Action Alert from Chairman Burton Re: Homeland Security Bill- -Message from Jeff Sell
Ladies & Gentlemen:
I just spoke with Beth Clay of the Committee on Government Reform.
Chairman Burton, Beth and others have been working all night to remedy the situation that we now face as a result of some late night, backroom brokering that placed certain anti-child provisions in the Homeland Security Bill.
Talking Points below!!!
So, here is the plan:
1. Contact Alan Gilbert at the White House and express your concerns NOW--
The White House Phone Numbers
COMMENTS: 202-456-1111
SWITCHBOARD: 202-456-1414
FAX: 202-456-2461
Apparently Anne Phelps left - she is out on maternity leave (and maybe permanently) - Alan Gilbert is a special advisor to the President and is filling in for her.
2. Contact Sen. Trent Lott's staff (Chairman Burton is meeting with Sen. Lott at this very moment.) He must here from us is large numbers. Go to Google or any search engine and simply type in "Sen. Trent Lott" for his contact info). I am on my laptop so I don't have access to my files--sorry.
As they say within the Navy Seals--"MOVE, MOVE, MOVE, MOVE, MOVE!"
Thank You.
Peacefully,
Jeff Sell
Hitt Patterson Sell
4309 Yoakum Blvd.
Suite 2000
Houston, Texas 77006
www.HittPattersonSell.com
JZSell@HittPattersonSell.com
713.654.7776
713.654.7789 (fax)
jzsell@pdq.net (home)
832.731.3145 (cell/v-mail)
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Homeland Security Bill
Problematic Provisions that Need Senate Action
HR 5710, the Homeland Security Act of 2002 passed the House on November 13.
Several provisions, not germane to the Legislation were inserted without the knowledge of some who voted to approve this Bill - and without discussion or
debate. Given the contentious nature and the significant reprocustiosn of these provisions, it would be prudent to remove Sections 1714, 1715, 1716
and Section 304 from the Senate Bill. These issues, all public health related, should be taken up for full discussion, debate and public input in the new 108th Congress.
These amendments to the National Vaccine Injury Compensation Act do not protect us from a terrorist threat against our country, instead the effect of these amendments serves only to protect large domestic chemical companies from potential civil liability to hundreds of thousands of vaccine injured children in the United States. Amending the Vaccine Act through this legislation is inappropriate.
The compensation program was created through an excise tax from the sale of vaccines, the chemical companies who manufacture components of vaccines such as thimerosal do not contribute to this fund. In fact, they are being offered a free ride, no liability, no discussion and debate, no opportunity for the public or the Special Masters who hear these cases to weigh in.
Proposed Changes - bolded sections are the proposed inserts)
TITLE 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE
SUBCHAPTER XIX - VACCINES
Part 2 - National Vaccine Injury Compensation Program subpart d -general provisions
Sec. 300aa-33. Definitions
-STATUTE-
For purposes of this part:
(1) The term ''health care provider'' means any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and
instrumentalities) under whose authority a vaccine set forth in the Vaccine Injury Table is administered.
(2) The term ''legal representative'' means a parent or an individual who qualifies as a legal guardian under State law.
(3) The term ''manufacturer'' means any corporation, organization, or institution, whether public or private (including Federal, State, and local
departments, agencies, and instrumentalities),
which manufactures, imports, processes, or distributes under its label any vaccine set forth in the Vaccine Injury Table, any vaccine set forth in the Vaccine Injury table, including any component or ingredient of any such vaccine except that, for purposes of section 300aa-28 of this title, such term shall include the manufacturer of any other vaccine covered by that
section. The term ''manufacture'' means to manufacture, import, process, or distribute a vaccine including any component or ingredient of any such
vaccine.
(4) The term ''significant aggravation'' means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or
illness accompanied by substantial deterioration of health.
(5) The term ''vaccine-related injury or death'' means an illness, injury, condition, or death associated with one or more of the vaccines set forth in
the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant
intentionally added to such a vaccine.
(6)(A) The term ''Advisory Commission on Childhood Vaccines'' means the Commission established under section 300aa-19 of this title.
