Contact:  Dr. Linda Lagemann, Liaison to the Petitioners (415-640-7343)

Attorney Jonathan Emord and his co-counsel Kendrick Moxon have filed a Supplement to their Citizen Petition of August 2016, protesting the FDA’s Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give “shock-treatment.”  The reclassification would make it easier for doctors to give the treatment.  Shock treatment is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo’s Nest.  More recently it was portrayed in the TV series Homeland when given to the star, destroying her memory and intelligence.  Memory loss and brain damage are the central issue in the attorneys’ filing.

For 40 years, the FDA has been responsible to ensure evaluation of the shock devices, which send up to 460 volts through a person’s brain. Although federal law and FDA orders in the 1970s required manufacturers of these devices to prove they were both safe and effective, the FDA never enforced the order. This, according to Mr. Moxon, has “allowed millions of persons over decades to be permanently damaged.”  He further states “Rather than enforce the law now, the FDA has proposed to simply change the law by reclassifying the devices, so no proof of safety or effectiveness need ever be provided.”

The original Citizen Petition was filed on behalf of 5 persons damaged by electroshock treatments. It requests that ECT be banned from the market or, at the least, that the Proposed Order be withdrawn as the manufacturers have never done pre-market clinical trials to prove it is a “safe and effective” device. No other treatment in medicine is so subject to objection and protest by patients – so much so that when the reclassification was proposed, thousands of patients, deeming themselves to be victims of the treatment, objected.

Mr. Emord, who has successfully litigated against the FDA more times than any other attorney in the US, stated “The FDA has utterly ignored clear-cut evidence of brain damage, memory loss and death resulting from ECT treatments. ECT is barbaric and should be removed from the market.” It is only fair to note that even the manufacturers have stated that a “risk” of the device is brain damage and severe memory loss.

The attorneys claim there are substantial conflicts of interest with ECT device manufacturers and the studies referenced by the FDA to support its proposed “declassification” of ECT devices.  Mr. Moxon says “The FDA used ‘junk science’ to propose reclassifying ECT machines out of the most dangerous category of all devices, in which it has been classified since 1978. Worse, the FDA ignored contrary studies by researchers who did not have conflicts of interest.”

This is shaping up to be a David and Goliath scenario with individuals damaged by ECT on one side and the FDA, under pressure from the industry that profits from ECT, on the other.

Mr. Emord stated that the proposed reclassification is a radical and irrational departure from FDA’s prior precedent demanding rigorous clinical proof of safety before Class III devices (deemed the highest risk) are reclassified to permit more common use.  He expects a challenge to the FDA’s proposed order would be upheld in federal court, if the FDA attempts to move forward with the proposed reclassification.

Review or download the Supplement to the Citizen Petition through the link below:

Supplement to Citizens Petition 29 July 17

The post PRESS RELEASE: Jonathan Emord Goes Round Two with the FDA on Electroshock Devices appeared first on Emord Blog.

The post Sacred Fire of Liberty Gala appeared first on Emord Blog.

Additional videos will soon be dispatched, including the remarkable speeches delivered by Bay Buchanan, Kate Obenshain, and Tammy Bruce at the Gala.

The post Video Replay Available of George Washington’s Address at the Sacred Fire of Liberty Gala appeared first on Emord Blog.

CONTACT: Connie Wood (202-466-6937)

Cambridge, Maryland—On September 5 and 6, 2014, the constitutional and administrative law firm Emord & Associates, P.C. held a spectacular celebration and awards program at the Hyatt Regency Resort on the occasion of its 20^th anniversary and in honor of George Washington.  The event was entitled the “Sacred Fire of Liberty Gala” (see sacredfiregala.com) and included over 300 people, inclusive of guests, speakers, and world class entertainers.  Fox News Chief National Correspondent Jim Angle (keynote); former Treasurer of the United States and Fox News Contributor Bay Buchanan; former Chairman of the Virginia Republican Party and Chief of Staff to Senator George Allen, Kate Obenshain; and New York Times best-selling author and radio talk show host Tammy Bruce each addressed the audience on September 5, and actor Dean Malissa (Acquarius (2000); The Real George Washington (2008); and LaFayette: The Lost Hero (2010)) gave a stirring speech as George Washington condescended from Heaven.

