Number 1228
August 24, 2011
Client Alert
Latham & Watkins Litigation Department
“Park exposes
corporate officers
to criminal
liability for FDCA
violations based
solely upon
their position of
responsibility
within the
company, and
penalties can
be harsh —
including large
fines, debarment
(prohibiting
executives from
providing services
to a regulated
company),
individual
and corporate
exclusion from
participation in
federal health care
programs, as well
probation and jail
time.”
Corporate Officers To Be Prosecuted for
Corporate Violations of The Food, Drug,
and Cosmetic Act Without Knowledge of
Criminal Conduct
The Food and Drug Administration
(FDA) has released aggressive
guidelines for prosecutions under the
Food, Drug, and Cosmetic Act1 (FDCA)
that put corporate officers at risk of
criminal liability merely because of their
position within a violating company. The
guidelines reinvigorate the long dormant
Park doctrine, which allows corporate
officers to be held criminally responsible
for corporate violations of the FDCA
and convicted of a misdemeanor even
if — unlike virtually all other criminal
laws — they had no knowledge of the
illegal conduct.2
For years Park prosecutions were rare,
but regulators see the Park doctrine
as a potentially powerful enforcement
tool that “can have a strong deterrent
effect on the defendants and other
regulated entities.”3 The release of Park
prosecution guidelines by the FDA
follows a series of statements by FDA
officials that enforcement efforts — and
Park prosecutions in particular — are
set to increase, and executives in
industries subject to the jurisdiction
of FDA cannot afford to ignore this
trend. Park exposes corporate officers
to criminal liability for FDCA violations
based solely upon their position of
responsibility within the company, and
penalties can be harsh — including
large fines, debarment (prohibiting
executives from providing services to
a regulated company), individual and
corporate exclusion from participation
in federal health care programs, as well
probation and jail time. And exposure
is broad: any employee in the chain of
command with authority to correct or
prevent a violation could potentially be
prosecuted.4
These announcements and the FDA’s
guidelines for prosecution underscore
the importance of implementing
and maintaining a robust corporate
compliance program designed to deter
and detect violations of the FDCA.
A compliance program structured to
show regulators that the company and
its employees do everything they can
to prevent violations is the single best
risk management tool companies and
executives have at their disposal to
avoid FDCA liability, and can have a
significant impact on the government’s
enforcement choices, including its
exercise of prosecutorial discretion.
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Latham & Watkins | Client Alert
The Park Doctrine
The Park doctrine originated in
Dotterweich v. United States,5 a
1943 case in which the US Supreme
Court held that individuals could
be prosecuted under the FDCA and
affirmed the conviction of a drug
company’s president for misdemeanor
misbranding,6 even though there was
no evidence that he participated in
the misbranding or knew that it was
occurring.7 In doing so, the Court
explained that the statute “dispenses
with the conventional requirement
of criminal conduct — awareness of
some wrongdoing,” to help ensure the
safety of food and drugs marketed to
the public: “In the interest of the larger
good [the FDCA] puts the burden
of acting at hazard upon a person
otherwise innocent but standing
in responsible relation to a public
danger.”8
After years of varying interpretations
by lower courts, the Supreme Court
affirmed and clarified Dotterweich
in the 1975 case of United States v.
