“Don’t let the world around you squeeze you into its own mould, but let God re-mould your minds from within...”
Romans 12:2

Merck's illegal MMR smokescreen continues

Hilary Butler - Tuesday, August 20, 2013

Question: When is a legal case really newsworthy?

Answer: When it’s never covered by the mainstream media. Yet the on-going Merck MMR case - which no-one is being told about - is even more important than VIOXX was.

I wonder how Merck has managed to so skillfully keep it out of mainstream media....

So let’s update the news, …. that isn’t being told.

An article planted recently in the pro-corporate website Law360 says pretty much what Merck’s lawyers wanted it to say.  Naturally, it was ignored by mainstream media. It said:

‘Eric Sitarchuk of Morgan Lewis & Bockius LLP emphasized that the suit brought by two former employees of the company does not hold up because they failed to demonstrate that the label of its mumps vaccine was false and that the FDA was misled about the efficacy of the vaccine….. “They’re asking the court to muscle the FDA out of the way and decide on the science,” Sitarchuk said. “It’s precisely that problem that’s why an Fair Claims Act case can’t be based on the alleged falsity of the label.”….. Sitarchuk argued that for the pair to succeed in their case they would have to allege that the government was the victim of active misrepresentations by Merck and show that the efficacy of the vaccine was less than what the company claimed.’

In two previous blogs about this case, I outlined the primary issues, and uploaded the original complaint:

Part 1: June 23, 2012.  Former Merck Scientists File Suit Against Merck Under The False Claims Act

Part 2: June 24, 2012.  Merck's Money Racket

What’s happened since then?

SRKW LAW is the co-lead counsel for the class action lawsuit which runs parallel to the core case.

It took a while to find all subsequent relevant documents, which I will not upload here, for obvious reasons - but here are my summaries from the three documents which provide the Judge with core arguments from relevant parties:

On 31st August 2012, Merck filled a 50 page “Motion to dismiss.” (Case 2:10-cv-04374-CDJ Document 45) which simply attempted to rewrite the original complaint with willful inaccuracies, disregarding all allegations, while inventing new circuitous ones. Here are key omissions, and highlights:

1) Merck does NOT deny that they crossed out the numbers and wrote in new ones.

2) Merck does NOT deny that they committed the alleged multiple acts of fraud, but instead try to pretend that the allegations merely involved a misbranded label.

3) Merck attempts to argue that the case is only alleged to be a fraudulent label. Were the issue a fraudulent label, that would remove the case from the False Claims Act to another act laying blame on the FDA, not Merck.

4) Merck then takes another tack, bizarrely arguing for an illegal application of the False Claims Act, limiting or barring cases for fraudulent conduct which violates FDA or federal laws and regulations, and legally requiring whistle-blowers to FIRST exhaust all administrative remedies stating in exhaustive detail, who, what, where, when and how - ignoring the fact that in cases of corporate fraud it’s impossible for plaintiffs to have full personal knowledge of malfeasance occurring further up the hierarchy, where sophisticated means of concealment are used. This judicial demand, would rip the heart out of the statute’s application, and make the False Claims Act pointless.

5) Merck then argues that the case should be dismissed because the False Claims Act doesn’t allow private citizens to challenge the FDA’s determination.

6) Merck indulges in pure make-believe by asserting that allowing the case would unduly interfere, usurp and intrude on the FDA’s expertise, judgment and discretion to enforce its own rules and regulations.

7) Merck tries to claim that the relators are first required to file a citizen’s petition with the Fda and exhaust all administrative remedies that might have been available even though there is no requirement for any such legal pre-requisite.

8) Merck asserts that the case should be dismissed because the relators waited nine years to lodge a case, and in that time, never utilized any processes with the USA FDA. So Merck is insinuating that because the two scientists should have complained harder, and they didn’t, there can’t possibly be a case.

9) Merck also infers that because the FDA let Merck get away with it, they couldn’t have done anything wrong.

10) Merck says is that the case has no merit because the DOJ decision not to intervene proves Merck’s innocence
. (I said at the end of this blog in June 2012, that Merck couldn’t be silly enough to claim this  but obviously Merck’s lawyers are sillier than I thought.)

