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Preemption
Stealth Tort Reform: How the Bush Administration’sAggressive Use of the Preemption Doctrine Hurts Consumers
A Center for Progressive Regulation White Paper
Examined in the context of relevant Supreme Court
In recent months, a flurry of media stories has drawn
precedent, it becomes clear that FDA’s recently articulated
public attention to the seemingly esoteric topic of the
position on preemption stretches the doctrine far beyond
Food and Drug Administration’s (FDA) attempts to
its appropriate and established bounds. No change in
preempt a variety of state tort suits against drug and
the relevant statute, regulations or case law has taken
medical device manufacturers. Under the direction of
place to prompt FDA’s aggressive new stance on
FDA Chief Counsel Daniel E. Troy, the agency has
preemption. Rather, it appears that the primary
submitted briefs in multiple lawsuits, each time
motivating concept behind FDA’s pro-preemption briefs
supporting the manufacturer’s argument that federal law
is the Bush Administration’s tort reform agenda. Already
preempts state common law claims. Much of the media
FDA’s briefs have prompted some courts to find state
coverage has focused on the potential conflicts of interest
tort claims preempted, thereby effecting significant
raised by Mr. Troy’s previous representation of
changes in the law that had not occurred prior to Mr.
companies such as those he now invokes FDA’s power
FDA’s amicus briefs represent part of a larger threat
While Mr. Troy’s endeavors prior to his appointment
that the Bush Administration poses to the crucial role
by President Bush as FDA Chief Counsel provide
that private tort suits play in supplementing regulatory
context to the agency’s recent aggressive push for federal
programs aimed at protecting health, safety and the
preemption, a much less visible aspect of these activities
environment. Recent questions concerning whether
is the contribution that his substantive legal arguments
FDA appropriately dealt with studies suggesting a link
are making to the Administration’s anti-consumer tort
between antidepressants and suicidal tendencies highlight
reform agenda. Although federal preemption of state
the crucial importance of the role and availability of tort
common law claims may seem like an obscure issue of
recovery as a supplement to regulatory oversight.
little concern to most consumers, Mr. Troy’s vigorous
FDA’s Recent Intervention in Private
assertion of federal preemption claims threatens to
deprive countless citizens of their rights under establishedstate law.
The Bush Administration’s FDA has garnered
considerable media attention, as newspapers have run
Both the legal arguments raised by Mr. Troy on
stories with eye-catching headlines such as: In a Shift,
behalf of FDA and the manner in which FDA has come
Bush Moves to Block Medical Suits; FDA Stepping Into Liability
to weigh in on the preemption question represent a
Lawsuits on Side of Drug Makers It Regulates; and FDA’s
significant departure from past agency practice. Acting
Chief Lawyer Stands Up for the Big Guys.1 These and other
in his capacity as the agency’s Chief Counsel, Mr. Troy
articles focus on the actions of Daniel E. Troy, President
has actively sought guidance from pharmaceutical firms
Bush’s appointee to the position of FDA Chief Counsel.
concerning lawsuits in which FDA could play a role in
Over the past two years, Mr. Troy’s FDA has filed “friend
promoting preemption. Since he assumed the helm of
of the court” (amicus curiae) briefs, or statements of
FDA’s legal ship, the agency has submitted briefs in five
interest, in five private lawsuits involving drugs or medical
recent lawsuits involving drugs or medical devices. More
devices, four of which were product liability suits brought
often than not, FDA has filed those briefs on its own
by injured consumers.2 In the briefs, Mr. Troy brings
initiative, without being asked to do so by the court.
FDA’s considerable weight to bear in favor of the
to safeguard its considerable expertise in regulating the
manufacturers’ defense that federal law preempts the
content of drug labeling and advertising.”10
Federal preemption is a principle of constitutional
Mr. Troy’s articulated rationale for FDA’s
law derived from the Supremacy Clause, which provides
intervention into private lawsuits represents a
that a federal law can supersede or supplant any
significant departure from the views on preemption
inconsistent state law or regulation.4 In the context of
consistently held by the agency during past
Mr. Troy’s recent legal briefs, preemption is the asserted
Administrations. In 1996, FDA’s Clinton-era Chief
authority of the federal government to override the
Counsel, Margaret Jane Porter, spoke at an FDLI
powers of the states to determine what label warnings
seminar.11 Her opening remarks referred to FDA’s “long-
(in the case of drugs) or design criteria (in the case of
standing presumption against preemption” even in the
medical devices) may be required by state legislation or
implementation of a section of the FDCA that contains
held subject to liability in litigation.5 Put simply,
an explicit preemption provision.12 In sharp contrast to
preemption causes “the nullification of state actions that
Mr. Troy’s stated position that “state courts and juries
conflict with or supplement FDA decisions.”6 If a court
should not second-guess the agency’s scientific
agrees with FDA and the manufacturer that a tort claim
determinations,”13 Ms. Porter explained that “FDA’s view
is preempted, the court must rule in favor of the
is that FDA product approval and state tort liability
defendant.7 The import of the preemption doctrine, and
usually operate independently, each providing a
the reason that Mr. Troy’s amicus briefs have garnered the
significant, yet distinct, layer of consumer protection.”14
attention they have, thus becomes clear – if a productmanufacturer can successfully argue that the federal law
In addition to the Bush Administration’s drastic
preempts plaintiff ’s claim, the lawsuit disappears (and
views on the roles of federal regulation, state common
precedent to support future assertions of the preemption
law and preemption, the agency has moved in a “radical
new direction”15 with respect to its involvement inprivate lawsuits. Specifically, Mr. Troy has taken the
The benefit of preemption to potential product
extraordinary step of seeking out lawsuits in which FDA
liability defendants is obvious: it provides a shield against
could intervene on behalf of product liability defendants
expensive settlements and/or judgments in favor of
(i.e., large drug companies) in support of preemption.
plaintiffs. What is less clear is why FDA, the agency
At a December 2003 conference on drug and medical
charged with regulating to protect the health and safety
device litigation for defense lawyers and in-house
of consumers, would work so hard to deprive consumers
counsel, Mr. Troy told the audience of several hundred
injured by the products it regulates of their only remedy.
pharmaceutical attorneys to suggest lawsuits into which
At a 2002 legal symposium, Mr. Troy and the Bush
the agency might intervene.16 The signed affidavit of a
Administration set forth plans for “FDA Involvement in
conference participant states that Mr. Troy cautioned
Product Liability Lawsuits.”8 At the symposium, held by
that since FDA “can’t get involved in every case,”
the Food and Drug Law Institute (FDLI), Mr. Troy
interested attorneys should make their particular cases
maintained that because the federal Food, Drug and
Cosmetic Act (FDCA) gives FDA broad authority toregulate the content of labeling for all drugs and
Indeed, even prior to Mr. Troy’s appeal at the
advertising for prescription drugs, allowing state courts
December 2003 conference, his office had responded to
and juries to impose additional requirements in conflict
pleas from defense counsel in at least two product liability
with FDA determinations could require drug firms to
cases. During the month of July 2002, when Pfizer faced
choose between state and federal compliance and lead
a lawsuit alleging that its antidepressant drug Zoloft
to inconsistency in drug firms’ communications to
caused a patient to commit suicide, one of the company’s
physicians and patients about drugs.9 Accordingly, Mr.
