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Seth Waxman argued before Supremes yesterday
Arguing for NCAA against more generous benefits for students athletes. He may lose that one.
Now HERE'S a battle over cert review.
Distributed for conference 17 times so far.
https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/19-1392.html
Lizz - am not sure any more clarity
Hope Karim has more than pablum to offer
https://reutersevents.com/events/customer/conference-agenda.php
Bhatt virtual presence at Hainan seminar
http://www.pharmcube.com/index/news/article/6666
At this conference, Professor Bhatt introduced in detail the development and significance of REDUCE-IT. Professor Bhatt said that the results of the REDUCE-IT study are very statistically significant. "The P value of the primary endpoint is 0.00000001, and there are 7 zeros after the decimal point, which is the secondary endpoint of the hard endpoint (cardiovascular death/myocardial infarction/stroke). It is 0.0000001, and there are 6 zeros after the decimal point. During my clinical research, I have never seen statistical results of this level. It is not accidental."
If it is Hikma/Reddy ...
Du could align with Patent Examiner ...
... and be on safe side no matter what Supremes could later decide. She would indicate that the mistake pointed out in Rule 60 motion makes the prima facie obviousness a closer call and the secondary considerations (long-felt need, unexpected benefit, company success) pushed her to a determination of non-obviousness.
That is positive.
Suit Concerning Flawed Heart Disease Drug Trial Dismissed
https://lawstreetmedia.com/health/pharmaceuticals/securities-suit-concerning-flawed-heart-disease-drug-trial-dismissed/?utm_source=rss&utm_medium=rss&utm_campaign=securities-suit-concerning-flawed-heart-disease-drug-trial-dismissed
https://www.docketalarm.com/cases/New_Jersey_District_Court/3--19-cv-06601/SHARMA_v._AMARIN_CORPORATION_PLC_et_al/82/
Who is more likely to admit mistake
Sydney Powell, who spread the big lie on TV encouraging knuckleheads to seek to stop Congress from carrying out a constitutional function OR the knucklehead who accepted these mistruths and was caught on video destroying property in Pelosi’s office. While I hope the former has huge civil liability in the defamation department, ultimately it is the guy wearing fur and horns who is most responsible for his own actions, and thus more likely to admit his mistake.
Not a perfect analogy for sure, but again who is more willing to admit their mistake. The expert witness who oops-a-daisily mischaracterized the statistical significance and conclusions to be drawn from some prior art OR the judge who destroyed Amarin’s property by accepting these mistruths and incorporating them into her judgment. In the Court’s mind, if mistake was made in a judgment, it is not so important to delegate blame but rather to ascertain how impactful it was and if there is an appropriate remedy.
The Rule 60 motion lays out mistake on the court’s part, but does focus much more on Hikma's actions. If Du needs further statistical tutoring, she’ll let you know, but that is unlikely given the motions and exhibits submitted. Daubert is important for this effort not for its gatekeeper function but because it stands for the highest court in the land taking a stand on scientific integrity in court trials, and by implication in its judgments. If the opportunity avails itself, focus should shift to pointing out the evidence of the Court’s mistake in the judgment itself. Remember, the remedy for innocent misrepresentation (vice negligent or deliberate misrepresentation) is still rescission. And any hopes for treble damages is a pipe dream. Go for a little less rice and don't fall for the old South Indian Monkey Trap.
From your mouth to Vishnu's ear
Eleven products get implementing decision; three PR today
Of the eleven products that received CHMP recommendation in January and an EC implementing decision 3/26, three issued PRs today.
https://www.businesswire.com/news/home/20210329005598/en/Incyte-Announces-the-European-Commission-Approval-of-Pemazyre%C2%AE-pemigatinib-as-a-Treatment-for-Adults-with-Locally-Advanced-or-Metastatic-Cholangiocarcinoma-with-a-Fibroblast-Growth-Factor-Receptor-2-FGFR2-Fusion-or-Rearrangement
https://www.prnewswire.com/news-releases/karyopharm-receives-conditional-marketing-authorization-from-the-european-commission-for-nexpovio-selinexor-in-combination-with-dexamethasone-for-the-treatment-of-adult-patients-with-relapsed-and-or-refractory-multiple-myeloma-301257702.html
https://www.pharmiweb.com/press-release/2021-03-27/paion-receives-european-commission-approval-of-byfavo-r-remimazolam-for-procedural-sedatio
Lizzy - 4 business days is rule for disclosing
I do think this info is material Probably tomorrow. Wednesday at latest.
