Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc.

Citations: 237 F.R.D. 106; 2006 U.S. Dist. LEXIS 50752; 2006 WL 2056494Docket: No. CIV.A. 03-891-JJF

Court: District Court, D. Delaware; July 25, 2006; Federal District Court

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The Court addressed several evidentiary objections raised during a bench trial. The plaintiffs objected to the admission of defendants’ demonstrative exhibits, citing a prior Court order from March 9, 2006, which stated such exhibits are only admitted if both parties agree. Since no agreement was reached, the Court sustained the plaintiffs' objection and excluded the exhibits. 

Additionally, the plaintiffs contested Dr. Burke’s testimony regarding salts in Example 2 of the '590 patent, arguing it was inadmissible due to lack of prior disclosure in his expert report, sworn declaration, or deposition, as required by Federal Rule of Civil Procedure 26(a)(2)(B). The Court noted that Rule 37(c)(1) imposes strict penalties for non-compliance only in cases of bad faith or willful deception, and found no evidence of such conduct by the defendants. The Court concluded that Dr. Burke's report sufficiently covered the opinions he provided at trial, and any discrepancies did not significantly prejudice the plaintiffs. Therefore, the Court overruled the plaintiffs' objection regarding Dr. Burke's testimony.

Plaintiffs objected to the inclusion of several exhibits related to Dr. Gelenberg's testimony, citing inadmissible hearsay under FRE 802, irrelevance under FRE 402, and lack of foundation under FRE 901. The contested exhibits (DTX 1197, 1156, 1238, 1213, and 1221) are internal emails among Plaintiffs' employees, which Dr. Gelenberg used to argue that published articles exaggerated the benefits of citalopram through selective data presentation. Defendants countered that these exhibits are not hearsay as they qualify as party admissions under FRE 801 and, even if deemed hearsay, fall under exceptions for “then-existing state of mind” and “records of regularly conducted activities” under FRE 803. They further argued that the exhibits are admissible as expert evidence under FRE 703 and that the Amended Pre-Trial Order establishes their authenticity. Defendants maintained these documents are relevant to the case and serve to challenge Plaintiffs' testimony. The Court ruled that the exhibits are not hearsay under FRE 801(d)(2)(D) because they are statements made by Plaintiffs’ employees within their employment scope. The Court also found that these exhibits meet the foundation requirements set out in the Amended Pre-Trial Order, as Plaintiffs provided no evidence to dispute their authenticity. Therefore, the Court overruled Plaintiffs’ objections regarding the relevance and admissibility of these documents.

Dr. Gelenberg's testimony regarding the impact of drug marketing on physicians’ prescribing habits is contested by Plaintiffs, who argue his lack of formal qualifications in marketing undermines his expertise. Defendants assert that Dr. Gelenberg's extensive experience as a clinical psychiatrist and his role in supervising clinical practices qualify him to provide relevant insights into prescribing behaviors. Under Federal Rule of Evidence (FRE) 702, an expert must be qualified based on knowledge and experience which can assist the court, and challenges to credibility should occur through cross-examination rather than exclusion. The Court finds Dr. Gelenberg sufficiently qualified and determines that Plaintiffs’ objections pertain to the weight of his testimony rather than its admissibility.

Regarding the exhibits linked to Dr. Gelenberg's testimony, which include various studies on the effects of pharmaceutical marketing, Plaintiffs challenge their admissibility, labeling them as hearsay and irrelevant. Defendants argue these studies are standard references in the field and should be admissible under the hearsay exception for market reports and commercial publications (FRE 803(17)). The Court acknowledges that Dr. Gelenberg testified these exhibits are relied upon by experts in his field, a point not disputed by Plaintiffs. The Court concludes that the studies possess probative value in supporting Dr. Gelenberg’s claims about marketing's influence on prescribing habits, and this value outweighs any potential prejudicial impact on Plaintiffs. Additionally, the data is relevant to the issue of obviousness under FRE 402. Consequently, the Court overrules Plaintiffs' objections to both Dr. Gelenberg's testimony and the accompanying exhibits.

Plaintiffs have challenged several exhibits related to Dr. Trombetta’s testimony, arguing they lack foundation and were not identified during his examination. Defendants counter that these exhibits were included in the demonstrative materials used by Dr. Trombetta, which, although not formally admitted, are part of the trial record by stipulation. The Court determined that the challenged exhibits are adequately identified in Dr. Trombetta’s testimony due to their inclusion in the demonstrative exhibits. It rejected Plaintiffs' claim that Defendants were improperly using demonstratives to introduce inadmissible evidence, stating that Defendants merely assert the exhibits were identified through the demonstratives. The Court found that certain exhibits authored by Plaintiffs and others by third parties, as well as journal articles disclosed during discovery, do not lack foundation under the Amended Pre-Trial Order. Consequently, Plaintiffs' objections to these exhibits were overruled.

