Merck Vaccine Fraud – 2nd US Court Case Over MMR Vaccine

[Guest guest]

http://childhealthsafety.wordpress.com/2012/07/02/merck-vaccine-fraud-2nd-us-court-case-over-mmr-vaccine/

Merck Vaccine Fraud – 2nd US Court Case Over MMR

VaccinePosted on July 2, 2012 by ChildHealthSafety

CHS here reports on Merck facing another second Court action

in the USA for allegedly fraudulently representing its MMR II vaccine

worked as claimed when it did not. Full details below.

The problem for the public in the UK, USA and rest of the world is this –

they have repeatedly been told by public health officials that numerous

studies have shown the MMR vaccine is safe and effective. But here

we see that appears not to be true. In fact it is allegedly not true to

the extent of being a fraud. If these studies claim to have found

the vaccine is effective when it is not how can they possibly have found

it to be safe. Answer: they cannot.

Additionally, if this has happened for one pharmaceutical, what other

similar practices does Merck engage in with other drug products and

vaccines.

Another problem is if as alleged the vaccine is not effective, then the

diseases are still circulating but may have become so mild that in many

cases children have no symptoms or such mild ones it is not apparent they

have the disease concerned at all. So the question is, what

purpose do the vaccines serve if the diseases have become so much

milder? This process of diseases steadily becoming milder is

called attenuation and is well known in medicine. It can be seen at

work here:

Vaccines Did Not

Save Us – 2 Centuries of Official Statistics. It is also

recorded in the medical literature. Here are some examples from

1972, 1978, 1998 and 2003 showing rates then of subclinical measles of

30%, 38% and 59%:

The high rate of sero-positivity (54%) amongst unvaccinated children

(who were also not attacked by measles) most probably indicates

sub-clinical or asymptomatic measles infection. About 30% measles

infection are subclinical in nature (1) . Other workers have also come

across subclinical cases of measles during their studies viz. Mehta et

al..(3) and Deseda Tous et a/..(17) found subclinical measles infection

to the rate of 38% and 59% respectively and both of these observations

are comparable to the findings of the present study.”

S.D. Kandpal et al.

Measles

antibody status amongst 9 mths- 5 yrs unvaccinated children Indian J.

Prev. Soc. Med Vol. 34 No. 1 & 2 14 Jan-June, 2003

REFERENCES 1. Sharma RS . An Epidemiological study of measles

epidemic in District Bhilwara ,Rajasthan. J Corn Dis 1998;20(4): 301-311.

3. Metha N.A, Nanavathi A, Jhala M . Sero-epidemiology of measles in

Bombay. Indian J Med Res 1972;60 :661-669. 17. Deseda-Tous, D,

Cherry M. Persistence and degree of antibody liter by type of immune

response. Am J Dis Child 1978:132 : 287-290.

As for the claims in the new US Court case against Merck the full

..pdf can be read here:

Chatom-Lawsuit-Merck. The first US Court case is reported

here:

Merck Scientists Accuse Company of Mumps Vaccine Fraud that Endangers

Public Health – “Protocol 007”

For your reading convenience we also set out in what follows the text of

the claims in the second US Court case [up to the heading " CLASS

ACTION ALLEGATIONS " ]

__________________________

UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

FILED JUN 25 2012

CHATOM PRIMARY CARE, P.C., on Behalf of Itself And All Others

Similarly Situated

Plaintiff,

v.

MERCK & CO., INC.,

Defendant.

CIVIL ACTION NO. 12 3555

CLASS ACTION COMPLAINT

JURY TRIAL DEMANDED

Electronically Filed

Plaintiff Chatom Primary Care, P.C., on behalf of itself and all others

similarly situated, brings this action against Merck & Co., Inc.

(“Merck or “Defendant”), and alleges as follows, based on information and

belief, counsel’s investigation, and a quitarn action filed by A.

Krahling and Joan A. Wlochowski (the “Relators”) captioned Krahling v.

Merck & Co., Inc., 2:10-cv-04374-CDJ (E.D. Pa.) (the “Qui Tam

Action”):

INTRODUCTION1 Merck is the exclusive

supplier of mumps vaccine (including M-M-R II and ProQuad) (collectively,

“Mumps Vaccine”) in the U.S.

2 This lawsuit is brought as a proposed class action

against Merck for unlawfully monopolizing the U.S. market for Mumps

Vaccine by engaging in a decade-long scheme to falsify and misrepresent

the true efficacy of its vaccine.

3 Specifically, Merck fraudulently represented and

continues to falsely represent in its labeling and elsewhere that its

Mumps Vaccine has an efficacy rate of 95 percent or higher. In reality,

Merck knows and has taken affirmative steps to conceal –by using improper

testing techniques and falsifying test data –that its Mumps Vaccine is,

and has been since at least 1999, far less than 95 percent

effective.

4 Merck manufactures its Mumps Vaccine using an

attenuated virus. An attenuated virus is created when its pathogenicity

has been reduced so that it will initiate an immune response without

producing the specific disease. Pathogenicity is reduced by “passaging”

the virus through a series of cell cultures or animal embryos. With each

passage, the virus becomes better at replicating in the host, but loses

its ability to replicate in human cells. Eventually, the attenuated virus

will be unable to replicate well (or at all) in human cells, and can be

used in a vaccine. When this vaccine is administered to a human, the

virus in it will be unable to replicate enough to cause illness, but will

still provoke an immune response that can protect against future

infection.

5 However, Merck knew and understood that the continued

passaging of the attenuated virus from which its Mumps Vaccine was

created (over forty years ago) had altered the virus and degraded its

efficacy.

6 For a variety of reasons, including Merck’s

development and quest for approval of a new combination vaccine that

contained its Mumps Vaccine, Merck initiated new efficacy testing of its

Mumps Vaccine in the late 1990s. As demonstrated below, the goal of this

new efficacy testing was to support its original efficacy findings at all

costs, including the use of scientifically flawed methodology and

falsified test results.

7 First, Merck designed a testing methodology that

evaluated its vaccine against a less virulent strain of the mumps virus.

After the results failed to yield Merck’s desired efficacy, Merck

abandoned the methodology and concealed the study’s findings.

8 Second, Merck designed an even more scientifically

flawed methodology, this time incorporating the use of animal antibodies

to artificially inflate the results, but it too failed to achieve Merck’s

fabricated efficacy rate. Confronted with two failed methodologies, Merck

then falsified the test data to guarantee the results it desired. Having

reached the desired, albeit falsified, efficacy threshold, Merck

submitted these fraudulent results to the Food & Drug Administration

(“FDA”) and European Medicines Agency (“EMA”).

9 Third, Merck took steps to cover up the tracks of its

fraudulent testing by destroying evidence of the falsified data and then

lying to an FDA investigator that questioned Merck about its ongoing

testing. Merck also attempted to buy the silence and cooperation of its

staff by offering them financial incentives to follow the direction of

the Merck personnel overseeing the fraudulent testing process. Merck also

threatened a relator in the Qui Tarn Action, Krahling, a

virologist in Merck’s vaccine division from 1999 to 2001, with jail if he

reported the fraud to the FDA.

10 Fourth, in 2004 Merck submitted its application for

approval for ProQuad, a combination vaccine containing mumps, measles,

rubella and chickenpox vaccines, certifying the contents of the

application as true even though Merck knew the statements about the

effectiveness of the Mumps Vaccine were, in fact, false. At no time

during this application process did Merck disclose to the FDA the

problems of which it was aware (or should have been aware) relating to

the significantly diminished efficacy of its Mumps Vaccine. Accordingly,

in 2005, the FDA approved Merck’s application for ProQuad.

