Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs”

SCOTUS Fosamax Ruling (May 20, 2019)

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning

Small Win for Defendants

Defendants Won the argument that a Judge not a jury is the proper authority to decide impossibility preemption arguments arising under the FDCA (Food and Drug Cosmetics Act, Title 21). However, the win on this one issue is a hollow victory for defendants considering the entirety of SCOTUS order and opinion.

SCOTUS ruled that judges not juries are the proper authority to decide the issue however, SCOTUS also placed significant limits on what those lower court judges could and could not consider when ruling on impossibility pre-preemption arguments like those raise by Merck in the Fosamax Case.

JUSTICE THOMAS SUMMARY OF RULING

JUSTICE THOMAS, concurring:

I join the Court’s opinion and write separately to explain my understanding of the relevant pre-emption principles and how they apply to this case.

“Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law”

Big Win for Plaintiffs

SCOTUS ruled that Judges decide however, SCOTUS went much further and defined limits on what facts and information could be considered by lower court judges when making decisions related to impossibly preemption arguments like those raised by Merck in Fosamax.

SCOTUS opinion limits the clear and convincing evidence standards to OFFICAL Acts taken by the FDA which would in general rise1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

2. If the defendant did not ask to make the specific label change (which plaintiffs allege was needed) having provided the FDA all relevant information, and the FDA OFFICIALLY denied the label change, then no pre-emption exists.

Arguments that postulate “hypotheticals” (absent either of the above official actions (facts)) are not to be considered. Communications between the defendant and the FDA, Statements by the FDA that do not constitute an official act under the law, are not to be considered.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court heard arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse event being that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referred solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

SCOTUS RULED 9-0

Additional Concurring Opinion on the judgment only (Jury vs Judge only) from Justices Cavanaugh, Alito’s  and Chief Justice Roberts could be interpreted as allowing lower court Judges to consider other Official acts by the FDA other than those delineated above however, the additional opinion did not define what official acts other than the two discussed could be considered and inasmuch as these two official actions are constitute the limit of the powers relevant to such matters, delegated to the FDA by Congress, it is doubtful that a defendant could show a lower court Judge any other document (without posing hypotheticals) that would constitute an official action taken by the FDA that would have prevented the defendant from meeting its State Law duties (impossibility preemption).

In that the only powers delegated to the FDA by Congress (powers under the law) are those defined in the two types of actions listed above, relevant to the type of impossibility preemption arguments that were raised in Fosamax, based on unofficial actions, communications and statements from the FDA (and that defendants hoped to raise in numerous other cases) the Fosamax ruling taken in its entity, is a major blow to defendants hoping to open major cracks in Wyeth v Levine.

The central issue in this case concerns federal preemption, which as relevant here, takes place when it is “‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certain associated risks.

FOSAMAX HISTORY

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

MERCK SHARP & DOHME CORP. v. ALBRECHT Opinion of the Court(excerpt)

III

We turn now to what is the determinative question before us:

Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of law, normally for a judge to decide without a jury?

The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize its considered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agency action”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questions respecting the . . . terms of any agency action” and its “application” are “questions of law”). To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.

We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury. Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiary factual disputes” that are part and parcel of the broader legal question.  Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewhere between a pristine legal standard and a simple historical fact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circumstances, “‘the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.’” Markman, 517 U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.

 IV

Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion.

It is so ordered.

____________________________________________________________

How Big Pharma’s cadre of lobbyists and congressional insiders attempt to reap major dividends, as we address the Fosamax ruling remains to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is paying off very well.

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  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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ZOSTAVAX VACCINE: Unpacking the Data from Merck & Co. Clinical Trials

ZOSTAVAX VACCINE:

Unpacking the Data from Merck & Co. Clinical Trials

October 11, 2018

 

 

 

 

 

 

 

 

 

 

The following information and conclusions are based on opinions formed after a review of relevant facts and data by John Ray, Senior Consultant, Mass Tort Nexus

Background

Herpes zoster (shingles) is a symptom of the varicella-zoster virus, the same virus that causes chickenpox. Individuals experiencing active herpes zoster infections often report debilitating pain and blistering skin rashes typically located on the face and torso. The varicella-zoster virus (chickenpox) can remain dormant in the body indefinitely and may emerge decades later as herpes zoster (shingles). Not all persons who have the varicella-zoster virus will develop herpes zoster, and it is impossible to predict who will and who won’t.

