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NYHPVlawsuit

NYHPVlawsuit

Page 1: NYHPVlawsuit

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Number of Pages:19

Date Created:March 3, 2017

Date Uploaded to the Library:March 08, 2017

Tags:NYHPVcomplaint, NYCRR, Fourteenth, Consent, gardasil, Injury, child, vaccine, knowledge, table, Constitution, amendment, Plaintiffs, health, HHS, defendant, State Department, Supreme Court, children, states, united


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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT NEW YORK
Lina Cole, behalf herself and her eleven-year-old
daughter A.C., Melissa Golpl, behalf herself and
her fifteen-year-old son P.K., Denise Randello, behalf herself and her thirteen-year-old daughter A.R., Lisa
Boyle Meyer, behalf herself and her sixteen-yearold daughter K.M., and Toby Doell-Carbone, behalf herself and her eleven-year-old twins M.C. and J.C.,
COMPLAINT
Plaintiffs,
-againstHoward Zucker, his official capacity the
Commissioner the New York State Department
Health,
Defendant.
Plaintiffs captioned above for their Complaint against the above-captioned Defendant
allege follows:
INTRODUCTION effort reduce the incidence
HPV
healthcare
professionals have placed substantial emphasis administering HPV vaccines, such Gardasil Gardasil-9 manufactured Merck Co., Inc., minor children. However, these vaccines
come with significant potential adverse reactions. Government data shows that since 2007 HPV
vaccines have been associated with least 48,601 cases adverse events, including: 300 deaths,
1,650 individuals permanently disabled, 4,168 hospitalizations, and 13,785 emergency room visits.
Nevertheless, May 2016 the New York Department Health DOH through
the Defendant, its commissioner, promulgated new regulation that asserts allows healthcare
professionals administer vaccines like Gardasil Gardasil-9 minor children without their
consent knowledge Consent Knowledge Rule The regulation
codified NYCRR 23.4.
Plaintiffs here are not intrinsically opposed the HPV vaccine, and their children
are otherwise completely vaccinated. But, they are concerned that their children may receive the
vaccine without their awareness and involvement. They are concerned that their children
experience adverse reaction the vaccination, they may not associate the reaction with the
vaccination and may not have sufficient knowledge properly seek treatment for their children. result, the Plaintiffs bring this action challenge the validity the
Consent Knowledge Rule the extent permits health care practitioners New York State
inject Gardasil Gardasil-9 manufactured Merck Co., Inc., into children without parental
consent knowledge. set forth herein, the Consent Knowledge Rule invalid because U.S.C.
300aa-26, part the National Childhood Vaccine Injury Act, requires that before child
injected with any vaccine, such Gardasil Gardasil-9, the parent legal guardian such child
must provided the Vaccine Information Statement created the Center for Disease Control for
the specific vaccine. The Information Statements for Gardasil and Gardasil-9 explain, inter alia,
who should avoid these products, the risks reaction, what look for after injection and what there serious reaction one these products. addition, enforcement the Consent Knowledge Rule unconstitutional
because violates the Fourteenth Amendment the United States Constitution, and enforcement unlawful for that separate and distinct reason. The Supreme Court has long recognized the
constitutional right parents present and have decision making role when medical
procedures are being performed their children.
Accordingly, this action seeks declaration the invalidity the Consent
Knowledge Rule and permanent injunction enjoining enforcement this rule.
PARTIES
Plaintiffs are all parents with children between the ages eleven and sixteen.
Plaintiff Lina Cole mother with eleven-year-old daughter A.C., and
registered nurse. They reside Webster, New York.
10.
Plaintiff Melissa Golpl mother with fifteen-year-old son P.K. who has
intellectual disability. They reside Buffalo, New York.
11.
Plaintiff Denise Randello mother with thirteen-year-old daughter A.R. They
reside Deer Park, New York.
12.
Plaintiff Lisa Boyle Meyer mother with sixteen-year-old daughter that has
been severely injured HPV vaccine. They reside Manhasset, New York.
13.
