[Congressional Record Volume 151, Number 168 (Thursday, December 22, 2005)]
[Extensions of Remarks]
[Pages E2649-E2650]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 CONFERENCE REPORT ON H.R. 2863, DEPARTMENT OF DEFENSE APPROPRIATIONS 
                               ACT, 2006

                                 ______
                                 

                               speech of

                         HON. JOHN CONYERS, JR.

                              of michigan

                    in the house of representatives

                       Sunday, December 18, 2005

  Mr. CONYERS. 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

[[Page E2650]]

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 
     U.S. 356, 365 (1973).
       The serious constitutional issues raised by this 
     legislation deserve a full airing and counsels against any 
     rush to judgment by the Congress. Whatever the merits of the 
     bill's purposes, they may only be accomplished by 
     consideration that assures its constitutionality .
     Erwin Chemerinsky.

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