Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_08-cr-00164/USCOURTS-cand-3_08-cr-00164-30/pdf.json

Parties Involved:
W. Scott Harkonen
Defendant
USA
Plaintiff

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United States District Court

Northern District of California

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

UNITED STATES OF AMERICA,

Plaintiff and Respondent,

v.

W. SCOTT HARKONEN,

Defendant and Petitioner.

Case No. 08-cr-00164-RS-1 

ORDER DENYING PETITION FOR 

THE WRIT OF ERROR CORAM NOBIS

I. INTRODUCTION

Petitioner and defendant W. Scott Harkonen moves this Court to set aside his conviction 

under the federal wire fraud statute, 18 U.S.C. § 1343, pursuant to the common law writ of error 

coram nobis, on the grounds that he received ineffective assistance of counsel within the meaning 

of Strickland v. Washington, 466 U.S. 668 (1984). While, in the clarity of hindsight, different 

decisions on the part of Harkonen’s trial attorneys may well have won him a more favorable 

result, their exercise of judgment was not so beyond the pale of reasonable conduct as to warrant 

the finding of ineffective assistance necessary to grant Harkonen’s request for relief. Harkonen, 

moreover, does not show valid reasons for failing to raise his claim of ineffective assistance at an 

earlier juncture. His petition must therefore be denied. 

II. BACKGROUND

Harkonen, a doctor and CEO of the biotechnology company InterMune, Inc., on April 13, 

2011 received a sentence of three years of probation following a jury verdict finding him guilty as 

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to one count of wire fraud under 18 U.S.C. § 1343, premised on the making of false or misleading 

statements with the intent to defraud or mislead. Specifically, Harkonen was found to have

approved a press release announcing the preliminary results of a clinical study, the GIPF-001 trial, 

for the drug Actimmune in treating fatal lung disease (idiopathic pulmonary fibrosis, or “IPF”). 

The press release, as charged, contained false and misleading information regarding Actimmune

and falsely portrayed the results of the trial as demonstrating that the drug helped patients live 

longer. The particular statements at issue in the press release were its headline, “InterMune 

Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF,” and the 

subheading “Reduces Mortality by 70% in Patients with Mild to Moderate Disease.” The jury 

furthermore found that these statements were made for the purpose of inducing doctors to 

prescribe, and patients to take, Actimmune for IPF. 

An allegation regarding the significance of data collected during a medical experiment 

comprises a scientific opinion. Because federal fraud statutes forbid prosecution concerning

scientific opinions about which reasonable minds may differ, the government bore the burden in 

this case to prove that the opinions expressed in the press release’s caption were not, and could not 

have been, held by reasonable experts in the fields of biostatistics or pulmonology. The 

prosecution thus advanced the theory that no reasonable scientist could have, in good faith, 

reported the trial to be anything but an abject failure because its results did not meet certain 

statistical principles it argued were immutable. 

The GIPF-001 study was a randomized, double-blind, placebo-controlled experiment to 

test Actimmune as a treatment for IPF. It primary endpoint, or target outcome, was “progressionfree survival,” with progression measured by decreased lung function, oxygen deficiency in the 

lungs, or death. Pet. for Writ of Error Coram Nobis, p. 7. At its outset, the study also identified 

nine secondary endpoints, the seventh being survival time in the two years from the study’s 

commencement to its cut-off date. 

In clinical trials, a p-value is a number between one and zero which represents the

probability that the results establish a cause-and-effect relationship, rather than a random effect, 

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between the drug and a positive health benefit. Because a p-value indicates the degree to which 

the tested drug does not explain observed benefits, the smaller the p-value, the larger a study’s 

significance. Study data referred to as “statistically significant” thus has a p-value lower than the 

study’s predetermined p-value threshold for significance. In general, the statistical integrity of 

results concerning secondary endpoints hinge on the primary endpoint achieving statistical 

significance. Clinical study protocols often set out, prior to commencing research, threshold pvalues, primary and secondary endpoints, and planned tests, in order to promote objective analysis

not dictated by the motive to demonstrate success. 

Here, the GIPF-001 team chose a p-value of 0.05 as its cutoff for statistical significance of 

its various endpoints. GIPF-001did not yield statistically significant results on its primary 

endpoint; the p-value for progression-free survival time was 0.52. Nor did the analysis for any of 

the secondary endpoints yield a p-value lower than 0.05. While the plan for GIPF-001 did not 

include at its outset an intent to perform such an analysis, a post-hoc tabulation of data from a 

subgroup of patients with mild to moderate IPF showed a survival benefit with a p-value of 0.004. 