Plaintiff Toby Doell-Carbone mother with eleven-year-old twin boys M.C. and
J.C. Ms. Doell-Carbone registered nurse whose duties included vaccinating patients. They
reside Ontario, New York. (All children whose initials are provided above shall referred
their
14. Health
Defendant Howard Zucker the Commissioner the New York State Department
DOH
JURISDICTION AND VENUE
15.
This Court has original subject matter jurisdiction adjudicate the claims asserted
herein because the claims arise under the Constitution, laws treaties the United States, within
the meaning U.S.C. 1331.
16.
Venue proper within this District pursuant U.S.C. 1391(a) because the
defendant Mr. Zucker
office located Albany, New York, where performs his official
duties.
FACTS Gardasil and Gardasil-9 Are the Only HPV Vaccines Available the United States
17.
The term Human Papillomavirus refers class viruses which can
transmitted, among other ways, through sexual contact. There are over 148 known strains HPV. some circumstances, the HPV virus can cause people develop certain cancers, such cervical
cancer.
18.
Currently there are two vaccines for HPV licensed and sold the United States,
Gardasil and Gardasil-9 manufactured Merck Co., Inc., which are intended protect against
four strains and nine strains HPV, respectively.
19.
Previously GlaxoSmithKline Biologicals also produced HPV vaccine called
Cervarix. However, GlaxoSmithKline has recently withdrawn Cervarix from the United States
vaccine market.
20.
Gardasil and Gardasil-9 are recommended given two three injections
over multi-month period. recommended that the vaccine administered children
between the ages and 12, through can given children young and older children
who have not yet contracted the virus.
21.
The HPV vaccine intended administered before child sexually active
has not been demonstrated provide protection against
disease from vaccine HPV types which person has previously been exposed through sexual
activity DOH New Regulation Permits Healthcare Practitioners Administer the HPV
Vaccine Without Parental Knowledge Consent
22. May 2016, the DOH put into effect new regulation, the Consent
Knowledge Rule, which claims permits healthcare practitioners New York administer
HPV vaccine minors without the consent knowledge their parent guardian.
23.
New York Public Health Law, Section 2305(2), enacted substance 1972,
diagnose, treat prescribe for person under the age twenty-
one years without the consent knowledge the parents guardian said person, where such
person infected with sexually transmitted disease, has been exposed infection with
sexually transmitted disease. (emphasis added.) Thus, enacting this Section, the Legislature
made the policy decision that the exigent need treat child for sexually transmitted disease
that the child either had contracted had been exposed to,
participate the decision
24.
Pursuant this statute, the DOH 2016 created the Consent Knowledge
Rule part its recent addition Section 23.4 Title the New York Codes, Rules and
NYCRR That new section provides relevant part:
When health care provider diagnoses, treats prescribes for
minor, without the consent knowledge parent guardian
permitted section 2305 the Public Health Law, neither medical
nor billing records shall released any manner made
available the parent guardian such minor without the minor addition being authorized accordance
with section 2305 the Public Health Law diagnose, treat
prescribe for person under the age years without the consent knowledge the parent guardian such person where the
individual infected with sexually transmitted disease, has
been exposed infection with sexually transmitted disease, health
care practitioners may (as authorized their scope practice)
render medical care related other sexually transmitted diseases
without the consent knowledge the parent guardian. NYCRR 23.4 (emphasis added).
25.
The emphasized language above goes beyond the narrow exception parental
consent created PHL 2305. The emphasized language for the first time permits medical
professionals provide care minors, including performing medical procedures, with regard myriad potential sexually transmitted diseases. Unlike PHL 2305, which limited care
acute circumstances where minor had either contracted been exposed disease,
new Section 23.4 allows professionals provide care, including preventative care, for any
sexually transmitted disease, regardless whether the minor had yet had any contact with the
disease.
26.
The DOH provided its reason for enacting such sweeping new rule its Notice Adoption for the regulation:
preventable sexually transmitted disease with vaccination protecting adolescents from HPV
infection. Section 23.4 permits health care providers prescribe and administer HPV vaccine
sexually active minors during confidential sexual and reproductive health care visits without
consent knowledge the parent guardian other words, the DOH explicit that
enacted Section 23.4 order allow healthcare providers administer Gardasil and Gardasil-9
knowledge. Federal Law Requires Informed Consent Provided the Minor egal
Representative Prior Vaccinating the Minor
27.
