Complaint to HHS requesting compensatory damages:
William A. Biglow
Deputy Associate General Counsel
U.S. Department of Health and Human Services
OGC/GLD/CELB
330 C Street, S.W.
Switzer Building, Suite 2600
Washington, D.C. 20201
William.biglow@hhs.gov William.biglow@hhs.gov
Addendum to SF95 Claim
INTRODUCTION
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The HHS/FDA belong to the Executive Branch of Government. The executive is the part of the government that has sole authority and responsibility for the daily administration of the state. The executive branch executes, or enforces the law. The division of power into separate branches of government is central to the idea of the separation of powers. The separation of powers system is designed to distribute authority among several branches…. an attempt to preserve individual liberty in response to tyrannical leadership throughout history. The executive officer is not supposed to make laws (the role of the legislature or interpret them, the role of the judiciary). The role of the executive is to enforce the law as written by the legislature and interpreted by the judicial system. Significantly changing policy remolds purpose altering the original intent of law. Specific to this complaint, I list numerous significant policies’ changed that altered normal administration of duties altering timing and intent of law. These significant policy changes where performed in the scope and time of employment of the individuals listed. CDER officials changed the regulatory scheme retroactively unsettling my reasonable investment-backed expectations destroying my private property, AMARIN COMMON STOCK.
The Court has frequently emphasized that the term “property”, as used in the Taking Clause, include the entire “group of rights inhering in the citizen’s [ownership]” United States v. General Motors Corp. The term is not used in the vulgar and untechnical sense of the physical thing with respect to which the citizen’s relation to the physical thing as the right to possess, use and dispose of it…The constitutional provision is addressed to every sort of interest the citizen may possess. I emphasize my Amarin common stock is my PROPERTY and affords me the rights to bring this complaint in accordance to the law.
COMPLAINT
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1. Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is an ultra-pure, EPA-only omega-3 fatty acid product available by prescription.
2. Vascepa was approved on 7-26-2012 in accordance to Phase 3 Clinical Trial study and design with the FDA, Marine Special Protocol Assessment. A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that a completed Phase III trial design, clinical endpoints, and statistical analyses are acceptable for FDA approval. SPA guidance is posted on the FDA website. Historically under SPA guidance if meeting all defined primary and secondary endpoints, FDA has ALWAYS approved the indication negotiated in SPA.
3. Vascepa was approved without an exclusivity determination; Amarin requested 5 years of exclusivity referred to as New Chemical Entity. An exclusivity determination is made at time of approval, otherwise known as the PDUFA date.
4. On 2-21-2014 CDER assigned Vascepa 3 years of exclusivity and denied Amarin the requested 5 years of New Chemical Entity.
5. On 2-27-2014 Amarin filed a lawsuit against FDA for "arbitrary and capricious" determination of exclusivity.
6. Amarin filed sNDA based on Anchor SPA, spring of 2013. FDA set PDUFA date for this applications indication for December 20th 2013, and an Advisory Committee was scheduled and met on 10-16-2013 to discuss this application.
7. On 10-29-2013 FDA rescinded Anchor SPA, and based its decision to rescind the SPA AGREEMENT on underpowered, post-hoc, and exploratory analyses of data from different drug classes tested in different patient populations that were KNOWN to the FDA YEARS before the SPA agreement was rescinded. Both houses of congress have requested an explanation for this significant policy change and wrote this request into the 2015 budget.
8. FDA delayed Anchor PDUFA date 12-20-2014 and did not communicate a new PDUFA date; this is a significant change in policy.
9. Amarin appealed the rescindment in early 2014 through October 2014; appeal was denied by all levels through review DMEPII, ODEII and ultimately Dr. John Jenkins, M.D. Director of Office of New Drugs.
10. Amarin stakeholders filed a Citizen Petition 12-6-2013, no answer has been given to date. The regulatory timeframe for an expected response is 150 days.... presently closing in on 400 days.