Park.9 John Park was the president of a
national retail food chain convicted of
violating the FDCA based on unsanitary
conditions in one of the company’s
warehouses. Mr. Park appealed his
conviction, arguing it should be
overturned because the jury did not
find that he engaged in any of the
underlying conduct. The Supreme Court
rejected his argument, explaining that
a corporate officer or manager can be
found guilty of a misdemeanor FDCA
violation “by reason of his position
in the corporation, responsibility and
authority either to prevent in the first
instance, or promptly to correct, the
violation complained of….”10 According
to the Court, the FDCA imposes upon
corporate executives, “not only a
positive duty to seek out and remedy
violations when they occur, but also,
and primarily, a duty to implement
measures that will insure that violation
will not occur.”11 The failure to prevent
an FDCA violation, the Court held,
is a strict liability offense — that is,
2
Number 1228 | August 24, 2011
an act that is criminal whether or
not the defendant was aware of the
underlying conduct. And, in tying the
defendant’s liability to his “responsibility
and authority” to prevent or correct
the violation, the Court left open the
possibility that lower-level employees
could be held liable as well — an
approach which lower courts have since
embraced.12
Recognizing the potential breadth of
its holding, the Park Court was careful
to add that defendants cannot be held
liable for FDCA violations that they
were “powerless” to prevent or correct.13
This statement has subsequently been
interpreted by courts to create an
affirmative defense for officers who can
show they exercised “extraordinary
care” to prevent a violation.14 Under
this standard, a corporate officer may
be able to escape liability by employing
the “highest standard of foresight and
vigilance.” This is a difficult standard
to meet, and the few defendants that
have litigated this question have not
been successful.15 While the dearth
of cases testing the bounds of the
extraordinary care standard makes it
unclear exactly what executives must
do to avoid liability under the Park
doctrine, implementing and maintaining
a rigorous compliance program is an
essential first step.
A misdemeanor conviction under the
FDCA can result in fines of US$100,000
per count for an individual and a
year of jail time.16 And — pursuant to
amendments adopted in 2008 — the
Sentencing Guidelines recommend
upward departures in cases where the
offense created a “substantial risk of
bodily injury or death.”17 Further, a
guilty plea or misdemeanor conviction
permits the Department of Health and
Human Services’ Office of the Inspector
General (OIG) to exercise its discretion
to impose a three-year exclusion of an
individual from participation in federal
health care programs.18 Similarly, such
a conviction is grounds for permissive
debarment by the FDA for up to five
years.19 Corporate executives could also
face exclusion when the companies
Latham & Watkins | Client Alert
they oversee plead guilty to or are
convicted of misdemeanor violations of
the FDCA, even if the executives are not
prosecuted themselves.
Recent FDCA enforcement activities
illustrate the gravity of the consequences
corporations and their executives can
face. Prosecutors in Philadelphia are
currently seeking prison terms for four
Synthes executives who pled guilty to
one misdemeanor count each for their
role in off-label promotion of a bone
cement.20 Along the same lines, in March
2011, Forest Laboratories pled guilty
to a misdemeanor in connection with
its marketing of Celexa and Lexipro,
and was ordered to pay US$313 million
dollars. A few weeks later, on April 8,
2011, Forest’s CEO received a letter
from the Department of Health and
Human Services indicating its intent to
exclude him participating from federal
health care programs, despite no
allegations that he engaged in or knew
of any wrongdoing. OIG ultimately
decided not to seek exclusion,21 but
the agency’s actions made clear that
corporate officers who do not face
criminal charges and who were not
aware of corporate violations may still
face exclusion. Forest Labs continues to
deal with fallout from the misdemeanor
conviction and subsequent exclusion
proceedings.22
Enforcement Trends
The Park doctrine was used with
relative frequency in the 1970s and
early 1980s, but fell out of favor in
the face of limited resources and
shifting enforcement priorities. But the
enforcement landscape is changing:
Park is increasingly seen by regulators
as a powerful tool for deterring and
punishing FDCA violations. In this
connection, FDA officials have indicated
that additional deterrence is necessary
because companies increasingly view
multi-million dollar settlements and
fines as costs of doing business, and as
a result, fines have not spurred broader
changes in corporate policies and
practices.23
3
Number 1228 | August 24, 2011
FDA officials have been signaling
stepped-up enforcement efforts against
responsible corporate officers for
over a year. For example, in a letter
to the Senate Finance Committee
in March 2010, Margaret Hamburg,
Commissioner of Food and Drugs,
stated that a committee of senior FDA
officials recommended increasing the
use of Park prosecutions.24 On May
27, 2010, Deborah Autor, director of
the FDA’s Center for Drug Evaluation
and Research, Office of Compliance,
testified in a Congressional hearing
that the agency is working to increase
enforcement on the criminal side.