See para B.1
https://www.sec.gov/files/form8-k.pdf
May be a little over the top Bird.
Junk science needs no qualifiers to be junky.
Embrace Mori and Kurabayashi - they are your friends. Exactly because of what they don't say.
Misinterpreting Daubert
Daubert criteria were:
1) whether the theories or techniques upon which the testimony relies are based on a testable hypothesis;
2) whether the theory or technique has been subjected to peer review;
3) whether there is a known or potential rate of error associated with the method; and
4) whether the method is generally accepted in the relevant scientific community.
You repeatedly refer to the court's gatekeeper function. I agree with that concept. But it does not typically refer to testimony per se but rather testimony about techniques or methods. Hence, under Daubert courts may exclude testimony about repressed memories, revelations under hypnosis, lie detector results, or testimony about only one test more than 50 years ago performed on whether the Kent cigarette filter in question released asbestos fibers. The junk science is the underlying techniques or theories. Not the testimony. Of course if the science is worthless than the testimony can have no value.
So, in invoking Daubert you appear to be claiming Mori and Kurabayashi are junk science. That the Court should have slammed the gate, keeping utterances of their very names from being made in court. Really. The analyses undertaken by Mori and Kurabayashi seem pretty reasonably undertaken to me, and not junk science. Daubert is about keeping bad science out of court. So, until expert testimony was allowed in which misrepresented that perfectly good science there was nothing to bar under Daubert principles. Just saying.
We are in agreement Bouf
We'll disagree on this one too
If allowed oral argument, maybe chance to re-characterize
... in tone if not substance. One strategy is to more align with Patent Examiner who also found prima facie obviousness based on prior art considerations, but then viewed secondary considerations as tipping the balance in favor of granting the patents.
Your honor, thank you for this opportunity. We believe that the Court has made mistake in its understanding and weighting of both Mori and Kurabayashi. As pointed out by the Curfman paper, written by disinterested scientists, and by our statistical expert, the Court used statistical mischaracterizations, abetted by the defense team’s grossly negligent or deliberate misrepresentations, to arrive at a verdict that is not supported by the two major pieces of prior art that the Court used in conjunction with the Lovaza PDR to reach a determination of obviousness.
You have read our motion, and thus understand the issues of significant versus nonsignificant results and within-group versus between group comparisons. We believe the statistical mischaracterizations made inappropriately affected both the analyses of the obviousness associated with the prior art and the secondary considerations of obviousness.
In support of our thesis, we look to the court’s own words. The judgment indicated that the Court credits Mori over von Schacky because "von Schacky incorrectly summarized Mori, and is therefore not credible." The court implicitly admits weighting Mori heavily in detracting from von Schacky because it incorrectly summarized Mori. It should be evident in our motion, that not only did von Schacky do this but Mori also incorrectly summarized Mori. Mori himself stated, without proper foundation, that DHA and EPA had differential effects on lipids and glucose metabolism. And as the Curfman paper clearly indicates, that is not true. If the Court was willing to disregard von Schacky because of its mischaracterization of Mori, the Court should similarly be willing to disregard Mori because of Mori's mischaracterization of its own findings.
The Court’s mistake in the two pieces of prior art on which it relied heavily are very much evident in the language of its judgement. “Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels.” The Court badly misconstrues Mori. LDL-C levels were in fact raised in Mori, but the rise was not statistically significant. And while there may have been the “suggestion” that EPA reduced Apo B levels when combined with estriol, this was a within group analyses, and does not provide anywhere near the clear and convincing evidence needed for the Court’s determination.