attorneys “called Dan Troy and informed him of the
Troy declared that FDA would “participate in product
case.”18 Within a couple of months, FDA had filed a
liability lawsuits brought under state law as necessary
brief before the United States Court of Appeals for the
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
Ninth Circuit, without being asked (by the court) to do
Dan Troy’s Legal Arguments in Context
Mr. Troy’s own justification for FDA’s aggressive
In another case, where a plaintiff sought damages
intervention in private lawsuits since his appointment is
for injuries allegedly sustained from pacemakers
that the agency “only intervenes in private-party lawsuits
manufactured by Pacesetter, Inc.,20 the Circuit Court of
when it has a significant, direct stake in the outcome and
Shelby County, Tennessee denied defendant Pacesetter
only files briefs in cases in which the courts have already
Inc.’s Motion for Summary Judgment.21 Soon thereafter,
ruled against the position the FDA supports.”34 His
counsel for Pacesetter wrote to the office of FDA Chief
explanation fails to address either why FDA is aggressively
Counsel, to remind FDA that motions in the interlocutory
seeking out lawsuits in which to intervene or why, in the
appeal of the matter were soon due, and that “accordingly,
absence of any intervening change in the governing law,
FDA’s Motion to Intervene should likewise be submitted
the agency’s substantive views on the preemption issue
by that time.”22 FDA timely submitted a brief in support
have changed so dramatically from FDA’s former “long-
standing presumption against preemption.”35
Responding to Mr. Troy’s unprecedented actions,
That presumption (now reversed under the guidance
Representative Maurice D. Hinchey (D-N.Y.) successfully
of Mr. Troy) is consistent with the fundamental principles
introduced legislation to cut $500,000 from the office of
upon which the doctrine of preemption rests. Time and
FDA Chief Counsel’s budget.24 Other veteran observers
again, the Supreme Court has articulated the basic canons
of FDA confirm Representative Hinchey’s assertions that
that should guide judicial evaluation of preemption
Mr. Troy’s active pursuit of, and intervention in, private
claims. The starting premise is that the States are
lawsuits takes the agency in a new direction. Professor
independent sovereigns in the United States federal
James O’Reilly, University of Cincinnati Law Professor
system of government.36 It is a familiar principle of
and former FDA counsel, noted that, “FDA is now in
constitutional law that powers not delegated to the federal
the business of helping lawsuit defendants” and that the
government are reserved to the States.37 Among the most
practice is “a dramatic change in what FDA has done in
basic reserved powers is the police power – the inherent
the past.”25 The Public Citizen Litigation Group agrees
power of a sovereign to make all laws necessary to
that FDA “has not supported preemption of personal
preserve the public safety, health and welfare.38
injury claims prior to this administration.”26
Accordingly, the Court assumes “that the historic policepowers of the States were not to be superseded by the
In an attempt to defend Mr. Troy’s actions, five former
Federal Act unless that was the clear and manifest purpose
FDA Chief Counsels27 wrote a letter claiming that “there
of Congress.”39 Consequently, “‘[t]he purpose of
is ample precedent for the actions that Mr. Troy has
Congress is the ultimate touchstone’ in every pre-emption
recently been undertaking,” and that his actions are “not
case.”40 In the case of the FDCA, the “overriding”
radical or even novel.”28 However, as noted in
purpose of the statute is to protect the public health, and the
Representative Hinchey’s response, the Former Chief
Supreme Court has made clear that the Act must be given
Counsels cite inapposite legal precedent.29 To
a liberal construction consistent with that intent.41
demonstrate by example that Mr. Troy’s active solicitationof lawsuit information from corporate defendants, and
There are two major classifications of federal
unsolicited intervention in private cases is “not radical
preemption, each of which is implicated by Mr. Troy’s
or even novel,”30 the Former Chief Counsels cited cases
recent rash of amicus briefs. Express preemption occurs
where FDA was either the defendant in the case to begin
when Congress expressly contemplated the role of the
with31 or was asked by the court to submit a brief.32
States and included a statutory provision that explicitly
Moreover, in a newspaper article published prior to
abrogates state power in a particular area.42 Even when
Representative Hinchey’s proposal to penalize the Chief
an explicit preemption provision appears in the statute
Counsel’s office, Peter Barton Hutt, FDA Chief Counsel
under consideration, the Supreme Court has found that
in the Nixon Administration, acknowledged that while
the presumption against preemption of state police power
he supported FDA’s legal position, he “probably wouldn’t
mandates a narrow interpretation of the scope of the
provision, consistent with “both federalism concerns
and the historic primacy of state regulation of matters
Though the trial court rejected Pacesetter’s assertion
of health and safety.”43 In product liability cases
of (and FDA’s support of) the preemption defense, the
involving medical devices, the issue before a court
matter will be re-visited on appeal.52 Nonetheless, FDA’s
charged with deciding whether plaintiff ’s tort claim is
brief in Murphree has already succeeded in aiding a federal
preempted is the proper scope of an express preemption
appeals court to rule in favor of a manufacturer and find
provision contained in the statute governing medical
a plaintiff ’s tort claims preempted.53 The United States
Court of Appeals for the Third Circuit recently held thatthe express preemption clause in the Medical Device
In the absence of express preemption, a court may
Amendments (MDA) to the FDCA preempted Barbara
still find that “a federal statute implicitly overrides state
Horn’s state law claim (on behalf of her deceased
law either when the scope of a statute indicates that
husband, Daniel Horn) against Thoratec Corporation.54
Congress intended federal law to occupy a field
The Bush Administration’s assertion ofpreemption in both medical device andprescription drug cases stretches thedoctrine beyond the bounds delineatedamicus briefs in prescription drug litigation rely on the
ensued, and a disconnection of the HeartMate apparatus
more tenuous doctrine of implied preemption. As
allowed an air bubble to travel to Mr. Horn’s brain.56
explained more fully below, however, the Bush
He then suffered a hemorrhage that rendered him brain
Administration’s assertion of preemption in both medical
dead.57 Less than four months after he was implanted
device and prescription drug cases stretches the doctrine
with the HeartMate, Mr. Horn was pronounced dead.58
beyond the bounds delineated by the Supreme Court.
Barbara Horn filed her husband’s state law claims
Medical Device Litigation: Murphree v. Pacesetter
against Thoratec in federal court, where she alleged that
and Horn v. Thoratec
the HeartMate had been defectively designed and
On September 20, 2000, Gary Murphree filed suit
manufactured and that Thoratec had failed to warn of
against Pacesetter, Inc. in the Circuit Court of Shelby
the alleged defects.59 Thoratec moved for summary
County, Tennessee.46 Mr. Murphree alleged that the two
judgment on the ground that Horn’s claims were expressly
pacemakers he had received, both manufactured and later
preempted.60 The court agreed, and Horn appealed.61
recalled by Pacesetter, left him with third-degree heart
Subsequently, FDA submitted its statement of interest
block, a failure of the heart’s electrical signals that can
in the Murphree case.62 Early this year, the Third Circuit
lead to cardiac arrest.47 After receiving a letter from
allowed Thoratec to amend the record on appeal to
Pacesetter’s counsel following the court’s denial of
include FDA’s brief in Murphree, and approximately one
Pacesetter’s motion for summary judgment,48 FDA filed
month later it asked FDA to submit a letter brief in the
a brief arguing that Murphree’s claim was preempted.49
Horn v. Thoratec appeal.63 The court’s opinion relied
In the brief, FDA argued that “the prospect of hundreds
substantially on both FDA briefs to reach its conclusion
of individual juries determining the propriety of
that Horn’s tort claims could not proceed.
particular device approvals, or the appropriate standards
In so concluding, the Horn court had to distinguish
to apply to those approvals, is the antithesis of the orderly
the Supreme Court’s seminal holding in Medtronic, Inc. v.
