Frank then examined the gross margins earned by the Defendants for the Asacol products and concluded that the gross margins were significantly higher than the gross margins for either generic products or products facing generic competition, providing evidence of a monopoly. Frank concluded that "the fact that virtually all branded firms pay rebates to insurers and PBMs especially for tier placement on formularies does not alter a branded firm's ability to increase and sustain higher supra-competitive branded prices.
As to Frank's opinion, the Defendants first argue that gross profits and promotional spending are irrelevant to the analysis of the Defendants' market power in the relevant market. The Court disagrees; while they may not be sufficient alone to prove market power, they are certainly relevant to an analysis of market power. See Coastal Fuels of P. Caribbean Petroleum Corp. Moreover, Frank does not rely exclusively on these factors in reaching his conclusions, but combines an analysis of those factors with the pricing over time of the Defendants' product and the evidence of switching between products.
Second, the Defendants contend that historic price increases are irrelevant and the ability of the hypothetical monopolist to exact a five percent price increase profitably has no place outside of the horizontal merger context. But the hypothetical monopolist test is the "touchstone of market definition," even in contexts outside of horizontal mergers.
Coastal Fuels of P. Third, the Defendants contend that Frank inappropriately uses wholesale prices without accounting for rebates to third-party payors, leading him to ignore competition between brand-name manufacturers for formulary placement with PBMs. While Frank did use wholesale prices, he also concluded that it was not necessary to account for rebates because rebates were smaller than the price increases.
The only evidence the Defendants have offered to support their contention that Frank erred in this conclusion is the statement of an Allergan employee, indicating that PBMs that he negotiated with told him that rebates for Lialda exceeded forty or fifty percent of list price. This is not sufficient to show that Frank's use of wholesale prices and rationale for doing so are an unreliable basis for his opinion. Finally, the Defendants argue that Frank inappropriately provided a medical opinion regarding the differences between competing ulcerative colitis treatments that he was not qualified to give.
This argument is unavailing; Frank compiled and reviewed reports documenting certain characteristics of various drugs, including FDA sources, to inform his expert economic analysis, and the Defendants will be permitted to challenge the validity of the bases of his opinion at trial.
Irwin Jacobs "Jacobs". The Plaintiffs first proffer Jacobs as an expert regarding the therapeutic characteristics of Asacol mg and Delzicol and the potential for creating a version of Asacol mg with DBP without using a capsule. Jacobs, in formulating his opinion, relied upon documents provided by Warner Chilcott; a report submitted by the Defendants' expert on the subject, Dr. Robbins; experience with the pharmaceutical industry; documents from the FDA's communication with Warner Chilcott; and his own expertise in the field.
Jacobs concluded that "[i]t was possible to achieve safety and bioequivalence to original Asacol mg tablets with reformulated Asacol mg tablets that replaced DBP with DBS without changing the dosage form to a capsule;" that there was no need to address the problem of microfractures by means of encapsulation; and that "[t]here is no technical or scientific reason why a company would need to encapsulate the tablet to accommodate a change to DBS formulation. The Plaintiffs also proffer Jacobs as an expert on the potential challenges that generic manufacturers would face in trying to create a generic version of Asacol mg.
Jacobs concluded that "no major scientific or technological hurdles existed to prevent drug companies from developing a generic version of Asacol [mg] that could meet [the] FDA's bioequivalence requirements and enter the market after Asacol [mg]'s patents expired. He reviewed the conclusions of the Defendants' expert, Dr.
Juergen Siepmann, regarding certain purported difficulties in developing a generic version of Asacol mg, and concluded that none of those purported difficulties were valid or material. The Defendants next contend that Jacobs' testimony is speculative because Jacobs does not identify a particular generic manufacturer with the capability of producing a generic version of Asacol mg.
Jacobs, however, used sufficiently reliable information about the technological capabilities of generic manufacturers generally, based upon other products they produced and the specific characteristics of the Asacol mg product, in reaching his conclusion. The Defendants next contend that Jacobs impermissibly took account of the fact that generic manufacturers produced generic versions of two other mesalamine products - Asacol HD and Lialda - in reaching his conclusions, despite the fact that Asacol HD and Lialda are different products from Asacol mg.
