Full opinion text
FINDINGS OF FACT AND CONCLUSIONS OF SARIS, District Judge TABLE OF CONTENTS Page I.INTRODUCTION AND SUMMARY..........................................37 II. FINDINGS OF FACT.......................................................39 A. Kaiser Foundation Health Plan and Kaiser Foundation Hospitals..........39 1. Kaiser’s Proactive Drug Management................................39 2. Kaiser’s Placement of Neurontin on Formularies......................40 B. Marketing of Neurontin ................................................41 1. FDA Approval of Neurontin For Epilepsy Treatment..................41 2. The “Strategic Swerve” to Maximize Neurontin Profits For Off-Label Indications.............................................42 3. Efforts to Expand On-Label Uses Fail at the FDA ....................42 4. The Two Marketing Partnerships....................................43 5. Use of Medical Liaisons for Off-Label Marketing.....................45 6. Investigation by the FDA............................................46 7. FDA Rejection of Neurontin for Neuropathic Pain and Approval For Post-Herpetic Neuralgia (PHN) ...............................46 8. Warner-Lambert Guilty Plea........................................47 C. Target: Kaiser.........................................................47 D. The Marketing Fraud...................................................48 1. Bipolar Disorder....................................................48 i. Direct Marketing to Physicians ................................49 ii. Publication Strategy ..........................................50 iii. Sponsorship of Continuing Medical Education (CME)............52 iv. Communications with the Cochrane Review.....................53 v. The Bottom Line..............................................53 2. “Kick Ass” on Neuropathic Pain.....................................53 i. Publication Strategy ..........................................54 ii. Direct Marketing and Sponsorship of CMEs.....................58 iii. Detailing Doctors.............................................59 iv. The Bottom Line..............................................59 3. Migraine...........................................................59 i. Publication Strategy ..........................................59 ii. Sponsorship of CME Events....................................61 4. Nociceptive Pain....................................................61 5. Doses Greater than 1800 mg/day......................................62 E. Kaiser’s Reliance on Pfizer’s Misrepresentations..........................63 F. Kaiser’s DUAT and DRUG Campaigns ...................................66 G. Injury/Damages........................................................67 H. Neurontin’s Efficacy for Off-Label Conditions ...........................70 1.Bipolar Disorder....................................................71 i. Pande Trial...................................................71 ii. Frye Trial....................................................71 iii. Guille Trial...................................................72 iv. Vieta Trial ...................................................72 v. Mokhber Trial................................................72 2. Neuropathic Pain...................................................74 i. Gorson Trial..................................................74 ii. Backonja Trial................................................74 iii. Reckless Trial ................................................75 iv. POPP Trial...................................................75 v. Tamez-Pérez Trial............................................75 vi. Morello Trial.................................................75 vii. Serpell Trial..................................................76 viii. Bone Trial....................................................76 ix. Tai Trial .....................................................76 x. Levondoglu Trial..............................................76 xi. Van de Vusse Trial............................................76 xii. Parsons Trial.................................................76 3. Migraine...........................................................79 i. Trial 879-200..................................................79 ii. Trial 945-217..................................................80 iii. Mathew Trial.................................................80 iv. Di Trapani Trial ..............................................80 4. Doses Greater than 1800 mg/day......................................80 III. CONCLUSIONS OF LAW...................................................81 A. Fraudulent Business Acts or Practices...................................81 B. Pfizer’s Legal Defenses.................................................83 1. Standing...........................................................83 2. Statute of Limitations ..............................................83 i. Tolling Under American Pipe ..................................83 ii. The Discovery Rule............................................84 3. Prescriptions Written Outside California.............................87 4. Causation..........................................................88 i. Reliance by DIS and P & T Committees.........................89 ii. Prescribing Behavior by PMG Physicians.......................91 iii. Quantifying the Fraud.........................................93 C. Restitution............................................................93 IV. ORDER...................................................................94 I. INTRODUCTION Approved by the Food and Drug Administration (FDA) in 1993 as a secondary treatment for epilepsy, Neurontin became one of the top selling drugs in the world. Sales rose from fewer than 50,000 prescriptions in 1995 to more than 1.4 million in 2004. The success of the drug was due to the illegal activities of Parke-Davis, Warner-Lambert and Pfizer, companies that undertook a nationwide effort to unlawfully market this drug for off-label uses for which there was little or no scientific evidence of efficacy. The Food, Drug and Cosmetic Act (FDCA) prohibits such off-label marketing by pharmaceutical companies. See 21 U.S.C. § 355(a). Dubbed “snake oil” by Pfizer’s own sales team, Neurontin was promoted through a publication strategy that suppressed negative clinical trials and showcased positive ones. Pfizer also sponsored continuing medical education programs and detailed doctors to promote off-label uses of the drug. Eventually Warner-Lambert pled guilty to criminal violations of the FDCA and paid civil fines and criminal penalties totaling $430 million. This action, which was independently-filed in the District of Massachusetts, is related to a larger multi-district litigation (MDL) that consolidates for pretrial purposes Neurontin-related civil lawsuits brought nationwide. One group of MDL cases consists of products liability actions claiming that Neurontin caused someone to commit or attempt to commit suicide. Another group of cases involves lawsuits related to the sales and marketing of Neurontin. This case falls within the latter category. Pfizer previously moved for summary judgment in most of the sales and marketing cases. The Court allowed the summary judgment motion as it related to plaintiffs Guardian Life Insurance Company and Aetna, Inc., two other third party payors, because the Court found that these companies had not provided admissible