# Bracco Diagnostics, Inc. v. Amersham Health, Inc.

> District Court, D. New Jersey · June 5, 2009 · 627 F. Supp. 2d 384

URL: https://www.frixlaw.com/law-library/cases/1974795

## Case

- **Full name:** BRACCO DIAGNOSTICS, INC., Plaintiff, v. AMERSHAM HEALTH, INC., Et Al., Defendants
- **Court:** District Court, D. New Jersey
- **Decided:** June 5, 2009
- **Citations:** 627 F. Supp. 2d 384; 2009 WL 1743699
- **Precedential status:** Published
- **Opinion:** Opinion by Wolfson
- **Judges:** Freda L. Wolfson
- **Cited by:** 38 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/1974795

## How later opinions describe it (automated extraction)

- finding, after a bench trial, that doctors are “sophisticated, knowledgeable consumers who are not easily misled” and that “committee members responsible for purchasing decisions who have knowledge of, and experience with, the advertised products are not likely to be deceived”…
- finding "allegedly false claims that explicitly or implicitly address product attributes of importance to customers and make statements that are measurable by comparative research are not puffery"

## Opinion text

AMENDED OPINION
FREDA L. WOLFSON, District Judge.
Glossary of Abbreviations
AHI Amersham Health Ine. (U.S.-based Counterclaim Plaintiff)
ASD GEH Area Sales Director
AWC Adequate and well-controlled study
BDI Braceo Diagnostics Inc.
[witness] D Designated deposition testimony
[witness] Dec Designated declaration
CE Continuing Education for doctors, nurses and technicians
CIN Contrast Induced Nephropathy or renal damage caused by x-ray contrast medium
CM Contrast Medium or Contrast Media
CME Continuing Medical Education for doctors
CMS Centers for Medicare and Medicaid Services
CT Computer Tomography. A type of x-ray procedure where the CM is given by i.v. administration
CT DCAM Novation’s DCAM for CT (i.e., x-ray) contrast media
CT+MR DCAM Novation’s DCAM for both CT (i.e., x-ray) and MR contrast media
Cx Braeco’s Proposed Post-Trial Conclusion Of Law at paragraph “x”
Dx: y Defendant’s Trial Exhibit “x” at page “y” (where y is the last three numbers of a Bates number, if applicable)
DCAM Decision Criteria Award Matrix
DHRxns Delayed Hypersensitivity Reactions
Dual DCAM Novation’s DCAM for a dual source award for both CT (i.e., x-ray) and MR contrast media
EC Financial Criteria
FDA United States Food and Drug Administration
GEH GEH Healthcare, which acquired the three named defendants, who in turn acquired Amersham and Nycomed
GPO Group Purchasing Organization
HOCM High Osmolar Contrast Medium
intra-arterial (form of administration directly into an artery)
Intra-venous (form of administration directly into a vein)
IOCM GEH’s trademarked term, Isosmolar Contrast Medium
ITB Novation’s June 14, 2004 “Invitation To Bid”
JACC Journal of the American College of Cardiology
KOL Key Opinion Leader
LBB “Low Best Bid” or “Low Best Bidder”
LOOM Low Osmolar Contest Medium
MA Meta-Analysis, a type of clinical study analysis
MACE Major Adverse Cardiac Events or Major Adverse Clinical Events, depending on the study design
MRDCAM Novation’s DCAM for MR contest media
MRI magnetic resonance imaging contrast media
NAC N-acetylcysteine
NEJM New England Journal of Medicine
NFC Non-Financial Criteria
NQWMI Non-Q-wave Miocardial Infarction
RFA GEH’s responses to Braeeo’s requests for admissions
RFP GPO Request For Proposal
OTSheet Omnipaque Toss Sheet
Px:y Plaintiff’s Trial Exhibit “x” at page “y” (where y is the last thi-ee
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numbers of a Bates number, if applicable)
PCI percutaneous cardiac intervention
PO Pretrial Order
POA Plan of Attack or Plan of Action
PTCA Percutaneous Transluminal Coronary Angioplasty
SR Systematic Review (type of clinical study analysis)
TCT Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium
TF Novation’s ICM Task Force
URTBrochure Unchallenged Renal Tolerability Brochure
xTy Trial Transcript Volume “x” at page “y”
WAT Visipaque Value Analyis Tool
Contrast Agents
Isovue Braceo x-ray contrast agent
ProHance Braceo MRI contrast agent
MultiHance Braceo MRI contrast agent
Visipaque GEH x-ray contrast agent
Omnipaque GEH x-ray contrast agent
Omniscan GEH MRI contrast agent
Optiray Tyeo/Mallinckrodt x-ray contrast agent
Hexabrix Tyeo/Mallinckrodt x-ray contrast agent
This matter comes before the Court upon a Complaint brought by Plaintiff Braceo Diagnostics Inc. (referred to herein as “Braceo”) against Defendants Amersham Health Inc., Amersham Health AS, and Amersham PLC (collectively referred to herein as “GEH”) for alleged false advertising in violation of the Lanham Act. In response, GEH filed a Counterclaim against Braceo for alleged false advertising of its own line of products. Braceo and GEH have competing product lines in the contrast medium healthcare industry. The crux of Bracco’s case is that GEH has falsely advertised the superiority of its product, Visipaque, over Bracco’s product, Isovue. The Court conducted a thirty-nine day bench trial with numerous experts
1
and witnesses testifying as to each party’s product lines and the underlying clinical studies upon which GEH and Braceo have based their advertising campaigns.
In light of the evidence presented at trial, the Court concludes that GEH did promote false messages which were sufficient in number to constitute actionable commercial advertisements or promotions under the Lanham Act, however the Court finds that Braceo has failed to establish a causal nexus between GEH’s false advertisements and Bracco’s alleged lost profit damages. In that regard, the Court determines that the greater number of GEH’s advertisements were in fact true and based on reliable scientific studies. The messages that the Court finds false are those that extrapolate beyond the studies’ results. 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. As to GEH’s counterclaim, GEH dismissed its claim for damages and Braceo has stipulated that it no longer uses the offending advertisements. Thus, although the Court finds that certain of Bracco’s ads were false, nonetheless, an injunction is not appropriate in this case. In addition, the Court imposes an alternative dispute mechanism applicable to both parties for safeguarding against any future false advertisements.
I. Overview
A. Parties and Product Lines
GEH and Braceo market and sell x-ray contrast media (“CM”) in the United States. CM are classified by osmolality. HOCM (high osmolar CM) have osmolalities of greater than 1500 mOsm/kg. LOCM (low osmolar CM) have osmolalities between 600 and 850 and include Omnipaque (iohexol), Isovue (iopamidol), Hexa
*398
brix (ioxaglate), Ultravist (iopromide), Iomeron (iomeprol), and Optiray (ioversol). The osmolality of blood is approximately 290 mOsm/kg. Both GEH and Braceo market LOCM; GEH sells Omnipaque and Braceo sells Isovue. In addition, GEH also markets a product called Visipaque (iodixanol) which it classifies as isoosmolar or isotonic, (i.e.-its osmolality equals blood). Visipaque is referred to in various medical literature as an IOCM (iso-osmolar CM). Part of GEH’s advertising campaign is that its iso-osmolar CM performs better than LOCM. Visipaque was introduced in 1996, ten years after Omnipaque and Isovue were marketed and is the only “IOCM” available in the U.S.
B. Procedural History
On December 16, 2003, Braceo filed a four count Complaint in the District of New Jersey against 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. GEH filed an Answer and two counterclaims against Braceo alleging: (1) dissemination into commerce of allegedly false and misleading statements concerning the relative safety of Omnipaque, Visipaque, and Isovue in violation of Section 43(a) of the Lanham Act; and (2) N.J.S.A. 56:4-1,
et seq.
GEH’s counterclaim was filed against Braceo and its foreign affiliates, Braceo S.p.A. and Braceo Imaging S.p.A. However, pursuant to an Order entered on September 7, 2004, GEH’s counterclaim against Bracco’s foreign affiliates was dismissed for lack of personal jurisdiction. Motions for Summary Judgment were denied by the Court, after which, a thirty-nine day bench trial was conducted between the period of May 7, 2007 and December 2007, followed by further written submissions. The Court held a hearing on May 15, 2008, wherein the Court resolved evidentiary objections regarding the admission of disputed exhibits. Subsequently, the parties submitted proposed Findings of Fact and Conclusions of Law, which were supplemented by Reply briefs and additional
Daubert
briefs to exclude expert testimony proffered by both sides.
II. Findings of Fact
A. Bracco’s Case in Chief
As set forth below, the Court finds that GEH advertises and promotes Visipaque with establishment claims asserting that studies show it is superior in several ways, including renal and cardiovascular safety, pain, heat and discomfort. The Court further finds that: the spike in Visipaque sales that started in 2003 was primarily due to the publication of the NEPHRIC study; GEH’s advertising of NEPHRIC through true renal ads and promotions also contributed significantly to GEH’s success with Visipaque; only a fraction of GEH’s ads were false; while these false ads were sufficient in number to constitute actionable promotions under the Lanham Act, they were not the cause of GPO contracts being awarded to GEH. In addition, the Court finds that the limited false ads disseminated by GEH were not willfully false because GEH relied on scientific studies, which have not been disproved, and that GEH had a protocol in place for approving advertisements that attempted to ensure against falsity.
1. GEH’s Establishment Claims Of Renal Superiority
In late 2002 to early 2003, GEH focused its ads and promotions on renal establishment claims based on the NEPHRIC study; GEH claimed that Visipaque had superior renal safety over competitor
*399
drugs or LOCM.
(See, e.g.,
P1672 (“[w]e will begin to shift our focus from a Excellent Patient Comfort/Cardiac Safety message to the prime message being Excellent Renal Tolerance”), P106, P849:932, P1269:219, P1147:261, P1265:203, P1266:208; 13 T 72, 16 T 95, 6 T 58-79,102-104, 17 T 69-70). These claims are of two types: the data (from NEPHRIC or other studies) show (a) Visipaque is superior to a LOCM or all LOCM or (b) Visipaque is as good as or better than LOCM with pretreatments.
2
GEH uses the term LOCM to obscure the fact that its own drug, Omnipaque, was the comparator in the NEPHRIC study, and to thereby lessen any impact on Omnipaque, specifically, and to generalize the results to all LOCM, including Isovue. (P1534, P1535, P1519, P1523; 13 T 62-63).
GEH designed and then planned to disseminate the claims through multiple promotional channels (print media, websites, GEH representatives, medical doctors and CME’s). (8 T 4-15,81-129, 135-37, 17 T 53,64-68; P869 (’03), P849 (’04), P2098 (’05)).
3
GEH determined that the claims were the most effective way to convert sales based on its experience,
(e.g.,
7 T 178), and marketing research (P196, P696, P1400, P1700, P1716:739, P1742, P2038; 13 T 27-28).
The GEH representatives were instructed in Plans of Action (“POA”)
(e.g.,
P210L559
(e.g.,
“less incidence of CIN”)), memoranda
(e.g.,
P102 (“top 3 messages”), PI04, P353, P398:394, P639:552 (“(CIN) in high-risk patients was 11X less likely ... than with LOCM”), P640, P661, P662, P696, P772, P1832:194, P2027, P4249; D790), training
(e.g.,
P651
(e.g.,
‘Visipaque is clinically proven to be ... safer for high risk patients”), P1136:370 (“safer”)) and Medical Bulletins
(e.g.,
P402:563
(e.g.,
“NEPHRIC data clearly demonstrate ... a significantly better renal safety profile than a traditional [LOCM], such as iohexol, in at-risk patients”), P538:888, P798:078) to disseminate the claims.
(E.g.,
P85, P632, P774, P1008, P1012, P1021, P1080, P1082, P1136, P1178, P1373:182, P1561, P1572:893, P1681, P1699, P1721, P2099, P2100, P2101, P3708; 8 T 68-81, 129-135, 148-80, 9 T 5-53, 65-80, 88-102).
4
The claims were then disseminated nationwide using print media, GEH representatives and continuing medical education (“CME”) presentations. The print media
(e.g.,
brochures, websites, presentations, articles) with extracted messages that were identified in Bracco’s pretrial
*400
brief and discovery responses and addressed at trial include:
5
• Press releases on its website:
“[]The NEPHRIC data clearly demonstrate that VisipaqueTM offers a significantly better renal safety profile than traditional low osmolar non-ionic contrast media in at-risk patients---- We believe that the data strongly support Visipaque as the agent of choice for these patient groups.” P2449:379, P69:915, P254:863, P772:340, P1448:898, P4149:p2; 7 T 68-69.
•
Computer Tomography (CT) brochures:
“Nonionic Dimer Provides Lower Osmolality, Reduced ... CIN” “CIN”: “Nonionic Dimer”: “Nonionic Monomer”: “f”. P410:965, 3649:408, 3649A:408; D2324:117.
•
Novation presentation:
“Isosmolar VISIPAQUE ... Demonstrated to significantly reduce incidence of Contrast-induced Nephropathy (CIN).” P2161:391. GEH rep efforts included the delivery of the claims and print media in face-to-face detailing of administrators, technicians, nurses and doctors, for which records were presented at trial from GEH’s sales call record system, emails and memoranda, e.g.”
6
•
Sales Calls Records:
“Discussed patient types that would benefit from Visipaque usage over Isovue. Re-affirmed with Nephric study.” P2312:A637284, P4049:A637284. “Discussed having hospital start using Visipaque for high-risk patients in CT. Detailed Nephric study and core visual aid to support benefits of isosmolar Visipaque vs. Isovue.” P2312:A637355, P4049:A637355. “[CJlinical studies, nephric etc show less risk nephrotox vs ... Isovue for [high risk] pts .... ” P2312:A659673, P4049:A659673. “reviewed why Visi. is the best for kidneys.” P2312:A670058, P4049A670058. “Approached dr. with nephric focus and differentiating vis from loem class with regards to osmoality. Reminded dr. that patients are 11 times likely to have CIN with the loem class than visi.” P3682:Omni/3727,4049:Omni/3727.
