FEDERAL PREEMPTION OF STATE LAW REMEDIES

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FEDERAL PREEMPTIONOF STATE LAW REMEDIES

• June 2008
• Alabama Association for Justice
• Leila H. Watson
• Cory Watson Crowder DeGaris, P.C.
• 205-328-2200
• lwatson_at_cwcd.com

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• ANGER AND DEPRESSION CANNOT COEXIST IN THE SAME
  PERSON AT THE SAME TIME.
• LET ANGER FUEL YOUR PASSION.

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FEDERAL PREEMPTION OVERVIEW OF THE ARGUMENT

• Only Congress can legislate
• The various federal agencies are not capable of
  doing the job
• Why cant we trust the jury? Should citizens
  have input as jurors?
• Can federal government that makes no provisions
  to hold the wrongdoer responsible, effectively
  take the place of state tort law? Can our
  government protect us from dangerous products and
  activities? (recognition for this question goes
  to Greg Cusimano)

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WHO HAS THE POWER TO LEGISLATE?

• Article I, Section 1 of the United States
  Constitution All legislative Power herein
  granted shall be vested in a Congress of the
  United States, which shall consist of a Senate
  and House of Representatives.
• The Supreme Court?...NOT!!
• The Executive Branch?...NOT!!

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EVEN FEDERALISM RECOGNIZES THAT SOME POWERS
BELONG TO THE STATES

• American government was created on the premise
  that there would power to the states and power to
  the federal government.
• Some matters are best left to the states to
  regulate
• -PUBLIC HEALTH AND SAFETY
• -Common law remedies
• -Police powers
• -Property and zoning laws, Building codes
• -Family law
• -Occupational licensing
• Any change in this structure requires legislation

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THE COURT CANNOT (SHOULD NOT) LEGISLATE

• The court does not create positive law it
  reviews jury verdicts.
• There is a distinction between state positive
  law and state tort law.
• A state positive law requirement is a rule of
  law that must be obeyed an event, such as a jury
  verdict, that merely motivates an optional
  decision, is not a requirement Bates v. Dow
  Agrosciences, 544 U.S. 431, 445 (2005).

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THE COURT CANNOT(SHOULD NOT) LEGISLATE

• Preemption of pharmaceutical cases.
• -The FDCA does not contain a preemption provision
  for drugs no preemption of drug case.
• -So what is Wyeth v. Levine about? This is the
  issue presented for decision to the USSC
  Whether the prescription drug labeling judgments
  imposed on manufacturers by the Food and Drug
  Administration ("FDA") pursuant to FDA's
  comprehensive safety and efficacy authority under
  the Federal Food, Drug, and Cosmetic Act, 21
  U.S.C. 301 et seq., preempt state law product
  liability claims premised on the theory that
  different labeling judgments were necessary to
  make drugs reasonably safe for use.
• -The USSC will have to legislate create
  positive law to come up with preemption of
  state law remedies.

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THE COURT CANNOT(SHOULD NOT) LEGISLATE(From the
NYT 3/16/08, Jeffrey Rosen, Supreme Court, Inc.)
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THE COURTS CANNOT(SHOULD NOT) LEGISLATEFrom the
NYT 3/16/08 Jeffrey Rosen, Supreme Court, Inc.
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THE COURT CANNOT(SHOULD NOT) LEGISLATE

• The FDA's position in these cases is an
  instance of backdoor federalization, a
  descriptive term commentators have recently used
  to describe a trend in the federal courts toward
  finding state law preempted. On the positive
  side, centralized federal control can facilitate
  uniform regulation of a national market (like
  that for pharmaceuticals) and prevent states from
  interfering with the affairs of other states.
  Samuel Issacharoff Catherine M. Sharkey,
  Backdoor Federalization, 53 UCLA L. Rev. 1353
  (2006).
• Colaciccio v. Apotex, Inc., 521 F. 3d 253, 284
  (3d Cir. 2008)(J. Abrom dissent)

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THE COURTS CANNOT(SHOULD NOT) LEGISLATE

• To review the history of this issue, the FDA
  has for over three-quarters of a century viewed
  state tort law as complementary to its warning
  regulations. Only for the last two years has it
  claimed otherwise. This sea change, Sharkey,
  supra, at 242, in the FDA's conception of the
  relationship between federal and state law has
  not appeared in a regulation subject to notice
  and comment, but in a preamble to a regulation.
  With this background, I believe courts should
  fear to tread where Congress has not given us a
  clear statement. Because I see sound legal and
  policy reasons to hold that the presumption
  against preemption is not overcome, I would allow
  the plaintiffs' suits to go forward. I
  respectfully dissent.
• Colaciccio v. Apotex, Inc., 521 F. 3d 253, 285
  (3d Cir. 2008)(J. Abrom dissent)

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THE EXECUTIVE BRANCH CANNOT (SHOULD NOT) LEGISLATE

• Recent assertions of preemption of state law by
  federal regulatory agencies are nothing less than
  the Executive Branch to abrogate power that
  properly belongs to Congress.
• Federal administrative agencies do not have the
  power to regulate with the force of law, absent
  express delegation of that authority from
  Congress.

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FEDERAL AGENCIES CANNOT(SHOULD NOT) LEGISLATE

• Executive Order 12,988 (1996) directs agencies,
  when issuing regulations, to specify in clear
  language the preemptive effect, if any, to be
  given to the law.
• Executive Order 13,132 (1999) prohibits agencies
  from preempting state law except where the
  Congressional act contains an express preemption
  provision, or the exercise of State authority
  conflicts with the exercise of Federal Authority
  under the Congressional act.

