Comments on: Supreme Court Limits Suits Against Device Makers

By: Bob

Bob — Fri, 21 Mar 2008 07:03:53 +0000

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

By: Bob

Bob — Fri, 21 Mar 2008 06:57:52 +0000

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.

By: Stephen

Stephen — Fri, 29 Feb 2008 10:25:46 +0000

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.

By: Mara

Mara — Wed, 20 Feb 2008 22:39:44 +0000

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.

By: Justice in Michigan

Justice in Michigan — Wed, 20 Feb 2008 20:06:42 +0000

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.”

By: WBP

WBP — Wed, 20 Feb 2008 19:50:55 +0000

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!!

By: AV Block

AV Block — Wed, 20 Feb 2008 18:45:17 +0000

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.

By: Dan

Dan — Wed, 20 Feb 2008 18:13:16 +0000

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.

By: Justice in Michigan

Justice in Michigan — Wed, 20 Feb 2008 17:58:31 +0000

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.

By: BDM

BDM — Wed, 20 Feb 2008 17:45:07 +0000

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!