And Eric Blumberg, the FDA’s Deputy
Chief Counsel for Litigation, stated in
speeches on April 22 and October 13,
2010 that corporate executives would
face criminal prosecution for violations
of the FDCA.25 In a Statement on August
5, 2011 OIG announced “[w]e remain
committed to investigating and, when
appropriate, sanctioning executives
and managers of health care entities…
[t]his includes individuals who directly
commit fraud as well as the executives
in a position of responsibility at the time
of the fraud.”26
On January 26, 2011, the FDA published
new guidelines in the FDA Regulatory
Procedures Manual (RPM) entitled,
“Special Procedures and Considerations
for Park Doctrine Prosecutions.”27
These guidelines expressly confirm
that participation in, and knowledge of,
misconduct are not prerequisites for a
Park prosecution (though they may be
relevant to an exercise of discretion),28
and list seven standard yet nonexhaustive criteria for FDA personnel
to consider when deciding whether to
recommend prosecution:
1.Whether the violation involves actual
or potential harm to the public;
2.Whether the violation is obvious;
3.Whether the violation reflects a
pattern of illegal behavior and/or
failure to heed prior warnings;
4.Whether the violation is widespread;
5.Whether the violation is serious;
Latham & Watkins | Client Alert
6.The quality of the legal and factual
support for the proposed prosecution;
and
7.Whether the proposed prosecution is a
prudent use of agency resources.29
The agency will also consider the
individual’s position in the company
and relationship to the violation, and
whether the official had the authority
to correct or prevent the violation.
Though the guidance is non-binding
and states that the factors listed are not
exclusive, it provides a starting point for
discussions with the agency in the event
of an investigation, and gives executives
an additional tool to evaluate the
likelihood of prosecution and prepare
defenses.
One additional development of interest
to companies navigating the current
FDCA enforcement environment is
the Supreme Court’s recent decision
in Sorrell v. IMS Health Inc.30 In
Sorrell, the Supreme Court struck
down a Vermont law preventing
pharmacies from sharing information
about doctors’ prescribing practices
with pharmaceutical marketers as a
violation of the First Amendment. Sorrell
provides pharmaceutical and medical
device manufacturers with powerful
constitutional arguments against the
comparatively narrow interpretation
of the First Amendment currently held
by the Department of Justice and the
FDA. Sorrell’s influence will unfold
in a variety of arenas — regulatory,
litigation, legislative — but prohibitions
on “off-label” promotions are likely
to be challenged by entities seeking
to legitimately provide physicians
with truthful and non-misleading
information about medically accepted
uses for pharmaceuticals and devices
approved by the FDA. Whether the
Sorrell decision causes enforcement
officials to pause before instituting Parkbased criminal prosecutions remains to
be seen.
Risk Reduction Strategies
Given the serious potential
consequences of criminal liability
4
Number 1228 | August 24, 2011
under Park and prevailing uncertainty
as to how and when it will be
used, it is essential that companies
implement comprehensive compliance
programs designed to show they took
“extraordinary care” to prevent FDCA
violations — to protect themselves
and their executives.31 Compliance
programs not only reduce the likelihood
of violations in the first instance but
position executives and companies
to mitigate potential consequences
and present a strong defense in an
enforcement action.
Several sources provide guidance as
to the kinds of compliance measures
that evidence “extraordinary care”
in the eyes of the FDA, including the
Sentencing Guidelines, OIG Final
Compliance Program Guidance, and
recent guidance on how OIG it will
exercise its exclusion authority.32 In
particular, the FDA has indicated that
recent corporate integrity agreements
with OIG, which impose compliance
obligations undertaken in settlements,
serve as “roadmaps” for shielding
executives from strict liability under
Park.33 As relevant here, common
provisions include: (1) Hire a compliance
officer/appoint a compliance committee;
(2) Develop written standards and
policies; (3) Implement a comprehensive
employee training program; (4) Retain
an independent review organization to
review regulated activities; (5) Establish
a confidential disclosure program and
(6) Restrict employment of debarred
individuals.34 OIG’s final Compliance
Program Guidance for Pharmaceutical
Manufacturers recommends similar
measures, including: implementing
written policies and procedures,
designating a compliance officer and
compliance committee, conducting
effective training and education,
developing effective lines of
communication, conducting internal
monitoring and auditing, enforcing
standards through well-publicized
disciplinary guidelines and responding
promptly to detected problems and
undertaking corrective actions.35 The
US Sentencing Guidelines incorporate
Latham & Watkins | Client Alert
similar measures in describing an
“effective corporate compliance and
ethics program,” likewise emphasizing
written standards, active oversight,
employee training, and promoting an
overall culture of compliance.36
Further, as the Guidelines suggest,
companies should regularly review and
audit existing compliance programs
in consultation with outside counsel
to ensure they represent current best
practices in compliance, incorporate
relevant legal developments, and
respond appropriately in a test
environment.37 Likewise, case law,
recent indictments of pharmaceutical
companies and executives, and OIG
guidance all underscore the importance
of responding to misconduct — both
in thoroughly investigating complaints
and implementing corrective actions
designed to prevent problems from
recurring. When appropriate, timely
reporting of misconduct also can
factor into favorable treatment from
the government.38 Finally, companies
should maintain thorough written
documentation of compliance measures
in the event they need to show they
exercised “extraordinary care.”