American pharmaceutical giant, Merck & Co. (Merck), released its Zostavax vaccine to the market in 2006. In its marketing campaign, Merck claims that “you have a 1 in 3 chance of contracting shingles,” and that the Zostavax vaccine reduces the occurrence of zoster by “51% overall in subjects aged 60 years or older.” The FDA approved the Zostavax vaccine prior to its market release.

Summary of Findings

  1. At a minimum, valid clinical trial results are based on two conditions: (1) trial participants must be diagnostically homogeneous (i.e., they share the same medical diagnosis); and, (2) the number of trial participants must be statistically significant (i.e., results may be reliably extrapolated to a larger group).
  2. Results from the Zostavax clinical trials conducted by Merck are arguably invalid because the trial participants were neither diagnostically homogeneous or comprised a statistically significant number.
  3. Because the risk of developing herpes zoster is higher for those that received the Zostavax vaccine than those who didn’t, Merck’s public marketing campaign of the Zostavax vaccine misled consumers, at best, and caused significant harm, at worst.

 Methodology Flaws in the Zostavax Clinical Trials

Diagnostically Homogeneous Trial Participants

Generally, clinical trials are intended to observe occurrences and outcomes from product administration with trial participants that share a medical diagnosis (i.e., diagnostically homogenous). For example, a clinical trial involving a drug to treat type 2 diabetes would only enroll individuals diagnosed with type 2 diabetes. Once a diagnostically homogenous group is identified and recruited for a clinical trial, an equal proportion of the group will be administered the drug being studied while the remainder will be administered either a placebo or another drug intended to treat the same disease or condition in trials testing one drug against another.

Zostavax vaccine clinical trials conducted by Merck differed significantly from normal clinical trial methodology in that Zostavax is not intended to treat an existing diagnosed disease or condition but rather is intended to prevent herpes zoster, a symptom of the varicella-zoster virus. If trial participants did not share a diagnosis of an existing disease or condition and could not reliably predict the future onset of a herpes zoster condition, trial participants were not—and could not be—diagnostically homogeneous. Therefore, conclusions reached by Merck from the Zostavax clinical trials are arguably invalid.

Statistically Significant Number of Trial Participants

After clinical trial observations are recorded, the results are extrapolated to represent predictable outcomes in a larger population. Extrapolations from statistically significant numbers are never as reliable as data collected from a larger, real-world population. Significant real-world data (e.g., data collected from Medicare, countries with national health care systems and/or unbiased third-party authorities) existed prior to the Zostavax trials regarding occurrence rates of herpes zoster by age group.

Numerous authorities and governments had already established that the probability of contracting herpes zoster during a lifetime was between 30 and 33%. Given the fact that a “risk without vaccination rate” was generated using far more reliable methods, there was no reason for Merck to include a placebo group in their trials when real-world data existed relevant to the unvaccinated.

In addition, Merck disqualified participants with compromised immune function from the Zostavax clinical trials. Immuno-compromised individuals are significantly more likely to develop herpes zoster. The 30 – 33% lifetime occurrence rate established by trusted sources from real-world data included persons with compromised immune function. As a result, the real-world data must be considered more accurate than the Zostavax trial data relevant to the placebo group.

The following chart shows the broad results of the first Zostavax trial conducted by Merck. Merck claims that for subjects 60 years of age or older there is a 51% reduction of risk. These results are misleading because they average occurrence rates of persons 80 years of age and older (who are significantly more likely to develop herpes zoster based on real-world data) with occurrence rates from age groups that are significantly less likely to develop herpes zoster. These statistics were used by Merck to obtain licensure for Zostavax from the FDA.