7
8
*401
•
Consorta detailing:
“Baluchi [from Consorta] asked about Isovue with respect to Omnipaque/LOCM as positioned in NEPHRIC. We made the point that Omnipaque represents a LOCM (gold standard) and confirmed his key take away that it is iso-osmolar versus low-osmolar that was studied, not necessarily Visipaque vs. Omnipaque.” P682:286. “I ... discussed the attributes of Isosmolar Visipaque including it’s impact on CIN-a clinical issue just coming to light; it’s elimination of costly drug therapies (fenladopan) to prevent CIN with std LOCM”. P793:514.
•
HPG detailing:
“Ami presented the Nephric data to Lew and he was very interested in the info.
He told her that one criticism of this paper was that it was not a head to head with Isovue. Ami showed him the list of references that prove the incidence of CIN with Isovue is equal to that of Omnipaque so it is reasonable to draw a correlation that the results of Nephric would be the same if Isovue had been used.
” P663:942 (emphasis added).
The Court also finds that GEH-sponsored CME presentations for doctors
(e.g.,
P849:946) delivered IOCM versus LOCM claims:
9
• 2001 CME On CIN:
“[R]ecent controlled trials have shown that
non-ionic Iso-osmolar contrast agents are superi- or to low-osmolar agents
in preventing CIN.” P425L210 (emphasis added). “The use of iodixanol in at-risk patients appears to minimize the risk of CIN even without additional pharmacological prophylaxis.” P425L212.
At trial, GEH’s sales rep, Mr. Joseph Murray, confirmed delivering these claims through the print media
(e.g.,
press releases and articles) and CME-type presentations to customers in order to convert sales to Visipaque.
(E.g.,
16 T 31-49, 56-58, 81-88, 97-114; 17 T 49-51, 64-132).
2. The Falsity Of GEH’s Renal Establishment/Superiority Claims
The Court finds that certain assertions made by GEH were supported by the studies’ (NEPHRIC and Chalmers) conclusions
(e.g.
— Visipaque may be renally superior over a LOCM — Omnipaque), while others were not (i.e.- — Visipaque may perform better than LOCM with prophylactics and Visipaque is renally superior over all LOCM). Braceo asserts that GEH’s representations are false and misleading because: (a) the NEPHRIC study omitted results and has flaws that contradict GEH’s claims (Pl.’s FOF ¶¶ 11-15,
*402
17); (b) the studies (NEPHRIC and Chalmers) cannot reliably (Pl.’s FOF ¶¶ 11-13) support a conclusion of Visipaque superiority over all LOCM; and (c) the weight of the clinical evidence is that Visipaque is not superior to all LOCM as a group or to Isovue individually (Pl.’s FOF ¶¶ 11-15, 17). For example, Braceo asserts that results of studies done with intra-arterial (“i.a.”) use are not reliable enough to predict with reasonable certainty intravenous (“i.v.”) results, (see P1733)
10
11; furthermore, Braceo points out that no studies compare Visipaque to a LOCM combined with pretreatments or even head-to-head with multiple LOCM.
The Court finds: (1) while there were flaws in NEPHRIC, those flaws do not vitiate its results; (2) the NEPHRIC and Chalmers studies are not unreliable in their conclusions; and (3) it has not been established by the weight of clinical evidence that Visipaque is superior to all LOCM as a group or to Isovue individually. Although there has never been one adequate and well-controlled (“AWC”) clinical study (let alone two, done the same way with the same drug) showing that Visipaque is superior to any LOCM (even Omnipaque), with or without pretreatments,
12
13 the Lanham Act does not demand such a rigorous finding. Nonetheless, although not dispositive, the FDA agrees with the Court’s findings in numerous letters sent to GEH, including one as recent as March 21, 2005, where it states that the results of the NEPHRIC study cannot be extrapolated to CM other than Omnipaque in GEH advertising. (P1894.)
To lay the foundation for Bracco’s claims, and GEH’s defenses, the parties first presented background clinical evidence at trial. The following pertains to such evidence: randomization in a clinical trial increases its reliability;
14
a primary endpoint is a clinically relevant endpoint around which a study is designed;
15
studies may also have secondary endpoints, which are of interest but are deemed to be of less importance to the study investiga
*403
tors;
16
a MA is a statistical combination of results from multiple studies;
17
a p-value is a statistical measure that provides a general estimate of the probability that two tested clinical strategies are different;
18
furthermore, the probability that two treatments are different can be roughly estimated as 1 minus the p-value.
19
After laying a foundation for generalized information regarding the interpretation of medical studies, the parties presented specific clinical evidence in connection with GEH’s claim that Visipaque is less nephrotoxic than other LOCM. Changes in renal function are commonly measured by serum creatinine (“SCr”).
20
Dr. Peter Aspelin, an M.D., Ph.D., a professor of medicine in Stockholm,
21
and the author of NEPHRIC, testified that CIN is commonly defined as an increase in SCr up to 3 days of 0.5 mg/dL, 25%, or both,
22
and that rises in SCr after 3 days may be due to factors other than administration of CM.
23
Braceo disputes this definition of CIN; it contends that rises in SCr after three days are significant. The Court need not determine the clinical significance of CIN after three days because while I find that such data is relevant to the weight given to a study’s conclusions, here I find that the use of either definition would not make the underlying study unreliable.
Nonetheless, it is undisputed that patients with both renal insufficiency (RI) and diabetes are at a higher risk for developing CIN, than patients with only RI or only diabetes.
24
In addition, Dr. Harold I. Feldman, an expert in internal medicine and nephrology, proffered by GEH, testified that patients with only diabetes have a lower risk than patients with only RI
25
and that greater contrast volume increases a patient’s risk of CIN,
26
while N-acetylcysteine (NAC) or sodium bicarbonate may reduce CIN.
27
Furthermore, it was established at trial, through expert testimony and exhibits, that there is a scientifically reasonable and widely held belief in the medical community that LOCM are less nephrotoxic than HOCM due to the reduced osmolality of LOCM.
28
This belief is also shared by Braceo.
29
As to LOCM, Dr. Feldman testified at trial, that as of February 2003, there was little evidence of differences in nephrotoxicity between Omnipaque and Isovue.
30
Bracco’s Dr. Spi
*404
nazzi testified, and published to his peers, that as of the date NEPHRIC was published, it was believed that all nonionic LOCM performed similarly even though he qualified the testimony as not being supported by “evidence in the field.”
31
Notwithstanding the prevailing belief in the field, the FDA found it to be misleading for GEH to advertise, based on the NEPHRIC results (comparing Visipaque to one LOCM, Omnipaque), that “Visipaque is safer than other conventional non-ionic contrast media.” (P1894). This implies that the FDA did not believe that there was sufficient support to conclude that all LOCM perform similarly. Thus, the FDA questioned, based on the NE-PHRIC study, claims of Visipaque superiority over ah LOCM as opposed to merely the LOCM tested in NEPHRIC.
GEH relies on several scientific studies to support its claim that Visipaque is less nephrotoxic than other LOCM, and hence has a better renal safety profile, but primarily, GEH relies on the Chalmers and NEPHRIC studies. Chalmers, first published in 1999, was a randomized head-to-head trial of Visipaque (iodixanol) and Omnipaque (iohexol) administered to patients with RI.
32
It showed Visipaque to be less nephrotoxic than Omnipaque.
33
NE-PHRIC was a double-bhnd, randomized, multi-center, head-to-head trial comparing the nephrotoxicity of Visipaque and Omnipaque in patients with RI and diabetes.
34
Dr. Aspelin was the principal investigator (“PI”) for NEPHRIC.
35
He has nearly 200 published papers and is a peer-reviewer for several journals.
36
Dr. Aspelin was not a consultant for'GEH and was not paid for his work on the NEPHRIC study, however, he did receive input from GEH regarding the formulation of the language used in his conclusions in NEPHRIC and indeed, GEH was the financial sponsor for the study.
37
NEPHRIC reported that Visipaque was less nephrotoxic and caused 11 times less CIN than the studied CM, Omnipaque.
38
Dr. Aspelin had overall responsibility for, and final authority over, the content of NEPHRIC.
39
The other NEPHRIC authors, including Dr. Berg (a renal physiology expert) contributed to and approved the contents of the article
40
While the results of the NEPHRIC study, which was a head-to-head comparison of Omnipaque and Visipaque, provide reasonable scientific support for the claim that Visipaque performs better than Omnipaque in high risk patients, it does not support the claim that Visipaque performs better than all LOCM for that patient group.
41
See infra
pp. 132-39. Other studies in the field and referred to at trial will be reviewed below.
*405
a. The RECOVER Study
RECOVER was a randomized blinded head-to-head clinical trial, published in 2006, comparing the nephrotoxicity of Visipaque and Hexabrix (ionic low osmolar CM) in patients with RI.
42
It showed that Visipaque was less nephrotoxic and caused less CIN than Hexabrix,
43
Neither party, Braceo nor GEH, was involved in the study or publication of RECOVER.
44
Braceo alleges that RECOVER is unreliable due to a discrepancy with an earlier published abstract. However, the RECOVER authors explained in a published letter to the editors that the published results in the Journal of the American College of Cardiology (herein “JACC”) were accurate, and that the results reported in the earlier abstract were based on preliminary data.
45
Accordingly, the Court finds this study to support the contention that Visipaque is less nephrotoxic than Hexabrix.
b. The Jingwei Study
Jingwei was a head-to-head clinical trial, also published in 2006, comparing the nephrotoxicity of Visipaque and Isovue in patients undergoing percutaneous cardiac intervention (“PCI”).
46
It showed that Visipaque caused smaller SCr elevations.
47
Nonetheless, there was no clinically significant difference in the occurrence of CIN. The record does not indicate any involvement by GEH or Braceo in the Jingwei study.
c.The McCullough Meta-Analysis (“MA”)
The McCullough Meta-Analysis (“MA”), published in 2006, used patient level data from head-to-head randomized intra-arterial clinical trials gathered from a GEH patient database.
48
Dr. Peter McCullough, a consultant for GEH, and co-authors had control over the MA
49
McCullough found that Visipaque was less nephrotoxic than LOCM in: (i) all risk level patients; (ii) patients with RI; and (iii) patients with RI and diabetes.
50
Bracco’s expert, Dr. Lee Jen Wei, re-analyzed the MA and confirmed that Visipaque causes less CIN than the LOCM analyzed in the study using the CIN definition chosen by McCullough.
51
However, as Wei cogently and significantly pointed out during his testimony, the McCullough MA was comprised of 16 studies, 9 of which were Omnipaque and 7 of which were non-Omnipaque LOCM. Isovue only represented 1 of the 16 studies. Dr. Wei concluded through statistical analysis, and the Court finds his testimony credible and persuasive, that when the non-Omnipaque studies were compared to Visipaque there was no statistically significant difference in CIN and that the nine Omnipaque studies skewed the results. Therefore, the Court does not find the McCullough Meta Analysis Study reliable for the claim that Visipaque (“IOCM”) causes less CIN than all LOCM.
*406
d. The VALOR trial
The VALOR study, sponsored by GEH, was an head-to-head clinical trial comparing the nephrotoxicity of Visipaque and Optiray, and allowed for the discretionary administration of Nacetylcysteine (“NAC”).
52
Following a protocol specified interim analysis, it was determined that patients receiving NAC had more CIN.
53
Thus, enrollment was suspended and then terminated.
54
A manuscript reporting on VALOR was submitted for publication in 2007.
55
The incidence of CIN was lower with Visipaque than Optiray, and Visipaque caused a lower maximum percentage change in SCr from the baseline.
56
However, the study concluded that there was no statistically significant difference in the incidence of CIN between the two CM tested; therefore no reliable conclusions can be drawn from this study as to Visipaque’s renal superiority.
e. The IMPACT article
IMPACT was a study sponsored by Braceo and completed in 2006.
57
It was not a prospective study, but combined secondary data from two previously completed Braceo studies, INVICTA and VIR-PACT, that were designed to study image quality, not CIN.
58
The post-hoc combination of data from two studies was not disclosed in the manuscript and is not an accepted practice in the scientific community.
59
Although Dr. Feldman testified that IMPACT does not contradict the conclusions of NEPHRIC because of the different patient sample groups, IMPACT does come to the conclusion that Visipaque and Isovue performed similarly and had similar renal safety profiles in patients at elevated risk for CIN.
60
f.The CARE Study
CARE was another Braceo sponsored study
61
comparing Visipaque and Isovue. CARE was published in May 2007, and, prior to that, was not available to GEH.
62
All patients received sodium bicarbonate according to a protocol from the Merten study, which showed that sodium bicarbonate reduced CIN when used with Isovue.
63
Merten concluded that sodium bicarbonate inhibited the negative effects of hyperosmolar stress caused by LOCM such as Isovue.
64
At the time the CARE protocol was finalized, there was no significant evidence that bicarbonate was beneficial when used with an iso-osmolar agent
*407
like Yisipaque.
65
Dr. Feldman testified that CARE does not speak to the relative nephrotoxicity of Yisipaque and Isovue
without
use of bicarbonate and does not contradict Chalmers, NEPHRIC, RECOVER, Jingwei, or the McCullough MA.
66
That is true, however, the Court finds this study’s findings probative because its results indicate no statistically significant difference in CIN between Isovue with sodium bicarbonate and Visipaque with sodium bicarbonate.
g. The Sharma Pooled Analysis, Solomon Systematic Review and Solomon/DuMouchel articles are biased and methodologically flawed
The Sharma Pooled Analysis (D262A) was drafted in-house by Braceo and was based upon a prior article by Dr. Alberto Spinazzi, Bracco’s senior vice-president responsible for medical and regulatory programs.