scheme Congress put in place and charged FDA with
Lohr. In that case, the Court held that although Section
implementing.”50 Private tort suits, the brief maintained,
360k of the MDA provides for express preemption of
would create uncertainty and chaos “for both the
certain state law “requirements” governing medical
devices, the relevant statutory and regulatory languageevidences “an overarching concern that preemption occur
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
only where a particular state requirement threatens to
courts to preempt state tort claims involving prescription
interfere with a specific federal interest.”64 The Lohr
drugs. FDA’s actions in this regard are especially
Court’s extensive analysis concluded that the statutory
remarkable, because (as noted above) the prescription
language itself, the overriding purpose of the MDA (to
drug portions of the FDCA do not contain a preemption
provide for the safety and effectiveness of medical devices
provision.75 Indeed, since the statute’s enactment, no
intended for human use)65 and the FDA regulations all
reported decision ever has held that the FDCA preempts
supported the conclusion that the tort claims under
common law claims for damages caused by drugs.76
review, including use of defective materials and failure
Moreover, in 1933, Congress rejected a suggested
to warn,66 were not of the specific nature required in
provision in a draft of the original FDCA providing a
order to be preempted by the MDA.67 The Supreme
federal cause of action for damages because “a common
Court reasoned that because the general state common-
law right of action (already) exists.”77 Keeping in mind
law requirements were not specifically developed “with
the maxim that “‘[t]he purpose of Congress is the ultimate
respect to” particular medical devices, they were not the
touchstone’ in every pre-emption case,”78 and the
kind of requirements that Congress and FDA feared
Supreme Court’s admonition that the historic police
would impede the ability of federal regulators to
powers of the States should not be found to be
implement and enforce specific federal requirements.68
preempted “unless that was the clear and manifest
Ultimately, the Court stated, “given the critical importance
purpose of Congress,”79 it becomes apparent that FDA’s
of device specificity in our (and FDA’s) construction of
arguments in favor of preemption in the prescription
§ 360k, it is apparent that few, if any, common-law duties
have been preempted by this statute.”69
In re Paxil
The Horn court distinguished Lohr first on the basis
Presently, a class action lawsuit is pending before a
that the federal requirement in question was of greater
California federal court, in which dozens of plaintiffs
specificity than the provision that was before the Supreme
contend that Glaxo SmithKline (GSK) has engaged in
Court.70 Turning next to the more analogous state law
false advertising by promoting its drug Paxil as “non-
requirements at issue, the Third Circuit went to great
habit forming.” Paxil is an antidepressant in the class of
lengths to diminish the importance of the Supreme
medicines known as SSRIs, or selective serotonin
Court’s statement that “it is apparent that few, if any,
reuptake inhibitors.80 SSRIs treat depression by
common-law duties have been preempted” by the MDA’s
normalizing levels of the brain chemical serotonin.81
preemption provision.71 FDA’s amicus arguments may have
However, SSRIs also have effects on numerous other
been especially persuasive in this regard. The court noted
parts of the brain’s cellular system.82
the agency’s unequivocal statement that “[s]tate commonlaw tort actions threaten the statutory framework for the
In August 2002, the court granted plaintiffs’ request
regulation of medical devices,” because tort relief in the
for a preliminary injunction barring GSK from continuing
form of damages could pressure manufacturers to add
to air television commercials claiming that Paxil was “non-
warnings that FDA had not approved.72 The court further
habit forming.”83 GSK motioned the court to reconsider
quoted FDA’s prediction that such “individualized
its ruling, and, after asking FDA to file a brief and
redetermination of the benefits and risks of a product”
considering all arguments, the court lifted the preliminary
could harm the public health by “resulting in scientifically
injunction.84 In its brief, FDA asserted, among other
unsubstantiated warnings and underutilization of
things, that Paxil does not cause withdrawal symptoms
beneficial treatments.”73 The Murphree court similarly
but merely causes a “discontinuation syndrome,”85 and
quoted FDA’s professed concern that “such uncertainty
that in any event, plaintiffs’ claim was preempted.
as to the status of medical devices would create chaos
Although the court ultimately lifted the preliminary
for both the regulated industry and FDA.”74
injunction on other grounds,86 it soundly rejected the
FDA (and GSK) argued for implied preemption on
Beyond pushing the law in a new direction in the
the ground that the comprehensive nature of the FDCA,
medical device arena, the current FDA is also pressing
when taken together with FDA’s expertise, evidences a
other SSRIs (such as Prozac) cause suicide and
Congressional intent to preempt state law.87 The court
determined on each occasion that the scientific evidence
found the argument that FDA has exclusive domain over
was insufficient to compel a warning linking Prozac to
control and regulation of prescription drug
suicidal behavior.99 Pfizer therefore argued that
advertisements to be unpersuasive.88 The court noted
“plaintiff ’s attempt to use state tort law to require
that neither FDA nor GSK had cited any case holding
warnings that Zoloft causes suicide” conflicted with
that the FDCA preempts state law, and noted that “if
FDA’s determinations concerning SSRI warnings.100
anything, FDA’s and GSK’s arguments ran contrary to
The district court rejected the preemption defense,
the grain of other decisions.”89 Judge Marianna Pfaelzer
instead finding on a variety of grounds that Pfizer had
failed to demonstrate that it would be impossible to
FDA’s and GSK’s position vitiates, rather than
comply both with FDA requirements and with a state
advances, the FDCA’s purpose of protecting the
law or decision requiring a stronger warning.101 In a
public. That is, FDA and GSK invite the Court
separate proceeding, the court granted summary
to find that in enacting the FDCA for the
judgment to Pfizer on the ground that Ms. Motus was
purposes of protecting public health, Congress
unable to present any evidence to establish that her
not only declined to provide for a private cause
husband’s doctor would have acted differently had Pfizer
of action, but also eliminated the availability of
included a warning about an association between Zoloft
Ms. Motus appealed the court’s judgment to the Ninth
Circuit, and Pfizer cross-appealed the earlier ruling on
Despite the court’s outright rebuff of FDA’s theory,
its preemption argument.103 FDA filed an amicus curiae
Mr. Troy plans to continue his “fight for the FDA’s
brief without being asked to do so by the court, and it
supremacy.”91 He has indicated that he intends to raise
did so within months of Mr. Troy’s receipt of a phone
the argument again before Judge Pfaelzer in the ongoing
call from one of Pfizer’s attorneys, requesting that the
government file a brief in support of preemption.104FDA’s involvement in the case was especially alarming
Motus v. Pfizer
to plaintiff ’s counsel, because before being appointed to
Five days after filing its brief in the Paxil litigation,
the position of FDA Chief Counsel, Mr. Troy had
FDA submitted an amicus curiae brief to the United States
represented Pfizer for pay as a private attorney.105
Court of Appeals for the Ninth Circuit93 in a case
According to Mr. Troy, since the mandatory recusal period
involving another SSRI drug, Zoloft.94 Flora Motus
had elapsed at the end of May, he “didn’t see any
initially brought the case in state court on behalf of her
problem” with filing a brief that supported Pfizer’s
husband Victor, who committed suicide approximately
one week after commencing to take Zoloft for his
In the brief, Mr. Troy and FDA argued that the claims
depression.95 Ms. Motus alleged that Pfizer failed to
adequately warn of the dangers, contraindications andside-effects of Zoloft.96 After successfully removing the
when Zoloft was prescribed for Victor Motus,
case to federal court, Pfizer moved for summary
any warning, no matter how worded, that could
judgment on the ground that the inadequate warning
reasonably have been read as describing or
alluding to [a causal relation to suicide] wouldhave been false or misleading, and therefore in
Specifically, Pfizer argued that FDA had instructed
conflict with federal law because there was no
it to use certain verbatim text in its labeling that did not
(and still is not) scientific support for such a
link suicide to the drug but rather warned that the
warning. This is not just because FDA had
possibility of suicide is inherent in depression.98
rejected any link between Zoloft and suicide
Additionally, before and during FDA’s consideration of
when . . . the agency approved the drug as a
the Zoloft application, the agency considered claims that
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
treatment for depression. Subsequently, in
that Congress intended to effect so sweeping a
response to petitions making similar allegations
change without even a comment. Rather, the
as to the related drug Prozac, FDA found no link
agency believes that Congress intended to restrict
between antidepressants and suicide.107
preemption to positive enactments (for example,legislation or regulations) that apply to the
In addition to arguing for implied preemption on
marketing of medical devices within a state, and
the basis of actual conflict, FDA raised the over-
did not intend to preempt state tort remedies for
deterrence argument that it has also advanced in the
Murphree and Horn cases108 involving medical deviceclaims:
The pre-Bush Administration FDA’s view on the
interplay between state tort claims and federal regulation
was expressed formally in a brief submitted to an Illinois
dissemination of scientifically unsubstantiated
court in 1996,114 when FDA asserted that because the
warnings, so as to deprive patients of beneficial,
federal approval process represents FDA’s endorsement
possibly lifesaving treatment, could well frustrate
of a minimum standard, federal approval should not
the purpose of federal regulation as much as over-
displace state common law that may provide additional
utilization resulting from a failure to disclose a
drug’s scientifically demonstrable adverseeffects.109
What has caused the agency’s views to shift so
drastically? The Supreme Court has not decided any case
In the end, the Ninth Circuit affirmed the lower
that reverses either its reading of the MDA’s preemption
court’s ruling that Mrs. Motus had failed to establish proof
provision or its mandates on the presumptions that
that stronger warnings could have altered her husband’s
inform any preemption decision (express or implied).
