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Andrea Calise/Micheline Tang
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Court Rules that GE Healthcare Engaged in False Advertising Campaign
against Bracco Diagnostics
GE Healthcare Permanently Enjoined; Ordered to Implement Corrective Actions
and Pay Bracco $11.4 million
Princeton, NJ, March 27, 2009—Bracco Diagnostics Inc. (“Bracco”) announced today
that the United States District Court in Trenton, New Jersey has ruled in favor of Bracco
and against GE Healthcare in one of the most significant false advertising cases to date.
Today’s ruling validates Bracco’s position that GE Healthcare and its predecessor
companies, including Amersham, engaged in a false and misleading advertising and
promotional campaign in an attempt to make false claims that its x-ray contrast agent
iodixanol was superior to Bracco’s market-leading x-ray contrast agent iopamidol.
In its ruling, the Court found GE Healthcare liable for disseminating false messages in
its advertising of iodixanol. The litigation is primarily related to a clinical study that was
published in 2003 by the New England Journal of Medicine (the NEPHRIC study)
comparing two GE Healthcare products: iodixanol and iohexol. While the study only
compared these two GE Healthcare products, GE Healthcare misrepresented the study
in an attempt to claim that Iodixanol was safer than other products that were not
included in the study, including Bracco’s iopamidol. In addition, independent studies,
Bracco studies, and GE Healthcare’s own clinical research demonstrated the
inappropriateness of GE Healthcare’s false claims.
As a result of GE Healthcare’s misconduct, the Court permanently enjoined GE
Healthcare from making further false claims and ordered them to implement a number
of corrective actions, including a press release and advertisements, to ensure that
healthcare providers are correctly informed about the false claims. The Court also
ordered GE Healthcare to pay Bracco $11.4 million in damages.
Carlo Medici, President and CEO of Bracco Diagnostics, stated, “Today’s ruling
highlights the importance of conducting pharmaceutical marketing in an ethically
responsible manner and accurately presenting the results of clinical research to
healthcare providers to ensure the best patient care. We are pleased that the Court has
demanded that GE Healthcare disclose the truth to healthcare professionals, many of
whom have paid a significant premium for iodixanol over many years as a result of false
statements that iodixanol was superior to iopamidol.”

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In its ruling, the Court stated the following:
“Here, the Court is the fact-finder, and has found that GEH’s [GE Healthcare]
conduct is in violation of the Lanham Act; accordingly, Bracco has demonstrated
actual success of the merits and in turn, irreparable injury.”
“Finally, it is well within the public interest for this Court to enjoin GEH from
disseminating false messages regarding iodixanol.”
“In connection with Bracco’s claim, the Court finds that an injunction and
damages for post and future corrective advertising are appropriate remedies to
prevent future violations of the Lanham Act.”
The Court has ordered GE Healthcare to take a series of corrective actions within 60
days, including, but not limited to:
Be permanently enjoined from making false claims about the comparative safety
profile of iodixanol;
Issue a press release that would also be posted on its website on the Court’s
decision;
Issue corrective advertisements;
Re-train its sales and marketing staff in accordance with the Court’s decision;
When citing studies in its advertising, plainly identify which studies the findings
relate to and refer to the comparator drugs by either their brand or scientific
names.
GE Healthcare had also filed a counterclaim against Bracco, but the Judge granted GE
Healthcare no relief whatsoever.
This litigation was originally filed in December 2003. The 39-day trial, taking place from
May to December of 2007 and including the testimony of seven contrast agent experts,
34 other witnesses and the entry into evidence of over 1400 exhibits, was one of the
most comprehensive examinations of false advertising claims in legal history. Kramer,
Levin, Naftalis & Frankel, LLP served as legal counsel to Bracco.
A copy of the Court’s Order follows this press release.
About Bracco Imaging
Bracco Imaging S.p.A. is one of the world’s leading companies in the diagnostic imaging
business. Bracco Imaging develops, manufactures and markets diagnostic imaging
agents and solutions that meet medical needs and facilitate clinical solutions.
Headquartered in Milan, Italy, Bracco Imaging operates in over 80 markets worldwide,
either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution
partnership agreements.