11 Fifth, Merck sought and secured FDA approval to

change the labeling for M-M- R II -which is composed of Merck’s mumps,

measles and rubella vaccines -to reflect an almost 40 percent reduction

in the minimum potency of the Mumps Vaccine component. It did this while

leaving its false representations of efficacy unchanged. And it did this

fully appreciating that if the current, higher potency vaccine had an

efficacy rate far lower than the falsely represented 95 percent, there

was no way the vaccine would achieve that efficacy with significantly

less attenuated virus in each shot.

12 Sixth, Merck continued to conceal what it knew (or

should have known) about the diminished efficacy of its Mumps Vaccine

even after significant mumps outbreaks in 2006 and 2009.

13 To be sure, Merck has now known for over a decade

that its Mumps Vaccine is far less effective than advertised publicly and

represented to government agencies. As Merck profited from its unlawful

scheme, health care providers around the country have purchased millions

of doses of Mumps Vaccine, with questionable efficacy, at artificially

inflated prices.

PARTIES

14 Plaintiff Chatom Primary, Care P.C. is an

Alabama corporation. During the Class Period (defined below), Chatom

Primary Care, P.C. purchased the Mumps Vaccine from Merck at artificially

inflated prices.

15 Defendant Merck is a New Jersey corporation with its

vaccine division based in West Point, Pennsylvania. Merck-directly and/or

through its subsidiaries, which it wholly owned and/or

controlled-manufactured, marketed and/or sold Mumps Vaccine that was

purchased throughout the United States, including in this district,

during the Class Period. Merck is one of the largest pharmaceutical

companies in the world with annual revenues exceeding $20 billion. Merck

is also a leading seller of childhood vaccines and currently markets in

the U.S. vaccines for 12 of the 17 diseases for which the CDC currently

recommends vaccination.

16 Merck is the sole manufacturer licensed by the FDA

to sell Mumps Vaccine in the U.S. Merck’s Mumps Vaccine, together with

Merck’s vaccines against measles and rubella are sold as M-M-R II. Merck

annually sells more than 7.6 million doses of M-M-R II in the U.S. for

which it derives hundreds of millions of dollars of revenue. Merck also

has a license in the U.S. to sell ProQuad, a combination vaccine

containing M-M-R II vaccine and chickenpox vaccine. Under a license from

the EMA, Merck also sells Mumps Vaccine in Europe as a part of

M-M-RVaxpro and ProQuad through Sanofi Pasteur MSD, a joint venture with

the vaccine division of the Sanofi Aventis Group. ProQuad has been sold

intermittently in the U.S. and Europe since its approval in 2005 until

2010.

JURISDICTION AND VENUE

17 The claims set forth in this Complaint arise

under Section 2 of the Sherman Antitrust Act, 15 U.S.C. 9 2. Plaintiff

seeks treble damages pursuant to Section 4 of the Clayton Act, 15 U.S.C.

5 15(a). Plaintiff also asserts claims for actual and exemplary damages

pursuant to state consumer protection and warranty laws, and common law

unjust enrichment, and seeks to obtain restitution, recover damages and

secure other relief against Defendant for violations of those laws.

Plaintiff and the Class (defined below) also seek attorneys’ fees, costs,

and other expenses permitted under federal and state law.

18 This Court has jurisdiction pursuant to Sections 4

and 12 of the Clayton Act, 15 U.S.C. 99 15(a) and 22, and pursuant to 28

U.S.C. $5 1331 and 1337.

19 This Court also has subject matter jurisdiction of

the state law claims pursuant to 28 U.S.C. 9 1332(d), in that this is a

class action in which the matter or controversy exceeds the sum of

$5,000,000, exclusive of interests and costs, and in which some members

of the Class are citizens of a state different from Defendant.

20 This Court also has supplemental jurisdiction of the

state law claims asserted herein pursuant to 28 U.S.C. fj 1367 because

they are so related to the claims asserted in this action over which the

court has original jurisdiction that they form part of the same case or

controversy.

21 Venue is proper in this District pursuant to

Sections 4 and 12 of the Clayton Act (15 U.S.C. $9 15(a) and22) and 28

U.S.C. 5 1391( and © in that the Defendant can be found in and

transacts business within this District, and a substantial part of the

events or occurrences giving rise to the claims alleged occurred in this

District. Indeed, Merck’s fraudulent scheme to maintain and further its

monopoly power was originated and continues to be carried out in this

District at Merck’s vaccine division facility in West Point,

Pennsylvania.

INTERSTATE COMMERCE

22 Throughout the Class Period, Merck manufactured,

produced, sold and/or shipped substantial quantities of Mumps Vaccine in

a continuous and uninterrupted flow of transactions in interstate

commerce throughout the U.S., including within this District. Merck’s

unlawful activities that are the subject of this Complaint were within

the flow of, and have had a direct and substantial effect on, interstate

trade and commerce.

FACTUAL BACKGROUND

A. The Market for Mumps Vaccine Has and Continues

to Be Dominated By A Single Manufacturer -Merck

1. Background on The Mumps Vaccine

23 Mumps is a contagious viral disease

characterized by fever, headache, muscle weakness, loss of appetite and

swelling of one or more of the salivary glands. Although severe

complications are rare, the mumps virus can cause inflammation of the

brain and spinal cord (among other organs), sterility and

deafness.

24 Merck first obtained approval for the Mumps Vaccine

in 1967 from Department of Biologics Standards of the National Institute

of Health (“DBS”), the government agency at the time responsible for

licensing vaccines. The vaccine was developed by Dr. Maurice Hilleman, at

Merck’s West Point research facility, from the mumps virus that infected

his five year-old daughter Jeryl Lynn. Merck continues to use this “Jeryl

Lynn” strain of the virus for its vaccine today.

25 Merck’s original Mumps Vaccine was delivered to

patients in a single, stand-alone injection called Mumpsvax. In 1971,

Merck developed M-M-R and that same year obtained DBS approval to

manufacture and sell M-M-R vaccine. In 1978, Merck obtained approval from

the FDA (which succeeded the DBS as the agency responsible for licensing

vaccines) for the manufacture and sale of M-M-R II, a replacement for

M-M-R containing a different strain of the rubella virus. Since that

time, Merck has sold more than 450 million doses of M-M-R II world-wide,

with approximately 200 million doses sold in the U.S.

26 In September 2005, Merck obtained FDA approval for

ProQuad, a multi-disease vaccine that includes vaccinations for mumps,

measles, rubella and chicken pox in a single injection. Merck sold

ProQuad in the U.S. from its approval in 2005 until June, 2007. According

to Merck, the vaccine became unavailable because of certain manufacturing

constraints. The vaccine was briefly available again in 2010 but has not

been available since then.

2. The U.S. Market for Mumps Vaccine and Merck’s Monopoly Power

27 As the only company licensed by the U.S.

government to sell Mumps Vaccine, Merck has had a monopoly and continues

to have a monopoly in the U.S. market for Mumps Vaccine since it obtained

its original license in 1967. This has extended to multi-disease vaccines

such as M-M-R, M-M-R II and ProQuad. However, Merck has maintained this

monopoly not through its legitimate business acumen and innovation or its

manufacture and sale of the safest, most effective and most

cost-effective Mumps Vaccine in the market. Instead, Merck has willfully

and illegally maintained its monopoly through its ongoing manipulation of

the efficacy of its Mumps Vaccine. Through this unlawful conduct, Merck

has been able to monopolize the Relevant Market (defined below) by

representing to the public and government agencies a falsely inflated

efficacy rate for its Mumps Vaccine, which has deterred and excluded

competing manufacturers from entering the Market.

(a) The Relevant Geographic Market is The U.S.

28 The U.S. (including all U.S. territories and

commonwealths) is the relevant geographic market in this case. Merck

manufactures and distributes its Mumps Vaccine throughout the U.S. The

unlawful and anticompetitive conduct at issue in this case affects only

U.S. sales of the relevant products. Mumps Vaccine requires FDA licensing

before it can be sold in the U.S.

