I am trying to get a grasp on what this actually means:
Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
On the one hand, I like the comfort zone that FDA approval would provide to makers of medical devices, but on the other hand, I don’t like that it appears that there will be no real means for redress for those damaged by faulty products. What happens in the case in which a company lies its way to FDA approval (or, given the corruption and cronyism and incompetence of this administration, someone on the FDA does not do due diligence and approves a faulty product) and someone is hurt by their product? Is the family just screwed? I am notoriously bad at interpreting the outcomes of legal cases, so fill me in.
wvng
Sure looks like a free pass to me. Although I’m not sure that this immunity would apply if the “device” was actually manufactured badly, versus having a design flaw in the product.
Good to know that, with bushies in charge, the technical oversight will be rigorous and there is no chance a faulty product could get past their eagle eyes.
Dennis - SGMM
Considering the terrific job that the FDA has done with the Dalkon Shield, Vioxx, inspection of Chinese drug factories, etc., there is obviously no need for redress.
This sounds like a not-so-subtle variation of “privatize the profits, socialize the risks.”
jenniebee
Best comment on it I heard yesterday: “what this means is, if you don’t like it, write your congressman.” The Supremes just read the laws and said that whatever Congress’s intent was, this is what their laws said to do. There’s a vulnerability here now, and Congress is the only body that can fix it.
Jen
According to the article:
As I understood it, the decision was based on the doctrine of pre-emption, wherein the federal government claims the exclusive right to legislate in a particular area, pre-empting the states. Consumers had been bringing suit against these companies based on state law, and now they can’t, except where they mirror federal laws.
I read this decision as giving immunity to the manufacturers, even when the device is *defective*, unless it’s defective due to not complying with F.D.A. specifications. What people sometimes don’t realize in their desire to create a comfort zone for manufacturers is that these cases are quite hard to win. They require expensive discovery and favorable facts, and the lawyers taking these cases on contingency have very little to gain from frivolous suits. There are probably some filed by green lawyers out there, but they’re not likely to get far.
When people start ranting about the frivolous suits filed by greedy trial lawyers, I like to ask for examples of what they’re talking about.
Robert Johnston
That’s about it. It’s a sad thing when the Supreme Court doesn’t believe in internalizing costs. Why do conservatives hate the free market so much that they’re unwilling to believe that honest companies could actually survive one? The purchase of insurance to cover liability for risks like the one at issue here should, of course, be a precondition of approval for any medical device or product, just as it’s a precondition for a doctor having a license to practice.
Zifnab
One would think you could sue the FDA. If company A goes to the FDA and says, “I’d like to sell this gum to the public. Can I do it under US law?” And the FDA says, “Yes”, because some official was negligent or paid off, one would assume the FDA has assumed liability.
If the FDA keeps getting hit with lawsuits for fucking up like this, we need to look at who is in charge and why they still have their jobs.
Sure, suing the FDA is about the same as suing everyone in America (it all comes out of the collective pocket), so this looks like “privatized profit, publicized cost”, but if the FDA is doing its job we shouldn’t see too many of these suits. Of course, if the federal government’s approach is to divert all the liability to a nigh-unsueable bureaucracy… then we’re all just getting screwed as usual.
Jen
Those kinds of suits, Zif, would have to fall under the Federal Tort Claims Act.
See, governments start with the idea of sovereign immunity, and then decide which lil areas they are going to allow themselves to be sued in. Neat, huh?
Cyrus
I’m not a lawyer so it looked really complicated to me too, but my first reading of this is basically the same as Dennis – SGMM. But after trying to read the article, it looks like the problem is probably in Congress or the ancient 1976 law rather than the Supreme Court.
Caidence (fmr. Chris)
QFT. They’re only telling you what the FDA provides for, given these circumstances. This doesn’t mean that the rules can’t be changed, and I wouldn’t be surprised this starts a backlash.
I’m guessing (probably correctly) the motive behind this is to deflect the ability for legislation every time some fourth-tier M.D. screws up.
I’m also guessing (probably incorrectly) that the Abused Citizenry will have None Of This, and promptly contact their Congressperson after their case is thrown out.
That is, if they can remember what a Congressperson does, what their name is, how to contact them.
Caidence (fmr. Chris)
When I rant, I’m more concerned about the price tag on the damages claim. I don’t understand why victims get rewarded monetarily for being in the right to knock a company down a peg.
Victims should get paid for medical bills, erring on the positive side a bit, and that’s it. If you have to damage a company more, damages money goes to a counteractive non-profit fund.
Is there a law-scholarly take on that?
jvill
I read it at a sort of end-around tort reform.
