Opinion
99 Civ. 9887 (BSJ), 99 CIV. 8926, M-21-81, MDL Docket No. 1291
February 6, 2002.
Opinion Order
The parties dispute the appropriate scope and extent of competing expert testimony in this case. In a letter dated February 1, 2002, Plaintiffs (collectively "Astra") moved by letter-brief to preclude Dr. Gardella, one of Defendant Andrx's experts, from testifying to any of the opinions or information recited in his Supplemental Expert Statement ("Gardella Supp."), which was provided to Astra on January 30, 2002. For the reasons stated below, the court grants in part and denies in part Astra's motion.
I. BACKGROUND
In Astra's infringement case against Defendant Andrx, the central issue is whether or not Andrx's product contains an HPMCP salt separating layer between its active core and its enteric coat. In support of its infringement case, Astra principally relies upon the testimony of Dr. Martyn Davies, who opined that his testing demonstrates the existence of that salt layer. The validity of each of the tests conducted by Dr. Davies is obviously critical to the evaluation of Dr. Davies' conclusions and the issue of infringement. Andrx now comes before this court, having done no discovery of the reliability of Dr. Davies' methodology and having previously disclosed no expert testimony attacking the acceptability of his testing methods, and asks to expand the testimony of its expert, Dr. Joseph Gardella, Jr., to cover these, and other, topics.
II. DR. GARDELLA'S SUPPLEMENTAL OPINIONS ARE NEW
There can be no real dispute as to whether the opinions contained in Dr. Gardella's Supplemental Expert Statement are previously undisclosed opinions. The substantive portion of Dr. Gardella's initial Expert Report ("Gardella Rep.") disclosed during discovery covered less than four pages of text. Only the following three relevant opinions are clearly disclosed therein: (1) Omeprazole "is detectable in the outermost layers of Andrx's active pellet samples." (Gardella Rep. at 2.) (2) The "concentrations of phosphate on the surface of active pellets are quite small" and "not as high as the simulated membrane formation reported by the Davies report." (Gardella Rep. at 4.) (3) Therefore, the "formation of a continuous membrane overlayer formed from a chemical reaction catalyzed or initiated by phosphate ions is unlikely." (Gardella Rep. at 4.)
By contrast, Dr. Gardella's Supplemental Expert Statement deals with subject matters entirely distinct from the opinions given in his Expert Report. The first opinion described in the Supplemental Expert Statement attacks Dr. Davies' analyses of his ATR-FTIR data and the conclusions he draws from them. (Gardella Supp. at 1-3.) The second opinion criticizes Dr. Davies' procedures and techniques in general terms. (Gardella Supp. at 3-4.) The third opinion questions Dr. Davies' opinion that there is a lactose-enriched layer in the Andrx product. (Gardella Supp. at 4-5.) The fourth opinion disputes Dr. Davies' opinion that there is an HPMCP sodium salt layer in the Andrx product. (Gardella Supp. at 5-7.) The fifth opinion claims that Dr. Davies improperly relied on a small subset of the data he collected. (Gardella Supp. at 7.)
Andrx purports to offer these new opinions by Dr. Gardella "for the purpose of challenging the reliability and admissibility of plaintiffs' expert testimony under Daubert and its progeny." (Gardella Supp. at 1.) However, in the following sentence, Andrx indicates that "Andrx makes no statement that what follows is related only to Daubert." (Gardella Supp. at 1.) Moreover, upon review of the opinions proffered in the Supplemental Expert Statement, the court finds that some of the opinions are not related to Daubert issues but instead go to the merits of Andrx's defense.