Under Federal law healthcare professional must provide legal representative child with certain written materials prior injecting such child with any vaccine, like Gardasil
See https://regs.health.ny.gov/sites/default/files/pdf/recently_adopted_regulations/2016-0518_sexually_transmitted_diseases.pdf
and Gardasil-9. These written materials disclose important information, including who should not
receive the vaccine, who should delay receiving the vaccine, the risks injecting these products,
and what parent should look for and after their injection serious reaction occurs.
28. the 1980s many pharmaceutical companies announced they would cease
producing vaccines due their liability from the injuries their vaccines were causing. response,
NCVIA U.S.C. 300aa-1 300aa-34, shield pharmaceutical companies from financial liability for
injuries caused vaccines they manufacture and ensure that individuals receiving the vaccines
are properly informed about the vaccines.
29.
The NCVIA
codified U.S.C. 300aa-25
Pursuant this sub-section, the Secretary
300aa-28.
HHS
develop and disseminate vaccine information materials for distribution health care providers the legal representatives any child any other individual receiving vaccine set forth
ion such materials shall
based available data and information, shall presented understandable terms and shall
include (1) concise description the benefits the vaccine, (2) concise description the
risks associated with the vaccine, (3) statement the availability the National Vaccine Injury
Compensation Program, and (4) such other relevant information may determined the
-26(c). response, the Secretary HHS has developed Vaccine
VIS
for each vaccine listed the Vaccine Injury Table, including for
Gardasil and Gardasil-9.
30.
Title U.S.C. 300aaaccine set forth the Vaccine Injury Table shall
provide the legal representatives any child any other individual whom such provider
intends administer such vaccine copy the
supplemented with visual presentations oral explanations, appropriate cases. Such materials shall provided prior the
administration such vaccine U.S.C. 300aa-33.
31. addition requiring that parents receive information, the NCVIA also
established the National Vaccine Injury Compensation Program
VICP
individuals who are injured vaccines the Vaccine Injury Table. Claims vaccine injuries
must made the VICP, which part the United States Court Federal Claims. U.S.C.
300aa-11. The respondent these claims the HHS. Id. Petitioners the VICP typically
must still prove causation and there maximum recovery $250,000 for death and for pain and
suffering. U.S.C. 300aa-15(a)(2)-(4). the ten years preceding 2016, over $1.6 billion has
been paid for vaccine injuries the VICP. Each VIS statement includes description the
VICP, and instructions how learn more about the program, including admonition that
there are time limits for filing claim the VICP.
32.
The HPV vaccines Gardasil and Gardasil-9 were added the Vaccine Injury Table February 2007. HHS has issued VIS for Gardasil and VIS for Gardasil-9, which updated December 2016. (81 23299.)
33.
Therefore, under Federal law, healthcare professional must provide the VIS and
appropriate supplemental explanations the legal representative child prior injecting the
child with Gardasil Gardasil-9, and any child injured the vaccine can typically only seek
redress through the VICP. HPV Vaccines Have Known Serious Adverse Reactions
34.
Gardasil and Gardasil-9 can cause serious adverse reactions.
35.
The VISs for Gardasil and Gardasil-9 provide warnings regarding who should avoid this
The VISs for Gardasil and Gardasil- these sections, the VIS describes what symptoms can result from adverse reaction
the vaccine
symptoms arise.
36.
The VIS for Gardasil and Gardasil-9 also advise parents the Vaccine Adverse
-sponsored the CDC and FDA.
VAERS
Health care providers report adverse reactions the VAERS voluntary basis, and such estimated capture only small fraction serious adverse events and typically only captures
acute reactions. Nevertheless, since 2007, VAERS has received reports 48,601 cases adverse
events following injection HPV vaccine, including: 300 deaths, 1,650 permanently disabled,
4,168 hospitalized, and 13,785 emergency room visits.
37.
The VIS for Gardasil and Gardasil-9 also informs parents the Vaccine Injury
Compensation Program.
38.