Though compliance programs can
seem burdensome to implement and
maintain, their cost pales in comparison
to the potential consequences of FDCA
violations. Even when a company
manages to avoid criminal liability
or exclusion, the costs of a FDCA
violation remain high — including
fines, burdensome remedial measures,
ongoing oversight, and potential
criminal liability and exclusion for
individual company executives.39
A compliance program structured
to deter violations and detect them
early is always a company’s best
option — particularly in the current
enforcement environment.
Conclusion
Misdemeanor FDCA violations are an
increasingly important enforcement
tool, and the FDA has warned that
criminal prosecutions and exclusion of
5
Number 1228 | August 24, 2011
individual executives are forthcoming.
To mitigate the risks of both corporate
and individual liability, companies and
their officers should take “extraordinary
care” to prevent FDCA violations
by implementing a thorough, welldocumented corporate compliance
program. Companies and executives
that can demonstrate a commitment to
compliance, regular monitoring, and
proactive and effective responses to
misconduct significantly reduce their
risk of criminal liability and position
themselves favorably to defend against
potential enforcement actions.
Endnotes
1
21 U.S.C. §§ 301 et seq. (2009). See especially
21 U.S.C. § 331 (prohibited acts); § 333
(penalties). Once a person has been convicted
of a misdemeanor under the FDCA, any
subsequent violation is a felony. 21 U.S.C. §
333(a)(2). Other felony violations require an
intent to defraud or mislead. Id.
2
See US Food and Drug Admin., Regulatory
Procedures Manual 6-5-3 (“Special
Procedures and Considerations for Park
Doctrine Prosecutions”), available at http://
www.fda.gov/ICECI/ComplianceManuals/
RegulatoryProceduresManual/ucm176738.htm
[hereinafter, “Park Guidelines”].
3
Id.
4
See, e.g., United States v. General Nutrition,
Inc., 638 F. Supp. 556 (W.D.N.Y. 1986) (finding
low-level store clerk and manager who claimed
they committed no criminal acts and did not
understand the criminality of such acts, could
be liable for misbranding violations because
the FDCA states “any person” shall be liable for
violations).
5
320 US 277 (1943).
6
21 U.S.C. § 331(a)(1) prohibits “The introduction
or delivery for introduction into interstate
commerce of any food, drug, device, or cosmetic
that is adulterated or misbranded.”
7
See 320 US at 285-86 (Murphy, J., dissenting)
(“There is no evidence in this case of any
personal guilt on the part of the respondent.
There is no proof or claim that he ever knew of
the introduction into commerce of the adulterated
drugs in question, much less that he actively
participated in their introduction. Guilt is imputed
to the respondent solely on the basis of his
authority and responsibility as president and
general manager of the corporation.”).
Latham & Watkins | Client Alert
8
320 US at 281 (emphasis added).
9
421 US 658 (1975).
10
11
were part of the Sentencing Reform Act of 1984.
The Senate Judiciary Committee Report about
the changes stated that the previous maximum
fine levels were too low to constitute effective
punishments. S.Rep. No. 98-225, at 50 (1983).