67
Braceo performed the statistical analysis
68
and paid Dr. Samin K. Sharma, a doctor at Mount Sinai School of Medicine, $50,000 for his costs associated with the article.
69
Braceo also drafted the Solomon Systematic Review (D107) and paid Dr. Richard J. Solomon, a specialist in internal medicine and nephrology and an expert proffered by Braceo, $30,000 for his involvement.
70
Together with Dr. Solomon, Braceo published an abstract of its review, but without data from Chalmers to “strengthen the argument” of equivalency between Isovue and Visipaque.
71
Braceo and Dr. Spinazzi were intimately involved in drafting the Solomon/DuMouchel article (D222).
72
Because of methodological flaws, the Court finds that no reasonable conclusions on the relative nephrotoxicity of Visipaque, Omnipaque and Isovue can be drawn from the Sharma, Solomon Systematic Review or Solomon/DuMouchel articles.
73
Bracco’s expert, Dr. Isabel Elaine Allen, attempted to validate the Solomon Systematic Review, but her analysis was plagued by errors.
74
The reported CIN rates in both Solomon and Sharma were in fact lower for Visipaque than for both Isovue
75
and Omnipaque,
76
although the difference in the rate of CIN between Visipaque and Isovue was not statistically significant. There was a statistically significant difference in the rate of CIN between Visipaque and Omnipaque, and furthermore a statistically significant difference between Isovue and Omnipaque; Visipaque and Isovue performed better than Omnipaque overall.
*408
h. The NEHPRIC Study
The NEPHRIC study, reported in the NEJM (P2467), compared Visipaque and Omnipaque head-to-head, but stated in its conclusion that “[njephropathy induced by contrast medium may be less likely to develop in high-risk patients when iodixanol [ (an iso-osmolar contrast medium) ] is used rather than a low-osmolar, nonionic contrast medium.” Braceo assails the reliability of the NEPHRIC study by contending: (1) it was not designed to test whether osmolality is responsible for CIN (e.g., 20 T 6) and therefore cannot support the conclusion that Visipaque performs better than all LOCM in connection with renal function and CIN; (2) it has never been repeated in an AWC study; (3) it does not provide any support for the conclusion that Visipaque is as good as or better than LOCM with prophylactics;
77
and (4) it does not represent the weight of scientific evidence. (P2467; 3 T 89-90).
In addition, Braceo avers, through the testimony of Dr. Solomon, that Table IV of the NEPHRIC article, which purports to present results from other studies, is inaccurate and misleading because it incorrectly reports the results of those studies. (3 T 126-31; P3148, 37, 2053, 2386, 2390). Braceo also alleges that Table IV is inaccurate and misleading because it does not report the allegedly contradictory results of GEH’s NEPHRIC II study;
78
but NEPHRIC II was not completed prior to the publication of the original NEPHRIC article and therefore could not have an impact on the reliability of the Table IV charts when published. Additionally, any such allegations as to the results of the NEPHRIC II study are speculative and it is improper for the Court to draw any inferences in the absence of its production.
According to Braceo there are several additional flaws inherent in NEPHRIC which make it unreliable:
• Primary outcome flaw. The record indicates that Nephric’s primary endpoint — mean peak change in serum creatinine — is not a reliable metric, although it is used in the article and GEH’s ads (e.g., the 11 times better assertion). (33 T 207) (Feldman). P4288:437 (“unknown clinical significance”), P200 (p3, FDA rejects Nephric’s mean peak change endpoint);
see also
P1540 (definition of clinically significant)
•
Omitting of key results.
The NEJM article does not report the 25% rise in serum-creatinine results (P44, P4144, P1887; D2039T), which GEH added to make the study more comparable to the Chalmers study and to provide a more rigorous test for CIN.
Id.;
3 T 90-99. Instead, the article falsely states that the secondary endpoints were significantly better. (P2467:913). GEH’s marketing director was aware of this unreported data (e.g., P195L131 (declining to provide the 25% results in Spain)) and he permitted the article to falsely report that all of the secondary outcomes showed a statistically significant (defined as p<0.05) difference between Visipaque and Omnipaque
79
*409
• Hydration flaws.
Inadequate hydration was described by a GEH doctor as one of the “greatest weaknesses of the study” but it was not acknowledged in the article or any ad. (P530:148, 20 T 25; 3 T 101-105).
•
Baseline and other population flaws.
The patients in the Omnipaque group had worse baseline values (P207-08, P979, P1887, P48, P49; 3 T 119-120; 20 T 35), which greatly increases the chance of getting CIN.
Id.
The patient groups also had other differences that were never analyzed together.
Id.;
3 T 105-109,112-117. Furthermore, since there was no standard hydration, and hydration changes baseline values to an unknown extent, there is no way to know the correct values and thus there was no way to accurately calculate mean peak change or CIN. P823, P4250; 20 T 39.
• Improper manipulation.
While the study was ongoing, and in violation of the protocol and proper practice, GEH took secret and forbidden peeks at the data looking for trends, and even changed the study endpoints and stopped the study early in response.
80
E.g.,
P562:821 (found “Mean of max day 2 and 3: 20% (25% for Omnipaque and 15% for Visipaque)” to compare treatment arms before study completion), 1882:966 (“The statistician thought the data [from the two treatment arms] looked equal in both CrCl groups.”); 11 T 20-26, 43-44, 71-75; D2039T (“pretend”, “plausibility will not increase”), 2339, 2440. These types of unplanned interim analyses (defined by D2340:42 and D2339:34 as any comparison of treatment arms prior to completion) and secret attempt to “fix” the study midstream makes the trial non-prospective. P830; 20 T 28-33, 11 T 14-44, 70-71; P130. When a NEJM reviewer asked whether there was an interim analysis (P1869, 46), GEH and the authors replied there was none, and then amended the article to falsely say there was none. (P68; 20 T 17-18).
•
Hidden duration of diabetes flaw.
Duration of diabetes may be a predictor of CIN (P 4377:29K; 34 T 57-62). GEH found that the statistically significant higher duration of diabetes in the Omnipaque patients may explain the results, independent of the CM, making the conclusion of the article unreliable. GEH did not reveal these results to the public. (P49, P967, P4364, P4364T, P4365, P4365T; 20 T 33-34).
•
Misrepresentative conclusion and manuscript.
GEH’s marketing director provided input to the NEJM article to try to make it misleading, and then celebrated the final version’s obscuring of the limitation of the results of the study to Omnipaque and its overly broad and unsupportable conclusion. P1519, P1534, P1535, P4210 (admitted to only show input), P1532, P4208, P1672, P1873 (conclusion same as TCT abstract), P1876, P4208; 6 T 87-89, 13 T 62-71; see also P480.
(PL’s FOF ¶ 13). Taking into consideration that the study compares one LOCM (Omnipaque) with Visipaque, nonetheless, the Court does not find that the study’s results are vitiated by the flaws identified by Braceo. In addition, the NEPHRIC
*410
study uses conservative language in its conclusion (e.g.-use of Visipaque “may” cause less CIN than “a” LOCM), which does not render the study unreliable merely because it only compared Visipaque and Omnipaque. As it pertains to GEH’s advertising, however, the non-definitive language used in the NEPHRIC conclusion permits GEH to use it for the contention that Visipaque may be renally better than a LOCM (which in the context of the article, means better than Omnipaque), but only if GEH plainly identifies, in same size print (and not in footnoted material), that Omnipaque was the only LOCM compared and that the NEPHRIC findings are limited to the studied CM.
81
The NEPHRIC article cannot be used to claim that Visipaque has a superior renal safety profile to all or any other LOCM. Further, in regard to the claim that “Visipaque is as good as or better than LOCM with prophylactics,” the Court finds that the results of the NEPHRIC study cannot reliably support such a conclusion because using a LOCM with prophylactics was not part of the results of the study and was only concluded through a MA.
Moreover, Braceo contends that reliance on NEPHRIC is unreasonable because all other reliable clinical trials, reviews and MAs demonstrate no basis for a superiority claim of Visipaque over Isovue. Indeed, Braceo contends that all reported AWC clinical evidence and properly conducted MAs
(e.g.,
Dr. Wei’s unrebutted MA of GEH data) show no statistically significant difference between Visipaque over either Isovue or Optiray, whether given i.a. or i.v.
82
(1 T-4 T, 11-12). Braceo also contends that for seven years prior to the NEPHRIC campaign, no doctors had ever observed that Visipaque caused less CIN,
Id.,
and that GEH’s internal hidden data, never mentioned in its ads, also show no renal superiority for Visipaque.
83
GEH reported to its representatives that the studies provide valid and reliable information and that anecdotal experiences are not reliable in making CIN comparisons. (P260:413; 13 T 72-74).
In further support of its claim for false advertising, Braceo also relies on FDA findings which declined to approve a renal superiority claim for Visipaque. The FDA has repeatedly found (e.g., in the years 1996, 2001, 2005) that there is inadequate support to make renal superiority claims for Visipaque. (E.g., P596, P457, P585,
*411
P200, P816, P1894; 7 T 54-56; 14 T 41-57; 15 T 25-37, 38-39, 43-48). Furthermore, in 2001, GEH submitted the proposed NE-PHRIC study to the FDA with proposed superiority claims. (P200, P199, P4205, P816, P556, P818, P1542, P264B, P271, P1670, P1543, P810, P972; 20 T 48-57; 14 T 57-62). The FDA again rejected GEH’s proposed claims, requiring AWC clinical trials and rejecting NEPHRIC as an AWC clinical trial (e.g., “the current [NE-PHRIC] protocol contained a number of sources of variability, which may confound the ability to clearly determine the effects of the drug on renal function”). (P200, 1542; 20 T 48-51).
As part of GEH’s rebuttal to the assertion that its representations constituted false advertising, GEH relied on four studies; Chalmers, NEPHRIC, RECOVER and the McCullough MA. Braceo contends that flaws in these studies vitiate their results as follows: (a) Chalmers was not AWC (small and unblinded), showed no significant difference (there was total agreement that the 10% test is irrelevant), and even the authors concluded it was weak (3 T); (b) NEPHRIC is unreliable; (c) RECOVER only involves Hexabrix (an ionic agent), it showed no differences in certain CIN measures and it is unreliable (3 T; Solomon Dec.; D1990; P3823); and (d) the McCullough MA is of limited value as demonstrated by Dr. Wei’s unrebutted testimony (11 T-12 T) that the McCullough MA results were mostly due to Omnipaque (and not Isovue).
84
The Court finds that these studies’ conclusions do not establish the proposition that Visipaque has renal superiority to all LOCM.
Turning specifically to the NEPHRIC study, despite certain flaws, there were significant reliable aspects. The Visipaque and Omnipaque groups in NEPHRIC were demographically comparable.
85
The requisite number of patients pursuant to the protocol were included.
86
All patients had RI and met the inclusion criteria.
87
Also, the Court is not convinced that the use of NAC in 11 patients affected the viability of the NEPHRIC results.
88
Furthermore, contrary to Bracco’s assertion, no interim analysis, as that term is understood and defined by the scientific community, was performed during NE-PHRIC.
89
ICH and FDA Guidelines for clinical trials, adopted by Bracco’s expert Dr. Sanford Bolton (an expert in pharmaceutics, physical pharmacy and bio-statistics, as authoritative),
90
define an interim analysis as the unblinded comparison of
*412
treatment results.
91
During NEPHRIC, the results were not unblinded and treatment results were not compared.
92
ICH and FDA Guidelines acknowledge that a sponsor may, without impacting a study’s validity, monitor the success of planned accrual targets and the appropriateness of design assumptions.
93
Indeed, it is the sponsor’s responsibility to do so.
94
Thus, GEH’s monitoring of patient enrollment, sample size assumptions and overall (not separated into two treatment groups) SCr changes (e.g., Ps 562, 1882, 1883, 1884, 1885 1890, 1891), do not constitute interim analyses.
95
As to Bracco’s claim that GEH influenced the wording of the NEPHRIC study conclusion, the Court finds that GEH did have input. Nonetheless, Dr. Aspelin’s first draft dated March 6, 2002, which was authored before GEH offered comments and before presentation of an abstract at the TCT conference, also included a conclusion applying NEPHRIC results to the class of LOCM.
96
97
Further, Dr. Aspelin testified that he, his co-authors, and the New England Journal of Medicine editors believed in the scientific reasonableness of the conclusion.
98
All of this lends support to the reliability of the article, but combined with the chronic rejection by the FDA of its use for superiority advertising and the fact that the NEPHRIC article only compares one LOCM to Visipaque, it cannot be concluded from the study and the article that Visipaque is renally better than all LOCM. Indeed, this latter finding is also supported by the non-definitive language used in NEPHRIC’s own conclusion that Visipaque
MAY
cause less CIN than
A
LOCM. Thus, the Court concludes that the NEPHRIC results do not support a claim of Visipaque renal superiority over all LOCM or any LOCM other than the one tested in that study (Omnipaque) because only one LOCM was compared, and because the NEPHRIC conclusion does not make an absolute claim of Visipaque renal superiority, hedging its findings with less than definitive language; NEPHRIC also does not support a conclusion that Visipaque has renal superiority over LOCM with prophylactics because the study did not compare any LOCM with prophylactics against Visipaque.
i. None of the Proffered Studies Demonstrate that all LOCM (including Isovue) without Prophylactics Cause the Same Rate of CIN
Braceo contends that P1937, an internal GEH document with MA results, shows
*413
differences in rates of CIN between LOCM and that as such, a head-to-head study with one LOCM cannot be extrapolated to other LOCM. GEH contends that this was not an analysis of relative CIN rates
99
and that published guidelines treat all LOCM, including Omnipaque and Isovue, as functionally interchangeable.