evidence to create disputed fact issues with respect to reliance or causation. See In re Neurontin Mktg. & Sales Practices Litig., 677 F.Supp.2d 479 (D.Mass.2010). Kaiser Foundation Health Plan and Kaiser Foundation Hospitals (collectively, “Kaiser”), bring this case against Pfizer, Inc. and Warner-Lambert Company (collectively, “Pfizer”), alleging violations of the Racketeer Influenced and Corrupt Organizations Act (RICO) and the California Unfair Competition Law (“UCL”). See 18 U.S.C. § 1962(c) (RICO); Cal. Bus. & Prof.Code § 17200(UCL). Kaiser spent about $200 million on Neurontin from 1996 to 2004. After a five-week trial, on March 25, 2010 a federal jury found that Pfizer engaged in a RICO enterprise that committed mail and wire fraud by fraudulently marketing Neurontin for off-label conditions such as bipolar disorder, neuropathic pain, and migraine, and at doses greater than 1800 mg/day. The jury found for defendants with respect to plaintiffs’ claims of fraudulent promotion of Neuron-tin for nociceptive pain. The jury rendered a verdict in plaintiffs’ favor on the remaining claims in the amount of $47,363,092. {See Jury Verdict, Docket No. 2760.) The statute requires the Court to treble the award to $142,089,276. 18 U.S.C. § 1964(c). Now before this Court is the question of whether that same conduct violated the UCL. During a trial that spanned five weeks, the parties presented testimony of twenty-one live witnesses and eighteen witnesses by deposition. The trial involved sixteen expert witnesses and more than 400 admitted exhibits. The Court was impressed with the caliber of most of the expert witnesses for both sides. Kaiser offered testimony from four of its executives, including the chairperson of the Southern California Pharmacy and Therapeutics Committee and the chairperson of Kaiser’s Drug Information Service. Remarkably, Pfizer did not offer live testimony from any officer or employee, nor was any Pfizer representative present during the trial. After a review of all the evidence, the Court orders entry of judgment in favor of Kaiser on its UCL claim, and finds as follows: 1. Kaiser has proven that Pfizer fraudulently marketed Neurontin by making material misrepresentations in advertising supplements, articles it sponsored, and direct communications to Kaiser. 2. Kaiser has proven that Pfizer fraudulently marketed Neurontin by showcasing positive information about Neurontin’s efficacy in the published literature, while suppressing negative evidence from Pfizer-sponsored clinical trials about Neurontin’s efficacy for bipolar disorder, neuropathic pain, migraine, and at doses greater than 1800 mg/day. 3. Kaiser has proven that there is little or no scientifically accepted evidence that Neurontin is effective for the treatment of bipolar disorder, neuropathic pain, nociceptive pain, migraine, or doses greater than 1800 mg/day. 4. Kaiser has proven that Pfizer’s conduct caused it injury in the form of reimbursements for Neurontin prescriptions in excess of payments for alternative prescriptions that would have been made for more or equally effective, but less expensive medicines, in the absence of Pfizer’s fraudulent marketing campaign. Kaiser is entitled to restitution in the amount of $95,286,518 in excess payments. II. FINDINGS OF FACT A. Kaiser Foundation Health Plan and Kaiser Foundation Hospitals 1. Kaiser’s Proactive Drug Management Kaiser is one of the largest health maintenance organizations in the United States and is a non-profit healthcare provider. (Trial Tr. vol. 5, 82, 92, Feb. 26, 2010.) It is composed of two separate corporations: the Kaiser Foundation Health Plan and the Kaiser Foundation Hospitals. The health plan provides medical insurance to approximately 8.6 million members located in nine states. Seventy-six percent of its members are located in California. (Id. at 82-83.) The health plan is organized into eight regions, each of which has its own Pharmacy and Therapeutics (“P & T”) Committee that determines which drugs to place on a formulary, a list of medications approved for prescription by treating physicians. In terms of corporate structure, each of the eight regional Kaiser entities is a separate corporation, and Kaiser Health Plan is the parent corporation of each. The Kaiser hospitals provide facilities at which health plan members receive medical care. The hospitals also have in-house pharmacies where health plan members may fill prescriptions. Neither the Kaiser hospitals nor the Kaiser health plan directly employs physicians to treat health plan members. Kaiser contracts for medical services from the regional Permanente Medical Groups (“PMG”). (Trial Tr. vol. 5, 92-93; Trial Tr. vol. 8, 99, Mar. 3, 2010.) PMG physicians work closely with Kaiser not only in providing treatment for members, but also in developing the drug formulary. PMG physicians sit as members on the P & T Committees and are permitted to submit requests to the P & T Committee regarding additions or changes to a drug’s formulary status. Kaiser takes a proactive approach to managing drugs prescribed by PMG physicians. The organization utilizes its centralized Drug Information Service (“DIS”) to research drugs and disseminate information about those drugs to physicians and to the P & T Committees. DIS is part of Kaiser Hospitals, and supports both Kaiser Hospitals and Kaiser Health Plan. The DIS chairperson is a nonvoting member of the Northern and Southern California regional P & T Committees. DIS pharmacists regularly prepare monographs on new drugs or drugs for which there are emerging uses. These monographs summarize the best available evidence on the drug’s safety and efficacy and provide recommendations on appropriate usage of the drug. DIS searches for publicly available evidence and requests unpublished information from pharmaceutical manufacturers. (Trial Tr. vol. 9, 46-47, Mar. 4, 2010; Trial Tr. vol. 10, 80-81, Mar. 5, 2010.) In making formulary decisions, P & T Committees rely heavily on DIS’s monographs. (Trial Tr. vol. 12, 93-94, Mar. 9, 2010.) Monographs are shared with all other Kaiser regions during monthly teleconferences with formulary personnel, chaired by the head of DIS. (Trial Tr. vol. 5, 110.) Information is also shared at regular interregional P & T Committee meetings. (Trial Tr. vol. 12, 93.) In addition, DIS maintains an inquiry service that responds to direct inquiries from PMG physicians. DIS regularly contacts pharmaceutical manufacturers when researching inquiries about drugs. (Trial Tr. vol. 9, 89-90.) As previously mentioned, Kaiser utilizes a drug formulary, which is essentially a list of medications approved by the P & T Committees to be prescribed to members for certain medical indications. Drugs on the formulary are either listed without restrictions, with restrictions, or with guidelines. If a drug is listed without restrictions, physicians may prescribe the drug to a patient for any indication they believe is appropriate. If a drug is listed with restrictions, prescribing may be limited to a group of physicians, such as neurologists or psychiatrists. If a drug is listed with guidelines, then any physician may prescribe the drug, but guidelines for appropriate prescribing in terms of indication or alternative treatments are included in the formulary. In order' to make a change to the formulary or add a new drug, PMG physicians or individual P & T Committee members may make a request to the P & T Committee. Once a request is made, DIS prepares a monograph that includes a recommendation for the P & T Committee. (Trial Tr. vol. 9, 46.) The P & T Committee discusses the evidence provided by the monograph, considers any other evidence or information submitted to the committee, and then votes on the proposed additions or changes. Kaiser will pay for off-formulary prescriptions. No prior authorization is required for any prescription. Nonetheless, an internal study found that 95% of prescriptions written by PMG physicians are in compliance with the drug formulary. (Trial Tr. vol. 5, 103-04, 108-09; Trial Exhibit (“TX”) 323 at 41.) 