The survival p-value for the overall patient group was, by contrast, 0.084. It was on the basis of 

this data that the press release reported a trend in survival data that appeared to demonstrate a 

benefit. 

In making its case, the prosecution therefore stressed testimony from its experts touting the 

view that study results without sufficiently low p-values are inherently unreliable and 

meaningless. The government also produced evidence suggesting Harkonen misrepresented the 

GIPF-001 trial’s results before the Food and Drug Administration (“FDA”) in the face of doubts 

expressed to him by other scientists involved in the study, and kept plans to publish the press 

release secret from his colleagues while purporting to have full support at InterMune for the 

conclusions it contained. 

In March 2008, Harkonen was indicted by a federal grand jury on two counts: (1) wire 

fraud under 18 U.S.C. § 1343, and (2) misbranding, under 21 U.S.C. §§ 331(k), 333(a)(2), and 

352(a). From the case’s inception up until sentencing, Harkonen received representation from a 

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trial team spearheaded by Marcus Topel and including Lyn Agre and William Goodman, all of the 

firm Kasowitz, Benson, Torres & Friedman, as well as Ann Moorman, now a superior court judge. 

Harkonen also hired Ron Winchell as independent counsel to advise him privately on all matters 

related to the case, and engaged Paul Kalb and Coleen Klasmeier, attorneys at Sidley Austin LLP,

to assist with locating potential defense experts and certain pre-trial motions. 

In its pretrial disclosures, the government indicated its intent, as to issues of biostatistics 

and study interpretation, to rely on testimony from Michael Crager, an InterMune biostatician, and 

Thomas Fleming, a professor of biostatistics who chaired a group of scientists appointed to 

oversee the GIPF-001 trial to safeguard patient interests (the Data Monitoring Committee, or 

“DMC”). The Topel team, in response, disclosed six experts: Lawrence Mayer and Patrick 

Hannon (both biostatistics experts), Roger Mayfield and Joseph Zibrak (both as clinical experts), 

and David Katz and Kathryn Zunich (other physicians identified as experts on drug regulation and 

advertising ). The trial judge denied the government’s motion in limine to exclude these defense 

experts. 

Throughout its case in chief, the government stressed testimony from Fleming and Crager 

who offered that, in the world of biostatistical analysis, a 0.05 p-value threshold is “somewhat of a 

magic number”; that the only meaningful p-value from a study is the one for its primary endpoint;

and that data from post-hoc subgroup analyses cannot be reported upon accurately without 

information about the rest of the sampling context. See Pet. for Writ of Error Coram Nobis, p. 72. 

That the primary endpoint p-value for GIPF-001 was 0.52 rendered all other reported outcomes 

from the study, in their opinions, not only statistically insignificant, but devoid of any value at all. 

As the government approached the close of evidence, it again moved to exclude defense 

testimony on statistical theories, arguing that its witnesses had laid the necessary groundwork for 

the jury to understand the relevant statistical methodology, and that no defense expert evidence on 

that score was warranted. Harkonen, countering that such exclusion of its experts would infringe 

his constitutional right of defense, again prevailed before the trial judge. Subsequent proceedings 

took place in which defense counsel discussed with the Court the intended scope of expert witness 

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examination. Then, after calling a small number of percipient witnesses, the defense rested its 

case without calling any experts. Harkonen’s current motion focuses on this decision, which left 

“undisputed,” in the words of the trial judge, the government expert’s testimony that the GIPF-001 

trial was a failure. 

The nature of Harkonen’s allegations implicate several specific details of his attorneys’ 

efforts. The defense team had scoured the country for over a year for potential defense 

biostatistics experts prepared to testify that the press release was accurate against the word of Dr. 

Fleming, whom the defense knew was likely to serve as a cornerstone witness in the government’s 

case. Numerous interviews yielded just two—Mayer and Hannon. Members of the trial team met 

multiple times with both experts, focusing in particular on confirming Mayer’s position on the 

press release and preparing him to testify. At the case’s outset, Mayer appeared to be a 

particularly important witness for the defense because his credentials rivaled those of Fleming, and 

he was prepared to challenge the prosecution on the fundamental principles of biostatistical 

analysis. 