100
However, the Court finds that even though multiple CM are categorized together as LOCM, it does not mean that they have the same effect, or produce the same rate of CIN. The Court is not persuaded that all LOCM perform identically — multiple studies introduced in evidence show that not all LOCM perform similarly nor do they produce the same rate of CIN.
(See
RECOVER, Jingwei, McCullough MA, VALOR, IMPACT and CARE).
3. GEH’s Establishment Claims Of Non-Renal Superiority
GEH also disseminated establishment claims of cardiovascular system, pain, warmth, discomfort and patient movement superiority, and establishment claims that Visipaque, and iso-osmolar agents generally, are a superior class of drugs that lead to lower hospital, legal and patient care costs. The Court finds that these claims explicitly or implicitly assert that data from clinical studies show that Visipaque is superior to a LOCM or all LOCM and thus they are establishment claims. As with the renal establishmenf/superiority claims, these claims were: (a) designed to be disseminated (Pl.’s FOF ¶ 4); (b) shown to be effective by GEH’s collective experience and marketing research (PL’s FOF ¶ 4); (c) disseminated by the GEH representatives (PL’s FOF ¶ 5); and (d) disseminated in various channels of communication.
101
a. GEH’s Non-Renal Cardiovascular Superiority Claims Are Not False And Misleading
Examples of the cardiovascular system establishment/superiority claims extracted from GEH’s print media, sales calls records and CME-type presentations are:
102
•
Press releases on website even during trial:
“Abstract Shows Significantly Lower Incidence of [Major Adverse Cardiac Events or Major Adverse Clinical (“MACE”) ] Following [PCI] Using Visipaque Compared to Isovue.... ” P2669:480, P3114H:857-58, P1893:94041, P4151:p2; 7 T 69.
•
CT brochures:
“Nonionic Dimer Provides Reduced MACE ...” P410:965, P3649:408, P3649A408, D2324:117.
• Sales call records:
“Visipaque doesn’t increase heart rate or B/P like LOCM”. P3682: Omni/38573, 4049:Omni/38573.
*414
i. MACE
Braceo contends that GEH’s cardiovascular claims are false because: (a) the studies do not support the claims
(e.g.,
no superiority over all LOCM, i.a. results do not predict i.v. results, and any difference purportedly shown in studies was fleeting because the results for different contrast agents converge after 30 days); (b) there were allegedly omitted results and flaws that contradict the claims made in GEH’s advertising; and (c) the studies GEH relies on (COURT and VICC) are unreliable. The following is a detailed analysis of Bracco’s allegations beginning with the various promotional materials disseminated and moving on to the integrity of the COURT and VICC trials. Bracco’s assertions, include: (1) the weight of the clinical evidence shows that Visipaque is not superior to all LOCM and definitely not superi- or to Isovue (Braceo concedes that ionic Hexabrix may be inferior); and (2) there has never been one AWC clinical study (let alone two, done the same way with the same drug) showing that Visipaque is superior to a LOCM with regard to MACE.
1. FDA findings
Referencing a series of letters dating back to 1996, Braceo argues that the FDA found no support for GEH to make cardiovascular superiority claims.
(E.g.,
P596, P457, P588, P585, P82; 15 T 25-39, 43-44). Nonetheless, some of these letters predate the COURT trial (circa 2000) and all pre-date the VICC trial (circa 2005) and since that time, new evidence has come to light. Thus, the Court finds these FDA letters are neither dispositive, nor highly probative as to whether GEH’s advertising was literally false regarding its claims of the incidence of MACE.
See infra
pp. 467-69.
2. COURT Study as Reported by GEH
Braceo asserts that GEH reported false information from the COURT study. (P2561). According to Braceo the study is limited to: (a) a comparison between Visipaque and ionic Hexabrix; (b) the patients studied (“extrapolation of these results to [a stable] population is not possible” (P2561), and the reported results were not consistent with the results from the less sick patients in the VIP study,
see
discussion
infra
at pp. 417-18, (P71)); and (c) a fleeting difference in adverse events between the two drugs cumulatively at the 30 day point (something not mentioned in GEH’s ads). (5 T 37-44). Braceo also asserts that the actual data, including data not disclosed by GEH, show that there were no differences between the drugs and the results were not reliable.
103
GEH responds by contending that COURT was a randomized head-to-head clinical trial comparing Visipaque and a LOCM, Hexabrix, in 856 high risk patients undergoing Percutaneous Transluminal
*415
Coronary Angioplasty (“PTCA”).
104
Dr. Davidson was the principal investigator (“PI”) and helped design and run it.
105
Dr. Kevin Harrison, the PI of the Braceo sponsored VICC trial, was also an investigator for COURT.
106
The primary endpoint of COURT was in-hospital MACE.
107
The in-hospital period is most relevant because MACE events caused from CM, as opposed to those caused by other factors, tend to cluster in the first few days.
108
The Visipaque group had less in-hospital MACE than Hexabrix (5.4% vs. 9.5%) and fewer myocardial infractions (“Mis”) (2.0% vs. 4.4%).
109
The incidence of MACE at 30 days favored Visipaque (9.1% vs. 13.4%).
110
Dr. Kern, a Braceo expert, agreed that COURT showed that “the incidence of [MACE] and major angiographic complications are reduced in high risk patients undergoing coronary interventions with Visipaque compared "with Hexabrix.”
111
MACE events in COURT were adjudicated in a blinded manner by the authors.
112
I need not find whether the COURT results could support a conclusion that MACE is related to osmolality,
113
because the conclusion in COURT only stated that Visipaque causes less MACE than Hexabrix in high risk patients undergoing coronary intervention.
114
The Court finds that, despite the qualms referenced by Braceo, the COURT study is sufficiently reliable to permit one to conclude with reasonable certainty that it established a cardiovascular superiority claim for Visipaque over Hexabrix for use in high risk patients undergoing coronary intervention. COURT does not, however, support such a conclusion as to any LOCM other than Hexabrix.
3. VICC study
The Bracco-sponsored VICC trial compared Isovue to Visipaque. (P2326, P3909). However, this study has never been published in a peer-reviewed journal
115
and Braceo contends that it was poorly designed and unreliable based on several flaws, including: (a) its crossover effect and lack of a washout period, (23 T 122-124); (b) its failure to uniformly measure CK-MB (23 T 126-127); (c) its side effect; and (d) the adjudicators’ failure to follow the rules on calculating CK-MB change (P3912:654). D1441; 5 T 44-67; 25 T 121-44; 33 T (Spinazzi). The Court finds that these concerns, whether in isolation, or in conjunction, do not make the study so unreliable as to render it unsup
*416
portable for the conclusions stated therein. The results of the trial show that Visipaque had statistically significant less incidence of in-hospital MACE than Isovue.
GEH correctly avers that VICC was a Braceo sponsored head-to-head randomized trial comparing Visipaque and Isovue in 1276 patients at mixed risk levels for MACE.
116
Dr. Harrison was the PI.
117
Drs. Charles Davidson and Morten Kern were co-investigators.
118
The idea for the VICC trial came from Duke University, which approached Braceo for support.
119
The evidence reveals that Braceo agreed to sponsor it and then tried to minimize publication of any negative results.
120
The primary endpoint of VICC was the incidence of MACE in the earlier of the first two days following contrast administration, or until hospital discharge.
121
The VICC protocol specified CK-MB for the primary diagnosis of non-Q-wave Mis.
122
CK-MB are commonly used in clinical practice for such diagnosis.
123
Visipaque caused less in-hospital MACE than Isovue (4.8% vs. 9.0%), including less in-hospital non-Q-wave Mis (3.4% vs. 7.5%), which the study concluded was significant for treatment.
124
At 30 days there were significantly fewer non-Q-wave Mis with Visipaque.
125
The periods of 0-7, 2-7, and 2-30 day MACE were included as secondary endpoints in VICC, but are not as clinically relevant as in-hospital MACE.
126
There was also no significant difference in repeat PCIs of the target vessel, i.e., the vessel treated at the time of procedure.
127
Repeat PCIs of non-target vessels are unlikely to be related to the effects of CM.
128
The Court finds that it is scientifically reasonable to conclude from VICC that (1) Visipaque is associated with significantly less in-hospital MACE than Isovue;
129
and (2) Visipaque is associated with fewer non-Q-wave Mis than Isovue.
130
The primary results of VICC and COURT are essentially the same.
131
VICC confirmed the findings of COURT, extended it to a different comparative agent, and was a
*417
more contemporary study based on the practice having changed, i.e., use of more stents and the use of more IIB/IIIA inhibitors.
132
Dr. Kern testified that the lack of a washout period in VICC makes the data difficult to interpret, but Dr. Harrison disagreed; he testified that it does not affect interpretability of the data.
133
In addition, Dr. Davidson testified that he did make sure that the patients in his portion of the VICC trial who underwent a diagnostic procedure got the same drug as in the interventional procedure, thus eliminating a crossover or a washout effect. (23 T 122:24-123:14). Furthermore, he found that Visipaque performed better than Isovue whether it was the same contrast agent being used in the procedures or whether there was contamination from another contrast agent. (23 T 123:18-124). Further, Dr. Kern signed the published abstract that did not mention the washout issue
134
and approved the protocol in conjunction with his colleagues.
135
The testimony reveals that Braceo believed VICC favored Visipaque, and thus would damage Isovue in the market. As a result, Braceo sought to contain damage by re-analyzing the data, seeking to undermine the validity of unfavorable results, and pressuring Dr. Harrison regarding the contents of the abstract and manuscript.
136
The Court finds that the VICC study is sufficiently reliable to permit one to conclude with reasonable certainty that Visipaque causes less in-hospital MACE than Isovue for patients undergoing PCI within the initial 48 hours after the procedure.
4. The VIP Trial
The Court finds that VIP, a study published in 2000, that compared Visipaque and Hexabrix in low risk patients,
137
does not undermine the conclusions of COURT or negate its findings regarding high risk patients. However, VIP’s conclusion that there is no statistically significant difference between Visipaque and Hexabrix in low risk patients with regard to MACE,
138
militates against any finding that Visipaque performs better than this low-osmolar contrast agent with regard to MACE in that patient group. Furthermore, since no other studies have focused on Visipaque and any other LOCM to confirm the incidence of MACE in low risk patients, there is no basis to assert any Visipaque superiority claims for MACE in low risk patients.
ii. Hemodynamic Effects
Braceo contends that GEH has not rebutted Bracco’s evidence that iso-osmolality and Visipaque are not superior over Isovue or other non-ionic LOCM for heart rate, blood pressure, ECG, LVEDP and other cardiovascular effects as shown by Dr. Kern and VIP (P71), IMPACT (P2799), Sutton I (P3770), Sutton II (P3855), Verow (P2356), Manninen (P3846), Palmers (P3847), and Klow (3844), or that iso-osmolality does not cause less red blood cell deformity than LOCM. 5 T (Kern); P27, P34, P41; 2 T (Katzberg). Moreover, GEH’s internal data also shows
*418
no superiority: DXVPRC01 (P1705); DXVD09 (P220:931). (5 T 76; 2 T 58-60).
Braceo contends that GEH’s rebuttal ignored Bracco’s proofs and relied on excerpts from three articles that are not cited in the ads in issue and that cannot support the scope of its claims: the Bergstra Article does not attribute the LVEDP difference seen between Omnipaque and Visipaque to osmolality differences (D814:222) and the Soiva and Murdock articles did not involve Visipaque (D2249; D2377). In fact, Soiva, finding significant differences between LOOM, showed that LOOM cannot be considered as a uniform group. Here, GEH incorrectly contends that there is a good basis to conclude, from clinical trials, that Visipaque causes fewer and milder hemodynamic effects
{e.g.,
heart rate changes) than LOOM
139
and that LOOM are all similar in this regard.
140
The Court finds that these conclusions are neither adequately supported nor reliably based upon the studies GEH cites.
b. GEH’s non-renal discomfort-type claims
Examples of the discomfort-type (i.e., claiming less pain, warmth, discomfort or patient movement or designed for such) establishment/superiority claims extracted from GEH’s print media, sales calls records and CME-type presentations are:
141
•
Website, brochures and CMEs:
“[Visipaque] offers significantly better comfort to the patient ...” P2508:767A, P2511C:781A, P4163:767A, P4166C:781A.
•
CT brochures:
“Less chance of extravasation-related complications — including pain, discomfort ... when used:” “Less chance of patient discomfort ... when used in:” “High concentration”, “High-rate injections”, “Multiple procedures”, “High-speed procedures.” P410:966.
•
Sales call records:
“She asked why use Vis Shared theory iso-osmolar, less fluid shifts and thus less pt discomfort, movement and need to rescan.... ” P2312:A650688, P4049:A650688.
GEH makes claims that Visipaque is superior to LOOM because it provides less pain, heat, and discomfort and that these benefits are due to its iso-osmolality. Braceo contends that these claims are false and misleading because: (a) the studies do not support the claims
{e.g.,
no superiority over all LOOM, i.a. results do not predict i.v. results, no difference in movement ever shown); (b) omitted results and flaws contradict the statements; and (c) the weight of the clinical evidence is that Visipaque is not superior to all LOOM and definitely not superior to Isovue. There may be a benefit in heat sensation that is sometimes
*419
described as pain in peripheral angiography, but that has never been proven and peripheral angiography is a de minimus use of CM. (1% today, 2 T 91; 29 T 158-159). GEH’s own Dr. Anthony Nicholson, an interventional radiologist, testified that GEH’s claims were too broad because any benefit of Visipaque is limited to direct local injections in small vessels, a limitation found in none of GEH’s advertising claims.
(Id.)
In addition, there has never been one AWC clinical study that was repeated and supports the claim that Visipaque is superior to a LOCM (or all LOCM) in a manner claimed by GEH. Furthermore, Braceo contends that the FDA found there was no support to make discomfort-type superiority claims for Visipaque.