2. Kaiser’s Placement of Neurontin on Formularies After Neurontin was approved by the FDA for epilepsy in 1993, Kaiser added Neurontin to the formularies in all its regions by 1994. In the Southern California region, Neurontin was originally restricted to prescriptions written by neurologists. (Trial Tr. vol. 12, 95.) In September 1997, Kaiser’s Southern California P & T Committee approved a request by its Chiefs of Anesthesiology to allow prescribing of Neurontin by anesthesiologists for the treatment of Reflex Sympathetic Dystrophy, a pain syndrome. , (Trial Tr. vol. 9, 49-51; TX 290 at 6.) In June 1999, the Chiefs of Neurology for the Southern California region recommended removing Neurontin’s prescribing restrictions and adding guidelines for use. The guidelines provided that Neurontin should be reserved for neuropathic pain patients unresponsive to, or intolerant of, tricyclic antidepressants and other treatments. For all indications, the recommendation suggested that the initial prescription should be limited to a one month trial. (TX 557.) The P & T Committee approved the request, despite a large predicted cost impact. (Trial Tr. vol. 9, 61-63, 69-70; Trial Tr. vol. 12, 98-100.) In September 1999, the Southern California P & T Committee voted to remove all remaining formulary restrictions on Neurontin. (TXs 327, 291.) B. Marketing of Neurontin Parke-Davis, the pharmaceutical company that developed the drug Neurontin, is an operating division of Warner-Lambert Company. Warner-Lambert was acquired by the pharmaceutical company Pfizer in 2000. (See, e.g., TX 143.) Pfizer is one of the largest pharmaceutical companies in the world. 1. FDA Approval of Neurontin for Epilepsy Treatment Neurontin was developed throughout the 1980s and early 1990s by Parke-Davis as an anti-epileptic drug (AED). Its generic name is gabapentin. The FDA approved Neurontin as an adjunctive therapy in the treatment of partial seizures in adults with epilepsy on December 30,1993. (TX 9 at 1, 6.) The maximum dose was set at 1800 mg/day. Plaintiffs’ expert, Dr. David Kessler, explained that, before approving a drag for a particular indication, the FDA requires that the manufacturer submit two favorable double-blind randomized controlled trials (“DBRCTs”). (Trial Tr. vol. 2, 30, Feb. 23, 2010.) Parke-Davis fulfilled that requirement with respect to the use of Neurontin as an adjunctive therapy for partial seizures. (Id. at 33.) In 1992, during its “medical statistical review” of Neurontin, the FDA found that certain patients taking Neurontin experienced depressive side effects, presenting safety concerns about the drug. (TX 207 at 117.) The FDA wrote that “less common but more serious [adverse] events may limit the drag’s widespread usefulness,” citing depression with or without suicidal ideation as one of those “more serious” adverse events. (Id.) In fact, as early as 1994, Neurontin’s FDA-approved label included information about depression and “suicide gesture” as adverse events observed during clinical trials. (TX 507 at 2.) Plaintiffs’ expert, Dr. Curt Furberg, testified that the FDA’s review of depressive side effects related to Neurontin suggested that the drag should be used “with caution.” (Trial Tr. vol. 13, 69, Mar. 10, 2010.) Specifically, Dr. Furberg stated that, according to his review of the available data, “there was about a 65 percent increase in risk of depression with the drug compared to placebo, the sugar pill.” (Id. at 71.) He added that “if you see harm in this population of epilepsy [patients], you would expect to see that in the treatment of other conditions.” (Id. at 72.) In his view, the incidence of depressive side effects is relevant to the use and marketing of Neurontin for patients with bipolar disorder because “bipolar disorder includes depression” along with a manic component. (Id. at 73.) In January 2008, the FDA issued an “alert” about eleven AEDs, including Neurontin, that warned physicians to “[b]e aware of the possibility of the emergence or worsening of depression, suicidality, or any unusual changes in behavior.” (Trial Tr. vol. 18, 82.) 2. The “Strategic Swerve” to Maximize Neurontin Profits for Off-Label Indications In 1994, Parke-Davis estimated that Neurontin would generate $500 million in profits over the duration of its patent. (TX 29.) In a memorandum circulated within Parke-Davis, one executive suggested a “strategic swerve” to increase the earning potential of Neurontin. (Id.) Some of the strategies explored included marketing the drug for epilepsy monotherapy, bipolar disorder and social phobia, and neuropathic pain. (See TXs 4, 7.) Defendants adopted these new strategies, which turned out to be stunningly successful: in 2003 alone, Neurontin sales exceeded $2 billion. (TX 111 at 5.) Beginning in 1995, Parke-Davis began developing strategies to market Neurontin for off-label conditions, that is, conditions not included on the official label approved by the FDA. The company was interested in Neurontin’s potential psychiatric uses, despite the uncertainty about its efficacy in treating bipolar disorder. In a cover letter attached to Parke-Davis’s 1995 bipolar marketing assessment for Neurontin, Oliver Brandicourt, a Parke-Davis employee, wrote that “[t]he results [of bipolar trials], if positive, will be publicized in medical congresses and published in peer-reviewed journals, but there is no intention to fully develop these indications at this point.” (TX 4 at 20559; see also Trial Tr. vol. 5, 21.) The assessment also included a “Recommendation” section that stated: “[D]ue to the lack of scientific rationale, since Neurontin has a different mechanism of action than the mood-stabilizing antiepileptics, it is recommended to implement only an exploratory study in outpatients with bipolar disorders with the results highlighted through a peer-reviewed publication.” (TX 4 at 20564.) The marketing team forecasted that a publication strategy for bipolar disorder would generate an additional $20 to $30 million in annual sales by 1999. (Id. at 20578.) The company also developed marketing assessments for various pain conditions, including neuropathic pain. In September 1995, Parke-Davis sponsored a consultants’ meeting where they discussed marketing options for Neurontin if it were found to be “analgesic” or pain-relieving. (TX 31 at 7; Trial Tr. vol. 6, 31.) Options discussed included sponsorship of a booth at the 1996 meeting of the American Pain Society, conferences and symposia with invited physicians, continuing medical education (“CME”) events, and sponsorship of “publications of seeding trials” to create “[a] drumbeat in the literature.” (TX 31 at 7.) The 1995 Neurontin marketing assessment for neuropathic pain forecast potential annual sales of an additional $20 to $25 million by 1999 if a marketing strategy was adopted for neuropathic pain. (TX 7 at 15.) 