[Merck’s Zostavax link: https://www.merckvaccines.com/Products/Zostavax/efficacy/]

Methodology Flaws in the Zostavax Clinical Trials

Diagnostically Homogeneous Trial Participants

Generally, clinical trials are intended to observe occurrences and outcomes from product administration with trial participants that share a medical diagnosis (i.e., diagnostically homogenous). For example, a clinical trial involving a drug to treat type 2 diabetes would only enroll individuals diagnosed with type 2 diabetes. Once a diagnostically homogenous group is identified and recruited for a clinical trial, an equal proportion of the group will be administered the drug being studied while the remainder will be administered either a placebo or another drug intended to treat the same disease or condition in trials testing one drug against another.

Zostavax vaccine clinical trials conducted by Merck differed significantly from normal clinical trial methodology in that Zostavax is not intended to treat an existing diagnosed disease or condition but rather is intended to prevent herpes zoster, a symptom of the varicella-zoster virus. If trial participants did not share a diagnosis of an existing disease or condition and could not reliably predict the future onset of a herpes zoster condition, trial participants were not—and could not be—diagnostically homogeneous. Therefore, conclusions reached by Merck from the Zostavax clinical trials are arguably invalid.

Statistically Significant Number of Trial Participants

After clinical trial observations are recorded, the results are extrapolated to represent predictable outcomes in a larger population. Extrapolations from statistically significant numbers are never as reliable as data collected from a larger, real-world population. Significant real-world data (e.g., data collected from Medicare, countries with national health care systems and/or unbiased third-party authorities) existed prior to the Zostavax trials regarding occurrence rates of herpes zoster by age group.

Numerous authorities and governments had already established that the probability of contracting herpes zoster during a lifetime was between 30 and 33%. Given the fact that a “risk without vaccination rate” was generated using far more reliable methods, there was no reason for Merck to include a placebo group in their trials when real-world data existed relevant to the unvaccinated.

In addition, Merck disqualified participants with compromised immune function from the Zostavax clinical trials. Immuno-compromised individuals are significantly more likely to develop herpes zoster. The 30 – 33% lifetime occurrence rate established by trusted sources from real-world data included persons with compromised immune function. As a result, the real-world data must be considered more accurate than the Zostavax trial data relevant to the placebo group.

The following chart shows the broad results of the first Zostavax trial conducted by Merck. Merck claims that for subjects 60 years of age or older there is a 51% reduction of risk. These results are misleading because they average occurrence rates of persons 80 years of age and older (who are significantly more likely to develop herpes zoster based on real-world data) with occurrence rates from age groups that are significantly less likely to develop herpes zoster. These statistics were used by Merck to obtain licensure for Zostavax from the FDA.

[Merck’s Zostavax link: https://www.merckvaccines.com/Products/Zostavax/efficacy/]

Merck’s Misleading Marketing Scheme

 

 

 

 

 

Merck used the blanket statement, “You have a 1 in 3 chance of contracting shingles,” in their fear-based advertising campaigns for Zostavax. If we ignore the placebo trial group data in favor of the more reliable real-world data which tells us that 33% of individuals will experience herpes zoster during their lifetime leaving 67% that will not, we can conclude the following:

Age Group 60-69

Merck claimed a Zostavax efficacy rate of 64%. When this rate is compared to the real-world data rate, we can conclude that administration of the Zostavax vaccine increased the risk of experiencing herpes zoster by 3% for this group. Those who do not receive the Zostavax vaccine have a 67% chance of never manifesting herpes zoster symptoms while those that do receive the vaccine have a 64% chance of never contracting Herpes Zoster.

Age Group 70-79

Merck claimed a Zostavax efficacy rate of 41%. When this rate is compared to the real-world data rate, we can conclude that administration of the Zostavax vaccine increased the risk of developing herpes zoster by 26% for this group. Those who do not receive Zostavax have a 67% chance of never manifesting herpes zoster symptoms while those that receive the vaccine have a 41% chance of never contracting Herpes Zoster.

 Age Group > 80

Merck claimed a Zostavax efficacy rate of 18%. When this rate is compared to the real-world data rate, we can conclude that administration of Zostavax increased the risk of developing herpes zoster by 49% for this group. Those who do not receive Zostavax have a 67% chance of never manifesting herpes zoster symptoms while those that receive the vaccine have an 18% chance of never contracting Herpes Zoster.

