Hospitals & Asylums
United States Congress Committee on Energy and Commerce
In Defense of Mindfreedom International
The New York and American Bar Associations
In re: Zyprexa Products Liability Litigation
Eli Lilly & Company, an Indiana Corporation v. Food and Drug Administration HA-12-2-07
Commissioner of the FDA, Honorable Andrew C. von Eschenbach MD
Chairman of the board and chief executive officer of Eli Lilly and Company, Sidney Taurel
People and Organizations against whose Copyright an Injunction was issued
Various Consumer Advocacy Groups involved in Zyprexa Product Liability Litigation
Ted Chabasinski, attorney for Mindfreedom
Jim Gottstein, attorney for Psych Rights
Sean P. Fahey, Pepper Hamilton LLP for Eli Lilly & Co.
First Injunction in Re Zyprexa Product Litigation MDL No. 1596. 18 December 2006
Memorandum of Points and Authorities of Respondents Mindfreedom International, NO. 04-MDL-1596. 1 February 2007
Memorandum of Points and Authorities NO. 07-0504. 6 February 2007
Lilly Settlement Notice 4 January 2007
Art 1 Sec. 8 Clause 3 Commerce clause
Art. 1 Sec. 8 Clause 8 Intellectual property clause
Art. 2 Sec. 4 Impeachment for High Crimes and Misdemeanors
1st Amendment Freedom of Speech, Press and to Sue the Government for a Redress of Grievances
14th Amendment Equal protection of the law, of nations
Agent Orange Product Liability Litigation, 821 F. 2d 139 (2d Cir. 1987)
Katherine M. Albers v. Eli Lilly & Co. No. 03-2320 7th Cir. Argued December 10, 2003—Decided January 6, 2004
O'Connor v. Donaldson, 422 U.S. 563 (1975)
Faith J. Meyers v. Alaska Psychiatric Institute. Supreme Court No. S-11021 30 June 2006.
Riese v. St. Mary's Hospital, 259 Cal. Rptr. 669, 774 P 2d 698 (1989)
Rogers v. Commissioner of Mental Health, 390 Mass. 489, 458 NE 2d 308 (1983)
Winkler v. Eli Lilly & Co, op. cit. In Eli Lilly & Company, an Indiana corporation v. Natural Answers, incorporated Florida corporation and Brian Feinstein No. 00-1375 US 7th Cir. Argued September 11, 2000--Decided November 21, 2000
Committee on Energy and Commerce. Increasing Generic Drug Utilization: Saving Money for Patients, No. 109-16. May 18, 2005
Committee on Energy and Commerce. Innovative Solutions to Medical Liability, No. 109-117, of July 13, 2006
Committee on Energy and Commerce. Patient Safety and Quality Initiatives, No. 109-17. June 9, 2005
Committee on Energy and Commerce. Product Counterfeiting: How Fakes are Undermining U.S. Jobs, Innovation, and Consumer Safety, No. 109-26. June 25, 2005
Medical Modernization Act (MMA)(P.L. 108-173)
Safe Medical Devices Act of 1990 (Pub. L. 101-629)
Social Security Act (P.L. 108-173)
UK. Corporate Manslaughter and Corporate Homicide Bill 220 2006-2007
UK. Joint Committee on Human Rights Fourth Report on the Mental Health Bill. 4 February 2007
Ways and Means Subcommittee on Health. Emergency Care. No. 109-80. 27 July 2006
Ways and Means Subcommittee on Health. Medicare Reimbursement of Physician Administered Drugs. No. 109-83. 13 July 2006
Ways and Means Subcommittee on Health. Patient Safety and Quality Issues in End Stage Renal Disease Treatment. FC-27. 29
Chamberlin, Judi. On our Own: Patient-Controlled Alternatives to the Mental Health System (McGraw-Hill, 1979)
Aaron Kesselheim and Jerry Avorn, The Role of Litigation in Defining Drug Risks, J.A.M.A., 17 January 2007
Lilly. Zyprexa Facts
Karl Marx and Frederick Engels. Manifesto of the Communist Party. 1948
Dr Mercola. "What Company Covered Up Health Risks of its Top Selling Drug for a Decade". 6 January 2007
Mindfreedom International. Eli Lilly Secrets Page
NPR. Former FDA Chief Charged with Lying About Stocks. 17 October 2006
World Intellectual Property Organization. Record Year for International Patent Filings with Significant Growth from Northeast Asia. PR/476-2007. Geneva. 7 February 2007
