Injured By A Medical Device? Supreme Court Says Tough Luck

[babylonsister]

Justices Make It Tougher to Sue Medical Device Makers


By DAVID STOUT
Published: February 20, 2008

WASHINGTON — In a case with huge implications for the health care-technology industry, the Supreme Court ruled on Wednesday that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury.

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.

In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.

But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’ suit on the ground that the catheter had been given premarket approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)

The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

more...

http://www.nytimes.com/2008/02/20/washington/20cnd-device.html?hp

[Hydra]

1. Ok, so the Feds don't check it, says it's ok, and you have no legal recourse?

I'm done going to the doctor. Period.

[blondeatlast]

3. That's about the size of it. If you have a chronic condition (as I do)

you are damned if you get treatment, and damned if you don't.

:scared:

[Hydra]

4. Sorry to hear about that

I have a few chronic conditions, but they can't help anyway, so I don't feel left out(especially since I don't get the bills anymore).

I can hardly think this is good press for them, but maybe they think there are no alternatives?

[blondeatlast]

2. I warned about this case back in November--I knew Medtronic (who distributes my

insulin pump)would win this. I'm stuck with them (the pump itself is manufactured by another comapny but carries the Medtronic label) but I'm NOT happy with them.

God help me--one step forward (breakthrough in stem-cell treatment of diabetes in mice) and one step back.

Those injections aren't looking so bad after all anymore. :cry: :mad:

[michaz]

5. 2 of my children have this device. One has had no problem and the other

had it go off 36 times in a row on her because of a lead problem. Guess what! The lead was not even the one they said was defective and on the list. It was, well, just a defective lead! Go figure! 2 of my 4 children had these devices implanted after our 16 year old son died suddenly while playing soccer at his school. This is just simply unbelievable!

[babylonsister]

7. Wow. I'm very sorry for your loss, michaz. And then to have

the SC treat this issue so cavalierly when you must worry so much about your kids. Sigh. :hug:

I'm sure this is going to sit well with a lot of people and does show how critical it is for us to get some liberal minds on the bench to counteract these people.

[blondeatlast]

9. We need to try to keep track of cases coming up on the SCOTUS docket.

I posted about this case in November (I think it was) when I first read about it--I had done a news search on Medtronic in regards to something else and found out about this.

Sadly, SCOTUS has become as political as any other branches. I wish it weren't so and I think it can be slowly reversed, but I knew Medtronic would win this because of the exptreme RW nature of the current court.

[michaz]

10. Thanks. My children have the implantable defibs. After my daughter went

through all that she had hers shut off. My children are older now and it was 17 years ago that our son died. We still have days but we are much better than we were, believe me. It is something that you just never get over.

[caligirl]

6. they make insulin pumps, a great company very careful very thorough. I thought.

But if you where an insulin pump they found out this past year that wearing a pump around an MRI machine is very bad. The insulin pumps were pushing unknown amounts of insulin without the knowledge of the diabetic attached to it. sudden severe lows resulted requiring emergency intervention. Don't know if anyone died. But now all pump wearers need to take the pump off while anywhere close to an MRI. And techs need to remind them to.

[blondeatlast]

8. I've had a few MRIS since pumping and the techs have always advised me

to remove it before going in anyway.

I'm glad they finally decided to make it official but I thought I always got good advice from the MRI techs.

I love my pump (I got my first when it still carried the MiniMed name) but I read about this case back in November and I was STEAMED.

[caligirl]

15. I didn't know it had gone on for any length of time. Our son hasn't needed

any MRIS. Medtronic sent out a sticky label to attach but of course we lost it. What happens though as they get into the implantable pump with a controller to release insulin. Its not like we can disconnect quick. I think this is bad news for patients rights.

[Howardx]

11. doesnt cheney have a pacemaker?

just sayin....

[penguin7]

12. Good Decision

The heat should go on the approval process where it belongs.

Oh I forgot the trial lawyers will make less money.