The blended rate (all age groups in the study combined) of 51% efficacy claimed by Merck compared with occurrence rates from real-world data, leads us to conclude that for all intended users, the risk of developing herpes zoster after vaccination with Zostavax is greater than prior to vaccination. Real-world data demonstrates that the relative risk of contracting herpes zoster post-vaccination is 49% while those who are not vaccinated face a 33% risk.

The following graph shows herpes zoster occurrence rates by age group. A comparison of Zostavax trial data to real-world occurrence rates supports another conclusion—the age groups most at risk for developing herpes zoster (and most in need of an effective vaccine) had the least probability of protection from administration of the Zostavax vaccine and were arguably at the highest risk for developing Zostavax as a result of receiving the vaccine.

The foregoing is an observation of statistics and data related to Zostavax. The method by which Merck used and manipulated this data in misleading marketing and advertising is covered in other sections of the material.

The conclusions contained herein are based on opinions formed by the author after a review of the relevant data. We acknowledge that others could draw differing conclusions and opinions based on the same observations.

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WHY THE ZOSTAVAX MDL 2848 IS NOT SUBJECT TO THE “VACCINE COURT” and the “VACCINE ACT”

There would be no MDL 2848 if this was a Vaccine Court case…

By Mark A. York (October 11, 2018)

See: Vaccine Rules – Court of Federal Claims

 

 

 

 

(MASS TORT NEXUS MEDIA) The National Vaccine Injury Compensation Program (VICP or NVICP) was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine. Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared the loss of herd immunity.[1]

The official standing of the “Vaccine Court” was confirmed February 22, 2011 by the US Supreme Court in Bruesewitz v. Wyeth, LLC et al, in https://www.supremecourt.gov/opinions/10pdf/09-152.pdf

The Office of Special Masters of the U.S. Court of Federal Claims, popularly known as “vaccine court“, administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury.

“In the vaccine court, the burden is on a plaintiff to show a biological theory of harm, demonstrate a logical sequence of events connecting the vaccine to the injury, and establish an appropriate time frame in which injury occurred. The petitioner must also show that there is not another biologically plausible explanation for the injury.[13]

A 2005 United States Court of Appeals for the Federal Circuit ruling[14] held that an award should be granted if a petitioner either establishes a “Table Injury” or proves “causation in fact” by proving the following three prongs:

  1. a medical theory causally connecting the vaccination and the injury;
  2. a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and
  3. showing of a proximate temporal relationship between vaccination and injury.

Pursuant to §11(c)(1)(A) of the Vaccine Act, the Vaccine Court has jurisdiction to only hear cases listed on the Vaccine Injury Table see 42 CFR 100.3 Vaccine Injury Table (Drug List).

  1. The ZOSTAVAX vaccine is not a vaccine listed in the Vaccine Injury Table
  2. The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 et seq. does not preempt a Plaintiff from filing a civil complaint in federal court.

 No Special Tax Was Paid By Zostavax

Merck & Co. did not pay the 75 cent tax per dose to the vaccine court, to have Zostavax included on the “Vaccine Injury Table” see 42 CFR 100.3 Vaccine Injury Table, that lists which drugs are under the “Vaccine Court” jurisdiction and not the normal courts of civil procedure in the United states.

Merck & Co. have taken the position that there is no overriding public interest in Zostavax being available, as there is with vaccines for contagious viruses that could potentially cause a public health epidemic.

The 75 cent excise tax on each vaccine administered to children and others, routinely gets routed to the Vaccine Injury Compensation Trust Fund, which is collected by the U.S. Department of the Treasury.

CDC Shingles Vaccine Warning of Feb. 12, 2018

Women should avoid getting pregnant for at least 1 month after getting a shingles vaccine. Have a weakened immune system due to disease (such as cancer or AIDS) or medical treatments (such as radiation, immunotherapy, high-dose steroids, or chemotherapy).Feb 12, 2018

For additional CDC information on vaccines see: https://www.cdc.gov/vaccines/index.html

Why is Varicella Vaccine on the Vaccine Court List?