Furthermore,
ardasil and Gardasil-9 provide the
following partial list adverse events following injection Gardasil Gardasil-9: death,
autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy,
pulmonary embolus, pancreatitis, asthenia, autoimmune diseases, hypersensitivity reactions
including anaphylactic/anaphylactoid reactions, bronchospasm, urticarial, arthralgia, myalgia,
acute disseminated encephalomyelitis, guillain-barre syndrome, motor neuron disease, paralysis,
seizures, syncope (including syncope associated with tonic-clonic movements and other seizurelike activity) sometime resulting falling with injury, and transverse myelitis. Plaintiffs Children Are Not Capable Making Informed Decisions Regarding HPV
Vaccinations
39.
There question that parents have constitutional due process right make
decisions concerning medical procedures for their children. Likewise, children have the right
gally rests presumption that parents possess what child lacks maturity, experience, and capacity for difficult decisions. Absent evidence abuse neglect,
parents are presumed best interests, and normally there reason for
the State inject itself into the private realm the family further question parent ability
make appropriate decisions about their child
40.
dment liberty interest familial
attention, and the child has corresponding right the love, comfort, and reassurance his
her parent while she receives medical care.
41.
Plaintiffs are committed parents who, like most parents, carefully oversee the
medical treatment their children. Plaintiffs believe that they their husbands are aware and
have been present for all medical procedures performed their children. Likewise, Plaintiffs
want know and present when their children undergo any medical procedure the future,
including receiving vaccine.
42.
Plaintiffs are especially concerned about vaccinations because their children have
experienced reactions prior vaccinations, including long after the vaccines were administered.
Ms. Gol
vaccination during which his
temperature exceeded 105 degrees, required multiple bags, and developed severe rash
including across his face. different occasion, P.K. experienced episode cellulitis from vaccine his thigh which became severely swollen and required multiple rounds antibiotics treat. Ms. Doell-
-year-old son had severe acute reaction prior vaccine
which included high fever, extreme lethargy, incessant screaming and inconsolable irritability;
ultimately suffered neurological issues result his reaction. Ms. Randello ten-year-old
son J.R. experienced severe reaction prior vaccine, which required active management
Ms. Randello for number days, and whose severity prompted her doctor conclude that her
son should not receive any further doses that particular vaccine.
son suffered
severe reaction including seizure from prior vaccine.
serious reaction the HPV vaccine which included being rushed the emergency room and she
has suffered intermittent and ongoing paralysis her legs from the HPV vaccine requiring use wheelchair, and when not paralyzed, has ongoing weakness her legs, impaired life functions,
and ongoing severe headaches, fatigue and nausea. Ms. Boyle Meyer reported this serious adverse
reaction the CDC through VAERS and nurse from the CDC contacted Ms. Boyle Meyer
confirm this was known reaction the HPV vaccine and
related the HPV vaccine.
43.
Plaintiffs are concerned that their children not have sufficient maturity assist
health care providers properly evaluating the risks associated with each vaccination
children are relatively young and not have sufficient knowledge inform healthcare
practitioner regarding their own medical histories, allergies, and potential contra-indications.
Likewise, Plaintiffs children not have the mental maturity articulate, properly recall
associate any reaction they may suffer result vaccination.
For example, Ms.
fifteen-year-old son has been diagnosed with intellectual disability and has impaired judgment
and maturity; typically incapable verbalizing any events, even positive ones, from his past
even with repeated prompting.
Ms. Gol
vaccination and untenable that her son could receive the Gardasil Gardasil-9 without least
her being present and able observe during the following hours and days for any reactions and
assure timely and proper management any such reaction.
reasons concerned about receiving vaccination, but not have sufficient mental maturity make informed decision
44.
The Consent Knowledge Rule implemented Defendant prevents Plaintiffs
from knowing that their child has received Gardasil Gardasil-9 and being present during the
procedure and decision making process leading that procedure. Without knowledge that
vaccines like Gardasil and Gardasil-9 have been injected into their children, Plaintiffs cannot
properly
Without Plaintiffs involvement, their children
could also receive additional unnecessary doses Gardasil Gardasil-9 their children have
already received this product and hence expose them the risk this product without any benefit.
Likewise, the Rule also prevents Plaintiffs from receiving the VIS for the product; without the
VIS, Plaintiffs may not aware the side effects and adverse reactions that they should
looking for, nor are they likely aware the VICP.