The search for pulmonologists proved similarly challenging; many members of the DMC 

were averse to Harkonen’s position, and one joined the government’s panel of witnesses alongside 

Fleming. Over two hundred calls to a list of Actimmune-prescribing physicians garnered just two 

responses, from Zibrak and Maxfield. A particular strategic challenge confronted the defense 

regarding pulmonology testimony. Having successfully won the exclusion from the trial of 

evidence of a study subsequent to the GIPF-001 trial supportive of press release falsity (the 

“GIPF-007 trial”), the defense risked opening the door to the GIPF-007 results on cross 

examination of any pulmonology witnesses regarding current knowledge as to Actimmune’s 

efficacy and its ongoing use. 

Still unsatisfied with the few experts identified through their extensive searches, the Topel 

team cast a broader net among physicians with drug regulation and advertising expertise willing to 

testify on Harknonen’s behalf, which led to Zunich and Katz. Harkonen’s attorneys also twice 

reviewed, but decided against including, a DVD compilation of various scientists’ impressions of 

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the GIPF-001 trial and of the efficacy of Actimmune shared at various scientific conferences and 

meetings. The reactions reflected on the tape were either mixed or irrelevant, with physicians in 

some instances indicating disagreement with the trial results or purported benefits of Actimmune. 

Topel stated at the commencement of trial that he intended to call expert witnesses to 

speak to the GIPF-001 study’s statistical significance and the benefits of Actimmune. Over the 

course of the prosecution’s case, the defense established a number of points in Harknonen’s favor 

on cross examination. For instance, Crager, who had filed a patent application for Actimmune, 

had attested in the application to the existence of statistically significant evidence of the drug’s 

positive effect on patients’ likelihood of survival. He furthermore did not report any negative 

impressions of the draft press release to Fleming, and had created a slide demonstrating a 

statistically significant outcome of GIPF-001, without any qualifying statements. Other 

government witnesses admitted they had known of the forthcoming press release and neither 

harbored nor expressed concerns as to its accuracy; had heard DMC members emphasize the 

significance of GIPF-001’s demonstrated survival benefits to IPF patients; and had themselves 

extolled its successes. 

In defense counsel’s judgment at the time, the headway made during the government’s 

case ultimately obviated the need for defense experts, especially in light of the associated risks, 

although discussion continued regarding the prospect of presenting Mayer’s biostatistics 

testimony. Having already flown in, Zibrak remained available to be called to offer pulmonology

expert testimony. The downsides to placing a pulmonologist on the stand described above,

coupled with the ground gained during the prosecution’s case, convinced the Topel team his 

testimony involved more potential to damage their position than to enhance it.

The decision not to call Mayer is the cornerstone of Harkonen’s present claims. According 

to Topel, the night before Mayer was to testify, the witness for the first time expressed doubt as to 

whether the press release was misleading. In the trial team’s judgment, Mayer’s testimony could 

no longer benefit Harkonen’s case in light of this shift. While Hannon was still available as an 

expert biostatistician, he was significantly less credentialed than both Mayer and Fleming, and 

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thus, in defense counsels’ opinion, risked undermining advances they had made during the 

prosecution’s case. Together with Harkonen and his personal counsel Winchell, the trial team 

decided against calling any defense expert witnesses. In his closing argument, Topel highlighted 

the favorable points elicited during cross examination of government witnesses and explained to 

the jury, “our experts came through in the government’s case . . . .” Trial Transcript at 3672-73. 

The six-week trial then came to a close. 

On September 29, 2009, the jury reached a verdict finding Harknonen guilty on the wire 

fraud charge and acquitting him on the felony misbranding charge. The defense then filed a 

motion for judgment of acquittal contending in part that the government had failed to qualify its 

biostatisticians as experts, and thus rendered it impossible for the jury to conclude that the press 

release was misleading. In denying the motion, the trial court noted that although the government 

did not officially proffer either Fleming or Crager as experts, both were listed in its expert witness 

disclosure, and Fleming’s curriculum vitae had been entered into evidence. Harkonen could, 

moreover, have attempted during cross-examination to undermine the jury’s confidence in their

credentials or testimony, but instead chose to focus on questions about statistical methodology. 

“Most damningly,” in the words of the trial judge, Harkonen had raised no objections to Crager or 

Fleming’s opinions about fundamental principles of biostatistical analysis or to their interpretation 

of secondary endpoint and post-hoc subgroup analyses. Dkt. No. 369. Because this testimony 

went unchallenged, reasoned the trial court, it was properly introduced and appropriate for the jury 

to have relied upon it in reaching its verdict. 