[crimsonblue]

13. It sucks that they ruled against but it might've been necessary

The way the FDA medical device process works is the device is classified in one of three classes. Class I is for medical devices that can be shown to be substantially similar to an already approved device, and also devices before 1976. They did this with old devices because they work not allowed (and it would've been impractical) to impose standards on devices that had been in use for years. The other classes are II and III. Classs III devices are for those are required to sustain or support life.. Anyway, catheters are mainly class 1 and 2, and are not subject to the same rigid requirements of Class III. Unless there has been documentation of the medical device failing in numbers, it will be very difficult to prosecute if failure occurs. That is, unless it is a class action, you're probably not gonna win. Now if the catheter broke from negligence or error of the Doctor or technician, then that's another story... Hopes this helps (finally i found a use for my 3 years of engineering undergrad...)

Edit: I'm not saying I agree with the ruling, but this was probably the justification they used. They don't want to set a precedent against companies in the biomed field, particularly since it is the fastest growing industry. Being an engineering intern at a med company, I can understand the need for protection, it's just sad that it is needed.

[The Backlash Cometh]

14. I've been sensing this kind of callousness to human life and well-being

for quite sometime. Whatever happened to safety, welfare and health?

[penguin7]

16. I want to know whether these devices are safe before a lawsuit

Thank you.

[The Backlash Cometh]

17. So what comes first, the chicken or the egg?

The device shouldn't be on the market unless some government agency has already seen it and approved it, but under the Bush Administration we know that the FDA has been understaffed for a reason. Repubs don't want government regulation. So that means everyone in the last eight to ten years, is just SOL according to you because you don't want the trial lawyers to get too much money?

[penguin7]

18. I do not want proper standard of care in medicine decided in a court room

I want experts making this decision. This is a very difficult subject and I do not want courts and lawsuits making it more difficult.

[blondeatlast]

19. So you don't want courts to offer justice to those who have been failed by the

FDA and the medical profession?

May you never need chronic medical care. I do, and I've thankfully never had to use the courts, but Medtronic (and I use another Medtronic device, fwiw) messed up badly here and ther has to be some justice somewhere.

I wish I lived in your world, because reality sucks a lot. :eyes:

[The Backlash Cometh]

21. I think that person is very young and has no clue what's coming down

the pike.

[blondeatlast]

22. Maybe so. I've noticed that s/he's very anti-legal profession.

Made lots of anti_edwards posts simply because he was a lawyer. :shrug:

[The Backlash Cometh]

23. We'll have to keep an eye on that one.

Especially if his/her arguments continue to lack anything more than a punchline.

[penguin7]

24. HUH?

I do not accept the notion that the trial lawyers are anything more than just another special interest group.

I also have no problem with spending whatever on the FDA. The companies that make these products should not be responsible for oversight. There should be no reason to sue them. If the FDA screws up, the FDA should take responsibility and the government should decide how to compensate the victims.

Our present system out and out stinks and the greedy lawyers are one of the many factors blocking change.

[The Backlash Cometh]

25. Oh, I see. What you propose is increasing the FDA's budget by

billions, and holding them financially accountable if something goes wrong. Here are the problems I see, just at a glance:

(1) You have to raise taxes to pay for those billions. You might succeed in raising it to improve the FDA's research facilities (because it badly needs it), but the public will never go for paying restitution if something goes wrong.

(2) One of the reasons why they won't buy into a blanket liability compensation plan, is because people don't always respond the same way to drugs or appliances. The doctor may actually have made an error of judgment that went against the FDA's recommendation, for instance. Why should the FDA be held responsible for that, then?

Yes, trial lawyers have abused their own purpose in society which is why they have developed a bad reputation. But if you get on in the family, believe me, it will help you enjoy the American dream a whole lot better.

[The Backlash Cometh]

20. So what are you going to do about all those people who are already

damaged? Do you understand that there are people out there who have been harmed and are awaiting justice and restitution? What are you proposing to do with them?