medical treatment or averted his suicide, and it therefore
Congress has not passed any legislation altering the
did not address the preemption issue.110 But the story
language of the MDA’s preemption provision or adding
of FDA’s brief in the case doesn’t end there. Though
a preemption provision to the FDCA’s prescription drug
FDA may not have succeeded in establishing precedent
sections. FDA has not gone through formal
in the Ninth Circuit, its amicus brief has been convincing
administrative procedures to promulgate a new regulation
lower courts to preempt similar tort claims in other
that interprets the MDA and/or the FDCA in such a
jurisdictions. Two federal district courts in Texas have
way as to preempt state tort claims. Stated simply, there
found failure to warn claims against Pfizer preempted,
has been no intervening change in the law of preemption
resting their holdings in large part on FDA’s views as
to justify such a drastic reversal by FDA. FDA’s Shift in Position: A Manifestation of
Instead, the Bush Administration’s FDA now argues
that the agency’s former view (that federal approvalshould not displace state common law that may provide
FDA’s legal briefs in Murphree, Horn, In re Paxil and
additional protection to consumers) fails to “take
Motus represent a 180-degree shift from the agency’s prior
sufficient account of the state-of-the-art risk management
position on the preemption issue. After the Supreme
principles that FDA currently follows.”116 FDA declared
Court’s landmark decision in Medtronic, Inc. v. Lohr, former
that “[t]he Government now believes” that the better
FDA Chief Counsel Margaret Porter stated that the
implementation of the statutory scheme is to focus “not
Court’s refusal to find the plaintiff ’s claims preempted
only on identifying the risk minimization appropriate for
was consistent with FDA’s “long-standing presumption
the device, but also on ensuring that the measures selected
against preemption.”112 Porter further elaborated, stating
do not present their own public health disadvantages.”117
Thus, with no more than a bare assertion that commonlaw tort claims might cause drug and medical device
[g]iven the harsh implications of foreclosing all
manufacturers to take actions that actually increase risk
judicial recourse for consumers injured by
to consumers, the Bush Administration has concluded
defective medical devices, FDA does not believe
that consumers are better off without private legal
recourse. For an administration that purports to respect
did not require the advice and consent of the Senate,
the authority of states, this conclusion has a derisive
was seen as a reaction to Senator Kennedy’s protest.124
implicit premise: State court judgments, according to
A medical device industry publication voiced the
the Bush Administration, are likely to be so erratic and
Administration’s hope: “Until Bush is able to place
unfounded as to harm the very people they intend to
someone in the commissioner’s office who will meet
Kennedy’s approval, perhaps Mr. Troy can bring aboutmore regulatory circumspection at the agency.”125
Such a speculative, condescending assertion cannot
by itself explain the Administration’s actions.
Indeed, Mr. Troy’s background is rife with themes
Consumers are not the constituency that will be made
of “regulatory circumspection.” After attending
better off by eliminating private legal recourse for injuries
Columbia University School of Law, he clerked for
sustained by drugs and/or medical devices. Instead,
outspoken conservative Judge Robert Bork of the
With no more than a bare assertion thatcommon law tort claims might cause drugand medical device manufacturers to takeactions that actually increase risk toconsumers, the Bush Administration hasconcluded that consumers are better off
up health care costs and impose a huge burden on the
drug companies.127 As an associate scholar of legal
economy.118 After declaring tort reform an “emergency”
studies at the American Enterprise Institute, he argued
upon assuming office as Governor of Texas, Mr. Bush
that companies that dumped toxics before it was illegal
helped to ensure enactment of seven tort reform bills,
to do so should not be held liable for the cleanup of
including measures that reduced punitive damage
such waste.128 Mr. Troy’s greatest anti-regulatory
liability and raised the burden of proof for plaintiffs
achievement may be his successful argument before the
seeking such damages.119 Business groups, many of
Supreme Court on behalf of Brown & Williamson
which were among Mr. Bush’s largest gubernatorial
Tobacco Corporation that FDA has no authority to
campaign contributors, had laid the groundwork for the
Mr. Troy’s philosophy as FDA Chief Counsel is, in
Mr. Troy has helped to advance George W. Bush’s
large part, consistent with his conservative views: agencies
pro-business, pro-tort reform tradition by establishing
should limit their actions to what the law explicitly
an “open-door policy” for industry, thereby earning for
authorizes them to do.130 Yet in the area of preemption,
himself a reputation for being as receptive to industry as
Mr. Troy argues consistently for FDA authority well in
any FDA Chief Counsel.121 It is no coincidence that
excess of what the relevant statutes stipulate, what the
FDA’s top legal voice is so closely aligned with the
Supreme Court has delineated, and what FDA has
Administration’s political agenda. In the summer of 2001,
historically asserted. In fact, in that area, he has managed
the Bush Administration had settled on Michael J. Astrue
to change the entire nature of the Chief Counsel’s office,
as its choice for FDA Commissioner.122 Senator Edward
converting it from a legal office to an activist policy
M. Kennedy, chair of the Senate Committee on Health,
Education, Labor and Pensions, opposed Astrue’s
Mr. Troy’s enthusiastic endorsements of broad FDA
candidacy on the ground that the then Senior Vice-
authority in the realm of preemption are best understood
President and General Counsel of Transkaryotic
as a manifestation of George W. Bush’s continued
Therapies, Inc. (a biopharmaceutical company) was too
attempts to promote tort reform. The Chief Counsel
closely tied to industry.123 President Bush’s appointment
has specifically stated that FDA “is deeply immersed in
of Mr. Troy to the position of FDA Chief Counsel, which
tort reform issues.”132 Jay P. Lefkowitz, former director
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
of President Bush’s Domestic Policy Council stated that
documents from unwilling defendant manufacturers,
FDA’s litigation strategy embodies “good health policy
question company representatives during depositions and
thereby uncover evidence of fraud andmisrepresentation.140 For example, court-ordered
In short, FDA’s 180-degree shift from the agency’s
discovery allowed counsel for the plaintiffs in the Paxil
prior position on the preemption issue represents neither
litigation to see raw data on the drug’s safety and efficacy,
a response to some intervening change in the law, nor a
while FDA saw only the completed write-ups.141 Also
reflection of drastically different “state-of-the-art risk
obtained in discovery but never seen by FDA were the
management principles.”134 The current FDA’s arguments
manufacturer’s internal communications about how to
– diametrically opposed to the views consistently held
by previous FDAs – represent a concerted effort toadvance the Bush Administration’s activist tort reform
Past examples of tort litigation uncovering
policy agenda. It is precisely for this reason that courts
information that FDA failed to find demonstrate just how
should regard FDA’s pro-preemption amicus briefs with
crucial the role of civil discovery through tort suits can
great circumspection. Although an agency’s construction
be. It was a trial lawyer, not FDA that discovered that
of its own regulations is normally entitled to substantial
one of the published clinical studies of thalidomide (the
deference by the courts, the fact that FDA’s complete
drug prescribed for morning sickness that caused severe
about-face has taken place in the absence of any credible
birth defects) had been ghost written by an employee of
change in legal or factual circumstances significantly
the drug’s manufacturer.143 In the state tobacco litigation,
private attorneys for the states discovered and made
What’s at Stake: Regulation, Tort Law and
available for public inspection documents establishing
facts that the industry had denied to FDA (and Congress)for decades.144
The Bush Administration’s FDA has vociferously
Recent revelations about data demonstrating a link
argued that allowing state tort claims against the
between SSRI drugs and suicidal behavior underscore
manufacturers of drugs or medical devices that FDA has
the very real need to protect the role of tort litigation in
approved would undermine FDA’s review and approval
supplementing FDA’s regulatory efforts. In June 2003,
of product labeling. In particular, state tort suits could
less than a year after FDA asserted to the United States
result in “scientifically unsubstantiated warnings” by
Court of Appeals for the Ninth Circuit in the Motus case
manufacturers that could, in turn, result in the
that its internal review of SSRI data disclosed that “there
underutilization of beneficial treatments, to the detriment
is no difference in the risk of suicide between those on
of consumers.136 This simplistic and speculative
SSRI’s and those on placebo,”145 the agency issued a
argument, however, fails to address the ramifications of
statement recommending that Paxil not be used in
eliminating tort remedies and implicitly rests on the
children and adolescents for the treatment of
assumption that FDA’s “centralized expert evaluation”137
depression.146 The recommendation was based on
is based on all relevant data and studies.
