|William J. Olson, P.C., Attorneys At Law
Virginia v. Sebelius, Amicus Brief for Virginia Delegate Bob Marshall et al. (U.S. Court of Appeals for the Fourth Circuit, April 4, 2011)
Today our firm filed an amicus brief in the case of Commonwealth of Virginia v. Kathleen Sebelius in the United States Court of Appeals for the Fourth Circuit on behalf of Virginia Delegate Bob Marshall, Gun Owners of America, Inc., Gun Owners Foundation, American Life League, Inc., Institute on the Constitution, the Lincoln Institute for Research and Education, Public Advocate of the United States, Conservative Legal Defense and Education Fund, The Liberty Committee, Downsize DC Foundation, DownsizeDC.org, and Policy Analysis Center.
Our amicus brief supports the Commonwealth of Virginia’s challenge to the minimum coverage provision of the "Patient Protection and Affordable Care Act” ("PPACA") arguing 1) Virginia has standing to bring this action, 2) the individual mandate cannot be justified as a constitutional exercise of Congress’s power to regulate interstate commerce, and 3) PPACA constitutes federal take-over of health and medicine in violation of the power of the states and of the people secured by the Tenth Amendment.
Federal Trade Commission v. Daniel Chapter One, A Story of Government Suppression of Alternative Medicine (March 2011)
Bill Olson and Herb Titus wrote "Federal Trade Commission v. Daniel Chapter One, A Story of Government Suppression of Alternative Medicine" which covers our firms representation of Daniel Chapter One, a historical perspective of the attack on alternative medicine, the federal assault on dietary supplements and alternative medicine, the story of Daniel Chapter One, and the litigation proceedings of the FTC’s abusive campaign against Daniel Chapter One.
Daniel Chapter One Reply Brief of Petitioners (October 1, 2010)
On behalf of Daniel Chapter One ("DCO"), today we filed with the U.S. Court of Appeals for the D.C. Circuit the reply brief of petitioners. The DCO reply brief argues that the FTC brief unjustifiedly disparages DCO and the Feijos' relationship to it in an erroneous effort to assert jurisdiction over a ministry. Further, the FTC brief's claim that DCO's ads created the overall net impression that its products claims were based upon controlled clinical studies is not supported in fact or by law. Finally, the FTC brief is mistaken about DCO's constitutional and Religious Freedom Restoration Act claims.
Daniel Chapter One -- District Court Order (September 14, 2010)
The U.S. District Court for the District of Columbia denied the Daniel Chapter One ("DCO") motion to dismiss, denied the government’s motion for a preliminary injunction enjoining defendants from violating the FTC's order, and stayed the case pending resolution of DCO’s appeal before the U.S. Court of Appeals for the D.C. Circuit.
Daniel Chapter One Motion to Dismiss and Opposition to Government's Motion for Preliminary Injunction (September 1, 2010)
On behalf of Daniel Chapter One ("DCO"), today we filed a motion to dismiss the goverment's complaint and a memorandum of points and authorities in support of the motion to dismiss with the U.S. District Court for the District of Columbia. On behalf of DCO, today we also filed with the U.S. District Court for the District of Columbia a memorandum of points and authorities in opposition to the government's revised motion for preliminary injunction. The memorandum was supported by the following declarations:
Declaration of James Feijo
Declaration of Patricia Feijo
Declaration of Tedd Koren
Declaration of Sally Lamont
Declaration of James A. Duke
Declaration of Karen S. Orr, D.C.
Declaration of Deane Mink, D.C.
Daniel Chapter One Brief of Petitioners (August 18, 2010)
On behalf of Daniel Chapter One ("DCO"), today we filed with the U.S. Court of Appeals for the D.C. Circuit the brief of petitioners. The DCO brief argues that the FTC failed to establish jurisdiction over DCO and exceeded its statutory authority by misuse of its "reasonable basis" theory and test. Further, the FTC order is arbitrary and capricious, being the product of a blind adherence to the religion of scientism. Finally, the FTC action and order unconstitutionally abridged DCO's freedom of speech, and the FTC erroneously dismissed DCO's Religious Freedom Restoration Act and First Amendment "speaker autonomy" claims.
Daniel Chapter One -- Court Order Denying Hearing on RFRA Claim (July 6, 2010)
The U.S. Court of Appeals for the D.C. Circuit denied the Daniel Chapter One ("DCO") motion requesting a hearing on the DCO claim under the Religious Freedom Restoration Act (“RFRA”).