1. Art. I Sec. 8 Clause 3 of the US Constitution grants to the US Congress the power to regulate Commerce with Foreign Nations, and among the several States, and with the Indian Tribes. Clause 8 of the same section promotes the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writing and Discoveries. The new Convention on the Rights of Persons with Disabilities bans discrimination and abuse of people with disabilities. This case has been written to secure Congressional hearings regarding the improved regulation of the anti-psychotic drug Zyprexa (olanzapine) whose warning label cautions against the consumption of alcohol but covers up the potentially lethal side effect of diabetes. This case began after Psych Rights founding attorney Jim Gottstein, leaked files to New Times journalist Alex Berenson resulting in more than a month of coverage of Zyprexa. The cause of action is that District Court for Eastern New York seized literally millions of pages of information on wrongful deaths and disabilities caused by Zyprexa, after a strange Emergency Oral Join Motion of Plaintiffs and Eli Lilly Co. was issued at the behest of the Special Discovery Master on 15 December 2006 that was enforced on the 18th MDL No. 1596. The parties to the proceeding seem forced to play the roles they know so well - the pillaged plaintiff and secretive corporation. The point at bar is that the Zyprexa drug has toxic, even lethal side effects when mixed with alcohol and the danger to society is aggravated by this ultra vires, unauthorized practice of law.
2. The questions at bar are;
First, whether the product liability litigation would be more constitutional and less dangerous to society if it were heard by Congress
and the FDA.
Second, whether the injunction against the evidence should be lifted and the claims given due process in the already approved settlement.
Third, whether there is sufficient evidence to put diabetes and weight gain on the Zyprexa warning label.
Fourth, whether to label Eli Lilly & Company ultra vires to bar it from further practice in courts of law, while instituting improved
internal civil tort liability mechanisms and Congressional and FDA oversight, aiming to increase mental health and pharmaceutical
legislation without permitting corporate bribes or censorship of advocates so as to represent the people not the oppressors.
Fifth, whether the Zyprexa patent needs to be revoked to keep the dangerous drug out of the hands of killers, kidnappers, judicial
enforcement, rent enforcement, surveillance professionals and other unethical people prone to discriminate and abuse the mentally ill,
diabetic drinkers and others merely imbibing alcoholic beverages that have been spiked, as well as those of the legitimate prescribing
psychiatrists and drug consumers who might be safer with a different atypical anti-psychotic.
3. Hearsay newspaper reports indicate that 10% of the population of New York City are suffering from diabetes, 200,000 of these cases being severe. Public health research is needed to confirm these suspicions and take preventative measures against the spreading of this disease by judicial officers, psychiatrists, bartenders and other sweet talkers in New York City, the state, nation and around the world using Zyprexa and other toxins. In 2006 Eli Lilly agreed to a $750 million settlement of lawsuits filed by 8,000 people who claimed that they contacted diabetes or suffered significant weight gain after being prescribed Lilly's best-selling drug Zyprexa. Zyprexa is a type of psychiatric drug called a neuroleptic or anti-psychotic. About 18,000 more lawsuits are pending. Attorneys for both sides of these lawsuits agreed to keep the approximately 11 million documents involved secret. Lilly has annual revenues greater than the gross national product of many small countries. Sales of Zyprexa were $4.4 billion in 2005, and $4.2 billion in 2006. It is widely prescribed to deal with schizophrenia and bipolar disorder. The company has received over $30 billion from sales of this drug since it first came on the market in 1996. 20 million people have been given Zyprexa, often involuntarily, since its introduction. New York Times, January 20, 2007. "The genie is out of the bottle. But Eli Lilly is still paying their hard-hitting attorneys to try to cover-up evidence of their fraud," said David Oaks, director of MindFreedom International. "This is reminiscent of the way the Nixon administration tried to keep the Pentagon Papers secret even after the materials were in the hands of the NY Times."