“reports of a possible increased risk of suicidal thinking
Aside from the harsh consequences to consumers
and suicide attempts” in children under the age of 18
who would be left without any means of obtaining
compensation for injuries caused by defective prescription
In July 2003, FDA asked manufacturers for
drugs or medical devices, preemption of tort claims
information about pediatric studies of other depression
would destroy the vital role that state common-law
drugs, including several SSRIs.148 After reviewing the
remedies play in supplementing and augmenting federal
data, FDA issued a Public Health Advisory to health
health and safety regulations.138 Specifically, the tort
care professionals, stating that it had not “been able to
system is often able to get to the truth in ways that are
rule out an increased risk of suicidality” for any of the
largely unavailable to regulatory agencies.139 The tort
drugs.149 FDA further stated that additional data and
system allows trial lawyers, so often vilified by President
analysis, as well as a public discussion of available data
Bush, to spend the resources needed to obtain and review
were needed.150 The public discussion recommended
by the Advisory was convened on February 2, 2004, for
to disregard studies that indicate that its product causes
the purpose of addressing concerns and gathering
death or injury if it knows that it may be held liable for
information from a variety of sources and perspectives
damages caused by that product in the future, and it
about the relationship between suicidal behavior and SSRI
will not be tempted to hide those studies if it knows
drugs.151 Prior to the meeting, FDA scientists met to
that a jury may award punitive damages when the cover-
discuss the agenda. Dr. Andrew Mosholder, an FDA
up is later uncovered. A complete shield from liability
drug-safety analyst who studied clinical trials of
based on an existing FDA label deprives consumers of
antidepressants, stated that he planned to present his
the additional incentive that the threat of tort recovery
conclusion: young people who took antidepressants were
provides to manufacturers. Without the possibility of
far more likely to show suicidal tendencies than those
damaging information ever being revealed through
litigation, manufacturers of drug and medical deviceswould have every incentive to withhold even more such
High-ranking officials at FDA, however, decided that
Dr. Mosholder would not be permitted to speak abouthis findings.153 Though Dr. Mosholder would attend the
In its Motus brief, FDA rested its preemption
meeting to make another presentation, upper level
argument in large part on the fact that FDA had rejected
decisionmakers decided that another FDA official would
a link between Zoloft and suicide, and it explicitly argued
describe the antidepressant drug data Mosholder had
that the agency “found no link between antidepressants and
analyzed without offering any conclusion.154 Concerned
suicide.”160 Consumers would be harmed, the agency
about the reliability of Dr. Mosholder’s conclusions, FDA
asserted, by over-warning about a link between SSRI
hired researchers at Columbia University to re-analyze
drugs and suicidal behavior.161 Two courts relied on FDA’s
the same data.155 The Columbia study, completed after
arguments to find a plaintiff ’s claims preempted, thus
the February meeting, reached conclusions nearly
preventing them from using discovery tools to explore
the merits of their assertions.162 Despite recentdevelopments, Mr. Troy has stated that FDA has “not
In September 2004, after an advisory committee
rethought [its] legal views on preemption merely because
meeting held as a follow-up to the February 2 meeting,
the facts [on SSRIs] change.”163 In the face of a flagrant
Dr. Robert Temple, director of FDA’s office of medical
failure of the regulatory system, the Bush Administration
policy, stated that “we now all believe that there is an
continues to believe that whether FDA is right or wrong
increase in suicidal thinking and action that is consistent
in its conclusions about the dangers of products it
across all the drugs.”157 Dr. Temple was one of the
regulates, consumers are better off without a legal remedy.
officials who decided to prevent Dr. Mosholder frompresenting the same conclusion in February.158 According
to Temple, the data demonstrating the consistent link
Mr. Troy’s successes in urging courts to adopt a
between antidepressants and suicidal behavior were
radically aggressive preemption policy illustrate “how a
contained in 15 clinical trials, some of which had been
White House can use its administrative and legal powers
hidden for years from the public by the drug companies
to change the regulatory terrain without taking the often
arduous course of asking Congress to change the law.”164
This timely example of the ability of regulated entities
The Bush Administration has pursued its tort reform
to hide data concerning the very dangers that FDA seeks
agenda through arcane legal vehicles that are largely
to protect the public against underscores the necessity
hidden from public view, and it has enlisted the industry
of preserving the tort remedies that the Bush
to alert it to chances to do so. Courts should be reluctant
Administration is trying so hard to eliminate. Common
to accept the flawed and unprecedented statements of
law claims hold companies liable for poorly designed
this administration’s FDA, and consumers should be
and manufactured products, and they can indirectly
outraged at these clandestine attempts to erode their
influence corporate conduct. A company is not as likely
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
and Drug Law Institute’s (FDLI) bi-monthly magazine, “was adaptedfrom remarks originally delivered at FDLI’s annual Advertising and
* Policy Analyst, Center for Progressive Regulation (CPR), B.A.,
Promotion Conference, September 11-12, 2002.” Id. at 4.
J.D., University of Maryland. This White Paper is the first in aseries of efforts by CPR to highlight the Bush Administration’s
pervasive attempts to consolidate federal power in the area of state
11 Margaret Jane Porter, The Lohr Decision: FDA Perspective and Position,
tort law. The author is grateful for the invaluable input and guidance
52 FOOD & DRUG L.J. 7, n a1 (1997) (noting that article is an updated
of the following CPR Scholars: Thomas O. McGarity, who holds
version of speech presented at FDLI’s seminar “After the Lohr
the W. James Kronzer Chair at the University of Texas School of
Decision: What You Can Learn to Help Reduce Your Organization’s Exposure
Law and is the President of CPR; David C. Vladeck, Associate
to Product Liability,” Washington, D.C. (Oct. 8, 1996)). Significantly,
Professor of Law and Co-Director of the Institute for Public
Ms. Porter opened her remarks at the seminar by noting that “earlier
Representation at Georgetown University Law Center (and former
versions of the program were billed as an opportunity to learn how
Director of the Public Citizen Litigation Group); and Douglas A.
to help reduce manufacturers’ product liability exposure. FDA was
Kysar, Assistant Professor of Law at Cornell Law School. not interested in providing such advice; the program was revised to offer
1 Robert Pear, In a Shift, Bush Moves to Block Medical Suits, N.Y. TIMES,
an opportunity to understand product liability exposure.” Id. at 7
July 25, 2004; Robert Cohen, FDA Stepping Into Liability Lawsuits on
(emphasis added). Mr. Troy’s markedly different view of the role
Side of Drug Makers It Regulates, THE SEATTLE TIMES, May 11, 2004,
for FDA can be seen in the way his appearance at a 2003 conference
at A2; and Patrick McGann, FDA’s Chief Lawyer Stands Up for the Big
for in-house counsel and trial attorneys was billed:
Guys, LEWISTON MORNING TRIBUNE, July 31, 2004, at 10A. See also,
This roundtable of top defense attorneys and in-house
e.g., Anne C. Mulkern, Watchdogs or Lap Dogs? When Advocates Become
counsel will provide an insightful update on the preemptionRegulators, THE DENVER POST, May 23, 2004, at A-01; Gary Young,
doctrine and defense techniques for ensuring the best use of it. Dan
FDA Strategy Would Pre-empt Tort Suits; Does it Close Off Vital Drug
Troy, Chief Counsel of the FDA, will kick off the
Data?, NATIONAL LAW JOURNAL, March 1, 2004, at 1; Jeff Swiatek,
discussion by giving his valuable insight into why the FDA
FDA Gets Involved in Court Disputes, INDIANAPOLIS STAR, October 20,
chooses to file amicus briefs on certain cases . . . and what
we’re likely to see next. This dynamic session is sure to be
2 Horn v. Thoratec, 376 F.3d 163 (3rd Cir. 2004); Motus v. Pfizer, 358
F.3d 659 (9th Cir. 2004); Dowhal v. SmithKline BeechamConsumer, 88
Full Agenda for the 8th Annual Conference for In-House and Trial
P.3d 1 (Cal. 2004); In re Paxil Litigation, 2002 WL 31375497 (C.D.
Attorneys: Drug and Medical Device Litigation, December 14, 15 & 16,
Cal. 2002); and Murphree v. Pacesetter, Inc. et al, No. 005429-00-3
2003, <http://www.americanconference.com/drug/
(Tenn. Circuit Ct.), appeal docketed, No. W2004-01432 (Tenn. Ct.
agenda_full.cfm> (site visited 12/9/2003) (on file with author)
3 See, e.g., Letter Brief of Amicus Curiae United States, 2004 WL
12 See Porter, supra, n. 11, at 7 (referring specifically to FDCA § 521,
1143720, Horn v. Thoratec, 376 F.3d 163; Brief of Amicus Curiae United
part of the Medical Device Amendments (MDA) to the FDCA).
States, 2002 WL 32303084, Motus v. Pfizer, 358 F.3d 659; and Brief
of Amicus Curiae United States, 2003 WL 23527781, Dowhal v.See Troy, supra, n. 9, at 7. SmithKline Beecham, 88 P.3d 1.