Merck’s lawyers wasted 74 pages filled with incredibly weirdly wending waffle, constant obfuscation, with a shot gun approach for various differing reasons, and in the process, repeatedly used dismissive phrases like, “minor shortcomings” “relator’s speculate” or “sleight of hand”.

Every possible attempt was made to shoot the messenger and not address any actual issues. Perhaps they thought if they were lucky, the Judge would be sleeping on the job.

Merck’s stated on page 35 of their “Motion to Dismiss” that “…relators must state with particularity the circumstances constituting fraud or mistakes, including the “time, place and substance of the defendant’s alleged conduct. This they failed to do.”

At this point you’d think that Merck’s lawyers would clearly realize the ridiculous paucity of their case – but in reality, what else could Merck lawyers do, if Merck is actually unable to deny any of the original allegations? Their only course of action was to hope that the judge was dumb enough to be easily confused by their illogic.

Which of course played right into the hands of the relators.

On 9th October 2012, the relators handed to the court, a 74 page “Memorandum to oppose Merck’s motion to dismiss” (Case 2:10-cv-04374-CDJ Document 47) in which they restated their original complaints, and listed clearly how they had actually fulfilled all Merck’s page 35 criteria, and more besides.

The relators gave a brief history and gave blow by blow evidence showing that the case against Merck centred around provable:

1) Improper efficacy testing.

2) Falsifying efficacy test data.

3) Destroying evidence of the fraud.

4) Lying to the FDA.

5) Putting fraudulent labeling on datasheets and bottles.

6) Making fraudulent Government submissions, fraudulent CDC purchase contracts, false certification of compliance, thereby fraudulently inducing CDC to enter into contracts.

7) Violating Merck’s subsequent multiple ongoing duties of government and public disclosures in order to maintain its marketing monopoly with CDC, while foreclosing the government from access to high quality and less expensive vaccines.

8) Subsequently lying to the European Medical Agency in 2004, stating that mumps component had more than 95% efficacy with the label stating 96.7%.

9) Merck lied to the FDA regarding MMRII, saying that it would actually reduce the amount of virus in the vaccine and maintain it’s 95% efficacy.

10) Merck did not tell its own funded puppet (Immunisation Action Coalition) these facts.

11) Merck did nothing to stop any third party repeating what Merck knows to be lies.

12) Merck continues to tell USA healthcare professionals in its websites that vastly outdated studies put the mumps component at 96% seroconversion rate.

13) Merck’s actions render false all certification by Merck since at least 1999.

On 25th May, 2013, the United States Department of Justice (DOJ) filed a 54 page document, (Case 2:10-cv-04374-CDJ Document 54) delivering a swift winkle-picker up the backsides of Merck’s lawyers, by incisively demolishing Merck’s arguments. The highlights of this document are:

1) The DOJ continues to remain a real party in interest with a strong interest in the outcome.

2) Merck's argument that suits by private citizens are not allowed, “is not supported by statutory text or case law and is inconsistent with the purposed of the False Claims Act”.

3) That the relators stand in the “government’s shoes”

4) That Merck’s illegal application interpretation of the of the False Claims Act, seeking to limit or bar cases for fraudulent conduct which violates FDA or federal laws and regulations, is inconsistent with the purposes of the Act.

5) That “it is no surprise that Merck cites to no decisions that only the Government and not a relator can litigate this type of False Claims Act suit” and that” the government is aware of no such holding in a False Claims Act”.

6) DOJ successively trashes the use of the cases argued by the Merck lawyers, making the Merck legal team look like a bunch on bunnies caught in headlights.

7) DOJ then took apart the other spurious arguments of Merck, in such a way that pretty much backs up the relators, stating “allowing relators to prosecute such False Claims Act suits (as long as sufficiently pleaded) serves the primary purposes of the qui tam provisions”.

8) And finally, the DOJ, opposed all Merck’s reasoning to dismiss the case.

For those with eyes to see, what this case is about is blindingly obvious.

The DOJ is practically telling the judge that Merck is guilty.

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