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WHY THE FDA CANNOT (SHOULD NOT) LEGISLATE

• The FDA is responsible for the safety of
  approximately 80 of food sold and all human
  drugs, vaccines, and medical devicesgoods worth
  about 1 trillion per year, or about 25 of all
  consumer spending. Yet Congress has starved the
  agency of funds, even as the FDAs functions have
  expanded vastly and public concern for the safety
  of foods, drugs, and medical devices has
  increased. The agency has only 9000 employees
  nationwide and needs twice its current level of
  funding to properly fulfill its mission.
• Gostin LO, The Deregulatory effects of preempting
  tort litigation, FDA regulation of medical
  devices. JAMA 2008 299 (19) 2313 2316.

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WHY THE FDA CANNOT (SHOULD NOT) LEGISLATE

• The FDAs own blue ribbon panel concluded that
  the scientific demands on the Agency far exceed
  its capacity to respond. This imbalance is
  imposing a significant risk to the integrity of
  the . . . regulatory system, and hence the safety
  of the public.
• Gostin LO, The Deregulatory effects of
  preempting tort litigation, FDA regulation of
  medical devices. JAMA 2008 299 (19) 2313
  2316.

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WHY NHTSA CANNOT (SHOULD NOT) LEGISLATE

• NHTSA does not have the capability to legislate.
  It has a staff of less than 650 people with
  limited information-gathering authority, and no
  demonstrated ability to act quickly.
• Eg 1) Congress had to force NHTSA to require
  installation of tire pressure gauges 2) NHTSAs
  fuel safety standard is 35 years old, even though
  fuel fed fires are a leading cause of fatalities
  in MVAs.

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WHY THE CPSC CANNOT (SHOULD NOT) LEGISLATE

• The CPSC is seriously understaffed (400 full time
  staff) and a skinny budget (half of what it was
  the year it was created).
• Recently, CPSC, without notice or following
  administrative procedures and Executive Orders,
  switched its position on flammability standards
  for mattresses, INCLUDING the addition of a
  preemption clause into the agency regulation.
  (CPSC, Final Rule, Flammability (Open Flame) of
  Mattress Sets, 71 Fed. Reg. 13,472 (March 15,
  2006))

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WHY THE FRA CANNOT (SHOULD NOT) LEGISLATE

• To end a debate in the courts regarding the
  preemptive effect of federal acts governing
  railroads, Congress enacted a provision to
  clarify that not all State law actions are
  preempted. (49 U.S.C. 20106(a)(2)and (b))
• THREE DAYS after enactment, the FRA published
  proposed rulemaking preempting any State law,
  regulation, or order, including State common law,
  concerning the operation of a cab
  car...locomotive as the leading unit of a
  passenger train...
• The FRA Preamble was used to preempt claims
  resulting from the Metrolink train accident in
  California that caused injuries and death to 150
  passengers.

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CONGRESS SHOULD LEGISLATE

• The debate whether federal law should preempt and
  displace state laws should occur in Congress,
  where all views can be aired and those directly
  accountable to the American people can make
  decisions on the public record.
• Testimony of David C. Vladeck, Georgetown
  University Law Center, speaking before the
  Committee on Judiciary, United States Senate
  (Hearings on Regulatory Preemption Are Federal
  Agencies Usurping Congressional and State
  Authority? September 12, 2007)

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WHY CANT WE TRUST THE JURY?

• Federal agencies and big business Because they
  are lay people second guessing the work of
  federal agencies for the benefit of a single
  person

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FEDERAL PREEMPTION

• IN THE UNITED STATES DISTRICT COURT
• FOR THE EASTERN DISTRICT OF ARKANSAS WESTERN
  DIVISION
• PREMPRO PRODUCTS LIABILITY LITIGATION
• DONNA SCROGGIN
• v.
• WYETH, et. al.
• 404CV01169
• SUPPLEMENT TO APRIL 10, 2008 ORDER
• As Defendants note, I did state that I was as
  confident as a Christian with four aces with
  respect to my FDA preemption ruling.
• In view of the United States Supreme Courts
  decision in Riegel v. Medtronic, Inc. and other
  recent appellate decisions, my confidence, while
  still in place, is at a lower level.
• It appears to me that an expansive reading of
  preemption is a part of the overall assault upon
  the citadel of the right to trial by jury (to
  paraphrase Cardozo). The finer points of the vice
  of too much preemption are well presented in
  Justice Ginsbergs dissent in Riegel, and by
  Judge Thomas Ambro in his dissent in Colacicco v.
  Apotex.
• The thought underlying expansive preemption
  (backdoor federalization) is that bureaucratic
  experts are better at determining what is
  reasonable, what is too dangerous, etc., than are
  juries.

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FEDERAL PREEMPTION

• (Scroggin v. Wyeth)
• Over the past several years I believe all three
  branches of government have become more and more
  distrustful of juries. They seem to forget that a
  jury is a cross section of the citizens who
  elected them to office (or elected those who
  appointed them). In political campaigns these
  citizens are paragons of virtue but when they
  are called for jury service, they somehow become
  incapable of making important decisions. The
  language in the decisions favoring preemption is
  high flown but, at bottom, it reflects distrust
  of the randomly selected citizens who sit on
  juries. Perhaps our public officials, including
  judges, have read too much Plato and too little
  Alexis de Tocqueville.
• Trial by jury is the essence of government
  reposed in the people. We should trust this
  institution in fact, not just in word.
• IT IS SO ORDERED this 16th day of April, 2008.
• /s/ Wm. R. Wilson, Jr.
• UNITED STATES DISTRICT JUDGE

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WHEN IS THERE NO PREEMPTION OF STATE LAW REMEDIES?

• Parallel claims plaintiff alleges violation of
  agency regulation. This claim does not urge a
  state regulation in competition with, or
  different than the agency reg.
• Breach of warranty
• Beyond the reach of the act

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