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Merck's Mumps Component of MMR Has Been in Lawsuit Since 2010: Krahling and Wlochowski v. Merck & Co.

Mumps can't playAs you read about students coming down with mumps, pleae remember that two whistle-blowers  who worked for Merck itself blew the whistle on their employer for the lies and dangerous sales tactics for a faulty vaccine.  Below is a full post from HuffPo from 2014 that discusses this case. Usually we excerpt, but HuffPo is likely to delete their post soon, as all vaccine related content is being purged.

United States ex rel Krahling and Wlochowski v. Merck & Co.

Keller Grover LLP represents Stephen Krahling and Joan Wlochowski in a False Claims Act case originally filed in 2010 and now pending in the United States District Court for the Eastern District of Pennsylvania, United States ex rel. Krahling and Wlochowski v. Merck & Co., Case No. 10-cv-4374.  Krahling and Wlochowski allege in their complaint that their former employer, Merck & Co., defrauded the government for more than a decade in an ongoing scheme to sell the government a mumps vaccine that is mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.  The federal government purchases more than half of all vaccines sold in the United States, including the mumps vaccine.  While the United States declined to intervene, it  filed a Statement of Interest in response to Merck’s motion to dismiss making clear the government has “a strong interest in the outcome, even though it has not intervened in the case.”  The government appeared at the hearing on Merck’s motion along with counsel for Krahling and Wlochowski and emphasized its position for the Court.  Merck’s motion to dismiss was subsequently denied.

09/25/2014 05:29 EDT | Updated 11/27/2014 05:59 EST

Merck Has Some Explaining To Do Over Its MMR Vaccine Claims

Merck now faces federal charges of fraud from the whistleblowers, a vaccine competitor and doctors in New Jersey and New York. Merck could also need to defend itself in Congress: The staff of representative Bill Posey (R-Fla) -- a longstanding critic of the CDC interested in an alleged link between vaccines and autism -- is now reviewing some 1,000 documents that the CDC whistleblower turned over to them.

Lawrence Solomon

Merck, the pharmaceutical giant, is facing a slew of controversies over its Measles-Mumps-Rubella (MMR) vaccine following numerous allegations of wrongdoing from different parties in the medical field, including two former Merck scientists-turned-whistleblowers. A third whistleblower, this one a scientist at the Centers for Disease Control, also promises to bring Merck grief following his confession of misconduct involving the same MMR vaccine.

The controversies will find Merck defending itself and its vaccine in at least two federal court cases after a U.S. District judge earlier this month threw out Merck's attempts at dismissal. Merck now faces federal charges of fraud from the whistleblowers, a vaccine competitor and doctors in New Jersey and New York. Merck could also need to defend itself in Congress: The staff of representative Bill Posey (R-Fla) -- a longstanding critic of the CDC interested in an alleged link between vaccines and autism -- is now reviewing some 1,000 documents that the CDC whistleblower turned over to them.

The first court case, United States v. Merck & Co., stems from claims by two former Merck scientists that Merck "fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act]."

According to the whistleblowers' court documents, Merck's misconduct was far-ranging: It "failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing."

These fraudulent activities, say the whistleblowers, were designed to produce test results that would meet the FDA's requirement that the mumps vaccine was 95 per cent effective. To the whistleblowers' delight, the judge dismissed Merck's objections to the case proceeding, finding the whistleblowers had plausible grounds on all of the claims lodged against Merck.

If the whistleblowers win, it would represent more than a moral victory (they repeatedly tried to stop Merck while still in its employ). Under the False Claims Act, the whistleblowers would receive a share -- likely 25 per cent to 30 per cent -- of the amount the government recovers. Previous settlements involving extensive fraud by pharmaceutical companies under the False Claims Act have run into the hundreds of millions of dollars, and in some cases such as against GlaxoSmithKline and Pfizer, into the billions.

The second court case, Chatom Primary Care v. Merck & Co. relies on the same whistleblower evidence. This class action suit claims damages because Merck had fraudulently monopolized the mumps market. Doctors and medical practices in the suit would be able to obtain compensation for having been sold an overpriced monopolized product, and a defective one to boot, in that the mumps vaccine wasn't effective (indeed, the suit alleged that Merck expected outbreaks to occur and, as predicted, they did -- mumps epidemics occurred in 2006 in a highly vaccinated population and again in 2009-2010).

"Plaintiffs have argued sufficient facts to sustain a claim for proximate causation, detailing the significant barriers that other companies would face to enter the mumps vaccine market," the court ruled.

The third whistleblower -- a senior CDC scientist named William Thompson -- only indirectly blew the whistle on Merck. He more blew it on himself and colleagues at the CDC who participated in a 2004 study involving the MMR vaccine. Here, the allegations involve a cover-up of data pointing to high rates of autism in African-American boys after they were vaccinated with MMR. In what could be high-profile House hearings before Congressman Posey's Science Committee -- hearings made all the more explosive given the introduction of race into the mix -- Merck could find itself under unprecedented scrutiny. The CDC still stands by its study although Frank DeStefano, the CDC's Director of Immunization Safety and a co-author in the CDC study, also stated that he plans to review his notes with an eye to reanalyzing the data.