( The Relevant Product Market is The Market for Mumps Vaccine

29 The U.S. sale of Mumps Vaccine (including

without limitation M-M-R II and ProQuad) (the “Relevant Market”) is the

relevant product market in this case.

© Barriers to Entry Are High in the Mumps Vaccine Market

30 There are significant barriers to entry inherent

in the manufacture and sale of a new vaccine. Vaccine production is a

capital-intensive, fixed-costs-based business, with the average cost to

bring a vaccine to market of about $700 million. Moreover, the research,

development, testing and government approval process is very expensive,

time-consuming and risky. Several years and millions of dollars might be

spent on developing a new vaccine only to find it fail in the final

stages of testing, or to have the government refuse to approve it or

significantly limit its application or distribution. Vaccine

manufacturers will therefore invest in developing a new vaccine only

where they see both a need for the vaccine as an improvement over an

existing vaccine and an opportunity to make a large enough return on the

significant capital investment and risk involved.

31 In the case of the U.S. Market for Mumps Vaccine,

this substantial and inherent barrier to entry is compounded by the

falsely inflated efficacy rate of Merck’s vaccine. As with the market for

any product, a potential competitor’s decision to enter a market hinges

on whether its product can compete with those products already being sold

in the market. If an existing vaccine is represented as safe and at least

95 percent effective, as Merck has falsely represented its vaccine to be,

it would be economically irrational for a potential competitor to bring a

new Mumps Vaccine to the Relevant Market unless it thought it could

compete with the safety and efficacy of the existing vaccine. Health care

providers, including Plaintiff and the Class, would not purchase it

otherwise.

(d) There is High Inelasticity of Demand in the Mumps Vaccine

Market

32 For those seeking immunization for mumps, Mumps

Vaccine is the only product available to achieve that result. So

regardless of the price Merck charges for its Mumps Vaccine, the extent

or frequency of any price increases for the vaccine, or whether Merck

incorporates the vaccine into multi-disease vaccines, as it does with

M-M-R II and ProQuad, there are no alternative products to which the

government, health care professionals or consumers can turn to obtain

this immunization.

33 The U.S. Market for Mumps Vaccine is further defined

by the CDC’s nationwide schedule of recommended childhood vaccinations,

including a vaccination against mumps, and the requirement around the

country that all public school students be vaccinated against mumps

(among other childhood diseases). If a child is to attend public school

–not to mention any private school, university, summer camp or other

educational or recreational institution in this country –he or she must

be vaccinated for mumps. There is no choice (but for rare exceptions).

There is no alternative. No other products can substitute for this

required vaccination.

B. Merck Willfully Maintained And Unlawfully

Enhanced Its Monopoly Power in the Mumps Vaccine Market Through A

Decade-Long Fraud

34 To obtain its original government approval to

sell its Mumps Vaccine, Merck conducted field studies of vaccinated

children and concluded that the vaccine had an efficacy rate of 95

percent or higher. This meant that 95 percent of those given the vaccine

were considered immunized against mumps. This is important because when

an adequate number of people have immunity, the chances of an outbreak

are reduced, and –ultimately –eliminated. If there is insufficient

immunity, a real risk of continued disease outbreaks exists. When a mumps

outbreak occurs in vaccinated populations, it afflicts adults and older

children who are at greater risk of serious complications.

35 While Merck obtained its original license in 1967

stating that its vaccine was at least 95 percent effective, Merck had

known and knows that the vaccine’s efficacy is significantly less than

that now. Merck knows that the continued passaging of the attenuated

virus to make more vaccine for distribution has altered the virus and has

degraded the efficacy of the product.

36 Rather than develop a new Mumps Vaccine with greater

efficacy, or permit other manufacturers to enter the U.S. Market with a

competing vaccine, Merck has instead taken pains to unlawfully and

unethically preserve its exclusive U.S. license by maintaining that its

more than forty-year old vaccine continues to have an efficacy rate of 95

percent or higher. This was easy to do for awhile because Merck was able

to refer back to the efficacy testing it conducted in connection with the

government’s original granting of Merck’s license to sell Mumps Vaccine.

However, beginning in the late 1990s, Merck initiated new efficacy

testing of its Mumps Vaccine. This testing coincided with an application

to change the M-M-R II labeling in the U.S. and an application for a

license to sell M-M-R II in Europe. This testing also coincided with

Merck’s development and quest for approval of ProQuad in both the U.S.

and Europe.

37 Without demonstrating that its Mumps Vaccine

continued to be 95 percent effective, Merck risked losing the monopoly it

had over the sale of Mumps Vaccine in the U.S. With respect to M-M-R II

or Mumpsvax, Plaintiff and members of the Class would either have

negotiated to pay less for the vaccine or stopped purchasing Merck’s

vaccine altogether as the door would be open to new manufacturers to

enter the Market. With respect to ProQuad, the government might not have

approved the vaccine at all for sale and use in the U.S. Under any of

these scenarios, Merck risked losing hundreds of millions of dollars in

revenue from this very profitable unlawful monopoly.

38 So, Merck set out to conduct testing of its Mumps

Vaccine that would support its original efficacy finding. In performing

this testing, Merck’s objective was to report efficacy of 95 percent or

higher regardless of the vaccine’s true efficacy. The only way Merck

could accomplish this was through manipulating its testing procedures and

falsifying the test results. Relators to the Qui Tarn Action participated

on the Merck team that conducted this testing and witnessed firsthand the

fraud in which Merck engaged to reach its desired results. Merck

internally referred to the testing as Protocol 007.

1. Merck Manipulated and Falsified Test Results

To Distort The True Efficacy of Its Mumps Vaccine

(a) Merck’s Abandonment of Its Original PRN Test

and Test Results

39 The original methodology Merck employed under

Protocol 007 was a Mumps Plaque Reduction Neutralization (“PRN”) Assay.

Preliminary testing commenced in 1999 at Merck’s West Point facility and

was led by Senior Investigator Krah and his second in command,

Yagodich. Merck’s Executive Director of Vaccine Research, Alan Shaw,

approved the testing methodology Krah and Yagodich employed. Relator

Krahling witnessed Krah and Yagodich as they conducted the preliminary

testing.

40 As the name of the test indicates, the PRN test

measures the virus neutralization that occurs after administration of the

Mumps Vaccine. Merck’s test was in some measure similar to the testing

procedure regarded in the scientific community as the “gold standard” for

testing how well a vaccine works. Blood samples are taken from children

both before they receive the vaccine and again after they have been

injected with the vaccine (after sufficient time has passed for the

vaccine to produce an immune response). The paired blood samples are then

individually incubated with the target virus and added to sheets of

cells. Where the virus replicates in the cell sheet it leaves a plaque,

or hole.

41 The pre-vaccinated child will not typically have

immunity to the disease. Therefore, the pre-vaccinated blood will be

unable to neutralize the virus and plaques will form where the virus has

infected the cells. In contrast, if the vaccine has stimulated the

child’s immune system to develop antibodies against the virus, the

post-vaccinated blood will neutralize the virus. The post-vaccinated

blood sample will consequently show a smaller number of plaques, or

holes, in the cell sheet compared to the pre-vaccinated sample.

42 A PRN test simply compares virus growth in the

presence of the pre- and post- vaccinated blood samples. The number of

plaques (where the virus has grown) is compared to determine if the

vaccine caused the child to develop a sufficient level of antibodies to

neutralize the virus. Results are reported in terms of seroconversion. A

seroconversion occurs when the pre-vaccination blood sample is “negative”

(meaning, insufficient antibodies to neutralize the virus) and the

post-vaccination sample is “positive” (meaning, sufficient antibodies to

neutralize the virus). Seroconversion occurs, therefore, when a blood

sample goes from “pre-negative” (insufficient antibodies) to

“post-positive” (sufficient antibodies). Seroconversion in the lab is the

best correlate for efficacy –how successful the vaccine is at immunizing

children. For the purposes of its testing, Merck was looking for a

seroconversion rate of 95 percent or higher to support its original

efficacy finding and the efficacy it continued to represent in its

labeling.