Daniel Chapter One Reply to FTC Opposition to Motion for Hearing on RFRA Claim (May 17, 2010)
On behalf of Daniel Chapter One ("DCO"), today we filed with the U.S. Court of Appeals for the D.C. Circuit a reply to the FTC's opposition to the DCO motion requesting a hearing on DCO's claim under the Religious Freedom Restoration Act (“RFRA”).
Daniel Chapter One Motion for Hearing on RFRA Claim (April 22, 2010)
On behalf of Daniel Chapter One ("DCO"), today we filed with the U.S. Court of Appeals for the D.C. Circuit a motion requesting a hearing on DCO's claim that application of parts of the FTC's modified final order substantially burdens DCO's exercise of religion in violation of the Religious Freedom Restoration Act (“RFRA”).
Daniel Chapter One Emergency Motion for Stay of FTC Order (March 26, 2010)
On behalf of Daniel Chapter One, this morning we filed an Emergency Motion for Stay Pending Review of FTC Modified Final Order (20 pages) with the U.S. Court of Appeals for the D.C. Circuit, as well as appended Exhibits A-G (162 pages).
Daniel Chapter One Application for Stay (February 25, 2010)
Today we filed an Application for Stay with the Federal Trade Commission, asking the Commission to stay its Order of January 25, 2010 against Daniel Chapter One, pending review in an Article III court. The Application was supported by a Memorandum, a Proposed Form of Order, and the following declarations:
Declaration of James Feijo
Declaration of Patricia Feijo
Daniel Chapter One
Health Freedom Fight
Declaration of Deane Mink, D.C.
Declaration of Karen Orr, D.C.
Declaration of Charles Sizemore, D.D.S.
Declaration of Jerry Hughes
Daniel Chapter One Motion to Dismiss (January 11, 2009)
Our firm has been retained to assist in the defense of Daniel Chapter One (DCO), a health and healing ministry, and which is under attack by the FTC. On January 11, 2009, DCO filed a Motion to Dismiss.
Information about the FTC attack on this ministry.
Bill Olson Interviewed on Conservative Roundtable TV Show on Health Freedom Issues (March 4, 2009)
Bill Olson was a guest on Conservative Roundtable's Television show to discuss health freedom issues. Among the matters discussed was the Daniel Chapter One case, where our firm is assisting in the defense of a health-related ministry promoting herbal and alternative medical products from an attack by the FTC. Information about the FTC attack on this ministry.
Supreme Court Decides Wyeth Case (March 4, 2009)
The Supreme Court ruled by a 6 to 3 vote that approval of a drug by the Food and Drug Administration (FDA) does not prohibit a state court jury from finding a pharmaceutical manufacturer liable for personal injury caused by the inadequacy of an FDA-approved warning label on that drug. We had filed an amicus brief urging this view for The Senior Citizens League (TSCL). Justice Thomas' Concurring Opinion reflected the views set out in the TSCL amicus brief that the Tenth Amendment secures to the states and the people common law rights that a federal agency, like the FDA, cannot trespass upon with impunity.
See TSCL Press Release.
Wyeth v. Levine, Amicus Brief for The Senior Citizens League in the U.S. Supreme Court (August 14, 2008)
On behalf of The Senior Citizens League (“TSCL”), we filed an amicus curiae brief in the Supreme Court in Wyeth v. Levine (Supreme Court Docket No. 06-1249) on behalf of the respondent, Diana Levine. The issue in this case is whether approval of a drug and its labeling by the Food and Drug Administration preempts state tort liability when the label as approved does not adequately warn of the dangers of certain forms of administration of a drug.
TSCL’s brief brought to the Court’s attention the unique arguments that federal preemption of this area would deprive Ms. Levine of a right to a remedy by “due course of law” as secured by the 10th Amendment of the U.S. Constitution and Article 1, Section 4 of the Vermont Constitution. Furthermore, the brief argued that state tort law systems provide necessary protection to consumers, as well as assisting the FDA in accomplishing its mission, and that the FDA’s scientific expertise is insufficient to protect the public health.
Abigail Alliance Case, Amicus Brief for The Seniors Citizen League In U.S. Supreme Court (December 13, 2007)
Today we filed an amicus curiae brief in the Supreme Court in the case of Abigail Alliance v. VonEschenbach, Commissioner of the FDA. The U.S. Supreme Court had been asked by an alliance of terminally ill patients with no conventional medical alternatives to overturn an en banc decision of the U.S. Court of Appeals for the D.C. Circuit which allows the FDA to bar these patients’ access to certain drugs, even after the FDA has approved them for Phase II testing.
Although the issue presented to the Court relates only to terminally ill patients, the underlying constitutional issue applies to any patient and his or her right to make health care choices.