III. ANDRX'S ADMISSIBILITY ARGUMENTS
Given the previously undisclosed nature of the opinions in Dr. Gardella's Supplemental Expert Statement, the only question is whether there is some reason why the court should permit Dr. Gardella to provide new expert testimony. Andrx makes two principal arguments as to why the court should, in fact, permit Dr. Gardella to do so. First, Andrx argues that Dr. Gardella's new testimony is permissible rebuttal to opinions testified to by Astra's experts allegedly heard for the first time during trial. (See Second Letter from Andrx to court of 2/1/2002, at 1-2.) This first argument encompasses two subjects. Andrx contends that some of Dr. Gardella's opinions are in response to new testimony offered at trial by Astra's experts concerning the presence of water in the Andrx manufacturing process and its role in the formation of an HPMCP salt layer in the Andrx product. Andrx also contends that Dr. Gardella's opinions concerning Dr. Davies' ATR-FTIR testing directly rebut new testimony offered by Dr. Davies at trial concerning the use of ATR-FTIR testing for quantitative analyses. Second, Andrx argues that the new opinions advanced by Dr. Gardella also speak to admissibility underDaubert, and, therefore, should be admitted by the court under the permissive policy toward Daubert testimony previously adopted during this trial.
IV. ATR-FTIR TESTING: ANDRX HAD NOTICE, ASTRA DID NOT
The first new area covered by Dr. Gardella's Supplemental Expert Statement is ATR-FTIR testing. Dr. Gardella's original Expert Report did not even mention Dr. Davies' ATR-FTIR work; moreover, throughout his deposition, Dr. Gardella explicitly disclaimed having made any such analysis. (See, e.g., Gardella 10/26/2000 Dep. Tr. at 97:22-98:24, 106:16-108:3, 110:6-111:4.) Nevertheless, Andrx contends that Astra had notice of Dr. Gardella's opinions on ATR-FTIR testing because Astra was aware of Dr. Gardella's expertise in ATR-FTIR testing from references in his Curriculum Vitae and because Astra questioned Dr. Gardella in detail about ATR-FTIR analyses during his first deposition. (See Second Letter from Andrx to court of 2/1/2002, at 3 (citing Gardella deposition transcript).) Andrx's claim actually cuts against allowing Dr. Gardella to testify to his criticisms of Dr. Davies' ATR-FTIR testing.
Presumably, counsel for Astra repeatedly questioned Dr. Gardella concerning ATR-FTIR and his criticisms of Dr. Davies' work for the specific purpose of illuminating any opinions relating to Daubert issues that Dr. Gardella might present at trial. See, e.g., Gardella 10/26/2000 Dep. Tr. at 93:17-98:24, 103:18-108:3, 112:23-119:25, 186:4-187:2.) To that end, Astra's counsel asked Dr. Gardella "what ATR-FTIR is and how it works," whether "ATR-FTIR is a quantitative technique," what one would "need to do" to perform an ATR-FTIR analysis on Andrx's product, whether Dr. Gardella considered performing ATR-FTIR on the Andrx product, and whether "ATR-FTIR would assist in determining the presence of a HPMCP salt." (Id.) Dr. Gardella repeatedly frustrated Astra's efforts and avoided Daubert-related questions by asserting that he did not "know what questions Dr. Davies was asked to answer," (Gardella 10/26/2000 Dep. Tr. at 34:18-19), 50 he could not give an opinion. When pressed, Dr. Gardella repeatedly indicated that he had not been asked to provide a critique of Dr. Davies' work and had not contemplated doing so. (See, e.g., Gardella 10/26/2000 Dep. Tr. at 34:10-35:5, 97:22-98:24, 106:16-108:3, 110:6-111:4.) Even during his supplemental deposition beginning on January 31, 2002, Dr. Gardella admitted that his Expert Report and initial deposition did not question the propriety of Dr. Davies' use of ATR-FTIR. ( See Gardella 1/31/2002 Dep. Tr. at 213:25-214:12.)
Dr. Gardella did testify at some length concerning the methodologies he would employ to run the types of tests conducted by Dr. Davies. (see e.g., Gardella 10/26/2000 Dep. Tr. at 93:17-98:24, 103:18-108:3, 112:23-119:25, 186:4-187:2.) The court will, therefore, permit Dr. Gardella to testify concerning those opinions under Daubert.