4. Eli Lilly has a long history of hiding the dangerousness of its products. In 1980, Lilly began marketing Oraflex, a drug for arthritis, in the United Kingdom and eight other countries. In 1982, it obtained FDA approval to market it in the United States. But the company hid from the FDA that Oraflex had caused many deaths and illnesses in the earlier markets. In the U.S., the company failed to warn consumers that the drug might damage the liver and kidneys. At least 100 people died from Oraflex in the U.S. The drug was withdrawn from the U.S. market in 1982, the same year it was introduced. In 1985, Lilly was prosecuted for its handling of the drug's marketing. Lilly, the corporation, was allowed to plead guilty to a misdemeanor, and fined $25,000. In its obsession with secrecy, Lilly obtained an injunction against subsequent plaintiffs in yet another consolidated case seeking compensation for the effects of Prozac on their family members, forbidding them from even attempting to find out the facts about the secret settlement in the earlier case. In 2002, the U.S. Department of Justice notified that Lilly's illegal marketing of Evista continued from 1998 to as late as 2000, in spite of the 1999 injunction. On 21 December 2005, the DOJ announced in a press release that Lilly agreed to plead guilty and to pay $36 million in connection with its illegal promotion of Evista. Global sales of Evista had reached $770.8 million for the first nine months of that year. The injunction was later vacated by the 7th Circuit. Winkler v. Eli Lilly & Co, op. cit. In Eli Lilly & Company, an Indiana corporation v. Natural Answers, incorporated Florida corporation and Brian Feinstein No. 00-1375 US 7th Cir. Argued September 11, 2000--Decided November 21, 2000 the basis of Lilly's claim for an injunction is that the name HERBROZAC comes unfairly close to Lilly's protected mark for PROZACþ. Circuit Judge Evans warns to avoid getting embroiled in a nasty court fight, especially one with a global pharmaceutical giant like the Eli Lilly company.
5. To confirm suspicions of foul play on the part of the District Court of New York the Court had three death penalty cases docketed at the time they chose to cover the mass murder of a pharmaceutical company, although the death penalty has not been used in the state of New York since 1953. The press reported that the jury verdict in the final case to the nation was a sentence of death, although the other two received lesser sentences. This sentence can only be ruled a mistrial for reasons of the Independence of the Judiciary, whereas at that exact moment the President of the United States, one of the world’s most homicidal people, mysteriously appeared to speak at the New York Stock Exchange. The murder of two undercover officers by an arms dealer seems less severe than the presumed poisoning deaths caused by such officers when administering their lethally sweetened Zyprexa drinks to punish diabetic drinkers. The death penalty is not acceptable to any reasonable New Yorker not party to the guerilla warfare and a robust prison sentence should be substituted and restitution made to the family. To lend credence to the heat of the guerilla warfare of the armed Republicans of the Bush camp, the proverbial last drink of the diabetic John Carter was staged at a hotel in Northern Kentucky the night before the President came to speak at the Northern Kentucky University, a day before there was a fatal mine explosion in the south of the State. By issuing a sentence of death against the killer of their undercover officers, while laundering a mass murder, the District Court has rendered itself incompetent. The death sentence case must be allowed to leave for the neutral ground of New York, the federal court is not impartial in regards to a case where it was their officer who was killed. It should be understood that the President and judicial officers are to be impeached and removed from this case for high crimes and misdemeanors under Art. II Sec. 4 of the US Constitution. It seems to be in the best interest of justice for the District Court to return their stolen goods and to uphold a separation of powers with health in the future and be subjected to the review of the NY and American Bar Association and the Judiciary Committees for the redress of their prosecutorial indiscretion. The Court of International Trade of the United States (COITUS), located in NYC turns out to be a tragic accident born of our nation’s lack of understanding of communism that invented a Stalinist invasion of privacy to finance our nation’s gulag with an obscene capitalist pig in the sky. The current poisoning problem is both old an new, the Judiciary, particularly at the ill conceived intersection with mental health at Probate Court that prevents that court from being the elected, the slavery free Justice of the Peace, the drug enforcement status quo of the DEA that needs to be transferred to DHHS and the new Homeland Security Department that finances bio-terrorism. If there is any injunction needed in NYC it is against COITUS that should change its name to either the US International Court (USIC-k) or International Tribunal (IT) to combat brainwashing.
6. In the last few decades, the American legal system has begun to recognize that psychiatric patients should be protected from arbitrary
deprivation of their liberty. O'Connor v. Donaldson, 422 U.S. 563 (1975); California Welfare and Institutions Code, section 5000 et seq.
And the courts have started to acknowledge the seriousness of forcing powerful psychiatric drugs on people without their consent.