Further, the Court uses Kurabayashi to undermine the Patent Examiner’s reliance on secondary considerations to grant valid patents to Amarin. The Court states that while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office's examiner did not consider Kurabayashi. The Court goes on to indicate that because the PTO did not consider Kurabayashi, it did not have all the material facts before it and its judgment loses “significant force.” So in considering Kurabayashi material in both its determination of prima facie obviousness and in its consideration of secondary factors, the court doubles the mistake associated with Kurabayahsi which merely showed that when EPA is combined with estriol it yielded significant within group differences over time but no significant between group differences. We feel that the legend that was inappropriately removed from Table 3 would have highlighted for the Court that Kurabayashi should not have been given any undue weight in either the prima facie obviousness determination or in the Court's analysis of secondary considerations.
In summary your honor, given the weight that the Court mistakenly put on the mischaracterizations of Mori and Kurabayishi in its judgement, we believe that the prima facie case of obviousness was never made. In the alternative, if the Court still believes the prima facie case was made, the Court should agree that given what the Court now knows what Mori and Kurabayashi really say and don’t say, that prima facie case is a much closer call now. And like the PTO, even if the Court finds a close prima facie case for obviousness, then the secondary considerations of ‘long-felt need’ and ‘unexpected benefit,’ now not being diminished by the presence of a less weighty Kurabayashi, should tip the balance for patent validation.
-----------------------------------
Summary: de-emphasis of fraud; allowance of court to use logic of PTO in finding patents valid.
Thanks for heads-up HDG.
Better stay away from Aesop's fable in court
Ralphey - you are not first to posit interaction
Ralphey - let me reframe your question more appropriately
In case you were wondering
Of the 13 medicines recommended for approval by the CHMP at the 25-29 January 2021 meeting, only one has received approval by EU.
COVID-19 Vaccine AstraZeneca received EU conditional approval on 29 January.
Meowza launches another water balloon from behind hedge.
Neither Du nor Heinecke are the bad guys
I’m afraid Du will not reverse her decision based on mistake or fraud, and all the statistical hand-wringing will not change her mind. I am not a patent law expert, and have forgotten way more than I retained from the one International Intellectual Property Law class I took. But I have scanned through much of the transcript from the case. Much emphasis is appropriately placed on the POSA (person of ordinary skill in the art) and what they would have thought about the ‘obviousness’ of the prior art. Valid patents, of course, must be non-obvious when considering the prior art. While the parties differed slightly, both Amarin and Hickma basically said that a POSA should be someone with a medical degree and several years of experience in the treatment of lipid blood disorders. Neither party suggested that the POSA should have a level of statistical expertise that was worth mentioning.
So, the question is not whether there were statistical mischaracterizations made, it is whether a POSA with the designated skill set would have looked at results from Mori and Kurabayushi and said “c’mon man, it is obvious that EPA is not going to increase LDL-C like DHA does. Mori showed, in individuals with mild hyperlipidemia, the DHA group significantly increasing in LDL-C, while the increase in LDL-C with EPA was not significant. This data point alone would not come anywhere near the clear and convincing standard required of the overall decision, but might a lipidologist with rudimentary statistical training say “it’s obvious that EPA might lower triglycerides without raising LDL-C”?
Further, it was Mori and not Heinecke that said, without proper foundation, that DHA and EPA had differential effects on lipids and glucose metabolism. Heinecke might have capitalized on this, but a POSA might have reached the same conclusion.
A POSA might have had an even easier time saying that the findings from Kurabayushi would have made development of EPA for hyperlipidemia obvious. Nonsignificant reductions in Apo-A and Apo-B in hyperlipidemic, menopausal women with estriol alone (known to elevate triglyceride levels) but highly significant reductions at each time point in women with EPA added to the estriol (27% reduction in triglyceride levels). Might a POSA have said, “c’mon man, it’s obvious someone should develop high purity EPA to combat hypertriglyceremia” knowing the results WITHIN these two groups.