Similarly, Andrx's claim that Astra withheld vital information on the ATR-FTIR testing techniques is without merit. Dr. Gardella's recent deposition transcript indicates that he had access to all the information relied on in his Supplemental Expert Statement, including all evidence related to the Andrx process, by November 2000. ( See, e.g., Gardella 1/31/2002 Dep. Tr. at 198:4-200:20, 232:16-233:2, 340:23-341:18, 398:2-398:20, 422:8-423:25, 429:3-430:16.) The one category of information Dr. Gardella and counsel for Andrx consistently indicate was not provided to them by Astra in a timely manner is a computer disk containing the digital backup data for Dr. Davies' experiments, which was recently produced in January 2002. However, the computer disk is "simply the digital record of the spectra that were provided in hard copy" in November 2000. (Letter from Astra to court of 2/4/2002, at 4.) If Dr. Gardella needed the digital files to formulate his opinions, a disk could have been requested long before trial. While it is true that the parties agreed to produce all expert test results and data, (see Letter from Andrx to court of 1/18/2002, ¶¶ 15, 15 n. 3), neither the parties' document requests nor their subsequent written agreement required production on computer disk instead of hard copy, (see Letter from Andrx to court of 1/18/2002, ¶ 15 n. 3 (collecting citations to relevant requests and letter agreement)). Moreover, the series of correspondence cited by Andrx, supposedly indicative of its requests for the computer disk, contain seven exceptionally specific, enumerated requests, none of which mention ATR-FTIR studies or computer disks. (See Letter from Andrx to court of 1/18/2002, App. 6 (collecting Letters of 12/14/2000, 1/2/2001, 1/3/2001 and 1/19/2001).)
Even the request Andrx made during Dr. Davies' deposition sought data files for "any additional experiments [Dr. Davies) conducted" other than the experiments reported in his expert report and in Exhibits 2110 and 2111. (Davies 11/9/2000 Dep. Tr. at 583:11-25 (emphasis added).) There were no additional experiments.
Astra did provide the data on a disk on January 19, 2002. For the most part, obtaining the computer data did not cause Dr. Gardella to alter his prior opinions or reach new ones — it simply reaffirmed what he already suspected from viewing the hard copy of the data. (See, e.g., Gardella 1/31/2002 Dep. Tr. at 273:23-274:24, 280:16-281:6, 300:5-20, 333:9-334:3.) Andrx does identify, however, two specific areas in which Dr. Gardella needed to review the computer data in order to identifyDaubert challenges to Dr. DaviesZ work. (See Letter from Andrx to court of 2/3/2002, at 2-3.) First, Andrx claims that the computer files demonstrated that the spectra in Dr. Davies' report were each from a single bead rather than an average of a number of beads. (See Gardella 1/31/2002 Dep. Tr. at 272:7-20, 301:8-25.) Andrx alleges that Dr. Gardella needed that information to determine whether Dr. Davies' tests were reproducible or representative of the Andrx product. (See Letter from Andrx to court of 2/3/2002, at 3.) There is no reason why the question of whether the spectra were from a single bead or represented an average of a number of beads could not or should not have been asked of Dr. Davies directly during his deposition. Second, Andrx claims that the computer files allowed Dr. Gardella to examine the data underlying Dr. Davies' charts to determine that the scaling decisions made by Dr. Davies and his team cut off the prominent talc peak, thereby exaggerating the size and significance of the smaller peaks in the graph. (See Letter from Andrx to court of 2/3/2002, at 3.) While the data may have made such scaling choices apparent, it is again ummaginable that Andrx, which had been provided with hard copies of the data, would not have questioned Dr. Davies on issues like scaling of graphs during his deposition in November 2000. Thus, while the recent production of the computer data may have buttressed Dr. Gardella's opinions concerning the reliability of the conclusions reached by Dr. Davies and his methodology, there is no reason why the computer files were necessary to the discovery of those opinions.