But Jacobs relied on those products because they were similar to Asacol mg in ways that made it reasonable to draw an inference about the ease of creating a generic version of Asacol mg from information about Asacol HD and Lialda. The Defendants also argue that Jacobs' conclusions regarding the feasibility of formulating a version of Asacol mg without DBP and without a capsule are inadmissible.
But this contention is not at odds with Dr. Jacob's testimony. The Defendants additionally contend that Jacobs inappropriately discounted a December study by Warner Chilcott on microfractures because they were done in a "water environment. In Jacobs' report, he dismissed the study because "it contains a small sample size, it is not a controlled experiment, and there is no substantiation of the conclusions. Jacobs opined that because microfractures originate in the manufacturing, shipping, and handling process - which are dry settings - a water environment is not the appropriate environment in which to test for the development of microfractures, D.
The Defendants also seek to exclude Jacobs' opinions on the Defendants' intent; the likelihood of certain action by the FDA such as approval of a product; and the relative costs of manufacturing an encapsulated versus non-encapsulated tablet. But, the Plaintiffs agree that Jacobs will not testify about the Defendants' intent. And, while Jacobs is not an expert in regulatory matters, he is a scientist who reviewed the technical documents released by the FDA on bioequivalence testing and opined on whether generic manufacturers would be able to meet those technical specifications - which is, along with manufacturing costs, within his scope of expertise.
Finally, the Defendants seek to exclude Jacobs's testimony weighing the credibility of the evidence regarding the existence of a microfracture problem or the likelihood of generic entry, because his testimony would usurp the role of the jury.
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This is not the case where an expert is doing so in explaining his review of the scientific evidence in rendering an opinion, a function that would aid the jury pursuant to Fed. David Kessler "Kessler". The Defendants first argue that Kessler's deposition testimony raised new opinions not disclosed in his initial report and those additional opinions should be excluded. See Fed. Specifically, the Defendants contend that Kessler went beyond the scope of his report in opining regarding the version of Asacol mg sold in the United Kingdom and the swallowability of the Delzicol capsule.
But Kessler did opine in his report that the Defendants could have reformulated a DBP-free version of Asacol mg without a capsule, D. Because the U. Similarly, Kessler also opined that the FDA did not require the capsule, for any safety-related reason or otherwise, D. Again, there is no prejudice to the Defendants as to this issue. But, Kessler is unquestionably an expert in the process of FDA decision-making, and to the extent that the FDA's actions in a but-for world are matters for the fact-finder to determine, based upon whether it chooses to credit such opinion, the Court does not conclude that such opinion is beyond the bounds of Rule The cases cited by the Defendants, D.
The Defendants next seek to exclude Kessler's opinion that the FDA never required the Defendants to withdraw Asacol mg once Delzicol was launched, both for reasons similar to those cited above which the Court does not accept and because the record does not support that conclusion. The Defendants also move to exclude Kessler's testimony regarding generic entry on the grounds that Kessler was only offered as a regulatory expert. But the opinions of Kessler regarding generic entry are focused on the lack of regulatory barriers to generic entry, and explaining why the experiences of Par and Roxane - which had submitted ANDAs with Paragraph IV certifications and met with regulatory barriers - were not applicable to generic manufacturers that might have submitted ANDAs with Paragraph III certifications.
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This is a fundamentally regulatory opinion and thus within the scope of Kessler's expertise. Finally, the Defendants move to exclude Kessler's testimony on technical formulation issues; the standard of care for ulcerative colitis patients; and the intentions of the executives of the Defendants. The Plaintiffs, however, do not seek to have Kessler opine on these topics. Thomas McGuire "McGuire".
The Plaintiffs engaged McGuire, a Professor of Health Economics at Harvard Medical School, to opine regarding "if Warner Chilcott's withdrawal of Asacol mg precluded competition and harmed consumers," and "on whether, had Asacol mg not been withdrawn from the market, rational, competitively acting generic firms would have been likely to enter after patent expiry. McGuire opines that it would be profit-maximizing for Warner Chilcott to pull Asacol mg from the market only if doing so would lead to higher profits for Delzicol, which would derive from consumers who preferred Asacol mg but were forced to switch to an alternative and chose Delzicol.
He concluded that, based on an analysis of yardstick products, generic entry for Asacol mg would have been likely if Warner Chilcott had not pulled Asacol mg from the market. The Defendants first contend that McGuire impermissibly assumed the possibility of generic entry without pointing to any particular potential entrants.
