merck whistleblowers

Merck whistleblowers – mumps and motions – updated

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 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 suit 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 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.

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 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 were 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 for 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 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 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 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 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 initially 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. 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.)

merck whistleblowers

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,

  1. It’s solvable even without tossing out the vaccine – you can add a booster dose.
  2. 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)

 

Editor’s note: This article was originally published in September 2014. This editor will update some new information recently published.

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.

Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), 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 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.
  • Pingback: The Pharmaceutical Industry's Most Infamous Repeat Offenders()

  • Pingback: Maine Coalition for Vaccine Choice legislation – bad law()

  • Anna

    Lots of ‘if’ ‘we’ll see’ ‘probably’ ‘we don’t know’ in this entry. Is this site Skeptical Raptor or Speculative Raptor?

  • Julia McCullough Perreman

    We don’t know if simply ‘adding a booster’ will protect the adult population. That has never been tested. There is sone mevidence, however, that if the first MMR vaccine did not successfuly produce enough antibody, a second injection may also fail. The ‘booster’ theory, is just that-a theory. Never tested.

  • TsuDhoNimh

    “Using animal antibodies to help manage the testing rate.”

    There are times when that is a legitimate way to test immunity. Antibodies might not be spotted by the test method in use, although they would be sufficient to provide immunity. Or you want to add enough complement (from animals) to make sure there’s enough for all the antibodies present.

    It’s possible that the “whistleblowers” were unskilled enough to not recognize a complement fixation test, although it’s one of the basic things you learn in immunology 101.

    https://en.wikipedia.org/wiki/Complement_fixation_test

    • wzrd1

      Testing with the vaccine strain and measuring antibody titers works and it beats the dickens out of testing with a biosafety level 2 virus.

      Still, the first thing done in any litigation is request dismissal, be the matter civil or criminal. It’s as much a custom as a legal maneuver. Finding of facts comes next, various motions will be filed and considered, including discovery motions for evidence from each side.
      After much maneuvering, a trial date is set, jurors are selected and trial begins.

      Prediction, between one and three anti-vaccination types will attempt contact with the jury, potentially disqualifying one or more jurors.

      • It’s been nearly six years. Yes, torts can take forever, but still, you begin to wonder if the plaintiffs have anything.

        • wzrd1

          Considering I have a *very* high sense of duty, I’ve served on “nothing” cases as a juror.
          Once, nothing was awarded.
          Once, some service employees wanted to award against any facts exposed in the trial, adding their own prejudices.
          I offered an *extremely* “blue story”, one unfit for mixed company, where the other jurors were those normally excluded from such topics.
          They were swayed to a compromise.
          The cigarette smoking decedent was awarded a laughable some, the widow awarded a miniscule sum.
          It kept her fed and shut up the chemtrail idiots.
          Lest I be forced to consider *America* *always* knew that asbestos caused cancer, even two hundred years ago.

  • Abraham Lincoln Brigade

    Regarding the contention of “DuaneHayes” that “No children were hurt,…” during AJW’s experi mentation on autistic children, does he regard coercion of a minor to undergo non-clinically indicated colonoscopy and spinal tap as not hurting? And SMith beat his rap on procedural technicalities and had retired already so the proceedings were dropped unlike the proceeding against AJWakefield who was disgraced, stripped of his physician credential and ultimately high tailed out of the country.He now espouses his fraudulent venom on Youtube and to credulous chiropracty students and antivaxxers at $60/plate. Shameful that the California Attorney does not PROSECUTE WAKEFIELD for fraud, quackery and reckless endangerment of children.

  • Pingback: Merck MMR Vaccine Failed to Protect Thousands from Mumps()

  • DuaneHayes

    Yes 95% and 70% effectiveness is better than 0, thanks for that, however, after having measles you are protected for life, in other words, 100% effective. Deaths globally from measles is far less than 1/10th of 1%. With those two facts Id rather have people get the measles when they should, in childhood. Im sure you know that measles can actually be much more dangerous when you are infected later in life.
    As far as this one case brought about by Merck whistleblowers, despite your effort to collude the facts, is real. Not only that, there are many more. Remember the 1998 Lancet report? Well. the British courts threw out the case against one of its authors, Prof John Walker Smith. Justice John Millings ruled that the UK’s General Medical Council’s conclusions were based on “inadequate and superficial reasoning, and in a number of cases, a wrong conclusion.” No children were hurt, there were no actual complainants and the parents of the children in the test actually stood behind Wakefields findings. Damning for the pro vaccine movement indeed. GSK has been found guilty of all kinds of dishonest practices, including personal injury. Johnson & Johnson are no different, same with Pfizer and AstraZeneca and Novartis just to name a few. How are you going to defend this growing groundswell? The very companies you are trying to defend are distancing themselves from legal action by either outsourcing safety monitoring or by changing the law to make it impossible to sue pharmaceutical companies. The media and in turn, doctors that get paid honorariums, free lunches and other sordid gifts are telling the world that the anti vaccinators are to blame when it is actually the nefarious actions of big pharma that has gained the distrust of parents. Doctors used to defend tobacco too, this will prove to have the same outcome.

