Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.The lawsuit, Riegel v. Medtronic, was brought by the Donna Riegel, whose husband, Charles, was injured in 1996 when a Medtronic Evergreen balloon angioplasty catheter burst after being over-inflated and left Mr. Riegel injured and disabled. He later died of brain cancer:
(CNNMoney.com) The Riegels sued Medtronic in 2002, but lost in a New York federal district court and then on appeal. The two courts, siding with Medtronic, ruled that a 1976 amendment to the federal Food, Drug and Cosmetic Act protects medical device makers from being sued.This case has important implications that extend beyond just the device industry. With the FDA now being asked to regulate everything from food products, over-the-counter advertising, drugs, and medical devices, a ruling in Medtronic's favor might become a large legal defense barrier for all sorts of manufacturers.
"The defendant says you can't sue us in state or federal court because it's pre-empted by the federal amendment from 1976," said Wayne P. Smith, a lawyer for Riegel. "It's a very devastating defense."***
Medtronic spokesman Robert Clark said his company will ask the Supreme Court to uphold the appeals court decision ruling against Riegel. Clark said that doctor malpractice, not device malfunction, caused the catheter to rupture because it was inflated beyond its FDA-approved limits.
"The product did not malfunction," said Clark. "The physician used the product in a manner that was outside its label and its intention. In this case, it was expanded beyond the labeled indication."
-Wes
4 comments:
Thank you for writing about this case. I sure do hope that Medtronic wins this one and it sounds like they do have a strong case. In fact, why not go further and not allow people to complain/sue if the device's failure rate is within those presented to FDA?
It'd be nice if people stopped suing businesses for every single thing that goes wrong. When is it going to dawn on us that no technology is 100% fool proof, safe and effective nor are people mistake-prone?
Medtronic devices will save millions of lives. I know there are issues with leads used on their ICD devices but they still are incredible in terms of the quality of life and extra "life" they give their recipients. It is unfortunate that people are so "sue happy". I hope Medtronic wins this one. (I couldn't find a final ruling on this yet so I am assuming one has not be rendered)
I do have a personal question -- hubby had a heart transplant earlier this year and wants his ICD device back to keep. I can't understand this. Do you know why someone would want that back??? It's like keeping your tonsils in jar.
kb-
There are lots of reasons why people would want to keep their defibrillator, just as people want to keep souvenirs.
For many, having an ICD requires courage and trust. Once in a while, someone's life is saved by one. Many, many patients grow attached to their device since, for a while, it was part of "them."
And then there's the curiosity part: what does it look like? is it heavy? , etc. (Most patients don't see it before it's implanted).
And don't forget that it costs a pretty penny, too.
So for lots of reasons, many folks want to have their device after it's explanted. I would suggest he return it, (so the company can do their quality assurance), but then ask that it be returned to him. (They'll usually do this).
After all, he paid for it (likely via insurance).
Thanks! After $140k I guess he can get it back. I joke and call my husband the Million Dollar Man because of all the interventions and subsequent heart transplant. (mostly insurance - thank the Lord) The numbers are close - give or take a $100k. Just glad to have him here to help raise our kids.
We have asked Medtronic for the device back and haven't seen it yet but my uncle is a Medtronic rep in TX and said they may take a while. Thanks for all your do everyday!
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