Talk:Franklin v. Parke-Davis

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Information about this court case is present in several Wikipedia articles including these:

This is a

WP:MERGED here then those articles should link to this one. Blue Rasberry (talk) 21:20, 4 May 2015 (UTC)[reply
]

Other sources of information

On Wikibooks some people wrote a bit about this.

Blue Rasberry (talk) 21:25, 4 May 2015 (UTC)[reply]

Grant program

I made a Wikipedia article for the Consumer & Prescriber Grant Program. This was a fund established with the fines from the lawsuit that would encourage nonprofit projects to counteract harmful aspects of medical advertising. Blue Rasberry (talk) 17:06, 21 June 2017 (UTC)[reply]

Celgene content

You asked me at my talk page about the revert... Jytdog (talk) 03:41, 1 August 2017 (UTC) User:JamieEdel about [https://en.wikipedia.org/w/index.php?title=Franklin_v._Parke-Davis&type=revision&diff=793092940&oldid=786825157 this:[reply]

A settlement of $280 million against

Celgene Corporation was announced in July 2017, and it is -- to date -- the largest off-label promotion whistleblower suit under the False Claims Act where the government did not intervene and that did not have a criminal component. [1][2][3] With $190 million allocated to resolve civil claims under the False Claims Act, Parke-Davis remains the second largest settlement against a pharmaceutical company in a non-intervened case under the False Claims Act.[4]

References

  1. ^ https://www.justice.gov/usao-cdca/pr/celgene-agrees-pay-280-million-resolve-fraud-allegations-related-promotion-cancer-drugs
  2. ^ http://www.prnewswire.com/news-releases/bio-pharma-giant----celgene----settles-case-alleging-marketing-violations-for-280-million-300494044.html
  3. ^ https://www.nytimes.com/2017/07/25/health/celgene-to-pay-280-million-to-settle-fraud-suit-over-cancer-drugs.html
  4. ^ https://en.wikipedia.org/wiki/Draft:List_of_largest_civil_only_pharmaceutical_settlements

A few issues with this. First, Wikipedia articles are not reliable sources -- this is described in

WP:RELTIME
, nothing in Wikipedia is "to date" - or vaguely "remains" -- articles have no dateline, so everything needs to be actually anchored to a date. Finally, the Celgene content has nothing to with this case per se. It is generally unhelpful to talk the ranking of things, since this changes with time. Things might have a rank as of a given date, which again is another reason to anchor everything to a date.

The section to which you added that was pretty messed up (RELTIME problems, unsourced content, etc) and I fixed it in these edits, which included bringing things up to date with the (rather shocking) ruling about the fish oil drug, which is already changing how the FDA regulates off-label marketing.

Does that answer? The content about the Celgene article should definitely go in the article about Celgene if it is not already there! Jytdog (talk) 03:41, 1 August 2017 (UTC)[reply]

Thanks, Jytdog. I have little issue with your changes in the Parke-Davis article and will leave them, but the fish oil ruling is of minimal significance and is not particularly changing how these cases are litigated, try, or settle as evidenced by the $280 million Celgene settlement. I work in this space and don't agree with Katie Thomas's article. I am aware that she has some forthcoming pieces on Celgene and maybe even a book, so perhaps she will do a more fulsome treatment, there. But to properly contextualize the Caronia and Amarin decisions and how they implicate off-label promotion and False Claims Act cases would take far more across-the-board edits than I have time do right now and sounds like there is no good way to address it within keeping of Wiki guidelines (to start, it's not been adopted by another Circuit Court, has not changed but not significantly changed the FDA approach -- as its most recent guidelines on off-label promotion evidence -- and does not apply to false or misleading off-label promotion). It might be doable but would take identification of numerous other articles on the point, and the issue remains somewhat in flux (there will be still newer FDA guidelines coming out for manufacturers on this). So, I will leave what you put.
I can appreciate that the additional Celgene content does not need to be in the Parke Davis article, but I thought the reference made sense in the impact section as that decision is still having impact. I'll leave the deletion, though.
As a final note, I would note the Franklin v. Parke-Davis article is no better sourced on it being one of the largest settlements (of its kind) of all time. Actually, there was no citation included for that statement at all. In addition to the Celgene article direct edits and edits on Parke-Davis, I added every single case I could find to the article on off-label promotional settlements since the Endo case (all where there was a press release, anyway), which took some time to do, as it has not been updated in years. And added a new article on civil only settlements. Citing to direct sources for each, like DOJ and attorney press releases. (The settlement agreements themselves are generally all public too, but I don't know how to cite to them; most are only on Pacer dockets and will not be accessible to most readers). It's simply true that this recent Celgen settlement is the second non-intervened settlement. And the 17th largest civil settlement under the FCA. It's also true that Parke Davis remains one of the largest settlements at a total of $430 million with $190 million allocated to the civil settlement (these numbers are discernible from the press release), but it's probably not possible to substantiate that statement about size in comparison to other cases other than linking to the other two articles and press releases. Having pointed that out, I will leave it as I'm not sure what the right change would be. (For either Parke-Davis or Celgene, I'm aware of no better source on comparative size than the absence of many relevant settlements in excess, shown in the other articles with links to DOJ press releases; it could be that DOJ end of year updates affirmatively address these, though, and I'd imagine that could be counted as a citable source). EDIT: I do see citations to some journals that make this statement the first time it is mentioned (though not later in the article), so I guess that's the substantiation needed. Nothing like that yet on Celgene so I agree with you that the representation should be left out until such statements are covered in similar journals. JamieEdel (talk) 05:44, 1 August 2017 (UTC)[reply]
Hm. Thanks for all that! Interesting about the Amarin decision and how other courts have not picked it up. Thanks for that. We generally consider DOJ press releases to be reliable sources, since they are a government agency. This is different from attorney press releases. Jytdog (talk) 13:42, 1 August 2017 (UTC)[reply]
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