Autistic children face lawsuit limits

St. Petersburg Times ^ | Nov. 16 | By SARA FRITZ

[kingedgars]

A measure slipped in the homeland security bill would mean those injured by childhood vaccines could collect only $250,000.

[kingedgars]

WASHINGTON -- If the long-awaited homeland security bill passes Congress next week as expected, it could mean a big setback for parents of autistic children like 4-year-old Nicholas Liu.

Kevin and Mache Liu are among the parents of some 150 autistic children who have filed suit against the drug industry in the past two years, alleging their children's conditions were caused by Thimerosal, a mercury preservative once included in childhood vaccines designed to prevent measles, mumps and rubella.

Although the bill is intended to create a federal Homeland Security Department, it includes a little-known, last-minute amendment that will effectively end legal battles for compensation from several major drug manufacturers.

The amendment would keep the lawsuits out of state courts, preventing huge judgments, and instead send complaints to a 14-year-old federal program limiting compensation for children who suffer side effects of vaccines to $250,000.

The amendment is one of more than a half-dozen tacked onto the bill. The homeland security bill has been agreed to by House and Senate leaders, but it is not expected to come to a final vote in the Senate until shortly before Congress adjourns next week.

Some Senate Democrats want to challenge the amendments, but that would be difficult because the House went home for the year after passing the bill. House members would have to be called back to Washington to approve the amended bill and get it to President Bush. House leaders have said they don't want to call representatives back.

"Does this have anything at all to do with homeland security? The answer is no," Sen. Byron Dorgan, D-N.D., told the Associated Press. "This is bad legislation."

As usual, nobody in Congress is taking direct responsibility for adding the drugmaker amendment, which will save the pharmaceutical industry millions, if not billions, of dollars.

Rep. Dick Armey, R-Texas, has denied reports that he wrote the amendment at the urging of White House officials. Armey's spokesman said it came from Sen. Bill Frist, R-Tenn. Frist's aides said that while he wrote a similar provision that never passed, he had nothing to do with putting it into the homeland security bill.

Executives of Eli Lilly & Co., a leading defendant in the parents' lawsuits, say they are pleased with the amendment but have no idea how it wound up being attached to the homeland security bill.

The pharmaceutical industry contributed more than $14-million to congressional candidates before the Nov. 5 election, more than three-quarters of it to Republicans. Lilly alone contributed $1.6-million, making it the most generous political donor in the industry. Democrats, meanwhile, were heavily backed by trial lawyers in this year's elections.

Attorneys for the autistic children were stunned to learn of the amendment.

"Holy smokes!" declared Jack Marstall, a lawyer in Louisiana.

"I guess my 4-year-old client represents a threat to homeland security," added Charles S. Siegel of Dallas.

"The industry has seized the opportunity presented by a Republican House and Senate to immediately pass legislation to get the industry off the hook," Dallas lawyer Andrew Waters told the Washington Post. "To me, it looks like payback for the fact that the industry spent millions bankrolling Republican campaigns."

Siegel's clients, the Liu family, are seeking compensation from the drug companies for medical and educational expenses, as well as for pain and suffering, on grounds the industry failed to warn parents of the potential danger of Thimerosal. No compensation figure is specified in their suit.

According to Siegel, Lilly executives told top White House officials recently that their company would not participate in the administration's program to produce smallpox vaccine unless it got immunity from suits filed by those who suffer from side effects of the vaccine.

Lilly spokesman Edward Sagbiel said the allegation was "absolutely false." He said the purpose of the amendment was to "stem the tide of frivolous lawsuits" filed by plaintiffs' lawyers against pharmaceutical and other industries.

Sidney Taurel, Lilly's chairman, president and chief executive, is a member of the White House Advisory Council on Homeland Security.

By executive order after Sept. 11, 2001, President Bush declared that makers of smallpox vaccine will be protected from any liability by the government if they are sued in the future for adverse reactions among patients. The administration has already indemnified Wyeth and Aventis Pasteur on that basis, and a third company is awaiting approval.

