Friday, June 12, 2009

"Shhhhhsh!" Say Sch-Merck Reverse-Merger Defendants. . . .


Overnight, in the consolidated federal putative class action litigation challenging the adequacy of the process by which the Schering-Plough/Merck merger transaction was structured, the Defendants have asserted, and the Plaintiffs' lawyers have agreed, to a very broad set of proposed confidentiality orders. All that is missing is the signature of Judge Cavanaugh. [Click image to enlarge, at right.]

As a general rule, for over 400 years, our courts, like the British ones on which they are based, have been run as open, public fora -- as from, and after the Elizabethan implementation of Magna Carta, or the "Great Writ", there were to be very few legitimate reasons to hold so-called "Star Chamber" proceedings, in secret.

Now, as is true with every rule, there are exceptions.

There are very good reasons to keep trade secret information from competitors' eyes. But keeping simply "sensitive" or "embarrassing" information from public scrutiny, in the face of the public's right to know about a $41 billion potential investment in the FDA-regulated delivery of human health phramaceuticals, largely will not do.

Therefore, within the bounds of the applicable law, I am committed to providing the readers assembled here with as much information as I possibly can, about the matters that will influence the status and outcome of this litigation, and the reverse merger, more generally. That is my promise.

~~~~~~~~~~~~~


UPDATED -- 06.12.09 @ 3:50 PM EDT -- Salmon, as ever has a great add here, from his comment (only slightly edited), below:
The abuse of secrecy is one of the most ignoble aspects of our legal system.

Yesterday the Senate Subcommitee on Oversight of Government, the Federal Workforce, and the District of Columbia held hearings on the proposed Whistleblower Protection Act S. 372.

The major problems with the bill the lack of an appeal to a Jury Trial and an avenue for disclosures of 'national security' issues. Even when defined as such several years after public release. The Obama administration is arguing against both. Although they are still trying to include loopholes as a backup strategy such as disclosure of national security issues only to a Star Chamber of hand picked individuals by the President.

The problem is who is going to know enough to navigate the rules properly?

See some of the attached documents, and additional ones that will be published in upcoming days.

Presently the whistleblower laws are so eviscerated that an FDA reviewer who would not have security issues could still have evidence pointing to intentional poisoning with drugs that will induce widespread toxicities that will require treatment with other drugs made by the same company. Yet unless that person is a lawyer who knew all the legal minutia and loopholes about how to disclose there is virtually no way you could win a whistleblower case on the merits. [That's] why since 1994 when the [federal] Whistleblower Protection Act was last strengthened only 3 of 200 government whistleblowers have won cases and [no one has a reported win] since 2000.

[Condor's Note: Of course, there have been settlements -- several, actually, in very large amounts -- but those, in general are. . . yep, you guessed it: kept secret!]

For a discussion of some of these loopholes, see Tom Devine's (GAP) document beginning on page 16. (GAP represented David Graham -- the Vioxx Whistleblower).

According to the FDA whistleblower letter to President Obama the the harassment and intimidation is so strong inside the FDA that it might make one suspect that there is likely incredible amounts of self censoring in FDA reviews.

Thus how can we possibly trust that approvals of drugs are made honestly?

-- Salmon

A very fair question, from Salmon.

2 comments:

Anonymous said...

The abuse of secrecy is one of the most ignoble aspects of our legal system.

Yesterday the Senate Subcommitee on Oversight of Government, the Federal Workforce, and the District of Columbia held hearings on the proposed Whistleblower Protection Act S. 372.

http://hsgac.senate.gov/public/index.cfm?Fuseaction=Hearings.Detail&HearingID=f657db46-9461-43ba-99de-2ac25593c899

The major problems with the bill the lack of an appeal to a Jury Trial and an avenue for disclosures of 'national security' issues. Even when defined as such several years after public release. The Obama administration is arguing against both. Although they are still trying to include loopholes as a backup strategy such as disclosure of national security issues only to a Star Chamber of hand picked individuals by the President.

The problem is who is going to know enough to navigate the rules properly.

See some of the attached documents and additional ones that will be published in upcoming days.

Presently the whistleblower laws are so eviscerated that an FDA reviewer who would not have security issues could still have evidence pointing to intentional poisoning with drugs that will induce widespread toxicities that will require treatment with other drugs made by the same company. Yet unless that person is a lawyer who knew all the legal minutia and loopholes about how to disclose there is virtually no way you could win a whistleblower case on the merits. Why since 1994 when the whistleblower protection act was last strengthened only 3 of 200 government whistleblowers have won cases and none since 2000.

For a discussion of some of these loopholes. See Tom Devine's (GAP) document beginning on page 16. (GAP represented David Graham the Vioxx Whistleblower).

According to the FDA whistleblower letter to President Obama the the harassment and intimidation is so strong inside the FDA that it makes you suspect that there is likely incredible amounts of self censoring in FDA reviews.

Thus how can we possibly trust that approvals of drugs are made honestly.

Salmon

Condor said...

This is going to the front, now!

Excellent, thanks Salmon!

Namaste