Harkonen v. Fleming

880 F. Supp. 2d 1071, 2012 WL 3026400, 2012 U.S. Dist. LEXIS 103227
CourtDistrict Court, N.D. California
DecidedJuly 24, 2012
DocketNo. C 12-1267 SI
StatusPublished
Cited by2 cases

This text of 880 F. Supp. 2d 1071 (Harkonen v. Fleming) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Harkonen v. Fleming, 880 F. Supp. 2d 1071, 2012 WL 3026400, 2012 U.S. Dist. LEXIS 103227 (N.D. Cal. 2012).

Opinion

ORDER GRANTING DEFENDANT’S MOTION TO STRIKE PURSUANT TO CALIFORNIA CODE OF CIVIL PROCEDURE SECTION 425.16 (ANTI-SLAPP)

SUSAN ILLSTON, District Judge.

On June 22, 2012, the Court held a hearing on defendant’s motion to strike the [1075]*1075complaint. For the reasons set forth below, the Court GRANTS defendant’s motion to strike the complaint.

BACKGROUND

Plaintiff Dr. Scott Harkonen is a medical doctor and former CEO of InterMune, Inc., a publicly traded biotechnology company. Harkonen Decl. ¶¶ 1-3. While plaintiff was CEO, InterMune conducted a clinical trial (“GIPF-001”) of the prescription drug Actimmune® (interferon gamma-lb) for the treatment of idiopathic pulmonary fibrosis (“IPF”), a fatal lung disease for which there is 'no FDA-approved treatment. Compl. ¶ 2; Sutro Decl. Ex. D at 12.1 Defendant Dr. Thomas Fleming, a professor and former chair of the Department of Biostatistics at the University of Washington, acted as the biostatistician on the Actimmune® trial’s Data Monitoring Committee (“DMC”), which was charged with monitoring data concerning patient safety and treatment efficacy. Fleming Decl. ¶¶ 1-2. Defendant is a publishing academic and is also active on the lecture circuit. This lawsuit arises out of allegedly defamatory statements made by defendant regarding a press release issued by plaintiff about the Actimmune® clinical trial, and the interpretation of data from that trial.

The complaint alleges that the cutoff date for the clinical trial was June 26, 2002. Id. ¶ 9. On August 28, 2002, InterMune issued a press release regarding the clinical trial. Id. ¶ 10; Harkonen Decl. Ex. B. The press release claimed that the drug demonstrated a survival benefit for treatment of idiopathic pulmonary fibrosis. Harkonen Decl. Ex. B. Its headline read: “InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF,” and was subtitled: “Reduces Mortality by 70% in Patients with Mild To Moderate Disease.” Id. The press release stated that data from the trial demonstrated a “significant survival benefit [for a subgroup of patients] ... versus control treatment.” Id.

It is undisputed that the survival benefit reported in the press release was baséd upon a post-hoc analysis, that is, an analysis of data which had not been pre-specified in the clinical trial protocol, in that the written protocol for the clinical trial had not called for an analysis of the subgroup of patients with mild to moderate disease. Further, the press release was based on an analysis of the clinical trial data through June 26, 2002, and did not include clinical trial data after that date, including two deaths that occurred after June 26, 2002, but before the August 28, 2002 press release.2

On September 5, 2002, defendant sent InterMune a letter regarding his “serious concerns” about “misrepresentations” in the press release. Fleming Decl., Ex. E at 1, 4. The letter stated that at an August [1076]*107619, 2002, meeting of the DMC during which the DMC reviewed the clinical trial data, the DMC concluded- that Actimmune® did not provide statistically significant evidence of benefit for the primary endpoint (objective) of the clinical trial. Id. The letter also stated,

The most comprehensive survival data, as presented to the DMC on August 19, indicated only a modest suggestion of survival benefit, (18 versus 28 deaths [ ]). Given that these survival data were only interim in nature, and that survival was only a secondary endpoint, with the protocol specifying that six other secondary endpoints were considered to be of greater “clinical relevance to IPF”, such evidence must be interpreted with much greater caution than as presented in the News Release. (Note that the survival data on June 26, 2002, cannot be interpreted as the “primary analysis” of the secondary survival endpoint. Per an agreement with FDA and with the DMC at its April 24, 2002 meeting, data on secondary endpoints, including survival, would be of an interim nature until completion of follow-up at the time of patients’ study completion visits. Once the sponsor knew about any survival outcomes that occurred after June 26-specifically that there were two additional deaths on Actimmune and none on control-these additional outcomes cannot be excluded without bias.)

Id. at 3.

The two other members of the DMC both expressed full agreement with defendant’s letter. Riley Decl. ¶ 8 & Ex. D; Reis Decl. ¶ 11 & Ex. D. In a letter dated September 27, 2002, InterMune replied to Dr. Fleming. InterMune reiterated that the clinical trial’s cutoff date was June 26, 2002, and stated that “[although we appreciate this point, it is our intention to discourage week-by-week analysis ... Our next analysis of survival status will ... be accomplished by a complete canvas of the vital status for all patients, including those who have discontinued formal study followup.” Fleming Decl., Ex. I at 4.

After plaintiffs criminal conviction, defendant wrote an article for the peer-reviewed Annals of Internal Medicine. Fleming Decl. ¶ 30 & Ex. M. When writing the article, Dr. Fleming solicited input from two doctors still employed at InterMune, Bill Bradford and Steven Porter. Id. ¶35. Both doctors provided permission to be acknowledged for their role in reviewing the paper, and neither recommended any changes to the allegedly defamatory statements in the article. Id. After publication of the article, plaintiff contacted the editor of the journal requesting certain corrections. Fleming Decl. ¶ 37 & Ex. O. Defendant wrote the journal a response to plaintiffs request and asked Dr. Bradford of InterMune to review a draft of the response before sending it. Fleming Decl. ¶ 39.3 Dr. Bradford reviewed the letter and commented that he was “happy to support [Dr. Fleming’s] efforts to provide an accurate response to the [plaintiffs] accusations, and [felt] a moral obligation to do so given the history and clear distortion of fact in [plaintiffs] letter to the Editor at the Annals.” Fleming Decl., Ex. Q.4 The editor of the journal made a correction regarding the cutoff date (changing it from June 15 to June 26, 2002), but the editor made no changes regarding the allegedly defamatory statements. Id., Ex. T.5

[1077]*1077Plaintiff alleges that he was defamed by defendant’s article in Annals of Internal Medicine, public lectures at universities, and defendant’s publication of those lectures on the internet, all of which concern the press release. Plaintiff alleges that in the Annals article and the lectures, Fleming made defamatory statements that Harkonen falsified the test data by improperly concealing the deaths of two people. Compl. ¶¶ 16-17. The complaint provides the following examples of allegedly defamatory statements:

• “The 10 secondary endpoints were all negative. OK survival had a bit of positive trend, P of Point 08, however, survival was an endpoint specifically targeted for follow-up until the clinical closeout visits in November. So the survival data are actually still not final. And in fact between the clinical cut date in October and the date in our [DMC] meeting there were two additional deaths in the acting Actimmune arm so that the updated data were even a little bit less favorable.”;

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880 F. Supp. 2d 1071, 2012 WL 3026400, 2012 U.S. Dist. LEXIS 103227, Counsel Stack Legal Research, https://law.counselstack.com/opinion/harkonen-v-fleming-cand-2012.