GE Healthcare Permanently Enjoined; Ordered to Implement Corrective Actions and Pay Bracco $11.4 million
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 Visipaque™ was superior to Bracco’s market-leading x-ray contrast agent Isovue®.
In its ruling, the Court found GE Healthcare liable for disseminating false messages in its advertising of Visipaque™. 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: Visipaque™ and Omnipaque®. While the study only compared these two GE Healthcare products, GE Healthcare misrepresented the study in an attempt to claim that Visipaque™ was safer than other products that were not included in the study, including Bracco’s Isovue®. 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 Visipaque™ over many years as a result of false statements that Visipaque™ was superior to Isovue®.”
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 Visipaque.”
- “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 Visipaque™;
- 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 agentsand 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 www.braccoimaging.com.
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UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY |
___________________________________ |
BRACCO DIAGNOSTICS, INC. |
Plaintiff, |
v. Civil Action No. 03-6025(FLW) |
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 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 |
Contacts:
ForBracco Diagnostics
Andrea Calise / Micheline
Tang, 212-521-4800
Andrea-calise@kekst.com
/ Micheline-tang@kekst.com