(B) The term ''Vaccine Injury Table'' means the table set out in section 300aa-14 of this title.
(7) The term `vaccine' means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or
administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the
vaccines's product license application and product label.
Effective Date:
The amendments made by sections 1714, 1715, and 1716 shall apply to all actions or proceedings pending on or after the date of enactment of this Act, unless a court of competent jurisdiction has entered judgment
(regardless of whether the time for appeal has expired) in such action or proceeding disposing of the entire action or proceeding.
What Does This Mean?
Inserting this provision in, and including the effective date effectively stops all ongoing litigation against manufacturers of thimerosal and any
other vaccine component. For the families of vaccine injured children who were poisoned with mercury-containing thimerosal and who ended up with
neurological damage leading to autism, (many of whom will not be able to come through the NVICP because of the statute of limitations), they will lose all legal recourse. This is simply unfair. Without the six-year
statute of limitation and the two-year look back provision, this provision is unacceptable. The Congress needs to think first of protecting the
children and families - especially those children who have been injured through mercury-containing thimerosal. It is important to remember that
symptoms of mercury toxicity are similar to the symptoms of autism AND that the FDA never required the manufacturers of thimerosal or newly developed
vaccines to prove it was safe through clinical trials. The only study on this was done in 1929 on about 22 dying meningitis patients. Subsequent research showed that thimerosal's components are highly allergic in up to 35% of the population and that there is at least a two week delay in the onset of illness. Thimerosal is known to cause kidney and central nervous system damage.
SEC. 1714. CLARIFICATION OF DEFINITION OF MANUFACTURER.
Section 2133(3) of the Public Health Service Act (42 U.S.C.
300aa-33(3)) is amended--
(1) in the first sentence, by striking `under its label any vaccine set forth in the Vaccine Injury Table' and inserting `any vaccine set forth
in the Vaccine Injury table, including any component or ingredient of any such vaccine'; and
(2) in the second sentence, by inserting `including any component or ingredient of any such vaccine' before the period.
SEC. 1715. CLARIFICATION OF DEFINITION OF VACCINE-RELATED INJURY OR DEATH.
Section 2133(5) of the Public Health Service Act (42 U.S.C. 300aa-33(5)) is amended by adding at the end the following: `For purposes of the preceding sentence, an adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label.'.
SEC. 1716. CLARIFICATION OF DEFINITION OF VACCINE.
Section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33)
is amended by adding at the end the following:
`(7) The term `vaccine' means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed
or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccines's product license application and product label.'.
SEC. 1717. EFFECTIVE DATE.
The amendments made by sections 1714, 1715, and 1716 shall apply to all actions or proceedings pending on or after the date of enactment of this Act, unless a court of competent jurisdiction has entered judgment
(regardless of whether the time for appeal has expired) in such action or proceeding disposing of the entire action or proceeding.
Section 304 does not belong in the Homeland Security Bill. There is major concern about the vague nature of the language of this section. Given that smallpox is the most dangerous vaccine - with known significant serious side effects and many that are likely not known, there needs to be full discussion and debate on this section prior to amending the Vaccine Injury
Compensation Program.
SEC. 304. CONDUCT OF CERTAIN PUBLIC HEALTH-RELATED ACTIVITIES.
(a) IN GENERAL- With respect to civilian human health-related research and development activities relating to countermeasures for chemical, biological, radiological, and nuclear and other emerging terrorist
threats carried out by the Department of Health and Human Services (including the Public Health Service), the Secretary of Health and Human Services shall set priorities, goals, objectives, and policies and develop a coordinated strategy for such activities in collaboration with the Secretary of Homeland Security to ensure consistency with the national policy and
strategic plan developed pursuant to section 302(2).
(b) EVALUATION OF PROGRESS- In carrying out subsection (a), the Secretary of Health and Human Services shall collaborate with the Secretary in developing specific benchmarks and outcome measurements for evaluating
progress toward achieving the priorities and goals described in such subsection.