11. Amarin common stock has been DECIMATED. The damage started with the approval of Vascepa on 7-26-2012, AMRN $15.96 (7-29-2012) to a low of $0.78 risking delisting of Amarin publicly traded shares.
NATURE OF THE ACTION
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12. This claim is filed pursuant to Federal Tort Claims Act and submitted to HHS Claims Office in accordance with Federal Statute 28 US Code Chapter 171- Tort Claims Procedure.
13. The complaint addresses HHS/FDA/CDER employees whom violated torts specific to Federal Statue 28 US 1346(b) while employed and acting in their assigned duties. As a direct result of these actions damaged my private property, Amarin common shares traded on NASDAQ US Stock Exchange.
14. Furthermore, the following tort violations led to significant policy changes that breached 1st, 5th “Takings Clause”, and 14th Amendments. These actions satisfy all Penn Central Points of a Regulatory Taking's Claim: 1) Economic impact of the regulation, undisputed decimation of Amarin public shares 2) Owner’s reasonable investment-backed expectations, expedient exclusivity after drug approval process and strict adherence to written SPA guidance 3) Character of the regulatory Action, Significant changes in multiple policy’s led to changing regulatory schemes and retroactively unsettling my stakeholder reasonable investment-backed expectations. These expectations where based on FDA/CDER policy and not covered under SEC safe harbor statement for publicly traded stock. Significant policy changes must either be approved by congress or vetted through post & comment rule making as required by law. Any other means of significant policy change remolds original intent of law and violates the constitutional division of power.
15. The following alleged torts remolded significant changes to policy without post and comment rule making required by congress for SIGNIFICANT changes. Negligent Supervision, Negligent Retention, Negligent Entrustment, and Negligent Hiring either remolded significant changes in policy or employees where not required to follow current policy. In either circumstance, CDER employees where not properly supervised in policy management, directly leading to changing regulatory schemes and retroactively unsettling Amarin stakeholder reasonable investment-backed expectations. Value of Amarin common stock dropped form high of $15.96 a week prior to Marine approval (7-19-2012) to a low of $0.78 (just recently) risking delisting from NASDAQ Stock Exchange.
16. Negligent Supervision, Negligent Retention, Negligent Entrustment and Negligent Hiring are recognized under FTCA and are torts covered under civil law in the District of Columbia the alleged location of action. Respondeat Superior is a legal doctrine, which states that an employer is responsible for the actions of employees performed within the course of their employment. These following allegations where all done in the scope and time of employment. FDA/CDER review team has a master and servant relationship ultimate supervision of CDER rests with Dr. Janet Woodcock. Dr. Janet Woodcock directly reports Commissioner Margaret Hamburg, Commissioner Hamburg report to Kathleen Sibelius now HHS Secretary Sylvia Burwell.
17. I'm requesting DUE PROCESS, affording to me by the 5th and 14th amendments, from your office and the sum certain JUST compensation of $3,319,782.76 Total 12.d of SF95 form. Due Thursday, April 16th, 2015.
18. I’m requesting this settlement “out of court” to not further waste tax dollars on such an obvious contravention of Regulatory Takings.
19. If no settlement can be reached the addition of Attorney’s fees will be added when the claim is filed in the appropriate venue. Both 5th and 14th amendments afford me the request for just compensation and due process.
COUNTS:
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(1) Negligent Supervision: Janet Woodcock, Mary Parks, Jean-Marc Guettier Eric Colman
20. Kati Johnson was the Regulatory Project Manager responsible for the review of Vascepa Marine NDA review. Eric Colman approved and signed the review despite NOT being completed with Vascepa exclusivity at the date of approval; this is customary policy…. now written policy MAPP 4520.1 Communicating Drug Approval Information. Rarely has this policy been deviated from, and NEVER has this decision taken 18 months and further remained unresolved as the determination is the topic of a lawsuit. Furthermore, CDER now has a written Policy, MAPP 4520.1 Communicating Drug Approval Information, covering the timely importance of this decision. Amarin requested 5 years of exclusivity referred to as New Chemical Entity. This was a significant policy change in regulatory scheme that damaged Amarin stakeholders. The absence or exclusivity inhibited Amarin CEO from following the publicly stated plan of selling Amarin for no less than $30 per share. 3000% greater than the current share price today! Lack of exclusivity makes it impossible for an acquiring company to value Vascepa life cycle. Absent exclusivity also prevented Amarin from negotiating partnerships to assist in launching Vascepa. Amarin was forced to leverage all IP (Patents) for $150,000,000 loan. There are multiple breaches in supervision pertaining to exclusivity at many different levels in the Division of CDER. The significant exclusivity policy and delay, changed regulatory scheme retroactively unsettling my reasonable investment-backed expectations of 5 years NCE awarded at time of approval, damaged my private property, Amarin common stock.
