Last updated on May 15th, 2025 at 01:20 pm

This article, about the recent Circuit Court of Appeals upholding of the dismissal of the lawsuit against Merck and the mumps component of its MMR vaccine, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Law San Francisco, who is a frequent contributor to this and many other websites, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

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

On 6 August 2024, the Third Circuit Court of Appeals upheld the district court’s summary judgment for Merck in a lawsuit brought by two former employees of Merck, Stephen A. Krahling and Joan A. Wlochowski, against Merck. The lawsuit against Merck alleged fraud against the United States about the effectiveness of the mumps component of its MMR II vaccine. The Third Circuit agreed with the district court that Krahling and Wlochowski did not prove that, if there was any fraud, which the court did not decide, it was material to the United States’ decision to buy MMR. 

This decision is more important than it seems because this lawsuit, now dismissed, was used as a basis for a recent anti-vaccine movie by Andrew Wakefield, Protocol 7. The movie did not tell viewers that the claimant lost the case on which they built the movie. I will say something about the movie at the end of this article.

However, because the Third Circuit largely agreed with the district court, I can keep this post short. For a discussion of the district court’s decision, see my previous post here. All unsourced quotes are from the Third Circuit decision, attached here.

The Merck MMR vaccine lawsuit in short

The debate in the case is around the shelf life of MMR-II, and what the label should reflect (yes, really. It’s not even about the effectiveness of MMR-II at the point of sale). FDA wanted the label to reflect “potency – i.e.,  the amount of live virus in the vaccine at the end of the labeled shelf life.” The debate is fairly technical, but the key points to keep in mind are: 

• In 1999, Merck increased the amount of virus in the vaccine to ensure that it met the FDA’s required potency. 
• Lots manufactured before the change did not meet the required potency, and the FDA knew that and issued several warning letters to Merck. The FDA did not demand that Merck withdraw the lots, and Merck’s internal documents showed it was not sure the lots would keep potency for more than 12 months, but still labeled the vaccine as having a 24-month shelf-life, and did not report this to the FDA. 
• Merck discussed a clinical trial – “protocol 007” – to justify showing a lower expected end potency on the label. The discussion between the FDA and Merck was about the trial and what it should include. FDA required that Merck show that the “seroconversion rate in the experimental groups (those receiving the lower potency doses) was (1) at least 90%…” in both PRN and ELISA testing. Merck did not do well on the PRN test for the wild virus (though it did well for the vaccine virus), and the claims in the lawsuit were that Merck was tempted to cheat on that. 
• In 2001, one of the people who brought the suit informed the FDA that data was being destroyed and “the lab was ‘instituting a policy to fraudulently lower the pre-positive rate’ in the PRN”, i.e., lowering when the samples can be claimed to seroconvert. FDA inspected the tests and issued a warning letter calling out serious issues, and Merck responded by saying that it retrained staff and reanalyzed the data. FDA rejected the reanalysis but accepted the original, unchanged results, before the alleged manipulation. In 2004, the FDA rejected Merck’s request to change the label, finding that the data was unacceptable. 
• Based on later scientific development, the FDA allowed Merck to use ELISA only, and in 2007, allowed a label change. 
• Despite the change, Merck did not reduce the virus potency that it started using in 1999.
• CDC consistently recommends MMR-II to children and buys it through the Vaccines for Children program. 

What this suggests to me is that Merck likely tried to misrepresent the data but was caught early on, the FDA knew of the issues and demanded a correction. This is the opposite of Merck getting away with fraud: the regulator was on top of things. Also, since Merck never reduced the potency, it moved to – and only the pre-change lots had lower potency – if the attempt had any practical effect, it was very limited.

Further, as the decision points out, the CDC, which recommended and bought the vaccine, did not depend on Merck for data on the effectiveness of the mumps component of the MMR vaccine; it had independent data and knew quite a bit about that effectiveness.

The lawsuit was a False Claims Act lawsuit, which, as I explained previously, allows private people to sue in the name of the United States government if there was fraud against the government. If they win, they get a portion of the damages. The government can intervene in the case or not.

To win, relators – as individuals suing in the name of the government are called – need to show that there was fraud against the government and that the fraud was “material,” that is, it would influence the decision to pay the money allegedly gotten through fraud. 