(E.g.,
P596, 457, 588, 585, 82; 15 T 25-39, 43-44). At most, the FDA permits GEH to make a very limited and inconclusive statement about a trend that is not a superiority claim. (14 T 66).
There have been eleven studies showing no difference in patient movement and no reliable study showing a difference in patient movement. GEH’s attempt to show a difference (DXV071) was a failure so GEH did not make great effort to release the results. (P557).
142
Furthermore, data from unpublished studies showed no consistent differences in pain, discomfort or movement: GEH MA (P549); DXV071 (P557); DXVA001 (P220:930); DXASG001 (P220:930); DXVD11 (P220:932); 2 T. Braceo asserts that Dr. Michael Rappeport’s survey demonstrated that the claim, Visipaque is superior regarding pain “compared to LOCM”, is understood by an overwhelming proportion of customers to claim superiority to all LOCM. (PL’s FOF ¶ 18). However the Court is excluding Dr. Rappeport’s survey for its inherent unreliability.
See infra
p. 90. In response to the Rappeport survey, GEH proffered Dr. Nicholson who presented several studies asserting differences in pain or discomfort (nothing on patient movement) but none compared Visipaque to all LOCM or even one LOCM in an AWC study that was ever repeated.
(See
29 T).
Conversely, GEH avers that CM can cause pain, discomfort or heat upon injection, and that this aspect of patient comfort is clinically relevant.
143
GEH also contends that Visipaque causes less pain, discomfort and warmth than LOCM, including Isovue, in certain procedures,
144
and that this difference is clinically relevant.
145
No study has shown Isovue to cause less pain than Visipaque.
146
Braceo acknowledged that there is less pain with Visipaque than Isovue in peripheral angiography procedures.
147
Bracco’s expert, Dr. Katzberg, acknowledged the same.
148
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Furthermore, GEH’s expert, Dr. Nicholson, could not substantiate by a reasonable degree of scientific certainty, based on the studies, that any claim of Visipaque superi- or regarding pain extended beyond peripheral angiography procedures.
149
Accordingly, the Court finds that GEH’s claims of comfort superiority are only supported in regard to peripheral angiography procedures. Thus, GEH’s broad assertions of superior patient comfort are not supported by the conclusions of the various studies it uses to bolster them and any such advertising must be limited to the procedures that were used in the studies.
c. GEH’s Osmolality Class/Cost Claims
Examples of the osmolality class and cost establishment/superiority claims extracted from GEH’s print media, sales calls records and CME-type presentations are:
150
•
Website:
“Isosmolar Visipaque. It’s innovative in a class of its own.” P2505:757A, 2511A:774A, 4155A:737, 4160:757A, 4166A:774A, 3448A:p2
•
Diagrams/claims repeated in websites, brochures and CMEs:
Showing “hyperosmolality” (i.e., osmolality higher than blood, like Isovue) leading to “altered morphology” of “erythrocytes” and “endothelial cells”, ultimately leading to “discomfort”, “warmth”, “coldness” and “pain.” P2508:766A, P2511C:781A, P4163:766A, P4166C:781A;
see also
P3114K:823, P2510:771A, P2508:763A, P2511C:779A, P4163:763A, P4165:771A, P4166C:779A, P2183:982, P2184:000, P2311:p4, P2298:p25, P4252:p3, P3828:929, P3261:011, P3829:036, P2156:036, P2157:212. Additional claims of less red blood cell effect of IOCM vs. LOOM can be found at: P2311:p5, P3710:p2, P2280:p5, P395:357, P409:945, P333:738, P410:960, P3649:403, P3649A:403, P436A:421, 27-28, P2298:p7, 13-14, P782:893, P216L387, P2183:991, P2184:009, P4252:pl2, P4174:pl, P3114J:821, P3210:934, 410:962, P3649:405, P3649A:405, P2510:772A, P2508:764A65A, P2511C:780A, P4163:764A-65A, P4165:772A, P4166C:780A; D2324:114, D2334:p2, D2324:112
•
Health Value brochure:
“Isosmolar VISIPAQUE may reduce financial burden
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due to serious adverse events”. P446:641, P649;665
•
Sales call records:
“Used the ‘cost’ story for Visi vs. LOCM” P3682:Visi/154349, P4049:Visi/154349
These claims are based upon alleged renal, cardiovascular or discomfort-type superiority tied to osmolality (e.g., 6 T 94-99) or costs. Braceo asserts that they are false and misleading because (a) the studies (shown above) do not support the claims (e.g., no superiority over all LOCM, i.a. results do not predict i.v. results), and (b) omitted results and flaws contradict the claims. The Court finds that the weight of the clinical evidence does not show that Visipaque is superior to all LOCM nor does it show that it is superior over Isovue, except perhaps under limited circumstances for pain and in-hospital MACE for patients undergoing PCI. The FDA found that there was no support for making class/cost superiority claims for Visipaque.
(E.g.,
P588, P585, P82; 15 T 33-39, 43-44). Furthermore, GEH’s medical officer testified that while iso-osmolality is a chemical property of the final Visipaque formulation, it does not put the drug in a proper, formal class of drugs separate from LOCM by FDA standards. (16 T 186-187) (“IOCM and LOCM are not separate classes, Correct?” “That is true.”). This is because the FDA classifies all iodinated contrast media the same.
(Id.)
In addition, Braceo contends that GEH improperly advertised the role of osmolality in causing adverse events. GEH’s documents give some indication that Visipaque has a much higher rate (5-7 times) of delayed adverse events than Isovue and other LOCM
(e.g.,
P1948:947(1.4% v. 0.2%), P2133, P1169, P544, P557, P3860:167; 13 T 82-85) and thus it belies GEH’s superiority claims in regard to Visipaque (and iso-osmolar Isovist, withdrawn for this reason).
In light of this data (P1169:703, P4240:670, P544), GEH countered with claims that there were an equal or lower number of adverse reactions.
(E.g.,
P229L054, 2305(Conclusion), 2309, 976, 2026, 2027, 2286; 15 T 151-152). GEH also argues that Bracco’s foreign affiliate and experts agree that osmolality is relevant to renal safety, cardiac safety, and pain/discomfort.
151
However, the Court does not attribute significant weight to these general assertions. Finally, Braceo asserts, and the Court agrees, that there is little evidence to support a claim of decreased costs using Visipaque. There is no support for GEH’s claims that studies show that there is less patient care, hospital care or legal liability costs for Visipaque versus all the LOCM or even one LOCM.
152
The only way to make such a cost inference is by associating the cost of treating additional instances of MACE and CIN to higher overall cost, but since the Court has not made such a finding with regard to CIN, the only viable means of advertising lower cost is through less incidence of MACE for patients undergoing PCI within the 48 hours after the procedure.
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4. Additional Evidence Regarding Dissemination
In addition to the proofs cited above, dissemination of allegedly false claims was confirmed by the testimony of Mr. Scott Kerachsky, Director of Marketing for GEH Healthcare, North America, (15 T 100-142), Dr. Peter McCullough (34 T 160-165), and stipulations by GEH. GEH representatives are instructed to present printed materials a section at a time, by pointing to specific parts, and not as a whole.
(E.g.,
15 T 116, 172-175; P2100:530, 2098).
But, in his testimony, Mr. Kerachsky also elaborated on the impact of GEH’s various levels of approval mechanisms over promotional materials and their dissemination. Specifically, Mr. Kerachsky identified four levels of approval, medical, regulatory, marketing, and legal, whose responsibility it is to ensure that the clinical data provides support for proposed promotional materials. (15 T 86, 90). Mr. Kerachsky also testified that every piece of promotional material used by GEH’s sales force was approved by medical, regulatory, marketing, and legal. (15 T 83, 86, 90). In fact, Mr. Kerachsky himself reviewed prospective promotional materials from a marketing prospective, mindful of FDA regulatory issues and possible conflicts with the underlying clinical data. (15 T 93, 95, 125). For example, with respect to NEPHRIC, Mr. Kerachsky testified that marketing “clarified, just to be extra careful, that it was iohexol” which was studied. (15 T 125).
For the time period covered by GEH’s sales call record production (i.e., Sept. 2003-2005), Braceo asserts that at least 87% of GEH’s representatives delivered GEH’s clinical superiority claims. (17 T 102,107; 18 T 25-34, 40, 42-43; P3493M, 3922, 4049; D2004). While Braceo asserts that at least 82.5% of GEH’s sales call records with substantive communications show the delivery of GEH’s clinical superiority claims to customers, the Court finds this number to be grossly inflated based upon its own evaluation of the records and expert testimony; nonetheless, some instances of false messages are supported by the record.
(See also
17 T 102, 107; 18 T 25-34, 40, 42-43; P3922, 4049; D2004).
GEH argues that Braceo has grossly mischaracterized the number of actionable sales call notes and promotional materials, specifically because of flaws in Mr. Russell’s testimony. For example, Mr. Russell could not identify the basis for his testimony that certain GEH promotional materials contain pain/discomfort superiority claims.
153
Mr. Russell improperly categorized: (1) accurate discussions of the NEPHRIC study,
154
and (2) a Visipaque logo as renal superiority claims.
155
Mr. Russell could not identify the basis for his categorization of GEH promotional materials, including a specific piece containing the statement “Is your contrast media this close to plasma?” as cardiac superiority claims.
156
Mr. Russell improperly categorized statements, including “Currently, there is no health care common procedural code to delineate iso-osmolar contrast agents such as Visipaque from low-osmolar contrast media LOCM,” as class claims.
157
Mr. Russell improperly categorized statements in GEH promotional material, including a piece that expressly states that medical personnel should consider taking
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prophylactic measures to reduce the risk of CIN, as promotion of “the lack of pretreatments and emergency use without renal function testing.”
158
Nonetheless, a number of the sales call notes reviewed by this Court do indicate that certain members of the GEH sales force were using the NEPHRIC study’s conclusion to make superiority claims.
In addition, GEH argues that Mr. Russell’s analysis of sales call notes is unreliable because of the allegation that Mr. Russell’s compilation of allegedly improper sales call entries was compiled by Bracco’s counsel
159
and was widely over-inclusive. The compilation was created from 314,468 GEH sales call notes produced in this case.
160
For example, Mr. Russell improperly categorized entries that reference only the word, “NEPHRIC,” as being “on-message.”
161
Also many included notes were duplicative.
162
In addition, GEH states that Mr. Russell’s compilation improperly categorized sales call notes as (1) renal superiority messages; (2) cardiac superiority messages; and (3) evidence of the application of Visipaque “leverage.” Indeed, Mr. Russell admitted that there was no reason that innocuous sales call entries such as “Discussed use of Visi for high risk patients”; “Told him about Visi for the coronary”; and “Thanked Dr. Vogel on the lead to move forward to bundle a LOCM and MRI contrast deal,” were included in the above categories, respectively.
163
GEH argues that due to the lack of standards employed, Mr. Russell’s compilations are inflated and unreliable.
164
The Court agrees that Mr. Russell’s opinions as to the percentage of “onmessage” sales call notes and representatives who made them are greatly inflated.
165
Nonetheless, the Court has had the opportunity to review the sales call notes and disagrees with GEH that the Court should only review sales call notes that mention Isovue as follows: (1) 284 notes that mentioned Isovue; (2) only 38 where Isovue was mentioned and a superiority claim that could arguably be construed from the note; and (3) 1,251 notes from a single GEH sales representative (Chad Chaney) who entered substantially the same comment for numerous notes.
166
I find that focusing on the subset of sales call notes that explicitly mention Isovue would understate of the number of sales calls that improperly made Visipaque superiority claims over all LOCM. GEH’s claim that Visipaque is better than
all
LOCM or a LOCM, without identifying the one LOCM compared, is what makes its advertising campaign problematic; a sales call need not mention Isovue specifically. In sum, Bracco’s position that any advertisement which references NEPHRIC is false is incorrect and thus results in an over-inclusive determination; conversely, GEH’s position that only those advertisements which compare or mention Isovue may be improper is under-inclusive.
5. Evidence Concerning Materiality
The evidence of materiality includes:
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• The repetition of certain unsupported claims by GEH’s sales and marketing teams.
• The substance of the claims
(e.g.,
CIN and other clinical data), which cannot be anecdotally observed with reliability
(e.g.,
P260:413; 5 T 28-29).
•The type of claims — i.e., drug safety, which GEH’s own observations (7 T 178) and market research showed were the most effective in converting sales
(E.g.,
P100-102, 104-106, 196:573-580, 1400,1436,1716:739, 2038, 2112).
• The limited evidence that it will take several years for Braceo to recover from GEH’s false claims once they are stopped (17T 117-118; 21 T 110-122).
These few examples, when considered in conjunction, demonstrate that GEH’s false advertising claims appear material to a consumer’s purchasing decision. Moreover, because I find that some of GEH’s claims are literally false, as stated
infra
p. 143-45, there is a presumption of materiality and deception.
6. Harm, Damages And Other Remedies
a. Causation For Bracco’s Losses
i. GEH’s Testimony and Business Records
Numerous GEH witnesses conceded that Visipaque renal safety claims drove substantial sales increases which came, in significant part, at Bracco’s expense. GEH’s President, Dan Peters, testified that GEH enjoyed a dramatic sales increase after the publication of NEPHRIC, primarily due to GEH’s renal safety message. (6 T 103;
see also
7 T 94-95; P2461, 1892:925-6). He acknowledged that GEH’s renal message had a “large impact” on the “whole market” while GEH tried to “minimize [Nephric’s] negative impact on Omnipaque.” (6 T 59-60, 100). GEH’s Vice President of Sales, Don Quinn, confirmed that the “NEPHRIC data coupled with a very consistent targeted marketing campaign has propelled demand for Visipaque to new heights.” (8 T 124-125; P849:934). He further admitted that GEH used NEPHRIC to convert competitive business, including Isovue accounts.
167
Mr. Quinn agreed that GEH set out to increase Visipaque’s market share through an “aggressive sales and marketing effort” and that there “[absolutely” was a connection between that effort and these increases.