Some say all publicity is good. In Merck's case, regardless of the ultimate merits, the publicity will be all bad.



Aimee Doyle

@David - thanks for the additional explanation.

I didn't realize that plaintiffs had to pay for tort representation in civil court. My understanding was that personal injury claims are generally taken on contingency, so plaintiffs would not need to pay. So causation is the thorny issue. That makes sense - personal injury firms don't typically take cases where causation is difficult (and incredibly expensive to prove, in any event).

Curious, though, why the earlier cases, those from 1980-86, didn't result in greater discovery implicating the vaccine industry. Well, I'm hopeful that this new case will result in great discovery.

I knew about the Bruesewtiz decision - and that design defects are not a cause of action.


ICAN sent a letter to ACIP dated July 31,2018 regarding the mumps case.
It read in part:
"Attached as Exhibit C is a copy of the Docket Report, dated July 13,2018, for the lawsuits which reflects that Merck &Co has filed every document related to the mumps efficacy under seal-see yellow highlighting.
It is respectfully suggested that ACIP request copies of these documents so that it can directly further access the actual efficacy rate of the mumps vaccine. Understanding same would appear critical to ACIPs mission."

David L

@Aimee, I believe the Jennifer Robi vs. Merck and Kaiser Permanente case regarding Gardasil will lead to some revelations since it allows for discovery with Merck and RFK Jr is involved. The law link I posted from Mary Holland says: Between 1980 and 1986, people who claimed vaccine injury brought over three billion dollars of damages claims to U.S. civil courts against vaccine manufacturers. Although some vaccine-injured plaintiffs’ claims were successful, most went uncompensated because of the difficulty of proving causation in the tort system. Many potential plaintiffs could not afford representation to bring their claims. The vaccine court was set up by the way so that if a claimant meets the Injury Table’s requirements for a specific injury, they would be entitled to compensation with no need to prove causation in civil court making it easier. However, 98% of cases are resolved off-Table since they havent updated the injury table much and deny major injuries have ties to vaccines, involving complex litigation over causation. And of course they completely deny any links to autism so most cases that get compensated only when they dont try to compensate for autism. This kind of litigation over causation is precisely what Congress intended to avoid by creating the NVICP.
The other part is that supreme court held in a split decision that you now cannot sue them in civil court for design defects. Here is one you can read on that: Mary Holland has joined the CHD Team to become its full-time General Counsel as well and CHD has mentioned recently they were looking at potential other ways that suing is still possible.

Aimee Doyle

@David L - thanks for explaining.

I can understand why a sizeable percentage of people would not reject vaccine court awards to file in civil court. Having a profoundly disabled child is financially ruinous.

But I'm still less clear on why people would reject filing in civil court if they were unsuccessful. Especially since the overwhelming majority of cases in vaccine court are unsuccessful. You say, "The claimant may reject the special master’s decision if dissatisfied with it and file a civil suit but only if the Vaccine Act’s other provisions do not preempt litigation."

I don't understand why there haven't been at least a few cases (over the 30+ years that that VICP has been in existence) where people want to pursue the matter and get the discovery that is denied in vaccine court. Perhaps that's in the provisions of the Act I'm not familiar with.

It seems like one key case, that successfully resulted in massive discovery, might tip the scales of justice?

David L

@Aimee, The Vaccine Act requires that claimants exhaust their administrative remedies first by bringing their claims to the NVICP ("Vaccine Court"). NVICP proceedings are exceptionally hostile and frequently take many years. Furthermore, the rigid three-year statute of limitations likely excludes many legitimate cases of vaccine injury. The claimant may reject the special master’s decision if dissatisfied with it and file a civil suit but only if the Vaccine Act’s other provisions do not preempt litigation. So, while the Vaccine Act greatly circumscribes plaintiffs’ access to state and federal courts, it does not completely eliminate it. In the event that a claimant does go to civil court, punitive damages are unavailable except in cases of fraud, intentional wrongdoing, or other illegal activity. The NVICP applies only to those vaccines that are listed on the Vaccine Injury Table which is most and includes new ones added to the childhood schedule. It does not apply to the shingles vaccine for adults for example. Individuals harmed by those vaccines may sue in civil court.
In practice, few people turn down NVICP awards to test their luck in civil court. Even before Bruesewitz v. Wyeth LLC foreclosed any opportunity to sue for vaccine design defects, fewer than 0.5% of successful claimants who received an award in the compensation program rejected it. “Virtually all” unsuccessful claimants declined to initiate suits in civil court. In a recent study of the NVICP, Stanford professor Nora Freeman Engstrom concluded that although Congress intended the NVICP to complement the civil justice system, in fact, the NVICP typically functions as an exclusive remedy.
With no private party able to hold vaccine manufacturers responsible for post-marketing safety defects, vaccine manufacturers in the United States enjoy the benefits of a captive market for mandated products with few economic incentives to make them as safe and effective as possible and are barred in the United States from bringing most civil lawsuits against manufacturers that might both compensate victims and stimulate manufacturers to improve vaccine safety.

