As we had earlier noted pre-acquisition Organon is involved in what was once a criminal investigation out of Boston, and has now settled into a civil False Claims Act/Qui Tam action captioned US v. Organon, Inc. (Case No. 07-2690, US Dist. Ct. NJ), nominally brought by Dr. Jeffrey Feldstein, MD (a former Organon scientist) against Organon, and its affiliates, for allegedly deceiving the public and the FDA about one of its anesthesia drugs, then a new drug called Raplon. That drug was voluntarily removed from the market in March of 2001, after the deaths of five patients. This case -- like so many others involving Schering-Plough -- is pending before federal District Court Judge Dennis M. Cavanaugh.
Arent Fox represents Schering-Plough in this matter, as Schering acquired these Organon businesses as of November 16, 2007. Arent Fox, on behalf of Schering, has been granted until June 27, 2008 to file a substantive answer to the claims of Dr. Feldstein.
That filing may well prove to be rather illuminating, on a host of fronts -- for it may offer a glimpse into the amounts, and kinds, of due diligence Schering (and its lawyers) chose to undertake, prior to acquiring Organon, as well as some sense of how seriously present management approaches such important matters.
Wednesday, June 11, 2008
Arent Fox allowed an additional 10 days to respond re Organon Qui Tam matter. . .
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2 comments:
Speaking of Arent Fox. Representative Chris Van Hollen (MD-D) whose district includes many FDA employees. Prior to becoming a member fo congress was a partner at Arent Fox.
Mr. Van Hollen also sits on the Government Reform Committee that sponsored the recent FDAAA legislation that was a everything Pharma wanted.
Opensecrets.org has a wealth of infomation about representative Van Hollen.
http://opensecrets.org/politicians/summary.php?cid=N00013820
For example he gets an awful lot of money from health care professional organizations, as well as Arent Fox, and Lawyers/Lobbyists.
Mr. Van Hollen was also an advisor to the Montgomery County Chapter of the National Association for the Mentally Ill. Whose national organization has close ties and has received over $ 10 millions from Pharma over a few years.
NAMI Montgomery County is also advocating in the Maryland legislature for forced outpatient treatment, in addition to lower standards for commitment, and guarenteed access to newer antipsychotics. It also has on its website links to the expert opinion treatment guidelines from a for profit business that tends to promote treatments favorable to Pharma.
www.namimc.org/PDF/News/Annual%20Report%202004-2005.pdf
http://www.namimc.org/websites.asp
Expert Consensus Treatment Guidelines
Mr Van Hollen's personal financial disclosures also shows >90% of his personal holdings in industries that are regulated by FDA. In particular he owns few individual stocks but those he does includes J&J and Pfizer and are among his largest individual holdings.
The Supreme Court has said government employee whistleblowers should go to their own representatives. If I were an FDA whistleblower in Mr. Van Hollen's District I sure wouldn't feel very comfortable going to him.
Wow! Great sleuthing, here.
This may well merit a follow-up, full-on post -- and I'll give you copious credit -- once Arent Fox files the above-mentioned pleading.
That sould be June 27, 2008 -- or next week.
Thank you so much for sharing it with me! Do stop back!
Namaste
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