168
In addition, GEH’s global brand manager, Mr. Paul Gehris, admitted that GEH saw “very good share growth since the NEPHRIC” that was “driven by awareness of the data and the perceived differentiation.” (13 T 77-80, 14-19; P1694:022). However, it remains that out of the entire GEH ad campaign relating to Visipaque, only a small fraction of the disseminated messages were indeed false. Most were proper and were backed up by the underlying scientific studies that they reference. Therefore, a causal connection cannot be made by a sales trend alone; the accurate touting of favorable results of reliable scientific studies plays too much of a significant part in this case to determine that the limited number of false ads disseminated are the cause of Bracco’s lost profits.
GEH sales representatives also gave testimony relating to GEH’s renal superiority claims. GEH’s representative sales
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person, Mr. Murray, testified during his deposition that in general, when talking with customers about high risk patients, he discusses that the NEPHRIC study shows that Visipaque has a better renal profile than traditional LOCM.
(See
16 T 84:4-11). However, when a question relating to that statement was posed to Mr. Murray at trial, Mr. Murray clarified his statement to mean that “when we were talking about NEPHRIC and the traditional LOCM, we were talking about [] Omnipaque.”
Id.
14-17. In fact, Mr. Murray testified that as a sales representatives “he tr[ied] to talk about Omnipaque and Visipaque.”
169
While it is difficult for the Court determine what was actually communicated to the customers, based on Mr. Murray’s testimony, some of this sales calls’ messages may be construed as misleading, especially when Mr. Murray did not qualify or specifically identity Omnipaque as being the traditional LOCM. Nonetheless, the Court finds in its review of the sales call notes that the instances of sales reps making such misleading statements were limited. Importantly, the majority of GEH’s messages were in fact true and properly relied on reliable scientific studies to support them.
GEH admitted that Visipaque’s premium price resulted from its “clinical differentiation” messages. Mr. Quinn testified that customers “absolutely” had to believe Visipaque provided patient benefits to pay the price premium.
170
The 2004 Marketing Plan states that “based upon its clinical differentiation ... a significant price premium has been placed on Visipaque when compared to low osmolar products.”
171
Mr. Gehris admitted the clinical differentiation strategy drove Visipaque’s premium price. (13 T 14-19; P1436:616,622,635). However, this was in large part a result of the underlying studies and GEH’s promotion of their results.
Quotes from GEH business records relating to GEH’s claims of renal differentiation include, for example:
• “The objective ... to increase market share ... will be accomplished strategically by clinically differentiating Isosmolar Visipaque from all other LOCM products....” (P849:932; 8 T 123-124).
• “The Nephric success stories continue to come in with the majority of new dollars coming from competitive LOCM products.” (P1311)
• “Sales performance reflects strong continued efforts in all markets to communicate NEPHRIC results and Visipaque clinical differentiation message .... Sales reports continue to highlight customer acceptance of these messages and adoption of Visipaque use in patients at risk of CIN.” (P1157:744)
• “2005 is projected to be the 3rd consecutive year of very aggressive growth____The NEPHRIC data, coupled with a very consistent and targeted marketing campaign ... has propelled demand for Visipaque to new heights.”
172
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Because the NEPHRIC study itself concluded that Visipaque
may
perform better than
a LOOM,
and that conclusion accurately reports the study’s findings, GEH’s internal documents which advocate differentiation of Visipaque from other LOCM did not lead to a false message so long as GEH actually disseminated an accurate portrayal of the NEPHRIC results and did not extrapolate them beyond the limited comparison of Visipaque and Omnipaque. However, to the extent that GEH did not so limit its comparison and message, it would result in a false message.
ii.Sales Trends
In the LOCM market, three players (GEH, Braceo and Tyco) control 97% of the market, with Tyco’s share almost entirely due to the Premier GPO. (P849:881; 8 T 123 (Quinn), 18 T 114 (Malackowski), 21 T 91-92 (Medici)). The Court finds that, outside of the Premier GPO (which is not part of Bracco’s damages claim), the LOCM market effectively is a two-player market. This finding is reinforced by the undisputed facts of record that Braceo and GEH were effectively the only two competitors for the Novation, Consorta and Kaiser contracts (as discussed below). Mr. Medici testified both parties’ market shares were stable but “changed dramatically” after the NEPHRIC article was published and its subsequent marketing, with GEH’s sales increasing and Bracco’s decreasing. (21 T 93, 97, 103-104, 110-113). Mr. Peters agreed that initially Visipaque had grown only gradually but “grew very well after the NEPHRIC study, yes.” (6 T 44).
173
iii. The Parties’ Surveys
The Court is excluding both Bracco’s survey expert, Dr. Rappeport, as well as GEH’s survey expert, Dr. Ericksen. However, Mr. Quinn, GEH’s Vice President of Sales, in an email to GEH officials, announced the results of an informal study of physicians and their feedback regarding the NEPHRIC article, including the “top 3 messages that excite physicians to action,” “Safety inpatient with creatine above 1.5,” “Less Nephropathy” and “Isosmolar Visipaque is 11 times less likely to cause renal failure.”
174
In this case, each of these general statements may be part of a true advertising campaign, but only if they plainly describe the circumstances of the underlying studies,
e.g.
type of patients tested, and the actual products that were tested (and not in small footnoted material); GEH may not extrapolate these findings to CM which were not compared in these studies.
iv. Bracco’s Harm and Response
Mr. Medici and Dr. Spinazzi testified that Braceo expended substantial resources, including spending millions of dollars, responding to the effects of GEH’s allegedly false
claims
— e.g., responding to purportedly deceived customers; responsive advertising; sponsorship of the Sharma, Solomon and Solomon/DuMouchel papers; and two head-to-head Visipaque versus Isovue studies (CARE and IMPACT).
(E.g.,
20 T 108-149; 21 T 99-110). Braceo alleges that GEH’s false ads caused Braceo and Isovue to lose sig
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nificant reputation and goodwill.
(Id.)
However, Bracco’s complaints about spending additional funds to sponsor studies verifying its product’s efficacy cannot all be laid at the feet of GEH. Braceo and GEH are the primary players in the field of CM and thus, fiercely compete against each other in the marketplace, obviously target each other, and look to tout their own products whenever possible. Indeed, as shown during the course of the trial, by way of the sheer number of sponsored studies proffered by both parties over the years, in this business it appears to be commonplace, if not a necessary part of the industry, for companies to spend significant amounts of capital in support of scientific comparative studies to promote sales of their products. Moreover, the Court was surprised by the revelations that virtually every clinical trial, study, and resultant publication in this area was sponsored by GEH or Braceo. In some cases, the principal investigators were paid consultants to one of these companies. This has lead the Court to conclude, and lament, that there is little in the way of a truly independent clinical study in the CM market.
v.Anecdotal Evidence of Visipaque Superiority
GEH argues that customers also observed Visipaque’s alleged superiority, anecdotally. However, GEH’s medical department concluded that “spontaneous clinical observation cannot give any statistical evidence” and only head-to-head studies can determine renal safety. (P260:413; 13 T 72-74). GEH’s clinical expert, Dr. Feldman, concurs, 35 T 118-120; P3738:P3, as does the Court. Consequently, the Court finds that anecdotal evidence does not impact the validity or invalidity of GEH’s superiority claims, and cannot be used to bolster the claims.
vi. Visipaque Leverage.
GEH developed a “Visipaque Leverage” strategy to keep existing accounts and convert competitive accounts by (1) “penetrating” the account with Visipaque; and (2) “leveraging” a contract award by threatening to raise Visipaque prices if GEH lost the bid for its other products. The 2004 Visipaque, Omnipaque, and Omniscan Marketing Plans all prominently feature Visipaque leverage.
175
Shortly after GEH developed its “WAT” tool to illustrate Visipaque Leverage to its customers, it observed “several examples already of customers threatening to leave [GEH] ... that reconsider their decision once they understand the consequences of Visipaque price increase should they decide to leave [GEH] on other products.” (P786:201, 470).
vii. The Novation Contract
In 2004, Novation issued an invitation to bid (ITB) for its Injectable CM (ICM) contract.
176
GEH, Braceo, Berlex Labora
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tories, Bristol-Myers Squibb, Guerbet, and Tyco Healthcare submitted bids.
177
Novation selected twelve members from Novation hospitals to comprise a Task Force (“TF”) charged with assisting in the evaluations.
178
Its members were experienced with CM. Shortly before the TF’s meeting at which it decided to award a separate technology contract for Visipaque, Novation provided the members with COURT, NEPHRIC, and VICC.
179
The TF recommended, and Novation awarded, a technology contract for Visipaque.
180
At the technology meeting, a Novation representative presented the technology claims for three products. With respect to Visipaque, the representative “went over all of the clinical documentation and referenced the pre-reading. The consensus of the TF was that this contrast agent is unique and innovative and offers clinically proven incremental benefits over other products on the market. The TF believes Visipaque should be carved out and identified as innovative.”
181
It is unknown which specific incremental benefits the TF considered or upon what specific information the TF relied in making its decision to carve Visipaque out of the ICM bid.
182
Generally, Novation asked the TF “to use [relevant] information along with their personal practical and own clinical experience to evaluate not only the bids but new technology submissions. And so it’s [Novation’s] belief that they do that.”
183
It also asked the TF members “to do their own research within their institutions and talk to those clinicians who have further experience, and we expect them to represent that fairly in their decision-making process.”
184
Novation saw no evidence that the TF relied on advertising in concluding that Visipaque offered clinical benefits.
185
Indeed, the stated conclusion of this experienced task force — that Visipaque offers “clinically proven” benefits— is itself evidence that experts in the field can reasonably conclude that Visipaque has advantages over other CM.
In April 2004, as a result of the technology award, Visipaque was carved out from the ICM contract decision process; the TF did not further consider Visipaque in analyzing either the non-financial or financial components of the ICM bids.
186
Even after Visipaque had been carved out, GEH received the highest scores from the TF with respect to all non-financial criteria (NFC).
187
Novation’s contract develop
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ment department evaluated the financial portions of the bids and scored each supplier with respect to the financial criteria (FC).
188
The bidder with the lowest ratio of FC score to NFC score has the low best bid.
189
Novation awarded a sole-source contract to GEH based upon its top score on the NFC and its low-best bid for an x-ray/CT and MR combined contract, and based upon the fact that it was the only qualified bidder on ultrasound.
190
The Novation TF appears to have based its evaluation of GEH’s bid on personal experience, feedback from physician colleagues, clinical information, and the positive relationship Novation had with GEH.
191
It is impossible to determine how, if at all, the award decision would have been “different if in fact the council viewed Visipaque differently than [it] did,” and had Visipaque not been carved out.
192
Ultimately, on March 1, 2005, Novation, a long-time customer of GEH, announced that GEH had won a sole-source contract for X-ray and MR CM. (P4118).
193
As is usual in this market, all bidders, except GEH and Braceo, were eliminated early.
194
Novation identified presumptive winners using a formula Low Best Bid (“LBB”) = FC/NFC. (P4126, 4083). The LBB results appear on a CT Decision Award Criterial Matrix (“DCAM”); MR DCAM; CT + MR DCAM; and Dual DCAM. (P4083). NFC scores were provided by the TF and FC scores were calculated “in-house” at Novation.
195
Braceo was the LBB for the CT DCAM and the Dual DCAM. Braceo was a very close second on the two other DCAMs;
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[[Image here]]
(19 T 63; P4083; 37 T 44-45). This is because Bracco’s FC scores were millions of dollars lower. (P4083; 37 T 38 — 40).
However, Braceo contends that if Visipaque had been included in the FC, Braceo would have been the lowest bidder for the CT + MR DCAM — by a margin of more than $13 million — and it would have therefore won both the CT and MR sole-source contracts.
196
Braceo further contends that GEH’s allegedly false Visipaque claims almost certainly affected the NFC scores as well. GEH’s NFC score was 138.2 points higher than Bracco’s. (P4083, 4084; Sweeney T 316-7). Braceo would have won the CT + MR DCAM (and thus both contracts) if GEH’s NFC score was only 15 points lower or, conversely, Braeco’s 13 points higher (or if both changed by 7-8 points). (P4085:101,103; 19 T 80-81; Sweeney T 256). The Court does not, however, find that GEH’s false advertising was a substantial factor in the TF’s carve-out decision. GEH maintains that Novation’s decision to renew its longstanding contract with GEH was not based on advertising, let alone GEH’s alleged false advertising, noting that GEH and its predecessors had held a sole source contract with Novation since at least the late 1980s and Novation was generally satisfied with GEH products and services.
197
In fact, Braceo even acknowledged that it was extremely unlikely that Novation would award a contract to another supplier and gave itself a 0% chance of winning a sole source award because of GEH’s strong relationship and history with Novation and the general satisfaction of Novation members with GEH products.
198
The Court finds this longstanding favorable business relationship highly probative of Novation’s decision to continue awarding the bid to GEH.
The Court also finds that the NE-PHRIC article itself was a substantial driver for Visipaque’s special carve out, and that even if there was false advertising in GEH’s ad campaign, it was not sufficient to be a material factor in this bid. The TF members and their colleagues
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were titled individuals chosen from the staff at various hospitals, who may have been exposed to GEH’s Visipaque promotional campaign,
199
but who were also privy to the underlying studies supporting such contentions. GEH’s pre-award sales call records on Novation member hospitals show the limited dissemination of GEH’s false superiority claims.
200
The Court finds that the offending sales call notes were too few to have a material impact on the award of the Novation contract nor were these sales calls made directly to any of the TF members participating in the decision. Although Braceo asserts that a few weeks before the carve out decision GEH met with the TF and again presented its Visipaque claims, the TF was still privy to the underlying studies and free to come to its own conclusions regarding Visipaque and its desirability as a CM.