Harkonen engaged a new defense team led by attorney Mark Haddad in December 2009

prior to the sentencing proceedings. Haddad’s team presented declarations from Zibrak. It also 

presented declarations from Drs. Steven Goodman and Donald Rubin, biostatisticians new to 

Harkonen’s case. Zibrak’s declaration spoke to the biological plausibility of Actimmune’s 

survival benefits and the lack of relevance of the press release to doctors’ prescribing habits. His 

supplemental declaration stated that GIPF-001 did not “conclusively prove[] the efficacy of 

Actimmune for IPF,” that he had stopped prescribing Actimmune to his IPF patients, and that 

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insurance companies are loath to reimburse for it. Dkt. Nos. 284, 317. Goodman’s declarations 

countered government testimony relied on by the jury concerning biostatistical analysis. 

Specifically, he asserted, a p-value of 0.05 is not necessarily a “magic” threshold for statistical 

significance, and that reasonable scientists apply a lower standard of proof of efficacy when 

dealing with fatal diseases like IPF, for which there exist no known effective treatments. Dkt. 

Nos. 282, 318. Rubin, in similar fashion, stated that the GIPF-001 results did not foreclose the 

conclusion that Actimmune retained survival benefits. Dkt. No. 283. Haddad’s sentencing 

presentation also included the DVD excerpts Harkonen’s prior counsel chose not to use, in which 

experts of various types shared positive impressions of the trial results. 

The Haddad team also filed two motions for a new trial, which the trial court heard in 

conjunction with the sentencing hearing on April 13, 2011. The first was based on an alleged

Brady violation, arising from the late disclosure of documents from the Department of Veterans’

Affairs supporting the press release’s lack of materiality to prescribing decisions. In denying this 

motion, the trial court noted that Harkonen had elected not to pursue ample opportunities at trial to 

mount an immateriality defense, including his option to present experts on the point, and so had 

waived his right then to raise the materiality point via a Brady motion. The second new trial 

motion arose from purported new evidence in the form of an amicus brief filed by the United 

States in a different case, Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), in which 

the government arguably took a position on statistical methodology opposite to the one it took in 

Harkonen’s case. The trial judge denied the motion, finding that a Supreme Court decision issued 

a year after the jury verdict was reached could not constitute “newly discovered evidence” in this 

instance under Rule 33 of the Federal Rules of Civil Procedure.

While the trial judge had before her all of the evidence accumulated by the Haddad team 

that had not been presented at trial, she nevertheless proceeded with sentencing based on the jury’s 

verdict. The sentencing decision rejected the government’s proposed ten-year prison sentence in 

favor of three years of probation and a $20,000 fine, largely on grounds of the press release’s 

materiality. It found that while the press release had “undoubtedly” influenced some individuals 

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to recommend or seek treatment with Actimmune, the government’s materiality case was 

exceptionally weak in that it had failed to attribute to the press release any specific instances in 

which Actimmune had been prescribed. Thus, for the purpose of considering sentence 

enhancement, the trial court found no actual or intended losses stemming from the conduct for 

which Harkonen had been convicted. See Sentencing Hearing Transcript at 77-78, 117. 

Harkonen appealed his conviction on April 25, 2011, and the government cross-appealed 

the sentencing decision on May 12, 2011. Harkonen emphasizes that, in affirming the trial court’s 

decision, the Ninth Circuit’s March 2013 unpublished opinion noted that Harkonen had for the 

first time presented his strongest evidence at sentencing, and “[b]ecause we must defer to the 

jury’s credibility determinations, we will not reverse the jury’s verdict based on evidence it never 

considered.” United States v. Harkonen, 510 Fed. Appx. 633, 637 n.2 (9th Cir. 2013). 

On August 23, 2011, Harkonen filed a professional negligence action in state court against 

Topel and the Kasowitz firm arising from the representation he received in his criminal case. On 

May 7, 2013, the Ninth Circuit denied his petition for rehearing en banc; and the Supreme Court 

denied his petition for writ of certiorari on December 16, 2013. His three-year probation term 

concluded on April 13, 2014. 

The Topel team’s mistakes, Harkonen contends, precluded him not only from the benefit 

of exculpatory evidence at trial, but also from consideration of such evidence on his motion for 

acquittal and before the Ninth Circuit. On grounds of ineffective assistance of counsel, Harkonen 

filed this petition on July 30, 2014. 