  • Pingback: Index of articles by guest author, Professor Dorit Rubinstein Reiss()

  • Pingback: Sidney Crosby, the NHL, and mumps–separating myth from science()

  • Pingback: All the fail you can fit into an infographic | The Poxes Blog()

  • Pingback: Mumps vaccine effectiveness and waning immunity()

  • Pingback: Whistleblowers disclosing safety AND efficacy problems in MMR - Mothering Forums()

  • Hey, Raptor, is there any merit to the claim that MMR has to be 95% effective to be approved?

    Great post as usual, Dr. Reiss!

    • Dorit Reiss

      The FDA did approve vaccines that were much less effective than 95%, so on its face, no. But if a vaccine was approved at 95%, later waning might be an issue.

      That statement here reflects the claims of the relators – but I think they’re wrong on this.

      And thank you very much.

      • You’re welcome.

      • multilis

        The claim is that 95% ensured monopoly rather than approval, if the rate was stated as “80%” then others would have market share.

      • wzrd1

        Considering the influenza vaccine typically is anywhere in the 60 – 65% efficacy range, obviously any number higher than zero is of worth and anything even 50% effective in a highly contagious disease is something that can break the back of an outbreak – preventing it from becoming an epidemic.

        Or as my mother frequently told me, better to have a half a loaf of bread than no bread at all.

  • Sullivan ThePoop

    I have one question about this. It was my understanding that it wasn’t that the vaccine had to have the 95% efficacy to be approved, but that another manufacturer had produced an MMR with a 90%-93% efficacy rate for the mumps portion and Merck didn’t want to lose their long standing US MMR contract to the other company. I am not sure where I read this at, but it would make the claim more plausible.

    • Dorit Reiss

      That would be my expectation, that either the high effectiveness rate was an anti-competitive step or that for a different vaccine it had to be at least as effective; but reading the complaint and the decision that’s not stated. It’s a little unclear – and Merck says it’s incorrect – to say that you have to meet a 95% effectiveness rate.

    • GSK and Sanofi make competitive vaccines to MMR.

      The FDA does not examine market competitive issues when examining a new product. And they don’t work with absolute numbers, so a “95% effectiveness” is probably statistically insignificant compared to a “93% effectiveness.” If the latter version worked and was equally safe, it would approve it. Now if the difference was 80% to 95%, maybe they wouldn’t.

      I think there’s more going on here. Merck has a virtual monopolistic hold on the parts of the vaccine market. But so does GSK and Sanofi. Irrespective of FDA issues, for the market to move to a new vaccine is borderline impossible, though not improbable.

    • wzrd1

      Put yourself in Merck’s “shoes”. You have a contract that is significant, if not highly profitable, it’s all about the scale.
      Your updated product isn’t as effective, endangering that contract.
      What do you do?
      Research the problem and find out why what was 95% is now less, which shouldn’t take all that long?
      Fake the results and risk losing government contracts, potentially forever?

      I work in a Fortune 200 company. Risk analysis is done all day, every day. The risk of losing the contract and potential punitive measures is far too high a risk. Finding out what went off of the wire is far less risky and the reward of having that product making it to market a bit delayed is far higher.
      I could give you a detailed calculation, but I’d have to actually see Merck’s books. Then, the NDA would prohibit me showing those calculations.

      Business decisions, be the business a vaccine company, networking service company, supermarket, butcher, baker, candlestick maker all end up calculated decisions. A business case has to be made that minimizes any risk or loss and maximizes prestige of brand and profit of product. Suggesting something like falsifying data, which would end up revealed when vaccinated children contract diseases that they’ve been vaccinated against would be an unacceptable risk. Epidemiologists would be looking at things in common and the vaccine most certainly is one thing in common, when lot numbers were distant in time from one another, a cause for why the multiple lots being ineffective would be sought.
      That gives an annualized loss expectancy of at best two years before 100% loss of product and possibly all vaccine products would occur, fines administered at record levels and trust destroyed internationally. The risk exposure would be at least 40%, likely higher.
      So, basically, the question is; spend millions or lose billions?