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Home » District Court dismisses 2010 Merck mumps vaccine lawsuit

District Court dismisses 2010 Merck mumps vaccine lawsuit


This article about the 2010 Merck mumps vaccine lawsuit 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 vaccination’s social and legal policies. 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On 27 July 2023, Judge Chad F. Kenney of the Federal District Court of the Eastern District of Pennsylvania (Philadelphia) dismissed a False Claims Act lawsuit brought by two former employees – Stephen A. Krahling and Joan W. Wlochowski – against Merck, alleging fraud related to the Merck mumps vaccine.

The lawsuit was dismissed without ruling on whether there was, in fact, any fraud, since the court found that even if there were any misrepresentations, they were not “material” – important – to the government’s decision to contract with Merck for its mumps vaccine. The government had its data about effectiveness and contracted on that basis.

We have written about this lawsuit (brought in 2010) before. I wrote about it first in 2014, when Merck’s motion to dismiss was rejected, though the article has since been updated. Our host and my good friend The Skeptical Raptor also wrote about the case, from a scientific perspective, in 2014.

The case was in the court for thirteen years, and went through lengthy discovery, though at the request of both parties, most of the evidence was kept under seal. Then, on July 27 the case was decided (in favor of Merck), and on August 3 it was finally dismissed. 

This article summarizes and explains the decision.

a sick man wiping his nose with tissue
Photo by cottonbro studio on Pexels.com

The False Claims Act Lawsuit

The False Claims Act allows liability against people who defraud the United States government. Most of the claims are against people who contract with the federal government, and the claim against Merck, as explained in the lawsuit, drew on its contracts with the CDC to supply MMR and MMRV vaccines through the Vaccines for Children program

The False Claims Act allows the government to sue for fraud, but it also allows individuals to bring such fraud lawsuits. These individuals are referred to as “relators” – that is the term the act uses – and the act allows such relators to receive a percentage of the damages awarded, which, given the size of many federal contracts, can be a lot of money. The government can choose to intervene in the case; the government has not intervened in this one. 

As the court decision here explains (p. 21), “To establish an FCA violation, four elements must be proven: “falsity, causation, knowledge, and materiality.””

The first half of the decision is devoted to a summary of the facts behind the fraud claims, and I will provide a very brief summary of them. They may deserve more attention since that’s where the anti-vaccine groups focused. But on p. 24, the court says:

But even assuming arguendo that Relators satisfy one of these categories of false claims, Merck is still entitled to summary judgment because, as explained below, Relators cannot show that any of these so-called false claims were material to the CDC’s purchasing decisions. 

In lay terms, the court is saying “We are not going to say whether the relators are right or wrong about fraud, because even if there were any misrepresentations, they did not matter to CDC’s contracts: CDC had the actual facts, and contracted with Merck anyway. So no defrauding of the United States government happened.” 

Given this, there is not a lot of point in going into the facts in too much detail, though a summary is important to show, among other things, that the claims were known to the government and thoroughly investigated.

The Alleged Merck Measles Vaccine Fraud

Under the National Childhood Vaccine Injury Act of 1986, the FDA reviews vaccine labels repeatedly. In “the mid-1990s”, according to the lawsuit, the FDA reviewed the label of the MMR-II vaccine (licensed in 1978), which contains the mumps vaccine.

This lawsuit focused on the data created about the minimum potency stated on the label of the Merck MMR-II (mumps, measles, and rubella) vaccine. The debate was around how to define potency. Merck stated that it thought the potency stated on the label until then referred to “the minimum ‘release potency’ — i.e., the amount of live virus in the vaccine when the vaccine is approved for release to the market by” the FDA’s Center for Biologics Evaluation and Research.”

But in 1996-1997 the “FDA stated that going forward it wanted the labeled potency to reflect the end-expiry potency — i.e., the amount of live virus in the vaccines at the end of its shelf life, which for MMR-II has always been 24 months.” The change required released vaccines to have higher minimum potency, to make sure they meet the minimum at the end of the vaccine’s life. Merck agreed to increase the potency from September 1999, and the FDA approved the agreement in February 2020.

Then, between August and October 2000, the FDA inspected Merck’s offices, found problems with the potency for lots released before the agreement discussed above, and issued two warning letters, since the problems were not fixed immediately. The FDA ended up not demanding that any lots be withdrawn. 

In the meantime, the FDA and Merck agreed on clinical trials to see if lower potency mumps vaccines work just as well in preventing mumps. This was protocol 007, about which the Relators – Krahling and Wlochowski – claimed fraud, and is also the focus of a new film by disgraced British doctor Andrew Wakefield.

