Indemnity Letters - What's the Deal?

#1
We have a customer who wants us to create one package that we they can use in both the U.S. and the EU. For the EU, one of the claims they want to make on the packaging is unsupported by our current test results so we said we can't put it on the packaging. They offered up an indemnity letter that appears to be protective of us. Due to the legal manufacturer concept in the EU, I'm uncomfortable but slightly okay with this. But when it comes to the U.S. - everyone is on the hook for everything so I'm thinking an indemnity letter won't help and might even hurt us.

Has anyone dealt with these things? They seem dodgy but might be common practice.

Signed,

n00badrai
 

Ninja

Looking for Reality
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#3
Not a lawyer, never dealt with this specific thing, not in medical devices...answering only since no one else has...

From my eyes, you would be counting on your customer to protect you from the results of your actions...and to protect you from US authorities.
I can easily see the first question being "Who put this label on the package? That's the only one I'm interesting in talking to."
The second question, of course, being "Do you have data to back this up?...That's a letter from someone, I asked for data."

Long and short, I would start discussing how to transfer labeling responsibilities to your customer. Let them hang themselves, not hang you.
HTH from what I would consider to be an uninformed source (me).
 
#4
Whether it is US or EU, I don't believe you can sell a device with a claim that is unsupported by data, that's akin to selling snake-oil. If your customer has this data, then they should relabel the device identifying them as the manufacturer. When you are being sued, do the have sufficient insurance to cover you? I agree with Ninja, I would stay away from this idea.
 
#5
Thanks everybody - this is enough information for me to understand this is NOT common practice in the medical devices world. I will lodge my objection accordingly.
 

Ninja

Looking for Reality
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#6
this is enough information for me to understand this is NOT common practice in the medical devices world
Im sure you heard it the first time...but just to be sure...

I have no idea what is or is not "common practice" in the medical device space...
 

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