Supreme Court Limits Suits Against Device Makers
12 CommentsBy Ed Silverman // February 20th, 2008 // 11:54 am
In a closely watched case, the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA.
The court reviewed a lawsuit that pitted Medtronic against a woman whose now-deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.
In the decision, Justice Antonin Scalia wrote that the FDA’s approval process was “rigorous” and precluded imposition of any additional requirements under state product-liability law (Please see page 4 of the ruling). Justice Ruth Bader Ginsburg was the only dissenter.
The ruling gives device makers an eagerly anticipated defense in product-liability lawsuits. The decision may also gladden drugmakers, which have appealed to the Supreme Court in two separate cases to restrict the ability of patients to file suits in state courts. Unlike medical devices, however, there is no statute providing for preemption for drugs. This separate battle centers on whether decisions by state courts and juries should have the right to trump an FDA rule, which the agency and industry say is the final word on safety and effectiveness.
The court’s ruling will affect devices most frequently targeted in lawsuits, such as bone screws and defibrillator wires that undergo the FDA’s “pre- market approval” process. By contrast, companies that year filed 3,130 applications under rules that provide for fast-track review of devices similar to those already on the market, Bloomberg News notes. In 1996, in another case involving Medtronic, a splintered Supreme Court allowed product-liability suits over devices cleared under the fast-track process.
In the latest case, device makers and the White House argued that the more rigorous federal pre-market system should preclude state-law claims that companies ought to have done more to ensure safety. Device makers said that invoking state laws would subject them to different legal standards around the country. Patient advocates, however, argued that a ruling in favor of Medtronic would leave patients unable to get adequate compensation for injuries caused by the most dangerous medical devices.
Nathan
Ed (or Justice in MI),
What does this statement mean:
“Unlike medical devices, however, there is no statute providing for preemption for drugs.”
I was not aware of this. Medical devices DO have some sort of preemtion statute in place? If so, how did this case get all the way to the supreme court? It seems that it would have been dismissed long ago. Why is there a difference (in statutes) between medical devices approved by the FDA and drugs approved by the FDA?
Justice in Michigan
Nathan - Yes, earlier legislation did establish express preemption for devices. The plaintiffs in this instance (I forgot all the particulars) were arguing that the specifics of the Medtronic case exposed the limits of blanket preemption - for this case, and therefore also as an all-inclusive principle.
As Ed notes, there is also the issue of compensation. As an aside, one of our pro-preemption state Senators (himself a cardiologist) has argued that if an approved drug/device does cause forseeable injury, than it should be the gov. which compenates injured or their survivors (since the FDA would have screwed up). I’m not entirely unsympathetic to such a position, but I don’t think it very realistic as things stand. Also, this presumes the company was really in compliance in more than a minimalist, passive-aggressive way and thus could not be considered partly responsible for the injuries/deaths.
The Supreme Court, if it chooses, can decide to engage such an issue. Not surprisingly, it was Public Citizen, not Medtronic, who wanted the case to be heard! It was a bit of a surprise that the Court agreed.
The Drug and Device Law Blog (bias assumed) has a few long posts that distinguish between drug and device issues and cases. Much as I disagree with their overall objectives, they are a good source on the relevant history, if not (from my perspective) its “moral.”
As usual, I will take issue with framing civil liability as “trumping an FDA rule.” As noted (often enough) by me here, FDA itself did not view it that way until the current administration. The formulation is useful for defendants, but has little to do with most actual cases. Again without over- reiterating, that is because they hinge on actions and warning companies _could_ have done under the FDCA but failed to do, did essentially delinquently or even fully fraudulently (whether or not FDA prosecutes which we know virtually never happens), or involved malfeasance outside of FDA’s purview but still relevant to what docs and pts do and do not have re: safety data.
Thus, the “second-guessing the FDA” argument is, in general, a clever but misleading bit of corporate lawyering.
BDM
This is just great! The Supreme Court puts the pockets of the device makers before the American public. Why should companies that make products that are designed to treat patients be exempt when they screw up? Most people have to take responsibility for their actions, but device makers now don’t?