14 See Porter, supra, n. 11, at 11.
4 BLACK’S LAW DICTIONARY 1197 (7th ed. 1999). See, e.g., Rose v.
15 150 CONG. REC. H5581-04 (daily ed. July 13, 2004) (statement of
Arkansas State Police, 479 U.S. 1, 3 (1986) (“[T]he Supremacy
Clause invalidates all state laws that conflict or interfere with an
Act of Congress (citing Hayfield Northern R. Co. v. Chicago & NorthSee Mulkern, supra, n. 1. Western Transp. Co., 467 U.S. 622, 627, and n. 4 (1984); Gibbons v.
17 See <http://www.house.gov/hinchey/issues/fda.shtml> (site
Ogden, 22 U.S. (9 Wheat.) 1, 211 (1824))).
visited September 2, 2004), quoting from Affidavit of Jessica R.
5 See James T. O’Reilly, A State of Extinction: Does Food and Drug
Dart, ¶5, Dusek v. Pfizer, Inc., No. H-02-3559 (S.D. Tex. Feb. 20,
Administration Approval of a Prescription Drug Label Extinguish StateClaims for Inadequate Warning?, 58 FOOD & DRUG L. J. 287, 288 (2003).
18 Michael Kranish, FDA Counsel’s Rise Embodies U.S. Shift, THE
6 See Young, supra, n. 1.
BOSTON GLOBE, December 22, 2002 (quoting Pfizer attorneyMalcolm Wheeler).
7 See, e.g., Needleman v. Pfizer, Inc., 2004 WL 1773697, *6 (N.D. Tex.
Aug. 6, 2004) (slip op.) (finding plaintiff ’s failure to warn claim
Brief of Amicus Curiae United States, Motus v. Pfizer, see supra, n.
preempted and granting summary judgment to Pfizer).
8 See Pear, supra, n. 1.
Kathleen Kerr, Can FDA Seal Be Broken?, NEWSDAY.COM, August
9 Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, UPDATE,
Jan.-Feb. 2003, at 4, 7. This article, which appeared in The Food
Letter from Michael J. Weber (Feldman Gale & Weber, P.A.) to
Paige Taylor (Assoc. Chief Counsel, FDA) (November 25, 2003),
available at: < http://www.house.gov/hinchey/issues/fda10.pdf>
“Former Chief Counsels’ Letter”).
29 Letter from Hon. Maurice D. Hinchey to Hon. Henry Bonilla, 2
(August 5, 2004), available at <http://www.house.gov/apps/list/press/ny22_hinchey/morenews/080504fda_bonilla.html> (site
23 Statement of Interest of the United States of America, Murphreev. Pacesetter, Inc. et al., No. 005429-00-3 (Tenn. Circuit Ct. Dec. 12,2003), cited and quoted in Horn v. Thoratec Corp., 376 F.3d 163, 171
30 See Former Chief Counsels’ Letter, supra, n. 21.
31 See Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973),
24 See 150 CONG. REC. H5581-04, supra, n. 15.
cited by Former Chief Counsels’ Letter, supra, n. 21.
25 See Mulkern, supra, n. 1.
32 See Bernhardt v. Pfizer, 2000 WL 1738645, *1, n.3 (S.D.N.Y. 2000)(noting that “[a]t the Court’s request, the United States has submitted
26 See Cohen, supra, n. 1.
a Statement of Interest”); and Jones v. Rath Packing Co., 425 U.S. 933
27 Each of the five former Chief Counsels are now in private
(1977) (inviting the Solicitor General to file brief expressing the
practice, working for firms that represent clients in the fields of
views of the United States), opinion at 430 U.S. 519 (1977), cited
by Former Chief Counsels’ Letter, supra, n. 21. The court’s opinionin the final case cited by the Former Chief Counsels does not reveal
Peter Barton Hutt is a partner at Covington and Burling in
what, if any, involvement FDA had in the case. SeeEli Lilly & Co.
Washington, D.C. See <http://www.martindale.com/xp/
v. Marshall, 850 S.W.2d 164 (Tex. 1993), cited by Former Chief
Martindale/Lawyer_Locator/Search_Lawyer_Locator/
Counsels’ Letter, supra, n. 21.
lawyer_search.xml> (site visited 9/21/2004).
33 See Mulkern, supra, n. 1.
Richard A. Merrill also works for Covington & Burling, as of
counsel. Id. Covington and Burling’s representative clients
Troy: Untitled Enforcement Letters Are Strong Enough to Support
include, among others, Eli Lilly, GlaxoSmithKline, Johnson &
Enforcement Acts, 10 FDA ADVERTISING & PROMOTION MANUAL,
Johnson and Merck. See <http://
MONTHLY BULLETIN, 1, 3 (November 2002).
35 See Porter, supra, n. 11, at 7 (referring specifically to FDCA § 521,
default.asp?action=rf&rf=fprofile&fid=3826>, (site visited 9/2/
part of the Medical Device Amendments (MDA) to the FDCA).
36 Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).
Richard M. Cooper is a member of Williams & Connolly LLP,
where his fields of expertise include Food and Drug Law. SeeSee U.S.C.A. Const. Amend. X.
<http://www.martindale.com/xp/Martindale/Lawyer_Locator/
38 See BLACK’S LAW DICTIONARY, supra, n. 4, 1178.
Search_Lawyer_Locator/lawyer_search.xml> (site visited 9/21/
2004). That firm’s clients include Wyeth, Bayer, and the United
Lohr, 518 U.S. at 485, (quoting Rice v. Santa Fe Elevator Corp., 331
States Surgical Corporation, “a leading manufacturer of wound
U.S. 218, 230 (1947); Hillsborough County v. Automated Medical
closure products and advanced surgical devices . . . .” <http://
Laboratories, Inc., 471 U.S. 707, 715-16 (1985)).
www.wc.com/practice.cfm?practice_ID=15&link=1&pf=1> (site
40 Id. (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992);
Gade v. Nat’l Solid Wastes Management Ass’n., 505 U.S. 88, 96 (1992);Malone v. White Motor Corp., 435 U.S. 497, 504 (1978)).
Nancy L. Buc is a Resident Partner at Buc & Beardsley, a boutiquefirm that specializes in Food, Durg, Medical Device, Biologics and
41 United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784,
Cosmetic Law. See <http://www.martindale.com/xp/Martindale/
Lawyer_Locator/Search_Lawyer_Locator/lawyer_search.xml>
42 See O’Reilly, supra, n. 5, 288.
43 Lohr, 518 U.S. 470 at 485.
Thomas Scarlett is a member of Hyman, Phelps & McNamara,P.C., a mid-size firm that specializes in “[p]ractice before all Courts,
44 Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2002) (internal citations
Government Agencies and International Regulatory Authorities
omitted) (quoting English v. General Elec. Co., 496 U.S. 72, 78-79
involving Foods, Drugs, Cosmetics, Medical Devices, Biologics,
Pesticides, Controlled Substances and Consumer Products.” See
45 21 U.S.C. §§ 351 et seq.
<http://www.martindale.com/xp/Martindale/Lawyer_Locator/Search_Lawyer_Locator/lawyer_search.xml> (site visited 9/21/
46 Murphree v. Pacesetter, Inc. et al, No. 005429-00-3 (Tenn. Circuit
Ct.), appeal docketed, No. W2004-01432 (Tenn. Ct. App.).
28 Letter from Peter Barton Hutt, Richard A. Merrill, Richard M.
Cooper, Nancy L. Buc and Thomas Scarlett to Hon. Henry
48 Letter from Weber to Taylor, supra, n. 21.
Bonilla (July 15, 2004), 150 CONG. REC. E1505-03 (daily ed. July22, 2004) (letter submitted into record by Rep. Barton) (the
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
49 Statement of Interest of the United States of America, Murphree
§ 360(e)(c). Id. at 164-65. The device at issue in Lohr had received
v. Pacesetter, supra, n. 23.
FDA approval through the “substantial equivalence” process setforth in 21 U.S.C. § 510(k). Lohr, 518 U.S. at 480. The Lohr Court
found that the generality of the federal requirements imposed under
the “substantial equivalence” process made the claim
52 Murphree v. Pacesetter, Inc., No. W2004-01432 (Tenn Ct. App.).
quite unlike a case in which the Federal Government hasweighed the competing interests relevant to the particular
53 Horn v. Thoratec Corp., 376 F.3d 163, 171 n. 13, 178 (3rd Cir. 2004).
requirement in question, reached an unambiguous
conclusion about how those competing considerationsshould be resolved in a particular case or set of cases, and
implemented that conclusion via a specific mandate on
Id. at 501. The Horn court read this language to suggest that “theanalysis would have been significantly different if the device at issue
in Lohr had weathered a more exacting federal investigation, such
as the PMA process.” Horn, 376 F.3d at 169 (citing Medtronic, 518U.S. at 501).