Both Sagbiel and Richard Diamond, spokesman for Armey, said the legislation was simply designed to clarify the intent of the 14-year-old National Childhood Vaccine Injury Act.

Lilly has not manufactured Thimerosal for 20 years, Sagbiel said, and the industry now relies on a different preservative in MMR vaccine. Medical research has not established a link between autism and Thimerosal.

Siegel said he does not understand why the drug industry needs help from Congress if their legal case is already so strong. "To say this is not an Eli Lilly bailout is ridiculous," he added.

Nicholas Liu of Pflugerville, Texas, was developing normally until he turned 16 months old, Siegel said. "Then he completely changed, as his parents say, retreating into his own world."

He said the parents are convinced the change was linked to the vaccine he received from his physician.

[dennisw]

This lawsuit isn't just for damages and medical expenses. It's for huge pain and suffering awards otherwise the big shot lawyers (greed head vultures) wouldn't be in on it. Sure the families should be made whole, but not by killing our drug companies with unwarranted claims. Let the vultures have their way and no new drugs will be developed by American companies and foreign companies won't do business here.

[TomB]

We were discussing this last night on another thread and I searched the Homeland Security Bill for the offending passages, but couldn't find them. Can you point me to the relevant parts?

[ventana]

There has to be balance, drug companies rush things to the market or pressure the system to use drugs/vaccines: Ritalin and the Hep Vaccine come to mind. Schools across the country innoculate children against Hep C, a disease found exclusively in high risk groups: gays; iv drug users; etc. It's a quick way to make a lot of money. And it may have adverse effects: linked to diabetes and autism. Shouldn't the public have a right of redress? I know you are not saying they should not, but don't be too quick to feel the big Pharmaceuticals pain. V's wife.

[fone]

|||Frist's aides said that while he wrote a similar provision that never passed, he had nothing to do with putting it into the homeland security bill.
Executives of Eli Lilly & Co., a leading defendant in the parents' lawsuits, say they are pleased with the amendment but have no idea how it wound up being attached to the homeland security bill |||

Feigning ignorance, both the schiester lobbiests and corrupt politicans have backbones made of jello: neither has the courage of their convictions.

[chance33_98]

scroll to last page.

[TomB]

Feigning ignorance, both the schiester lobbiests and corrupt politicans have backbones made of jello: neither has the courage of their convictions.

And, of course, the courageous trail lawyers are merely fighting for patients rights, and not the immense payouts they risk losing.

[TomB]

scroll to last page.

I read all the amendments, could you be a little more specific (like amendment number)?

[Moonman62]

Medical research has not established a link between autism and Thimerosal.

I like how this is stuck at the end of the article.

[chance33_98]

Section 304, though you need to read the whole section as it generally states smallpox vaccine. Not sure how to interpret it yet (still reading). Will post it here in a moment.

[fone]

yeah, right

[chance33_98]

SEC. 304. CONDUCT OF CERTAIN PUBLIC HEALTH-RELATED
ACTIVITIES. 19
(a) IN GENERAL.—With respect to civilian human 20
health-related research and development activities relating 21
to countermeasures for chemical, biological, radiological, 22
and nuclear and other emerging terrorist threats carried 23
out by the Department of Health and Human Services (in- 24
cluding the Public Health Service), the Secretary of 25
F:\V7\111302\111302.005
November 13, 2002 (5:17 AM)

75
H.L.C.
Health and Human Services shall set priorities, goals, ob- 1
jectives, and policies and develop a coordinated strategy 2
for such activities in collaboration with the Secretary of 3
Homeland Security to ensure consistency with the national 4
policy and strategic plan developed pursuant to section 5
302(2). 6
(b) EVALUATION OF PROGRESS.—In carrying out 7
subsection (a), the Secretary of Health and Human Serv- 8
ices shall collaborate with the Secretary in developing spe- 9
cific benchmarks and outcome measurements for evalu- 10
ating progress toward achieving the priorities and goals 11
described in such subsection. 12
(c) ADMINISTRATION OF COUNTERMEASURES 13
AGAINST SMALLPOX.—Section 224 of the Public Health 14
Service Act (42 U.S.C. 233) is amended by adding the 15
following: 16
‘‘(p) ADMINISTRATION OF SMALLPOX COUNTER- 17
MEASURES BY HEALTH PROFESSIONALS.— 18
‘‘(1) IN GENERAL.—For purposes of this sec- 19
tion, and subject to other provisions of this sub- 20
section, a covered person shall be deemed to be an 21
employee of the Public Health Service with respect 22
to liability arising out of administration of a covered 23
countermeasure against smallpox to an individual 24
F:\M7\ARMEY\ARMEY.038
F:\V7\111302\111302.005
November 13, 2002 (5:17 AM)