Rogers v. Commissioner of Mental Health, 390 Mass. 489, 458 NE 2d 308 (1983); Riese v. St. Mary's Hospital, 259 Cal. Rptr. 669, 774
P 2d 698 (1989); Myers v. Alaska Psychiatric Institute, 138 P. 3d 238 (2006). The British Joint Committee on Human Rights Fourth
Report on the Mental Health Bill of 4 February 2007 made great progress enforcing the Winterwerp criteria for a lawful psychiatric
detention require objective medical evidence of a true mental disorder. This is provided for by the reports from a psychiatrist and another
doctor (section 12), which are presented to the competent authority which is the managers of the relevant hospital (section 6). The mental
disorder must be of a nature or degree making treatment in hospital appropriate, and it must be the case that treatment cannot be provided
without detention (sections 2 and 3), treatment must be necessary for the patient's health or safety or for the protection of other persons.
The report recognizes that it may be necessary to consider the fact that often it is a near or nearest relative who may have sought the
detention of the patient into the mental health facility. This may lead to a breakdown of trust and place strain on such a relationship,
making it inappropriate for such a person to determine the future of the patient. It even requires that restrictions on conduct be
proportionate and that conditions may not be imposed which collectively amount to a deprivation of liberty should be enshrined in the
statute, and that a patient should be entitled to seek review of the conditions before a Mental Health Review Tribunal.
7. To redress the case at hand the equal protection of the law of nations is sought with the Corporate Manslaughter and Corporate Homicide Bill 220 2006-2007 that Create a new offence whereby an organization will have committed the new offence if it owes a duty of care to another person in certain circumstances and there is a management failure by its senior managers which amounts to a gross breach of that duty has resulted in a person’s death. In this case regarding Lilly failed to warn consumers of the dangers of diabetes and weight gain. The offence will be punishable by an unlimited fine and remedial orders requiring organizations to take steps to remedy the management failure concerned shall be made. In R v P & O European Ferries 93 CAR 72 Turner J, in his classic analysis of the relevant principles, said at 83 “Where a corporation through the controlling mind of one of its agents, does an act which fulfils the prerequisite of the crime of manslaughter, it is properly indictable for the crime of manslaughter. The breach of duty must have been gross. This will be so if the conduct alleged to amount to a breach of the duty concerned “falls far below what can reasonably be expected of the organization in the circumstances”. It is interesting to note that the frequent corporate killers, the police, fire and children's services are exempt under this law. They are still entitled to individual liability under manslaughter statutes.
8. For the class of people alleged to be mentally ill drug liability settlements have become a vital part of the pursuit of economic equality. Most of the peer support groups have gone so far to label themselves consumer groups to conform with the current fraud of the overseers regarding force feeding anti-psychotic drugs tested by torturers illegally researching on detainees, to save lives. For instance, the only litigation Mindfreedom International engages in involves drug liability. Anti-psychotic drugs are relatively new. They did not become commonplace until the 1970’s when the psychiatrists made a deal to enforce drug consumption while the DEA slaves the competition, damn the privacy of the medical profession, that has yet to seize that agency with their Secretary of hush money. Drug addiction is a leading cause of mental illness and the capitalist torturers of psychiatric deinstitutionalizing institutions went for the long term investment. In the 1980’s the legislature reinforced the right of people who are alleged to be mentally ill to disability insurance. One congressman, John Conyers, commented at the time, "On the one hand, street criminals are prosecuted to the full extent of the law. On the other hand, corporate officials who may be responsible for the death and injury of hundreds of thousands of people are merely slapped on the wrist." New York Times, August 29, 1985; TIME magazine, September 2, 1985. The legal settlement for mandatory restitution for false arrest and civil tort for torture remains un-winnable and dangerous with long term consequences as the result of the virulence of the local corruption resisting the forfeiture of inpatient facilities. The dedicated leaders of the mentally ill community have focused on product liability to supplement the class income from disability insurance in pursuit of their fully paid middle class role as the caregivers of the mentally ill well enough to know their name and the dispossessed alleged to be mentally ill equipped with community shelters. Class warfare is so prevalent in the mental health system that it has been designed as a community system in order to drive people to study communism which is primarily focused on the class struggle between the working proletariat and the capitalist bourgeois with the intention to redistribute the wealth to the poor through an income tax and taking excess private property for public use. Karl Marx and Frederick Engels. Manifesto of the Communist Party. 1948. In the US both the communist party and capitalist pigs, are prohibited by Congress.