71 Id. at 174-76. The Third Circuit reasoned that because Justice
Breyer wrote separately to emphasize that he was “not convinced
62 Statement of Interest of the United States of America, Murphree
that future incidents of MDA preemption of common-law claims
v. Pacesetter, supra, n. 23.
will be ‘few’ or ‘rare,’” Lohr, 518 U.S. at 508 (Breyer, J., concurringin part), the appropriate reading of the Lohr decision was not the
63 Third Circuit Asks FDA to Submit Brief in Pending Medical Preemption
broad pronouncement made by Justice Stevens that few, if any,
Case, BNA PRODUCT LIABILITY DAILY, March 10, 2004. The court
common-law duties had been preempted. Rather, the Third Circuit
allowed Thoratec to amend the record on appeal by including FDA’s
read Lohr to advise that “a court should carefully examine the state
filing in Murphree on January 24, 2004 and requested FDA to submit
common law claim in order to determine whether that claim would
a letter brief on February 27, 2004. Id. impose a substantive requirement that conflicts with, or adds a greater
64 Medtronic, 518 U.S. at 500. The MDA preemption section
burden to, a specific federal requirement.” Horn, 376 F.3d at 174.
The court concluded that “Horn’s general state law claims wouldimpose substantive requirements on [Thoratec] that would conflict
§ 360k. State and local requirements respecting devices
with, or add to, the requirements imposed by FDA involved in the
design, manufacturing, fabrication and labeling of the HeartMate.”Id. at 176.
Except as provided in subsection (b) of this section, noState or political subdivision of a state may establish or
72 Id. at 177-78 (quotingLetter Brief of Amicus Curiae United
continue in effect with respect to a device intended for
(1) which is different from, or in addition to, any
74 Id. at 178 (quoting Statement of Interest of the United States
requirement applicable under this chapter to the device,
of America, Murphree v. Pacesetter, 7-9).
75 21 U.S.C. §§ 351 et seq.
(2) which relates to the safety or effectiveness of thedevice or to any other matter included in a requirement
76 Brief of Amicus Curiae Public Citizen, 2003 WL 22716063, *13,
applicable to the device under this chapter. Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004).
77 See Robert S. Adler & Richard A. Mann, Preemption and MedicalDevices: The Courts Run Amok, 59 MO. L. REV. 895 (1994) (citingH.R. 6110, 73d Cong., 1st Sess. Section 25 (1933); S. 1944, 73d
Cong., 2d Sess. S24 (1933); Hearings Before a Subcommittee of
the Committee on Commerce of the United States Senate on S. 1944, 73d Cong., 2d Sess. 400, 403 (1933)).
78 Id. (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992);
Gade v. Nat’l Solid Wastes Management Ass’n., 505 U.S. 88, 96 (1992);
70 Horn, 376 F.3d at 169-73. Thoratec’s HeartMate had been through
Malone v. White Motor Corp., 435 U.S. 497, 504 (1978)).
FDA’s Pre-Market Approval (PMA) process, pursuant to 21 U.S.C.
79 Medtronic v. Lohr, 518 U.S. at 470, 485 (1996) (quoting Rice v. SantaFe Elevator Corp., 331 U.S. 218, 230 (1947); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-16 (1985)).
80 See, e.g., Jamie Talan, Paxil Subject of Suit; AG, in First Actionof its Kind, Accuses GlaxoSmithKline of Concealing Details
101 Id. at 1096. The court summarized its findings:
About Drug’s Risks, NEWSDAY, June 3, 2004, p. A06.
[S]everal other courts have determined that FDA
requirements are minimum standards and that FDAapproval is not a shield to liability; 21 CFR § 314.70(c)(2)(1)
permits manufacturers to strengthen warning labels
83 In re Paxil Litigation, 2002 WL 31375497, *1 (C.D. Cal. 2002).
without prior FDA approval; Pfizer has not limited itsattack to any specific warnings; and finally the FDA has
not made any statement that Pfizer could not include a
strengthened suicide warning. In light of these factors,the Court finds that Pfizer has not established that it would
86 The court lifted the preliminary injunction based largely on FDA’s
be impossible to comply simultaneously with FDA
explanation of its own consideration of whether the advertisements
requirements and with a state law or decision requiring a
were misleading. FDA’s “extensive fact finding process engaged in
by FDA with regard to Paxil and its approval of Paxil’sadvertisements” changed the court’s “evaluation of Plaintiffs’
likelihood of success on the merits to a degree dictating that the
102 Motus v. Pfizer Inc., 196 F.Supp.2d 984, 999 (C.D. Cal. 2001)
preliminary injunction should be denied.” In re Paxil, 2002 WL
103 See Motus III, 358 F.3d at 660.
104 See Kranish, supra, n. 18.
105 Letter from Karen A. Barth (counsel for Flora Motus) to Daniel
Troy, Esq., (January 3, 2003) (on file with author); see also Kranish,
90 Id. at *1 (internal citation omitted).
91 See Kranish, supra, n. 18.
92 Matt Fleischer-Black, Cosmetic Advocacy, T
Brief of Amicus Curiae United States, supra, n. 3, *21 - *22,
Motus III (emphasis in original).
93 FDA’s brief in the Paxil litigation was filed on September 5, 2002.
FDA’s argument that excessively strong warnings could result in
In re Paxil, supra, n. 86 at *1. Its amicus brief before the Ninth
under-utilization of a treatment were successful in the limited
Circuit was filed on September 10, 2002. Brief of Amicus Curiae
context presented by the case of Dowhal v. SmithKline Beecham
United States, Motus v. Pfizer, 358 F.3d 659, supra, n. 3. Consumer Healthcare, 88 P.3d 1 (Cal. 2004). In Dowhal, a citizen ofCalifornia filed suit against SmithKline, seeking to force the
94 Motus v. Pfizer, 358 F.3d 659 (9th Cir. 2004) (Motus III). Zoloft is
company to include a warning required by the California Health
the registered trademark and brand name in the United States for
and Safety Code in its labeling of nicotine replacement therapy
sertraline hydrochloride, an SSRI. Motus v. Pfizer, 127 F. Supp.2d
(NRT) products. Id. at 917-19. The warning required by the
1085, 1088 (C.D. Cal. 2000) (“Motus I”).
California law would have warned that NRT products “contain[] a
95 Motus I, 127 F. Supp.2d at 1086.
chemical known to the State of California to cause birth defects orother reproductive harm.” Id. at 918. FDA did not permit
SmithKline to use the stronger warning, however, instead requiring
a label that warned that the “medicine is believed to be safer thansmoking. However, the risks to your child from this medicine are
98 The text of the warning FDA instructed Pfizer to
not fully known.” Id. at 919. FDA filed an amicus brief in support
of preemption. Brief of Amicus Curiae United States, 2003 WL
Suicide – The possibility of a suicide attempt is inherent in
depression and may persist until significant remission
The court concluded that it had no reason to question FDA’s expert
occurs. Close supervision of high risk patients should
determination that “the risk of harm may be so remote that it is
accompany initial drug therapy. Prescriptions for Zoloft
outweighed by the greater risk that a warning will scare consumers
(sertraline) should be written for the smallest quantity of
into foregoing use of a product that in most cases will be to their
capsules consistent with good patient management, in
benefit.” Id. at 934. However, the court rejected the broader
order to reduce the risk of overdose.
arguments raised in FDA’s brief, noting that in most cases FDA
Stealth Tort Reform: The Bush Administration, FDA, and Preemption
warnings and the California state warnings would “serve the same
125 Id. The position of FDA Commissioner remained vacant from
purpose — informing the consumer of the risks involved in use of
January 19, 2001 through November 14, 2002, when Mark B.
the product — and differences in wording would not call for federal
McClellan was sworn in as Commissioner. <http://
preemption.” Id. In the specific case of NRT use by pregnant
www.fda.gov/oc/commissioners/mcclellan.html> (site visited
09/28/2004). In the 14-month period between his ownappointment and that of Commissioner McClellan, Mr. Troy held
[T]he FDA warning serves a nuanced goal — to inform
at least 50 meetings with representatives of the industries FDA
pregnant women of the risks of NRT products, but in a
regulates, none of which were memorialized in any way. See
way that will not lead some women, overly concerned about
those risks, to continue smoking. This creates a conflictwith the state’s more single-minded goal of informing the
Dr. Lester M. Crawford Jr., who was appointed deputy commissioner
consumer of the risks. That policy justifies federal
in February 2002 and headed the agency until McClellan’s
appointment, was named to lead FDA as acting commissioner asof March 27, 2004, following Dr. McClellan’s departure. <http://
www.fda.gov/oc/commissioners/mcclellan.html>.