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That argument fails for the same reason it was rejected above for Clark's testimony. Second, the Defendants contend that McGuire did not calculate the quantity of lost profits, but only calculated the lost revenue and inferred the lost profits from that. But the Defendants do not explain why that inference is flawed - especially given the other evidence in the record, provided by Frank, that Asacol mg was a highly profitable drug.
But, as discussed above, this is not a reason to exclude his testimony.
Fourth, the Defendants challenge McGuire's model, which indicates that a hard switch by a brand-name manufacturer generally suppresses generic entry because the brand-name manufacturer would not pull a profitable product from the market unless it could make up those profits by increased sales of the new product that would come from consumers who preferred the old product and would likely have adopted a generic competitor to that product. The Defendants contend that this model has no "limiting principle" and thus would not be useful to a jury.
But this type of obj ection goes to the weight, rather than admissibility, of McGuire's testimony, and can be raised before a fact-finder in cross-examination. Fifth, the Defendants contend that McGuire impermissibly failed to incorporate into his analysis the pro-competitive benefits of Delzicol.
However, the presence of any pro-competitive benefits of Delzicol is a disputed issue of material fact here. The Defendants are free to challenge McGuire's assumption that there were no procompetitive benefits to Delzicol before the jury, but it is not grounds for excluding his testimony.
Sixth, the Defendants argue that McGuire's test would create, in the mind of the jury, an impermissible presumption of anti-competitive conduct wherever a brand-name manufacturer executes a hard switch, which is not a proposition of law that has been adopted by any court or an economic theory published in any economic journal. Other courts have, however, found that hard switches may be anti-competitive.
See, e. Schneiderman v. McGuire's economic analysis provides an explanation for why a hard switch might generally be anticompetitive, but there is no reason for the jury to conclude that such is the case here. The fact that McGuire's theory has not yet been published is not alone grounds for its exclusion at trial.
The reasons proffered by the Defendants for why not all hard switches are anticompetitive are all appropriate grounds for cross-examination. Seventh, the Defendants seek to exclude the portion of McGuire's testimony that supports his conclusion that the introduction of Delzicol did not lead to a drop in the price of Asacol HD. The Defendants contend that McGuire did not specify for them at his deposition whether he used the invoice date, accrual date or pay date to calculate the relevant date to associate with particular price data, and thus must be excluded.
But, the Court does not conclude that this is a sufficient basis alone for the drastic measure of excluding this opinion and declines to do so. Eighth, the Defendants contend that McGuire erred by using price data that did not reflect rebates given to third-party payors and did not include comparisons to relevant similar ulcerative colitis drugs.
But McGuire did adjust the price data to reflect rebates from the manufacturer, D. McGuire's analysis of price data was limited to the general proposition that prices for Asacol HD trended up from December to August , so his failure to analyze price trends in other drugs is irrelevant - he does not purport to opine that Asacol HD prices moved in a way that was different from other drugs.
Finally, the Defendants contend that McGuire's conclusions about the likelihood of generic entry should be excluded because McGuire does not identify any particular generic manufacturer that would have entered. The Court rejects this argument for McGuire as it did for Clark. The Plaintiffs move to exclude the testimony of Dr.
Bruce Strombom "Strombom" , the Defendants' expert. Strombom opines about the number of uninjured class members, certain putative defects in Conti's model and the aggregate damages calculation. The Plaintiffs contend that Strombom's testimony about the number of uninjured consumers should be excluded because Strombom classifies consumers as "uninjured" where the consumer experienced an overcharge but later received recoupment for that overcharge, in contrast to legal precedent, which holds that an antitrust injury occurs "the moment the purchaser incurs an overcharge, whether or not that injury is later offset" by "savings attributable to the same or related transaction.
For the purposes of the class certification inquiry, the Court applies First Circuit law and does not rely on this portion of Strombom's analysis. For the purposes of the total damages calculation the jury must perform, however, Strombom's opinions regarding the likely impact of generic entry, the importance of rebates and coupons in offsetting damages and price trends in a but-for world remain of value, and therefore the Court does not exclude them. Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; b.
All persons or entities who purchased Asacol mg, Asacol HD, or Delzicol only directly from Defendants or for resale; c.