FOR IMMEDIATE RELEASE Media Contact: Andrea Calise ...


FOR IMMEDIATE RELEASE Media Contact: Andrea Calise ...


Andrea Calise/Micheline Tang

(212) 521-4800 or

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.”


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


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


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.


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

# # #






Plaintiff, : Civil Action No. 03-



v. :




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


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;


(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


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

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