I wonder how much these companies have contributed to W’s campaign treasure chest in the past and how many highly-paid lobbyists they have running around Washington? The answers are no doubt millions and way too many for the public good!
Justice in Michigan
Re: my post above, I should have added that preemption as now framed provides no possible compensation for _preventable_ injury or death.
Re: BDM’s comment, I am not in favor of holding companies accountable if they complied with FDA regulations reasonably and in good faith. We know there is a spectrum between that kind of compliance and outright fraud. Part of the role of civil liability - and the reason FDA itself did not see it as a competing system until the current administration - is to determine when, within that spectrum, a company has strayed too far.
Of course, this also implies an FDA different than the one that currently exists, but that is a separate issue.
Dan
I’ve about had it after reading this. To posit that an FDA product is flawless, and therefore harmless, is a severe deviation from reality.
Making others aware of such situations is perhaps the only remedy.
AV Block
Lawsuits are a significant contributor to healthcare costs. Finally, the Supreme Court did something good for the country. At the end of the day, unnecessary product liability suits are costs that that ultimately fall on consumers. Don’t get me started with a related problem, defensive medicine, either!! If you want to solve the problem of the uninsured, stop corrupt journalists and corrupt trial lawyers.
WBP
I’m sorry, but I believe that the makers of medical devices should be responsible for the quality of their products. If an angioplasty baloon explodes in a coronary artery, it was probably defective. If a stent cather gets stuck in a coronary because it malfunctioned, then it was probably defective. If a pacemeker stops working suddenly not due to battery supply, then it’s probably defective. Most of the problems with medical devices are due to quality issues. The device makers are responsible for this, just as the automobile manufacturers have been held responsible for rolling vehicles, emploding gas tanks, defective equipment over the years. if anything, the device manufacturers should be more careful!!
Justice in Michigan
Point of info: As I recall, part of Medtronic’s defense was that the cath was “overinflated” as related to specs. Thus, the company was shifting responsibility to the surgeons. Thus, they were anything but trying to solve the problem of “defensive medicine.”
Mara
I read this to mean that lawsuits based on ’safety and efficacy’ are precluded, but that lawsuits based in negligence (failure to exercise due care during manufacture) or based in fraud (for example, sending false data to the FDA, which bases their decision on that data) would still be permitted.
Furthermore, hiding data (ketek, anyone?) could also be the basis for a lawsuit (it borders on fraudulent behavior).
Off-label use or misuse could shield the company, but not the medical provider, although the way that biliary stents are used in the peripheral anatomy is an example of off-label use that has become “standard of care”, which could still impact a company, since the use is established sufficiently that the manufacturer knew, or should have known, of any problems with the off-label use.
Stephen
My mother suffered a major stroke paralizing her left side after having her kidney implanted with a biliary stent. Any information that would help me find an expert on this subject or any other helpful information would be greatly appreciated.
Bob
I have a fidelis lead from medtronic implanted attached to a defibullator. These have been recalled by Medtronic and of course there are thousands of lawsuits. Now who’s fault is it that these leads are fracturing. Well lets see, the supreme court says that the manufacture is not responsible because the FDA approved it. Well guess what, when a company screws up bad or loses alot of money, who get the boot. Usually not the guy that caused the issue, its usually the guy in charge. THE FDA.
Bob
I have a fidelis lead from medtronic implanted. These have been recalled by Medtronic and of course there are thousands of lawsuits. Now who’s fault is it that these leads are fracturing. Well lets see, the supreme court says that the manufacture is not responsible because the FDA approved it. Well guess what, when a company screws up bad or loses alot of money, who get the boot. Usually not the guy that caused the issue, its usually the guy in charge. THE FDA. I think the supreme court opened up a can of worms. The next thing you know, Lawyers will be suing the FDA. There may be a way around this one however, as Medtronic kept selling them even when they knew they had a problem. Now who is going to cover that one up. Selling something you don’t know is bad is one thing, but selling it after the fact is a whole new ball game