In fact, Dr. Davies was asked during his deposition how many beads he checked using the ATR-FTIR. (See Davies 11/9/2000 Dep. Tr. at 582:10-11; see also id. at 582:10-594:19.) counsel for Andrx even went so far as to suggest, "[a]nd I might be able to help you on that one." (Davies 11/9/2000 Dep. Tr. at 582:11-12.)
Questions were asked, for example, concerning the scale used for Dr. Davies' TOF-SIMS testing. (see Davies 11/8/2000 Dep. Tr. at 452:23-455:24.) Similar questions about scaling were raised with respect to Dr. Davies' UV microscopy testing. (See Davies 11/9/2000 Dep. Tr. at 524:2-525:6.)
V. GARDELLA'S SUPPLEMENTAL OPINIONS ARE NOT PERMISSIBLE REBUTTAL
In the event its notice arguments fail, Andrx argues that Dr. Gardella's new opinions are permissible rebuttal. With respect to the supposedly new opinions offered by Astra's experts at trial, it is unclear to the court why Andrx failed to provide notice to Astra or the court of Andrx's supposed need to rebut those opinions with new expert testimony of its own until the end of January. Dr. Davies' report was submitted in August 2000, and his deposition occurred in November 2000. Moreover, after Dr. Davies testified at trial on December 13, 17 and 18, Andrx had time, including a lengthy break during the holiday season, to present Dr. Gardella's new opinions in the form of a supplemental report. Instead, Andrx waited. Attempting to resolve numerous disputes among the parties concerning the appropriate scope of expert testimony, the court ordered the parties to submit each expert's report and deposition testimony to the court prior to that expert's trial testimony. Only then, on January 28, 2002, did Andrx implicitly reveal Dr. Gardella's new opinions by handing over a book of exhibits and demonstratives Andrx proposed to use during Dr. Gardella's testimony. Astra notified the court of the potential dispute in a letter dated January 29, 2002. When the court itself indicated concern over the admissibility of Dr. Gardella's new opinions in a conference between the parties on January 30, 2002, Andrx finally supplied the Supplemental Expert Statement and proffered Dr. Gardella for an additional deposition. (Trial Tr. at 3393:20-3395:22, 3413:7-3414:23.)
The court acknowledges that, as a result of a scheduling aberration during discovery, Dr. Gardella, a rebuttal expert, was deposed prior to Dr. Davies and without the benefit of Dr. Davies' deposition testimony. (See Second Letter from Andrx to court of 2/1/2002, at 3 n. 2.) Andrx argues that the court now should permit Dr. Gardella to comment on Dr. Davies' opinions and methodologies without prior disclosure because Astra chose not to rede pose Dr. Gardella after it produced Dr. Davies. That argument is entirely unpersuasive. Without a supplementation of Dr. Gardella's report, it was impossible for Astra to know there was a reason to seek a second deposition of Dr. Gardella.
While Andrx is correct that its experts are permitted to rebut new or changed opinions offered for the first time at trial, Andrx must first convince the court that at least one of Plaintiffs' experts actually introduced a new or changed opinion in his testimony. The question of whether Astra has introduced new opinions or evidence through its experts on ATR-FTIR testing or other issues forces the court to take a second look at a series of correspondence submitted by Andrx and Astra concerning allegedly new theories proffered by Astra during its infringement case. The court has once again conducted an in-depth review of the parties' submissions, as well as consulted the trial testimony, deposition transcripts, and expert reports proffered by both Dr. Langer and Dr. Davies. As the court has previously noted, Andrx's submissions have not convinced the court that either of Astra's experts testified to theories or opinions at trial relating to disputed issues in the Andrx case that were previously undisclosed during discovery. (See Trial Tr. at 3300-3301.) For the most part, the court finds that Andrx's complaints are completely unfounded and mischaracterize events as they have unfolded in this case. See Trial Tr. at 3300:22-3302:1.) The majority of the issues raised in Andrx's letters to the court of January 18, 2002, and January 28, 2002, do not merit comment. However, the court will address a few of Andrx's concerns that are particularly pertiment to the issues raised by Dr. Gardella's new opinions.