From nominations received throughout 2013 and 2014, an awards committee of the Emord firm selected the following individuals to receive excellence awards in the following categories:

Excellence in Nutrition Science Award: Dr. Sidney Stohs; Dr. Mary Enig; Dr. Melvyn Grovit; Dr. Adrianne Bendich; Dr. Charles B. Simone; Dr. Jeffrey Bland; Dr. Robert I-San Lin; Dr. Harry G. Preuss; Dr. Jeffrey Blumberg; Elwood Richard; Dr. Jeanne Drisko; Dr. Neal D. Barnard; Dr. Stanley Dudrick; Michael Stroka; and Sally Fallon Morell

Excellence in Integrative Medicine Award: Dr. Martin P. Gallagher; Dr. Dennis J. Courtney; Dr. Jonathan V. Wright; Dr. Julian M. Whitaker; Dr. Warren Levin; Dr. Charles B. Simone; Dr. Aruna Bakhru; Dr. Edmund Chein; Dr. Stanley Dudrick; Dr. Melvyn Grovit; Dr. Robert Verkerk; Dr. Harry G. Preuss; Dr. Alan R. Gaby; Dr. Gina Cushman; Dr. David Perlmutter; Dr. Joya Schoen; Dr. Stephen T. Sinatra; Dr. Carolyn Dean; Dr. Sherri Tenpenny; Dr. Sidney Stohs; Dr. Neal D. Barnard; Dr. Jonathan Collin; Dr. John Abramson; Dr. Ronald D. Hoffman; Dr. Michael Schachter; Dr. Andrew Weil; Dr. W. Lee Cowden; Dr. Joseph Mercola; Dr. Mark Hyman; Dr. Peter R. Holyk; Dr. Garry Gordon; Dr. Russell Jaffe; Dr. Mayer Eisenstein; Dr. Hyla Cass; Dr. Allan Magaziner; Dr. Bruce Shelton; Dr. Sara Gottfried; and Dr. Robban Sica

Excellence in Medical Research Award: Dr. Stanislaw Burzynski; Dr. Charles B. Simone; Dr. Charles B. Simone II; Dr. Nicole Simone; Dr. Neal D. Barnard; Dr. Harry G. Preuss; Dr. Alan R. Gaby; Bastyr University; the Center for Integrative Medicine at the University of Arizona College of Medicine; Dr. Joel D. Wallach; Dr. Melvyn Grovit; Dr. Stanley Dudrick; Dr. Jonathan Wright

First Amendment Hall of Fame Award: Durk Pearson; Sandy Shaw; Dr. Julian M. Whitaker; Dr. Joel D. Wallach; Ray Hamel; Peter Hamel; Gretchen DuBeau; Dr. Alexander Schauss; and Dr. Richard Kleinberger

Free Speech Global Award: Dr. Robert Verkerk

Sacred Fire of Liberty Award: Donald E. Washkewicz; Paul F. Glenn; Hunter Lewis; NOW Foods; Berkley Bedell; William Faloon; Ben Suarez; Dr. Julian M. Whitaker; Julie Whitman Kline; Dr. Joseph Mercola; & Manoj Bhargaba

Freedom of Informed Choice Award: Alliance for Natural Health—USA; Alliance for Natural Health—International; Life Extension Foundation; Institute for Responsible Technology; Bert Schwitters; Citizens Council for Health Freedom; Campaign for Liberty; Dr. John Abramson; Sheila Matthews-Gallo; Dr. Joseph Mercola; Mary Jo Siegel; Richard DeSylva; Dr. Jane Orient; Donna Navarro; Barbara Loe Fisher; Doris Wood; and Twila Brase

Excellence in Health Product Innovation Award: Dr. Mark Whitacre; Brian W. Shilhavy; Dr. Nicholas Perricone; Jerry Smith; Dr. Charles B. Simone; Dr. Patricia Bragg; Dr. Reginald McDaniel; Dr. Joel D. Wallach; Will Block; Dan Caudill; Dr. Luke Bucci; Corey Anderson; Janet Cherry; Frank Key; Scott Henderson; James Komorowski; Stan Soper; Durk Pearson; Sandy Shaw; Roland Jerch; Elwood Richard; Val Anderson; Scott Henderson; and Christian Wilde