45. result, Plaintiffs are extremely concerned that one more their children
will injected with Gardasil Gardasil-9 without their consent knowledge, and that they will
not have sufficient information react timely fashion their child has adverse reaction
the vaccine.
CAUSES ACTION
COUNT U.S.C. 1983
DEPRIVATION RIGHTS AND PRIVILEGES SECURED FEDERAL LAW
46.
Plaintiffs incorporate the preceding paragraphs though set forth herein.
47.
The HPV vaccines Gardasil and Gardasil-9 manufactured Merck Co. were
added the Vaccine Injury Table February 2007, and information materials commonly
referred VISs for these products were created HHS required U.S.C. 300aa26(a).
48.
Pursuant U.S.C. 300aa-26(d),
rovider who administers
vaccine set forth the Vaccine Injury Table shall provide the legal representatives any child any other individual whom such provider intends administer such vaccine copy the
information materials developed pursuant subsection (a), supplemented with visual
presentations oral explanations, appropriate cases. Such materials shall provided prior
the administration such vaccine
49.
Hence, under Federal law, the VIS for Gardasil Gardasil-9 supplemented with
appropriate visual presentations oral explanations must provided the legal representative,
i.e., the parent legal guardian, child prior injecting such child with Gardasil Gardasil9.
50.
The VIS for Gardasil Gardasil-9 provide warnings regarding who should avoid also
VAERS and the VICP.
51. the extent that NYCRR 23.4 permits children injected with Gardasil Gardasil-9 without parental consent knowledge, deprives Plaintiffs and others similarly
situated their right pursuant U.S.C. 300aa-26 receive VIS for Gardasil Gardasil9 from the health care provider that intends inject their child with those vaccines, along with
appropriate additional information regarding those vaccines, before that health care provider
performs the injection.
52.
Accordingly, pursuant U.S.C. 2201 there actual case controversy
between the parties that requires this Court resolve, and Plaintiffs are entitled declaration
that NYCRR 23.4 violates Plaintiffs rights pursuant U.S.C. 300aa-26 the extent
that allows health care provider administer HPV vaccine without that health care provider
first giving
supplemented with any
appropriate visual presentations oral explanations.
53.
Further, Plaintiffs respectfully request that the Defendant enjoined from any
prospective conduct, enforcement, dissemination promotion NYCRR 23.4 intended
encourage permit administration HPV vaccine child without the health care provider
such HPV vaccine supplemented with any appropriate visual presentations oral explanations.
COUNT U.S.C. 1983
DEPRIVATION RIGHTS AND PRIVILEGES SECURED THE CONSTITUTION
PROCEDURAL DUE PROCESS
54.
Plaintiffs incorporate the preceding paragraphs though set forth herein.
55.
The Fourteenth Amendment the United States Constitution provides, relevant
56.
Among other things, due process law guarantees the citizenry that officers and
bodies the State will responsibly regulate government rules, programs and initiatives that may
interfere with life, liberty property.
57.
The State may not delegate its authority private actors unless the State proscribes
clear standards guide the conduct said private actors, and the State exercises reasonable
degree
58.
Plaintiffs have liberty interest with regard their children and the right
present and have knowledge when their children are being injected with product that could cause
serious injury death.
59.
Gardasil and Gardasil-9 are intended prevent HPV but also can have serious
adverse reactions including permanent disabilities and death.
60.
The Consent Knowledge Rule improperly delegates discretion private
actors determine when, where and how Plaintiffs children will injected with Gardasil
Gardasil-9 and even requires them withhold any knowledge such injection from Plaintiffs.
61.
The Defendant did not prescribe any standards govern when these private actors
can inject Gardasil Gardasil-9 into Plaintiffs children nor any assurance that these private actors
and possible contra-indications, nor are these private actors required monitor Plaintiffs children
for numerous days after injecting Gardasil Gardasil-9 assure symptoms appear which
would require timely attention.
62.
Therefore,
delegation power private actors inject Gardasil Gardasilwithout their consent knowledge violation the Fourteenth Amendment the United
States Constitution.