Testimony at the trial also indicated that Amarin told investors in 2010 that results from Mori and Kurabayushi bode well for the development of AMR-101 (Vascepa), which certainly did not help them with their non-obvious arguments.
Heinecke did not tell blatant lies (see testimony below). He did what Amarin’s expert witness did as well – couched his answers in the most favorable terms to who he represented.
Really, the only thing that Amarin might have done and been successful would have been to put a statistical expert on the stand to get into an unfettered discussion about what Mori and Kurabayushi specifically did NOT say. I don’t think anything less than that would have worked on Du. But I do think that if Professor H. Kush has been put on the stand for a mer 60 minutes to explain the ins and outs of these findings, Du would have listened and maybe even ruled accordingly. It would have been a small investment for Amarin, the need should have been anticipated, and interviewing your own expert beats the hell out of mudwrestling the other side’s medical expert to a draw.
While Du would have listened to statistical expertise before the decision, doing so post-verdict is another kettle of fish. The Curfman paper is very strong. It is not so much opinion as statement of fact. Du will come to understand the statistical principles that Marjac puts forward, but she can still tell herself that the verdict should stand because a POSA still would have found the invention obvious. I think ‘mistake’ might have been the way to go with Kurabayushi too. Telling Du she was defrauded by an omitted legend containing redundant information sends the message that she was incapable of interpreting the ‘NS’s’ in the table without a legend holding her hand. She probably is not willing to accept that version of herself.
Let’s not forget that the Examiner at the Patent Office granting Amarin patents indicated that they were prima facie obvious based on the prior art. It was only based on secondary considerations that the patents were granted. Relatedly, Du did say that the ‘long-felt but unresolved need’ indicia for non-obviousness worked in Amarin’s favor, but she was viewing this factor as secondary to her analysis of the invention and the prior art, per the Federal Circuit’s obviousness test. Whether those secondary factors are to be integrated into the primary analysis is the issue before the Supreme Court.
If (huge if) the Supreme Court took the case, indicated that the non-prior art considerations deserved primary consideration, and remanded to the District Court, then Marjac’s brief well might provide her with the rationale to tip the scales to rule in Amarin’s favor. But that would be a long time off and she is not going to stay her original opinion in the interim. If there is a denial of cert on April 19th or the immediate weeks following, Du would likely deny Marjac’s Rule 60 motion shortly thereafter. I don’t think Marjac lives in an alternate reality. And that is why he deserves such high kudos for expending so much in the way of time and energy in the face of overwhelming odds against him. Thanks again Marjac/HK.
------ Some Heinecke testimony ------------(DDX's refer to exhibits)
Q. Did Kurabayashi report any changes in apo B levels in patients taking purified EPA?
A They did. They state that the apolipoprotein B level in the EPA group was significantly lower at week 48. They have those results shown in the table. What we're looking at here is the percent change in apo B at week 48, and what is found is that there is a nonsignificant change in the control group of minus 1.5 percent, and a highly significant change, a decrease, in the EPA group of 6.9 percent. The P value there is less than .001. That's very significant. And this was -- the analysis in this study was carried out by the one way repeated analysis of variance. So I might mention one of the advantages of this study is that they had multiple determinations of the apo B levels over the course of the study, and so they were able to use all of those in concert to determine the change in the apo B levels. And this is a more powerful approach than simply measuring the values at the beginning and the end of the study.
Q Now, based on these data, would a person of skill in the art have attributed the reduction in apo B to the estriol or to the EPA in Kurabayashi?
A The EPA therapy.
Q And why is that?
A Because a control group had a nonsignificant decrease in apo B, and the addition of EPA led to a significant decrease in apo B levels. So in this study design that would indicate that the effect was due to the EPA treatment.
Q. Could you identify this document for the record.
A Yes. This is the 2000 publication of Mori, entitled "Purified EPA and DHA Have Differential Effects on Serum Lipids and Lipoproteins."