Excellence in Health Journalism Award: James Gormley; William Skinner; Shane Starling; Robert Scott Bell; Dennis J. Courtney; John Rappoport; Bob Swientok; Frankie Boyer; Paul Rothfuss; Elaine Watson; Ron Waldman; Peter Starr; Vaishali; Dr. Ronald D. Hoffman; Deborah A. Ray; Dr. Joseph Mercola; Dr. Stephen T. Sinatra; Dr. Jonathan Collin; Joe Cosgrove; Dennis McCuistian; William Faloon; Dr. Neal D. Barnard; Mike Adams; and Dr. Julian M. Whitaker

Voice of Liberty Award: Ted Anderson; Erskine; Mike Adams; Alex Jones; George Noory; Jeff Rense; John Stossel; Lars Larsen; Jerry Doyle; Robert Scott Bell; Deborah Ray; Sean Hannity; and Erskine

Fount of Freedom Award: Paul Walter; Wayne Barrett; Peter Schweizer; Kim R. Holmes; Jay Sekulow; Robert Oulds; Ramona Morrison; Rae Capitka; Cheryl K. Chumley; and Tim Delmastro

The two-day gala, on September 5 and 6, was emceed by Hollywood actor and producer Terrence McNally and included musical entertainment from gospel music great Alma Randolph; world renowned tenor Mark Harris; Fresh Air Music Entertainment’s Motown revue; and George Mason University’s fife and drum, string ensemble, and brass quintet.

Over the next several weeks video footage from the gala will appear on the sacredfiregala.com web site and on YouTube.

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The post PRESS RELEASE: EMORD & ASSOCIATES HONORS LEADERS IN NUTRITION, INTEGRATIVE MEDICINE, MEDICAL SCIENCE, AND JOURNALISM AT SPECTACULAR GALA appeared first on Emord Blog.

Freedom From Choice investigates the loss of our liberties.  It asks whether our daily choices, from what we eat to what we read, are in fact our choices or whether they are choices that are being made for us by regulations and red tape, lobbyists and businesses.

In the film, experts, including Emord & Associates’ principal Jonathan W. Emord, explain how and why our choices have become limited.

Delmastro’s interview and a short excerpt of the film featuring Emord is scheduled to air on July 17 at 9 PM ET on Fox Business, with a likely re-run on July 20 at 10 PM ET on Fox News.  We invite you to tune in.

The post Emord Interview in Freedom From Choice to Appear on the Stossel Show appeared first on Emord Blog.

On July 2, 2014, the Food and Drug Administration (“FDA”) published a notice requesting that interested groups and individuals nominate bulk drug substances (active ingredients) that may be used by outsourcing facilities to compound drugs in accordance with section 503B.  For the FDA to fully evaluate the inclusion of a bulk drug substance on the list, it requested specific information concerning:  (1) the general background of the bulk drug substance, (2) the clinical need for compounding with the bulk drug substance, and (3) the drug product that will be compounded with the bulk drug substance.  Nominations are due by September 30, 2014.

The FDA also published a proposed rule that would add 25 drugs to its list of drugs that cannot be compounded because they have been withdrawn or removed from the market because they are unsafe or ineffective.   If the proposed rule is finalized, drugs included on the list will not be entitled to exemptions provided in sections 503A and 503B of the FDCA.   Comments on the proposed rule are due by September 2, 2014.

Please contact our firm by August 1, 2014 if you would like to nominate a bulk drug substance for use in compounding or if you would like to comment on the proposed rule that will limit the drugs that can be compounded.

The post FDA Requests Nominations for Drug Compounding List appeared first on Emord Blog.

