Merck MMR - Malone Sworn Expert Witness Testimony

Expert witness report in the case of Stephen A. Krahling and Joan A. Wlochowski vs Merck & Company, Inc.

I am often asked what event caused me to essentially turn against my industry (clinical research, regulatory affairs, vaccine development) during the COVID crisis, and to speak publicly in a way that was against my own interests (as the original inventor of the use of mRNA as a drug and for vaccines, as documented here and here).

Although there continues to be manufactured controversy regarding my role in this invention (despite publication of the original invention disclosure document), the record on this is quite clear. The following is a quote from correspondence with Dr. Stan Gromkowski, formerly the head immunologist at Vical after I left that company. This is his follow-up to his interview with the author of the Atlantic Monthly hit piece on me.

“I spoke with Tom earlier today. We had a good, 1 hr long conversation. He heard from me, too, who came up first with the idea of using mRNA to induce immune responses. It was you :-)! I also gave him my opinion about other actors who are struggling to get their names into credits... You know who those actors are.”

He is specifically referring to Drs. Phillip Felgner (my former collaborator when I was under Inder Verma at the Salk Institute, and subsequent boss at Vical) and Dr. Jon Wolff.

Certainly my experiences with the avarice, jealousy, corruption and stolen valor surrounding my early work in 1987 to 1991 had set me up to be very aware of the corruption that is rampant in this sector. Earlier, as an undergraduate student at UC Davis, I watched as one of my mentors (Dr. Murray Gardner) was threatened by Dr. Robert Gallo with loss of all future NIH funding if he continued to work with the LAV virus isolate (subsequently renamed HIV) that he had obtained from Dr. Luc Montagnier of the Pasteur Institute, rather than with the isolate named by Gallo as HTLV III (subsequently demonstrated to have been illicitly obtained from and identical to LAV). My subsequent experiences while serving as an Assistant Professor at UC Davis included objecting to what I saw as unethical gain of function research by Professor Paul Luciw who swapped human cytokine genes into the sequence of the Simian Immunodeficiency Virus (SIV) in an effort to make that virus more pathogenic. This was my first encounter with those promoting the logic of gain-of-function research. Although rarely reported, years later the modern embodiment of that UC Davis group were deeply involved in the gain of function work that resulted in SARS-CoV-2, including a role in actually training the infamous “bat lady” of the Wuhan Institute of Virology. After that objection, I found my academic pathway forward at UC Davis to no longer be viable, and I agreed to a recruitment package to the U Maryland Baltimore School of Medicine, where I first pioneered the use of pulsed electrical fields for genetic delivery into mammalian tissues (muscle, skin). Then there were the many meetings of the CDC Advisory Committee on Immunization Practices (ACIP) that I attended as an observer and reported about on behalf of various clients. This opened my eyes to how the vaccine industry manipulated the ACIP, and the structural pro-industry, pro-vaccine advocacy that has been ingrained into the CDC.

But the experience that really opened my eyes to the corruption in industrial vaccine development involved being hired to do diligence and generate a comprehensive expert witness report concerning two legal cases involving the whistleblower (qui tam) cases brought by Stephen A. Krahling and Joan A. Wlochowski (former Merck employees) against Merck & Company, Inc. HHS Secretary Robert F. Kennedy recently referred to these cases in an interview with Dr. Phil.

As summarized and paraphrased on X by Camus , the Secretary made the following points:

In a hard-hitting interview with Dr. Phil, Health and Human Services Secretary Robert F. Kennedy Jr. zeroed in on the troubling downsides of the MMR (measles, mumps, rubella) vaccine, raising urgent concerns about its waning effectiveness and lack of safety testing. With public trust in vaccines wavering, Kennedy’s revelations demand attention. Kennedy warned that the MMR vaccine’s protection fades over time—approximately 4% per year, he claimed—leaving many older adults with little to no immunity. “It’s a leaky vaccine,” he said, echoing Sir Graham Wilson, a leading infectious disease expert in 1963, who predicted its long-term limitations. This waning effect, Kennedy noted, contributes to breakthrough cases, even among the vaccinated, in communities hit by outbreaks. The mumps component of the MMR vaccine drew Kennedy’s fiercest criticism. “It’s never worked effectively,” he told Dr. Phil, citing a whistleblower lawsuit against Merck, the vaccine’s manufacturer. Lab technician John Krahling alleged Merck ordered fraudulent practices to overstate the mumps vaccine’s efficacy. Though dismissed on a technicality, the case revealed disturbing flaws, Kennedy said. This is alarming, as mumps in older individuals—a paradoxical vaccine outcome—can lead to severe complications like sterility, unlike the typically benign childhood illness. Even more shocking, Kennedy revealed that the MMR combination shot was “never safety tested” as a single vaccine. He suggested that combining measles, mumps, and rubella vaccines may cause viral interference, potentially linked to adverse events not seen with individual shots. “People assumed the combination was safe, but we now know that’s not true,” he said. HHS is now launching studies to probe these safety gaps, a first in vaccine science, Kennedy emphasized.