Aimee Doyle

@David L - "Jennifer’s attorney, Sol Ajalat, initially brought her case in Vaccine Injury Compensation Program and then, following a judgment in the program, elected to proceed in civil court."

Do you know why more petitioners don't do this - move on to civil court after a judgment in vaccine court? I haven't heard about it happening...wasn't even sure that it was allowed.

Angus Files

I cant find any update since 2014 where the corts were waiting for Merck to respond apart from copying and pasting results from 65 years ago.

But eye watering stuf the firm that is sueing Merck..fraud is common place nothing to see folks move on...

Pharma For Prison



Yes can anybody provide the current status of this case and......isn't there an HPV vaccine injury trial somewhere in the works?

David L

Another Merck lawsuit is in civil court not the vaccine court, against Gardasil. Merck is being accused of fraud, deceit and negligence. Jennifer’s attorney, Sol Ajalat, initially brought her case in Vaccine Injury Compensation Program and then, following a judgment in the program, elected to proceed in civil court. Since VICA (the Vaccine Injury Compensation Act) forbids recoveries for product defect or negligence, Ajalat brought Jennifer’s civil case under the theories that Merck committed fraud during its clinical trials and then failed to warn Jennifer (and, by implication, other injured girls) about the high risks and meager benefits of the vaccine. This case is moving forward, RFK Jr is involved and discovery is allowed.

Lawsuits exist for Merck zostavax. The drug maker currently faces more than 600 product liability lawsuits involving allegations that the live virus used in the controversial shingles vaccine was not sufficiently weakened, causing plaintiffs to develop more severe and persistent shingles outbreaks, as well as various auto-immune disorders, such as meningitis, acute disseminated encephalopmyelitis (ADEM), Guillain-Barre syndrome, paralysis and other health problems.

I covered the MMR lawsuit and the mumps (as well as measles) outbreaks that have been ravishing people including twice vaccinated individuals around the world.

Merck’s Corporate Rap Sheet includes court adjudicated lawsuit findings against the company which has paid multi-billion dollars in settlements for False Claims, Product Safety/Concealment of serious adverse effects, Bribery, Tax fraud, and more. Multiple Merck products caused severe harm, including deaths; these include: the arthritis drug Indocin® (1960s); the widely prescribed drug for pregnant women, diethylstilbestrol (DES)® drug that caused women vaginal cancer (1970s); Vioxx®, the painkiller prescribed for arthritis (1999-2004) caused, 140,000 heart attacks and an estimated30 to 60,000 deaths. Merck paid $4.85 Billion to settle Vioxx lawsuits. Another controversial drug is Fosamax® prescribed for osteoporosis (1990s) which causes osteonecrosis of the jaw and thighbone fractures; Januvia® , linked to pancreatitis, pancreatic cancer, and severe joint pain. Lawsuits claim baldness drug Propecia causes sexual problems even after the drug is stopped and depression. The judge sealed evidence – uncovered by Reuters – suggesting the maker downplayed the known side effects.

Jill in MI

So what is the current status of this court case?

Bob Moffit

Ah yes … how does that old adage go .. JUSTICE DELAYED IS JUSTICE DENIED

Classic DELY, DENY, HOPE THE ALLEGATIONS DIE industry marketing strategy of a known dangerous product .. a strategy successfully used by tobacco industry for decades .. now being used successfully by pharmaceutical companies.

These "allegations" if proven true .. open MERCK to CRIMINAL RICO PROSECUTIONS .. as described thus;

"Passed in 1970, the Racketeer Influenced and Corrupt Organizations Act (RICO) is a federal law designed to combat organized crime in the United States. It allows prosecution and civil penalties for racketeering activity performed as part of an ongoing criminal enterprise. Such activity may include illegal gambling, bribery, kidnapping, murder, money laundering, counterfeiting, embezzlement, drug trafficking, slavery, and a host of other unsavory business practices.

To convict a defendant under RICO, the government must prove that the defendant engaged in two or more instances of racketeering activity and that the defendant directly invested in, maintained an interest in, or participated in a criminal enterprise affecting interstate or foreign commerce. The law has been used to prosecute members of the mafia, the Hells Angels motorcycle gang, and Operation Rescue, an anti-abortion group, among many others."

Yes .. MERCK is not exempt from being PROSECUTED UNDER RICO .. no different than other organized RACKETEERS .. such as .. the Mafia and Hells Angels .. being as MERCK crimes are far worse than either the Mafia and Hell's Angels .. their victims are INNOCENT HEALTHY CHILDREN AND THEIR PARENTS.

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