Amarin Corp Plc (AMRN)

[ratna1]

Marj, thank you for your contribution. I just took the liberty to quote your complaint in my retort of yesterdays scandalous slander of AMARIN's press release by the editor of Seeking Alpha.
See here what I published :

"I can see why an editor can produce such a headline reeking either of an attempt to ridicule AMARIN’s proven heart drug VASCEPA or of complete ignorance of science without being fired on the spot when he is actually adressing an audience that matches his lack of comprehension....
To play to an audience for a cheap laugh whilst undermining the livesaving capacity of VASCEAP means putting lives at risk - maybe for just the audience he just alienated to the true beneifits of VASCEPA.SInce 45 % of all fatalities in the USA are caused by cardiovascular disease that likelihood is quite high!
This is an ethical concern!
The American Heart Associaton as well as Harvard Medical School hailed VASCEPA as the most important new drug in heart medicine in 30 years! VASCEPA has been declared "Standard Of Care" for diabetes, but an editor for Seeking Alpha assumes he knows better than that…..
VASCEPA is not even just purified EPA - which is a part of all Omega3 formulations - but an Ethyl Esther derived from it. As such it is a "New Chemical Entity" and was therefore given additional legal protection as AMARIN had found or produced a molecule not know before to man!
Mixing up this lifesaving prescription drug with fish oil smells of either an hidden agenda of libel and slander or plain ignorance and fails ANY journalistic code of conduct to do due dilligence before reporting!
It just makes me sick
It is this prescription medicine that is preventing between 30 to 35 % of heart attacks and strokes and other "Major Adverse Cardiac Events" !
Actually the numbers go up to over 45% for patients that have taken VASCEPA for longer than 5 years !
A newly released study shows that patients taken VASCEPA had 45 % less bypass or open
heart surgeries!

In contrast ALL (!) 400 plus clinical studies of Omega3 supplements have failed to prove ANY heart benefit whilst at the same time it was found circumstantially that most of these supplements were actually toxic or degraded as the fish oil got rancid, changed chemical components or held heavy metals. NONE of the 400 plus studies sponsored by the DS industry ever showed any health benfitat all which is why the European Medical Agency has forbidden the prescription of ALL Dietary Supplement claiming heart benefits EXCEPT only the pharmaceutically pure, new drug VASCEPA!
It appears that the Ethyl Esther in VASCEPA is stopping most of the inflammatory processes in the body by reducing the level of Archidonic Acid (AA) in the blood. AA is being targeted as it is considered the root cause for so called "Systemic Inflamation Cascade"!
It has been shown that VASCEPA can reduce AA in the blood by up to 90% in a matter of months !
This is why AA/EPA ratio is held as a gold standard by many in preventive medicine:
https://blog.healthmatters.io/2018/12/27/what-is-the-aa-epa-ratio/

Because of this ability of VASCEPA to modulate and reduce inflammatory processes in the body it was overdue that it is being researched as COVID 19 shows numerous traits that no other virus ever displayed and thus undermines traditional approaches to respiratory infections:
Coronavirus hijacks cells in unique ways that suggest how to treat it - STAT-News
https://www.statnews.com/2020/05/21/coronavirus-hijacks-cells-in-unique-ways

So a link to the original press release would have been the least to do for journalistic objectivity:
https://investor.amarincorp.com/news-releases/news-release-details/amarin-supports-trial-investigate-effects-vascepar-icosapent

In closing I would like to muse that an editor being this reckless should be worried that a case is being brought against him for libel and slander as just happened to Judge Du who presided over the scandalous mistrial in Nevada that was ripe with at least 6 legal and procedural faults because Judge Du also clearly did not understand the difference between fish oil and VASCEPA:

See for yourself. This complaint has ALL the scientific facts spelled out:

"FORMAL JUDICIAL MISCONDUCT COMPLAINT AGAINST JUDGE DU FOR VIOLATING CANON 3A(6) HAS BEEN FILED TODAY. Expect it to take 14-21 days to be processed and docketed.

