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 which 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 issue 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 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 MMRII. 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.
- 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 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 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.
The anti-trust claim & others
The claims brought by the private practice and two physicians – Chatom v. Merck – were different, though to make their case these plaintiffs were relying on the ability of the relators to prove their allegation of falsifying data – in other words, the other lawsuit really needed the Merck whistleblowers to be successful. These plaintiffs were bringing a class action based in part on the Sherman Act and in part of the violation of multiple state laws prohibiting fraud.
The Sherman Act forbids anti-competitive behavior that can lead to monopoly power. The plaintiffs argued that Merck’s misrepresentation – claiming their vaccine was 95% effective when it was actually much less – guaranteed it a monopoly on the market by deterring other competitors with lower effectiveness from trying to compete for a government contract, assuming the fight was lost from the start. The judge acknowledged that this was a “slightly novel” way of using the Sherman Act, but decided the act was broad enough to at least allow the plaintiffs to try.
The court also found that while the plaintiffs had standing to bring claims under state law in their home states, since they may have suffered an injury there related to Merck’s conduct (again, assuming the relators could prove their case) they did not have standing to sue in other states where they do not practice –they were not injured there.
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 effective 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 the 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 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.)
Waning immunity is an issue. We don’t want a vaccine that leaves people exposed to mumps in adulthood, when complications may be higher. But if that’s the problem,
- It’s solvable even without tossing out the vaccine – you can add a booster dose.
- More importantly for our purposes: it does not support the claim that data was falsified. And the evidence for the waning immunity claim is pretty strong.
Note that there can still have been misdeeds around testing – including faking result – even if the issue is waning immunity. Fact-finding can, hopefully, shed further light on this question. And if there are, it’s appropriate to put them in the open and penalize Merck accordingly. Faking test results is – obviously – unacceptable, and if proven, merits a strong sanction.
We will have to see – if the case goes to fact-finding, rather than a settlement between parties – what facts are found. By deciding the way he did, appropriately, on a legal standard that requires not denying someone their day in court unless they have nothing to show, the judge gave the relators a chance to prove their case. Let’s see what they make of it.
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 who 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.
Editor’s note – This article was originally published in September 2014. As you can tell, legal cases of this sort rarely move with any speed, so we thought it was appropriate to put in any up-to-date information in the article. In addition, we fixed broken links, copyedited the article, and reformatted everything.