Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc. (In re Neurontin Mktg. & Sales Practices Litig.)

• Decision Date: 27 July 2011
• Docket Number: Civil Action No. 04–cv–10739–PBS.
• Citation: 799 F.Supp.2d 110
• Parties: In re NEURONTIN MARKETING AND SALES PRACTICES LITIGATION.This Document Relates to:Kaiser Foundation Health Plan, Inc., et al. v. Pfizer, Inc., et al.
• Court: U.S. District Court — District of Massachusetts

799 F.Supp.2d 110

In re NEURONTIN MARKETING AND SALES PRACTICES LITIGATION.This Document Relates to:Kaiser Foundation Health Plan, Inc., et al.

v.Pfizer, Inc., et al.

Civil Action No. 04–cv–10739–PBS.

United States District Court, D. Massachusetts.

July 27, 2011.

Joel Z. Eigerman, Attorney–at–Law, Thomas G. Shapiro, Shapiro Haber & Urmy LLP, Pavel Bespalko, Boston, MA, Mark D. Fisher, Rawlings & Associates, P.L.L.C., Louisville, KY, Marlene F. Gibbons, Justine J. Kaiser, Cohen, Milstein, Hausfeld & Toll, P.L.L.C., Washington, DC, Linda P. Nussbaum, Grant & Eisenhofer PA, New York, NY, Mark S. Sandmann, Rawlings & Associates, LaGrange, KY, for Plaintiff, The Guardian Life Insurance Company of America.

David B. Chaffin, White and Williams LLP, Boston, MA, for Defendant, Parke–Davis.

Mark S. Cheffo, Skadden, Arps, Slate, Meagher & Flom LLP, New York, NY, for Defendant, Pfizer, Inc.

MEMORANDUM AND ORDER

SARIS, District Judge.

After a lengthy trial, a jury returned a verdict on RICO claims for plaintiff Kaiser on March 25, 2010 in the amount of $47,363,092. (Jury Verdict, Docket No. 2760.) Under the statute, the award on the RICO claims was trebled to $142,089,276. On November 3, 2010, this Court issued an opinion finding that defendants engaged in fraudulent business acts or practices under California's Unfair Competition Law and awarded plaintiffs $95,286,518 in restitution. In re Neurontin Mktg. & Sales Practices Litig., 748 F.Supp.2d 34 (D.Mass.2010). Judgment was entered on February 22, 2011 (Docket No. 3326).

Defendants have filed a Motion for New Trial and to Re–Open Evidence or, Alternatively, to Alter or Amend Judgment pursuant to Fed.R.Civ.P. 59 (Docket No. 3362). The Court DENIES defendants' motion for new trial, and writes now only to address three of the issues raised therein.

I. DISCUSSION

A. Motion to Re–Open Evidence and Admit 2011 Cochrane Review

Defendants seek to re-open the evidence in order to submit an article issued by the Cochrane Collaboration titled “Gabapentin for chronic neuropathic pain and fibromyalgia in adults (Review).” (Docket No. 3362, Ex. A.) The Court previously found that “[t]he Cochrane Group is an international nonprofit organization that provides compilations of the most reliable scientific evidence available about the use of certain drugs to treat various indications.” 748 F.Supp.2d at 43 n. 4. The new Cochrane report on the use of Neurontin to treat neuropathic pain finds that “Gabapentin provides pain relief of a high level in about a third of people who take it for painful neuropathic pain.... More conservative estimates of efficacy resulted from using better definitions of efficacy outcome at higher, clinically important, levels, combined with a considerable increase in the number of studies and participants available for analysis.” (Docket No. 3362, Ex. A at 2.)

The authors concluded that results might vary among different neuropathic pain conditions, and that the amount of evidence for some conditions is “low, excluding any confidence that it works or doesn't work.” ( Id. at 28.) Overall, the 2011 Cochrane report included 29 studies, five of which studied postherpetic neuralgia (which is an on-label indication for Neurontin), and eight of which studied painful diabetic neuropathy. ( Id. at 7.) The 29 studies involved 3,571 participants. Approximately 75% of those participants were enrolled in studies of postherpetic neuralgia (“PHN”), painful diabetic neuropathy (“PDN”), or mixed neuropathic pain. Id. Accordingly, the authors wrote that “[t]hough gabapentin was tested in 12 different neuropathic pain conditions, only for three was there sufficient information to be confident that it worked satisfactorily, namely PHN, PDN, and mixed neuropathic pain, itself principally, though not exclusively, PHN and PDN.” ( Id. at 25.)

