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Misbranding (by someone we've contracted with) in a Publication

tebusse

Involved In Discussions
#1
Greetings all!

I've got a regulatory issue that I've never encountered...

Someone we've contracted with submitted an abstract for publication in a high impact journal without our knowledge. Within the abstract our device is misrepresented, specifically, the regulatory approval, intended/indications for use and metrics are not in line with our current labeling or FDA registration.

Has anyone encountered this type of misbranding and, if so, how was it rectified?

I propose to have the abstract rescinded. If this isn't possible, as it was already published, write to the journal regarding the errors and have them publish a comment. Additionally, I would engage the FDA and discuss the issue with them. Inform the FDA we're aware of the misbranding, state that it was a publication without our knowledge, and propose our solution.

Any additional guidance or thoughts would be most helpful and appreciated.

Regards, TEB
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Someone who doesn’t work for your organization submitted a paper for publication without a legal and technical review by your organization? How is that possible? Who gave him/her authorization to do that?
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Happens all the time in publications...I referee a few professional publications still...been there, done that (though not in medical).

Contact the authors...let them know they have legally misrepresented material facts...allude (but do not accuse) to the fact that there are potential financial implications for both you and them (stoke the fire for re-edit).

The authors can adjust their publication as long as it hasn't hit print yet (Abstract does not equal publication).

If it is important as a safety valve...contact the publication directly and let them know that there are material errors in Abstract # ___ regarding a product that you produce (that the author does not produce). Publishers take a big hit when they publish flasehoods...they should respond with alacrity.

While you're at it...work with the author to get your name referenced in the author line...just for the cherry on top...and in doing so, insist on final or joint editorial review as a sine-qua-non.

:2cents:
 

tebusse

Involved In Discussions
#4
Thank you for the reply. We did not authorize the publication and I'm sure this does happen all of the time.

The author has already been contacted. The abstract has been published, but in taking your advice we'll contact the journal and inform them of the errors.

The abstract was also submitted for a presentation at an upcoming meeting. All of the meeting attendees have received the abstract.

I'm assuming no further regulatory action needs to be taken?
 
S

Sarah Stec

#5
I've also seen this happen more than a few times. Sometimes wrangling those KOLs is a full-time job in itself...:rolleyes:

On your end, you may want to do a CAPA-esque analysis - document when you found out, what you told the author, whether your contracts already prohibit this (and if not, why not, and when they will prohibit this and when the person will sign the amended contract), whether the person managing the relationship knew of this, etc.

There's not only misbranding but also healthcare compliance issues to worry about as well. You should talk to your lawyer to make sure your bases are covered. :2cents:
 

Ninja

Looking for Reality
Staff member
Super Moderator
#6
I'm not in medical...certainly not medical regulation...so I won't comment either way there.

In my experience, most of these types of inflationary things are accidental, or a simple miscommunication or misunderstanding.

All the same, you are wise to make sure you don't have liability or second-hand damage from someone else's misstep.
Good luck.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
Couple of material questions.

1. How did you obtain the abstract?
2. What do you contract with them for? Is this publication in breach of the contract?
3. Are consumers of the device likely to see this publication as endorsement of the product.
4. As mentioned prior, what remediation has been done, and what does your legal department believe in the implication?


Greetings all!

I've got a regulatory issue that I've never encountered...

Someone we've contracted with submitted an abstract for publication in a high impact journal without our knowledge. Within the abstract our device is misrepresented, specifically, the regulatory approval, intended/indications for use and metrics are not in line with our current labeling or FDA registration.

Has anyone encountered this type of misbranding and, if so, how was it rectified?

I propose to have the abstract rescinded. If this isn't possible, as it was already published, write to the journal regarding the errors and have them publish a comment. Additionally, I would engage the FDA and discuss the issue with them. Inform the FDA we're aware of the misbranding, state that it was a publication without our knowledge, and propose our solution.

Any additional guidance or thoughts would be most helpful and appreciated.

Regards, TEB
 

BradM

Staff member
Admin
#8
Most all journals I've been associated with requires some document, statement, attestation, etc. regarding conflict of interest, whether they had permission to post, etc.

I would call the publisher and ask if any of that information was requested/submitted.
 

tebusse

Involved In Discussions
#9
Couple of material questions.

1. How did you obtain the abstract?
2. What do you contract with them for? Is this publication in breach of the contract?
3. Are consumers of the device likely to see this publication as endorsement of the product.
4. As mentioned prior, what remediation has been done, and what does your legal department believe in the implication?

We obtained the abstract through the journal.

We're still trying to determine if the publication is a breach of contract.

Yes, consumers of the device are likely to see this publication as endorsement of the product.

Current remediation has been to contact the author. We're a very small company (10 employees), so we don't have a legal department in-house. We are internally working on a remediation plan. If you have any suggestions, I'm more than interested.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#10
We obtained the abstract through the journal.

We're still trying to determine if the publication is a breach of contract.

Yes, consumers of the device are likely to see this publication as endorsement of the product.

Current remediation has been to contact the author. We're a very small company (10 employees), so we don't have a legal department in-house. We are internally working on a remediation plan. If you have any suggestions, I'm more than interested.
I am in agreement with most of the advice given, but I would add the following:

I am not an attorney, but I would get an attorney to get an injunction against the journal from publishing the article. You are not in violation of misbranding, but rather the victim of libel. The knowing publication of false information is against the US Law. Unfortunately for you, it's wait and see till you figure out the breach of contract. If the journal supplied you the abstract as either public record (they publish abstracts for all papers) or supplied you the abstract as you are party to the article, they should not publish an article if you object to the content as being false.
 
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