(2) Negligent Retention: Eric Colman
21. Eric Colman was maintained as Deputy Director of Division of Metabolism and Endocrinology Products Office of Drug Evaluation II despite past complaints from Arena Pharmaceutical Stakeholders of unfair treatment at past Advisory Committee meeting.
(3) Negligent Supervision: Elizabeth H. Dickinson
22. Elizabeth H. Dickinson is the FDA Chief Counsel; she is directly responsible for the legal review of the Director of CDER Dr. Janet Woodcock exclusivity decision. On June 22, 2012 Amarin met with Elizabeth H. Dickinson, Esq., to discuss Vascepa exclusivity. Elizabeth H. Dickinson failed to supervise the correct and TIMELY decision of exclusivity. On 2-21-2014 Dr. Janet Woodcock assigned 3 years of exclusivity to Vascepa. However, the final determination of exclusivity is still legally unanswered and is still being litigated in the District Court of Columbia 1:14-cv-00324-RDM AMARIN PHARMACEUTICALS IRELAND LIMITED v. FDA. This decision does not add to the merits of ripeness.
(4) Negligent Entrustment: Director Janet Woodcock
23. October 16th, 2013 Dr. Mary Parks had already failed to either follow or institute appropriate policy, a timely review and determination of Marine Vascepa exclusivity. At the time of the Advisory Committee meeting product exclusivity was 15 months over due. Dr. Parks was assigned the ranking member of CDER present at the October 16th Advisory Committee. The policy’s related to Anchor review where clearly not understood or not going to be followed, Vascepa’s exclusivity delay was enough to assume Mary Parks was under qualified or not properly trained in policy to lead at Advisory Committee.
(5) Negligent Hiring: Director Janet Woodcock
24. Negligent Hiring: The October 16th Advisory Committee members are paid special government employees, they must disclose conflicts to qualify for service. On October 16th 2013, Special Government employees failed to disclose significant conflicts of interests. These concerns where brought to CDER’s attention through an email communications with CDER Ombudsmen, prior to Ad Com meeting.
(6) Negligent Supervision: "res ipsa loquitur" Mary Parks, Jean-Marc Guettier. Video, Transcript, and Policy are available for public viewing.
25. Mary Parks and Jean-Marc Guettier, ranking members of CDER at October 16th Advisory Committee, failed to DIRECTLY supervise Eric Colman. Dr. Colman revealed for the first time, in a public forum, CDER had strong considerations of rescinding Anchor SPA. This communication directly violated FDA SPA Guidance and significantly changed the regulatory scheme unsettling my reasonable investment-backed expectation.
These SPA communications should have been disclosed to Amarin, in a privately held meeting in accordance to Special Protocol Guidance available to investors on the FDA website. Dr. Colman violated Federal Ethics rules by disclosing non-public information at a public forum. Amarin stakeholders learned for the first time, CDER was considering rescinding Anchor SPA.
(7) Negligent Supervision: Mary Parks
26. Mary Parks, ranking CDER member at October 16th Advisory Committee, failed to DIRECTLY supervise Acting Designated Federal Officer Stephanie L. Begansky, when special government employees requested the voting question be changed they where ultimately refused the request. This contributed to the negative vote, used as evidence to support rescinding Anchor SPA. It has been common policy to change the wording of the voting question when the direction of the question has been unclear and a request has been made. In fact, to my knowledge, a request has NEVER been denied.