In preparing this expert witness report, I spent hundreds of hours reviewing thousands of pages of internal documents from both Merck and GSK relating to the testing of their Mumps vaccines and MMR products in general. A required condition for my being allowed access to review these confidential internal corporate documents, I had to agree to a lifetime ban on my freedom to do any subsequent research regarding Mumps or MMR vaccines. I was also prohibited from discussing any information or opinions about this case that were not otherwise publicly disclosed during the proceedings. Therefore, I am constrained in commenting about the case beyond reciting or quoting other publicly available documents.

This is just the way things are.

This effort, which took more than a year, resulted in an expert witness report and rigorous video cross-examination by a battery of high-powered lawyers hired by Merck to discredit me and my report. The expert witness report has been made public during the subsequent court proceedings, and so I am able to reference that report.

You can download and read a copy of that report, originally filed in 2018, at this location.

Here are my main findings regarding mumps component of Merck’s MMR vaccine:

Astute readers will appreciate that the information and conclusions that I reached and summarized closely aligned with the practices involved in the Pfizer/BioNTech/Moderna/FDA “logic” and justifications used in the case of the gene therapy-based COVID ‘“vaccines”, and in particular the reliance on limited data involving mouse antibody responses used to justify authorization of the “booster” products. Astute readers will also note that I completed this task the year before the novel coronavirus known as SARS-CoV-2 first infected the general human population triggering the cascade of events that I often refer to as the COVIDcrisis. My view on the vaccine industry and the role of the federal government in providing oversight of this industry was profoundly impacted by what I learned while serving as an expert reviewer and witness in this case.

Although I have a written transcript of my sworn testimony and interrogation by the Merck lawyers, this was not made public by the court and so I am not able to provide this at this time. I have requested permission to disclose from the law firm that led on this case, but have not heard back. All of this is now once again topical and timely due to the recent comments by the Secretary of HHS as discussed, which is why I am now posting this substack essay.

The two cases involved have both been dismissed in Federal Court on technicalities.

As I am not allowed to comment on these cases other than by linking or quoting from other public sources, below I have included a learned legal expert’s summary of the case.

Reprinted from the “Skeptical Raptor” blog:

Merck whistleblowers – mumps vaccine lawsuit motions and updates

by Dorit Rubinstein Reiss, 2021-09-11

This article about the so-called Merck whistleblowers was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In August 2010 Stephen A. Krahling and Joan A. Wlochowski (“the relators”), former Merck virologists and often called “Merck whistleblowers,” filed suit in the name of the United States – a so-called qui tam action, where the prosecution shares any fines or penalties with the two virologists – against Merck.

They claimed that by faking effectiveness testing, Merck misled the United States government as to the effectiveness of the mumps component of its MMRII vaccine (a vaccine that protects individuals against mumps, measles, and rubella). In 2012 a clinic and two MDs filed a class action against Merck claiming a violation of the Sherman Act – monopolistic, anti-competitive behavior resulting from the fraud – and violation of various state laws. (U.S. v. Merck and Chatom v. Merck). The suits were handled together.

Court decision on one motion

On September 5, 2014, Judge Jones II of the Federal District Court for the Eastern District of Pennsylvania mostly rejected Merck’s motion to dismiss.

This post explains that decision. It begins by explaining some of the legal issues and the factual basis as best as I can and then explains what the judge decided and what it means.

The Merck whistleblowers claims

The starting point for this discussion is that a motion to dismiss is a big deal: it means a party doesn’t get its day in court, doesn’t get to prove its case. It’s not something to be done lightly.

Because of that, when a court decides on a motion to dismiss, the court gives the party against whom the motion is directed it all the benefits of the doubt. In this case, Merck was asking the court to dismiss the claim brought by Krahling and Wlochowski, the Merck whistleblowers, and the other plaintiffs.

When deciding on the claim, the Judge was required to assume everything the plaintiffs claimed was, in fact, true, and interpret everything in the most favorable light for them. (See Phillips v. County of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).