43 While Merck’s PRN test was modeled after the

neutralizing test generally accepted in the industry, it diverged from

this “gold standard” test in a significant way. It did not test the

vaccine for its ability to protect against a wild-type mumps virus. A

wild-type virus is a disease-causing virus. That is the type of real-life

virus against which vaccines are generally tested. Instead, Merck tested

the children’s blood for its capacity to neutralize the attenuated Jeryl

Lynn strain of the virus. This was the same mumps strain with which the

children were vaccinated. The use of the attenuated Jeryl Lynn strain, as

opposed to a virulent wild-type strain, subverted the fundamental purpose

of the PRN test, which was to measure the vaccine’s ability to provide

protection against a disease-causing mumps virus that a child would

actually face in real life. The end result of this deviation from the

accepted PRN gold standard test was that Merck’s test overstated the

vaccine’s effectiveness.

44 Even with a deviation that could only overstate how

well the vaccine worked, the results from Merck’s preliminary testing

(which involved testing blood samples of approximately 60-100 children)

yielded seroconversion rates significantly below the desired 95 percent

threshold. Krah admitted as much to Relator Krahling. He also admitted to

Krahling that the efficacy of Merck’s vaccine had declined over time,

explaining that the constant passaging of virus to make more vaccine for

distribution had degraded the product and that because of this, mumps

outbreaks would increase over time.

45 Krah further admitted to Krahling that he and

Yagodich tried numerous other, often undocumented, techniques to modify

the PRN test to improve the seroconversion results they could measure,

including trying different virus dilutions, different staining procedures

and even counting plaques more liberally. These other techniques –like

using the vaccine strain rather than a wild-type strain of the virus

–subverted the purpose of the PRN test. In the end, however, none of it

mattered. Merck had to abandon its methodology because no matter how Krah

and Yagodich manipulated the procedures, they could not reach the 95

percent seroconversion threshold.

46 So, Merck abandoned the PRN methodology that yielded

unsatisfactory results and worked towards developing a new, rigged

methodology that would allow Merck to report its desired seroconversion

results.

( Back to the Drawing Board: Merck’s Improper Use of Animal Antibodies

In Its “Enhanced” PRN Test

47 The new methodology Merck devised and ultimately

used to perform the mumps efficacy testing under Protocol 007 was an

“enhanced” PRN Assay. It was again led by Krah and approved by Shaw and

commenced in 2000. Relators Krahling and Wlochowski participated on the

team that conducted the testing using this supposedly enhanced

methodology. Each of them witnessed firsthand the falsification of the

test data in which Merck engaged to reach its 95 percent seroconversion

threshold. In fact, each was significantly pressured by Krah and other

senior Merck personnel to participate in this fraud.

48 From the outset, Merck’s objective with this

“enhanced” procedure was clear. It was not to measure the actual

seroconversion rate of Merck’s Mumps Vaccine. It was to come up with a

methodology that would yield a minimum 95 percent seroconversion rate

regardless of the vaccine’s true efficacy. The very first page of an

October 2000 Merck presentation on the “enhanced” methodology stated just

that:

Objective: Identify a mumps neutralization assay format . . . that

permits measurement of a > 95% seroconversion rate in M-M- R II

vaccinees.

Notably, nowhere in this presentation did Merck provide any kind of

justification or explanation for abandoning its original PRN methodology

and the unsatisfactory seroconversion results it yielded.

49 To reach the stated objective for its “enhanced”

test and increase the measured seroconversion rate to the predetermined

95 percent threshold, Merck continued to use its scientifically flawed

PRN methodology –that tested against the vaccine strain rather than a

wild-type strain –but with one additional material change. Merck added

animal antibodies to both the pre and post-vaccination blood samples. The

use of animal antibodies in laboratory testing is not uncommon. They can

serve as a highlighter of sorts to identify and count human antibodies

that otherwise might not be identifiable on their own. When used in that

way, animal antibodies make it easier to see the human antibodies. They

do not alter what is being measured. However, Merck added animal

antibodies for the singular purpose of altering the outcome of the test

by boosting the amount of virus neutralization counted in the

lab.

50 In a laboratory setting, animal antibodies can

combine with human antibodies to cause virus neutralization that would

not otherwise occur from the human antibodies alone. Merck’s “enhanced”

methodology permitted various types of human antibodies to be counted as

mumps neutralizing antibodies when it was actually the animal antibodies

combining with those human antibodies causing the neutralization. Merck

also did not apply a proper “control” to isolate whether virus

neutralization was caused by the human antibodies alone or in combination

with the animal antibodies. Rather, Merck included in its seroconversion

measure all virus neutralizations regardless of whether they resulted

from human antibodies or by their combination with the animal antibodies.

This “enhanced” PRN methodology thereby allowed Merck to increase

dramatically the recordable instances of mumps virus neutralization and

to count those neutralizations toward seroconversion and its measure of

the vaccine’s success.

51 Merck knew that the neutralizations attributable to

the animal antibodies would never exist in the real world. This is

because the human immune system, even with the immunity boost provided by

an effective vaccine, could never produce animal antibodies. And adding

this external factor as a supplement to a vaccine was not an option

because it could result in serious complications to a human, even death.

Thus, the “uncontrolled” boost to neutralization Merck designed using

these animal antibodies in its laboratory did not in any way correspond

to, correlate with, or represent real-life (invivo)virus neutralization

in vaccinated people.

52 But the use of the animal antibodies allowed Merck

to achieve its high seroconversion objectives. In fact, paired blood

samples that were found under Merck’s 1999 PRN methodology to lack

sufficient virus neutralizing antibodies were now considered

seroconverted using the “enhanced” methodology. Indeed, in one panel of

sixty paired blood samples, Merck measured a seroconversion rate of 100

percent. In other words, non-neutralizing concentrations of antibodies

that would never protect a child from mumps in the real world were, under

Merck’s “enhanced” methodology, treated as vaccine successful solely

because of the additional neutralization provided by the animal

antibodies.

53 Krah defended the use of the animal antibodies in

the “enhanced” PRN test by pointing to the FDA’s purported approval of

the process. However, whatever FDA approval Merck may have received for

this testing, there is no indication that the FDA was fully aware of the

extent of Merck’s manipulation of the testing, including Merck’s

wholesale fabrication of test data to reach its preordained 95 percent

efficacy threshold.

© Back to the Drawing Board Again: Merck’s Falsification of the

“Enhanced” PRN Test Results

54 There was a significant problem with Merck’s

improper use of the animal antibodies to boost its virus neutralization

counts which would be evident to any scientist reviewing the test data.

The animal antibodies boosted neutralization counts not only in the post-

vaccination blood samples. They also boosted neutralization counts in the

pre-vaccination samples. However, too much virus neutralization in the

pre-vaccinated sample created a “pre- positive,” which means enough virus

neutralization to characterize the child as immune without the

vaccine.

55 Pre-positives ordinarily occur in a small percentage

of the child population that is immune to mumps even without vaccination.

This immunity would principally come from a previous exposure to the

mumps virus, or from immunity transferred to a child from the mother in

utero. However, the incidence of this immunity is small, generally

measured by the scientific community at around 10 percent of the child

population.

56 The problem for Merck was that with the addition of

the animal antibodies to the pre-vaccination blood samples it was seeing

a significantly higher percentage of pre-positives than the 10 percent

industry recognized occurrence of such immunity. In the results of one

test that Relators Krahling and Wlochowski both witnessed in the summer

of 2001, the pre-positive rate was more than 80 percent. Krah instructed

Wlochowski to throw out the results and the actual experimental plates of

that particular test, thereby destroying all traces of the unwanted

results.