Due to subsequent revisions, if death occurs
the fines increase to a maximum of $250,000
per individual per count and the fines can be
increased to up to double the amount of the
defendant’s pecuniary gain or victim’s pecuniary
loss.
421 US at 673-74.
421 US at 672 (emphasis added).
12
See, e.g., United States v. General Nutrition,
Inc., 638 F. Supp. 556 (W.D.N.Y. 1986) (finding
low-level store clerk and manager who claimed
they committed no criminal acts and did not
understand the criminality of such acts, could
be liable for misbranding violations because
the FDCA states “any person” shall be liable for
violations).
13
421 US at 673.
14
This affirmative defense is known as the
“impossibility defense.” Though there have been
few cases since Park that focus on responsible
corporate officer liability, the lower courts
interpreting Park have held that “to establish
the impossibility defense a corporate officer
must introduce evidence that he exercised
extraordinary care, but was nevertheless unable
to prevent violations of the Act.” United States v.
Gel Spice Co., 601 F. Supp 1205, 1213 (E.D.N.Y.
1984). (aff’d. 773 F.2d 427 (2d Cir. 1985)). For
example, in United States v. Starr the Ninth
Circuit affirmed the conviction of a food company
executive after the company’s warehouses
were found infested with rodents. The convicted
executive was responsible for handling sanitation
problems and was aware of the infestation. The
court applied the extraordinary care standard
and found that it was not impossible for the
executive to control the infestation because it
was foreseeable that rodents would migrate from
a nearby field and because he failed to follow
up with a janitor tasked with addressing the
problem. 535 F. 2d 512, 515-16 (9th Cir. 1976).
The same court also rejected the impossibility
defense in United States v. Y. Hata & Co.,
535 F. 2d 508 (9th Cir. 1976), finding that an
executive exercising the highest standard of
foresight vigilance would have implemented
a system to prevent birds from accessing
food in a warehouse long before he did so.
Id. at 511-512. Similarly in Gel Spice Co., the
Second Circuit affirmed the conviction of a spice
company president for unsanitary conditions
at a warehouse, rejecting the defendant’s
impossibility defense because the “shocking”
amount of filth at the warehouse demonstrated
he could not have exercised extraordinary care,
and satisfactory inspections in the past showed
that it was objectively possible to control rodents.
773 F.2d at 429.
15
See supra note 11.
16
18 U.S.C. § 3571, provides for these large
monetary fines and § 3581(b)(6) provides for
imprisonment for up to one year. These changes
6
Number 1228 | August 24, 2011
17
US Sentencing Guidelines Manual § 2N2.1,
Application Note 3 (2010). The Guidelines state
the reason for the amendment was that “public
comment and testimony indicated that [prior
penalties] may not adequately account for the
substantial risk of bodily injury or death created
by certain offenses.” Id. at app. C.
18
The enactment of HIPAA in 1996 and the
Balanced Budget Act of 1997 expanded OIG’s
sanction authorities to include individuals
providing services or items to federal healthcare
program beneficiaries. OIG’s Exclusion authority
is codified at 42 U.S.C. § 1320a-7.
19
The FDA was first authorized to debar individuals
in 1992 by The Generic Drug Enforcement Act.
Pub. L. No 102-282, 106 Stat 149 (codified at 21
U.S.C. § 335a).
20
David Sell, Prison Terms Sought for 4 over
Deadly Medical Tests, Phil. Inquirer June 5, 2011
http://www.philly.com/philly/business/123187273.
html?cmpid=15585797.
21
“US Ends Bid to Oust Forest Labs CEO
Solomon, Law360 (August 5, 2011), http://
www.law360.com/health/articles/262985?utm_
source=newsletter&utm_medium=email&utm_
campaign=health.
22
Id.
23
See Anna Edney, Drugmaker CEOs May Be
Targets for US FDA in Off-Label Cases, Lawyer
Says, Bloomberg, Oct. 14, 2010, http://www.
bloomberg.com/news/2010-10-14/drugmakerexecutives-may-become-targets-of-fda-for-offlabel-promotions.html and Derrick Gingery, OffLabel Prosecution May Be Where FDA “Parks”
Aggressive Enforcement Tools First, The Pink
Sheet, Oct. 18 , 2010.
