Ninth Circuit Quashes Harkonen’s Last Chance

With the benefit of hindsight, even the biggest whopper can be characterized as a strategic choice for trial counsel. As are result of this sort of thinking, the convicted have a very difficult time in pressing claims of ineffective assistance of counsel. After the fact, a reviewing or an appellate court can always imagine a strategic reason for trial counsel’s decisions, even if they contributed to the client’s conviction.

In the Harkonen case, a pharmaceutical executive was indicted and tried for wire fraud and misbranding. His crime was to send out a fax with a preliminary assessment of a recently unblinded clinical trial. In his fax, Dr Harkonen described the trial’s results as “demonstrating” a survival benefit in study participants with mild and moderate disease. Survival (or mortality) was not a primary outcome of the trial, but it was a secondary outcome, and arguably the most important one of all. The subgroup of “mild and moderate” was not pre-specified, but it was highly plausible.

Clearly, Harkonen’s post hoc analysis would not be sufficient normally to persuade the FDA to approve a medication, but Harkonen did not assert or predict that the company would obtain FDA approval. He simply claimed that the trial “demonstrated” a benefit. A charitable interpretation of his statement, which was several pages long, would include the prior successful clinical trial, as important context for Harkonen’s statement.

The United States government, however, was not interested in the principle of charity, the context, or even its own pronouncements on the issue of statistical significance. Instead, the United States Attorney pushed for draconian sentences under the Wire Fraud Act, and the misbranding sections of the Food, Drug, and Cosmetics Act. A jury acquitted on the misbranding charge, but convicted on wire fraud. The government’s request for an extreme prison term and fines was rebuffed by the trial court, which imposed a term of six months of house arrest, and a small fine.1 The conviction, however, effectively keeps Dr Harkonen from working again in the pharmaceutical industry.

In post-verdict challenges to the conviction, Harkonen’s lawyers were able to marshal support from several well-renown statisticians and epidemiologists, but the trial court was reluctant to consider these post-verdict opinions when the defense called no expert witness at trial. The trial situation, however, was complicated and confused by the government’s pre-trial position that it would not call expert witnesses on the statistical and clinical trial interpretative issues. Contrary to these representations, the government called Dr Thomas Fleming, as statistician, who testified at some length, and without objection, to strict criteria for assessing statistical significance and causation in clinical trials.

Having read Fleming’s testimony, I can say that the government got away with introducing a great deal of expert witness opinion testimony, without effective contradiction or impeachment. With the benefit of hindsight, the defense decision not to call an expert witness looks like a serious deviation from the standard of care. Fleming’s “facts” about how the FDA would evaluate the success or failure of the clinical trial were not relevant to whether Harkonen’s claim of a demonstrated benefit were true or false. More importantly, Harkonen’s claim involved an inference, which is not a fact, but an opinion. Fleming’s contrary opinion really did not turn Harkonen’s claim into a falsehood. A contrary rule would have many expert witnesses in civil and in criminal litigation behind bars on similar charges of wire or mail fraud.

After Harkonen exhausted his direct appeals,2 he petitioned for a writ of coram nobis. The trial court denied the petition,3 and in a non-precedential opinion [sic], the Ninth Circuit affirmed the denial of coram nobis.4 United States v. Harkonen, slip op., No. 15-16844 (9th Cir., Dec. 4, 2017) [cited below as Harkonen].

The Circuit rejected Harkonen’s contention that the Supreme Court had announced a new rule with respect to statistical significance, in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27 (2011), which change in law required that his conviction be vacated. Harkonen’s lawyer, like much of the plaintiffs’ tort bar, oversold the Supreme Court’s comments about statistical significance, which were at best dicta, and not very well considered or supported dicta, at that. Still, there was an obvious tension, and duplicity, between positions that the government, through the Solicitor General’s office, had taken in Siracusano, and positions the government took in the Harkonen case.5 Given the government’s opportunistic double-faced arguments about statistical significance, the Ninth Circuit held that Harkonen’s proffered evidence was “compelling, especially in light of Matrixx,” but the panel concluded that his conviction was not the result of a “manifest injustice” that requires the issuance of the writ of coram nobis. Harkonen at 2 (emphasis added). Apparently, Harkonen had suffered an injustice of a less obvious and blatant variety, which did not rise to the level of manifest injustice.

The Ninth Circuit gave similarly short shrift to Harkonen’s challenge to the competency of his counsel. His trial lawyers had averred that they thought that they were doing well enough not to risk putting on an expert witness, especially given that the defense’s view of the evidence came out in the testimony of the government’s witnesses. The Circuit thus acquiesced in the view that both sides had chosen to forgo expert witness testimony, and overlooked the defense’s competency issue for not having objected to Fleming’s opinion trial testimony. Harkonen at 2-4. Remarkably, the appellate court did not look at how Fleming was allowed to testify on statistical issues, without being challenged on cross-examination.


2 United States v. Harkonen, 510 F. App’x 633, 638 (9th Cir. 2013), cert. denied, 134 S. Ct. 824 (2013).

4 Dave Simpson, “9th Circuit Refuses To Rethink Ex-InterMune CEO’s Conviction,” Law360 (Dec. 5, 2017).

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