A. WATER AND THE HPMCP SALT LAYER FORMATION
Despite Andrx's strenuous arguments to the contrary, Dr. Davies did not present new testimony concerning the formation of the HPMCP salt layer in the Andrx product. Moreover, Astra did not present any evidence — through expert reports, deposition testimony, or trial testimony — that water, present or not in the Andrx process, was required to form the HPMCP salt layer. Andrx's suggestion that Dr. Davies did not describe how Andrx's HPMCP salt layer forms during discovery "is wrong." (Letter from Astra to the court of 1/23/2002, at 5.) In his Affirmative Expert Report ("Davies Rep."), Dr. Davies expressly explained that he had found an HPMCP salt layer and attributed its formation to the reaction of disodium hydrogen phosphate and HPMCP. (Davies Rep. at 6-7.) Dr. Davies provided discovery of his opinions that Andrx's active pellets contain "disodium phosphate," (Davies Rep. at 4), that the active pellets have only two distinct regions and no intense region, (id.), that the active pellets are coated with HPMCP, (id.), and that the coated pellets have two different regions of intensity, (id. at 4-5), which were identified as the enteric coating and the HPMCP salt layer, (id. at 5-7). Dr. Davies readily admits that he did not form an opinion as to the specific detailed process conditions in the Andrx process that cause the formation of the HPMCP salt layer. (Davies 11/9/2000 Dep. Tr. at 565:2-22.) However, he felt he did not need to do so — he showed it is there. (Davies 11/9/2000 Dep. Tr. at 565:10-14.)
Thus, Astra's initial position at trial does not necessarily require formation of the salt layer at any particular time or in any particular manner during Andrx's production process; it simply requires that the salt layer be present in the Andrx product. (See. e.g., Davies 11/9/2000 Dep. Tr. at 565:2-22.) Andrx's theory that water is required to form the HPMCP salt layer and that there is insufficient water during Andrx's manufacturing process to form the salt layer is a defense that should have been pursued and disclosed by Andrx during discovery. Any evidence about the requirement of water for salt layer formation or the presence of those conditions in Andrx's process is a defense argument to erode Astra's argument that the layer is present at all; to the extent it was not disclosed during discovery, it is precluded.
Andrx is correct that after extensive questioning on crossexamination, Dr. Davies did agree with counsel for Andrx that "[w]ater is a prerequisite in the case of disodium hydrogen phosphate reacting with that carboxylic group," which implies that the HPMCP salt layer cannot form in the absence of water. (Trial Tr. at 947:12-14.) He also "speculated on crossexamination about the possibility that water in Andrx's organic solvents could permit a salt to form." (Second Letter from Andrx to court of 2/1/2002, at 5; see Trial Tr. at 935:3-15.) On redirect, counsel for Astra asked Dr. Davies to explain that testimony, and he did so. (See Trial Tr. at 1026:18-1027:11.) Given that Dr. Davies had offered no affirmative opinions concerning the requirement or presence of water for the formation of the salt layer, the entire line of questioning on crossexamination appears to have been an effort on the part of Andrx to insert "water" into their case. By obtaining a new theory on water from Astra's expert on cross-examination Andrx hoped to justify its belated proffer of a defense theory and previously undisclosed expert opinions about water. It is clear to the court that the testimony at trial concerning water in the formation of the HPMCP salt was not an issue in Astra's affirmative infringement case. Andrx cannot use cross-examination as a contrivance to inject the previously undisclosed issue into the case as "rebuttal."
B. ATR-FTIR TESTING
In part, Andrx claims that Dr. Gardella should be permitted to present new opinions concerning Dr. Davies' ATR-FTIR testing because Dr. Davies introduced new opinions at trial concerning the quantitative use of his ATR-FTIR results and the Beer Lambert Law. Contrary to Andrx's characterizations, Dr. Davies did not present new opinions concerning quantitative analysis with ATR-FTIR or the Beer Lambert Law at trial. Although Andrx is correct that Dr. Davies did not mention the Beer Lambert Law by name in his report or deposition, he described both the use of ATR-FTIR as a quantitative technique and the Beer Lambert Law in words in his deposition. (See Davies 11/9/2000 Dep. Tr. at 697:5-23.) Dr. Davies' original report and deposition testimony made it clear that he was comparing the intensities of the lactose and omeprazole peaks from the surface and the interior of Andrx's active pellet. (Davies Rep. at 5-6; Davies 11/9/2000 Dep. Tr. at 543:24-544:15, 697:5-698:12.) His trial testimony did not go beyond those opinions.
