Mr. Speaker, I rise in opposition to the legislation. Specifically, I oppose the avian flu liability provision which provides sweeping blanket immunity for the drug companies while again leaving American citizens unprotected. This…
Mr. Speaker, I rise in opposition to the legislation. Specifically, I oppose the avian flu liability provision which provides sweeping blanket immunity for the drug companies while again leaving American citizens unprotected. This legislation, which appears both unconstitutional and contrary to federalism, has not been reviewed by any committee of jurisdiction. In fact, this language was added to the Department of Defense Appropriations Conference Report in the middle of the night, long after the conferees approved the bill.
Under the current provision, punitive damages for any claims are barred, allowing for no corporate liability. Drug companies that engaged in the worst kinds of abuses could not be penalized by juries. In addition, the legislation limits the total liability of any manufacturer or distributor. The result is no out of pocket payments by reckless corporations and no real recovery for injured citizens.
Consider this example: The Secretary of Health and Human Services declares a potential public health emergency and designates a vaccine as a countermeasure. Later production of the vaccine demonstrates that the vaccine has vast problems with its potency and may render the vaccine harmful. With this knowledge, the company still sends the vaccine to thousands of distributors and when it is administered, the result is numerous deaths. Under this provision, families who are trying to gain compensation for their losses are left without recourse.
This provision requires that before an injured person can pursue a claim, the Secretary of HHS must determine, by clear and convincing evidence, that there was willful misconduct on the part of the manufacturer, distributor, or administrator of a covered product. First, this would insure that no injured person, including first responders and medical personnel, would have coverage. Second, it is doubtful that ``willful misconduct,'' which is defined as actual knowledge that a covered product would cause harm, could actually be proven. Third, even if an injured victim proved willful misconduct by clear and convincing evidence, the massive tort reform such as no punitive damages and capped non-economic damages would severely limit any compensation.
In addition, this portion of the conference report applies to a wide range of drugs, vaccines, and other products. The provision does
not limit its application to only new drugs or vaccines used in a pandemic context. Instead, it applies to any ``drug, biological product or device'' that is used to treat or cure a pandemic, epidemic or limit the harm that a pandemic or epidemic might cause. As drafted, this legislation would include drugs such as Tylenol or AdviI.
Finally, the conference report falsely claims to establish a compensation process. This ``compensation process'', under the sole direction of the Secretary of HHS, is governed by regulations created by the Secretary alone and includes caps on compensation awards. Further, no monies have been appropriated for the fund and consequently, the ``compensation process'' is whole inoperable. The provision has no true compensation program.
Attached to my statement is a letter from Professor Erwin Chemerinsky, Alston & Bird Professor at the Duke University School of Law which further outlines the problems and issues concerning this preparedness provision. Instead of putting the burden on the victim by cutting compensation and protecting the drug manufacturers, we must ensure corporate accountability and protection for our citizens. I strongly urge a ``no'' vote.
Alston & Bird Professor of Law and Political Science,
Duke University School of Law,
December 20, 2005.
Dear Senator: I understand that the Congress is considering
legislation that has been denominated as the ``Public
Readiness and Emergency Preparedness Act.'' This legislation
would give the Secretary of Health and Human Services
extraordinary authority to designate a threat or potential
threat to health as constituting a public health emergency
and authorizing the design, development, and implementation
of countermeasures, while providing total immunity for
liability to all those involved in its development and
administration. In addition to according unfettered
discretion to the Secretary to grant complete immunity from
liability, the bill also deprives all courts of jurisdiction
to review those decisions. Sec. (a)(7). I write to alert the
Congress to the serious constitutional issues that the
legislation raises.
First, the bill is of questionable constitutionality
because of its broad, unfettered delegation of legislative
power by Congress to the executive branch of government.
Under the nondelegation doctrine, Congress may provide
another branch of government with authority over a subject
matter, but ``cannot delegate any part of its legislative
power except under the limitation of a prescribed standard.''
United States v. Chicago, M., St. P. & P.R. Co., 282 U.S.
311, 324 (1931). Recently, the Supreme Court endorsed Chief
Justice Taft's description of the doctrine: ``the
Constitution permits only those delegations where Congress
`shall lay down by legislative act an intelligible principle
to which the person or body authorized to [act] is directed
to conform.' '' Clinton v. City of New York, 524 U.S. 417,
484 (1998)(emphasis in original), quoting J.W. Hampton, Jr.,
& Co. v. United States, 276 U.S. 394, 409 (1928). The breadth
of authority granted the Secretary without workable
guidelines from Congress appears to be the type of
``delegation running riot'' that grants the Secretary a
``roving commission to inquire into evils and upon discovery
correct them'' of the type condemned by Justice Cardozo in
A.L.A. Schechter Poultry Corp. v. United States, 295 U.S.
495, 553 (1935)(Cardozo, J., concurring).
Second, the bill raises important federalism issues because
it sets up an odd form of federal preemption of state law.