The old version of section 482.28 provided that only the practitioner responsible for the care of a patient could order the patient’s diet, including a therapeutic diet.  CMS proposed that the rule be revised to also allow a “qualified dietitian” to order a patient’s diet as authorized by medical staff.  According to CMS, it suggested the term  “qualified dietitian” because “a few States elect not to use the regulatory term ‘registered’ and choose instead to use the term ‘licensed’ (or no modifying term at all) . . .” 78 Fed. Reg. 9126, 9222 (Feb. 7, 2013).  CMS claimed that the rule needed to be revised because “[p]hysicians, APRNs, and PAs often lack the training and educational background to manage the sometimes complex nutritional needs of patients with the same degree of efficiency and skill as RDs who have benefited from curriculums that devote a significant number of educational hours to this area of medicine.” Id. at 9223.  CMS further stated that dietitians are “the professionals who are best qualified to assess a patient’s nutritional status and to design and implement a nutritional treatment plan in consultation with the patient’s interdisciplinary care team.” Id. at 9222.

In CBNS’ comments, it recommended that a “qualified nutritionist” also be allowed to order a patient’s diet.  CBNS explained that some nutritionists have far more advanced training in Medical Nutrition Therapy and therapeutic diets than some dietitians.  CBNS also pointed out that a person’s status as a dietitian does not guarantee that he possesses the level, degree, quality or quantity of education, training, and experience needed for reliably competent and effective ordering of therapeutic diets and Medical Nutrition Therapy.

In response to comments CMS received, it revised section 482.28 to allow “registered dietitians and other clinically qualified nutrition professionals to be privileged to order patient diets under the hospital conditions of participation (CoPs).”   Specifically, CMS amended the rule to now require that all patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient of by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals.” (Emphasis added.)  In explaining the reason for this change, CMS stated:

Our use of the term “registered dietitian,” in the proposed regulatory language, along with our use of this term and the terms “qualified dietitian” and “RD” in the preamble, was not meant to be exclusive of other nutrition professionals qualified to practice in the hospital setting. We agree with commenters that the regulatory language for § 482.28 should be inclusive of all qualified nutrition professionals.  We do not agree with commenters who requested that we use the term “registered dietitian” or define “qualified dietitian” as an individual specifically registered with the Commission on Dietetic Registration.  We agree that a more flexible approach would be the best way to ensure that patients benefit from the improved quality of care that these professionals can bring to hospital food and dietetic services. Additionally, we believe that it is best left to individual States to determine the regulatory processes by which these professions are governed and that hospitals, through their medical staff privileging processes, should be allowed the flexibility to determine the credentials and qualifications for dietitians and nutrition professionals, in accordance with their respective State laws if and when they choose to grant ordering privileges to these professionals.

CMS’ decision is a blow to the Academy of Nutrition and Dietetics (“AND”), which has worked towards establishing a monopoly of registered dietitians.

The post CMS Final Rule Benefits Qualified Nutritionists appeared first on Emord Blog.

As explained in a legal memorandum we prepared on the issue, the Vermont GMO labeling bill will likely survive a First Amendment Challenge in the Second Circuit, for the following reasons:

• The Second Circuit is a particularly favorable jurisdiction for proponents of compulsory labeling laws.  Specifically, it applies rational basis review to compulsory commercial speech when the compelled speech is factual in nature, as opposed to viewpoint laden.  Under rational basis review, the Second Circuit will uphold such a law if there is a rational connection between its purpose and the means employed to realize its purpose.   Here, the Vermont labeling law compels factual speech, i.e., the disclosure of a genetically engineered component.  Plus, there is a rational connection between its purpose, the protection of public health and safety, and its means, requiring the disclosure of GMOs so consumers can avoid potentially dangerous products.

• Legislatures have broad power to define legislative terms, such as the term “natural.”  Here, Vermont has defined “natural” to mean a product that was not produced through genetic engineering.  If a product that was produced through genetic engineering bears a “natural” claim in Vermont, the claim is false and not entitled to constitutional protection.

The post Vermont GMO Labeling Bill is Constitutional Under the First Amendment appeared first on Emord Blog.

Hank Schultz, “Companies must walk fine line when bringing a supplement to market in US that is a drug elsewhere,” www.nutraingredients-usa.com  (Mar. 27, 2014).

The post Attorney Bethany R. Kennedy Comments on NDI Notifications appeared first on Emord Blog.

Pompeo’s bill, named the Safe and Accurate Food Labeling Act, would give FDA sole authority to require mandatory GMO labeling.  Specifically, it would require companies to submit new GMOs to FDA for review, and if the agency determines they pose a health or safety risk, FDA can require a label.  It would also allow GMOs to be labeled as “natural.”