(c) ADMINISTRATION OF COUNTERMEASURES AGAINST SMALLPOX- Section 224 of the Public Health Service Act (42 U.S.C. 233) is amended by adding the following:
`(p) ADMINISTRATION OF SMALLPOX COUNTERMEASURES BY HEALTH PROFESSIONALS-
`(1) IN GENERAL- For purposes of this section, and subject to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an individual during the effective period of a declaration by the Secretary under paragraph (2)(A).
`(2) DECLARATION BY SECRETARY CONCERNING COUNTERMEASURE AGAINST SMALLPOX-
`(A) AUTHORITY TO ISSUE DECLARATION-
`(i) IN GENERAL- The Secretary may issue a declaration, pursuant to this paragraph, concluding that an actual or potential bioterrorist incident
or other actual or potential public health emergency makes advisable the administration of a covered countermeasure to a category or categories of
individuals.
`(ii) COVERED COUNTERMEASURE- The Secretary shall specify in such declaration the substance or substances that shall be considered covered
countermeasures (as defined in paragraph (8)(A)) for purposes of administration to individuals during the effective period of the declaration.
`(iii) EFFECTIVE PERIOD- The Secretary shall specify in such declaration the beginning and ending dates of the effective period of the declaration, and may subsequently amend such declaration to shorten or
extend such effective period, provided that the new closing date is after the date when the declaration is amended.
`(iv) PUBLICATION- The Secretary shall promptly publish each such declaration and amendment in the Federal Register.
`(B) LIABILITY OF UNITED STATES ONLY FOR ADMINISTRATIONS WITHIN SCOPE OF DECLARATION- Except as provided in paragraph (5)(B)(ii), the United
States shall be liable under this subsection with respect to a claim arising out of the administration of a covered countermeasure to an individual only
if--
`(i) the countermeasure was administered by a qualified person, for a purpose stated in paragraph (7)(A)(i), and during the effective period of a declaration by the Secretary under subparagraph (A) with respect to such countermeasure; and
`(ii)(I) the individual was within a category of individuals covered by the declaration; or
`(II) the qualified person administering the countermeasure had reasonable grounds to believe that such individual was within such category.
`(C) PRESUMPTION OF ADMINISTRATION WITHIN SCOPE OF DECLARATION IN CASE OF ACCIDENTAL VACCINIA INOCULATION-
`(i) IN GENERAL- If vaccinia vaccine is a covered countermeasure specified in a declaration under subparagraph (A), and an individual to whom the vaccinia vaccine is not administered contracts vaccinia, then, under the circumstances specified in clause (ii), the individual--
`(I) shall be rebuttably presumed to have contracted vaccinia from an individual to whom such vaccine was administered as provided by clauses (i) and (ii) of subparagraph (B); and
`(II) shall (unless such presumption is rebutted) be deemed for purposes of this subsection to be an individual to whom a covered countermeasure was administered by a qualified person in accordance with the terms of such declaration and as described by subparagraph (B).
`(ii) CIRCUMSTANCES IN WHICH PRESUMPTION APPLIES- The presumption and deeming stated in clause (i) shall apply if--
`(I) the individual contracts vaccinia during the effective period of a declaration under subparagraph (A) or by the date 30 days after the close of such period; or
`(II) the individual resides or has resided with an individual to whom such vaccine was administered as provided by clauses (i) and (ii) of subparagraph (B) and contracts vaccinia after such date.
`(3) EXCLUSIVITY OF REMEDY- The remedy provided by subsection (a) shall be exclusive of any other civil action or proceeding for any claim or suit this subsection encompasses.
`(4) CERTIFICATION OF ACTION BY ATTORNEY GENERAL- Subsection (c) applies to actions under this subsection, subject to the following provisions:
`(A) NATURE OF CERTIFICATION- The certification by the Attorney General that is the basis for deeming an action or proceeding to be against the United States, and for removing an action or proceeding from a State
court, is a certification that the action or proceeding is against a covered person and is based upon a claim alleging personal injury or death arising
out of the administration of a covered countermeasure.