3. Efforts to Expand On-Label Uses Fail at the FDA Meanwhile, efforts to expand “on-label” uses of Neurontin hit a brick wall. In 1996, Parke-Davis submitted a supplemental new drug application to the FDA, seeking approval of Neurontin as a monotherapy for the treatment of seizures and requesting an increase of the effective dose range to include 3600 mg/day and the maximum recommended dose range to 4800 mg/day. (TX 91; Trial Tr. vol. 2, 37-38.) However, the FDA did not approve either of these changes, stating that “[t]he evidence from controlled trials fails to provide evidence that higher doses of Neurontin are more effective than those recommended.” (TX 91 at 3.) 4. The Two Marketing Partnerships Throughout the time period at issue in this case, 1995-2004, defendants engaged in two partnerships to further their goal of marketing Neurontin for off-label indications such as bipolar disorder, neuropathic pain, and migraine, and at doses greater than 1800 mg/day. The first such venture began in 1995 and involved a partnership between Parke-Davis and a healthcare advertising agency called Cline Davis Mann (CDM). CDM joined Parke-Davis’s internal Extended Neurontin Disease Team, an interdisciplinary team that had primary oversight over the marketing of Neurontin. (Knoop Dep. Tr., 231-32, 235 (played Mar. 11, 2010).) Between June 1995 and June 2000, CDM prepared marketing strategy proposals for Neurontin and then devised tactics to implement those strategies, including Parke-Davis’s strategy to “Expand Emerging Uses.” (See, e.g., TXs 17, 44, 75.) After Pfizer acquired Parke-Davis in 2000, it implemented a “publications strategy” to ensure the placement of key messages relating to off-label uses of Neuron-tin in medical journals. (TX 138 at 62.) In order to implement this strategy, Pfizer engaged in a second venture that involved a partnership with Medical Action Communications (MAC). The MAC partnership began in 2001 and ended in 2004. MAC and Pfizer worked together through the joint Publications Subcommittee, which developed “key messages” to be used in publications. (TX 136.) These key messages focused on the claim that Neurontin was effective for off-label uses such as bipolar disorder, neuropathic pain, migraine, and high doses. (TX 210.) These key messages were disseminated throughout the medical community through the sponsorship of CME seminars and journal publications. (TX 259 at 11617.) MAC also helped Pfizer spin, delay and/or suppress negative evidence about Neurontin. For example, MAC took the position that the negative Reckless study, discussed infra, which showed that Neurontin was not effective for neuropathic pain, should not be “pushed for publication.” (TX 136 at 4.) This plan was followed, and as will be seen, the negative Reckless study was suppressed in the medical literature. Dr. Kay Dickersin, an expert in clinical trial design from Johns Hopkins University and the director of the U.S. Cochrane Group, gave a particularly helpful overview of defendants’ use of scholarly publications as a tool to provide misleading information about Neurontin to physicians. (Trial Tr. vol. 4,14-119, Feb. 25, 2010.) Dr. Dickersin reviewed defendants’ research study protocols, research reports, internal emails and documents, and publications, when available. (Id. at 23-24.) Dr. Dickersin found that “what was in the published record didn’t agree with what was actually planned or what had been done” and that there was a “failure to publish results that were known.” (Id. at 24.) She reviewed twenty-one trials sponsored by the defendants, and found that each and every trial exhibited “some form of bias or deviation from the truth.” (Id. at 38.) Dr. Dickersin’s testimony was credible and compelling. The failure to publish results was a particular concern in this case, because, as Dr. Dickersin testified, defendants’ marketing assessments for pain, migraine, and bipolar indicated that results of clinical trials would only be published “if positive.” (Trial Tr. vol. 4, 36-37; TX 4 at 20559; TX 216 at 1586.) She explained that doctors who practice “evidence-based medicine,” or make diagnoses and give treatments based on evidence from research, rely on published studies in medical and scientific journals because they do not have access to unpublished research reports. (Trial Tr. vol. 4, 26-27.) Therefore, if doctors do not have access to negative reports that are unpublished, they may prescribe a drug without being fully informed of the available evidence. (Id.) Aside from the problem of unpublished trials, Dr. Dickersin explained a concept called “publication bias,” which is “a failure to publish related to the direction and the strength of the results that you get in a study.” (Id. at 30-31.) One type of publication bias is “selective outcome reporting.” In designing a trial protocol, an investigator defines one primary outcome to be studied in the trial (e.g. change in median pain score after seven weeks). She also defines several secondary outcomes, or measures that she is interested in but that are not as important as the primary outcome. If the results of the study are negative for the primary outcome, but positive for one of the secondary outcomes, the investigator might publish an article that describes a previously-defined secondary outcome as the primary outcome studied. (Id. at 32-33.) This “selective outcome reporting” is viewed as problematic within the scientific community. According to Dr. Dickersin, scientists should not “cherry-pick” outcomes that support their other interests, whether academic or financial, because it increases the likelihood that the results are not accurate if they are chosen after the study has been completed. (Id. at 33-34.) Another type of publication bias described by Dr. Dickersin is “location bias” or “gray literature bias” where a company publishes a negative trial in a journal that has a smaller circulation than more well-known medical journals. (Id. at 35.) Pfizer also engaged in this type of publication bias. These efforts to market Neurontin for unapproved uses were incredibly successful. Before Pfizer acquired Parke-Davis, a Pfizer employee sent an internal email referring to Neurontin as “the ‘snake oil’ of the twentieth century.” (TX 479.) As the following chart illustrates, Neurontin use for epilepsy was largely static throughout the relevant time period, while off-label use skyrocketed. (TX 405-B). By the time Pfizer acquired Parke-Davis, Pfizer estimated that 87.5% of Neurontin prescriptions were for non-epilepsy indications, including 14.7% for bipolar disorder, 33% for neuropathic pain, and 3.8% for migraine. (TX 143 at 1170.) 