Merck’s next problem - Japan. A culture that is very much into compliance and obedience in many ways... is the first country whose parents have had the guts to ..... say......
Cervical cancer vaccine victims urge permanent halt to vaccination
TOKYO, August 24, 2013. KYODO.
Eight teenage sufferers of severe side effects of cervical cancer vaccines and their parents called on Health Minister Norihisa Tamura on Friday, to permanently end the Government’s subsidy program for the vaccines.
Merck’s next problem - Japan. A culture that is very much into compliance and obedience in many ways... is the first country whose parents have had the guts to ..... say......
These are important thinking points which come out of this case, which readers with an indepth knowledge of Merck's litany of lies in the past will appreciate.
There are the main issues:
1) The more you investigate the legal history of Merck, you wonder how anyone can have any faith in medical articles, data sheets or information presented by Merck to the public. As far as I’m concerned Merck has never had any ethics, and the way their top staff is ‘selected’ is proof of that. Jobs for the boys who ring the tills. Or girls, as it is in the case of Dr Julie Gerberding, responsible for fast-tracking Gardasil, and now head of Merck’s vaccines division. You scratch my back, I’ll pay you handsomely.
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. Continue Reading
The Supreme Court in USA, in a case called Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142. has just ruled that drug companies are now exempt from lawsuits even when the adverse reaction (toxic epidermal necrolysis) was one of several hidden by the drug makers, and later forced to be included on all warning labels.
As this blog says, the Supreme Court “cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs,” and “that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts….”
The court ruled “that the original inventors and manufacturers of pharmaceutical drugs, also known as ‘name brand’ drugs, are the only ones that can be sued for mislabeling, fraud or adverse drug reactions and side effects. If the generic versions of the drugs are made from the exact same formula and labeled with the exact same warnings as their brand name counterparts, the generics and their manufacturers were not liable.”
As the blog said, “Immediately upon the Supreme Court’s ruling, both drug manufacturers and Wall Street investors were celebrating. As one financial analyst pointed out, drug company profits should skyrocket going forward. Not only do the pharmaceutical companies no longer have to worry about safety or side effects, they are exempt from the multi-million dollar court-imposed settlements awarded to victims of their drugs.”
Remember this, the next time your doctor wants to give you a cheap generic.
Read the Reuter’s news item on this topic which amongst other things said:
"The generic industry dodged a bullet on this one," BMO's Maris said. "Had it gone against them it would have put a big cloud over the industry."
(BMO stands for Banque d’Montreal, which is a huge conglomerate industry with fingers in more pies than you can imagine…)
And even more important, remember THIS: If the companies don’t care about you, (even though they murmur platitudinous words to the contrary….,) and neither does FDA, .... shouldn’t you be looking at other ways to fix “shoulder pain” - or whatever the problem is that you have, instead of slapping a “band-aid” on, to simply suppress the symptoms accompanying a problem?
Shouldn’t you be asking yourself, why it is, you would WANT to even take any non-steroidal anti-inflammatory? Particularly the drug this girl took, sulindac, which has been known since 2003, to carry a high risk of liver damage? Sulindac causes decreased kidney filtration with transient and permanent kidney problems If you read the left column of this book page, you will see it causes proteinuria. All red flags for anyone who thinks.
So why is it that people and doctors, reach first for a toxic drug like sulindac just for shoulder pain?
And there is one more issue here: Sulindac, is the generic version of Merck & Co Inc's Clinoril, and we all know about the ways and means that Merck has, of weaselling out of drug and vaccine reactions! Make no mistake… Merck took more than a passing interest in the outcome of THIS drug, since according to the extract above it is implied that Merck is really the one who should have been slapped with this court case, since apparently, they were the ones to first hide the nasty outcome data.
So why is anyone surprised that the Supreme court has yet again, conspired to protect Merck et al? The huge and varied vested interests know how to pull all the strings of protection: to manipulate and hide data, twist motives and the interpretation of “legal safeguards” so that the “justice system” covers their butt for them. Continue Reading
There is no place for pro/anti vaccine divides, when it comes to allegations of corporate fraud.