24
This committee was convened in response to a
Government Accountability Office investigation
and issued a report that criticized FDA
enforcement efforts, particularly the lack of
coordination between the FDA and the Office
of Criminal Investigations (OCI). Food and
Drug Administration: Improved Monitoring and
Development of Performance Measures Needed
to Strengthen Oversight of Criminal Misconduct
Investigations. GAO-10-221 (Washington, D.C.:
March 1, 2010) available at http://www.gao.gov/
Latham & Watkins | Client Alert
new.items/d10221.pdf.
25
For coverage of Blumberg’s remarks see Anna
Edney, Drugmaker CEOs May Be Targets
for US FDA in Off-Label Cases, Lawyer
Says, Bloomberg, Oct. 14, 2010, http://www.
bloomberg.com/news/2010-10-14/drugmakerexecutives-may-become-targets-of-fda-for-offlabel-promotions.html and Derrick Gingery, OffLabel Prosecution May Be Where FDA “Parks”
Aggressive Enforcement Tools First, The Pink
Sheet, Oct. 18 , 2010.
26
The full Statement can be accessed at http://
freepdfhosting.com/71698081e3.pdf.
27
Park Guidelines, supra note 2.
28
Id.
29
Id.
30
No. 10-779, slip op. (June 23, 2011).
31
While the new FDA guidance does not explicitly
mention “extraordinary care,” the care taken
by a responsible corporate officer to prevent
violations is likely to weigh favorably under the
factors listed, as well as under the principles of
federal prosecution. See US Attorney’s Manual
§§ 9-27.000 et seq., available at http://www.
justice.gov/usao/eousa/foia_reading_room/usam/
title9/27mcrm.htm.
32
US Dep’t of Health & Human Scvs. Office of
Inspector General, Guidance for Implementing
Permissive Exclusion Authority Under Section
1128(b)(15) of the Social Security Act (2010)
available at http://oig.hhs.gov/fraud/exclusions/
files/permissive_excl_under_1128b15_10192010.
pdf.
33
Gingery, supra note 13.
34
US Department of Health and Human Services,
Office of Inspector General, “Corporate Integrity
Agreements,” available at http://oig.hhs.gov/
fraud/cias.asp.
35
OIG Compliance Program Guidance for
Pharmaceutical Manufacturers, 68 Fed. Reg.
23731 (May 5, 2003).
36
US Sentencing Guidelines Manual § 8B2.1(b).
Though the Guidelines discuss corporate
compliance in the context of organizational
and not individual liability, prosecutors will
likely consider the same factors for individual
responsible corporate officers.
37
See id. at § 8B2.1(b)(5).
38
See US Sentencing Guidelines Manual §
7
Number 1228 | August 24, 2011
8B2.1(b)(7); US Department of Health and
Human Services, Office of Inspector General,
“Corporate Integrity Agreements,” available at
http://oig.hhs.gov/fraud/cias.asp. The decision of
whether to report potential violations should be
made with care, after assessing relevant facts in
consultation with counsel.
39
See, for example, the agreement one
pharmaceutical company entered into with HHS
effective earlier this year which requires the
creation of audit and compliance committees that
submit quarterly reports to HHS and the costly
retention of an independent review organization
to assess and review nearly all of the company’s
policies, procedures, and practices. All OIG
imposed CIAs currently in effect are available at
http://oig.hhs.gov/fraud/cia/cia_list.asp.
If you have any questions about this
Client Alert, please contact one of the
authors listed below or the Latham
attorney with whom you normally
consult:
Alice S. Fisher
+1.202.637.2232
alice.fisher@lw.com
Washington, D.C.
Barry M. Sabin
+1.202.637.2263
barry.sabin@lw.com
Washington, D.C.
Nathan H. Seltzer
+1.202.637.2206
nathan.seltzer@lw.com
Washington, D.C.
John S. Cooper
+1.202.637.1022
john.cooper@lw.com
Washington, D.C.
Andrea Mangones
+1.202.637.3313
andrea.mangones@lw.com
Washington, D.C.
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