So when the FDA is held liable it is the ever-present “process” that will receive the blame, and everyone will go about their business, just like always.
And if by some act of God someone is able to pursue a case for 20 years and successfully win a lawsuit against the FDA for not properly vetting a product, that money will come out of tax-payer pockets, rather than the slipshod company.
Grover Norquist couldn’t be happier.
Jen
Well, you’ve taken a harder line than even most tort-reformers with that. The object in a civil case, generally speaking, is to try to restore the plaintiff to the position they would be in had they not been damged. Other economic damages that even tort reformers don’t typically dispute would include lost wages, for example. Then there’s pain and suffering, which they typically want to cap at $250,000 or so rather than eliminate. Neither of those damages are considered punitive towards the company, they are rather considered part of making the plaintiff “whole”. Tort-reformers do typically have an opinion about punitive damages, but those are pretty rare and are supposed to be reserved for instances where the defendant misbehaves willfully.
Consider how Ford weighed recalling the Pinto, and decided that the litigation costs resulting from deaths and injuries were going to be less than the cost of recalling the fleet, hence no recall? — and I think you’ve got the case for punitives.
Jen
I should clarify that pain and suffering is considered a “noneconomic” damage, i.e. not easily quantifiable, but is not punitive.
Jen
Oh, and what should be done with punitive damages is a subject of debate. I think there’s a very good case to be made that they should go to a Legal Aid fund. The stated purposes are to punish the wrongdoer, and to deter other companies from behaving the same way. There’s nothing about those purposes which necessitates that the money go to the plaintiff.
NonyNony
I read it as yet another effort by this Republican-led administration to trash “State’s Rights” where those rights conflict with the “right” of a corporation to earn a profit. So hooray – the Supreme Court has found yet another area where the will of the Feds trumps whatever you do at a local level to protect your own citizens.
Also – now companies have even less incentive to do the expensive thorough testing they need to do on these products. Now they just need “good enough for FDA inspectors”. Sure screwing up majorly is a big PR hit that doesn’t do much for the good of the company, but most execs don’t think past two fiscal quarters, let alone the impact their actions might have four or five years down the road. So the perverse incentive will be to do just enough testing to get the FDA to sign off on it and then get it to market.
Caidence –
Because money is the only punishment a corporation knows. So if a jury wants to punish the corporation for their malfeasance, the only method they have for doing it is to up the award to the level of “painful for the corporation who screwed up”.
If there was a mechanism in place to force corporations to pay the actual expenses and then punitive damages be given to charity or someone other than the victims you’d probably see those massive sums drop. Likewise if there were some kind of non-monetary punishment that could be meted out to a corporation. But with our legal system if you want to have a punishment for a corporation that commits a wrongdoing you end up with outrageous dollar figures like that.
demimondian
I haven’t read the decision. I’d like to see the reasoning around what the Justices mean by “the agency’s specifications”. That’s the loophole that can either make this a terrifying give-away or a meaningless exercise in technicality — or anything in between.
I foresee many future lawsuits about exactly what those words mean.
Timb
As a law student working in a PI firm, I would officially like to announce my love for Jen. She is a gem
Caidence (fmr. Chris)
I think you took me as more eloquent than I am. I was being simplistic. I’m ok with lost wages returned, and stuff like that. But “lost wages” needs to be in line with society. If you’re some jerk off who makes 300K, but lives to spend it all, why should that enhance your ability to punish a company?
furthermore…
That’s I DO want to destroy. Because I’m an engineer, I’m very intimate with the concept that entropy is everywhere, and shared by everyone. If you get hosed by a bad product, you’re not facing P&S because the company was negligent. You’re facing P&S because that’s how you respond to entropy. (Simpler, just in case: entropy, in real-life, is when disorganization and decay occurs, causing problems).
You feel P&S because that’s the organic response to entropy; to cause you to turn around and handle the problem. While it IS the negligent party’s fault that you’ve been given an inordinate burden, it’s not their fault that evolution has developed for us a sense of pain. In fact, if there was no P&S caused by the negligent party, why would the plaintiff file a case in the first place? Isn’t P&S the obvious motive for the case — to handle the problem in front of the plaintiff?
Add on top of that that there’s no empirical formula for measuring pain and suffering, and I become adamantly against it’s application in court.
Of course, I’m probably completely ignorant of the legal meaning for P&S, and there’s something the size of an elephant that I’m not noticing.
Caidence (fmr. Chris)
I understand the mechanism you’re outlining, but — again I’m underlying my engineering perspective — it’s really bad design to disregard super-absolute motivations (like greed) just because they’re currently working in your favor. Those things can turn right around on you. At the very least, you need to put a check in place to keep the mechanism from slipping out of place and popping you in the face.