Some confusion may exist due to the fact that Varicella vaccines are listed on the Vaccine Court list, this reference however does not refer to Zostavax. The Varicella Vaccines subject to vaccine court are related to the Chickenpox vaccines and not the Shingles vaccine.

Only vaccines that have been determined to be in the public interest despite being unavoidably unsafe are on the vaccine court list. No Vaccine Act preemption arguments arise from the Vaccine Act. for Zostavax.  Zostavax was not permitted to be unsafe as drugs listed on the Vaccine Injury Table are classified.

The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines.[4] The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine.[1] The VICP uses a no-fault system for resolving vaccine injury claims. Compensation covers medical and legal expenses, loss of future earning capacity, and up to $250,000 for pain and suffering; a death benefit of up to $250,000 is available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims.[5]

Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award, a claimant must have experienced an injury that is named as a vaccine injury in a table included in the law within the required time period or show a causal connection. The burden of proof is the civil law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare.[1]

John Ray and other speakers will cover the Zostavax MDL 2848 case criteria and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”
November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.
For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.
For the most up to date information on all MDL dockets and related mass torts visitwww.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
To obtain our free newsletters that contain real time mass tort updates, visitwww.masstortnexus.com/news and sign up for free access.

 

“VACCINE COURT” Related References

  1. Sugarman SD (2007). “Cases in vaccine court—legal battles over vaccines and autism”. N Engl J Med. 357 (13): 1275–7. doi:1056/NEJMp078168PMID 17898095.
  2. Doja A, Roberts W (2006). “Immunizations and autism: a review of the literature”. Can J Neurol Sci. 33 (4): 341–6. doi:1017/s031716710000528xPMID 17168158.
  3.  Maugh TH II, Zajac A (2010-03-13). “‘Vaccines court’ rejects mercury–autism link in 3 test cases”. Los Angeles Times.
  4. Edlich RF; Olson DM; Olson BM; et al. (2007). “Update on the National Vaccine Injury Compensation Program”. J Emerg Med. 33(2): 199–211. doi:1016/j.jemermed.2007.01.001PMID 17692778.
  5. “Filing a claim with the VICP”. Health Resources and Services Administration. Retrieved 2013-08-19.
  6.  “Vaccine Injury Table”. Health Resources and Services Administration. 2007. Retrieved 2008-01-22.
  7. “National Vaccine Injury Compensation Program statistics reports”. Health Resources and Services Administration. 2008-01-08. Retrieved 2008-01-22.
  8. Balbier TE Jr (1999-09-28). “Statement on National Vaccine Injury Compensation Program”. U.S. Department of Health and Human Services. Retrieved 2008-01-22.
  9.  “Who Can File”. www.hrsa.gov. Last Reviewed: February 2016: U.S. Department of Health and Human Services Health Resources and Services Administration. Retrieved 12 October 2016.
  10. Holder v. Abbott Laboratories, 444 F.3d 383
  11. Davis WN (2006). “No longer immune”. ABA Journal. 92 (7): 19, 43.
  12. Pear R (2002-12-14). “Threats and responses: legal risks; for victims of vaccine, winning case will be hard”. New York Times. Retrieved 2008-01-22.
  13. Keelan, J; Wilson, K (November 2011). “Balancing vaccine science and national policy objectives: lessons from the National Vaccine Injury Compensation Program Omnibus Autism Proceedings”. American Journal of Public Health. 101 (11): 2016–21. doi:2105/ajph.2011.300198PMC 3222385PMID 21940934.
  14. Althen v. Secretary of Health and Human Services (Fed. Cir. July 29, 2005). Text This decision, which is binding upon the United States Court of Federal Claims, clarified the standing for proving “causation in fact” absent a “Table Injury” under 42 U.S.C. 300aa-11(c)(1)(C)
  15. Offit PA (2008). “Vaccines and autism revisited—the Hannah Poling case”. N Engl J Med. 358 (20): 2089–91. doi:1056/NEJMp0802904PMID 18480200.
  16. Rovner J (2008-03-07). “Case stokes debate about autism, vaccines”. NPR. Retrieved 2008-03-07.
  17.  Holtzman D (2008). “Autistic spectrum disorders and mitochondrial encephalopathies”. Acta Paediatr. 97 (7): 859–60. doi:1111/j.1651-2227.2008.00883.xPMID 18532934.
  18.  Honey K (2008). “Attention focuses on autism”. J Clin Invest. 118 (5): 1586–7. doi:1172/JCI35821PMC 2336894PMID 18451989.
  19. Kirkland, A. (13 March 2012). “Credibility battles in the autism litigation”. Social Studies of Science. 42 (2): 237–261. doi:1177/0306312711435832PMID 22848999.
  20. Omnibus Autism Proceeding, US Court of Federal Claims, http://www.uscfc.uscourts.gov/omnibus-autism-proceeding, visited October 12, 2016.
  21. Bridges A (2007-06-12). “Children with autism get day in court”. USA Today. Retrieved 2007-10-14.
  22. Freking K, Neergaard L (2009-02-12). “Court says vaccine not to blame for autism”. Associated Press. Retrieved 2009-02-12.