Permitting the regulation remain valid law would unlawful
deprivation the constitutional rights Plaintiffs. Plaintiffs thus also respectfully request that
the Defendant enjoined from any prospective conduct, enforcement, dissemination
promotion NYCRR 23.4 intended encourage permit administration HPV vaccine child without
COUNT III U.S.C. 1983
DEPRIVATION RIGHTS AND PRIVILEGES SECURED THE CONSTITUTION
SUBSTANTIVE DUE PROCESS
63.
Plaintiffs incorporate the preceding paragraphs though set forth herein.
64.
Most children, even adolescence, simply are not able make sound judgments
concerning many decisions, including their need for medical care treatment. Recognizing this
fundamental aspect the human condition, the law presumes that parents possess what child
lacks maturity, experience, and capacity for difficult
decisions, and therefore grants parents the constitutional right make all significant medical
decisions for their children.
65.
The State may not give parental decision-making authority adult healthcare
professionals, outside emergency other exigent circumstances.
The Fourteenth
Amendment Due Process Clause has substantive component that provides heightened
protection against government interference with certain fundamental rights and liberty interests, their children. There presumption that best interests; there normally reason for the State inject itself into the private realm the family further
heir children.
66.
Parents are presumed fit under the due process clause the Fourteenth
Amendment. Nevertheless, the Consent Knowledge Rule turns this presumption its head
assuming that parents are not able make appropriate decisions regarding the HPV vaccination.
67. effect, the Consent Knowledge Rule declares all parents the State
unfit make the decision regarding when their child will injected with the Gardasil Gardasil9 product, even know that this medical procedure has been performed their child.
68.
Therefore, Plaintiffs respectfully request declaration that Defendant Plaintiffs fundamental right make decisions concerning the care, custody, and control
their children permitting health care providers inject their minor children with Gardasil
Gardasil-9 without their consent knowledge violation the Fourteenth Amendment the
United States Constitution. Permitting the regulation remain valid law would unlawful
deprivation the constitutional rights Plaintiffs. Plaintiffs thus also respectfully request that
the Defendant enjoined from any prospective conduct, enforcement, dissemination
promotion NYCRR 23.4 intended encourage permit administration HPV vaccine child without
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs respectfully request that the Court enter judgment granting the
following relief:
(i)
Injunction pursuant U.S.C. 1983 and the Parte Young doctrine
enjoining Defendant from any prospective conduct, enforcement, dissemination promotion NYCRR 23.4 intended encourage permit
administration HPV vaccine child without the health care provider
guardian VIS for such HPV vaccine supplemented with any appropriate visual
presentations oral explanations;
(ii)
Declaration pursuant U.S.C. 2201 and 2202, and U.S.C. 1983 and
the Parte Young doctrine that NYCRR 23.4 violates Plaintiffs rights
pursuant U.S.C. 300aa-26 the extent that allows health care
provider administer HPV vaccine without that health care provider first
with any appropriate visual presentations oral explanations;
(iii)
Declaration pursuant U.S.C. 2201 and 2202, and U.S.C. 1983
and the Parte Young doctrine that NYCRR 23.4 unconstitutional
violation Procedural Due Process, violation the Fourteenth Amendment the United States Constitution, the extent permits Plaintiffs children injected with Gardasil Gardasil-9 without parental consent knowledge,
and injunction enjoining Defendant from any prospective conduct,
enforcement, dissemination promotion NYCRR 23.4 intended
encourage permit administration HPV vaccine child without the
(iv)
Declaration pursuant U.S.C. 2201 and 2202, and U.S.C. 1983 that
the Consent Knowledge Rule unconstitutional violation
Substantive Due Process, violation the Fourteenth Amendment the
United States Constitution, the extent permits Plaintiffs children
injected with Gardasil Gardasil-9 without parental consent knowledge,
and injunction enjoining Defendant from any prospective conduct,
enforcement, dissemination promotion NYCRR 23.4 intended
encourage permit administration HPV vaccine child without the and
(v)
Such other relief favor the Plaintiffs the Court deems just and proper,
action.
DEMAND FOR JURY TRIAL
Plaintiff demands trial jury this action all issues triable.
Dated: March 2017
SIRI GLIMSTAD LLP
______________________________
Aaron Siri
200 Park Avenue, 17th Floor
New York, New York 10166
Tel: (212) 532-1091
Attorneys for Plaintiffs