But I’d just be conservative and say “you can’t savage a company just because you think companies are big meanies” and drop that mechanism entirely. When you don’t know something, you don’t touch it. Turn it off. Ground it. Dismantle it, and rebuild it. If you can rebuild it confidently, be my guest. But leaving it sit there just because it’s in your favor. Naasssssty stuff.
See Also: Republicans forging Executive Privilege, Signing Statements, Wiretapping and the Democrats coming reign.
dmbeaster
I looked at the decision. It is really a stretch to find that tort laws governing product liabilities constitute a regulation in violation of federal pre-emption of the design regulations for medical products. It is the sort of biased thinking typical of this bunch — judicial activism in favor of business, but be ruthless about implying extension of laws in other areas.
From this article in the NY Times:
The medical device statute contains a pre-emption clause that bars states from imposing “any requirement” related to a medical device that is “different from, or in addition to” a federal requirement. The question of statutory interpretation at the heart of the case turned on what Congress meant by “any requirement.”
Justice Scalia said that state tort law, by imposing duties of care on product makers, amounted to such an additional requirement.
Funny how it took 32 years for someone to decide that this statute had this alleged meaning — that Fed approval prevented a claim that the product as designed was defective. At the same time, the medical device makers will howl if the Fed actually subjected them to the level of scrutiny that the product be certain to be safe and worth the risk before authorizing it. Nothing in the regulatory scheme supposes this level of scrutiny before products are authorized.
In the case at hand, the patient was harmed by a burst angioplasty device. Did the Fed carefully scrutinize the cost benefit of the strength of materials used for the balloon? And what is the rule when medical technology improves? Under traditional tort law, the manufacturer has to keep his product up to the design art. No such motivation will exist under this disgusting result by Scalia. Manufacturers are immune from liability for approved products even if the improvement in technology makes them dangerously defective. Only Fed action could require the product be taken off the market, rather than liability concerns.
LonghairedWeirdo
Near as I can tell, it says that the victim and/or family are screwed. I think this violates the spirit of liability law.
I mean, I can get FDA approval negating any chance of gross or willful negligence (unless there was information hidden from the FDA), but it shouldn’t negate actual liability.
If your car is in perfect condition, and you drive perfectly, but a child runs into the street unexpectedly, and you hit the kid, you’re still liable. No one can fault your driving or the state of your car, everyone agrees that you’re no criminal, but you’re still liable. No one considers that an additional regulatory burden on driving; they just accept that if you want the benefits of driving, you take on the risk of liability.
Jen
Well, the problem with your arguments (can I just say I have never heard of an entropy argument against pain & suffering before? That was just bizarre.) is that they are just inconsistent with the entire purpose of the civil justice system, to restore to the extent possible the position the plaintiff was in before he was injured. You would have to change the entire history of common law jurisprudence to something more like “plaintiff only gets things that have an exact and immediately quantifiable dollar value to them.”
Caidence, lots of things, including some economic damages, have no empirical formula for their calculation. Consider when someone who is unemployed but intends to return to the workplace, is harmed in such a way that their income potential is indisputably affected. That’s an economic damage. It may be very hard to put a dollar figure on, but that’s what we consider juries to be for. Future medical expenses for someone who may have ongoing, even lifetime medical expenses. It can be hard to tell how long you’ll need nursing care or whether or not you’ll need more surgery. Again, it’s a question for the jury to value.
The pain and suffering awards are, simply, a way to acknowledge that you have been harmed in a way that no one can undo, but that money is the only remedy we have. They are there in service to the general principle of the civil justice system, making the plaintiff “whole”. It is obvious that money does not compensate for certain things, but it at least acknowledges that the damages exist.
The entropy/evolution argument is very…novel. Isn’t is also evolution that led us to have large brains and walk upright? If your back is injured, the insurance company should be able to say that it’s not their fault you walk upright and if you’d been crawling where you belonged your back would be fine?
One more noneconomic damage you might be able to relate to. Loss of consortium has a broader definition than “loss of sex”, but in many circumstances that’s where it’s applied. If that particular ability were taken from you because of someone else’s negligence, would you not consider that to be worth something….?
Jen
It sounds like you’re saying there’s strict liability for hitting kids in the street, which isn’t true. Aside from some very limited strict liability exceptions, the child would still have to show your negligence. I’m not saying your insurance company, faced with a lawsuit from a severely injured child, wouldn’t settle favorably, but that has to do much more with their enormous exposure, even if it were unlikely, than with any admission of negligence.
