Opinion ID: 3217049
Heading Depth: 4
Heading Rank: 1

Heading: Clinical Formulation ID

Text: Ranbaxy argues on appeal that the assignment of a non-unique Clinical Formulation ID to Absorica falsely represents that Absorica is not clinically unique, thereby misleading pharmacists into believing they may safely substitute generic acne medications for Absorica. At the outset, FDB correctly notes that this is not the theory Ranbaxy pursued in its complaint. There, Ranbaxy alleged that “[b]y assigning the same [Clinical Formulation ID] to Absorica and all other Isotretinoin-based products . . . , FDB falsely and incorrectly indicates to FDB Subscribers that Absorica is therapeutically equivalent to, and may be safely substituted for, other branded or generic Isotretinoin-based products.” App. 1 at 7. It was only after discovery that Ranbaxy advanced the theory that FDB falsely represented the clinical uniqueness of Absorica. In any event, however, the district court was correct in concluding that there is no genuine issue of material fact because no reasonable reader would understand Absorica’s Clinical Formulation ID to mean that Absorica had therapeutic equivalents or that it could be substituted for other drugs. Ranbaxy first argues that because the MedKnowledge documentation indicates that unique Clinical Formulation IDs may be assigned when a drug’s dosage form is “clinically unique,” Absorica should have its own Clinical Formulation ID. Ranbaxy points to testimony from MedKnowledge’s corporate 12 Case: 15-12996 Date Filed: 06/24/2016 Page: 13 of 20 representative explaining that clinical uniqueness may include “differences in absorption when a product is taken in the fed or fasted state in clinical trials.” App. 74-11 at 27. But there is no evidence that FDB has ever assigned a unique Clinical Formulation ID merely because a drug may be taken in a fasted state.2 And despite an extensive list of dosage forms, nothing in the MedKnowledge documentation suggests that such a metric is relevant to FDB’s determination of clinical uniqueness. That an FDB corporate representative admitted that a drug’s ability to be taken in a fasted state may be a sign of clinical uniqueness has no impact on what a reasonable reader would glean from the database and the accompanying documentation. The MedKnowledge documentation belies any claim that the assignment of a non-unique Clinical Formulation ID to Absorica is misleading to a reasonable reader: the documentation makes clear that the Clinical Formulation ID “is not sufficient to determine therapeutic substitutability,” and nothing in the documentation suggests that a drug’s effectiveness in a fasted state is a metric that warrants a new dosage form. App. 74-2 at 5. Ranbaxy protests that the MedKnowledge documentation is so lengthy and cumbersome that no representative from FDB could even say they read the entire manual, and there is no evidence that any customers have actually done so. 2 Even Ranbaxy’s expert seemed unconvinced by this argument: “Q: And is it your testimony that FDB is required to create a new dosage form for Absorica? . . . A: I – I can’t – I can’t – that’s up to them.” App. 74-13 at 38 (deposition testimony). 13 Case: 15-12996 Date Filed: 06/24/2016 Page: 14 of 20 Ranbaxy’s insistent reference to the size of the documentation is of no help. The user documentation is not a novel to be read cover-to-cover; it is a reference manual, designed to be consulted and searched as needed. The very passages cited by the parties in this litigation can be found simply by referencing the Table of Contents, Index, or other search function. And as explained above, the MedKnowledge documentation, which is made available to all MedKnowledge subscribers, is necessary to understand the data provided in the coded fields. It strains credulity to suggest that FDB’s customers, responsible for designing software to make prescription decisions for ailing patients, would simply neglect to consult the authoritative guide explaining the various data fields. Tellingly, Ranbaxy’s argument regarding clinical uniqueness makes sense in the first place only if we assume that customers read the portion of the documentation explaining that clinical uniqueness may be a basis for developing new dosage forms. Nor is it appropriate to call the detailed explanations in the MedKnowledge documentation “disclaimers.” Unlike in the cases cited by Ranbaxy, this is not a situation in which FDB has made false statements and has attempted to insulate itself from liability by disclaiming responsibility for their accuracy. See Off Lease Only, Inc. v. Carfax, Inc., No. 12-80193-cv, 2012 WL 1966372, at  (S.D. Fla. May 31, 2012) (defendant provided disclaimer that “in no event [are] the [reports] warranted as being error free” (alterations in original)); Harcrow v. Struhar, 511 14 Case: 15-12996 Date Filed: 06/24/2016 Page: 15 of 20 S.E.2d 545, 546 (Ga. Ct. App. 1999) (defendant implied that plaintiff was guilty of a crime, but added that “I’m not saying that they are responsible for this atrocious act”).3 FDB does not disclaim responsibility for the accuracy of its data in the documentation; it provides explanations for each of the coded fields