III. LEGAL STANDARD

“[T]he writ of error coram nobis is a highly unusual remedy, available only to correct 

grave injustices in a narrow range of cases where no more conventional remedy is applicable.” 

United States v. Riedl, 496 F.3d 1003, 1005 (9th Cir. 2007); see also United States v. Morgan, 346 

U.S. 502, 511 (1954) (characterizing the writ as an “extraordinary remedy” available “only under 

circumstances compelling such action to achieve justice”). It bridges the “very precise gap” in 

federal criminal procedure for post-conviction defendants for whom relief to have a sentence or 

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conviction vacated, set aside or corrected under the federal habeas corpus provision, 28 U.S.C. § 

2255, is unavailable because they have already completed their time in federal custody. While 

Fed. R. Civ. P. 60(b) abolished this remedy in civil cases, the Supreme Court has thus maintained 

its availability in the criminal context. Telink, Inc. v. United States, 24 F.3d 42, 45 (9th Cir. 1994). 

To obtain relief under the writ, a petitioner carries the burden to demonstrate that (1) a 

more usual remedy is unavailable; (2) valid reasons kept the petitioner from attacking his or her 

conviction earlier; (3) the conviction bears consequences sufficiently adverse to satisfy Article 

III’s case or controversy requirement; and (4) the error is of the “most fundamental character.” 

Hirabayashi v. United States, 828 F.2d 591, 604 (9th Cir. 1987). Conceding the first and third 

factors, the government contends only that Harkonen fails to show both valid reasons for not

attacking his conviction at an earlier point, and that any error was of a fundamental nature. 

IV. DISCUSSION

A. Timeliness of Harkonen’s Attack 

Although the writ of error coram nobis is not subject to any particular statute of 

limitations, the petitioner bears the burden of proof to offer valid reasons for delay. Hirabayashi, 

828 F.2d at 604; Morgan, 346 U.S. at 12 (requiring a showing that “sound reasons exist for failure 

to seek appropriate earlier relief”); Kwan, 407 F.3d at 1014 (“The law does not require [petitioner] 

to challenge his conviction at the earliest opportunity, it only requires [petitioner] to have sound 

reasons for not doing so.”). 

Harkonen filed this petition on July 30, 2014: three months after completing his probation,

seven months after the Supreme Court denied his petition for cert, over a year after the Ninth 

Circuit’s affirmance of his conviction, and nearly three years after filing his state court 

professional negligence suit. Final judgment in hand in December 2013, Harkonen could 

technically have mounted a collateral attack on his conviction under Section 2255 between that 

time and the conclusion of his probation in April 2014. He contends, however, that financial 

constraints occasioned by his parallel Medical Board proceedings and clawback arbitration 

brought by InterMune for his trial defense cost; the effort required to retain present counsel to 

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prepare this petition; the time required properly to investigate evidence concerning Harkonen’s 

representation at trial; and the long duration of his appellate proceedings from April 2011 to 

December 2013, all kept him from filing such a collateral attack during his probation period. 

Even accepting these reasons as valid causes for Harkonen’s inability to file a habeas 

petition, Harkonen nevertheless fails to address fully in his motion or reply why he declined to 

raise a direct challenge to his conviction on grounds of ineffective assistance prior to sentencing, 

via a motion for a new trial or in support of arguments for a downward departure. He does not 

contest that all evidence supporting his claim was available to him, and that he could have retained 

counsel separate from Topel and Haddad’s teams to represent him on such a claim. Indeed, his 

state court professional negligence action was filed in August 2011 while Haddad continued to 

represent Harkonen on appeal. 

Rule 33 requires a defendant’s motion for a new trial for any reason “in the interest of 

justice” other than newly discovered evidence to be raised within fourteen days of the guilty 

verdict. See United States v. Allen, 153 F.3d 1037, 1045 (9th Cir. 1998) (affirming trial court’s 

denial of Rule 33 motion for new trial based on “newly discovered evidence” of ineffective 

assistance of counsel) (internal citations and quotation marks omitted). Harkonen points out that 

such a motion grounded on allegations of ineffective assistance had to have been filed under Rule 

33 within fourteen days, and that this window had expired by the time the Topel team’s initial new 

trial motion citing newly discovered evidence had been denied. His reply moreover invokes case 

law suggesting that collateral attack is the customary approach for raising ineffective assistance 

claims, and that courts are “chary” of analyzing such claims on direct motion or appeal, given that 

a fuller record may be developed in a Section 2255 proceeding. See United States v. Schaflander, 