Q Now, turning to DDX 6.44, there is another snapshot of the Mori study, which is DX 1538, from pages 1 to 2. What was the objective of the Mori 2000 study?
A The objective was to determine whether EPA -- and they say "and," but I would say "or DHA" -- have differential effects on serum lipids and lipoproteins. It was a double-blind, placebo-controlled trial. That means that the investigators were not aware of the intervention, that they used two interventions, and they compared the effects of those interventions with a group that received no therapy, a placebo group. The treatment was 4 grams of purified EPA a day, or purified DHA. And I'll note that none of the subjects were regularly taking lipid-lowering drugs, or other drugs known to a lipid -- known to affect lipid metabolism.
Q So were any of the patients in Mori 2000 taking concurrent lipid-altering therapy?
A No, they were not, and that would include the estriol or other estrogenic drugs.
Q So turning to DDX 6.45, with another snapshot of DX 1538, this time from pages 2 to 3, what was the purity of EPA used in the Mori 2000 study?
A They note that it was approximately 96 percent pure, and, again, it was given at a dose of 4 grams a day.
Q And according to Mori, what were the effects of 4 grams a day of purified EPA and purified DHA on lipid levels?
A Again, they observed a significant reduction in -- here they call them triacylglycerols, but that's triglycerides -- of 18.4 percent with EPA and 20 percent with DHA. In my opinion, the difference between 18 percent and 20 percent reduction is indistinguishable and of no clinical significance. They also note that LDL cholesterol increased significantly with DHA, by 8 percent, but not with EPA, strongly suggesting that these two Omega-3 fatty acids could have distinct effects on LDL cholesterol levels.
Q Now, does the 3.5 percent higher value for EPA indicate that there was an increase in LDL-C levels for the EPA group?
A No, it does not, and I think this comes back to trying to understand what the significance of changes is in terms of statistical testing. If one repeatedly measures a variable over and over again, there will always been variation, and so by chance alone you can have a small increase or decrease. The way one assesses a significance of a change is by making the assumption that it is different from chance. And so this is a key concept. I think it's very important to realize that small variations around the mean do not mean that those are necessarily significantly different
Q Now, turning to DDX 6.73, did the key prior art that you rely on disclose the elements that appear in all of the asserted claims?
A In my opinion, yes. The first key element is for the patient to have a triglyceride value of greater than or equal to 500 milligrams per deciliter, and I believe the Lovaza and Hayashi publications support this. The duration of therapy had to be at least 12 weeks, and, again, the Lovaza and the Kurabayashi publications would support this. The dosage needs to be about 4 grams a day, and, again, Lovaza and Mori. And, finally, the purity of the preparation of the EPA should be about 96 percent, and Mori and Kurabayashi both use EPA preparations of this purity.
Q And turning to DDX 6.74, did the key prior art that you rely on disclose the remaining elements that appear in only some of the asserted claims?
A Yes. So some of the claims require no increase in LDL cholesterol, and this would be addressed by Mori, Hayashi, and Kurabayashi. There was another requirement for a triglyceride reduction of at least 20 percent, and Hayashi addresses this issue. There was a requirement for an apo B reduction, and Kurabayashi indicates this. Moreover, Mori, et al., demonstrated that unlike DHA, purified EPA, 4 grams a day, reduced triglycerides without increasing LDL cholesterol levels. And it's -- it's obvious to me a clinician interested in this situation would have considered using 4 grams of purified EPA to treat patients with triglycerides greater than 500 with the desirable goal of not increasing LDL cholesterol level.
Excerpts from Heinecke cross examination ---
THE COURT: Counsel, I'm going to ask you to pause for a moment. I keep hearing this odd scratchy noise. Miss Clerk is going to find out what's going on.
THE WITNESS: Oh, I'm sorry, that's me. I apologize, Your Honor. I'm getting a little agitated over here.
THE COURT: All right.
MR. SIPES: I'm doing my best, Your Honor. I don't mean to agitate any one.
