Katherine Watt
Mar 17, 2025
Edwin Chemerinsky submitted a letter, dated Dec. 20, 2005, to Senator Patrick Leahy, which was entered into the Congressional Record dated Dec. 21, 2005.
2005.12.21 Congressional Record PREP Act discussion S14233 to 14240
2005.12.21 Congressional Record PREP Act discussion S14241 to 14254 Chemerinsky
2005.12.21 PREP Act Senate Roll Call
2005.12.30 Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act – PL 109-148, 119 Stat. 2818. Synopsis from Bailiwick American Domestic Bioterrorism Program timeline: “…Division C at last 14 pages: Public Readiness and Emergency Preparedness (PREP) Act. Amended Public Health Service Act. Established power of Secretary of Health and Human Services, during self-declared public health emergency under Section 319, to unilaterally issue declarations recommending “manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures.” Codified at 42 USC 247d-6d(b). Added more detail on liability shields for pandemic and epidemic products and security countermeasures. Set pre-suit hurdle requiring HHS to first bring claims against defendants, and bar private claims until after HHS claims resolved…Set liability standard at willful misconduct, “establishing a standard…more stringent than negligence in any form or recklessness,” requiring proof defendant 1) intentionally engaged in misconduct 2) proximate to victim’s injury or death. Established just-following-orders defense for vaccinators and others in the chain of distribution…”
Sen. Leahy voted later the same day (Dec. 21, 2005) with 92 other senators to commit treason and pass the military funding and hurricane recovery bill to which the PREP Act had been attached.
Leahy introduced Chemerinsky’s letter.
Mr. LEAHY. Late Sunday night [Dec. 18, 2005] , Republican leadership slipped language [PREP Act] into a lengthy appropriations conference report that will immunize drug companies against reckless misconduct and will impede our ability to protect our citizens from the threatened avian flu pandemic. This provision is a gift to the drug manufacturers and will likely have a devastating effect on our ability to protect our constituents.
Under the guise of a threatened pandemic, this legislation goes far beyond the scope of vaccine preparedness and includes language that is far more sweeping than any language previously passed by the House or the Senate. Instead of focusing on protecting American families from avian flu or ensuring that victims of any untested vaccine will be compensated for their injuries, the provision simply shields drug companies from any culpability for injuries caused by its actions. The scope of this immunity is so expansive that once the Secretary of Health and Human Services has declared a public health emergency even for a future threat, drug companies would not be held accountable for any injuries or deaths caused by the drugs they manufacture, including drugs that are not specifically used in a pandemic context. This is disgraceful and will deter Americans from taking vaccines and drugs if we ever experience a health crisis.
The only exception to the broad immunity given to drug companies in this proposal is the possibility that a victim could prove that the company acted with ‘‘willful misconduct.’’ Knowingly committing health violations would not even suffice to state a claim. Knowing violations as well as gross negligence would be immunized from accountability. Even if the drug company acted with the intent to harm people, it would nevertheless be immune from criminal conduct unless the Attorney General or Secretary of Health and Human Services initiates an enforcement action against a drug company that is still pending at the time a personal claim is filed. That is unbelievable.
I question whether such a role for the Secretary of HHS is even constitutional. Since when do we in Congress allow a political appointee of the administration to determine when, and if, someone injured by willful misconduct can be compensated for their injuries?
Professor Erwin Chemerinsky sent a letter yesterday that outlines his concerns regarding the constitutionality of the provision and I ask that his letter be made part of the [Congressional] Record.
Chemerinsky’s letter, recorded at S. 14247:
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. [(b)(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. [(b)(8)]. However, for the extremely 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 permissible 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 ‘‘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 Lakewood 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 tradition’’ 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.
Christ buried by Joseph of Arimathea. Giacinto Brandi
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Gen-X Catholic writing about Covid-times law, geopolitics, philosophy and theology.
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