76
H.L.C.
during the effective period of a declaration by the 1
Secretary under paragraph (2)(A). 2
‘‘(2) DECLARATION BY SECRETARY CON- 3
CERNING COUNTERMEASURE AGAINST SMALLPOX.— 4
‘‘(A) AUTHORITY TO ISSUE DECLARA- 5
TION.— 6
‘‘(i) IN GENERAL.—The Secretary 7
may issue a declaration, pursuant to this 8
paragraph, concluding that an actual or 9
potential bioterrorist incident or other ac- 10
tual or potential public health emergency 11
makes advisable the administration of a 12
covered countermeasure to a category or 13
categories of individuals. 14
‘‘(ii) COVERED COUNTERMEASURE.— 15
The Secretary shall specify in such dec- 16
laration the substance or substances that 17
shall be considered covered counter- 18
measures (as defined in paragraph (8)(A)) 19
for purposes of administration to individ- 20
uals during the effective period of the dec- 21
laration. 22
‘‘(iii) EFFECTIVE PERIOD.—The Sec- 23
retary shall specify in such declaration the 24
beginning and ending dates of the effective 25
F:\M7\ARMEY\ARMEY.038
F:\V7\111302\111302.005
November 13, 2002 (5:17 AM)



77
H.L.C.
period of the declaration, and may subse- 1
quently amend such declaration to shorten 2
or extend such effective period, provided 3
that the new closing date is after the date 4
when the declaration is amended. 5
‘‘(iv) PUBLICATION.—The Secretary 6
shall promptly publish each such declara- 7
tion and amendment in the Federal Reg- 8
ister. 9
‘‘(B) LIABILITY OF UNITED STATES ONLY 10
FOR ADMINISTRATIONS WITHIN SCOPE OF DEC- 11
LARATION.—Except as provided in paragraph 12
(5)(B)(ii), the United States shall be liable 13
under this subsection with respect to a claim 14
arising out of the administration of a covered 15
countermeasure to an individual only if— 16
‘‘(i) the countermeasure was adminis- 17
tered by a qualified person, for a purpose 18
stated in paragraph (7)(A)(i), and during 19
the effective period of a declaration by the 20
Secretary under subparagraph (A) with re- 21
spect to such countermeasure; and 22
‘‘(ii)(I) the individual was within a 23
category of individuals covered by the dec- 24
laration; or 25
F:\M7\ARMEY\ARMEY.038
F:\V7\111302\111302.005
November 13, 2002 (5:17 AM)



78
H.L.C.
‘‘(II) the qualified person admin- 1
istering the countermeasure had reasonable 2
grounds to believe that such individual was 3
within such category. 4
‘‘(C) PRESUMPTION OF ADMINISTRATION 5
WITHIN SCOPE OF DECLARATION IN CASE OF 6
ACCIDENTAL VACCINIA INOCULATION.— 7
‘‘(i) IN GENERAL.—If vaccinia vaccine 8
is a covered countermeasure specified in a 9
declaration under subparagraph (A), and 10
an individual to whom the vaccinia vaccine 11
is not administered contracts vaccinia, 12
then, under the circumstances specified in 13
clause (ii), the individual— 14
‘‘(I) shall be rebuttably presumed 15
to have contracted vaccinia from an 16
individual to whom such vaccine was 17
administered as provided by clauses 18
(i) and (ii) of subparagraph (B); and 19
‘‘(II) shall (unless such presump- 20
tion is rebutted) be deemed for pur- 21
poses of this subsection to be an indi- 22
vidual to whom a covered counter- 23
measure was administered by a quali- 24
fied person in accordance with the 25
F:\M7\ARMEY\ARMEY.038
F:\V7\111302\111302.005
November 13, 2002 (5:17 AM)