The decision explained:

Protocol 007 was designed to study “the effect of vaccination on children who had not yet received the vaccine and who would be randomized to receive vaccine lots at different potencies.” …. Two types of tests, or assays, were used in Protocol 007: (1) a plaque reductions neutralization assay (“PRN”) and (2) an enzyme linked immunosorbent assay (“ELISA”).

The relators were part of a lab doing some of the tests here. They called the FDA alleging fraud. FDA did an on-site inspection, and found some truth to the allegation, concluding that there were four areas of problems: 

(1) raw data was being changed with no justifications; (2) there was no procedure to assess whether a research lab is suitable for clinical testing prior to the start of testing; (3) spreadsheets used to determine questionable results and retesting had not be [sic] validated; and (4) notebooks did not identify each technician performing each task.

FDA did two more on-site inspections, and Merck agreed to take steps, including retraining the staff. Merck also alleged that tests found no difference “between the corrected and uncorrected data sets concerning seroconversion.” FDA rejected the corrected data, “electing instead to accept Merck’s proposal to use the originally recorded results from the PRN to support its potential label change.” 

There was substantial additional back-and-forth between the FDA and Merck, with the FDA rejecting an initial change request. Eventually, the FDA accepted Merck’s request and allowed Merck’s label to reflect a lower potency, but in practice, Merck did not reduce the potency it agreed to in 1999. 

The Relators’ claim is built on their initial complaints of wrongdoing, alleging that Merck misrepresented the data. As this description should suggest, the FDA thoroughly investigated these claims, and found some truth in them; because the judge found that any misrepresentation is not material, the judge did not analyze the evidence to say whether there are, in fact, ongoing misrepresentations, or whether the corrective actions mentioned by Merck fixed the problems. 

The government consistently purchased vaccines containing Merck’s mumps vaccine for its vaccines for children’s program. With the introduction of the mumps vaccines, mumps cases dropped dramatically. But since 2006, mumps outbreaks have returned – not as large as pre-vaccine, but evidence, and mostly in vaccinated individuals.

The outbreaks have been more convincingly attributed to waning immunity than any lack of potency in the vaccine when it comes out. Because of that, in response to them, the Advisory Committee on Immunization Practices (ACIP) has added recommendations for a third vaccine dose in some circumstances, as summarized in the decision. Doing its own studies, the CDC found consistently “that the “median effectiveness of [two] doses of MMR vaccine in preventing mumps is 88%, with estimates ranging from 31% to 95%.”

So there were problems with Merck’s manufacturing. FDA investigated the problems and actions were taken. While we do not know with certainty whether the actions were good enough, this is not a system of oversight not working: this is a system actively monitoring the vaccines. 

And, as the court emphasized, Merck’s data was not the be-all-have-all of the evidence we have. 

Further, in 2022, the FDA licensed an MMR vaccine by GSK, and ACIP made a recommendation treating both vaccines as interchangeable – as equivalent. 

The Court found that any Fraud was not Material

To win under the False Claims Act, the government – or private relators – need to prove more than fraud, since the goal is to prevent defrauding of the government, not just prevent fraud in the abstract. They need to prove “falsity, causation, knowledge, and materiality.”

Materiality looks at whether the claim that is alleged to be fraudulent can influence the receipt of money. The decision reminds us that “[t]he Supreme Court has emphasized that ‘[t]he materiality standard is demanding’ and that strict enforcement is necessary to prevent the statute from becoming “a vehicle for punishing garden-variety breaches of contract or regulatory violations.”

The court here found that any fraud, even if there had been one, was not material to the government’s decision for three reasons.

First, although vaccine effectiveness is really important, the CDC:

…conducts its own effectiveness studies and has acknowledged that the effectiveness measured in field studies has been lower than the effectiveness reported in the clinical studies that supported licensure of Merck’s mumps vaccine. See supra Section I.C. Nonetheless, the CDC has continued to recommend that two doses of the mumps vaccine are 88% effective (range 31%–95%) against mumps. 

In other words, the CDC does not depend on Merck to know how effective the vaccine was, and any misrepresentation by Merck on this score would not be determinative in deciding if to buy the vaccine.

Second, as the court said, 

CDC, despite this suit having been litigated for over ten years at this point, has continually recommended Merck’s mumps vaccine and has continually asserted that two doses of the vaccine are 88% (range: 31%–95%) effective. See supra Section I.C. Furthermore, there is no evidence to show that either the one internal model of potency loss or the results of Protocol 007 went to the essence of the bargain. Accordingly, this factor gives further weight to the conclusion that no jury could rule in Relators’ favor on materiality.