5. Use of Medical Liaisons for Off-Label Marketing Dr. David Franklin, the whistleblower in the initial Neurontin litigation in 1996, testified about the direct marketing of Neurontin to physicians for off-label uses. Dr. Franklin was hired in 1996 as a medical liaison for Parke-Davis. As part of his job he was provided training on off-label marketing of Neurontin. (Trial Tr. vol. 15, 35, Mar. 12, 2010 (“[I]t was our job to ... actually talk to physicians and sell Neuron-tin for off-label indications.”).) His job was “99 percent focused on off-label promotion.” (Id. at 43.) Soon after Dr. Franklin was hired in 1996, he attended a national training for all Parke-Davis medical liaisons in Ann Arbor, Michigan. (Id. at 36.) During one session of the training meeting, two attorneys gave a presentation on FDA regulations related to off-label promotion. (Id. at 37-40.) This session was videotaped. (Id. at 38.) While the camera was recording, the two attorneys explained the FDA’s rules regarding off-label promotion of drugs, although they stated their belief that these were “odd” rules. (Id.) Dr. Franklin was surprised by this presentation because “[i]t couldn’t have been any more different” from what he had been doing in the field as a Parke-Davis medical liaison. (Id. at 41.) After this segment of the presentation on compliance with FDA rules, the two attorneys turned off the video camera and explained that the medical liaisons should not worry about these FDA regulations. They told the audience of medical liaisons “that it was ... our job to sell” and “that we needed to dismiss what [was] just said and just be very careful ... about how we went about doing [off-label marketing].” (Id. at 41-42.) During another presentation given at the Ann Arbor training in 1996, a ParkeDavis employee named Sandra Pace handed out two notepads with the text “Ladies and Gentlemen of the Jury” and “Your Honor, I plead.” (Id. at 43-44.) She explained that these notepads were meant to emphasize the “importance of not creating a paper trail.” (Id.) Once Dr. Franklin became concerned that his activities as a medical liaison for Parke-Davis were violating the law, he recorded several phone conversations that were played in court. In one voicemail message recorded on May 23, 1996 from Parke-Davis employee Phil Magistro to all medical liaisons, Mr. Magistro said So what we need to do is focus on Neurontin. When we get out there, we want to kick some ass, we want to sell Neurontin on pain. And monotherapy and everything that we can talk about, that’s what we want to do. ‘Cause, I’m embarrassed. I don’t know if you guys are embarrassed, but I’m embarrassed with where we are with Neurontin. (TX 105 at 1-3.) After working for the company for four months, Dr. Franklin consulted an attorney and ultimately filed a qui tam, or whistleblower, action under the False Claims Act with this Court, alleging that Parke-Davis was illegally promoting Neurontin for off-label indications. See United States ex rel. Franklin v. Parke-Davis, 147 F.Supp.2d 39 (D.Mass.2001); see also Trial Tr. vol. 15, 60-61. The case was sealed until January 2000. Ultimately, Dr. Franklin received a Relator’s share as a result of the litigation in the amount of $24,640,000. 6. Investigation by the FDA In July 1996, the FDA advised ParkeDavis that it was investigating the company’s off-label promotion of Neurontin for chronic pain, bipolar disorder, and other indications. The FDA sought particular information from Parke-Davis concerning the company’s financial relationship with certain doctors, including Dr. Gary Mel-lick, a paid Parke-Davis consultant who submitted a letter to the editor of a medical journal stating that Neurontin was effective in the treatment of Reflex Sympathetic Dystrophy. (TX 87; Trial Tr. vol. 2, 55-58.) Despite this warning, ParkeDavis continued its off-label marketing campaign. 7. FDA Rejection of Neurontin for Neuropathic Pain and Approval for Post-Herpetic Neuralgia (PHN) In 2001, Pfizer (which had by then acquired Parke-Davis) attended a meeting with the FDA, during which the company discussed its planned submission of a supplemental New Drug Application (“NDA”) seeking approval of Neurontin for the broad indication of neuropathic pain. During this meeting, the FDA stated: The general neuropathic pain indication cannot be granted for Neurontin based on the clinical trials in painful diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). These two conditions are distinct, pathophysiological states and, therefore, will be treated as two indications. In order for a general neuropathic indication to be granted, the sponsor must provide evidence that the underlying disease process is similar for DPN, PHN, and the pain of other neuropathic disorders and/or that the drug is effective for the neuropathic pain of all (or at least most) etiologies. (TX 200 at 4.) In addition, the FDA gave Pfizer specific feedback about the use of Neurontin for the treatment of diabetic peripheral neuropathy: “The sponsor must provide evidence of efficacy replicated in a second study for DPN. This trial must be 12 weeks in length at fixed doses, as required for a chronically administered drug.” (Id.) Pfizer filed a supplemental NDA for a broad neuropathic pain indication, but later withdrew that application. (Trial Tr. vol. 2, 46.) After Pfizer met with the FDA to discuss a broad neuropathic pain indication in May 2001, it convened a meeting with a group of outside, non-FDA experts at the Crowne Plaza Hotel in Ann Arbor, Michigan. (Trial Tr. vol. 2, 44.) These experts concluded that the “preclinieal and clinical data to date is that the evidence is not convincing to support a broad neuropathic pain claim.... New analyses/data not only do not support the broad claim, they provide evidence contrary to a broad indication.” (TX 173 at 1.) One expert said, ‘You’re done.” (Id. at 2.) In August 2001, Pfizer filed another supplemental NDA seeking approval of Neurontin specifically for the treatment of post-herpetic neuralgia. (TX 195.) In addition, Pfizer sought approval for doses above 1800 mg/day. (Trial Tr. vol. 2, 48.) In May 2002, the FDA approved Neuron-tin for the treatment of PHN, a type of neuropathic pain associated with shingles, in adults. (TX 195.) However, the FDA did not approve the use of doses greater than 1800 mg/day, finding that there was no evidence of increased efficacy at higher doses. (Id. at 31; Trial Tr. vol. 2, 48.) The FDA required that the Neurontin label include the phrase “[ajdditional benefit of using doses greater than 1800 was not demonstrated.” (TX 195 at 32.) 8. Warner-Lambert Guilty Plea On May 13, 2004 the Department of Justice filed a criminal information charging Warner-Lambert with illegal off-label promotion of Neurontin. (TX 366.) The same day, Pfizer caused Warner-Lambert (which it owned) to plead guilty to two felony counts of marketing Neurontin for various unapproved uses, including painful diabetic neuropathy, bipolar disorder, reflex sympathetic dystrophy (RSD), and migraine headaches. (TX 371 ¶ 1 (stating that ‘Warner-Lambert expressly and unequivocally admits that it committed the crimes charged in the Information. Warner-Lambert agrees that the facts set forth in the Information are true.”).) As a result of its guilty plea, Warner-Lambert agreed to pay a $240 million criminal fine. (Id.) The guilty plea included an admission that the company promoted the sale and use of Neurontin for the off-label indications of neuropathic pain, bipolar disorder, and migraine through the use of sales representatives, medical liaisons, advisory board meetings, consultants meetings, and teleconferences. (TX 366 ¶¶ 9, 20-22, 23-24, 25-32, 33-36.) In addition to the $240 million criminal fine, Pfizer paid an additional $190 million in civil fines to the government. (Trial Tr. vol. 15, 75.) A year after the guilty plea was entered, Kaiser brought this lawsuit against Pfizer in the District of Massachusetts. C. Target: Kaiser As early as 1994, Parke-Davis identified Kaiser as a potentially lucrative target for its marketing campaign. The marketing team listed Kaiser Health Plans second on its list of “Top 10 HMOs Targeted for Neurontin” in 1994. (TX 90 at 11.) Defendants’ focus on Kaiser continued throughout the relevant period. For example, in 2004 Pfizer developed an “Operating Plan” specifically for marketing to Kaiser. (TX 250.) This plan listed the following Kaiser-specific marketing strategies for Neurontin: (1) “[ijdentify and build relationship [sic] with the P & T members;” (2) “[p]rovide clinical and outcomes information to the Drug Information Coordinators on a regular basis;” (3) “develop relationships with [P & T members] who are not considered ‘whistle blowers;’ ” (4) “maintain and improve the existing relationships and develop new relationships with physicians, Drug Education Coordinators (DECs), Drug Information, Kaiser research entities and brokers;” and (5) “support and attend the Kaiser conferences.” {Id. at 25, 26, 29.) Pfizer had significant contacts with PMG physicians, not only through detailing but also through the employment of PMG doctors to serve on speakers’ bureaus and publish articles. According to Dr. Ambrose Carrejo, the pharmaceutical contracting leader for Kaiser, Pfizer detailed PMG physicians and drug information specialists about Neurontin throughout the relevant time period. (Trial Tr. vol. 5, 97-98.) It also recruited and paid prominent PMG physicians to serve on its Neurontin speakers’ bureau. (Trial Tr. vol. 8,120-22; TXs 276, 278, 279.) For example, Dr. William McCarberg, a PMG pain specialist, worked for Pfizer as a “pain mentor” and a Neurontin speaker. (TXs 276, 279.) He also reached out to Pfizer while writing an article with another PMG author to request information that would help dissuade his co-author from writing about “the overuse of Neurontin for questionable pain conditions.” (TX 278.) In the final article, published in American Family Physician in February 2005, Dr. McCarberg and his co-author cast Neurontin in a positive light with respect to pain conditions and did not disclose that Dr. McCarberg used information from the company while developing the article. (TX 795.) D. The Marketing Fraud Defendants conducted marketing largely through three tactics: direct marketing to physicians, publication of positive Neurontin articles in medical journals and suppression of negative trials, and the sponsorship of CME events attended by physicians. The Court finds that fraudulent marketing activities took place during the following time periods for each indication: (1) bipolar disorder: July 1998 through December 2004; (2) neuropathic pain: November 1997 through December 2004; (3) migraine: April 1999 through December 2004; and (4) doses greater than 1800 mg/day: November 1997 through December 2004. 1. Bipolar Disorder To backtrack, Parke-Davis’s internal documents suggest an initial reluctance among its marketing team to pursue a bipolar indication. In 1995 the company’s internal recommendation stated: “[D]ue to the lack of scientific rationale, since Neurontin has a different mechanism of action than the mood-stabilizing antiepileptics, it is recommended to implement only an exploratory study in outpatients with bipolar disorders with the results highlighted through a peer-reviewed publication.” (TX 4 at 20564.) Pfizer conducted numerous scientific studies, none of which provided evidence that Neurontin was effective for treating bipolar disorder. I briefly describe these studies, which will be reviewed in greater depth later in the opinion, before addressing defendants’ marketing activities with respect to bipolar disorder. The first DBRCT to examine Neuron-tin’s efficacy in the treatment of bipolar disorder was the Pande trial, conducted from March 1996 through July 1997, by Dr. Atul Pande, a Parke-Davis employee. (Trial Tr. vol. 4, 128; TX 383 at 1.) The results of the Pande trial showed that the placebo outperformed Neurontin in treating patients with bipolar disorder. ParkeDavis was aware of these results as early as July 1998. (Trial Tr. vol. 4, 130-31; TX 383 at 1, 8.) The Frye trial was an independent DBRCT conducted between 1997 and 1999 that compared Neurontin to the drug Lamotrigine and placebo in the treatment of refractory, or difficult to treat, bipolar disorder. (Trial Tr. vol. 4, 132-33; TX 1477.) The Frye trial found that Lamotrigine outperformed both Neurontin and placebo, and that there was no statistically significant difference between Neurontin and placebo. (TX 1477 at 610-11.) Interim results of the study were presented at the American Psychiatric Association meeting as early as 1997, and the final results of the study were published in the Journal of Clinical Psychopharmacology in 2000. (Id. at 607.) The Guille trial was also a DBRCT that compared Neurontin to placebo in treating refractory bipolar disorder. (TX 211 at 63.) The trial investigators found no significant difference between Neurontin and placebo for treatment of bipolar disorder, and presented their results at the 1999 annual meeting of the American Psychiatric Association. (Id.; TX 1335.) The Vieta trial was a DBRCT funded by defendants that compared Neurontin to placebo. It was completed in February 2004. (TX 398.) The Vieta trial showed no difference between Neurontin and placebo in the “intention-to-treat” (ITT) population, meaning the entire population of study participants who were included in the trial. (Trial Tr. vol. 4, 138-40; TX 398 at 4.) However, the study investigators did find a statistically significant difference between Neurontin and placebo in the “per protocol” (PP) subpopulation, or those patients who were healthier and more compliant than others in the group. (Trial Tr. vol. 4, 138-40.) Finally, the Mokhber trial was a Pfizer study, published in 2008, that compared Neurontin to Lamotrigine and Tegretol in the treatment of dysphoric mania, which is a state of bipolar disorder in which a patient presents both manic and depressive symptoms. (TX 2004 at 227.) The Mokhber trial showed improvements in both mania and depressive symptoms by those patients taking gabapentin, but there was no placebo group used to control the study. (Id. at 227; Trial Tr. vol. 18, 112-16, Mar. 19, 2010.) (i) Direct Marketing to Physicians Despite the fact that the scientific evidence just described did not support the use of Neurontin for the treatment of bipolar disorder, defendants nonetheless marketed the drug for that indication. As early as April 1996, Parke-Davis medical liaisons were trained to tell physicians that Neurontin was “highly effective” for bipolar disorder, and they failed to disclose both that there was no scientific support for that indication and that the FDA had found an associated increased risk of suicide and depression for Neurontin patients. (Trial Tr. vol. 15, 55-56.) Dr. Franklin, for example, was trained to talk to physicians about Neurontin’s supposed effectiveness in treating bipolar disorder: For depression, what I was trained to do was explain to physicians that 50 percent of people initially described or diagnosed with depression were actually bipolar. And so that even their patients who were diagnosed with depression, they — they needed to consider Neuron-tin for those patients also for the effectiveness in bipolar. (Id. at 55.) While Pfizer protests that Dr. Franklin worked only in the northeast region, his testimony described a national program for medical liaisons. His testimony, particularly about his training at a national conference, supports the reasonable inference that the same strategy of direct marketing was being employed nationwide. (ii) Publication