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Bracco Imaging is a subsidiary of Bracco S.p.A., the holding company of the Bracco
Group which also markets Ethical and Over The Counter (OTC) pharmaceutical
products in Italy as well as Advanced Medical Technology systems worldwide.
Furthermore, the Bracco Group offers diagnosis services through the Milan-based
Centro Diagnostico Italiano (Italian Diagnostic Center). For more information, visit
www.braccoimaging.com.
# # #
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
___________________________________
BRACCO DIAGNOSTICS, INC. :
:
Plaintiff, : Civil Action No. 03-
6025(FLW)
:
v. :
:
AMERSHAM HEALTH, INC., et al., :
: ORDER
Defendants. :
__________________________________
THIS MATTER having been opened to the Court by Plaintiff Bracco Diagnostics, Inc.
(“Bracco”), through its counsel Donald L. Rhoads, Esq., on a four count Complaint
against Defendants Amersham Health Inc., Amersham Health AS, and Amersham PLC
(collectively “GEH”), alleging (1) dissemination of false and misleading advertisements
in violation of Section 43(a) of the Lanham Act; and (2) N.J.S.A. 56:4-1 et seq.; (3)
violations of the common law of unfair competition; and (4) negligent
misrepresentations; it appearing GEH, through its counsel Richard L. DeLucia, Esq.,
filed a Counterclaim against Bracco for alleged false advertising; it appearing that this
Court held a thirty-nine day bench trial in the above-captioned matter; it appearing that
after the trial, the parties submitted proposed findings of fact, conclusions of law,
Daubert motion papers, and post-trial briefs; it appearing, as agreed by the parties, that
this Court would reserve judgment on any pending Daubert motions at trial and rule on
those motions in this Court’s Findings of Fact and Conclusions of Law as appear in this

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Court’s Opinion; for the reasons stated in the Opinion filed on this date, and for good
cause shown;
IT IS on this 25th day of March, 2009,
ORDERED that following the Daubert analysis, these experts are excluded: (1)
John Russell; (2) Dr. Michael Rappeport; (3) Dr. David Carl Schmittlein; (4) Dr. Marion
Stewart; (5) Dr. Christopher Schmid; and (6) Dr. Eugene P. Ericksen; and it is further
ORDERED that other experts and their testimony were limited, in accordance
with this Opinion; and it is further
ORDERED that GEH is in violation of Section 43(a) of the Lanham Act, having
disseminated false messages in its advertising of Visipaque; and it is further
ORDERED that GEH is permanently enjoined, based on the studies presented at
trial, from claiming:
(1) All low osmolar contrast medium (“LOCM”) produce the same rate of contrast
induced nephropathy (“CIN”);
(2) Visipaque is renally superior to all LOCM;
(3) Visipaque performs better than all LOCM because of lower osmosality and
associated costs
(4) Visipaque causes lower incidence of Major Adverse Cardiac Events (“MACE”)
than all LOCM, although GEH may claim, based on the VICC trial, that Visipaque
causes less MACE than Isovue for patients undergoing percutaneous cardiac
intervention (“PCI”) within the initial 48 hours after the procedure;
(5) Visipaque performs as well or better than LOCM with prophylactics;
(6) Visipaque causes less discomfort than all LOCM;
(7) Visipaque has superior hemodynamic effects over all LOCM;

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(8) Visipaque has superior patient comfort over all LOCM, although GEH may
claim that Visipaque has comfort superiority with respect to peripheral
angiography procedures; and
(9) Visipaque cost superiority over all LOCM, except in limited circumstances
where GEH associates the cost of treating additional instances of MACE to
higher overall cost; and it is further
ORDERED that GEH’s advertising must be limited to the procedures, contrast
medium (“CM”), patient types, and circumstances that were used in the studies
presented at trial;
ORDERED that when citing studies in its advertising, GEH plainly identify, in
same size print (and not in footnoted material), the CM used in the study and that the
findings of that study are limited to the studied CM; and it is further
ORDERED that GEH issue a press release, including on its website, regarding
this Court’s decision and issue corrective advertisements; and it is further
ORDERED that in comparative advertisements relying upon studies, GEH must
consistently refer to the comparator drugs by either their brand names, e.g., Visipaque
vs. Omnipaque, or their scientific names, e.g., iodixanol vs. iohexol; and it is further
ORDERED that GEH re-train its sales and marketing personnel in accordance
with this Court’s decision; and it is further
ORDERED that GEH shall have 60 days from the date of this Order to comply
with this Court’s order of injunctive relief; and it is further
ORDERED that any future disputes arising between the parties concerning CM
advertisements shall first be submitted to a qualified neutral panel or individual of the
parties’ choice; and it is further
ORDERED that the losing party in the alternative dispute forum shall pay the
costs of the neutral panel or individual; and it is further

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ORDERED that the panel or individual, in deciding future disputes, shall adhere
to the findings of this Court; and it is further
ORDERED that GEH shall pay Bracco $11,376,500 for Bracco’s corrective
advertising costs incurred as a response to GEH’s wrongful conduct; and it is further
ORDERED that no other damages shall be awarded in the above-captioned
matter; and is further
ORDERED that because Bracco has discontinued its use of advertisements GEH
alleged to be false in its Counterclaim, GEH is not entitled to injunctive relief.
s/ Freda L. Wolfson ]
The Honorable Freda L. Wolfson
United States District Judge