9. In his Memorandum of Points and Authorities of Respondents Mindfreedom International, NO. 04-MDL-1596 of 1 February 2007, Teb Chabasinski, California Bar No.132871, argues that they are going to the court to recover their stolen their work, and explained the unwitting role of the patent prosecutor in the murder for hire scandal. In re Agent Orange Product Liability Litigation, 821 F. 2d 139 (2d Cir. 1987): It is undisputed that a district court retains the power to modify or lift protective orders that it has entered. He argues that it is the legal system, rather than other government agencies like the FDA, that is most effective and necessary in bringing to the public's attention the problems with drugs, as the FDA often acts to support the drug companies rather than protect the public. In a very recent article, even the Journal of the American Medical Association, recognized that the FDA is inadequate for the task and that litigation is essential in finding the true facts about over-hyped medications. Aaron Kesselheim and Jerry Avorn, The Role of Litigation in Defining Drug Risks, J.A.M.A., January 17, 2007. The current administration, whoever the secret policeman is, is so craven to the courts of slavery that former head of the Food and Drug Administration Lester Crawford DVM will be responding to charges from the Justice Department that, while heading the FDA for only several months, he and his wife deliberately lied about owning stocks and stock options in companies regulated by the department after being warned by the Department of Health and Human Services. NPR. Former FDA Chief Charged with Lying About Stocks. 17 October 2006. The FDA is clearly in some disrepute at this time it is highly recommended to lobby the patent registry for prescription drug from Congress.
10. Theoretically, the tort system is supposed to serve the function of discouraging or preventing non-criminal but reprehensible behavior. But faced with tortfeasors for whom billion-dollar settlements are simply a cost of doing business, money damages can no longer serve this function. The next sentence is one of death for the patent prosecutor, “the only way to change this situation is through an informed public opinion and the involvement of the criminal justice system”. By seeking to involve police in general, in toxic litigation, the attorney set the stage for the issuance of superior orders for the administration of poisons by the criminal justice system. It is highly unlikely that this was intentional. The attorney, without any knowledge of how unauthorized an authorized practice of law is, in any country, is probably only trying to get a positive reaction from a judge. In regards to this conformity Judi Chamberlin writes in her book On our Own: Patient-Controlled Alternatives to the Mental Health System (McGraw-Hill, 1979): Mental health and mental illness are terms that have entered the popular vocabulary. Yet they are terms that few people can define. Lay people and psychiatrists alike tend to call people mentally healthy when they like their behavior and mentally ill when they dislike their behavior. Unlike physical illnesses, which affect particular parts of a person's body, mental illness affects that abstraction known as the mind. Once it has been decided that a person has a sick mind, enormous social consequences ensue. A finding of mental illness, which is often a judicial, as well as a medical, determination, frequently results in loss of liberty. Judges are even more transparent in their weakness for force and law colleges fail to instill the wisdom that there is only one kind of lawyer and that is a criminal defense attorney, sworn to defend people equally against crime. Lawyers who are not fair, are not honored and must use force, we call these prosecutors and seek to remove them from office to protect the public from their abuse of power. In this case the in court litigation is extending the life of a patent that prosecutors seize upon to realize their lifelong ambition to poison the Bar thereby wearing it out fast. Keep prosecuting patents until there is a lawyer willing to believe that freedom has value and enough understanding of the Constitution to go to Congress.
11. The role of the drug company, in these ultra vires legal proceedings, is to instill the value and power of secrecy on the police force and their pro-death penalty drug administrators who kill their “bleeding heart liberals” and “rats” to get their Probate will, by demonstrating that secrecy can be used to prosecute an injunction against the will of the copyright holder of information that infringes upon their patent although it is even more inappropriate to commit crimes in behalf of a defendant than a plaintiff. In the Memorandum of Points and Authorities NO. 07-0504 of 6 February 2007, Mr. Chabasinski argues that Lilly has failed to make their case.It appears that Lilly has come to recognize how disturbing the litigation is. While engaged in this injunction against Mindfreedom International Eli Lilly entered into settlement agreements with 14 plaintiffs' firms (or groups of plaintiffs' firms) involved in Zyprexa liability litigation to resolve the vast majority of remaining product liability claims against Lilly relating to the medication. These settlement agreements follow a master settlement agreement Lilly entered into in June 2005 that covered approximately 8,000 claimants in the United States, as well as additional settlements of approximately 2,500 claims. "While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians," said Sidney Taurel, chairman of the board and chief executive officer of Eli Lilly and Company. "We wanted to reduce significant uncertainties involved in litigating such complex cases”. These settlements include federal and state product liability lawsuits that have been brought against Lilly, and claims that were the subject of "tolling agreements" that extended the deadline for potential claimants to file a lawsuit, as well as other un-filed claims against Lilly. The agreements also will result in the dismissal of claims against physicians and other healthcare professionals named as co-defendants in any cases relating to the prescription of Zyprexa covered by this settlement.
