Organon Whistleblower Defends His Claims
12 CommentsBy Ed Silverman // August 5th, 2008 // 7:32 am
Last month, Schering-Plough’s lawyers filed a motion in federal court in New Jersey arguing that a former medical director at Organon, which the drugmaker recently paid $14.3 billion to acquire, wasn’t qualified to bring a whistleblower lawsuit alleging Organon covered-up serious side effects prior to launching two drugs several years ago.
The employee, Jeff Feldstein, alleges Organon failed to disclose to the FDA concerns about serious adverse events involving bronchospasm that were cited by clinical trial investigators studying Raplon, a neuromuscular blocking agent, prior to its 1999 launch (back story). The drug was withdrawn in 2001. He also charged Organon allegedly diluted data in an NDA submission showing excessive bleeding caused by the Arixtra blood thinner before it was approved in December 2001 (back story).
Yesterday, Feldstein’s lawyers fired back, belittling claims he wasn’t an original source of the info upon which his lawsuit is based and denied he relied on news accounts or product-liability lawsuits against Organon. They also argued the former Organon employee successfully cleared a legal hurdle known as rule 9b, a controversial provision of the False Claims Act, which requires a whistleblower to provide specific info about false claims submitted to the government for payment.
These are, in fact, standard points of argument in whistleblower lawsuits, although important ones that can easily determine whether a case proceeds. You can read Feldstein’s motion here. The outcome may have serious implications for Schering-Plough, which already raised a troubling point in its own motion last month. The drugmaker charged Feldstein failed to prove the “successor (company) had notice of the claim before the acquisition.”
In other words, Schering-Plough’s lawyers suggest the drugmaker may not have known about the lawsuit, despite the potential for a sizeable liability. This raises an embarassing due diligence issue. We looking forward to reading the next motion filed by Schering-Plough and its lawyers to see if are able to come up with an explanation for this interesting revelation.
harpy
“Yesterday, Feldstein’s lawyers fired back…”
Do you mean Schering-Plough’s lawyers? Or do I need more coffee?
Condor
Dang!
Great work, here Ed! I should have checked the federal NJ court filings docket yesterday afternoon — as I usually do, on Mondays, Wednesdays and Fridays, but I let the day get away from me. Live and learn — I guess, now –appropos of Bejing — the race goes, as always, to the swiftest. . . . and that is. . . . you!
I’ll read the filing closely, now, and offer some thoughts, here — and on mine, sorta’ in tandem — shortly.
Well-done!
Condor
First — harpy — it is Dr. Feldstein’s lawyers, answering Schering/Organon’s lawyers motion to dismiss Feldstein’s Qui Tam/False Claims Act suit. So, Ed is (as ever) correct.
This — for my money — is the best zinger in the filing (at pages 28 to 29). It is Dr. Feldstein’s answer to whether Feldstein suit should be stopped because Schering was “unaware” of the allegedly bad conduct of Organon, when Schering acquired Organon last November (as Ed mentions toward theend of his post, above):
“. . .Defendants [Schering and Organon] cannot seriously assert that the statement does not provide them with adequate notice of the successor liability claim and the ground upon which it is based. The facts that will ultimately determine the validity of that claim
are within Schering’s possession. . . .”
In other words — Dr. Feldstein’s law firm is saying — “this does NOT pass the ’straight face’ test” — those Schering lawyers cannot even utter it aloud, in open court, in front of Judge Cavanaugh, without (unsucessfully, I might add) suppressing smirks — smirks, of their OWN incredulity. . . .
Sweet! More to come.
Namaste
Condor
I have a lil’ more up on this, now. . .
will add to it (and add some more here, as well), during the day — but for now I am off:
http://shearlingsplowed.blogspot.com/2008/08/pharmalot-has-scoop-dr-feldsteins.html
Cheers!
SP 2
No wonder the FDA is concerned about potential serious safety issues with sugammadex!!!!
harpy
Thanks Condor. I do need more coffee.
Piper
I think your missing the reason for why dismissal is warranted. 1) the harmful effects of Raplon have been in the public domain for 7 years now, 2 ) three individuals, with DIRECT knowledge of the situation, already took OBS to court and WON, 3) Dr. Feldstein was not directly involved with Raplon, such that his testimony is mere heresy and his email proved nothing before the facts of the drug were already being known:
“Dr. Feldstein *alleges* that he obtained an e-mail during his employment that led him to believe Organon hid information from the FDA regarding Raplon before the drug was approved. The e-mail contains statements from which an *inference* easily can be drawn that Organon fraudulently concealed information from the FDA before the drug’s approval regarding the side effects of Raplon.”
*Sounds like a lot of assuming and not a lot of proving….
My Guess
I think Piper is a lawyer who works for Big Pharma.
Doc
Piper,
1.) Dr. Feldstein does not need to have been directly involved with Raplon to bring his suit.
2.) Methinks you meant hearsay, not heresy - although your post seems heretical to many of us.
Condor
All my meetings ran way long — so it is very late, late, PM, now — that I am finally seeing Piper’s, above.
S/he is clearly no lawyer.
Each of her grounds for dismissal would be inappropriate — even if established by admissions from Dr. Feldstein — at this stage of the litigation. This litigation is just NOW beginning the process of discovery — a process by whcih Dr. Feldstein will be allowed to try to gather evidence from Organon and Schering to support his allegations.
Schering seeks to dismiss it, at this stage, by essentially saying “even IF every word Dr. Feldstein utters is proven absolutely true — it will amount ot no violation of the law” — so, please dismiss.
Um. . . . can you say “Not likely”? Sure you can.
See — Dr. Feldstein’s suit was originally sealed, and handled as a CRIMINAL inquiry for over six years, out of the Boston US Attorneys’ Offices (with what also looked to be some involvement by the Manhattan offices) — the unsealed portions of that sealed case file reveal the above facts.
So, he is no “Johnny-come-lately” to this particular party.
For Piper — my advice? — you should stick to things you know something about.
Cheers!
Piper
Condor, here’s something I know about qui tam actions: 1. If the DOJ declines to intervene in a False Claims suit, there is a much higher probability it will be dismissed. 2. Claims may be prejudiced if disclosure of the alleged unlawful act has been reported in the press, as was the case with Raplon. 3. If complaints were filed to an agency (such as the FDA) instead of in a lawsuit, claims may be prejudiced. 4. If the person filing a claim under the act was not the first person to do so (Feldstein was the LAST - doesn’t matter if he was waiting on the Boston Office - the DOJ has 60 DAYS to decline to intervene, not 6 YEARS….), claims may dismissed. The following would NOT be actionable under the False Claims Act: Cases based upon allegations or transactions that have been publicly disclosed, UNLESS the filer had DIRECT (no - Feldstein had INDIRECT - not first hand) and INDEPENDENT (no - an email inference) knowledge of those allegations or transactions, and had provided the information to the government prior to filing suit.
Condor, Schering isn’t seeking a dismissal based on whatever garbage you just spewed forth in your post. They are seeking dismissal on the grounds of elimination - the case lacks the appropriate criteria to be filed under the False Claims Act.
Why can’t you just state the facts and get over it? So bitter….so hating of Schering…
BP Watch
It may be time for Schering-Plough to “pay the piper.”