Sojourner
Anyone who has spent any time working with the government knows that the standards they set are (a) absolute minimums (b) heavily influenced by the private sector.
Result: low standards, defective products, and little motivation to improve the situation other than pure altruism.
Jen
Well, the FDA is fairly notorious for its slow, painful testing. It actually gets criticism on the left that a lot of potentially beneficial treatments can’t get approved, that alternative medicines can’t get approved, that desperate people willing to assume risks cannot do so, etc. On the plus side, it never legalized thalidomide like many countries did.
swellsman
Actually, I used to work for a law firm where we specialized in making this argument. Our chief client at the time was a pacemaker company (since defunct) whose bad design of a pacing lead — the wire that leads from a pacemaker to the heart wall, and that supplies the electrical stimulus to keep the heart going — kept killing a small but not insignificant percentage of its recipients.
This is not, actually, a new view of the law. The phrase at issue “state regulations in addition to or different than” those imposed by the FDA had been around for a while, but no one thought they preempted state tort law until the Supreme Court ruled otherwise with respect to a very similar, almost identical, phrase in the law governing the marketing of cigarettes. All of a sudden, defense attorneys argued that the Medical Device Amendment should be interpreted the same way.
Essentially, the policy argument is as follows: in order to obtain approval from the FDA to market Class III medical devices (those that are known to involve a great deal of medical risk, but are allowed anyway because the perceived benefit is greater than the perceived risk; usually these are surgically implanted devices), a manufacturer has to submit extremely voluminous documentaiton to the FDA outlining exactly how the safety and the benefits of this device have been tested, exactly how the device is to be manufactured, exactly what the design is going to be, exactly what the packaging, labeling, instructions are, etc. etc.
This process usually takes around 2 years before approval is given, and the approval process is supposed to involve independent verification by the FDA, amendments and changes, etc., required by the FDA. Once approval is obtained, the medical device manufacturer CANNOT deviate from the manufacure/design/labeling without FDA approval.
So, the policy argument is that the Medical Device Amendment to the Food Drug and Cosmetic Act was intended to work out a compromise between the competing interests of (i) fostering further advances and progress in development of these very dangerous, but very necessary, devices, and (ii) allowing for a reasonable degree of safety. Essentially, if a manufacturer expends the necessary time, money and resources to obtain FDA approval AND the device is manufactured and marketed as approved by the FDA, then the manufacturer is shielded from liability if the device goes bad (as a certain percentage almost certainly will) and kills someone.
Essentially, Congress hoped that by providing this “safe harbor” manufacturers would be encourage to continue taking risks in developining new devices, while the public was also ensured against assuming excessive risks of unsafe products by the supervisory role of the FDA.
Now, in truth, I don’t think Congress consciously intended any such thing; it is just that they used language that the Supreme Court could interpret to result in this conclusion when they drafted the statute.
Additionally, even if Congress did intend such an outcome, that doesn’t necessarily mean that Congress’s balacing of these two policy goals — medical innovaction and public safety — was perfect or even close to ideal.
Finally, even in Congress DID intend this outcome and even if you believe that the balance it struck was appropriate, the entire scheme rests on the FDA being given sufficient resources to actually perform its oversight function in approving medical devices.
The most recent news reports on this front leads me to think they haven’t been, recently.
Caidence (fmr. Chris)
I AM Bizarre.
I was so afraid that was going to be the straight-up answer. Ugh. Me no likey.
Good counter. I don’t think I have a response to that yet. I think I’d go with “The insurance company is a contracted service, what they cover would be delineated in the contract you both sign.” However, I can’t effectively speak regarding the medical company and the patient, because IANAL, so I’ll shut up.
Thanks, Jen.
Jen
Swellsman clearly works in an area of the law somewhat relevant to the question asked, unlike me, resident hack lawyer. You should probably listen to him. :)
You don’t sign a contract with the insurer of the negligent, other, party.
You’re welcome, CFC, always a pleasure.
LonghairedWeirdo
My understanding of the law – and I admit I’m no lawyer – is that certain activities bring with them certain liabilities, and that driving was one of them. Thus, I’ve been told (admittedly, not by lawyers rendering an opinion) that if you hit someone while driving your car, you might not be criminally accountable, but would be held civilly liable. The lack of negligence would make you liable to a much smaller degree than if you’d been negligent.
The one thing I do remember hearing a lawyer say was that there was a huge difference between “liability” and “blame”. That someone is not reasonably to blame for an incident doesn’t make liability disappear.
FS
Isn’t this what those socialist European countries do – use regulation rather than legal remedies to deal with the concerns of the public? Who knew that Republicans were actually socialists in their heart of hearts?