`(B) CERTIFICATION OF ATTORNEY GENERAL CONCLUSIVE- The certification of the Attorney General of the facts specified in subparagraph (A) shall conclusively establish such facts for purposes of jurisdiction pursuant to this subsection.
`(5) DEFENDANT TO COOPERATE WITH UNITED STATES-
`(A) IN GENERAL- A covered person shall cooperate with the United States in the processing and defense of a claim or action under this subsection based upon alleged acts or omissions of such person.
`(B) CONSEQUENCES OF FAILURE TO COOPERATE- Upon the motion of the United States or any other party and upon finding that such person has failed to so cooperate--
`(i) the court shall substitute such person as the party defendant in place of the United States and, upon motion, shall remand any such suit to the court in which it was instituted if it appears that the court lacks subject matter jurisdiction;
`(ii) the United States shall not be liable based on the acts or omissions of such person; and
`(iii) the Attorney General shall not be obligated to defend such action.
`(6) RECOURSE AGAINST COVERED PERSON IN CASE OF GROSS MISCONDUCT OR CONTRACT VIOLATION-
`(A) IN GENERAL- Should payment be made by the United States to any claimant bringing a claim under this subsection, either by way of administrative determination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover for that portion of the damages so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any covered person to carry out any obligation or responsibility assumed by such person under a contract with the United States or from any grossly negligent, reckless, or illegal conduct or willful misconduct on the part of such person.
`(B) VENUE- The United States may maintain an action under this paragraph against such person in the district court of the United States in which such person resides or has its principal place of business.
`(7) DEFINITIONS- As used in this subsection, terms have the following meanings:
`(A) COVERED COUNTERMEASURE- The term `covered countermeasure', or
`covered countermeasure against smallpox', means a substance that is--
`(i)(I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or
`(II) vaccinia immune globulin used to control or treat the adverse effects of vaccinia inoculation; and
`(ii) specified in a declaration under paragraph (2).
`(B) COVERED PERSON- The term `covered person', when used with respect to the administration of a covered countermeasure, includes any person who is--
`(i) a manufacturer or distributor of such countermeasure;
`(ii) a health care entity under whose auspices such countermeasure was administered;
`(iii) a qualified person who administered such countermeasure; or
(iv) an official, agent, or employee of a person described in clause (i), (ii), or (iii).
`(C) QUALIFIED PERSON- The term `qualified person', when used with respect to the administration of a covered countermeasure, means a licensed health professional or other individual who is authorized to administer such countermeasure under the law of the State in which the countermeasure was administered.'.
Vaccine Injury Compensation Program Investigation and Proposed Legislation
The Committee on Government Reform, over the last two years has conducted an extensive investigation into the Vaccine Injury Compensation Program. After six months of negotiations, on February 13, Chairman Dan Burton and Ranking Minority Member Henry Waxman in collaboration with Congressman (and physician) Dave Weldon, and broad bipartisan group of Congressmen introduced, HR 3471, the National Vaccine Injury Compensation Program Improvement Act of 2002.
This Bill would:
* Increase compensation for future lost earnings for injured children. Under current law, compensation is based o the average weekly earnings of full and part-time workers as determined by the Bureau of Labor Statistics. This bill would specify that only full-time workers should be used in the calculation.
* Increase the level of compensation to a family after a vaccine-related death from $250,000 to $300,000. The death benefit has remained unchanged since the program's inception in 1986.
* Allow families of vaccine-injured children to be compensated for the costs of family counseling and creating and maintaining a guardianship to administer the funds.
* Allow for the payment of interim attorneys fees and legal costs while a petition is being adjudicated. The costs of assembling the necessary medical records and obtaining expert witnesses are substantial.
Under current law, these costs, as will as attorney's fees, are not reimbursed until a case is fully resolved, which oftentimes takes years..
* Extend the statute of limitations for seeking compensation to six years from the date of injury. Under current law, families must file within two years of a child's death or three years of a child's injury.
* Provide a one-time, two-year period for families to file a petition if they were previously excluded from doing so because they missed the statute of limitations.
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