(8) Negligent Supervision: Director Janet Woodcock
27. CDER Direct Dr. Janet Woodcock failed to provide Senior level staff educated in policy to supervise the October 16th Advisory Committee. The significant policy changes changed the regulatory scheme retroactively unsettling my reasonable investment-backed expectations of DUE PROCESS.
(9) Negligent entrustment: Director Janet Woodcock
28. It is reasonable for stakeholders to assume FDA Advisory Committee members and special government employees, be trained in the applicable policy’s relevant to the voting question. Special Government employees where voting to add significant change in regulatory SPA policy they where not granted the authority to make.
(10) Negligent Supervision: Curtis J. Rosebraugh, M.D., and Director ODEII
29. Director Rosebraugh failed to supervise Mary Parks, Jean-Marc Guettier, Eric Colman when ODEII, made a decision to rescind Anchor SPA. FDA SPA guidance was not followed. Amarin and stakeholders where refused due process and the significant change in the regulatory scheme retroactively unsettling Amarin stakeholders reasonable investment-backed expectations of due process. The decision to rescind Anchor SPA was made before October 16th Ad Com. The following day after the October 16th Advisory Committee, Amarin common stock price crashed on massive record volume. The stock dropped to levels not supported by institutional investors. It’s economic FACT this jeopardized the vary existence of Amarin to survive as a publicly traded company while maintain it’s current structure. As a result the company laid off half its sales staff; further damaging sales in the months that followed. Rescinding Anchor SPA also significantly jeopardizes Amarin’s ability to finish the large Cardiovascular Outcome Trial, REDUCE-IT.
(11) Negligent Supervision: Director Janet Woodcock
33. CDER Director Dr. Woodcock failed to properly supervise all subsequent appeals of Amarin Anchor SPA rescindment. The high standards Congress set to rescind a SPA, where significantly changed. The FDA had three appeal opportunities to correct the policy errors. Instead, each appeal review continued to use an underpowered, post-hoc, and exploratory analyses of data from different drug classes tested in different patient populations as scientific evidence to rescind Anchor SPA. These studies where KNOWN to the FDA YEARS before the SPA agreement was rescinded, yet none of this was communicated to Amarin in accordance to written SPA protocol.
(12) Negligent Supervision: Director Janet Woodcock
34. CDER Director Janet Woodcock failed to supervise the Office of Policy, this office is charged with the timely review and response to Citizen Petition. Specifically the Citizen Petition requesting the approval of Anchor and reinstatement of Anchor SPA. To this date due process in accordance to congressional law has been denied.
(13) Negligent Supervision (14) Negligent Retention (15) Negligent Entrustment and (16) First Amendment: CDER Director Janet Woodcock
35. Director Janet Woodcock failed to supervise Office of Policy who administered rules censoring private citizens comments. Specifically to Citizen Petitions requesting Anchor SPA reinstatement and Anchor approval. This continued even after written communication of alleged First Amendment violations requesting comments be posted. Policy and laws cannot be made to supersede the constitutional rights of American citizens. Amarin stakeholders where denied the ability and “right of the people peaceably to assemble, and to petition the government for a redress of grievances”. This allegation has been directly reported to congress.
(17) Negligent Supervision (18) Negligent Entrustment (19) 14th Amendment
36. On September 21 2012, Beverly Friedman Office of FDA Regulatory Policy FDA was sent a patent extension application of US patent no. 8,188,146. The application requested Vascepa product confirmation; this form was never completed despite a reminder letter sent from USPTO, again to Ms. Friedman on June 11 2013. Under 35 USC 156, Vascepa was not granted due process. This will costs Amarin valuable life cycle sales potentially amounting to Billions of dollars.