Yet all across the media, the focus of the discussion about the Merck lawsuit is not to really discuss the issue, but to slap the "vaccine foes". The first example came out loud and clear in Forbes magazine. You don't have to read further than the title, to know where Gergana Koleva is heading. She is hoping Krahling and Wolchowski lawsuit is all lies, and so she plants a decoy story. Her article title was “Merck Whistleblower suit a boon to vaccine foes even as it stresses the importance of vaccines.” The URL, reads, "Merck whistleblower suit a boon to anti vaccination advocates though it stresses importance of vaccines."
Way back in 2004, a group of New Zealanders learned what it meant to be hit over the head by Big Pharma. Pfizer to be precise. While IAS was Pfizer's actual target, in reality, I was the bull's eye, because the information was written by me, and therefore, I had most of the references in order to defend the complaint. I had written, and made comments based on the very well documented FACTS that the use of paracetamol to reduce fever during infection, downgrades the very part of the inate immune system that triggers the fever, which then sends out cytokine signals, which then release a series of armies which attack invading pathogens. Turning this part of the immune system off, can make diseases much more serious, AS WELL AS increase the likelihood of death.
On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania District Court accusing Merck of a longstanding scheme to mislead and defraud Government health authorities worldwide. Two of Merck’s former employees have accused the pharmaceutical giant of marketing multivalent MMR vaccines under false pretenses. According to the complaint, these vaccines have been mislabeled, misbranded, adulterated and falsely certified as having a 95% efficacy rate.
Before the lawsuit was filed, 21 doctors added their voices to other groups of doctors who are calling for MMR vaccines to be used as a regular booster every 4 – 8 years, in order to control mumps outbreaks. These doctors all assume that the mumps component of all MMR vaccines have the 95 – 98% efficacy promised by Merck.
Sitting back watching the medical and political system defending Gardasil is quite amusing. First, the usual bloggers who fall under the “anti the anti-vaccine people” catagory, take uneducated speculative ranting swipes (and I’m not providing URLs because their ignorance is worse than their insolence), and then, as usual, the media doesn’t understand the significance of this issue. Either that, or they have been told to shut up. None of them lived through the polio/SV40 debacle, and ants have longer institutional memory than journalists living under high pressure situations where the motto is “write, present and forget”.
Part of what they face are the fairy-wands or bulldust waved by manufacturers and government officials, to try to persuade journalists not to run the story. After all, most journalists have no idea that this is the latest in a long history of vaccine contaminants. The manufacturers’ and authorities’ intent, is that journalists will think the issue a big yawn, and not put pen to paper (“Mustn’t scare the public, eh?!” Pass the bean dip, please...).
All New Zealand samples contaminated.
A few days ago, an American organisation put on their website a copy of a letter sent to the FDA, in which they stated that thirteen samples of Gardasil from Poland, France, Spain, USA, New Zealand and Australia, made in four different Merck factories (USA, Holland, France and CSL Australia) had been tested, and found to contain genetically engineered dna fragments which the purification process failed to remove. Yesterday, a more detailed press release was put onto SANE-Vax's site, which showed samples contaminated with HPV DNA 11 and 18. The New Zealand results can be seen here.
One of the genetically engineered particles found is said to be a genetically engineered syntheticaly constructed gene designed to instruct the yeast or baculovirus cells, to make the HPV-11 outer capsid protein (virus-like particles) for the Gardasil vaccine.
This is the Pubmed site for GenBank Locus SCU55993, which is the picture below, of ONE of the alleged contaminants:
Wavy lines mean nothing to me, and probably nothing to you.
SANE-vax's letter doesn't specifically say what the other contaminants are, but say that the rest of their proof is available for review provided that FDA provides " appropriate safeguards ... to protect the proprietary processes and information utilized by our laboratory to test the samples."
To me, no platitudes and fob-offs on this issue are acceptable.
The first question that comes to mind is,
"Is this a big deal?"
This isn't a quality issue in one factory.
The problem, according to the testing done by SANE-vax shows;
A global manufacturing fault.
A global manufacturing issue relating to vaccine design, process and purity - IS - a big deal.
The next question is:
Are the "genetically altered HPV DNA fragments" a big deal?Continue Reading
This post is specifically for parents who believe their children have been damaged by Gardasil, and is an attempt to put in the public arena, information which has been conveyed privately, until now. This is information you need to know if your child is damaged, or had died after Gardasil. Continue Reading
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