Regarding Dr. Gibbons' testimony, Plaintiffs objected to portions they claimed exceeded the scope of his expert reports, particularly relating to the Auquier and French studies. Dr. Gibbons characterized the Auquier study as “hypothesis-generating,” which Plaintiffs argued was not included in his report. However, the Court noted that Dr. Gibbons’ report did indicate the Auquier study was a “meta-analysis,” aligning with the definition of “hypothesis-generating.” Since his expert report analyzed both studies, the Court concluded that Dr. Gibbons' testimony was a permissible synthesis of his prior analyses and overruled Plaintiffs’ objection.

Plaintiffs raised objections to Dr. Gibbons' testimony regarding violations of the French study protocol and his opinions about FDA responses to such violations. While the expert report identified issues with the study, it did not explicitly label them as protocol violations or address FDA concerns. The Court ruled that Dr. Gibbons' elaboration on the protocol violations was acceptable, but his comments on FDA treatment were not, as they were absent from his expert report. The Court overruled the objection related to protocol violations but sustained it concerning FDA treatment.

Regarding Dr. Gibbons' testimony on the impact of removing a treatment center from the French study analysis, the Court noted that this testimony was not included in his expert report. Defendants argued this deviation was warranted as a rebuttal to Dr. Thisted's late-produced expert report; however, the Court found that Defendants had adequate time to respond before trial and concluded Dr. Gibbons should not have introduced this testimony at trial. Consequently, the Court sustained the objection concerning this testimony.

Finally, the Court addressed Dr. Gibbons' comparison of assumptions in his analysis to those of Dr. Thisted. The Court determined that this comparison fell within the scope of Dr. Gibbons' expert reports, which detailed his analyses and assumptions related to the French study. Therefore, the Court overruled the Plaintiffs' objection to this portion of his testimony.

Additionally, Plaintiffs objected to the foundation of Dr. Bogeso's testimony and certain exhibits. The Court found that these exhibits were authenticated as per the Amended Joint Pretrial Order, thus negating the foundation objection. The Court had already overruled the objection at trial, leading to a final decision to overrule the objection concerning Dr. Bogeso's testimony and the related exhibits.

Plaintiffs objected to the admission of DTX 800, a newspaper article, and related deposition testimony from Dr. Olanoff, claiming it was hearsay and lacked foundation. The Court found Dr. Olanoff's agreement with a statement in the article constituted an adopted admission under FRE 801(d)(2), overruling the objection. 

Defendants raised evidentiary objections regarding two testimonies: 

1. Dr. Bogeso's testimony on the pharmacological effects of the (R)-enantiomer of citalopram was challenged because he was not presented as an expert and admitted to lacking pharmacological expertise. The Court determined that Dr. Bogeso's testimony was based on his firsthand knowledge from his research, enabling it to meet the standards of FRE 701 for admissibility. Therefore, the objection was overruled.

2. Dr. Lader's testimony asserting that (S)-citalopram was a major breakthrough drug was contested by Defendants on the basis that he lacked sales expertise and that his testimony exceeded his expert report's scope. The Court clarified that Dr. Lader's opinion was grounded in his clinical experience rather than sales data, and his expert report sufficiently covered his views on (S)-citalopram as a breakthrough drug. Consequently, the Court overruled the objection while acknowledging Dr. Lader's limited sales expertise would affect the weight of his testimony.

Mr. Gundertofte's testimony regarding his attempts to separate the enantiomers of citalopram using chiral HPLC is deemed admissible by the Court, despite Defendants' objections under FRE 701, as most of his testimony is factual, based on his personal experience at Lundbeck. The Court finds that any opinion offered by Mr. Gundertofte is reliable and helpful, thus overruling the Defendants' objection.

Dr. Lader's testimony about the absence of subgroup analyses in the Moore study is also upheld by the Court. Although Defendants argue it exceeds the scope of his expert report, the Court notes that Dr. Lader's detailed report already encompasses his opinions regarding the MADRS scores relevant to the study, leading to the overruling of the objection.

Dr. Pochapsky’s testimony about the unpredictability of chiral acids is accepted by the Court as a legitimate elaboration on his expert report, which discusses the theory and use of chiral acids. The Court finds that his opinion fits within the scope of his report, thus overruling the Defendants' objection.

Finally, Dr. Thisted's testimony concerning Dr. Gibbons’ calculation of effect sizes in the Moore study is permitted, as it directly relates to the content of his expert report where he previously addressed effect sizes. The Court concludes that this testimony is relevant and within the scope of Dr. Thisted’s report, leading to the overruling of the Defendants' objection.