All relevant state laws are preempted. Sec. (a)(8). However,
for the exttemely narrow instance of willful (knowing)
misconduct by someone in the stream of commerce for a
countermeasure the bill establishes that the substantive law
is the law of the state where the injury occurred, unless
preempted. Sec. (e)(2). The sponsors appear to be trying to
have it both ways, which may not be constitutionally
possible. The bill anticipates what is called express
preemption, because the scope of any pennissible lawsuits is
changed from a state-based to a federally based cause of
action. See Beneficial Nat'l Bank v. Anderson, 539 U.S. 1, 8
(2003).
Usually, that type of ``unusually 'powerful' '' preemptive
statute provides a remedy for any plaintiff's claim to the
exclusion of state remedies. Id. at 7 (citation omitted).
Here, rather than displace state law in such instances, the
bill adopts the different individual laws of the various
states, but amends them to include a willful
misconduct standard that can only be invoked if the
Secretary or Attorney General initiates an enforcement
action against those involved in the countermeasure and
that action is either pending at the time a claim is filed
or concluded with some form of punishment ordered.
Such a provision raises two important constitutional
concerns. One problem is that this hybrid form of preemption
looks less like an attempt to create a federal cause of
action than an direct attempt by Congress to amend state law
in violation of Erie Railroad Co. v. Tompkins, 304 U.S. 64
(1938) and basic principles of federalism. Although Congress
may preempt state law under the Supremacy Clause by creating
a different and separate federal rule, see Crosby v. Nat'l
Foreign Trade Counc., 530 U.S. 363, 372 (2000), it may not
directly alter, amend, or negate the content of state law as
state law. That power, the Erie Court declared, ``reserved by
the Constitution to the several States.'' 304 U.S. at 80. It
becomes clear that the bill attempts to amend state law,
rather than preempt it with a federal alternative, when one
realizes that States will retain the power to enact new
applicable laws or amend existing ones with a federal overlay
that such an action may only be commenced in light of a
federal enforcement action and can only succeed when willful
misconduct exists. The type of back and forth authority
between the federal and state governments authorized by the
bill fails to constitute a form of constitutionally
authorized preemption.
The other problem with this provision is that the
unfettered and unreviewable discretion accorded the Secretary
or Attorney General to prosecute an enforcement action as a
prerequisite for any action for willful misconduct violates
the constitutional guarantee of access to justice, secured
under both the First Amendment's Petition Clause and the
Fifth Amendment's Due Process Clause. See Christopher v.
Harbury, 536 U.S. 403, 415 n. 12 (2002). In fact, the Court
has repeatedly recognized that that ``the right of access to
the courts is an aspect of the First Amendment right to
petition the Government for redress of grievances.'' Bill
Johnson's Restaurants v. NLRB, 461 U.S. 731. 741 (1983),
citing California Motor Transport Co . v. Trucking Unlimited,
404 U.S. 508, 510 (1972). First Amendment rights, the Supreme
Court has said in a long line of precedent, cannot be
dependent on the ``unbridled discretion'' of government
officials or agencies. See, e.g., City of Lake wood v. Plain
Dealer Pub. Co., 486 U.S. 750, 757 (1988). At the same time,
the Due Process Clause guarantees a claimant an opportunity
to be heard ``at a meaningful time and in a meaningful
manner.'' Armstrong v. Manzo, 380 U.S. 545, 552 (1965). The
obstacles placed before a claimant, including the insuperable
one of inaction by the Secretary or Attorney General, raise
significant due process issues. The Supreme Court has
recognized that official inaction cannot prevent a claimant
from being able to go forth with a legitimate lawsuit. See
Logan v. Zimmerman Brush Co., 455 U.S. 422 (1982). The
proposed bill seems to reverse that constitutional
imperative.
Third, the complete preclusion of judicial review raises
serious constitutional issues. The Act, through Sec. 319F-
3(b)(7), expressly abolishes judicial review of the
Secretary's actions, ordaining that ``[n]o court of the
United States, or of any State, shall have subject matter
jurisdiction,'' i.e., the power, ``to review . . . any action
of the Secretary regarding'' the declaration of emergencies,
as well as the determination of which diseases or threats to
health are covered, which individual citizens are
protected, which geographic areas are covered, when an
emergency begins, how long it lasts, which state laws
shall be preempted, and when or if he shall report to
Congress.
The United States Supreme Court has repeatedly stressed
that the preclusion of all judicial review raises ``serious
questions'' concerning separation of powers and due process
of law. See, e.g., Johnson v. Robison, 415 U.S. 361 (1974);
see also, Oestereich v. Selective Service System Local Board
No. 14, 393 U.S. 233 (1968); McNary v. Haitian Refugee
Center, Inc., 498 U.S. 479 (1991); Reno v. Catholic Social
Services, 509 U.S. 43 (1993). Judicial review of government
actions has long regarded as ``an important part of our
constitutional traditional'' and an indispensable feature of
that system,'' Lehnhausen v. Lake Shore Auto Parts Co., 410