126 See Fleischer-Black, supra, n. 92.
110 Motus III, 358 F.3d at 661.
127 See Mulkern, supra, n. 1.
111 Needleman v. Pfizer Inc., 2004 WL 1773697, *4 (N.D. Tex. Aug. 6,
128 See Kranish, supra, n. 18. Troy’s book, Retroactive Legislation, was
2004) (slip op.) (“[T]he Court places weight on FDA’s unambiguous
published under the auspices of the American Enterprise Institute
statement [in the Motus brief] that it would view any statement
in 1998. See <http://www.aei.org/publications/bookID.223/
describing a relationship between Zoloft use and suicide as “false
book_detail.asp> (site visited 09/28/2004).
and misleading” and it would deem any state warning requirementpreempted”); Dusek v. Pfizer, Inc., No. H-02-3559, 12-13 (S.D. Tex.
129 See Kranish, supra, n. 18.
Feb. 20, 2004) (slip op.) (“The Court concludes that the FDA’s
130 See Carey, supra, n. 122.
position as stated in the [Motus] amicus brief that any label suggestingthat Zoloft can cause suicide would be false or misleading provides
131 See Shultz, supra, n. 121.
132 See <http://www.house.gov/hinchey/issues/fda.shtml> (site
visited September 2, 2004), quoting from Affidavit of Jessica R. Dart, ¶6, Dusek v. Pfizer, Inc., No. H-02-3559 (S.D. Tex. Feb. 20,
114 Kernats v. Smith Indus. Med. Sys., Inc., 669 N.E.2d 1300 (Ill. App.
134 See Letter Brief of Amicus Curiae United States, Horn, supra, n.
115 Letter Brief of Amicus Curiae United States, Horn, supra, n. 3,
135 See, e.g.,Letter Brief of Public Citizen, Counsel for Appellant, at
3-4, Horn v. Thoratec, 376 F.3d 163, available at <http://
www.citizen.org/documents/HornSurreply4.601.pdf>; see UnitedStates v. Mead Corp., 533 U.S. 218, 228 (2001) (degree of deference
due to government depends on, among other things, consistency
119 Richard A. Oppel, Jr. and Jim Yardley, The 2000 Campaign: the
and formality of government’s position). Texas Governor; Bush Calls Himself Reformer; the Record Shows the Label
136 See Letter Brief of Amicus Curiae United States, Horn, supra, n. May Be a Stretch, THE NEW YORK TIMES, March 20, 2000, at A16.
3, *25-*26; Brief of Amicus Curiae United States, Motus III, supra,
121 See Stacey Shultz, Mr. Outside Moves Inside, U.S. NEWS & WORLD
137 See Letter Brief of Amicus Curiae United States, Horn, supra, n.
REPORT, March 24, 2003 (quoting Wayne Pines, former FDA official
and current president of regulatory services and healthcare at
138 See Thomas O. McGarity, Beyond Buckman: Wrongful Manipulation
APCO, a Washington, D.C. communications consulting firm.)
of the Regulatory Process in the Law of Torts, 41 Washburn L.J. 549,
122 John Carey, Just What the Doctor Ordered for FDA?, BUSINESS
124 James G. Dickinson, Bush Taming FDA? Some Think Not,
141 Young, supra, n. 1. Karen Barth Menzies of the Los Angeles
MEDICAL DEVICE & DIAGNOSTIC INDUSTRY, October 2001.
law firm Baum Hedlund represents the plaintiffs in In re Paxil.
143 McGarity, supra, n. 138, at 571 (citing Michael D. Green, Bendectin
151 Transcript of the February 2, 2004 meeting of the
and Birth Defects, 78 (1996)).
Psychopharmacologic Drugs Advisory Committee with the Pediatric
Subcommittee of the Anti-Infective Drugs Advisory Committee,12-13, available at: <http://www.fda.gov/ohrms/dockets/ac/04/
145 Brief of Amicus Curiae United States, Motus III, supra, n. 3, *22.
transcripts/4006T1.pdf> (site visited 09/30/2004).
The brief was submitted on September 10, 2002. Id at *i.
146 FDA Statement Regarding the Anti-Depressant Paxil for the PediatricPopulation, June 19, 2003, available at <http://www.fda.gov/bbs/
topics/ANSWERS/2003/ANS01230.html> (site visited 09/02/
155 Gardiner Harris, FDA Links Drugs to Being Suicidal, THE NEW
147 Id. The statement also included a large block warning in its
YORK TIMES, September 13, 2004 at A1.
statement advising that “[d]espite the new possible concerns about
the use of Paxil in children, it is essential that patients taking Paxil
do not suddenly discontinue use of the drug.” Id. Nine months
earlier, FDA’s brief in the Paxil litigation had asserted that the drug
did not cause withdrawal symptoms but merely a “discontinuation
syndrome.” See Kranish, supra, n. 18. FDA’s brief in the Paxil
litigation was filed on September 5, 2002. In re Paxil, supra, n. 86 at
Brief of Amicus Curiae United States, supra, n. 3, *21 - *22,
Motus III (emphasis in original).
148 Anna Wilde Mathews, Mood Disorder: In Debate Over Antidepressants,FDA Weighed Risk of False Alarm, THE WALL STREET JOURNAL, May25, 2004, at A1. FDA sought the information for Prozac, Zoloft,
162 Needleman v. Pfizer Inc., 2004 WL 1773697, *4 (N.D. Tex. Aug. 6,
Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron. Id.
2004) (slip op.); Dusek v. Pfizer, Inc., No. H-02-3559, 12-13 (S.D. Tex. Feb. 20, 2004) (slip op.), supra, n. 111.
149 FDA Public Health Advisory, Reports of Suicidality in PediatricPatients Being Treated with Antidepressant Medications for Major DepressiveDisorder (MDD), October 27, 2003, available at <http://
www.fda.gov/cder/drug/advisory/mdd.htm> (site visited 09/02/2004). About the Center for Progressive Regulation Founded in 2002, the Center for Progressive Regulation is a nonprofit research and educationalorganization of university-affiliated academics with expertise in the legal, economic, and scientific issuesrelated to regulation of health, safety, and the environment. CPR supports regulatory action to protecthealth, safety, and the environment, and rejects the conservative view that government’s only function is toincrease the economic efficiency of private markets. Through research and commentary, CPR seeks toinform policy debates, critique anti-regulatory research, enhance public understanding of the issues, andopen the regulatory process to public scrutiny. Direct media inquires to Matthew Freeman at[email protected]. For general information, email [email protected].Visit CPR’s website at www.progressiveregulation.org. The Center for Progressive Regulation is gratefulto the Deer Creek Foundation for its generous support of this project and CPR’s work in general.1200 New York Ave., NW, Suite 400, Washington, DC 20005202-289-4026 (phone) / 202-289-4402 (fax)
Clinical Physiology 21(4), 2001, in print Heart rate dynamics and cardiorespiratory coor- dination in diabetic and breast cancer patients H. Bettermann1, M. Kröz2, M. Girke2, C. Heckmann1 1Department of Clinical Research, Gemeinschaftskrankenhaus Herdecke, 58313 Her-decke, Germany 2 Institute of Clinical Research, Gemeinschaftskrankenhaus Havelhöhe, 14089 Berlin, Germany Short t
Bibliografia selecta di Giulio Busi 1. Monografie Horayat ha-qore’: Grammatica ebraica del secolo XI . Frankfurt am Main: Lang, 1984. Libri e scrittori nella Roma ebraica del Medioevo . Rimini: Luisè, 1990. Anania Coen: Editore e letterato ebreo tra Sette e Ottocento . Bologna: AISG, 1992. Il succo dei favi: Studi sull'umanesimo ebraico . Bologna: Fattoadarte