743 F2d 714, 717 (9th Cir. 1984); United States v. McGowan, 668 F.3d 601, 606 (9th Cir. 2012). 

Such a motion was, however, procedurally permissible, and Harkonen offers no insight as 

to what precluded such a filing. See McGowan, 668 F.3d at 606 (dismissing ineffective assistance 

claim without prejudice to its renewal in a Section 2255 petition). Harkonen also ignores the

express permission in Federal Rule of Criminal Procedure 45 to extend a party’s time period to act 

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“after the time expires if the party failed to act because of excusable neglect.” This provision has 

supported a finding that a defendant’s ineffective assistance claim made seven months after 

conviction was not untimely. See United States v. Brown, 623 F.3d 104, 112 (2d Cir. 2010). Why 

Harkonen did not immediately pursue a new trial on ineffective assistance grounds, or attempt to 

show excusable neglect under Rule 45 in order to make such a motion after fourteen days had 

expired. Especially in light of his ample access to legal counsel before, throughout, and after trial, 

and other extensive efforts to challenge his conviction, his failure to do so remains unexplained. 

Harkonen’s window to raise ineffective assistance claims in support of a downward 

sentencing departure was, moreover, far broader. Convicted in September 2009, he had until his 

April 2011 sentencing to offer evidence of his counsel’s purported incompetence to the trial court. 

See Rivera-Sanchez, 222 F.3d 1057, 1060 (9th Cir. 2000) (permitting a direct appeal of ineffective 

assistance claim where the district court had held a hearing to examine the question for purposes 

of determining whether it warranted a downward sentencing departure). Given that Harkonen 

engaged Haddad’s team to replace Topel well in advance of sentencing, and Haddad filed for 

sentencing purposes several pieces of evidence the Topel team had declined to use at trial, it is 

unclear why Haddad did not also pursue Harkonen’s present allegations against Topel and his 

associates further to strengthen the case for a reduced sentence. 

Delay has been ruled reasonable in this circuit where the applicable law changed, 

previously unavailable evidence was uncovered, or where counsel improperly advised the 

petitioner to forego seeking habeas relief. See Reidl, 496 F.3d 1003, 1007 (9th Cir. 2007) 

(aggregating cases). In Reidl, the petitioner’s coram nobis action failed on timeliness despite the 

petitioner’s attempt to justify her delay with arguments not dissimilar to those Harkonen presents 

here. Convicted in November 1999 and sentenced to 66 months in prison and subsequent 

deportation pursuant to the conviction, Reidl raised her coram nobis action in January 2006, about 

a year after completing her sentence and being deported to Austria. Reidl cited her incarceration, 

diminished capacity, forfeiture of certain assets, and her deportation to justify the timing of her 

petition. The Ninth Circuit noted, however, that none of Reidl’s reasons explained why she didn’t 

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raise her challenges—void-for-vagueness and insufficient evidence arguments—during trial, on 

direct appeal, or through a habeas petition. It, indeed, found “fatal” her concession that she could 

“have possibly” raised the claims on direct appeal or under Section 2255. Id. at 1006. 

Like Reidl, Harkonen has not identified a case showing he was foreclosed from any 

possible opportunity to raise his ineffective assistance claim at an earlier juncture. See Maghe v. 

United States, 710 F.2d 503, 503-04 (9th Cir.1983) (denying coram nobis petition as untimely 

where claim could have been raised earlier and there were no sound reasons for the delay). Prior 

to sentencing, and arguably throughout all of his proceedings, Harkonen appears to have had 

ample access to assets and counsel, and consistently demonstrated that he was willing and able to 

apply these resources to challenging his conviction. Nor does he contend that incompetent 

counsel hampered him from raising his claims. As noted earlier, he pursued a professional 

negligence suit against the Topel team in state court soon after his sentencing. 