The deposition testimony was, in part, as follows:
Q. can the ATR-FTIR technique tell you the relative abundance of compounds on'a surface?
A. In the context of the samples we analyzed and the approach we took we can.
Q. How would one go about quantifying the relative abundance of compounds using the ATR-FTIR data that you had?
A. One would compare the relative intensities of the peaks, the diagnostic of specific functional groups or materials.
(Davies 11/9/2000 Dep. Tr. at 697:5-23.)
While it is true that Dr. Davies first mentioned the term "Beer Lambert Law" on direct examination, (Trial Tr. at 853:12-24), his testimony did not vary from the general description he provided at his deposition until he was pressed for additional details on cross-examination. In fact, the bulk of Dr. Davies' testimony concerning these topics occurred in response to questioning by counsel for Andrx. At that point, Dr. Davies admitted that he had not "put a number" on the calculation or relied on a number for his opinions; instead it was "obvious to [him), looking at the spectrum" itself. (Trial Tr. at 1008:7-9.) Dr. Davies' further testimony on the topic occurred at the prompting of counsel for Andrx — he did not rely on any calculation in his affirmative opinions.
Andrx argues that Dr. Davies improperly relied on "two prominent peaks" characteristic of HPMCP in his trial testimony, (Trial Tr. at 832:5-20), even though Dr. Davies only described one such peak explicitly in the text of his Affirmative Expert Report, (Davies Rep. at 5). However, all information including identification of the "missing" peak was available to Andrx in the body of Dr. Davies' Affirmative Expert Report. Every spectrum relied on by Dr. Davies was attached to the report, as identified in his demonstrative exhibits. (See, e.g., Ex. 17, PTX 1036, Slide 6.) Andrx's enteric-coated product peaks are identified in Exhibit 4, (Ex. 15, PTX 222), and Exhibit 10, (Ex. 15, PTX 228), of Dr. Davies' Affirmative Expert Report. Clearly, information contained in spectra attached as exhibits to Dr. Davies' Affirmative Expert Report cannot constitute new opinions at trial.
Andrx also argues that Dr. Davies relied on a new document to support the reference spectrum for his "new" peak — PTX 769. (See Letter from Andrx to court of 1/18/2002, ¶ 13.) That document is one of five new documents the court permitted in evidence for, as Astra itself indicates, "the very limited purpose of showing that the techniques used were generally recognized in peer review articles." (Letter from Astrato court of 1/23/2002, at 4.) The entire testimony concerning the document was a single statement by Dr. Davies that the document "discloses, this is infra-red spectroscopy and it also uses an ATR, Attenuated Total Reflectance accessory which is the type of accessory that we used to look at the surface of the material." (Trial Tr. at 792:17-20.) Since the document was admitted solely for Daubert purposes, Andrx is not entitled to present non-Daubert testimony or rebuttal evidence about the document.
C. CONCLUSION
In sum, Andrx has not identified any truly new substantive testimony or evidence presented by Astra. Therefore, with the exception of limited presentation of Daubert materials, Dr. Gardella will not be permitted to testify to any new opinions as "rebuttal" — no such rebuttal is warranted. (See Trial Tr. at 3301 ("Having just reviewed the Langer and Davies submissions, I think Astra is playing by the rules thus far. And the notion that I have permitted them to get more testimony in and allowed the defendants to be surprised is wholly without merit.").)VI. DAUBERT ISSUES
A. DR. GARDELLA'S SUBSTANTIVE SUPPLEMENTAL OPINIONS
ARE INADMISSIBLE
Even though the court will permit Dr. Gardella to testify to his previously undisclosed opinions concerning application of the Daubert standard of admissibility to Dr. Davies' testing, that does not mean that all of the opinions expressed in Dr. Gardella's Supplemental Expert Statement are admissible. Specifically, the court finds that the opinions expressed in item number four in the report, see Gardella Supp. at 5-7), do not go to the Daubert issues in this case and they are inadmissible.