so that its customers can translate those fields into usable data for pharmacists. Ranbaxy next points to two publications outside the MedKnowledge database that it claims give rise to an issue of fact. Like the district court, we are uncertain whether these separate publications are germane to our analysis of the falsity of the MedKnowledge database. Nevertheless, we conclude that these publications do not create a genuine issue of material fact. Ranbaxy cites language in a series of “MEDITECH Customer Connection” newsletters, sent to a subset of FDB’s customers, explaining that “because FDB’s Clinical Form ID classification groups identical products under a shared numerical value (ID), users are able to easily identify a replacement [National Drug Code] for a pharmaceutically substitutable product.” App. 74-24 at 6. Though Ranbaxy is correct that these newsletters describe Clinical Formulation IDs as identifying “identical products,” it ignores the rest of the sentence, which plainly states that the codes merely identify “pharmaceutically substitutable product[s].” And a table produced just 3 A third case cited by Ranbaxy, Machleder v. Diaz, 538 F. Supp. 1364 (S.D.N.Y. 1982), is inapposite. There, the “disclaimer” ignored by the court was a statement made by the plaintiff, explaining that he was not responsible for the acts improperly attributed to him by the defendant. 538 F. Supp. at 1372–73. 15 Case: 15-12996 Date Filed: 06/24/2016 Page: 16 of 20 one page earlier in the same document makes clear that Clinical Formulation IDs group together products with the same “Ingredients, Strengths, Dosage Forms, and Routes.” App. 74-24 at 5. Ranbaxy is not permitted to make its case by taking terms out of context and ignoring the plain meaning of the immediate context. A reasonable reader does not read terms in isolation, but puts them in the context in which they were published. See, e.g., Fid. Warranty Servs., Inc. v. Firstate Ins. Holdings, Inc., 74 So. 3d 506, 515 (Fla. Dist. Ct. App. 2011); Ward v. Zelikovsky, 643 A.2d 972, 980 (N.J. 1994). Ranbaxy also cites to a “Monthly Interest” newsletter in which FDB discussed, as an example of clinical uniqueness, two drugs, one that needed to be taken in the evening with dinner and one that needed to be taken in the morning without regard to meals. Accepting, as we must at this stage, that a reasonable reader would interpret this newsletter to mean that FDB assigns a unique Clinical Formulation ID to drugs that can be taken in a fasted state, there is no basis upon which to assume that a reasonable reader would ignore the numerous explanations that “[t]he purpose of the [Clinical Formulation ID] is to allow grouping of pharmaceutically equivalent products,” and that “[a] good rule of thumb to follow is to use the [Clinical Formulation ID] plus the Orange Book code to identify possible generic equivalents.” App. 74-25 at 4–5. These passages inform readers that the fact that two drugs share a Clinical Formulation ID is only sufficient to 16 Case: 15-12996 Date Filed: 06/24/2016 Page: 17 of 20 show pharmaceutical equivalence, and that substitution decisions should be made by consulting the Orange Book. No reasonable reader would understand that assignment of a non-unique Clinical Formulation ID indicated therapeutic equivalence or substitutability. Again, Ranbaxy seeks to remove small portions of text from their plain context; such a strategy does not create a genuine issue of material fact. The last piece of evidence relied upon by Ranbaxy is a set of FDB customer inquiries. These inquiries questioned why Absorica shares a generic code (its Clinical Formulation ID) with other Isotretnoin-based medications, even though Absorica is not generally substitutable with other drugs. Although we have acknowledged that in the context of a Lanham Act claim, “evidence of actual confusion” is the “best evidence of likelihood of confusion,” Amstar Corp. v. Domino’s Pizza, Inc., 615 F.2d 252, 263 (5th Cir. 1980), we are assessing falsity, not likelihood of confusion. And the inquiries are not evidence of actual confusion, but are instead targeted questions about how FDB organizes its data. Moreover, deferring to the judgment of actual customers would require us to ignore the Supreme Court’s direction that falsity is viewed from a reasonable reader’s perspective—the inquiry is an objective, not a subjective, one. In the face of the plain language of the MedKnowledge documentation, which provides clear and ample explanation of how Clinical Formulation IDs are generated and used, 17 Case: 15-12996 Date Filed: 06/24/2016 Page: 18 of 20 five isolated instances of customers inquiring about the Clinical Formulation ID are insufficient to raise a genuine issue of material fact. The MedKnowledge documentation, which is necessary to understanding the vast fields of data provided by FDB, dispels any notion that FDB has published false information about Absorica by assigning it a non-unique Clinical Formulation ID. There is nothing in the MedKnowledge database or the accompanying documentation that would lead a reasonable reader to believe that every drug that may be taken in a fasted state is assigned a unique Clinical Formulation ID.