57 The existence of such a high percentage of

pre-positives threatened the viability of Merck’s “enhanced” methodology.

As a practical matter, with a pre-positive, any favorable results in the

post-vaccinated sample could not be counted as a vaccine success toward

the 95 percent efficacy target. A sample appearing positive before the

vaccine, and staying positive after the vaccine, was not a

seroconversion.

58 Just as important, the high pre-positive rate would

red flag the methodology as flawed. The FDA would question the results of

a test that had such a high level of pre-positives. Krah stated this

explicitly to the members of his lab, including Relators Krahling and

Wlochowski. If Merck wanted to keep the artificial boost in

post-vaccination positives provided by the animal antibodies, it would

have to eliminate the associated boost in pre-vaccination

positives.

59 In the October 2000 presentation, Merck acknowledged

that its initial “enhanced” PRN testing results yielded a level of

pre-positives that was too high. Merck also made clear that it needed to

“optimize” the amount of animal antibodies used in the process so that

the testing would yield a pre-positive rate of 10 percent or less and a

seroconversion rate of 95 percent or more: “Pre-positive rate is higher

than desirable,” and “Continue evaluation of results using optimized

[animal antibodies] amount (target 5 10% pre-positive rate and 2 95%

seroconversions).”

60 The problem was that no amount of tinkering with the

amount of animal antibodies added would produce a pre and

post-vaccination virus neutralization for Merck’s vaccine within the

desired range. Without the animal antibodies, Merck could not support a

sufficient level of post-vaccination neutralization. Conversely, by

adding the animal antibodies, Merck could not avoid having too high a

level of pre-vaccination neutralization (i.e. too many pre-positives).

This left only one way for Merck to reach its desired seroconversion

outcome –falsify the test results.

61 Specifically, Krah and Yagodich and other members of

Krah’s staff falsified the test results to ensure a pre-positive

neutralization rate of below 10 percent. They did this by fabricating

their plaque counts on the pre-vaccination blood samples, counting

plaques that were not actually there. With these inflated plaque counts,

Merck was able to count as pre-negative those blood samples that

otherwise would have been counted as pre-positive because of the

increased neutralization caused by the animal antibodies.

62 Merck’s falsification of the pre-vaccination plaque

counts was performed in a broad-based and systematic manner from December

2000 until at least August 2001

Krah stressed to his staff that that the high number of pre-positives

they were finding was a problem that needed to be fixed. Krah directed his staff to re-check any sample found to be

pre-positive to see if more plaques could be found to convert the sample

to a pre-negative. Krah and Yagodich falsified plaque counts to convert pre-positives to

pre-negatives, and directed other staff scientists to do the same. Krah appointed Yagodich and two others to “audit” the testing that

other staff scientists had performed. These audits were limited to

finding additional plaques on pre-positive samples thereby rendering them

pre-negatives. Krah instituted several measures to isolate the pre-positive samples,

to facilitate their “re-count,” and to convert them to pre-negatives. For

example, when manually changing original counting sheets proved too

time-consuming, Krah employed an excel spreadsheet which would automatically

highlight the undesirable pre-positives so that they could be targeted

more efficiently. The data was entered, highlighted and changed before it

was ever saved. Krah also engaged in the destruction of evidence to minimize the

chances of detection. He not only employed the excel spreadsheet which

left no paper trail. He also destroyed test results, substituted original

counting sheets with “clean” sheets, and ordered the staff in the lab to

do the same. Merck cancelled (in March 2001) a planned outsource of the testing to

a lab in Ohio because the outside lab was unable to replicate the

seroconversion results Krah was obtaining in his lab. Krah and his staff

conducted all the remaining testing instead.

63 Unsurprisingly, none of the “recounting” and

“retesting” that Krah and his staff performed as part of the “enhanced”

testing was performed on any post-vaccination samples or on any

pre-vaccination samples that were pre-negative. This additional “rigor”

was only applied to the pre-positive samples, the very samples Merck had

identified as undesirable and which kept Merck from attaining its target

of 5 10% pre-positive rate and L 95% seroconversion.

64 Relators Krahling and Wlochowski engaged in numerous

efforts to stop the fraud. They questioned and complained to Krah about

the methodology being employed, particularly the manipulation of

pre-positive data. They attempted to dissuade others from participating.

They initiated numerous calls to the FDA to expose the fraud. And they

attempted to document the fraud, even as evidence of it was being

destroyed. But Relators’ efforts were to no avail. For every effort they

took to stop the fraud, Merck adapted the scheme to assure the

falsification continued. For example, when Relators objected to changing

their own plaque counts, Krah appointed other staff, as so-called

auditors, willing to falsify the data.

65 In July 2001, Relators Krahling and Wlochowski

secretly conducted their own audit of the test results to confirm

statistically the fraud that was occurring with the “enhanced” testing.

They reviewed approximately 20 percent of the data that Merck had

collected as part of the “enhanced” test. In this sampling, they found

that 45 percent of the pre-positive data had been altered to make it

pre-negative. No pre-negatives were changed to pre-positives. No post-

positives were changed to post-negatives. No post-negatives were changed

to post-positives. The statistical probability of so many changes

occurring in just the pre-positive data and in no other data was more

than a trillion to one. And that is a conservative measure given the

likelihood that an even greater number of pre-positives were changed but

remained undetected because the changes were not recorded in Merck’s

files.

(d) The Complicity of Merck’s Senior Management

66 Krah did not act alone in orchestrating the

falsification of the “enhanced” PRN test results. He acted with the

knowledge, authority and approval of Merck’s senior management.

67 For example, in April 2001, after Merck cancelled

the planned outsourcing of the remainder of the Mumps Vaccine efficacy

testing, Emilio Emini, the Vice President of Merck’s Vaccine Research

Division, held a meeting with Krah and his staff, including Relators

Krahling and Wlochowski. Emini was clearly on notice of protests that had

been going on in the lab because he directed Krah’s staff to follow

Krah’s orders to ensure the “enhanced” testing would be successful. He

also told the staff that they had earned very large bonuses for the work

they had completed on the project so far. He was going to double the

bonuses and pay them once the testing was complete.

68 In July 2001, after completing the secret audit,

Relator Wlochowski openly accused Krah during a lab meeting of committing

fraud in the Mumps Vaccine testing. Relator Krahling then met with Alan

Shaw and confronted him about the fraudulent testing. Krahling told Shaw

of the falsification of the pre-positive data. Krahling also confronted

Shaw about the improper use of the animal antibodies to inflate the

post-vaccine neutralization counts. Shaw responded that the FDA permitted

the use of the animal antibodies and that should be good enough for

Krahling. Shaw refused to discuss anything further about the matter.

Instead, Shaw talked about the significant bonuses that Emini had

promised to pay the staff in Krah’s lab once the testing was

complete.

69 Relator Krahling then met with Bob Suter, Krahling’s

human resources representative at Merck. Krahling told Suter about the

falsification of data and Shaw’s refusal to get involved. Krahling told

Suter that he was going to report the activity to the FDA. Suter told him

he would go to jail if he contacted the FDA and offered to set up a

private meeting with Emini where Krahling could discuss his

concerns.

70 Shortly thereafter, Emini agreed to meet with

Krahling. In an early August, 2001 meeting with Emini, Krahling brought

actual testing samples and plaque counting sheets to demonstrate to Emini

the fraudulent testing that Krah was directing. Emini agreed that Krah

had falsified the data. Krahling also protested against the use of the

animal antibodies to inflate the seroconversion rate. Emini responded

that the animal antibodies were necessary for Merck to achieve the

project’s objective. Krahling proposed a scientific solution to lower the

pre-positive rate and end the need to falsify data –stop using the animal

antibodies. When Emini declined, Krahling asked him what scientific

rationale justified using the animal antibodies. Emini explained that

Merck’s choice to use the antibodies was a “business decision.”