THE COURT: Perhaps you should take a deep breath between each sentence. That would also help the court reporter. All right. Let's resume.
...
Q Dr. Heinecke, in 2000, you –
A This might be the FDA's conclusion, but it's not my conclusion.
THE COURT: So, Dr. Heinecke –
THE WITNESS: Yes.
THE COURT: You should listen to the question asked. There was no question asked whether you agree with the FDA or your opinion of the FDA. You should take your advice about breathing before you answer.
THE WITNESS: Thank you.
THE COURT: So let's wait for the question.
THE WITNESS: Thank you.
THE COURT: All right?
THE WITNESS: Thank you. I will try and do that. Thank you very much, Your Honor.
Do your moods swing with your investment's shareprice?
If so, then Vascepa may be for you.
https://clinicaltrials.gov/ct2/show/NCT04811404?term=vascepa&recrs=abdf&draw=3&rank=14
oneman - so what is the evidence
I'd be delighted to have 30% chance
... of being discussed by the Supremes. Just don't think all those 200 cases rejected for cert last week were discussed just because they were listed for "discussion conference". If everyone is on it, it wouldn't be much of a short list. I do think there is a short list put together by the clerks in consultation with their bosses and their fellow clerks. When Friday rolls around, the justices meet with a roomful of binders (and no clerks). I might even go so far as to say, 20 days out from our scheduled conference, the binders haven't even been finalized yet.
oneman - we can disagree on this but
I think if you look at the 200 certs denied this past Monday, and put their case numbers in the docket search, they were all "distributed for conference." They couldn't all have been on a short list.
https://www.supremecourt.gov/orders/courtorders/032221zor_l5gm.pdf
No "ignore altogether" option for Supremes
Boils down to Du being a statistical naif
... and the judge's willingness to admit it
Yes, the legend was omitted, but all the intergroup "NS's" were in the table in her opinion. Are we saying she didn't know what those NS's meant?
Yes, she fell for the statement "In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA
would have attributed the reduction in Apo B to EPA." but there were statistically significant differences "OVER TIME" in one group and not the other, and the end of that phrase "a POSA would have attributed the reduction in Apo B to EPA" is statistically unsound opinion rather than a statement of fact by Heinecke that was adopted by Judge Du. Admittedly, the wording is weaselly.
So, combined with her misunderstanding of what Mori really was saying, it is clear that she lacked the statistical sophistication to handle this case. Sure she had some help from Heinecke, but it was on her and it is her judicial decision. (It would have been nice if Amarin could have helped her understanding). So, is she big enough to admit here naivete?
Vincent Gambini has nothing on you.
Marjac: ""Look at our Exhibit F, the Kurabayashi paper. Now look at Table 3, it has five rows. Now look at Defendants' Post-trial Findings of Fact (their final submission before the Court began deliberating on its decision), there are only three rows. Now look at the Court's Opinion, there are only three rows. HOW DOES THIS HAPPEN?"
Heinecke was medical expert not statistical expert
And even though HK deliberately and fraudulently misled the board by stating Heinecke was a PhD scientist, after HK had spent months studying this man's words in preparing his Rule 60 motion, alas, Heinecke is but a lowly MD, who pointedly are not known for their statistical prowess.
While of course I am being facetious about the intentionality of HK's inadvertent mischaracterization of Heinecke's graduate degree, people do make errors, including the cutting off of legends and captions from a figure. However, regardless of Heinecke's level of statistical expertise, as defense's expert he had a duty to get the figure right, and his documented training indicates that he knew in advance that to commit the infraction that he committed, could be held up as potential fraud.
HK - agreed, but nice that fraud his word
Nobody will accuse you of being consistent STS66
First, you want to say that a cropped table shows the "discarding of data" where there is no evidence of an affirmative act indicating "throwing out."
And then when a slide raises the question, by its own words, does fraud occur when non-supporting data is left out of a figure, you state it "totally lacked evidence of anything". You could not be more wrong. It certainly is evidence that the presenter was making a potential connection for his viewers between the omission of information from a figure and a fraudulent act.