The case involves the "life" and "liberty" rights protected by the Fifth Amendment, and the concept of Substantive Due Process. The brief calls upon the Court to reject its ever-evolving and arbitrary Substantive Due Process test, as set out in Washington v. Glucksberg, and to examine the text of the Fifth Amendment to learn the framers' "authorial intent." Of course, "life" and "liberty" in the Fifth Amendment followed the framers’ use in the Declaration of Independence, where they are identified as being sourced in our Creator. The brief explains how the Commentaries of William Blackstone are the best evidence to explain what the framers meant by these terms, and that Blackstone views these rights as being best described in Holy Scriptures. Our brief then examines the Holy Scriptures to understand the type of God-given "life" and "liberty" rights that the framers intended to protect. Lastly, the brief explains that common law procedural guarantees were individualized and judicial, completely unlike the FDA procedures, which apply to the populace generally, and are merely administrative.
TSCL Comments on FDA Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims (September 7, 2007)
On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s “Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims.” http://www.cfsan.fda.gov/~dms/hclmgui5.html.
The FDA Draft Guidance asserts that the FDA is authorized by the NLEA to treat health claims for both conventional food and health claims for dietary supplements in virtually the same manner. In 1990, Congress adopted a “significant scientific agreement” standard applicable to “conventional food health claims” and the FDA subsequently purported, by regulation, to extend that same standard to “dietary supplements health claims,” even though the statute provided that this standard did not apply to dietary supplements.
Moreover, the Draft Guidance would adopt an evidence-based scientific model more suitable to tracing the cause and effect between a single, potentially-toxic pharmaceutical and a disease, rather than to the identification of the complex manner in which foods and dietary supplements are used by the body in achieving overall health wellness. Instead of submitting such claims to a review process that would assess the series of interconnections, cross-connections, and recombinations of nutrition in order to assess the effectiveness of appropriate combinations to achieve health wellness, health claims for foods and dietary supplements are assessed by studies that evaluate “the relationship between a substance and a disease.”
If the Draft Guidance were adopted, TSCL submits that the FDA will have exceeded its statutory authority, and violated senior citizens’ constitutional right to have important information about dietary supplements on the label of the product. While appearing to comply with the instructions given in a 1999 D.C. Circuit decision (Pearson v. Shalala), designed to make it easier to obtain health claim approval, the FDA instead is attempting to tighten its grasp on health claims.
Our comments urged the FDA to withdraw its Draft Guidance on the grounds that its proposal to regulate dietary supplement health claims as food health claims not only has not been authorized by Congress, but also appears to contradict the legislative authorization for an FDA standard in this area.
FDA Draft Guidance for Industry on Complementary and Alternative Medicine (May 29, 2007)
On May 29, 2007, on behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation.” http://www.fda.gov/cber/gdlns/altmed.htm. According to the Draft Guidance, the FDA asserted that it had authority to regulate products utilized by practitioners of Complementary and Alternative Medicine (“CAM”), with special emphasis upon its power to regulate vitamins, minerals, and dietary supplements as drugs, if those products were “intended” to be used by a CAM practitioners as part of a disease treatment program. Additionally, the FDA stated in its Draft Guidance that it had the right to regulate products used in chiropractic and massage as medical devices. If the Draft Guidance is adopted by the FDA, it could mean that ordinary foods such as raw vegetable juice would be subject to FDA “premarket review” just as is the case now for prescription drugs used in conventional allopathic medicine. Further, if the Guidance were adopted, the FDA presumably would make substantial intrusions into the regulation of alternative medicinal practices traditionally left to the states.
In our Comments submitted on behalf of TSCL, we urged the FDA to withdraw its Draft Guidance on the grounds that its proposal to regulate ordinary foods as drugs was both unauthorized and unworkable. Additionally, the Comments raised serious questions about the fairness of the Draft Guidance procedure, confusing to the public and prejudicing the rights of seniors by depriving them of adequate time to respond to the FDA’s far-reaching proposal. Finally, our comments pointed out the likely adverse effects of the Draft Guidance: (a) on the financial health of Medicare; (b) on Congressional policy encouraging CAM; (c) on the traditional role of state regulation of the practice of medicine; and (d) the constitutional rights of the free exercise of religion and of self-preservation.
FDA Draft Guidance for Industry on Complementary and Alternative Medicine (April 26, 2007)
Today, on behalf of TREA Senior Citizens League, we filed with the FDA for both Clarification of, and Extension of, the deadline for comments in response to the FDA's rulemaking in Docket No. R2006D-0480, entitled "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by Food and Drug Administration."