71 To assuage Krahling’s concerns, Emini promised to

conduct an “internal audit” of the Mumps Vaccine testing. Krahling

countered that the FDA should be contacted since only the FDA could

perform an audit that was truly independent. Emini ordered Krahling not

to call the FDA. Immediately after the meeting, Suter approached Krahling

and again threatened that he would be put in jail if he contacted the

FDA.

72 The next morning, Krah arrived early to the lab and

packed up and destroyed evidence of the ongoing Mumps Vaccine testing.

This evidence included garbage bags full of the completed experimental

plates, containing the cell sheets with plaques, that would have (and

should have) been maintained for review until the testing was complete

and final. The destruction of the plates would make it difficult to

compare the actual plaque counts in the test with what was documented and

changed on the counting sheets, as Krahling had done the day before in

Emini’s office. Despite the threats he received from Suter and Emini,

Krahling called the FDA again and reported this latest activity in

Merck’s ongoing fraud.

(e) The FDA Interview of Krah and Shaw

73 On August 6, 2001, in response to Relator

Krahling7s repeated calls, an FDA agent came to Merck to question Krah

and Shaw. The FDA agent’s questions were largely focused on Merck7s

process for counting plaques in the “enhanced” PRN test. Krah and Shaw

misrepresented the process that Merck was actually conducting and the

fact that Merck was falsifying the pre-positive test data.

74 For example, the FDA agent asked whether there was

any ad hoe revisiting of plaque counts. Krah falsely responded that

plaque counts were being rechecked only for verification, controls and to

check hypervariability. Krah also misrepresented to the FDA that they did

not change the data after it was entered in the excel workbook. When the

FDA agent pressed Krah on the criteria for changing original counts on

the counting sheets, Krah left the interview without answering the

question. In Krah’s absence, Shaw informed the FDA agent that a memo

would be added to the standard operating procedure to address changes.

The FDA agent then asked Shaw why they had not taken care of this before

the project started. Shaw offered that Krah and another Merck employee

had identified “trends” and “problems” with the original counts without

ever explaining what those “trends” or “problems” actually were.

75 The interview proceeded in this manner with Shaw and

Krah obfuscating what was happening in the lab and obstructing the FDA’s

efforts to find out what was really going on with Merck’s manipulation of

the testing procedure to reach its targeted seroconversion rate.

76 The entire FDA interview with Krah and Shaw was

short, probably less than half an hour. The FDA agent did not question

Relators Krahling or Wlochowski or other members of Krah’s staff in order

to corroborate what Krah and Shaw said. As far as Relators witnessed, the

FDA agent did not attempt to substantiate Krah’s or Shaw’s responses by

reviewing any of the testing samples or backup data that had escaped

destruction. And the FDA agent did not address the actual destruction of

evidence that Krah had already facilitated.

77 The FDA issued a one page deficiency report

identifying a few relatively minor shortcomings in Merck’s testing

process. These principally related to flaws in Merck’s record- keeping

and in its validation/explanation of changes to the test data.

78 The report did not address or censure Merck for any

issues relating to Merck’s improper use of the animal antibodies or

Merck’s wide-scale falsification of pre-positive test data. The FDA did

not discover this fraudulent activity in the course of the perfunctory

visit because of Krah’s and Shaw’s misrepresentations to the

FDA.

(f) Merck’s Completion and Use of the Fraudulent Test Results

79 In order to comply with the FDA’s deficiency

report, Merck made minor adjustments to its testing procedure relating to

its heretofore ad hoc procedure for counting plaques. The new, more

formalized procedure explicitly provided for supervisory oversight and

review of plaque counts in pre-vaccinated blood samples and where plaques

were difficult to read because of the condition of the sample. In other

words, under the “new” procedure, Merck continued to falsify the test

data to minimize the level of pre-positives and inflate the

seroconversion rate.

80 After the FDA visit, Relator Krahling was barred

from any further participation in the Protocol 007 Mumps Vaccine testing

project. He was also prohibited from accessing any data related to the

project. Shortly thereafter, he was given a poor performance review and

barred from continuing to work in Krah’s lab on any matter. He was

offered a position in a different lab within Merck’s vaccine division,

but it involved work for which Krahling had no prior experience or

interest. In December, 2001 Krahling resigned from the Company.

81 Relator Wlochowski continued to work at Merck,

though she was transferred out of Krah’s lab at the end of September,

2001. She spent an additional year working at Merck in a different lab

before she too left Merck.

82 Before Relators Krahling and Wlochowski left Krah’s

lab, Merck conducted the internal audit Emini had promised Relator

Krahling would take place. However, as Krahling had warned against, the

audit was anything but independent. Unsurprisingly, therefore, Merck

completed its Protocol 007 testing in late summer or early fall 2001 and

Merck reported the 95 percent seroconversion it had targeted from the

outset. What no one knew outside of Merck –not the FDA, the CDC or any

other governmental agency –was that this result was the product of

Merck’s improper use of animal antibodies and the wide-scale

falsification of test data to conceal the significantly diminished

efficacy of its Mumps Vaccine.

83 Notably, while Relators Krahling and Wlochowski were

immediately removed from Krah’s lab for their protests against and

efforts to stop the fraudulent testing, those that facilitated the fraud

remained. Indeed, Krah, Yagodich and other members of Krah’s staff who

were instrumental in the fraud continue to work jn vaccine development at

Merck today and are still working together in Krah’s lab.

2. Merck Fraudulently and Deceptively Marketed Its Mumps Vaccine For Over

a Decade

84 Since at least the beginning of the Protocol 007

testing and continuing through the present, Merck has falsely represented

to the government and the public that its Mumps Vaccine has at least a 95

percent efficacy rate. It has done so even though Merck is well aware,

and has taken active steps to keep secret, that the efficacy rate is far

lower.

(a) Merck’s False Representations Through Package Inserts

85 Merck principally has made these false

representations in the package insert or labeling that accompanies each

dose of Merck’s Mumps Vaccine. This is the product material that the law

requires which, among other things, informs health care providers and the

public of the composition of the vaccine and its overall efficacy at

immunizing the recipient from contracting mumps.

86 Merck’s Mumps Vaccine insert has changed over the

years, but at least one thing has remained constant –Merck’s reporting of

at least a 95 percent efficacy rate. The current package insert for M-M-R

II provides that “a single injection of the vaccine induced . . . mumps

neutralizing antibodies in 96% . . .of susceptible persons.” Merck

neither identifies the study performed or the date it was performed that

supposedly supports this representation. The current insert further

provides that: “Efficacy of measles, mumps and rubella vaccines was

established in a series of double-blind controlled field trials which

demonstrated a high degree of protective efficacy afforded by the

individual vaccine components.” As support for this representation, Merck

cites the more than forty-year old studies it conducted to obtain the

original governmental approval for its Mumps Vaccine in 1967. Merck’s

M-M-R II package insert has contained this language and “support” since

at least 1999.

87 Merck’s product insert is a clear misrepresentation

of the efficacy rate of its Mumps Vaccine. It cites outdated or

unidentified studies that are not reflective of what Merck knows now

about the vaccine’s current effectiveness as confirmed by Merck’s efforts

to manipulate the methodology and ultimately falsify the data to report

at least 95 percent seroconversion. In short, as Merck well knows, the

efficacy rate of its Mumps Vaccine is not anywhere near 95 percent. Yet

Merck continues to falsely represent a 95 percent efficacy rate to ensure

its continued lock on the sale of the vaccine in the U.S.

( Merck’s False Representations Through

Expanded Distribution of the Vaccine

88 Merck’s misrepresentations relating to its Mumps

Vaccine have not been made just for M-M-R II. Merck has also obtained

approval to sell M-M-R II in Europe and to sell ProQuad in the U.S. and

Europe. Merck obtained these approvals by again misrepresenting to the

FDA (in the U.S.) and the EMA (in Europe) the efficacy rate of its Mumps

Vaccine.