201
More importantly, Braceo has not proffered evidence to show that any of the TF members were influenced by the ads as opposed to the underlying studies when they made their decisions.
202
In fact, Novation gave the TF a 27-page summary of the “things ... viewed to be most important” from GEH’s 300-page bid. Dan Sweeney, Vice President, Contract and Program Sales at Novation, testified that Novation provided the TF with GEH’s bid summary to serve as the main reference to evaluate GEH’s bid.
203
However, Mr. Sweeney could not testify what additional information the TF members considered except for their own personal experience in the medical field. (Sweeney T 66:9-23). Even if the TF only considered the bid summary, the Court finds that the bid summary does not claim Visipaque superiority to
all
LOCM. In response to the bid summary’s inquiry as to clinical studies that evaluate the safety and efficacy of the proposed products, GEH cited to the NEPHRIC, COURT, and VICC studies. Specifically, GEH expounded on NEPHRIC’s results as to renal safety, stating that “[i]n a comparison of VISIPAQUE vs. iohexol, VISIPAQUE was demonstrated to significantly reduce incidence of contrast-induced-nephropathy (CIN) ... and the conclusion was that nephropathy induced by contrast medium may be less likely to develop in high-risk patients when VISIPAQUE is used rather than
the
low-osmolar, non-ionic contrast medium.” (P4137:6331) (emphasis added). In light of their experiences, the TF members should have known that iohexol is Omnipaque and that NEPHRIC’s conclusions are limited to that comparison, given the language in the bid summary that Visipaque may be safer renally than
“the
lowosmolar, non-ionic contrast medium” compared in NEPHRIC. Absent from the bid
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summary is any mention of another LOOM, i.e. Isovue, or any statements that seek to extrapolate NEPHRIC’s findings to another LOOM. Essentially, the TF members were left to weigh the value of NEPHRIC and the other studies cited with respect to Visipaque.
Visipaque safety claims are the most salient feature of the NFC portion of the summary and likely account for most of the large disparity in GEH’s and Bracco’s NFC scores.
204
Mr. Sweeney, although
not
a member of the TF, admitted that the TF members likely read GEH’s bid summary to mean that Visipaque has superior safety to other CM and less pain than “traditional LOCM” which would include Isovue.
205
GEH’s GPO expert admitted that Braceo’s NFC score certainly could have been lowered by GEH’s Visipaque safety claims. Braceo alleges that the clinical information in the summary was so misleading that Mr. Sweeney thought that the NEPHRIC and COURT studies might have been against Isovue.
206
However, Mr. Sweeney was not on the Novation TF, and was only responsible for the financial aspect of the bidding process, without any sophisticated knowledge of the clinical nature of GEH’s bid. In fact, Mr. Sweeney conceded that he has limited knowledge of the clinical studies that evaluated the efficacy and safety of Visipaque. (Sweeney T 175-77). Accordingly, his lack of knowledge regarding scientific names of drugs (i.e. iohexol vs. iodixanol) that were represented in various studies is not probative of what was understood by the decision-makers — the TF members — because they had the underlying studies and were able to come to their own decisions regarding the efficacy of the products. Furthermore, the Court does not find this to be a substantial factor in the bid, because the vast majority of the material in the summary was not false or misleading and consisted of appropriate advertising materials which touted the NEPHRIC study results in an acceptable way, (See 37 T 6, 21; 36 T 220-229). The Court finds that any inaccurate information in the summary, limited as it was, did not have a material impact on the TF, particularly when combined with the TF members’ satisfaction with GEH’s products and GEH’s longstanding relationship with Novation.
viii. The Consorta Contract
In 1999, Consorta entered into a five-year, sole-source contract with Braceo for supply of x-ray and MRI CM.
207
Consorta put the contract out for bid in 2003 and received bids from at least Braceo, GEH, Berlex, and Tyco/Mallinckrodt.
208
In January 2004, Consorta awarded separate solesource contracts to GEH for X-ray and MR agents (Braceo is seeking only damages for loss of the X-ray contract). (P702). The X-ray contract awarded to GEH by Consorta was a three-year sole source contract.
209
Consorta’s Award Rationale states: “The imaging subcommittee agreed that the clinical acceptability of radiographic [x-ray] agents [ (e.g. — Isovue,
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Visipaque, and Omnipaque) ] would not be an issue,”
210
nonetheless, it also states that “Bracco’s ProHanee™ [ (Bracco’s paramagnetic agent) ] ... had not garnered high compliance ... and that determining clinical acceptance of the paramagnetic agents was a critical step in the decision making process.” The Consorta Award Rationale later states that GEH “was the only company that could provide clinically acceptable products, with formidable market positions, for both our radiographic and paramagnetic needs [and furthermore, that GEH] “is the only manufacturer of Isosmolar Contrast Media (Visipaque™).” ”
211
GEH avers that the reasons for the award were: (1) GEH is the only manufacturer of Isoosmolar CM; (2) GEH’s more competitive prices for Omnipaque and Visipaque; (2) low clinical acceptance of Bracco’s MRI product, ProHanee; and (3) Con-sorta’s belief that Braceo acted unethically during the bidding process.
212
Also, the Consorta members’ satisfaction with GEH’s products, based in part on their own clinical trials, contributed to their decision to contract with GEH.
213
Braceo asserts that, despite all the abovementioned factors, that GEH’s false advertising campaign was a material factor in the Consorta Award. The Court disagrees, but will begin its analysis by looking at internal GEH dialogue and the dialogue between Consorta and GEH. Mr. Jay Rapp, National Accounts Director at GEH, told Mr. Smith, his supervisor, that “[w]e need to drive as much Visipaque business within Consorta accounts as possible between now and the RFP process.”
214
Mr. Smith agreed “Visipaque will be key to our success” and said the “POA should [include] specific elements for increasing Visipaque sales.”
215
Mr. Rapp told Consorta’s Dan Ingram, Manager of Imaging Contracts, that Visipaque “must be part of the [financial] comparison,” and further stated in an internal GEH email that Dan Ingram “understands this, but we need to make this clear at the [July 2003] presentation as well as individual meetings ... and explai[n] the cost of not using Visipaque.” (P629; 12 T 111— 112; P4226, 608). GEH’s July 2003 presentation devoted nine slides to Visipaque’s alleged benefits (versus three Omnipaque
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slides). (P782:890 — 901; 12 T 138-148). Braceo points to evidence that Consorta “asked about Isovue with respect to Omnipaque/LOCM as positioned in NEPHRIC” and that GEH responded: “it is Iso-osmolar versus low-osmolar that was studied [in NEPHRIC], not necessarily Visipaque versus Omnipaque.” (P682; 2 T 153-157).
GEH’s statements emphasize the possible extension of the NEPHRIC head-to-head study to all LOCM, and at the same time deflect negative reaction away from Omnipaque. The above statement is ambiguous at best, but is not necessarily false, because the NEPHRIC study and article devotes part of its analysis to extending the conclusion from the two CM studied, Visipaque versus Omnipaque, to Visipaque versus other LOCM. Furthermore, NEPHRIC hedged its conclusion to say that Visipaque
may
perform better than
a
LOCM. The Court does not find that NEPHRIC was unreliable for this latter conclusion, but does find that GEH must disclose that the two CM used in the study were Visipaque and Omnipaque, and that GEH may not extend NEPHRIC’s results to a claim that Visipaque performs better than any LOCM other than Omnipaque. Here, Consorta was clearly aware that NEPHRIC compared Omnipaque and Visipaque. However, Braceo contends that GEH took its advertising a step further.
One example of the alleged false advertising in the GEH presentation was a NE-PHRIC slide claiming “high risk patients 11X less likely to develop CIN with an isosmolar CM, iodixanol, than with a lowosmolar CM.” (P782:A251897). However that same slide also presents a chart showing iodixanol (Visipaque) versus iohexol (Omnipaque).
(Id.)
While this slide appears to obscure the name brands of the products tested, it still presents the two CM that were tested in the study. Thus, the slide was not false, but it may have been misleading. Braceo contends that the aftermath of this presentation was that a Consorta “inside person” reported that GEH “made a good showing” and “Visipaque is something that has to be considered.” (P680; 12 T 158-160). But, this does not tell the Court whether it was the slides that made an impact.
As far as cost, Consorta told GEH it was “very concerned with Visipaque because of the impact increased use will have on Expense Budgets,” and Ron Smith concluded that “it will be imperative ... to effectively communicate ... a clinical reason ... to justify Visipaque use in high risk patients” and “it is essential that we clearly show the consequences on Visipaque pricing in a win and lose scenario.” (P612, 666; 12 T 174-178). GEH’s RFP response emphasized the alleged clinical superiority of Visipaque; for example, GEH stated: “the safety profile of Isosmolar Visipaque [] has propelled its growth in recent years” and “[c]ontrast with higher osmolalities could affect patients with at-risk conditions....” (0945:425-6,430; 12 T 179-180). Nonetheless, these statements are nothing new to the medical community, and certainly have not been disproven. The Court finds that inserting the word
“could”
merely re-states the conclusion of the NEPHRIC study, and does not contain additional spin. Notwithstanding, as set forth herein, more precision will be required of GEH’s ads in the future as limited by this Opinion. In short, an implication that NEPHRIC’s conclusions can be applied to any LOCM other than Omnipaque will not be permitted based on NE-PHRIC alone. In addition, any comparative advertisement based upon a study must be consistent in its reference to the names of the drugs tested; for instance, if GEH were to advertise the comparative results of NEPHRIC, its reference to the
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drugs must be “Visipaque v. Omnipaque”
or
“iodoxianol v. iohexol.”
Consorta’s January 2004 press release stated that GEH’s products were “preferable due to Amersham’s range of product that includes ... the only iso-osmolar agent Visipaque available in the United States.” (P702:540; 12 T 197-199). Con-sorta’s internal announcement shows that its “Award Decision” was based in part on increasing use (and costs) of Visipaque. (P715:851-2; 12 T 201-203; P163:110, 146). Mr. Smith recognized how crucial Visipaque Leverage was to GEH’s win, stating that Consorta “had to consider what would happen to prices if Consorta went away from us [i.e.,] with Visipaque ... so we just can’t assume that our offer was $6 million better than Bracco’s offer. It wasn’t.” (P1469).
Braceo asserts that the most direct evidence of Visipaque Leverage is a memorandum produced by Consorta itself. In that document, Consorta compared the prices of a dual source award, Braceo (X-ray) / Berlex (MR), to a sole source award to GEH. (D212:004 (col. 2 and 3)).
216
The “three year spend” in the GEH column is slightly (0.4%) lower than the Bracco/Berlex column, but only because a Visipaque line item is included under Bracco’s heading. Braceo argues that if that Visipaque line item is replaced with Isovue, Braceo would have won the contract by a comfortable margin.
217
This evidence, however, does not establish that GEH’s false advertising was a material factor in the award; all it means is that Consorta viewed Visipaque as “a must have” product. Since Consorta could have come to this conclusion by reading the NEPHRIC article, and agreeing with its conclusions, it does not mean that the limited false or misleading ads GEH disseminated to Consorta were a substantial factor, particularly in light of other facts, as set forth below.
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1. GEH’s prices were more competitive than Bracco’s prices
The primary reason Consorta switched suppliers for its 2004 contract was pricing.
218
Consorta determined it would save about $16 million over three years by accepting GEH’s bid over Bracco’s bid, notwithstanding Bracco’s efforts to convince Consorta that the actual cost of contracting with GEH would be higher than contracting with Braceo.
219
Braceo decided not to lower its price for Isovue, despite being aware before submitting its bid that Consorta wanted lower prices.
220
Even Braceo, in hindsight, rec.ognized that it should have offered Consorta a lower price during the contract extension negotiations.
221
Mr. Malackowski, Bracco’s damages expert, admitted that GEH’s bid was less than Bracco’s initial bid due to the low Omnipaque price, even after accounting for so-called “Visipaque leverage.”
222
However, the second bid by Braceo was competitive. One of the key issues was pricing in the event that Consorta obtained a dual source contract with GEH and Braceo. Under those conditions, GEH would have charged a bigger premium for Visipaque which effectively made the GEH bid better. This shows that Consorta took into account that Visipaque was the only isosmolar CM on the market. In light of these findings, this Court disagrees with Bracco’s assertion that GEH’s false advertising as to Visipaque renal superiority over LOCM had a material effect on the bid process. Braceo has not demonstrated that the few false ads shown by GEH to Consorta were a material factor in its favorable view of Visipaque.
2. Bracco’s ProHance product was not well accepted
Another asserted reason for Consorta’s award was the low compliance with the MR portion of its contract when Braceo was the incumbent.
223
Consorta’s members had clinical concerns about ProHance, including its inducement of vomiting.
224
Not surprisingly, Consorta officials were highly receptive and impressed with GEH products, so much so that some, based on their own clinical trials, wanted to continue
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using GEH products. Although a dual source bid would have alleviated concerns about the ProHance product and was an option that would have had competitive pricing had it not been for the Visipaque premium, Consorta’s award rationale appears to be based primarily on GEH’s ability to provide clinically acceptable products across all spectrums as contrasted with Braceo. Thus, the Court finds that GEH’s limited false advertising was not a material factor, while Bracco’s failing ProHance product was a material factor in Consorta’s award rationale.
3. Consorta believed Braceo acted unethically in bidding
After the suppliers submitted bids to Consorta, Braceo learned through “competitive intelligence” that GEH had submitted a much lower bid.
225
Braceo then restructured its bid so that it was similar to GEH’s and submitted a revised bid.
226
Consorta believed that it would be unethical for it to consider the revised bid.
227
Indeed, Bracco’s internal documents also attribute the loss of the Consorta contract to a variety of other factors, unrelated to alleged false advertising, including Bracco’s lack of understanding of Consorta’s contracting process and a lack of “depth and breath [sic] of relationships” between Braceo and Consorta.