This is a qui tam lawsuit under the False Claims Act (31 U.S.C §3729 and on). A qui tam suit is a suit brought by a private individual acting for the government. The False Claims Act allows people who are not members of the government to sue when a contractor submitted or caused to submit fraudulent claims to the government.

The relator – the person bringing the suit – then gets a portion of the win. The government may intervene in the suit, which the United States government declined to do so far in this suit (though the government did file memoranda of opinion on some of the legal issues – see below). If the government does not, the relator gets a larger part of any win.

So what is this Merck whistleblower suit about?

In 1971 the United States approved the use of an MMR vaccine made by Merck, containing the Jeryl Lynn strain of mumps vaccine. In 1978 Merck introduced the MMR II, using a different strain of the rubella vaccine.

The relators – virologists Krahling and Wlochowski – claim that over the years the effectiveness of the Jeryl Lynn mumps vaccine declined because of its repeated passage (a term in cell culture science that is essentially the number of generations that have passed since a cell line was established) through eggs. Initially, it was over 95% – to continue the license, say the relators, Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years.

It’s not quite clear what this is based on, since the FDA does approve vaccines with lower effectiveness than 95%, and in its response, Merck highlights that there was no such absolute number it had to reach.

In 1997, the FDA required Merck to conduct effectiveness testing of the MMR-II vaccine. The relators claim that Merck engaged in a variety of more or less dishonest testing practices to bump up the vaccine’s effectiveness they reported.

These included:

• Using the vaccine virus to test effectiveness rather than the wild virus.

• Using animal antibodies to help manage the testing rate.

• Faking the result of the tests that used animal antibodies.

I don’t know enough about the subject matter to know if the first two are, indeed, illegitimate. I don’t know if it’s illegitimate to use the vaccine virus, and I don’t know if it’s illegitimate to use animal antibodies here – apparently, it’s legitimate at least in some circumstances, depending on how they were used.

But if test results were faked, that’s clearly dishonest and unacceptable. At the least, it raises concerns about the process and the ability to trust the vaccine. At worst it can mean that children are less protected against a potentially harmful disease than the government and others believe and that such lesser protection increases the chances of outbreaks.

Krahling and Wlochowski claim that when the other methods did not work, faking test result is what Merck resorted to – and that their warning to superiors that data was faked was not acted upon and resulted in steps taken against them. It’s a very, very serious allegation.

The decision on the Motion to Dismiss

Merck filed a motion to dismiss using a number of legal arguments.

Merck’s main legal claim against the suit was that the relators’ claim was, in fact, that Merck violated its labeling requirements – and that such a violation was something that only the FDA can act on: because it’s already covered by another act – the Food, Drug and Cosmetics Act – the False Claims Act doesn’t apply. In its documents, Merck pointed out that the relators reported their concerns to the FDA, and the suit stems from their unhappiness with the FDA’s response.

As a legal authority Merck relied on a 2001 Supreme Court decision, Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). There, the Supreme Court ruled that plaintiffs cannot sue in state courts in torts claiming fraud against the FDA, because the federal Food, Drug and Cosmetics Act and FDA’s regulatory scheme preempt – take precedence – over a state law that will inevitably conflict with it.

The judge rejected that claim, highlighting the difference between state law and federal law in this context. The purpose of the False Claim Act, a federal statute, was to allow relators to bring such claims in the name of the government. Interpreting the Food, Drug, and Cosmetics Act as preempting such claims would undermine the goal of the False Claims Act. The government, in a Statement of Interest, agreed.

Nor did the case prevent the suit by the other plaintiffs – the ones initiating a class action – for a number of reasons. The most important one was probably that Wyeth v. Levine, 555 U.S. 555, 563 (2009) suggests that Buckman does not apply beyond the context of medical devices – and a vaccine is not a medical device – and that it does not apply when a ruling would not affect the way the FDA regulates Merck, which the court said was the case here.

The relators made two claims: that Merck knowingly submitted false claims to the government and that Merck knowingly used or made a false statement material to a fraudulent claim (although these sound similar, they are from two different clauses of the statute, and have different elements). To withstand a motion to dismiss the relators had to show that if everything they claimed was true, and giving them every benefit of the doubt, they had a chance to prove their claim.

Examining the relators’ claim the court found that the relators have provided enough facts to allow them to try and prove that Merck submitted claims to the government that were false, and that Merck knew were false. Among the evidence the court emphasized was evidence of Merck’s legal duties to provide information and the relators’ own testimony that they saw supervisors tell staff people to hide information about the lower efficacy of the vaccine from the government. Again: for the purpose of a motion to dismiss, the court has to assume the relators are telling the truth. During fact-finding things can turn out either way.