(20) 5th Amendment "Takings Clause"
37. The totality of violations, (1) – (19) significantly changed the regulatory scheme unsettling my reasonable investment-backed expectations destroying my private property, AMARIN COMMON STOCK. Policy’s where changed or simply not followed. Significantly changing policy remolding purpose altering the original intent. Congress has instructed the FDA in the proper procedure to significantly change policy; this procedure was not applied to these policy changes. The division of power into separate branches of government is central to the idea of the separation of powers. The separation of powers system is designed to distribute authority among several branches…. an attempt to preserve individual liberty in response to tyrannical leadership throughout history. The "Takings Clause" requires the government to pay just compensation to individuals and businesses when changed regulatory scheme retroactively unsettles their reasonable investment-backed expectations and thereby destroys their property. Many of these policy breaches occurred at the October 16th Advisory Committee. Advisory Committees should have significant leeway to tease out scientific points; however, policy and laws cannot be made to supersede the constitutional rights of American citizens and the due process given to them under the 14th Amendment. However, the egregious violations of the First Amendment must not be overlooked or discounted as frivolous, as so I’m requesting JUST COMPENSATORY DAMAGES of $25,000,000.
Nothing can be worse than our Government willfully suppressing the rights of Free Speech. Under this circumstance compensatory damages "are intended to redress the concrete loss… that (I) plaintiff has suffered by reason of the defendant's wrongful conduct”. A plaintiff may be compensated for intangible, psychological injuries as well as financial, property, or physical harms proximately caused by the wrongful conduct. Compensable losses include lost or diminished earnings, lost profits, pain and suffering, and emotional distress.
Case Law:
Pacific Mutual Life Insurance Co. v Haslip
$1 million in punitive damages awarded in that case was four times the amount of compensatory damages that had been sought and awarded.
TXO Production Corp. v. Alliance Resources Corp.
In TXO, the Court upheld an award of $19,000 in compensatory damages and $10 million in punitive damages in a bad-faith slander of title action against TXO.
State Farm Mutual Insurance Co. v. Campbell
Supreme Court held that the ratio of punitive damages to compensatory damages awarded must generally not exceed a single-digit ratio (in this particular case, the award’s ration would have been three digits: 145:1
Philip Morris USA v. Williams
In that case, decided in 2007, the Court held that a jury may not award punitive damages for a defendant’s conduct against individuals who are not parties to a suit. Put another way, a jury may consider only harm that the defendant caused to the parties of the lawsuit when calculating punitive damages.
Williams involved a jury’s awarding the plaintiff $821,000 in compensatory damages and $79.5 in punitive damages (nearly a 100:1 ratio). Interestingly, the Supreme Court did not strike down the award under the single-digit ratio guideline it had established in State Farm. Rather, it remanded the case to the Oregon Supreme Court to determine whether there had been a procedural-due-process violation in the trial judge’s instructions to the jury. The Oregon Supreme Court ended up finding no procedural-due-process violation and affirmed the verdict, and in 2009 the U.S. Supreme Court surprisingly dismissed the certiorari petition as having been improvidently granted, leaving the verdict untouched.
38. The Court has frequently emphasized that the term “property” as used in the Taking Clause include the entire “ group of rights inhering in the citizen’s [ownership]” United States v. General Motors Corp., 323 US 373 (1945). The term is not used in the vulgar and untechnical sense of the physical thing with respect to which the citizen’s relation to the physical thing as the right to possess, use and dispose of it…The constitutional provision is addressed to every sort of interest the citizen may possess. I ATTEST MY COMMON SHARES OF AMARIN STOCK is property.
39. My property damages are directly related to significant changes in FDA/CDER policy's, written and unwritten, changing the regulatory scheme and unsettling my reasonable investment-back expectation of a JUST review of Vascepa NDA from both Marine and Anchor SPAs, timely Marine exclusivity decision, and expectations my Civil Rights would not be violated.
41. My private property, Amarin common shares have been decimated due to a significant change in the regulatory scheme, policy and unsettled my reasonable investment-backed expectation CDER would ADHERE to current SPA guidance leading to the full approval of the Anchor indication at the given December 20th PDUFA date.