Defendants bring their motion pursuant to Fed.R.Civ.P. 59(e). “Rule 59(e) motions are granted only where the movant shows a manifest error of law or newly discovered evidence.” Kansky v. Coca–Cola Bottling Co. of New Eng., 492 F.3d 54, 60 (1st Cir.2007) (citing Marie v. Allied Home Mortgage Corp., 402 F.3d 1, 7 n. 2 (1st Cir.2005)). “An order for a new trial on the ground of newly discovered evidence requires proof of the following elements: (1) The evidence has been discovered since the trial; (2) The evidence could not by due diligence have been discovered earlier by the movant; (3) The evidence is not merely cumulative or impeaching; and (4) The evidence is of such nature that it would probably change the result if a new trial is granted.” Raymond v. Raymond Corp., 938 F.2d 1518, 1527 (1st Cir.1991). “ ‘[N]ewly discovered evidence’ normally refers to ‘evidence of facts in existence at the time of trial of which the aggrieved party was excusably ignorant.’ ” Rivera v. M/T Fossarina, 840 F.2d 152, 156 (1st Cir.1988) (quoting Brown v. Pa. R.R. Co., 282 F.2d 522, 526–27 (3d Cir.1960)). Examples of “newly discovered evidence” under Rule 59 that have been accepted by courts include: (1) newly located witnesses with personal knowledge germane to the case, see Compass Tech., Inc. v. Tseng Labs., Inc., 71 F.3d 1125, 1130–31 (3d Cir.1995); (2) evidence belatedly disclosed by opposing party such that the movant did not have time to recognize it as useful evidence, see Alpern v. UtiliCorp United, Inc., 84 F.3d 1525, 1536–37 (8th Cir.1996); and (3) evidence that a key witness committed perjury, see Krock v. Electric Motor & Repair Co., 339 F.2d 73, 75 (1st Cir.1964); In re Vioxx Prods., 489 F.Supp.2d 587, 591–92 (E.D.La.2007).

After trial, the Court concluded that “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, or doses greater than 1800 mg/day.” 748 F.Supp.2d at 38–39. The Court also found that “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.” Id. at 39.

The new Cochrane report is related only to the Court's findings about the use of Neurontin to treat neuropathic pain. The findings regarding the other three indications (bipolar disorder, migraine, and high doses) are unrelated to this discussion.

As the Court acknowledged in its findings, the conclusion that Neurontin was not effective in the treatment of neuropathic pain was “a closer call” when compared to the three other indications, for which there was no scientific evidence of efficacy. Id. at 78. Two credible defense experts testified that they believed Neurontin was, for some patients, an effective treatment for neuropathic pain. Id. at 77–78. In addition, “some trials studying the use of Neurontin to treat diabetic peripheral neuropathy found that, using some secondary outcomes ... Neurontin outperformed placebo.” Id. However, after weighing all of the evidence, including 12 double-blind randomized controlled trials and testimony from three experts, the Court concluded that, “using the generally accepted standard of scientific efficacy followed by the FDA and the scientific community ... there is insufficient reliable evidence of the efficacy of Neurontin with respect to the broad indication of neuropathic pain.” Id. at 79.

At trial, defendants introduced the 2005 Cochrane report on the use of Neurontin for neuropathic pain into evidence, which found that “there is adequate evidence to support that there's efficacy of gabapentin for the treatment of neuropathic pain.” Id. at 78. However, the Court found that the 2005 Cochrane report was not persuasive because defendants suppressed data from trials studying the use of Neurontin to treat neuropathic pain that had negative results. Id. Specifically, the authors of the 2005 Cochrane report did not have access to the unpublished Reckless and POPP trials, and they did not have access to the raw data for the Backonja, Gorson and Serpell trials. Id. The Court's conclusion was supported by the testimony of plaintiffs' expert, Dr. Kay Dickerson, who also published her findings based on discovery materials in this case in an article in November 2009 in the New England Journal of Medicine. Dr. Dickerson found that each of twenty-one clinical trials sponsored by the defendants exhibited some sort of bias or deviation from the truth. See Kay Dickerson, et al., “Outcome Reporting in Industry–Sponsored Trials of Gabapentin for Off–Label Use,” 361 New Eng. J. Med. 1963 (2009). Significantly, the new 2011 Cochrane report was made possible by the release of previously suppressed trials and data that were disclosed during the Kaiser trial and discovery process.

The Court concludes that a new trial is not warranted for two reasons. First, the Cochrane report is not newly discovered evidence that defendants could not have replicated before trial, but rather is a scholarly article that provides a meta-analysis of scientific studies, most of which were available during trial.¹ Pfizer could have performed a similar meta-analysis prior to the trial. Indeed, plaintiffs' expert, Dr. Thomas Perry, did perform a similar meta-analysis, albeit one that reached an opposite conclusion. Moreover, Dr. Robert Gibbons, a highly qualified biostatician who testified as defendants' expert in this trial, has previously provided the Court with similar meta-analysis testimony in the related products liability litigation that refutes the FDA's conclusion that gabapentin was associated with increased rates of suicide and suicidal ideation. See In re Neurontin Mktg., Sales Practices & Prods. Liab. Litig., 2011 WL 1048971 (D.Mass. Mar. 18, 2011).

Pfizer argues, though, that the Cochrane Group's opinion should be considered new evidence because it is...