The court also found that there was enough support for the relators’ claim that Merck knowingly “made or used a false record or statement material to a false or fraudulent claim.” The false record or statement was found in package inserts, representing effectiveness as 95% during the 2006 mumps outbreak, in labeling materials, and to the Immunization Action Coalition, even though, say the realtors, Merck knew effectiveness was lower.

What does this ruling actually mean?

It’s important to remember fact-finding hasn’t actually happened here. We don’t know if a jury or judge will find that the plaintiffs are telling the truth or acting out of some grudge. We don’t have Merck’s response on the facts yet – Merck’s documents mostly, though not only, addressed the reasons the claim should not move forward, what the relators failed to prove. We have a decision allowing the suit to proceed to fact-finding.

So the first thing this means is that the relators and the other plaintiffs get their day in court, a chance to prove all the claims sustained – basically all of them besides the claims in Chatom v. Merck under the laws of states the current plaintiffs don’t belong to (and other plaintiffs can be added).

It also does not mean the vaccine is worthless, as some anti-vaccine sites claim. If the vaccine effectiveness is, say, 70% rather than 95%, that’s still a lot higher than zero.

Does this mean that Merck falsified data? Well, with what we have, we don’t know. Maybe, though there are reasons to doubt it. And there are even stronger reasons to doubt the claim that this falsification if it happened, made the vaccine less effective than initial claims.

Supporting the claim that data was falsified:

• Two former employees of Merck say data was falsified. They say they told their supervisors, who then conspired to hide that fact. They describe a set of facts in elaborate detail in their complaint. We don’t know what will come up during fact-finding and what the result will be.

• While not mentioned in the decision or the complaint, the employees may have documentary evidence supporting their claim.

• The major professional textbook on vaccines (Vaccines: Expert Consult – Online and Print, 6e (Vaccines (Plotkin/ Orenstein)) see page 435) mentions that “The effectiveness of mumps vaccines determined in field studies (Table 22-9) is lower than efficacy determined in clinical trials. The effectiveness of a single dose of the Jeryl Lynn strain of mumps vaccine (given as a monovalent vaccine or as trivalent MMR) under conditions of routine use is approximately 78% (95% CI, 75%-82%), compared with 95% or more demonstrated in efficacy trials.”

• There have been several outbreaks of mumps in highly vaccinated communities.

Evidence that refutes the claim that data was falsified:

The heart of this is that there is no evidence that vaccine effectiveness is, in fact, lower than described. In fact, there’s evidence against that.

• The number of mumps cases is still very low. Before the vaccine, the United States had over 150,000 cases a year. The outbreaks reported now are in the single thousands – the 2006 outbreak had 6500 cases total, and 2009-2010 about 3500. With respect to the 2014 mumps outbreak, the CDC stated that “from January 1 to August 15, 2014, 965 people in the United States have been reported to have mumps.”

• There is more than a little evidence suggesting that the problem – if any – with the mumps vaccine is waning immunity, rather than ineffectiveness when given. This evidence includes most of the outbreaks in question occurred on college campuses, i.e. long after immunization and not among school children, which supports waning immunity, rather than initial low effectiveness, as the problem.

• Other evidence supports the claim of waning immunity as the likely culprit rather than a lack of effectiveness.

• Also, the major textbook, Vaccines, states that “such estimates may also be indicative of waning of immunity, which is not a factor in controlled clinical trials with a relatively short follow-up period.” (See Page 435.)

Update 1 (14 June 2015)

This story refuses to die, according to an article in Fierce Vaccines, a pharmaceutical industry news service. The attorney representing the two Merck whistleblowers has written a public letter about Merck’s response. He claims that Merck is being “consistently evasive” in providing answers to his questions.

He also accuses Merck of “hiding behind a facade of confusion and obfuscation as to what efficacy means.” The attorneys claim that “efficacy is a common term used throughout the industry to identify how well a vaccine works. It is also a term Merck has, until now, freely used throughout these proceedings to describe how well its vaccine works.” Well, actually vaccine manufacturers use “effectiveness,” a slightly different term which implies what percentage of the population would be immune to the vaccine-preventable diseases. Efficacy is generally used for prescription drugs.