MICHAEL S. KASANOFF, LLC

ATTORNEY AT LAW

157 BROAD STREET, SUITE 321
P.O. BOX 8175
RED BANK, NJ 07701

PHONE: [phone]
FAX: [phone]
E-MAIL: [e-mail]
REPLY TO P.O. BOX 8175

May 20, 2020

VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Judicial Council of the Ninth Circuit
Attn: Judicial Misconduct
P.O. Box 193939
San Francisco, CA 94119

Re: In the Matter of the Honorable Miranda M. Du, U.S.D.J.
COMPLAINT OF MISCONDUCT

Dear Sir/Madam:

I am submitting a formal Complaint of Misconduct for violating Canon 3A(6) of the Code of Conduct for United States Judges, against the Honorable Miranda M. Du, U.S.D.J., who is the Chief Judge for the District of Nevada. Please note that this Complaint of Misconduct is not being submitted on behalf of, or with any endorsement from, Amarin Pharma, Inc., but is being submitted exclusively on behalf of myself. Pursuant to Local Rule 6.1(e), enclosed is an original and one copy of the Complaint, Statement of Facts, and Exhibits.

1. Name of Complainant: Michael S. Kasanoff, Esq.

Contact Address: 157 Broad Street, Suite 321,
P.O. Box 8175
Red Bank, NJ 07701

Daytime telephone: [phone]

2. Name(s) of Judge(s) Honorable Miranda M. Du, U.S.D.J.

Court: District of Nevada

3. Does this complaint concern the behavior of the judge(s) in a particular lawsuit or lawsuits?

[X] Yes [ ] No

If “yes”, give the following information about each lawsuit:

Court: District of Nevada

Case Number: 2:16-cv-02525 (MMD) (NJK)
Amarin Pharma, Inc. v. Hikma
Pharmaceuticals, USA, Inc., et. al.

Docket number of any appeal to the Federal Circuit: 20-1723

Are (were) you a party or lawyer in the lawsuit?

[ ] Party [ ] Lawyer [X] Neither

If you are (were) a party and have (had) a lawyer, give the lawyer’s name, address, and telephone number:

Not applicable

4. Have you filed any lawsuits against the judge?

[ ] Yes [X] No

If “yes”, give the following information on each such lawsuit:

Court: Not applicable

Case Number: Not applicable

Present status of lawsuit: Not applicable

Name, address, and telephone number of your lawyer for the lawsuit against the judge:

Not applicable

Court to which any appeal has been taken in the lawsuit against the judge:

Not applicable

Docket Number of the appeal: Not applicable

Present status of the appeal: Not applicable


5. Brief Statement of Facts (1198 Words)

I. SUMMARY OF THE COMPLAINT OF MISCONDUCT

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). In the May, 2020 issue of the Nevada Lawyer, Judge Du stated how she gets “tutored on varied technical issues involved in patent cases such as learning . . . . the benefits of fish oil.” (emphasis added) (Exhibit “A”).

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. (Statement of Facts, ¶5-¶12; Exhibit “B”). By making this comment, Judge Du essentially trade labeled Amarin, and its flagship product, Vascepa, thereby violating Canon 3A(6), as interpreted by the Comment.

II. STATEMENT OF FACTS

A. Judge Du’s Verdict

1. On March 30, 2020, after presiding over a month-long bench trial in January, 2020, Judge Du, 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, devastating both the company and its shareholders.

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) (Exhibit “A”).

4. The reporter who conducted the interview, Jennifer Smith-Pulsipher, can confirm that the interview took place in February, 2020, after the bench trial concluded on January 31, 2020, but prior to the verdict on March 30, 2020.

C. Vascepa vs. Fish Oil

5. As stated on Amarin’s web site in the section entitled, “The Vascepa Difference”(Exhibit “B”), “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.”

6. “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.”

7. “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.”

8. “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).”

9. 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.”

10. 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.”

11. 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.”

12. 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].”

III. APPLICABLE LAW - 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.”

IV. JUDGE DU’S “FISH OIL” REMARK IN THE MAY, 2020 NEVADA LAWYER
INTERVIEW VIOLATES CANON 3A(6) AS INTERPRETED BY THE COMMENT

The subject 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)(Exhibit “C”). 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, ¶5-¶12).

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 perception 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 evaluation 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.

6. Acknowledgment, declaration and signature:

I understand that even if I successfully prove that the judge engaged in misconduct or is disabled, this procedure cannot change the outcome of the underlying case.

I, declare under penalty of perjury that the statements made in this complaint are true and correct to the best of my knowledge.

(Signature) S/Michael S. Kasanoff (Date) 05/20/2020



Respectfully submitted,
Michael S. Kasanoff"