89 In 2004, Merck submitted an application to the FDA

for approval of ProQuad. Merck certified the contents of its application

were true. In 2005, after reviewing Merck’s application, the FDA approved

ProQuad. According to the FDA’s clinical review of the studies Merck

submitted in support of ProQuad, “[cllinical efficacy of.. . mumps .. .

vaccine strain w[as] shown previously … using [the] monovalent. [Tlhe

vaccine response rates were 95.8 to 98.8% for mumps. " Merck knew

from its Protocol 007 testing that this falsely represented the efficacy

of its Mumps Vaccine. Now that it is licensed, Merck's package insert

continues to misrepresent the efficacy of its Mumps Vaccine, stating:

" Clinical studies with a single dose of ProQuad have shown that

vaccination elicited rates of antibody responses against measles, mumps,

and rubella that were similar to those observed after vaccination with a

single dose of M-M-R 11 " and " [a]ntibody was detected in 96.7%

for mumps.”

90 In 2006, Merck obtained a license from the EMA to

sell the M-M-R II analogue (called M-M-RVaxpro) through the joint venture

Sanofi Pasteur MSD. Merck used the falsified results of the “enhanced”

PRN test to obtain this approval. The EMA actually cited Protocol 007 as

a “pivotal clinical study” in support of its decision to grant the

approval. Since then, Merck has been manufacturing M-M-RVaxpro at its

West Point facility for Sanofi Pasteur MSD to sell in Europe.

91 Around the same time, Merck also obtained a license

from the EMA for Sanofi Pasteur MSD to sell Merck’s ProQuad in Europe. As

with M-M-RVaxpro, Merck’s joint venture submitted the falsified results

of Protocol 007 to the EMA as supportive clinical information in its

vaccine application. Relying on this information, the EMA found “no major

concern” about the efficacy of the mumps component of the

vaccine.

92 Thus, by 2006, Merck had the exclusive licenses to

sell M-M-R II and ProQuad in the U.S., as well as licenses to sell

M-M-RVaxpro and ProQuad in Europe.

© Merck’s False Representations Through Its

Application for a Labeling Change on Potency of M-M-R 11

93 In 2007, Merck changed its M-M-R II labeling to

reflect a decrease in the potency of the mumps component of the vaccine.

Potency measures how much of the attenuated virus is included in each

dose of the vaccine. The labeling change –approved by the FDA –allowed

Merck to represent a lower minimum potency, from 20,000 to 12,500 TCID5o

(or tissue culture infective dose, which is the scientific measure of

vaccine potency). This represented a 37.5 percent reduction in how much

of the attenuated virus could go into each dose of the vaccine.

94 At no time during Merck’s efforts to secure approval

to change its M-M-R II labeling did Merck disclose to the FDA what Merck

knew about the diminished efficacy of the vaccine. Nor did Merck take any

steps to address the efficacy information that was falsely represented in

the labeling. That portion of the labeling remained unchanged.

95 Merck was thus representing throughout the approval

process that it could actually reduce how much attenuated virus Merck put

into each vaccine shot and still maintain its represented 95 percent

efficacy. Merck did so even though it knew that at the higher potency the

vaccine was nowhere near this efficacy. Clearly, if the FDA had known the

truth about the vaccine’s efficacy it would not have approved the

labeling change to reduce the minimum potency.

(d) Merck’s False Representations Through Recent Mumps Outbreaks

96 With Merck’s significantly degraded vaccine as

the only protection against the mumps in this country, there has remained

a significant risk of a resurgence of mumps outbreaks. That is exactly

what Krah –who was well aware of the Mumps Vaccine’s failings –predicted

would occur. In a conversation he had with Relator Krahling in the midst

of the “enhanced” PRN testing, Krah acknowledged that the efficacy of

Merck’s vaccine had declined over time, explaining that the constant

passaging of virus to make more vaccine for distribution had degraded the

product. Krah predicted that because of this, mumps outbreaks would

continue. And that is exactly what has happened.

(i) The 2006 Mumps Outbreak

97 In 2006, more than 6,500 cases of mumps were

reported in the Mid-West in a highly vaccinated population. This was the

largest mumps outbreak in almost twenty years and a significant spike

from the annual average of 265 cases that had been reported for the years

leading up to the 2006 outbreak. Astoundingly, 84 percent of the young

adults who contracted the disease had been vaccinated with two doses of

the Mumps Vaccine.

98 The CDC, FDA and Merck publicly worked together to

determine the cause of this 2006 outbreak. Of course, only Merck knew

that outbreaks would occur because its vaccine had degraded over time and

was weaker than what Merck represented. Nonetheless, Merck continued to

represent its inflated efficacy rate while government and private health

care providers continued to believe that there was no problem with the

vaccine. During the investigation of the outbreak, the CDC’s then

Director, Gerberding, reaffirmed the CDC’s view that nothing was

wrong with the Mumps Vaccine, a belief fed by Merck’s continued

misrepresentations: “We have absolutely no information to suggest that

there is any problem with the vaccine.” Director Gerberding and the CDC

emphasized that “[tlhe best protection against the mumps is the

vaccine. "

99 Even though Krah, the Merck investigator who ran

Protocol 007, expected outbreaks to increase because of the degraded

product, scientists at the CDC and elsewhere continued researching to

understand the origins of such a large outbreak within a highly

vaccinated population. One of the leading studies was led by Dr. Gustavo

Dayan, then a doctor at the CDC, and published in 2008 in the New England

Journal ofMedicine. After considering possible causes for the outbreak,

Dr. Dayan recommended that " [fluture studies will help evaluate

national vaccine policy, including whether the administration of a second

dose of M-M- R vaccine at a later age or the administration of a third

dose would provide a higher or a more durable immunity. " Gustavo H.

Dayan, " Recent Resurgence of the Mumps in the United States, "

New England Journal of Medicine, 358; 15 (Apr. 10,2008) 1580.

100 Dr. Dayan's study ultimately concluded that

" [a] more effective Mumps Vaccine or changes in vaccine policy may

be needed to avert outbreaks and achieve elimination of mumps.” Id.

(emphasis added). Of course, if Dr. Dayan had the benefit of what Merck

knew but willfully withheld from the government and the public, his

findings would have been significantly less equivocal on what needed to

be done to stop the reemergence of mumps outbreaks.

101 At the same time Dr. Dayan published his study

questioning whether it may be time for a new vaccine, Merck publicly

proclaimed that its Mumps Vaccine had not been changed since its

introduction in 1967 and that Merck had no plans to change it. So, while

Dr. Dayan questioned whether it “may” be time for a new vaccine, Merck

attempted to reassure the public that there was no need for any such

change. The vaccine worked just fine.

102 In another study on the 2006 outbreak, several

scientists questioned Merck’s use of the Jeryl Lynn strain, instead of a

wild-type virus, in Merck’s PRN testing. They noted that with this kind

of testing, vaccine efficacy can be significantly overstated because

“good results can be obtained that do not reflect the actual ability of

the vaccine to provide protection from disease. A vaccine failure is

investigated properly only if, in addition to avidity testing, the

ability of antibodies to neutralize wild mumps virus has been checked.”

Heikki Peltola, et al., “Mumps Outbreaks in Canada and the United States:

Time for New Thinking on Mumps Vaccine,” Clinical Infectious Diseases,

2007:45 (15 Aug. 2007) 459, 463.

103 What is perhaps most notable about this study is

that it scientifically questioned Merck’s stated efficacy based solely on

Merck’s use of the vaccine strain instead of a wild-type virus to test

efficacy. The critique did not (and could not) even account for Merck’s

concealed efforts to further inflate its efficacy results with the

improper use of animal antibodies and the falsification of test

data.

