Politics - U. S. Congress
Senate Eyes Vaccine Liability Reform
Fri Nov 15, 4:50 PM ET


While senators debate shielding childhood vaccine makers from lawsuits,
the Bush administration already has provided such protection for at
least two vaccines key to the war on terrorism - smallpox and anthrax.

With little fanfare, President Bush  used an executive order to immunize
smallpox vaccine makers from lawsuits, officials say.  Under an order he
issued after last year's Sept. 11 terrorist attacks, the Department of
Health and Human Services can take on liability for companies it contracts
with to fight terrorism.

So far, the department has indemnified two companies providing smallpox
vaccine - Wyeth and Aventis Pasteur - and is working on an
arrangement with a third contractor, Acambis Baxter, agency spokesman
Bill Pierce said Friday. That means that if someone sues for negligence
over the vaccine, the department assumes liability rather than the
"We have asked them to do this for us for a program that we are running
and managing," Pierce said. "So, therefore, instead of them holding the
risk, we're holding the risk, since we are the ones driving this."
The smallpox vaccine hasn't been administered in the United States in
years, and the companies are back in the business of providing it only
because the government asked, Pierce said. The department isn't taking
on liability for the maker of Cipro or other anthrax treatments because
those products were already in the marketplace, he said.
Other government agencies involved in national defense have long had the
power to indemnify contractors; the Department of Defense for example,
has granted indemnity to Bioport, the maker of an anthrax vaccine. Bush's
executive order added the health department to the law allowing it.
While that drew little attention, a move this week to reduce liability
for vaccine makers - whether their shots are used to fight terrorism
or not - by the GOP-controlled House in legislation creating a
Homeland Security Department has brought strong opposition from several
Senate Democrats.
They promised Friday to try to take that provision out of the bill, and
accused Republicans of providing a last-minute reward to the
pharmaceutical industry, a major GOP political donor.
"Does this have anything at all to do with homeland security? The answer
is no," said Sen. Byron Dorgan (news, bio, voting record), D-N.D. "This
is bad legislation."
The Association of Trial Lawyers of America , a major Democratic donor,
also was lobbying to have the provision removed.  ATLA spokesman Carlton
Carl said it would directly affect parents who believe a child's autism was
caused by Thimerosal, a mercury-containing ingredient that used to be a
component of several childhood vaccines, Carl said.
The provision would require those who wish to sue former makers of
Thimerosal such as Eli Lilly to instead pursue their claims through a
federal vaccine compensation program that caps damages at $250,000, Carl
said. Medical research has not established a link between autism and
Thimerosal, but many parents believe the ingredient may be to blame and
are suing manufacturers.
"Ask a parent of an autistic child if $250,000 is going to take care of
that child's needs for the rest of his life and you will probably hear
that absolutely not," Carl said.
Richard Diamond, a spokesman for retiring House Majority Leader Dick
Armey, R-Texas, lead sponsor of the homeland security legislation, said
the provision affects pharmaceutical companies beyond those who made
Thimerosal and does have national security implications.
Diamond said that under the provision, if an ingredient is listed on a
vaccine label, the manufacturer cannot be held liable for something that
happens as a consequence of the ingredient. It's up to the physician
prescribing the vaccine to weigh the dangers involved, he said.
"We put that in there because if these companies are being sued by trial
lawyers, they are going to be reluctant to put life-saving medicines on
the market," Diamond said.
The White House and Republican leaders in the House and Senate supported
the provision, which first appeared in a proposal earlier this year by
Sen. Bill Frist , R-Tenn., though Frist did not add it to the homeland
security legislation, Diamond said.  Diamond declined to say who first
sought to have it added to the bill.  "There's a lot of stuff that gets
thrown into the mix," Diamond said.  "We'll take ultimate responsibility
for it."
Eli Lilly spokesman Edward Sagebiel said the company sought the language
when Frist first proposed his vaccine legislation, but had not lobbied
on it since. The Pharmaceutical Research and Manufacturers of America
also supported Frist's bill but did not lobby to have the vaccine
provision added to the homeland security bill, spokeswoman Jackie
Cottrell said.