that the general rule is that juries are allowed to consider how the conduct in question compares to the industry standard or OSHA or trade association standards (for better or worse).
On the general question of whether an entire way of doing business can be negligent:
Not usually, but yes. Classic example: industry standards on manufacturing/labeling/handling asbestos-containing materials, 1950s time era. Liability based on the duty of Ds to be aware of the medical and scientific literature. Same with Benzene, up to the 1970s.
Note: (Not having read the GD). One of the bases for liability in the McDonalds case was that McDonalds had a specific policy of making their coffee hotter than other chains. Allegedly (I’m not an expert but I think this is correct) to make coffee smell stronger and cut down on refills. Accordingly, “industry standard” helped the Plaintiff in that case.
JohnW77707, Esq., Board Certified in Personal Injury Trial Law, Texas State Board of Legal Specialization
Well, I wasn’t talking about strict liability, but it’s true that conforming to industry standard is no defense in strict liability; still, in such a case, the jury must decide whether a defect exists at all. One type of defect is a defective design, and one way of showing that the design was not defective is to show that the entire industry uses the same basic design. It’s not proof, but it’s something.
Can an entire industry be negligent? What I was talking about was recovery from a single company that had adhered to the industry standard. In a negligence claim (as opposed to strict liability), adherence to industry standards supports the argument that the defendant was not negligent; but the jury is free to conclude that the whole industry is wrong and the plaintiff is right.
There was a lawsuit a while back where someone sued a car manufactured (I think it was Chrysler) for not putting an airbag in a econo-model back when they were just being introduce and were only in high end models… The plaintifs claimed that the manufacturer should have put this safety feature in all cars, even though Federal regulations allowed automatic seatbelts at the time.
I believe the case was thrown out, but don’t know for sure. It could be argued that once a manufacturer knows the safety benefits of a device they should include it. I don’t think that argument holds much water, but I believe that was their case.