79
H.L.C.
terms of such declaration and as de- 1
scribed by subparagraph (B). 2
‘‘(ii) CIRCUMSTANCES IN WHICH PRE- 3
SUMPTION APPLIES.—The presumption 4
and deeming stated in clause (i) shall 5
apply if— 6
‘‘(I) the individual contracts 7
vaccinia during the effective period of 8
a declaration under subparagraph (A) 9
or by the date 30 days after the close 10
of such period; or 11
‘‘(II) the individual resides or has 12
resided with an individual to whom 13
such vaccine was administered as pro- 14
vided by clauses (i) and (ii) of sub- 15
paragraph (B) and contracts vaccinia 16
after such date. 17
‘‘(3) EXCLUSIVITY OF REMEDY.—The remedy 18
provided by subsection (a) shall be exclusive of any 19
other civil action or proceeding for any claim or suit 20
this subsection encompasses. 21
‘‘(4) CERTIFICATION OF ACTION BY ATTORNEY 22
GENERAL.—Subsection (c) applies to actions under 23
this subsection, subject to the following provisions: 24
F:\M7\ARMEY\ARMEY.038
F:\V7\111302\111302.005
November 13, 2002 (5:17 AM)

[HiTech RedNeck]

Sure the families should be made whole, but not by killing our drug companies with unwarranted claims.

If the stuff DOES cause child autism, $250K is not going to pay for the lifelong maintenance, let alone any pain-and-suffering claims. The families will be bankrupted and thrown on welfare.

[chance33_98]

oops - sorry, did not mean to hit Post yet, was trying to format :( At any rate, I think they were using that as a basis and links to 'remedy' in other places may well expand on that. Let me know if you come up with anything or if this is just a boogeyman :)

[chance33_98]

Hey when you get up and get some coffee going would you throw on a robe and delete my #12 please? I will repost pertinent parts with better formatting (unless I get busy here at work). Thanks!

[dennisw]

If the stuff DOES cause child autism, $250K is not going to pay for the lifelong maintenance, let alone any pain-and-suffering claims. The families will be bankrupted and thrown on welfare.

True. I can only wonder what kind of compensation the lawyers and victims are seeking. 10 or 20 million per autistic child? And does the substance actually cause autism?

[TomB]

Everything there says that the liability is limited to smallpox. Is there something else?

(B) LIABILITY OF UNITED STATES ONLY 10 FOR ADMINISTRATIONS WITHIN SCOPE OF DEC- 11 LARATION.—Except as provided in paragraph 12 (5)(B)(ii), the United States shall be liable 13 under this subsection with respect to a claim 14 arising out of the administration of a covered 15 countermeasure to an individual only if—

[End The Hypocrisy]

Well said. There are some myths floating around about how the vultures are supposedly the consumer rights' advocates, not the insurance companies that don't even want to pay when they're obligated to. Isn't it hypocritical, for example, how the medical profession complains that there aren't enough doctors because of lawyers, when in fact the medical profession severely restricts membership? Overseas one can get a medical degree as an undergraduate, and for a lot less money and suffering. In the USA, reliable academic sources have revealed just how few medical students are in the industry for anything but the money. And only 1 in 4 med. malpractice lawsuits results in a favorable award for the plaintiff. Think how much worse those cold & calculating doctors would be if they didn't have such a disincentive though.

For more statistical details:

http://www.atla.org/medmal

Does our Republican Party really want to become known as the party of corporate impunity?

[PGalt]

Interesting post, thanks.

[TomB]

Sorry, I missed your other post. No I've read through it a few times, and I still can't find the offending passage.

It's funny, I've seen at least 3 articles and heard a radio report on this in the past 24 hours and they all say the same thing but don't mention the specific amendment.