According to a Merck spokesman:

Merck’s mumps vaccine led to a 98 percent reduction in the incidence of mumps in the United States, according to the US CDC. Our vaccine is the only vaccine for mumps ever used in the United States. The labeling for M-M-R®II accurately reflects the safety and efficacy of the vaccine as approved by the U.S. FDA.

This is probably just a typical public relations battle between an attorney who needs to win and a corporation that is supported by multiple large publications in peer-reviewed journals. The story will be updated as necessary.

Update 2 (31 January 2016)

The court ordered that discovery, the process of gathering evidence, must be completed by 1 March 2017, over a year from now. The court also ordered that expert discovery needs to be completed by 31 October 2017.

Even further into the future, other motions must be filed by 20 December 2017. A motion for class action certification must be filed by 1 March 2018, two years from now. And finally, the defendant, Merck, must file it’s opposition to class certification by 5 April 2018.

And this is just to file motions, it’s not even the start of a trial. If these accusations have any merit whatsoever, we are many years from ever getting any type of decision. Any claims that these accusations are true are wrong.

Update 3 (25 March 2018)

The last movement in the case was on December 22, 2017. The magistrate issued an order, based on the parties’ joint stipulation – joint request – stating that: “…ALL EXPERT DISCOVERY SHALL BE COMPLETED BY 9/7/2018. ALL DISPOSITIVE MOTIONS SHALL BE FILED AND SERVED ON 10/29/2018. PLAINTIFFS SHALL FILE AND SERVE THEIR MOTION FOR CLASS CERTIFICATION BY 2/15/2019…” We are therefore still waiting for the completion of expert discovery.

Update 4 (2 April 2019)

Typical of these types of cases not much has happened in the past 12 months, except for numerous filings. Here’s what has happened over the past year or so:

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Here are quotes from a Reuters article summarizing the outcome of the case:

Oct 7 (Reuters) - Merck (MRK.N), is immune from an antitrust lawsuit accusing it of misleading regulators about the effectiveness of its mumps vaccine in order to ward off competition, a federal appeals court ruled on Monday.

A 2-1 panel of the 3rd U.S. Circuit Court of Appeals found that, opens new tab Merck is protected by a legal doctrine known as Noerr-Pennington immunity, which states that parties cannot face antitrust claims for petitioning the government even if they are advocating for government action that would reduce competition.

Merck and a lawyer for the plaintiffs — a group of doctors and medical practices claiming they overpaid for the vaccine — did not immediately respond to requests for comment.

New Jersey-based Merck made the only mumps vaccine in the U.S. from 1967 until 2022. It is sold as part of a combined vaccine against mumps, measles and rubella, known as MMR-II, and another product called ProQuad that additionally protects against varicella, also known as chickenpox.

In the late 1990s, the U.S. Food and Drug Administration raised concerns that the mumps vaccine lost potency toward the end of its 24-month shelf life, according to the lawsuit, which was filed in 2012 in Philadelphia federal court.

Merck responded by boosting the initial potency of the vaccine in the hope of addressing the problem and submitted a supplemental application to the FDA to continue selling the vaccine without revising its efficacy claims.

However, the plaintiffs said, Merck relied on a flawed clinical trial to show that the measure worked and concealed the problems with the trial from the FDA, leading the agency to approve the supplemental application.

As a result of that deception, competitor GSK (GSK.L), which is not part of the lawsuit, decided not to pursue its own mumps vaccine because it believed it would not be able to show that it was as effective as Merck's, the plaintiffs allege. GSK only went ahead with its vaccine after learning about the problems with Merck's trial.

The plaintiffs said that Merck deliberately misled the FDA in order to prevent competition from GSK, violating the federal Sherman Act and state consumer protection laws.

U.S. District Judge Chad Kenney in Philadelphia last year granted Merck summary judgment on the state law claims but let the Sherman Act claim go forward, and Merck appealed.

But the majority of the 3rd Circuit panel, reversing Kenney's ruling, found in Monday's non-precedential opinion that Noerr-Pennington immunity held even if Merck's actions were "unethical."

"The record contains troubling evidence that Merck sought to extend its apparent monopoly by misrepresenting facts about its mumps vaccines on the FDA-approved drug labeling," Circuit Judge Tamika Montgomery-Reeves wrote for the panel. "But those allegedly false claims were the result of Merck's genuine and successful petitioning of the FDA."

That meant that the Noerr-Pennington doctrine, established by the U.S. Supreme Court in a pair of decisions in the 1960s, clearly applied, she wrote.

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Do your own diligence, and think for yourself. Please also consider downloading and reading my expert witness report regarding this case. You can download the full PDF version here.

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