 

 

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Zostavax MDL 2848 (Shingles Vaccine) Consolidated In USDC ED Pennsylvania

Zostavax MDL 2848 Puts Merck Back on the MDL Hotseat

By Mark A. York (August 14, 2018)

 

 

 

 

 

 

 

The JPML has created the Zostavax MDL 2848 and assigned the lawsuits filed related to Merck’s shingles vaccine to the United States District Court of Pennsylvania and Judge Harvey Bartle III. See Mass Tort Nexus Zostavax brief case: ZOSTAVAX-(Zoster-Vaccine-Live)-MDL-2848-USDC-Eastern-District-of-Pennsylvania.

Shingles is a rash on the side of the face or body, usually affecting persons over 50. The U.S. Food and Drug Administration approved Zostavax as a shingles vaccine in 2006.

The August 2, 2018  order by the U.S. Judicial Panel on Multidistrict Litigation consolidates Zostavax MDL 2848 in the US District Court of Pennsylvania (Eastern District) in front of U.S. District Judge Harvey Bartle, who has been hearing one of the initial Zostavax cases filed in  016. The lawsuits, filed in courts across the country including, Pennsylvania, New Jersey, New York, Wisconsin and Massachusetts, allege that Merck failed to warn that the virus in the vaccine caused shingles, brain damage and death, among other things.

In a move not often seen, defense counsel for Merck had moved for an MDL assigned to Judge Bartle in Pennsylvania or U.S. District Judge James Moody of the Middle District of Florida.

“Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Zostavax are common to all actions,” wrote the JPML chairwoman, Sarah Vance. “Seven actions are pending in this district, and they are the earliest filed and most advanced actions in this litigation.”

Lead Counsel Comments

“My cases pending before Judge Bartle are the most advanced in the Zostavax litigation,” said Mark Sadaka of The Law Offices of Sadaka Associates in Englewood, New Jersey, a plaintiffs lawyer who supported sending the cases to Bartle. “Merck has already produced millions of pages of documents in my cases in the Easter District of Pennsylvania. Judge Bartle has already decided two summary judgment motions. I look forward to working together with other plaintiffs counsel to finally move our cases to trial.”

Other plaintiffs lawyers had formally opposed creation of an MDL.

Marc J. Bern & Partners in New York, a firm with by far the most individual plaintiffs in the country—over 5,000 Zostavax clients stated “we will be looking to be leaders in this MDL” and “certainly, Judge Bartle is a judge with long experience, has handled successfully other MDL’s” said name partner Marc Bern.

Merck Previously Admits Shingles Vaccine Can Cause Eye Damage and Shingles

Two important FDA approved changes to the warning label of Merck Pharmaceutical’s shingles vaccine, Zostavax, have been made since the controversial drug was introduced in 2006.  The first was in August 2014, when, in addition to potentially causing chickenpox, another side effect was added: shingles! That’s right. The vaccine that had been – and continues to be — aggressively marketed to prevent seniors from contracting this excruciating condition was found to actually cause shingles in some individuals.