12. According to the Lilly News release, from Indiana, of 4 January 2007 at this time, the exact number of claimants covered by this settlement cannot be determined, but is estimated to be more than 18,000, representing the vast majority of existing Zyprexa product liability litigation. Approximately 1,200 claims that have been identified to Lilly are not included in this settlement. For several months, plaintiffs' lawyers have been discussing a possible settlement that would resolve a substantial number of Zyprexa cases. "We are happy that we have been able to negotiate a settlement agreement that we believe is in the best interest of our clients, as well as patients, physicians and caregivers," said Richard Meadow, New York office of the Lanier Law Firm. "Prolonging this litigation further is in no one's best interest." Taurel said, "The litigation stirred concern for physicians and spread fear among patients and caregivers, which has interfered with the process of physicians making treatment decisions. We want physicians to feel comfortable choosing the medication they believe best meets the treatment needs of their patients with schizophrenia and bipolar disorder." Most of the lawsuits claim that before September 2003, the information in the package insert, which listed the risk of hyperglycemia and diabetes as an infrequent adverse event since 1996, was not adequately displayed. In September 2003, the Food and Drug Administration required label changes for all atypical anti-psychotics that added information about the confounded relationship between these medicines and diabetes. The FDA did not, however, find that a causal relationship exists, corruption is however suspected and Congress should be invoked to process this patent.
13. The Honorable Jack Weinstein of the Federal District Court for the Eastern District of New York, the judge supervising the Zyprexa multidistrict litigation, stated recently, “while the court expressed skepticism at the outset of the litigation with respect to the merits of the of any future cases following a global settlement. The change in Zyprexa's label in September 2003, as ordered by the federal Food and Drug Administration, makes less viable, on statute of limitations grounds, such future cases. A good faith attempt to resolve an entire dispute by defendants and plaintiffs bar, which will provide fair compensation to plaintiffs and allow a pharmaceutical company to put major litigation behind it, and get on with its main work of producing pharmaceuticals, becomes more difficult when there is no clear way to end finally the whole litigation”. The objective of this case it to do exactly that, end the whole litigation. By enforcing the injunction against 11 million pages of information it is the Eastern District Court who is obstructing the settlement of the case disregarding the warning to avoid getting embroiled in a nasty court fight, especially one with a global pharmaceutical giant like the Eli Lilly company of Eli Lilly & Company, an Indiana corporation v. Natural Answers, incorporated Florida corporation and Brian Feinstein No. 00-1375 US 7th Cir. Argued September 11, 2000--Decided November 21, 2000. If the District Court would merely retract their injunction the product liability litigation would settle without any loose ends. In Katherine M. Albers v. Eli Lilly & Co. No. 03-2320 7th Cir. Argued December 10, 2003—Decided January 6, 2004, the Court notes that Lilly sometimes behaves opportunistically and that both sides should have the option to dismiss the appeal.
14. To stress the importance of patent law as the civil method for resolving product liability disputes the World Intellectual Property Organization (WIPO) Patent Cooperation Treaty (PCT), the cornerstone of the international patent system, has since it began in 1978, seen continuous growth with a record 145,300 applications filed in 2006, representing a 6.4% growth over the previous year. “The number of international patent applications continues to rise with impressive growth from north east Asian countries. Increasingly developing country economies are capitalizing on the tools of the intellectual property system for wealth creation,” said Mr. Francis Gurry, Deputy Director General who oversees the work of the PCT. "Innovation has been traditionally dominated by Europe and North America. New centers of innovation – in particular in northeast Asia - are emerging and this is transforming both the geography of the patent system and of future global economic growth” he added. Pharmaceutical drugs comprised 21% of the patent filings for 2006. With 49,666 patent filings the USA was far and away the leading country of origin for patents. The PCT offers inventors and industry an advantageous route for obtaining patent protection internationally. By filing one “international” patent application under the PCT, protection of an invention can be sought simultaneously in each of a large number of countries. World Intellectual Property Organization. Record Year for International Patent Filings with Significant Growth from Northeast Asia. PR/476-2007. Geneva. 7 February 2007. Under Section 16 of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), as codified in 21CFR3.1 the FDA is designated to have primary jurisdiction for the pre-market review and regulation of products that are comprised of any combination of a drug and a device. The purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for determining which agency component will have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. Nothing in this section prevents FDA from using any agency resources it deems necessary to ensure adequate review of the safety and effectiveness of any product, or the substantial equivalence of any device to a predicate device.