Of course, Dr. Gardella can testify to his opinions that the concentrations of phosphate on the surface of the active pellets are so small that "formation of a continuous membrane overlayer formed from a chemical reaction catalyzed or initiated by phosphate ions is unlikely." (Gardella Rep. at 4.) Although portions of that opinion are restated in item number 4(a)(1) in his Supplemental Expert Statement, (Gardella Supp. at 6), Dr. Gardella also disclosed those opinions in his original Expert Report, (Gardella Rep. at 4)
There are two opinions expressed in item number four. First, Dr. Gardella indicates that Dr. Davies "offered no reliable methodology to support his opinion that the required conditions exist in the Andrx manufacturing process to permit the formation of an HPMCP sodium salt separating layer during that manufacturing process." (See Gardella Supp. at 5-6.) As discussed above, Dr. Gardella's previously undisclosed opinions concerning the manufacturing process employed by Andrx, including the amount of water present, go to Andrx's defense that an HPMCP salt layer cannot form in Andrx's product under its processing conditions. Andrx cannot transform these substantive opinions into Daubert testimony simply by inserting the words "Daubert" and "methodology" into the text.
Second, Dr. Gardella opines that Dr. Davies "did not demonstrate that the portion of the Andrx product that he believed constituted the HPMCP sodium salt separating layer was water soluble." (See Gardella Supp. at 7.) This opinion, like the one before it, is merely a legal argument suggesting a deficiency in Astra's proof. Specifically, the opinion goes to Andrx's defense that any alleged subcoating in Andrx's product is not "soluble or rapidly disintegrating in water" as required by the formulation patents. (See `505 Patent, Cl. 1(b), at Col. 16, 11. 48-49; see also `230 Patent, Cl. 1(b), at Col. 13, 11. 10-11 (requiring "an inert subcoating which rapidly dissolves or disintegrates in water").) Thus, this opinion also goes to Andrx's noninfringement defense, notDaubert. Since the opinions expressed by Dr. Gardella under item number four in his Supplemental Expert Statement go to noninfringement defenses that should have been disclosed by Andrx during discovery, Dr. Gardella is precluded from testifying to them. Any documents Andrx seeks to produce in support of these opinions are likewise precluded.
B. SOME NEW OPINIONS ARE ADMISSIBLE UNDER DAUBERT
Since the court finds that Astra has not presented any objectionable new theories going to the merits of Astra's case against Andrx, as noted above, the court will not permit Dr. Gardella's new opinions to be admitted for purposes of Andrx's noninfringement defense. Thus, the admissibility issue is now narrowed to a Daubert analysis, and the court must discuss its policy with respect to admission of Daubert evidence at this trial. On December 3, 2001, three days before trial began, Andrx filed a motion in limine challenging the admissibility of the testimony of Astra's experts on Daubert grounds. In that twopage motion, Andrx offered no evidence in support of preclusion of Astra's experts. Andrx did not request a pretrial hearing but rather agreed with the court thatDaubert proof would come into the case during the testimony of the defense experts. The court fully expected that such expert testimony had been disclosed previously in expert reports and inquired into during depositions because the Daubert issue, if one exists, would be critical to Andrx's defense. (See Trial Tr. at 3391:17-22, 3392:15-19.) As it happens, Andrx's experts neither expressed opinions critical of Dr. Davies' methodology nor did they do the same testing to directly compare the results during discovery.