228
Consorta’s subjective view of Bracco’s actions in the bid process, as opposed to GEH’s advertising, sounded the death knell for Bracco’s bid.
ix. GEH’s Allegedly False Visipaque Claims And Leverage were not a Material or Substantial Factor in the Award of the Kaiser Contract
In August 2003, GEH signed a sole-source agreement with the Kaiser IDN, even though Kaiser had joined the Broad-lane GPO which had a sole-source contract with Braceo. Braceo avers that GEH’s allegedly false claims about Visipaque were a material factor in GEH’s contract win at Kaiser and that it is shown by GEH’s post-award analysis that GEH won the contract by demonstrating to Kaiser that its “contrast media spend budget would increase” as a result of “increased Visipaque penetration” and a “[p]riee increase from 45% to 20% off list for Visipaque if they switched to Braceo and Broadlane.”
229
However, the Court fails to see how this links the alleged false advertising with the Kaiser bid. Offering a more competitive price and offering other products at a discount for putting other GEH products on contract is an acceptable business practice. In addition, GEH had
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held a sole source agreement with Kaiser for the supply of x-ray CM since 1993 and had enjoyed a favorable relationship with Kaiser.
230
In addition, during negotiations for an extension, GEH lowered its price on Omnipaque.
231
There is no evidence that advertising played any role in the renewal.
III. GEH’S Counterclaim
GEH alleges that Braceo has disseminated ads in violation of 43(a) of the Lanham Act and New Jersey State Law. During the course of trial GEH stipulated to dropping all claims for damages in its counterclaim, leaving only a request for injunctive relief. (36 T 4-8). In Bracco’s Revised Findings of Fact (¶ 96) it stipulated that the Braceo ads and promotions identified by GEH (except D2013) in connection with its counterclaim are no longer in use. Braceo contends that due to this stipulation any injunctive relief against Braceo would have no effect on GEH, Braceo or the market.
A. Bracco’s Comparison of Results from Kay and NEPHRIC
GEH contends that Braceo advertisements
(e.g.
D3, 31, 2014, 2015) promote Isovue as less renally toxic than Visipaque and/or Omnipaque. In order to make that claim, Braceo relies on the results of the Kay study and represents in these advertisements that NEPHRIC and Kay were similar studies.
232
GEH argues that the two studies were not similar because: (1) NEPHRIC patients were at greater risk for renal injury than patients in Kay; (2) NEPHRIC patients received a greater iodine dosage than the Kay patients; and (3) Kay did not even report the iodine concentration of Isovue used. In support of its contention that D2014 and 2015 disseminated false messages, GEH proffered Dr. Harold Feldman, who testified that in his opinion, the studies were not comparable.
(E.g.,
21 T 139:12-159:13; 32 T 73:23-75:5). The Court finds that Bracco’s advertisements that compare the results of Kay and NEPHRIC advance comparisons that are unreliable given the distinct differences between Kay and NEPHRIC, specifically that the patients in NEPHRIC had a substantially higher risk of renal injury than those patients in the Kay study. Indeed, any claim of Isovue superiority over Visipaque and/or Omnipaque based on comparative results of the Kay and NEPHRIC studies strays too far from the actual results.
IV. Daubert Motions
Necessarily, the Court must dispose of remaining evidentiary issues in connection with the admission of expert testimony. At trial, numerous experts for both sides testified on a broad swath of subjects ranging from the reliability of clinical studies using contrast media to testimony on the impact and dissemination of the parties’ marketing materials. These experts provide the lynchpin to the parties’ claims. Furthermore, expert testimony is critical in establishing damages and proving liability under certain prongs of the Lanham Act’s false advertising regime.
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A. Standard
Federal Rule of Evidence 702 requires that only reliable testimony, offered with a sufficient factual basis, be admitted. It was amended in response to the Supreme Court’s decision in
Dauberb v. Merrell Dow Pharms., Inc.,
which established a “gatekeeping role for the judge,” whereby the court must determine the admissibility of expert testimony. 509 U.S. 579, 597 , 113 S.Ct. 2786 , 125 L.Ed.2d 469 (1993).
Kumho Tire v. Carmichael
explained that the Court’s gatekeeper function applies not only to cases involving “scientific” knowledge but also in cases involving “technical” and “other specialized” knowledge. 526 U.S. 137, 141 , 119 S.Ct. 1167 , 143 L.Ed.2d 238 (1999).
Together,
Daubert
and Rule 702 impose three requirements for admissibility of expert testimony: “qualification, reliability, and fit.”
Calhoun v. Yamaha Motor Corp.,
350 F.3d 316, 321 (3d Cir.2003). First, the witness must have specialized expertise appropriate to his testimony.
Feit v. Great-West Life and Annuity Ins. Co.,
460 F.Supp.2d 632, 636 (D.N.J.2006). Second, the testimony must be reliable, which excludes opinions based on subjective belief or speculation; the opinion instead must “reliably flow from the facts known to the expert and the methodology used.”
Id.
at 637 . Third, the testimony must be relevant to issues in the case and assist the trier of fact.
Id.
at 636 .
B. Motion to Preclude the Expert Reports and Testimony of John Russell
Mr. John Russell, Bracco’s pharmaceutical marketing expert, has 33 years of experience in sales, sales management, sales operations, product management, new product launches, reimbursement, pricing strategy, contracting strategy, market research, and business planning concerning pharmaceuticals. Mr. Russell authored four expert reports and testified about pharmaceutical sales and marketing. Braceo asserts that his testimony is intended to provide a full and detailed understanding of the manner in which pharmaceutical companies traditionally sell and market their products as well as his understanding of GEH marketing and sales practices. His opinions were informed by analyzing GEH internal documents, deposition transcripts, review of other expert reports and discussions with people in the specific field of selling CM.
1. Mr. Russell’s Opinions on Whether Alleged Implicit “Messages” Contained in GEH Advertisements and Internal Documents are False are Excluded.
Mr. Russell testified that GEH documents, including advertisements and sales call notes, contained implicit messages. He based his conclusions on other expert reports provided to him. (17 T 12:25-13:10). During trial, the Court stated that Mr. Russell, who is not a physician or scientist, and has no experience with contrast media, may provide testimony based on the assumption that Defendants’ disseminated messages were false, but that he is not qualified to make an independent determination of their falsity. (17 T 12:25-13:10, 106:6-107:3-5). Mr Russell also testified to customers’ supposed expectations of pharmaceutical advertising. (17 T 49:9-15). However, Mr. Russell did not conduct or rely on any official customer survey for his opinions (17 T 34:14-18), and relied primarily on his own belief of what customers would understand and expect. (18 T 10:7-24, 11:20-14:3, 14:14-18:18, 21:2-22:2, 22:8-23:12).
The Second Circuit has discussed the critical role of customer surveys in the
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context of establishing a claim of false advertising under the Lanham Act.
Generally, before a court can determine the truth or falsity of an advertisement’s message, it must first determine what message was actually conveyed to the viewing audience. Consumer surveys supply such information. Once the meaning to the target audience has been determined, the court, as the finder of fact, must then judge whether the evidence establishes that they were likely to be misled.
Johnson & Johnson Merck Consumer Pharms. Co. v. Smithkline Beecham Corp.,
960 F.2d 294, 298 (2d Cir.1992) (citations and quotations omitted). Furthermore, the Second Circuit went on to state that:
Absent such a threshold showing, an implied falsehood claim must fail. This follows from the obvious fact that the injuries redressed in false advertising cases are the result of public deception. Thus, where the plaintiff cannot demonstrate that a statistically significant part of the commercial audience holds the false belief allegedly communicated by the challenged advertisement, the plaintiff cannot establish that it suffered any injury as a result of the advertisement’s message. Without injury there can be no claim, regardless of commercial context, prior advertising history, or audience sophistication.
Id.
In addition, the Third Circuit has concluded that, in the context of direct marketing to consumers, an expert’s “personal opinion is not the legal standard by which courts must determine whether customers were misled” and that absent evidence such as customer surveys, no court can conclude that consumers were mislead. See
Johnson & Johnson-Merck Consumer Pharms. Co. v. Rhone-Poulenc Rorer Pharms. Inc.,
19 F.3d 125, 136 (3d Cir.1994).
Here, Mr. Russell’s opinion as to falsity of messages is not only unsupported, but is also irrelevant to the issue of customers’ understanding and reaction to the advertisements. Therefore, the Court finds that Mr. Russell’s net opinion or personal belief about alleged implicit messages or customers’ expectations is legally irrelevant because he is not a member of the relevant purchasing group, did not rely on a survey of this group, and is unqualified to opine on the issue of how physicians would evaluate and act upon scientifically oriented ads or promotions for x-ray contrast media. Consequently, Braceo cannot rely on Mr. Russell’s testimony as a substitute for its failure to conduct an adequate survey.
2. Mr. Russell’s Opinion on Intent, the Actions of Sales Representatives, Causation, and Sales Call Notes are Unreliable.
a. Mr. Russell Cannot Opine on GEH’s State of Mind
Mr. Russell purported to divine what GEH was “trying” to do with its marketing strategy and what it believed was right or wrong.
{See, e.g.,
17 T 65:6-17, 66:19-22, 81:14-16). However, as the Court stated during trial, experts cannot opine on intent. (17 T 4:19-7:18);
see AstraZeneca LP v. TAP Pharm. Prods., Inc.,
444 F.Supp.2d 278, 293 (D.Del.2006) (precluding expert opinion of what party recognized,
felt,
concluded, or was
concerned
about and recognizing that expert witnesses are not “permitted to testify ... regarding [the defendant’s] intent, motive, or state of mind, or evidence by which such state of mind may be inferred.”);
In re Rezulin Prods. Liability Litig.,
309 F.Supp.2d 531, 547 (S.D.N.Y.2004) (concluding that “[i]nferences about the intent or motive of parties or others lie outside the bounds of expert testimony”). Accordingly, the Court strikes Mr. Russell’s testi
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mony to the extent that it opines on the intent or state of mind of others.
b. Mr. Russell’s Speculation About the Actions of GEH Sales Representatives is Unreliable
Mr. Russell speculated that GEH sales representatives posted protocols for Visipaque usage; that conclusion is unreliable and in conflict with the factual record. (17 T 101:13-14). During the course of trial, the Court quoted
Crowley v. Chait,
which concluded that no expert or “any other witness will be permitted to simply summarize the facts and the depositions of others. Such testimony comes ‘dangerously close to usurping the [factfinder’s] function’ and ‘implicates Rule 403 as a needless presentation of cumulative evidence and a waste of time.’ ” 322 F.Supp.2d 530, 553-54 (D.N.J.2004) (quoting
United States v. Dukagjini,
326 F.3d 45, 54 (2d Cir.2003)). GEH witnesses uniformly and credibly testified that Visipaque protocols were not posted (6 T 75:1-7; 15 T 191:9-22; 16 T 151:17-152:1), and accordingly, the Court finds that it is not Mr. Russell’s function as an expert to judge the credibility of those witnesses, or to supplant the factual record with speculative testimony.
c. Mr. Russell’s Testimony Regarding Causation is Unreliable
GEH argues that Mr. Russell’s opinions , about causation,
(See, e.g.,
17T 115:12-18, 116:1-5, 116:12-21, 117:1-4), are speculative and unreliable because he has no experience with contrast agent purchasing decisions and did not fully consider the factual record. It is true that Mr. Russell never negotiated a contract to sell contrast agents to a GPO or hospital (17 T 31:8-11), was never on a committee evaluating contrast agents (17 T 31:12-15), never made purchasing decisions at a hospital or GPO (17 T 31:16-18), and has not worked on any GPO contract since 1992. (17 T 31:19— 21). Furthermore, the Court finds that Mr. Russell did not undertake a systematic or scientific analysis of all factors to determine the specific effect of any particular piece of advertising, (i.e., he did not separate out the effect of any particular piece of advertising, marketplace effects or influences other than alleged false advertising, including true advertising). (17 T 34:3-38:12).
For example, with regard to Consorta and Novation, he failed to consider the economics of the bids (17 T 145:12-20, 148:5-11, 150:18-20, 166:12-25), and in the case of Consorta, did not consider Braceo and Consorta documents showing that Consorta was displeased with Bracco’s conduct during the bidding process and with its MRI agent ProHance (17 T 145:3-20; D 2098 at Consorta 0322; D 204 at A143081; D 212 at Consorta 002). Mr. Russell also failed to talk to Braceo executives about the Consorta contract (17 T 145:21-146:24), and did not consider GEH’s long-time incumbency at Novation, despite opining that Bracco’s incumbency at Consorta was a reason that it would have kept the contract. (17 T 168:14-170:4).
GEH argues that Mr. Russell’s opinions about customer purchasing decisions are connected to the facts of the case only by his own
ipse dixit
and thus, are unreliable.
See Calhoun,
350 F.3d at 321 (where the court excluded testimony that offered opinions on specific matters without a reliable foundation);
Ortiz v. Yale Materials Handling Corp.,
No. 03-3657, 2005 WL 2044923 , at *4, 2005 U.S. Dist. LEXIS 18424 , at *15 (D.N.J. Aug. 24, 2005) (holding that “[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered”
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and thus exclude the expert’s testimony). Nonetheless, an expert need not take into account every possible factor in rendering an opinion.
See MicroStrategy Inc. v. Business Objects, S.A.,
429 F.3d 1344, 1355 (Fed.Cir.2005) (“While an expert need not consider every possible factor to render a ‘reliable’ opinion, the expert still must consider enough factors to make his or her opinion sufficiently reliable in the eyes of the court.”);
Callahan v. A.E.V., Inc.,
182 F.3d 237, 257 (3d. Cir.1999) (where the court rejected defendant’s argument that an expert report was inadequate because it failed to rule out every possible alternative cause for plaintiffs loss);
Yarchak v. Trek Bicycl

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/1974795. Public record. Not legal advice.