In addition, Harkonen’s attempt to raise the equitable doctrine of laches in order to 

advocate for application of an analogous statute of limitations to his coram nobis action is 

misplaced. Laches is an equitable defense a respondent may raise; in doing so, the respondent 

undertakes the burden to make a prima facie showing of prejudice due to the petitioner’s delay. In 

such contexts, courts may look to analogous statutes of limitations to determine whether laches 

should apply. If the respondent meets his or her initial burden to show prejudice, it is then up to 

the petitioner to demonstrate that the respondent was not actually harmed by the delay, or that the 

petitioner applied reasonable diligence in filing his or her claim. United States v. Reidl, 496 F.3d 

1003, 1008 (9th Cir. 2007); Telink, 24 F.3d at 47. Here, the government has not raised any laches 

argument as a supplemental defense that would then make the statute of limitations for a provision 

analogous to the writ an appropriate factor to consider. Rather, the key question is the one posed 

under Hirabayashi’s second prong (valid reasons for not attacking conviction earlier), and the one 

Harkonen has failed to answer. His petition thus appears deficient under this prong. In any event, 

as addressed below, it is most certainly deficient under Hirabayashi’s fourth prong (is the error of 

the “most fundamental” character?). 

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B. Nature of the Error: Ineffective Assistance of Counsel

The Ninth Circuit has recognized ineffective assistance of counsel under Strickland v. 

Washington as constituting fundamental error sufficient to sustain a coram nobis petition. See 

United States v. Chan, 2015 WL 4113883 (9th Cir. July 9, 2015); United States v. Mett, 65 F.3d 

1531, 1534 (9th Cir. 1995) (holding that a post-conviction defendant no longer in custody may 

petition under the writ of error coram nobis to attack his conviction on Sixth Amendment 

assistance of counsel grounds). According to Strickland’s two-part test, a petitioner received 

ineffective assistance where counsel’s performance fell below “objective standards of 

reasonableness” and, if it did, “there is a reasonable probability that, but for counsel’s 

unprofessional errors, the result of the proceeding would have been different.” 466 U.S. 668 at 

694. 

Courts exercise considerable deference when reviewing the reasonableness of trial 

counsel’s conduct in order to avoid the “distorting effects of hindsight.” Smith v. Stewart, 140 

F.3d 1263, 1268 (9th Cir. 1998) (internal citations and quotation marks omitted). According to 

Harkonen, the Topel team’s failure to call defense expert witnesses was, nevertheless, objectively 

unreasonable. 

The team first erred, he contends, when it decided against putting any biostatistician on the 

stand to counter the government experts’ interpretation of the GIPF-001 trial’s reported p-values

and endpoints. That they didn’t have another qualified biostatistician in the wings when Mayer 

appeared to equivocate, he argues, reflects incompetence. Yet the government documents

extensively the Topel team’s thorough investigation of Harkonen’s case; their search far and wide 

for well-credentialed experts willing to testify in Harkonen’s favor and against the government’s 

likely expert witnesses; and the effort they expended confirming the positions of these witnesses, 

assessing their demeanor and articulateness, and preparing them for trial. While courts have found 

counsel’s performance deficient in instances where it is clear that counsel failed to explore 

reasonable defenses, see Luna v. Cambra, 306 F.3d 954, 961 (9th Cir. 2002) (counsel’s inadequate 

performance not challenged on appeal where counsel failed to interview and subpoena two alibi 

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witnesses and an exonerating witness), strategic decisions made subsequent to a rigorous 

investigation of relevant law and facts are “virtually unchallengeable.” Strickland, 466 U.S. at 

690. 

Here, after having prepared as many experts as reasonably possible, the Topel team 

evaluated headway made through cross examination of prosecution witnesses and weighed 

perceived risks of relying on these gains versus calling their own witnesses. The decision of 

whether to place a prepared witness on the stand is one that draws “heavily on professional 

judgment,” and courts “are not in a position to second-guess.” Lord v. Wood, 184 F.3d 1083, 1095 

n.8 (9th Cir. 1999). 

Harkonen, citing a supplementary declaration from Mayer, contends the expert did not at 

any point express to Topel thoughts that the press release might be misleading. Mayer does 

indeed declare that he maintains “no specific memory of doing so,” and moreover that “if I did it 

was in the context of explaining that an FDA regulator or a trialist such as Fleming might think the 

release misleading.” Dkt. No. 423, Ex. L. Yet whether or not Mayer expressed clear doubts to 

Topel about his position the night before he was to testify, Topel and Harkonen’s several other 

attorneys—many of whom had spent considerable time evaluating Mayer’s strengths as a witness 

and preparing him to testify—considered Mayer’s demeanor and behavior, and made a calculated 

strategic decision against calling him to the stand. Harkonen’s contentions that Topel failed to 

spend adequate time preparing Mayer and rushed through the trial for personal reasons are 

unsupported, if not contradicted, by the record. 