The court has noted, however, that "the most important thing is to get the right answer in this case" and that "it seems to me too important an issue to start precluding everybody from Putting in Daubert proof." (Trial Tr. at 3389, 3391-3393.) For those reasons, the court has been liberal in permitting all parties, but Particularly Defendants KUDCo and Andrx, to present evidence going to Daubert analyses that was not disclosed during discovery.
It is true, as Andrx argues, that neither Dr. Davies nor Dr. Langer presented opinions on the admissibility of Dr. Davies' testing underDaubert in their expert reports. (See Letter from Andrx to court of 2/3/2002, at 1-2.) That state of affairs is not surprising, however, given the dearth of discovery conducted by Defendants on the issue. Astra was, however, permitted to introduce into evidence five new documents and briefly elicit testimony from Dr. Davies concerning the validity of his testing methods. (Compare Andrx Letter to Court of 1/18/2002, at ¶ 7, with Astra Letter to court of 1/23/2002, at 3-5.)
Andrx repeatedly reminds the court of other instances where the court permitted Daubert evidence and testimony to come in even though it had not been disclosed during discovery. For example, in support of its argument for the admissibility of Dr. Gardella's new opinions concerning Dr. Davies' ATR-FTIR analyses, Andrx reminds the court that Dr. Davies testified on redirect at trial concerning ToF-SIMS testing, (see Trial Tr. at 937:17-939:22, 1022:16-1026:7), presumably to rebut Dr. Gardella's choice to use ToF-SIMS testing. (See Second Letter from Andrx to court of 2/1/2002, at 4-5.) Another situation, not mentioned in Andrx's correspondence, in which the court was similarly permissive and allowed an expert to testify concerning Previously undisclosed Daubert opinions occurred during the testimony of Dr. Salzberg, one of Andrx's expert witnesses. See Order of 1/18/02. Given the court's desire to determine the reliability of the testing methods relied on in this case and its rulings on Daubert evidence in the past, the court will permit Dr. Gardella to testify to those opinions contained in his Supplemental Expert Statement that go to Daubert issues.
C. ASTPA MAY REBUT ANDRX'S NEW DAUBERT THEORIES
Of course, Astra will be permitted to rebut Dr. Gardella's new opinions on Daubert issues. While Daubert issues are too important to be precluded wholesale in this case, "by the same token, there is no way it's going to go in without everybody having an opportunity to do the discovery they need." (Trial Tr. at 3393:21-25.); see In re Paoli Railroad Yard PCB Litigation, 35 F.3d 717, 739 (3d Cir. 1994) (holding that a district court "certainly had the power to provide that the experts who were to testify at the in limine hearing [on Daubert] be subject to discovery," including depositions). Astra has already deposed Dr. Gardella extensively on his Daubert opinions. Astra will also be permitted to present documents and testimony, whether by Dr. Davies or a different witness, to rebut those previously undisclosed Daubert theories. To present rebuttal on Dr. Gardella's Daubert opinions, Astra must disclose the rebuttal documents and testimony, including submitting a new expert report if necessary and permitting any witness to be deposed by Defendants. "[B]ecause under Daubert a judge at an in limine hearing must make findings of fact on the reliability of complicated scientific methodologies and this fact-finding can decide the case, it is important that each side have an opportunity to depose the other side's experts in order to develop strong critiques and defenses of their expert's methodologies." In re Paoli, 35 F.3d at 739.
VII. CONCLUSION
For the foregoing reasons, Astra's motion to preclude the opinions set forth in Dr. Gardella's Supplemental Expert Statement is GRANTED in part and DENIED in part. Dr. Gardella will not be permitted to testify to any new substantive opinions, including those listed under item number four in his Supplemental Expert Statement. The court will permit Dr. Gardella to testify to his new Daubert opinions, even though they should have been disclosed previously. However, Astra will be permitted to offer rebuttal testimony and evidence on those Daubert arguments. Astra is directed to advise the court in writing by 5:00 p.m. today what, if any, rebuttalDaubert proof it intends to present. The court will convene a conference among the parties at 9:00 a.m. on Thursday, February 7, 2002, to discuss scheduling and other outstanding evidentiary issues.