In other words, The CDC knows of the lawsuit, but this knowledge has not changed its assessment of its own evidence. And one problematic protocol, says the court, would not be determinative. The court’s own decision mentions at least four sets of data the FDA drew on in deciding whether to change the labeling and points out that the first request to change the standard was rejected (so the FDA is clearly not rubberstamping anything), and further, that whatever the label says, Merck has not changed the potency used in practice. 

Third, the government’s choice to continue paying in the light of information also works against the issue being “material” – relevant to the choice of payment (and remember, this act is about liability for getting fraudulent payment from the government). Here, not only did the FDA’s warning letters reflect the allegation, but the CDC and FDA have “been involved in the years of discovery and has had access to the evidence.” The government as a whole investigated the allegations to decide if to intervene. The court concluded:

The reality is that the Government does know all of the facts, but these facts were simply not persuasive to the CDC, or any other agencies, to prompt them to take any action. The CDC has “regularly” paid for Merck’s mumps vaccines and “has signaled no change in position, [which is] strong evidence that the requirements are not material.

…The CDC, the FDA, and the DOJ have been given all the evidence. And with knowledge of this evidence, the CDC has continued to purchase Merck’s mumps vaccines and recommend the vaccines as effective, and the FDA has continued to license Merck’s mumps vaccines.

After the first stages, the government has not even asked Merck to take any corrective action about the MMR-II vaccine. Nor, once the GSK MMR vaccine was approved, has the government made a preferential recommendation for that.

All this suggests that the allegations are not “material” – maybe not even relevant – to the government’s decision to pay Merck for MMR-II, and hence, the claim that Merck defrauded the United States government of money here does not hold. For this reason, the court rejected the lawsuit. 

Andrew Wakefield’s Coming New Film on This

Apparently, Andrew Wakefield is making a “narrative” film – not a documentary – about this case, with a dramatized mother who thinks her son’s autism is due to MMR acting as the lawyer. On 22 December 2023, the anti-vaccine broadcast “The Highwire” posted an interview with Wakefield about the movie that included the trailer. 

The trailer strongly connects the movie to claims that MMR causes children to regress into autism (that is the way it is presented in the trailer), and suggests the case is ongoing. I watched the interview carefully to see whether – in late December 2023 – Wakefield would mention that the case had been dismissed. He did not. He did discuss the dangers of mumps at a later age (but did not mention that complications are rare in people who are vaccinated). 

There are, of course, several problems with this. First, large studies covering millions of children did not find a link between MMR and autism; this vaccine has been studied more than others.

Second, the Merck mumps vaccine lawsuit – as described above – has nothing to do with autism or safety. It’s about effectiveness. So the link between the alleged regression and the lawsuit is.. strange. 

Third, as explained above, the Merck mumps vaccine lawsuit was rejected because the CDC has its own evidence about MMR effectiveness. It does not depend on Merck.

Even if there was undiscovered fraud – and the facts above show that the FDA knew of the claims, investigated them, found issues, and efforts were made on both sides to correct, and certainly there were repeated investigations of Merck – the external effectiveness data would be there. And as the court said, one problematic protocol – even if it showed real misinformation – would not change the overall data’s picture. The decision did not rise or fall on one set of data here, as the court’s decision details. 

So the movie that Andrew Wakefield and Del Bigtree seem to think is a big deal should be a nothing-burger, though in the current atmosphere of misinformation, it may have more success than it should. 

What next? 

The Relators, Krahling and Wlochowski appealed to the Third Circuit, where the latest move on November 23, 2023, read:

“ORDER (Clerk) Action on the foregoing motion is deferred. Appellants have failed to demonstrate why 44 volumes of the appendix need to be sealed. Appellee, in its original motion and its response to Appellant’s motion to seal, sought only to seal 12 specific documents, which are located in 5 volumes of the appendix. Appellants are directed to file a supplement to the motion addressing why each of the remaining documents needs to be sealed. See In re Cendent Corp., 260 F.3d 183, 194 (3d Cir. 2001)(explaining the showing necessary to overcome the right of public access). It is not sufficient to merely state that the documents were designated as confidential in the district court. The supplement must be filed within 7 days of the date of this order. The Clerk’s Office will hold the unredacted version of Appellant’s brief and the joint appendix provisionally under seal pending Appellants’ compliance with this order. (EAF) [Entered: 11/20/2023 11:41 AM]”

I have not seen them file a supplement on the docket, so we may have to wait until they decide whether the appeal justifies making whatever is in the 44 volumes public, from their point of view. I do not know what’s in there, so can’t predict where they will go. I want to point out that it’s not Merck asking for extensive sealing here – it’s the plaintiffs.

I will continue to follow this case, and let you know. But at this point, the resolution suggests there’s nothing there to suggest unknown issues with the Merck mumps vaccine or a lack of oversight. 

Dorit Rubinstein Reiss

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