Okay sts66 - show us the "discarding of data"
Because that sounds like a deliberate act.
Here's what real experts say:
"The last point in the definition is crucial; the key distinction between misconduct or fraud and honest error is intent (fraud is ‘intent to cheat’). For instance, forgetting to report a value is honest error, deliberately not reporting the value is fraud; incorrectly copying a value is honest error, purposely changing the value is fraud."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4340084/
so, we are back to demonstrating intent
HK - saying something was deliberate isn't proof
Again, I applaud the job done by you and Marjac on the motions; it is fantastic work.
But,
"The legend describing the lack of intergroup difference by student unpaired t-test for each time point was deliberately omitted
"This Court was misled by a deliberate misrepresentation of the scientific truth, hidden behind a cropped table with a critically omitted legend,
It is a high standard for intentional misrepresentation, and it should be. Like you might have a recording of a conversation indicating that "the table must be cropped in order for us to win." Or the statistical significance levels were whited-out.
But, gross negligence by an expert in the statistical subject matter of the testimony given in court is tantamount to fraud without needing any proof of intentionality. I just think the team needs to consider other options to get to the same point rather than relying on language like "Defendants have hidden the fact" (deliberate concealment) and "deliberately misled." I'm sure marjac will plead various alternatives if the case gets further along but I just don't see the direct evidence of fraud. That kind of rhetoric might be fine for closing statements but might be seen as hyperbole at earlier stages. It is early yet, and you can always rely on the fact that you knew that defense's medical expert was previously on record as indicating that omitting less-supporting information from a figure to make a stronger scientific point raises the specter of fraud.
Fraud is hard to prove because of “intentional” component
At best Heinecke would argue that he didn’t intentionally give any false evidence. If a proceeding (or brief) got to that point, thought should be given to arguing that Heinecke’s misrepresentation raises to a level of fraud under contract principles.
The argument goes like this:
In any judicial proceeding, the lawyers and the judge are bound by an oral contract to follow the codes of professional conduct. The oral agreement is basically, that the parties agree to act honestly and in return, the judge agrees to render an impartial decision. Pertinent rules seen below:
Rule 3.3. Candor Toward the Tribunal. (NEVADA RULES OF PROFESSIONAL CONDUCT)
(a) A lawyer shall not knowingly:
(1) Make a false statement of fact or law to a tribunal or fail to correct a false statement of material fact or law previously made to the tribunal by the lawyer;
(2) Fail to disclose to the tribunal legal authority in the controlling jurisdiction known to the lawyer to be directly adverse to the position of the client and not disclosed by opposing counsel; or
(3) Offer evidence that the lawyer knows to be false.
Rule 3.4. Fairness to Opposing Party and Counsel. (NEVADA RULES OF PROFESSIONAL CONDUCT) A lawyer shall not:
(a) Unlawfully obstruct another party’s access to evidence or unlawfully alter, destroy or conceal a document or other material having potential evidentiary value. A lawyer shall not counsel or assist another person to do any such act;
(b) Falsify evidence, counsel or assist a witness to testify falsely, or offer an inducement to a witness that is prohibited by law;
Rule 2.2. Impartiality and Fairness. A judge shall uphold and apply the law, and shall perform all duties of judicial office fairly and impartially. (Nevada judicial conduct code)
Further, under established contract law, there are three forms of misrepresentation:
- Innocent
- Negligent
- Intentional
The remedy for negligent misrepresentation, is rescission of the contract (the judicial decision) and damages.
It could certainly be argued that when the defense put on an expert witness that gave written testimony that was at odds with basic research ethics principles that he himself had taught, that, if not outright fraud, this misrepresentation was gross negligence that was tantamount to fraud under established legal principles and thus the contract requirement of tribunal honesty was breached by the Hikma defense team and the “contract” (decision) should be rescinded and damages awarded.
It is a bit of a stretch, but not as tough as proving what was in the mind of an expert witness when he gave misleading testimony.