15. The Constitution is very clear that the regulation of Commerce is the domain of Congress. The FDA, the CFR, however makes no
reference to the legislative branch. House Rule X(t)(9) give the Ways and Means Subcommittee on Health jurisdiction over matters
pertaining to the federal finance of health care under the Social Security Acts. The 109th Congress used their finance of patients with
kidney failure since 1972 to justify a “Hearing on Patient Safety and Quality Issues in End Stage Renal Disease Treatment” on 29
of the Social Security Act (P.L. 108-173) imposes specific obligations on Medicare participating hospitals that offer emergency services
to provide a medical screening exam when a request is made for examination or treatment for an emergency medical condition, including
active labor, regardless of an individual's ability to pay. The Hearing on “Medicare Reimbursement of Physician Administered Drugs”
of 13 July 2006 No. 109-83 found that the Medical Modernization Act (MMA)(P.L. 108-173) includes very complicated and
significant changes to reimbursement for these drugs and the services required to deliver them. Prior to the MMA, Medicare only
covered drugs that were covered incident to physician services or administered through covered durable medical equipment items.
These drugs were covered in Medicare and reimbursed 95 percent of the average wholesale price. Additionally, Medicare beneficiaries
were responsible for 20 percent coinsurance on the drug payment. Mr. Kuhn Director of CMS stated, “Part B Medicare covers a
limited number of prescription drugs. In 2005, carriers paid $10 billion for Part B drugs, and intermediaries paid another $5 billion”.
Mark Miller Executive Director of the Medicare Payment Advisory Commission reported, “in 2005 there was actually a reduction in
expenditures. This is because Medicare has realized lower prices for these drugs”.
16. In conclusion, this is not a case regarding the finance of pharmaceutical drugs by social security, this is a case regarding the safety of the atypical anti-psychotic Zyprexa, the wisdom of the litigious behavior of Eli Lilly & Co. and consumer advocates, the satisfactory settlement of victims of side effects of the drug, the unlawful injunction against class action litigants and whether the patent is due to be revoked. The House Committee on Energy and Commerce Subcommittee on Health has jurisdiction for the Public health and quarantine; hospital construction; mental health and research; biomedical programs and health protection in general, including Medicaid and national health insurance; Food and drugs; Drug abuse; and, Homeland security-related aspects of the foregoing. In the letter to the Commissioner of the FDA the Honorable Andrew C. von Eschenbach MD, of 22 January 2007 the Committee launched an inquiry into conflicts of interest in the FDA. The jurisdiction in regards to holding hearings regarding “Zyprexa Products Litigation” could fall upon any of the subcommittees or the whole committee. Debate clearly falls under the domain of the Patient Safety and Quality Initiatives, No. 109-17, of June 9, 2005, where the committee was skeptical that medical errors were the fifth leading cause of death, other reports indicate that it is the leading cause. In regards to patent rights arguments for both sides can be found in Increasing Generic Drug Utilization: Saving Money for Patients, No. 109-16, of May 18, 2005 that found a typical patient could reduce their per-day cost by 14 to 16 percent by fully utilizing generic pharmaceuticals. Amazingly, for every 1-percent increase in generic drug utilization, it has been estimated that consumers and third party payers could save between $1.3 and $4 billion every year and Product Counterfeiting: How Fakes are Undermining U.S. Jobs, Innovation, and Consumer Safety, No. 109-26, of June 25, 2005 found that over 10 percent of the world’s medicines are simply counterfeit with percentages reaching as high as 60 percent in the developing world.. Innovative Solutions to Medical Liability, No. 109-117, of July 13, 2006 leads us to conclude that global pharmaceutical companies as commercial ventures are not the jurisdiction of the judiciary, and unlike medical liability that is referred to the state medical license bureau, are instead referred to Congress under the Art. 1 Sec. 8 Clauses 3 & 8 of the US Constitution and the FDA under Section 16 of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), as codified in 21CFR3.1.
Anthony J. Sanders