104 Currently, Emory University is conducting a

clinical trial of its university students in yet another attempt to

explain the cause for the 2006 mumps outbreak among college-age students

who had received both doses of the vaccine. However, Merck is listed as a

collaborator on that study and is providing funding, thus continuing to

exert its influence to perpetuate its fraudulent efficacy

findings.

105 Merck’s ongoing misrepresentations and omissions

with respect to the effectiveness of its vaccine continue to conceal the

role its degraded product played in the 2006 outbreak.

(ii) The 2009 Mumps Outbreak

106 In his 2008 study, Dr. Dayan also predicted

another mumps outbreak would follow three years after the 2006 outbreak.

This followed from the three-year cycles in which outbreaks occurred

before children were widely vaccinated for mumps. “[iln the pre-vaccine

era, mumps activity followed 3 year cycles, so the current low activity

rate [at the time of his 2008 study] may be transient while another

critical mass of susceptible persons accrues.” Dayan, New England Journal

of Medicine. 358;15 at 15 87-88.

107 In August 2009, another mumps outbreak began just

as Dr. Dayan predicted. As with the 2006 outbreak, the 2009 outbreak

occurred despite high vaccination coverage among the U.S. children’s

population. In total, roughly 5,000 cases were confirmed by the CDC

during the 2009 outbreak. This outbreak reaffirmed Krah’s prediction that

mumps outbreaks would reemerge and increase over time.

108 Faced with a mumps outbreak in 2006, and without

complete information as to what might have caused it, the CDC

acknowledged that it would consider the possibility of recommending a

third dose of Mumps Vaccine. According to the Deputy Director of the

CDC’s Viral Diseases division in 2008, “If there’s another outbreak, we

would evaluate the potential benefit of a third dose to control the

outbreak.”

109 Because of the 2006 and 2009 outbreaks, the CDC has

also pushed back its target date for eradicating mumps from its original

20 10 goal to no earlier than 2020. But no amount of extra time or

dosages will be enough to eliminate the disease when the vaccine does not

work as represented in the labeling. It will merely allow Merck to

continue to misrepresent the vaccine’s efficacy and thereby maintain its

exclusive hold on the Relevant Market with an inadequate

vaccine.

110 To date, the government has not acted on Dr.

Dayan’s conclusion that it “may” be time for a new Mumps Vaccine.

Instead, it continues to build its strategy around the existing vaccine.

Nor is Dr. Dayan likely to pursue his own conclusion. He left the CDC to

take a position in the Clinical Department of Sanofi Pasteur, the vaccine

division of the Sanofi Aventis Group, Merck’s partner in manufacturing

and selling M-M-RVaxpro and ProQuad in Europe. Dr. Gerberding has also

left the CDC. In January 2010, she became the president of Merck’s

Vaccine Division, a position she holds currently.

(e) Merck’s False Representations Through the

Immunization Action Coalition

111 The Immunization Action Coalition (IAC) is a

non-profit organization which describes itself as the “nation’s premier

source of child, teen, and adult immunization information for health

professionals and their patients.” It provides educational materials and

“facilitates communication about the safety, efficacy, and use of

vaccines within the broad immunization community of patients, parents,

health care organizations, and government health agencies.”

112 The CDC works closely with the IAC. Indeed,

“[a]lmost all of IAC’s educational materials are reviewed for technical

accuracy by immunization experts at the CDC.” The CDC also provides the

IAC with financial support for the purpose of educating health care

professionals about U.S. vaccine recommendations. Several CDC physicians

currently serve on IAC’s Advisory Board. So does the current Director of

the National Vaccine Program Office at the Department of Health and Human

Services.

113 Merck also provides funding to the IAC. The IAC

asserts that Merck’s Mumps Vaccine has an efficacy rate of 97 percent.

This comes from the following Mumps Vaccine “Question and Answer”

information sheet posted on the IAC’s website: “How effective is this

vaccine? The first dose of M-M-R vaccine produces good immunity to .. .

mumps (97%)”

114 Merck has done nothing to correct this widely

disseminated misinformation, approved and supported by the CDC, about the

efficacy of Merck’s Mumps Vaccine. If anything, through its funding and

support of the IAC, Merck has once again positioned itself to facilitate

the spread of this false efficacy information.

C. The Anticompetitive Effects of Merck’s

Unlawful Monopolization of The Mumps Vaccine Market

115 Through its false representations of the Mumps

Vaccine’s efficacy rate and its efforts to conceal the significantly

lower efficacy rate that the Protocol 007 testing confirmed, Merck has

unlawfully monopolized the Relevant Market and foreclosed potential

competitors from entering the Market with a new Mumps Vaccine. No

manufacturer is going to sink the time, energy and resources into

developing the vaccine for sale in the U.S. with the artificially high

bar Merck has unlawfully devised.

116 Entering the Relevant Market would be particularly

risky in the case of the Mumps Vaccine given the four-decade lock Merck

has had on the Market.

117 But for Merck’s anticompetitive conduct, including

its fraud and other misconduct, one or more competing manufacturers would

have entered this lucrative Market –with its guaranteed sales of almost 8

million doses a year –with a competing Mumps Vaccine. For example,

GlaxoKline, a manufacturer of numerous FDA approved vaccines, has an

M- M-R vaccine, PriorixB, that is widely sold in Europe, Canada,

Australia and other markets. PriorixB is not licensed or sold in the

U.S., even though the company has a U.S. patent covering the vaccine and,

according to an industry journal, had plans to enter the U.S. market with

it.

118 By continuing to monopolize the Relevant Market,

by, inter alia, misrepresenting an artificially high efficacy rate, and

engaging in the above-described misconduct, Merck has foreclosed

GlaxoKline and any other manufacturer from entering the U.S. market.

So long as Merck continues to monopolize the Relevant Market and engage

in this misconduct, these manufacturers will continue to be excluded from

the Relevant Market and Merck will unlawfully retain its unlawful

monopoly with a vaccine that does not provide adequate

immunization.

119 There are no legitimate pro-competitive

efficiencies that justify Merck’s anticompetitive and/or otherwise

unlawful conduct or outweigh its substantial anticompetitive

effects.

120 Merck’s unlawful conduct has harmed competition by

foreclosing other manufacturers from entering the Relevant Market.

Without such competition, Merck has been able to unlawfully maintain and

profit from its monopoly in this Market even though it is manufacturing

and selling a sub-par vaccine. In the absence of this illegal market

foreclosure, other manufacturers would have entered the Relevant Market

with a higher quality and/or cheaper vaccine. This competition, or the

threat of such potential competition, would have forced Merck to respond

by either selling its existing vaccine at a lower price or developing a

better vaccine.

121 By unlawfully excluding and impairing competition,

Merck’s conduct has caused Plaintiff and other Class members to pay more

for Mumps Vaccine than they otherwise would have paid absent Merck’s

illegal, exclusionary conduct.

122 Given the absence of any competition in the

Relevant Market, Merck has used its unlawful monopoly power to charge

artificially inflated prices for its Mumps Vaccine. During the Class

Period, Merck increased the prices it charged private health providers

such as Plaintiff for M-M-R II vaccine by an astounding 85%. See Figure

1.

Pediatric MMRII Vaccine Price

Price Lists

Figure 1

123 As a result of Merck’s unlawful,

anticompetitive conduct, Plaintiff and members of the Class were

compelled to pay, and did pay, artificially high and supra-competitive

prices for Mumps Vaccine.

124 Plaintiff and members of the Class have, as a

consequence, sustained losses and damage to their business and property

in the form of the payment of overcharges for Mumps Vaccine. The full

amount of such damages will be calculated after discovery and upon proof

at trial.

CLASS ACTION ALLEGATIONS

Read the full .pdf for the remaining details:

Chatom-Lawsuit-Merck

http://medind.nic.in/ibl/t03/i1/iblt03i1p8o.pdf

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

http://homeopathycures.wordpress.com

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start July 12