The district court found that even assuming that there were false claims – and the court did not decide that either way – no jury could conclude that such claims were “material” to the CDC’s decision to buy the vaccine. There are three things a court examines in assessing whether something was “material” for this purpose, drawing on Supreme Court precedent:

(1) whether the representation went to a condition of payment (i.e., an express condition or an implied condition for which the Government would have the option to decline payment, though neither is dispositive);

(2) whether the representation was “minor or insubstantial”; and

(3) if the Government knew the facts surrounding the representation, the Government’s reaction to it (i.e., whether it continued to pay the claim in full).

The court concluded, as the district court did, that “no reasonable jury could conclude that the representations were material to the CDC’s purchasing decision”. 

However, the alleged misrepresentations (the court did not rule if they happened) did not violate a condition of payment: the vaccine was licensed, recommended by ACIP, and had a shelf life of at least 12 months, as the contract required. There is no evidence that the vaccine did not fit its purpose, and it’s not clear any regulatory violations affected the purchasing decision: the CDC knew the vaccine’s effectiveness in the real world was less than the clinical trial, and still recommended it. Conditions of payment were met.

In addition,

Merck’s misrepresentations as to potency and its Protocol 007 testing were “minor or insubstantial” with respect to the CDC’s purchasing decisions, and hence not material to such decisions. It is undisputed that

(1) the ACIP conducted its own effectiveness studies and recommended purchasing the vaccine based on them;

(2) the ACIP made this recommendation knowing that effectiveness rates in its own studies (which measured real world effectiveness) were lower than the efficacy reported in the clinical trials; and

(3) the CDC’s purchases are based on ACIP’s recommendations.

In other words, since the CDC recommended buying MMR based on its different data of effectiveness, Merck’s alleged (again, they are not clearly proven) attempts to trick the FDA on it, which did not seem to succeed, were not important to the decision to buy the vaccine.

And finally, the government knew the facts from the beginning – both the FDA and the CDC knew this. And FDA considered the violations “insubstantial.”

So the relators lost. 

Wakefield’s movie

I have not seen Wakefield’s new movie, Protocol 7. It has not come to a theater near me, and it did not get enough traction to make paying $9.99 for streaming it worthwhile. I did see the trailer and read the reviews. Based on that, I would say:

1. The trailer suggests a successful fraud undisclosed until a lawsuit. However, the relators complained to the FDA early, and the FDA knew of the events early and took action. So this is not a case where Merck got away with something until a brave whistleblower sued.
2. The only question affected by the allegations in the lawsuit was whether the mumps component of the MMR vaccine would stay potent enough for 24 months with a lower viral load. Which, by the way, was never put in the vaccine after 1999, though it was in lots before that. That’s not even a big effectiveness question.
3. The CDC would not depend on these trials for effectiveness anyway. Every vaccine undergoes effectiveness testing in the real world because what happens in the trials may not reflect the real world, even without fraud. Trials use specific populations and controlled environments, and things change. 
4. The trailer seems to suggest a safety problem with the MMR vaccine, but this lawsuit did not touch on the safety of MMR at all. Again, the question was a pretty technical one about potency. 

In other words, if the movie was structured around the events related to Protocol 007 and this lawsuit, it very much misrepresented them, even before the actual court decisions. Not unusual for Andrew Wakefield, who has a history of misrepresentations, but something people should consider in this context.

Conclusion about the Merck MMR vaccine lawsuit

As described by both the district court and the court of appeals, this was a highly technical debate about proving the effectiveness of the mumps component of MMR. Merck may well have tried to misrepresent the data, but that was caught early.

Any possible fraud had very limited success, and if anything, these events show the regulatory system working to catch issues. It’s also unclear whether any attempt at misrepresentation had any effects on the ground since Merck never reduced the potency from the 1999 level, and protocol 007 was to try out whether it could reduce that potency. Merck eventually got its change of label, but the vaccine contents did not change.

That is not, however, why the courts rejected the claims. To prove a claim under the False Claims Act, the relators had to show fraud related to a payment decision. The courts pointed out that even if there was fraud – and the courts did not rule on that – it clearly had no relevance to the government’s continued decision to purchase MMR, since the government had its own data on effectiveness in the real world, different from Merck’s initial submission, and continued buying the vaccine based on it.

So, where are the fraudulent payments? They just did not happen. 

The lawsuit was clearly lost, and as explained, based on the trailer alone, Andrew Wakefield’s movie on the topic is full of misrepresentations.