Why is the US Solicitor General Supporting Merck in Supreme Court Fosamax Preemption Appeal?

WILL BIG PHARMA LOBBYING EFFORTS BE PAYING DIVIDENDS IN 2019?

By Mark A. York (December 7, 2018)

The Supreme Court’s decision involving Merck’s osteoporosis drug Fosamax could have a ripple effect across Big Pharma and Mass Torts.

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The U.S. Supreme Court agreed in June to hear Merck & Co.’s appeal in the long running Fosamax liability litigation, (MDL No. 2243, District Judge: Honorable Joel A. Pisano, USDC New Jersey) where plaintiffs are suing Merck & Co over its osteoporosis drug Fosamax, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

The plaintiffs have requested the U.S. Supreme Court uphold a federal appeals court ruling that allowed their cases to move forward, however acting U.S. Solicitor General Jefferey Wall asked for permission to present oral arguments. It would be a plus for Merck, because Wall has been a major supporter of the Big Pharma position on the issue of preemption, which revolves around the question of whether FDA decisions protect pharma companies from state legal challenges.

How the Court answers this question will no doubt shape the drug and device industry for years to come. Levine provided that a drug manufacturer could not be held liable under a failure-to-warn theory if the FDA had previously considered—and rejected—a proposed amendment to the product’s warning label. But Levine did not clearly define when preemption would apply in these circumstances, and as a result, lower courts have struggled to uniformly apply this rule.  With Albrecht, the Court now has an opportunity to clear up the ambiguities left in Levine’s wake.

On December 3, 2018 the Supreme Court agreed to let the Solicitor General’s office participate in the oral arguments, which probably caused the executive suites at Big Pharma to raise a toast to Jeffrey Wall.

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 will hear 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 evenet bieng 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’ referr[ed] 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.

Merck said it tried to update the label earlier, but failed because the FDA rejected its proposed wording. Because it was the FDA’s call, pre-emption should apply, Merck claimed and Wall concurred. Now, the Supreme Court will offer 10 minutes for the U.S. to make its case.

“The government has a significant interest in the proper resolution of the case, which concerns the manner in which the scope and effect of an FDA labeling decision is determined in private tort litigation,” asserted Wall in his MOTION OF THE UNITED STATES AS AMICUS CURIAE FOR LEAVE TO PARTICIPATE IN ORAL ARGUMENTS.

At least three court members (Thomas, Gorsuch, and Roberts) appear likely to support preemption under this set of facts, and it would not be unreasonable for Kagan, Ginsburg, and/or Breyer to hold similarly, given that the latter two were both part of the Levine majority, which stated that preemption would apply if there existed “clear evidence that the FDA would not have approved a change[.]” Wyeth v. Levine, 555 U.S. 555, 571 (2009). The odds of a five-justice majority favoring preemption could be buttressed if Kavanaugh is confirmed. Regardless, all one can truly hope for is that the Court avoids a plurality decision, since such an outcome would leave the Third Circuit’s opinion intact and muddy the waters further.

SCOTUS Docket: Merck Sharp & Dohme Corp. v. Albrecht

17-290 3d Cir.  Hearing Date January 7, 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. CVSG: 05/22/2018.