Dr. Danishefsky's testimony regarding the hypothetical patenting of substantially pure citalopram in 1988 is deemed relevant to the issue of obviousness, despite Defendants' claims of its irrelevance and speculation. The Court finds that the cross-examination focused on whether the separation of citalopram's enantiomers would have been obvious to a skilled person in the art, which supports the relevance of Dr. Danishefsky's testimony under FRE 401.

Furthermore, the Court addresses Defendants' objection to Dr. Danishefsky’s characterization of Dr. Bogeso, Mr. Perregaard, and Mr. Gundertofte as persons of ordinary skill in the art. Plaintiffs assert that this testimony is pertinent to the factual claims regarding the failure of Lundbeck workers, which relates to the standard of obviousness set forth in Graham v. John Deere Co. The Court acknowledges that while the “person of ordinary skill” is a hypothetical construct, comparisons to real individuals are permissible and relevant in evaluating the concept of obviousness.

Additionally, Defendants object to the admission of PTX 746A, a certified translation of the Moore study's statistical analysis plan, citing foundation issues, denied discovery, and scope concerns regarding Dr. Lader's expert report. The Court notes that Defendants previously submitted this exhibit as DTX 1335, addressing foundation and discovery objections. It concludes that Dr. Lader can testify on an updated analysis plan since it relates to the prefinal analysis discussed in his report. The admissibility of PTX 746A is justified to prevent prejudice arising from earlier versions of the study and to counter Dr. Gibbons' testimony, resulting in the overruling of Defendants' objection.

Defendants objected to various exhibits on several grounds, primarily concerning the admissibility and translation of evidence. For PTX 819, while Defendants argued the lack of a certified translation prejudiced them, the Court found no prejudice since Defendants did not provide a certified translation as requested and the exhibit's purpose was merely to demonstrate the existence of a Danish patent. Thus, the objection was overruled. 

For PTX 1082, Defendants contended the title was misleading, yet the witness confirmed its accuracy regarding the relative sizes of branded companies in the SRI market, leading the Court to overrule the objection due to the absence of confusion during the bench trial.

Regarding PTX 21, Defendants claimed it was inadmissible hearsay because Dr. Smith was not an expert witness; however, they waived this objection by failing to raise it in a timely manner. Consequently, the Court overruled the objection. 

Defendants objected to PTX 778 on the grounds that Dr. Gundertofte was not an expert. However, since Plaintiffs agreed to redesignate it as a demonstrative exhibit, the Court deemed the objection moot. 

For DTX 190, 191, 192, and 198, Defendants argued they were inadmissible hearsay without proper foundation, but as with PTX 21, the objections were overruled due to untimeliness in raising them. 

Lastly, objections to DTX 690 and Dr. Gundertofte’s testimony as hearsay were also overruled; the Court found the testimony to be appropriate lay opinion based on personal experience rather than expert opinion. Defendants also objected to Plaintiffs’ corrections to translations of several documents due to untimeliness, but the Court ruled they could not raise this objection post-trial, thus overruling it as well.

Plaintiffs' demonstrative exhibits are not to be considered as evidence per the Amended Joint Pretrial Order, which states they are marked for identification only unless agreed otherwise. Plaintiffs concur with this position, leading the Court to deem Defendants' objection to these exhibits moot. Regarding PTX 1151, which Defendants claim is irrelevant and misleading, the Court also finds this objection moot as PTX 1151 is categorized as a demonstrative exhibit, consistent with the earlier ruling on demonstrative exhibits. Ultimately, the Court will overrule and/or sustain the various objections raised by both parties, and a formal Order detailing these rulings will be issued.

Plaintiffs’ objections to the admissibility of several pieces of evidence and expert testimony have been ruled upon as follows: 

1. The objection to Defendants’ demonstrative exhibits is sustained.
2. Dr. Burke’s testimony on salts in the ’590 patent is admissible.
3. Dr. Gelenberg’s testimony regarding medical literature and marketing effects on prescribing habits is admissible.
4. Various objections to Dr. Gibbons’ testimony related to the Auquier study and French study protocol are partially sustained and partially overruled, with specific concerns about the removal of a treatment center being sustained.
5. Dr. Bogeso’s testimony and related exhibits are admissible.
6. Defendants’ objections to multiple experts’ testimonies (including Dr. Lader, Dr. Pochapsky, Dr. Thisted, and Dr. Danishefsky) are all overruled.
7. Several exhibits presented by both parties have been ruled admissible, while a few objections have been deemed moot.

Overall, the order details a series of rulings on the admissibility of expert testimonies and exhibits, establishing a mixed outcome for both Plaintiffs and Defendants.