JUDGE DU HAS VIOLATED THE CODE OF CONDUCT FOR UNITED STATES JUDGES
I. STATEMENT OF FACTS
A. Judge Du’s Verdict
1. On March 30, 2020, after presiding over a month-long bench trial in January, 2020, the Chief Judge for the District of Nevada, the Honorable Miranda M. Du, U.S.D.J., entered a verdict where she ruled that the Amarin patents at issue in the case, are invalid on grounds of obviousness. That ruling is currently on appeal before the Federal Circuit Court of Appeals.
2. In the immediate aftermath of this shocking ruling, Amarin lost billions of dollars in market cap, and the stock plummeted, losing 70% of its value. Amarin, which had just received expanded label approval from the FDA a few months prior, suffered a devastating blow to its planned capitalization upon the expanded label, and its shareholders likewise saw the value of their Amarin holdings annihilated.
B. The May, 2020 Nevada Lawyer Interview
3. In an interview published in the May, 2020 issue of the Nevada Lawyer, Judge Du, one of the Nevada District’s three specially designated patent judges, describes how she enjoys her work on patent cases, “I get tutored on varied technical issues involved in patent cases such as learning how tasers work or the benefits of fish oil.” (emphasis added).
C. Vascepa vs. Fish Oil
4. As stated on Amarin’s web site in the section entitled, “The Vascepa Difference”, “Vascepa is the first and only prescription EPA treatment approved by the FDA to lower very high triglycerides.” “Vascepa is now approved, along with certain medicines (statins), to reduce the risk of heart attack, stroke, and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more risk factors for heart disease.”
5. “Prescription medications are clinically proven and FDA-approved to treat medical conditions. They follow strict manufacturing and regulatory standards, are only prescribed by a doctor, and are purchased at a pharmacy.”
6. “Dietary supplements such as common fish oils and Omega-3s are not FDA-approved.” (emphasis added). It’s important to know that they are not intended nor proven safe or effective to treat patients with medical conditions such a very high triglycerides.”
7. “Most unproven fish oil supplements contain DHA, an Omega-3, which can raise bad cholesterol (LDL-C).” (emphasis added). Prescription EPA Vascepa has “no DHA; and Vascepa was shown not to raise bad cholesterol (LDL-C).”
8. Common fish oil is “not FDA-approved to treat medical conditions, including very high triglycerides.” (emphasis added). Vascepa is “FDA-approved and clinically proven to lower very high triglycerides.”
9. In terms of daily dose, Common fish oil “may take up to 10-40 capsules to equal the EPA in a daily dose of Vascepa.” (emphasis added). The Vascepa daily dose is “two 1-gram capsules twice a day.”
10. Common fish oil is “reported to have fishy taste or cause fishy burps.” (emphasis added). Vascepa has “no fishy burps taking four grams per day of Vascepa in a clinical trial.”
11. Common fish oil is “prone to deterioration” as the “fishy smell suggests chemical change and may be covered up by an added scent or flavor.” (emphasis added). Vascepa has “proven stability” and “demonstrated multi-year stability [preserves full effect].”
II. CODE OF CONDUCT FOR UNITED STATES JUDGES
1. The Code of Conduct for United States Judges includes the ethical canons that apply to federal judges and provides guidance on their performance of official duties and engagement in a variety of outside activities.
2. Canon 3 provides that a “Judge Should Perform the Duties of the Office Fairly, Impartially and Diligently.” Canon 3A governs “Adjudicative Responsibilities”. The Canon at issue, Canon 3A(6) provides, “A Judge should not make public comment on the merits of a matter pending or impending in any court.”
3. Canon 3A(6) is clarified in the Comment which provides, “The admonition against public comment about the merits of a pending or impending matter continues until the appellate process is complete. If the public comment involves a case from the judge’s own court, the judge should take particular care so that the comment does not denigrate public confidence in the judiciary’s integrity and impartiality which would violate Canon 2A.” (emphasis added). (Canon 2A, entitled “Respect for the Law”, provides that a “judge should respect and comply with the law and should act at all times in a manner that promotes public confidence in the integrity and impartiality of the judiciary.”
III. JUDGE DUE’S “FISH OIL” REMARK IN THE MAY, 2020 NEVADA LAWYER INTERVIEW VIOLATES CANON 3A(6) AS INTERPRETED BY THE COMMENT
If a Judge’s “public comment involves a case from the judge’s own court, the judge should take particular care so that the comment does not denigrate public confidence in the judiciary’s integrity and impartiality which would violate Canon 2A.” Canon 3A(6)(Comment). Judge Du’s “fish oil” remark violates Canon 3A(6) as interpreted by the Comment.
In the May, 2020 issue of the Nevada Lawyer, Judge Du, glibly remarked in pertinent part, how she gets “tutored on varied technical issues involved in patent cases such as learning . . . . the benefits of fish oil.” (emphasis added). Unless Judge Du presided over a fish oil case that nobody knows about, she can only be referring to Amarin’s recently completed trial against Hikma and Dr. Reddy’s involving the Vascepa patents.
That trial involved several days of expert testimony and over 2000 exhibits. The Stipulated Facts in the Final Pretrial Order stipulate that Vascepa is a “pharmaceutical composition” consisting of at least 96% pure EPA. (See Final Pretrial Order, page 22-23, ¶169-¶174). The scientific evidence indisputably establishes that Vascepa is a refined, purified FDA approved prescription medication providing substantial, documented cardiovascular health benefits while fish oil is essentially garbage which provides no documented cardiovascular health benefits. (See Statement of Facts, ¶4-¶11).
Judge Du knew or should have known all of this, yet she publicly proclaims that she learned about the “benefits of fish oil”, even though fish oil is documented to have no benefits, and even though Vascepa is indisputably distinct from fish oil. If after being exposed to all of the above, Judge Du still thinks of Vascepa as mere “fish oil”, then the public confidence in Judge Du’s impartiality would most certainly be denigrated in the eyes of any reasonable person with even the most rudimentary understanding of the facts surrounding Vascepa and the underlying case.
This is especially cogent when evaluated in the context of the Canon 3A(6) Comment’s admonition that a Judge’s public comments concerning cases in her own court, are subject to enhanced scrutiny so that the comment does not denigrate public confidence in the judiciary’s integrity and impartiality. Judge Du’s reckless comment is probative of the contention that she either did not understand the case, or she simply did not pay attention while rendering an arbitrary, destructive judgment based upon pre-conceived notions about “fish oil”, rather than impartial scrutiny of the evidence as she is duty bound to do. Judge Du has therefore violated Canon 3A(6), as clarified and placed in context by the Comment.
IV. REMEDIES
1. A formal Complaint should be filed with the Judicial Council of the Ninth Circuit.
2. The May, 2020 Nevada Lawyer article should be added to Amarin’s Appendix, and quoted in Amarin’s Reply Brief as a crystalized “Picture is Worth 1000 Words” example of how Judge Du’s analysis and conclusions in this case were “anything but rigorous”, and in all candor, completely detached from reality.
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