The FDA approved a label change to warn those who prescribe the Zostavax vaccine of another potential side effect: “Eye Disorders: necrotizing retinitis.”

According to the authors of a Health Sciences Institute (HSI) article in January, 2016, “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up.”  While Merck claims Zostavax is 50% effective, in the placebo group, 3.3 percent of the study participants developed shingles, compared to 1.6 percent in the vaccine group. So, while that is a 50% difference, the real, absolute risk reduction is just 1.7 percentage points.

The case criteria generally include the following injurie:

  • Autoimmune disorders, including Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Meniere’s Disease
  • Bell’s Palsy (facial paralysis)
  • Cardiovascular event
  • Congestive heart failure
  • Death
  • Hearing loss
  • Herpetic Neuralgia (disorder in the nerves)
  • Myelitis (spinal cord inflammation)
  • Pneumonia
  • Postherpetic neuralgia, or PHN (pain continuing after shingles blister subside)
  • Serious neurological diseases or disorders, including brain inflammation (encephalitis)
  • Stroke
  • Vasculitis
  • Vision problems, including blindness, eye infections, retinal damage, acute retinal necrosis

The JPML was aware of certain issues related to creation of MDL 2858, may delay cases for some plaintiffs, many of whom are older, but coordination of the  litigation would help resolve all the cases, “even if some parties might experience inconvenience or delay.”

The JPML order does not apply to lawsuits brought on behalf of 300 plaintiffs in California state court and 800 plaintiffs in New Jersey state court.

One of the lawsuits filed by female plaintiff Joria Bentley from Nevada, claims she suffered high blood pressure, an eye injury and other side effects from Merck & Co.’s Zostavax shingles vaccine in Zostavax litigation filed in the Philadelphia’s Court of Common Pleas. Ms. Bentley claims in her complaint that the patient information sheet, label and prescribing information that accompanied the vaccine did not provide any warning of the risk of viral infection and cites to the many instances of adverse events and other reports on medical issues caused by Zostavax.

Patients who received the injections are filing product liability lawsuits against Merck, alleging the company produced and sold an “unreasonably dangerous vaccine” that caused serious injuries after vaccination. Hailing from a range of states including Louisiana, South Carolina, Tennessee, Michigan and Wisconsin, the plaintiffs filed their suit in Merck’s home state of New Jersey. Instead of preventing shingles, Zostavax caused the plaintiffs to “contract a persistent strain of herpes zoster,” according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases.

The common allegations in all complaints are negligence, defective design, failure to warn, breach of express and implied warranties, misrepresentation involving risk of physical harm and unjust enrichment.

“Merck knew, or should have known, that its product caused viral infection, and was therefore not safe for administration to consumers,” the suits claim. There are “thousands of complaints” yet to be filed according to one of the lead plaintiff attorneys, adding “I think Merck has failed terribly to warn about the very serious side effects and the failure of the vaccine to do what they claim it does” as Merck continues to profit from

National Vaccine Information Center

NVIC provides links and resources such as the manufacturer product information inserts for Zostavax and shingles.

What is Shingles?

  • This information is for educational purposes only and is not intended as medical advice.

What is Zostavax?

Zostavax is a vaccine made by pharmaceutical giant Merck, and approved by the U.S. Food and Drug Administration in 2006. It was the only approved shingles vaccine in the United States until late 2017, which allowed the company to earn as much as $749 million in sales from the vaccine in 2016, according to reports.

This vaccine is designed to reduce the risk of getting herpes zoster — a painful and debilitating condition commonly known as “shingles” — in individuals ages 50 years and older, who are at increased risk of developing the virus. Zostavax is typically recommended for people aged 60 years and older by the U.S. Centers for Disease Control and Prevention, and doctors commonly give the vaccine in a one-dose shot.

Zostavax differs from some vaccines in that it contains a live, but weakened form of the herpes zoster virus (this is officially referred to as a “live, attenuated virus”). People with weakened immune systems cannot receive these types of vaccines.

 

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