Even assuming that Mayer never faltered from his original stance on the press release, his 

behavior coupled with the concessions already elicited from government experts gave the Topel 

team reason to believe they had more to lose than gain from Mayer’s live testimony, and thus 

needed to shift course. The reasons the government furnishes for the Topel team’s decision 

against pitting Hannon against the more highly-accredited and influential scientist Fleming are, 

likewise, objectively reasonable. 

Harkonen next asserts that his counsels’ decision against calling Zibrak, their lead 

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pulmonology expert, to speak on the press release’s materiality and his positive experiences 

prescribing Actimmune for IPF patients, similarly constituted performance falling below objective 

standards of reasonableness. It is not in dispute, however, that Zibrak’s position in his expert 

disclosure was that doctors do not make prescribing decisions “solely” on the basis of a press 

release. Opp. p. 70. His testimony would therefore have tended to support the government’s 

position that the press release was among factors capable of influencing prescribing decisions, and 

was thus material. Further, while Zibrak had used Actimmune to treat patients, by the time of 

trial, he had ceased prescribing it. The risk Topel’s team perceived that Zibrak’s testimony could 

open the door to evidence from GIPF-007 that would be catastrophic to Harkonen’s use of the 

prior study in the press release, prompting their decision against placing him on the stand, was 

therefore not beyond the pale of reasonableness. Harkonen furthermore does not dispute that he 

and his independent counsel Winchell were involved in the team’s final strategic decision not to 

call any defense witnesses. 

Harkonen further argues in his reply that the Topel team’s decisions were also objectively

unreasonable in that they failed to line up Goodman and Rubin, whose declarations were 

introduced at sentencing by the Haddad team, as experts at trial. As noted, both scientists’ 

declarations suggested that reasonable researchers sometimes apply lower standards for proof of 

efficacy in certain instances like the one here, in which the drug being tested is for a fatal disease 

with no known effective treatments; and that the GIPF-001 study’s results did not entirely 

foreclose a conclusion that Actimmune showed survival benefits. Harkonen’s contention on this 

score fails for two reasons. First, there is no indication that the testimony of either Goodman or 

Rubin would have altered the trial’s result (indeed, the trial judge forged ahead with sentencing 

even after assessing their declarations). Second, Harkonen himself acknowledged that the 

opinions of both those experts constituted “newly discovered evidence” not previously available 

despite counsels’ exercise of reasonable diligence in their search for experts. See Dkt. No. 293. 

Harkonen finally contends that his trial counsel committed fundamental error when they 

failed to introduce the DVD excerpts at trial to counter the government’s assertion that GIPF-001 

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represented a complete failure. Again, however, this decision appears to have been reached 

through an objectively reasonable consideration of a multitude of factors. Upon several reviews of 

the tapes, Harkonen’s attorneys concluded that even where physicians shared positive impressions 

of Actimmune’s potential to yield survival benefits to IPF patients, they did not affirm GIPF-001’s 

statistical significance, and, by contrast, shared reasons why the results as reported in the press 

release were “controversial” and would be subject to criticism. Opp. p. 78, 80. Their attempts to 

contact scientists on the tapes to serve as trial witnesses in Harkonen’s favor were, in addition, 

fruitless, casting doubt on the reliability of the positions taken in the tapes, and raising hearsay 

inadmissibility issues the team would face if they attempted to introduce the DVD clips at trial in 

the absence of the taped experts. 

Because ample evidence supports a finding that each of these strategic decisions was 

objectively reasonable, Strickland’s second prong (the “but-for” test) need not even be reached 

here. An adequate showing of prejudice requires that the petitioner demonstrate counsel 

committed errors so serious that they undermine confidence in the verdict originally reached. 

Strickland, 466 U.S. at 693-94. Harkonen’s case, at best, highlights close judgment calls made by 

his attorneys that perhaps in hindsight resulted in lost opportunities to present evidence that could 

have swayed the jury in his favor. That each of these decisions was made in response to 

legitimately perceived risks, however, precludes a finding that the verdict reached in Harkonen’s 

case should be questioned. 

V. CONCLUSION

In that Harkonen fails to identify valid reasons for declining to attack his conviction 

earlier, and falls short of demonstrating that he received ineffective assistance of counsel under 

Strickland’s rigorous standard, his petition for the writ of error coram nobis must be denied. 

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IT IS SO ORDERED.

Dated: August 21, 2015

______________________________________

RICHARD SEEBORG

United States District Judge

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