42. I request compensation for my damages, $3,319,782.76 Total 12.d of SF95 form and JUST COMPENSATORY DAMAGES of $25,000,000 for
Intangible damages, lost profits, pain and suffering, and emotional distress brought on by suppression of Free Speech and interference with due process.
THE PARTIES
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43. Kati Johnson, Regulatory Project Manager
44. Beverly Friedman, FDA
45. Eric Colman-deceased R.I.P., Deputy Director of Division of Metabolism and Endocrinology Products Office of Drug Evaluation II
46. Jean-Marc Guettier, M.D. Director DMEP II
47. Curtis J. Rosebraugh, M.D., Director ODEII
48. Mary Parks, M.D., Associate Director ODEII
49. Rachael Sherman, M.D., Director Office of Medical Policy, CDER
50. John Jenkins, M.D., Office of New Drugs
51. Janet Woodcock, M.D. Director CDER
52. Elizabeth H. Dickinson J.D., FDA Chief Counsel
53. Margaret A. Hamburg M.D., Commissioner FDA
54. Kathleen Sibelius, Secretary HHS
JURISDICTION AND VENUE
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55. This action arises under the FTCA 28 USC 1346(b)
56. Has been filed under the FTCA 28 U.S. Code Chapter 171- Tort Claims Procedure and submitted to the appropriate party within the time limits of the statue.
57. The torts violated caused damage to private property, shares of Amarin (AMRN) stock publicly traded on NASDAQ.
58. The Court has emphasized that the term “property” used in the Taking Clause include the entire “ group of rights inhering in the citizen’s [ownership]” United States v. General Motors Corp., 323 US 373 (1945). The term is not used in the vulgar and untechnical sense of the physical thing with respect to which the citizen’s relation to the physical thing as the right to possess, use and dispose of it…The constitutional provision is addressed to every sort of interest the citizen may possess. I ATTEST MY COMMON SHARES OF AMARIN STOCK is my property.
59. The torts violated are not covered under the SEC safe harbor statement for publicly traded stock; Amarin is NOT liable for the damages to their stock.
60. Under U.S. law, section 27A of the Securities Act of 1933, as amended, and section 21E of the Securities Exchange Act of 1934, as amended, businesses must comply to standards of communication that limit risk factors. These acts were put into place partially to protect investors from ambiguous language, preventing them from making a poorly informed investment decision based on speculative statements.
PRAYER FOR RELIEF
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61. The Takings Clause requires government to pay compensation to individuals and businesses when changed regulatory scheme retroactively unsettles their reasonable investment-backed expectations and thereby destroys their property. I request compensation for my damages. Starting with the approval of Vascepa on July 26 2012 it’s retroactively clear the FDA change numerous Policy’s destroying the value of Amarin common stock.
62. Investment-backed expectations 1) I Expected Vascepa exclusivity to be approved with product approval July 26 2012 2) I expected based on successful Anchor SPA, Vascepa earned the said indication at PDUFA date of December 20th 2013, and it would be granted 3) I expected DUE PROCESS and rescinded Anchor SPA would be reversed in the appeals 4) I expected CDER would answer the Citizen Petition I sent a significant amount of energy on. 5) I expected DUE PROCESS and my comments, including scientific information would be posted. 6) I expected Separation of Powers, as a member of the Executive Branch I expected the FDA to regulated within set policies and not make new significant policy or interrupt law retroactively changing policy. The torts alleged changed regulatory scheme and retroactively unsettled my reasonable investment-backed expectations and thereby destroyed my property.
Payment for direct losses:
$3,319,782.76
Compensatory Damages for intangible harm, lost profits, pain and suffering, and emotional distress magnified by suppression of Free Speech and interference with due process:
$25,000,000.00
Total:
$28,319,782.76
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ADENDDEM TO AMOUNT OF CLAIM
==============================6
72. Sub Total 12d. $3,319,782.76
77. Compensatory Damages $25,000,000.00
78. Total requested settlement $28,319,782.76