Date Proceedings and Orders (key to color coding)
Jun 23 2017 Application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, submitted to Justice Alito.
Jun 27 2017 Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
Aug 22 2017 Petition for a writ of certiorari filed. (Response due September 25, 2017)
Aug 31 2017 Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
Sep 11 2017 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
Sep 19 2017 Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
Sep 20 2017 Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
Sep 21 2017 Order extending time to file response to petition to and including October 25, 2017, for all respondents.
Sep 22 2017 Because Justice Alito now realizes that he should have recused himself from consideration of this application, the order of June 27, 2017, is vacated. Pursuant to Rule 22.2, the application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, has been submitted to Justice Sotomayor.
Sep 22 2017 Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)
Sep 25 2017 Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
Sep 25 2017 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Oct 25 2017 Brief of respondents Doris Albrecht, et al. in opposition filed.
Nov 08 2017 DISTRIBUTED for Conference of 12/1/2017.
Nov 08 2017 Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 04 2017 The Solicitor General is invited to file a brief in this case expressing the views of the United States. Justice Alito took no part in the consideration or decision of this petition.
May 22 2018 Brief amicus curiae of United States filed (to be corrected and reprinted).
May 22 2018 Brief amicus curiae of United States filed (Corrected brief received 5/29/18).
Jun 05 2018 DISTRIBUTED for Conference of 6/21/2018.
Jun 05 2018 Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
Jun 07 2018 Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Jun 27 2018 DISTRIBUTED for Conference of 6/27/2018.
Jun 28 2018 Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits granted. The time to file the joint appendix and petitioner’s brief on the merits is extended to and including September 13, 2018. The time to file respondents’ brief on the merits is extended to and including November 14, 2018.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits filed.
Sep 12 2018 Blanket Consent filed by Respondents, Doris Albrecht, et al..
Sep 13 2018 Brief of petitioner Merck Sharp & Dohme Corp. filed.
Sep 13 2018 Joint appendix (2 volumes) filed. (Statement of costs filed)
Sep 17 2018 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
Sep 20 2018 Brief amicus curiae of Washington Legal Foundation filed.
Sep 20 2018 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Sep 20 2018 Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.
Sep 20 2018 Brief amicus curiae of United States filed.
Oct 12 2018 Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
Oct 26 2018 Justice Alito is no longer recused in this case.
Nov 14 2018 Brief of respondents Doris Albrecht, et al. filed.
Nov 21 2018 Brief amicus curiae of Public Citizen filed.
Nov 21 2018 Brief amici curiae of Commonwealth of Virginia, et al. filed.
Nov 21 2018 Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.
Nov 21 2018 Brief amici curiae of MedShadow Foundation, et al. filed.
Nov 21 2018 Brief amicus curiae of The Cato Institute filed.
Nov 21 2018 Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.
Nov 21 2018 Brief amici curiae of Public Law Scholars filed.
Nov 21 2018 Brief amici curiae of Jerome P. Kassirer, M.D., et al. filed.
Nov 21 2018 Brief amicus curiae of American Association for Justice filed.
Nov 28 2018 SET FOR ARGUMENT ON Monday, January 7, 2019
Nov 30 2018 CIRCULATED

The SCOTUS ability to resolve the preemption question could have a ripple effect on the entire pharma industry. The issue generated heated debate a few years back, when a liability case raised questions about whether generics makers can be held responsible for patients’ injuries, given that they must use label language the FDA approved for branded versions of the drugs.

In a close 5-4 decision, the justices ruled that generics makers could not be held liable in those cases.

Initially, it looked as if Merck would prevail in its preemption argument, too, as the  defense had won two bellwether lawsuits filed over alleged Fosamax injuries. Then, in 2014, a federal judge tossed out 5,000 lawsuits from patients who claimed their fractures were caused by Fosamax, followed by a federal appeals court reviving those cases by over-ruling that dismissal.

Lawyers representing the patients in this case have argued that Merck’s preemption argument is faulty because it’s largely based on an internal memo recounting a phone conversation one of its employees had with the FDA.

“Respondents are aware of no other preemption case in which the manufacturer relied on hearsay accounts of informal FDA communications,” the lawyers said in a recent brief.

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.

Both Merck and the Solicitor General contend that if the FDA believed there was scientific reasoning to support a labeling change, the agency would have added the warning, because federal laws require it to do so.

As SCOTUS gets set to hear the case, many individuals and organizations have filed briefs in support, urging the justices to uphold the lower court ruling that would allow those thousands of Fosamax suits to go forward. Consumer watchdog group Public Citizen, for example, filed a brief earlier this month suggesting that Merck’s pre-emption argument is invalid because federal statutes do not support the idea that “the FDA’s rejection of a particular proposed warning constitutes a determination ‘that no new labeling language is warranted.’”

Besides, Public Citizen argued (PDF), SCOTUS should preserve patients’ rights to pursue drug liability claims in state courts, and by siding with Merck, the judges might make it much harder for those suits to be filed.

“Allowing patients to pursue tort claims against pharmaceutical manufacturers for injuries caused by inadequate warnings is important as both an incentive for manufacturers to be vigilant about product safety and a means to provide remedies to patients,” Public Citizen wrote. “For this reason, the case has important implications that go well beyond the interests of the parties.”

How Big Pharma’s cadre of lobbyists and congressional insiders appears to be paying major dividends as we approach 2019 remaons 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 apying off very well.

To access the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

March 8-11, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

       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.

      2. To obtain our free newsletters that contains real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

 

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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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