Strategy In addition to directly detailing doctors at their offices, defendants also pursued a publication strategy to create a buzz about the use of Neurontin for bipolar disorder. An article co-authored by a group of physicians, pharmacists, and researchers, published in the Journal of Psychiatric Practice in March 2008, explained that the extensive use of Neurontin in bipolar disorder was due to widespread positive reports in journals that created an “echo chamber” effect: The large number of case series and case reports reported encouraging results that were not confirmed by the later small randomized trials. The number of reports and their distribution in a number of journals created a type of “echo chamber” effect, through which the sheer number of publications and citations may have given legitimacy to the practice of using gabapentin for bipolar disorder. (TX 1995 at 19-20.) In February 1996, three members of Parke-Davis’s department of Central Nervous System Clinical Research and Development published an article entitled “Effect of Gabapentin (Neurontonin® [sic ]) on Mood and Well-Being in Patients with Epilepsy” in the journal Progress in Neuro-Psychopharmacology and Biological Psychiatry (“Dimond Article”). (TX 1158; Trial Tr. vol. 13, 73-75.) The Dimond Article examined the same five epilepsy trials that the FDA had examined in its 1992 medical statistical review, and claimed that Neurontin had beneficial effects on mood. However, the authors failed to reference the FDA’s findings that Neurontin increased the risk of depression with or without suicidal ideation. (TX 1158; Trial Tr. vol. 13, 73-76; Trial Tr. vol. 16,146-48, Mar. 15, 2010.) In 1998, Parke-Davis sponsored the publication of a supplement to the Cleveland Clinic Journal of Medicine that reported the results of a symposium held July 24, 1998. The supplement, titled “New Treatment Strategies in Psychiatry: Role of Anticonvulsants,” discusses several case reports indicating that Neurontin is effective for the treatment of bipolar disorder and concludes that “[t]he data presented here indicate that gabapentin holds promise for treatment of bipolar disorder.” (TX 110 at SI — 11.) However, at the time the supplement was published in the fall of 1998, Parke-Davis was aware of the negative results of the Pande trial, which found that Neurontin was worse than a placebo for the treatment of bipolar disorder. The negative Pande trial results, disclosed to investigators on July 28, 1998, were not included in the supplement. (Trial Tr. vol. 5,25.) The supplement, which was distributed to 43,000 psychiatrists, purported to gather the available evidence about the use of Neurontin in the treatment of bipolar disorder. I find that this supplement was intentionally misleading by only publishing half-truths. The next year, an article written by Parke-Davis employee Leslie Magnus was published in a supplement to the journal Epilepsia. This article discussed several case studies, case series, and even a single-patient ease report, but did not disclose the negative results of the Pande trial. (TX 2079 at S68-S69; Trial Tr. vol. 5, 26-27.) At this point, Pfizer likely knew about the Frye study as well. The article, published in 1999, concluded that [gjabapentin, a novel AED, has a unique mechanism of action. Its favorable safety profile and lack of drug interactions make it an attractive alternative for use in a wide array of neurologic and psychiatric conditions. The usefulness of gabapentin has been demonstrated in neuropathic pain syndromes, bipolar disorder, movement disorders, migraine prophylaxis, and cocaine dependence. (TX 2079 at S71.) The circulation was to 5,000 physicians. (Trial Tr. vol. 5, 27.) Similar to the Cleveland Clinic supplement, this article was intentionally misleading and is factually untrue in light of the Frye and Pande studies. Also in 1999, Dr. Atul Pande, a ParkeDavis employee and the lead author of the negative bipolar DBRCT completed in 1998, published an article in the Journal of Clinical Psychopharmacology entitled “Treatment of Social Phobia with Gabapentin: A Placebo-Controlled Study.” This article stated that “[i]n clinical studies of patients with epilepsy, gabapentin produced improvements in mood and general well-being.” (TX 1324 at 342.) The footnote supporting that statement does not mention the negative results of Dr. Pande’s earlier DBRCT, completed the year before this article was published, in which a placebo outperformed Neurontin in the treatment of bipolar disorder. (TX 1324 at 347; Trial Tr. vol. 5, 28-29.) Dr. Pande’s article on social phobia was distributed by Parke-Davis to 25,150 psychiatrists. In addition, 125,850 copies of the article were printed and given to sales representatives, who visited psychiatrists and distributed the article in person. (Trial Tr. vol. 5, 29-30.) Pfizer’s failure to disclose the results of Dr. Pande’s other study (as well as the results of the Frye and Guille studies) to these psychiatrists constitutes a fraudulent half-truth. Moreover, despite publishing the positive social phobia study by Dr. Pande in 1999, defendants suppressed the negative results of Dr. Pande’s original bipolar study in 1998, completed in 1997, until October 2000, when the study was published in the journal Bipolar Disorders, a “fairly narrow” and “small journal” with a circulation of only 455 physicians. (TX 1393; Trial Tr. vol. 4, 131-32.) The article blamed the negative results of the study on poor study design and failed to cite the negative results of two other Parke-Davis DBRCTs conducted by Drs. Frye and Guille, which were sponsored by defendants and the results of which were available at the time of publication. This placement of the negative Pande article in a small, lesser-known journal is an example of “location bias” as described by Dr. Dickersin. To sum up, Parke-Davis sponsored two publications that contained intentional misrepresentations about the efficacy of Neurontin for the treatment of bipolar disorder: the Cleveland Clinic supplement in 1998 and the Epilepsia supplement in 1999. In addition, it detailed psychiatrists to sell Neurontin for bipolar without disclosing to doctors the information about the negative clinical studies. Finally, it suppressed the negative Pande study for three years, and completely suppressed the negative Guille and Frye studies. (iii) Sponsorship of Continuing Medical Education (CME) Defendants funded the development of several CME events attended by large numbers of psychiatrists and other physicians. In 1998, Parke-Davis sponsored a CME titled “New Frontiers in Social Phobia and Bipolar Disorders” that was attended by 5,645 physicians in thirty cities, including Los Angeles, San Diego, and San Francisco. (TX 360.) Thirty-three PMG physicians from four different Kaiser regions attended this CME. (TXs 360, 923.) Later that year, on November 21, 1998, Pfizer sponsored another CME called “New Options in Bipolar Disorder.” During that conference, attendees were shown a slide that indicated Neurontin was an effective add-on treatment for bipolar disorder, citing a study by Dr. Trevor Young that was completed in 1997. (Trial Tr. vol. 2, 116-18.) However, the slide did not indicate that the Young study was sponsored by Pfizer, only included 15 people, and was not a randomized controlled trial but rather an open-label study. (Id. at 116, 119; TX 1197.) Nor did the slide indicate that the Pande study, the results of which were disclosed to investigators in July 1998, found that Neurontin was “significantly inferior to a sugar pill.” (Trial Tr. vol. 2, 116.) As this CME purported to provide information from various sources about the use of Neurontin in treating bipolar disorder, the slide constitutes an intentional misrepresentation. In 1999, Parke-Davis sponsored a CME event titled “New Frontiers in Anxiety, Substance Abuse and Bipolar Disorders” that was presented to 8,500 doctors, predominantly psychiatrists, across the country. (TX 63 at 3; Trial Tr. vol. 5, 31.) The slides prepared for the bipolar disorder segment of this CME include a slide titled “Gabapentin: Advantages and Disadvantages” that lists “reports and open-label data suggesting efficacy” as an advantage and “need for controlled studies” as a disadvantage. (TX 63 at 42.) Nowhere in the slide deck is the negative Pande or Frye trial for bipolar disorder mentioned. (Id.; Trial Tr. vol. 5, 31-32.) In addition, the materials for this CME recommend a dosing range of 900-3600 mg per day (sometimes higher) for gabapentin, which exceeds the maximum dose on the FDA label of 1800 mg/day. (TX 63 at 42.) In fact, in 1996 the FDA rejected Parke-Davis’s request to increase the maximum dose due to a lack of evidence of increased efficacy. The information presented at this CME involved fraudulent half-truths. In June 2000, Pfizer prepared an internal strategy document titled “Neurontin: 2001 Situation Analysis” that stated the following: “Currently bipolar disorder represents over half of all psychiatric drug uses for Neurontin.... The increased use comes despite the results of the “Gabapentin in Bipolar Disorder” trial (945-209) [Pande] which showed no significant improvement when compared to placebo.” (TX 213 at 19-20.) Despite the company’s express acknowledgment of the negative trial results, the same document contains a Neurontin marketing plan for psychiatry that includes meetings and symposia at gatherings of the American Psychiatric Association and other organizations, half-day courses on anxiety and bipolar disorders, dinner meetings, and publications. (Id. at 28-29.) The document also states that “Parke-Davis plans to continue to support educational initiatives in the psychiatric arena that will discuss the broad utility of AEDs in a range of medical conditions such as bipolar disorders, anxiety states and substance abuse (alcohol withdrawal and cocaine treatment).” (Id. at 19.) (iv) Communications with the Cochrane Review In July 2003, Dr. Karine Maeritchie of the Cochrane Review, an internationally recognized review organization, contacted Pfizer about development of a protocol focused on Neurontin for the treatment of bipolar disorder and requested all data “published and unpublished, complete or ongoing, which would meet our inclusion criteria.” (TX 236 at 1.) In response to an internal Pfizer email chain discussing what information to send to the Cochrane Review, Bruce Parsons, a Pfizer employee, wrote “I would not send unpublished Neurontin data to anyone outside Pfizer.” (TX 159 at 1.) After repeated requests for data went unanswered, Cochrane abandoned its plans to complete a protocol on the use of Neurontin for bipolar disorder in April 2007. (Trial Tr. vol. 2, 123-24.) By referring the Cochrane Review researchers to positive, published articles about the use of Neurontin for the treatment of bipolar disorder without disclosing the negative, unpublished trials known to the defendants, Pfizer committed fraud. (v) The Bottom Line Beginning in July 1998 when ParkeDavis obtained (and began to suppress) the negative results of the Pande trial, the defendants engaged in the fraudulent marketing of Neurontin for the treatment of bipolar disorder. In addition to fraudulent detailing, Pfizer sponsored at least two fraudulent supplements, engaged in a fraudulent publication strategy by publishing only positive information and suppressing negative; conducted at least two fraudulent continuing medical education programs; and made a fraudulent misrepresentation, through a half-truth, to the Cochrane Review. 2. “Kick Ass” on Neuropathic Pain Defendants focused a significant portion of their marketing efforts on neuropathic pain because they recognized it as a potentially enormous market for Neurontin. Pfizer conducted numerous scientific studies to analyze the efficacy of Neurontin in the treatment of neuropathic pain. I briefly describe several of the studies that are relevant to the defendants’ marketing strategies before addressing the marketing activities related to neuropathic pain. Again, the Court will revisit these studies in its discussion of the scientific proof of the efficacy of Neurontin. 1. Gorson Trial — Completed in 1997, the Gorson trial was funded by Parke-Davis and showed that Neurontin was no more effective than placebo in the treatment of painful diabetic neuropathy. This study was never published as a full article. 2. Backonja Trial — Also completed in 1997, the Backonja trial was a Parke-Davis study that concluded that Neurontin was effective in the treatment of painful diabetic neuropathy. The Backonja trial was published in JAMA in December 1998. This study involved issues of potential “unblinding” that compromised the integrity of its results. The article falsely stated that it was “the first trial to evaluate gabapentin’s efficacy” for neuropathic pain. (TX 1250 at 1832.) It also omitted any reference to the negative results of the Gorson study. (Id. at 1836.) 3. Reckless Trial — This study, which included three times as many patients as the Backonja study, was a Parke-Davis DBRCT completed in late 1999 that concluded that Neurontin was not effective for the treatment of painful diabetic neuropathy. The Reckless trial was never published. 4. POPP Trial — The POPP trial was sponsored by Pfizer and completed in November 2001. The investigators released their research report in 2003. This study concluded that Neurontin was not effective, on the study’s primary measure, for the treatment of postsurgical or traumatic nerve injury pain. The POPP trial was not published until 2008. 5. Morello Trial — The Morello trial was published in 1999, and compared Neurontin with a tricyclic antidepressant to compare the drugs’ efficacy for the treatment of painful diabetic neuropathy. The study found the drugs to be comparable. 6.Serpell Trial — This study, sponsored by Pfizer and completed in 2002, examined Neurontin’s efficacy in treating people with a wide variety of neuropathies, including postherpetic neuralgia and painful diabetic neuropathy. The study found Neurontin to be effective. However, when those patients with postherpetic neuralgia (for which Neurontin has been approved by the FDA) were removed from the study’s results, the drug was no longer shown to be effective. The marketing of Neurontin for neuropathic pain was accomplished through the use of direct marketing by sales representatives and medical liaisons, through a publication strategy, and through the sponsorship of CME events for physicians, (i) Publication Strategy In the mid-1990s, eager to get into the pain market, Parke-Davis sponsored a DBRCT conducted by Dr. Kenneth Gorson to study the effectiveness of Neurontin in the treatment of painful diabetic neuropathy. In August 1997, Dr. Gorson faxed Parke-Davis his manuscript from the study, which found that Neurontin “at a dose of 900 mg/day, is probably no more effective than p