Presently, FDA allows companies to voluntarily indicate whether foods have or have not been developed using biotechnology so long as the statements are truthful and not misleading.  For example, as explained in its 2001 draft guidance on the issue, FDA stated that “the use or absence of use of bioengineering in the production of a food or ingredient does not, in and of itself, mean that there is a material difference in the food.”  Accordingly, FDA explained that “a label statement that expresses or implies that a food is superior (e.g., safer or of higher quality) because it is not bioengineered would be misleading.”

According to Pompeo, his bill is necessary because mandatory GMO labeling misleads consumers into believing that GMOs pose a safety risk when they have really made food safer and more abundant.  His critics, however, claim that he is simply catering to his financial backers from the food and agribusiness industries, such as General Mills, and his bill would deny consumers their right to know what they are buying and eating.

The post Congressman Pompeo Introduces Bill to Block State GMO Labeling Laws appeared first on Emord Blog.

ConAgra’s petition proposed that the following two model health claims be allowed on the labels or in the labeling of whole grains and food containing whole grains:

(1)    Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.

(2)    Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.

FDA concluded that the proposed model claims must be further qualified to prevent them from misleading consumers.   The agency revised the claims to state as follows:

(1)    Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.

(2)     Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.

FDA’s revised claims likely violate the First Amendment of the U.S. Constitution.  In Alliance for Natural Health U.S. v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010) (“ANH”), Emord & Associates, P.C. represented plaintiffs who challenged, inter alia, FDA’s qualification of their proposed health claim regarding the relationship between selenium and prostate cancer risk.  The plaintiffs proposed the following model claim: “Selenium may reduce the risk of prostate cancer.  Scientific evidence supporting this claim is convincing but not yet conclusive.”  FDA found that two-nested case control studies suggested that selenium may reduce risk of prostate cancer, but it rejected the model claim because it thought it was false and misleading to characterize the evidence in support of the claim as “convincing but not yet conclusive.”  FDA revised the claim to state as follows:  “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”

The ANH plaintiffs claimed that FDA’s revision violated the First Amendment because it “constructively suppress[es] [this] claim with the imposition of an onerous, value laden set of qualifications that only allow Plaintiffs to propound a false, negatively value-laden, and inaccurate claim to the public.”  The D.C. District Court agreed.  It held that “FDA’s proposed claim is at odds with the Supreme Court’s mandate that there be a ‘reasonable fit’ between the government’s goal and the restrictions it imposes on commercial speech.”  The court reasoned that FDA was required to draft a “precise disclaimer” that would qualify the plaintiffs’ claim while also adhering to the “First Amendment preference for disclosure over suppression,” but what FDA did was replace the Plaintiffs’ claim entirely and effectively negate any relationship between prostate cancer risk and selenium intake.  As a result, the court ordered FDA to draft a new short, succinct, and accurate disclaimer.

In spite of the court’s instructions to FDA in ANH, FDA is once again drafting unreasonable, negatively value-laden disclaimers that likely violate the Constitution, as evidenced by the ConAgra decision.

The post FDA’s Qualified Diabetes Health Claims are Unreasonable appeared first on Emord Blog.

–  It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube.

–  It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;

–  It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;

–  It is intended to be used under medical supervision; and

–  It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

To illustrate the effect of these requirements, FDA explained that medical foods cannot be used to manage diseases like diabetes and conditions such as pregnancy because modification of the normal diet alone is sufficient to manage them.   FDA also clarified that medical foods are not required to be available by prescription and that use of the symbol “Rx only” symbol or NDC numbers misbrands medical foods.

According to the draft guidance, FDA distributed it “for comment purposes only,” and the agency requested that comments be submitted no later than October 15, 2013.  Nonetheless, FDA is currently enforcing its tenets.  For example, on August 13, 2013, FDA issued a warning letter to Metagenic’s Inc. on the grounds that its products were misbranded because their labeling was false or misleading in that they were labeled as medical foods but did not meet the definition of a medical food.  FDA reasoned that the products were not medical foods because they were intended to support diseases or conditions that do not have distinct requirements for certain nutrients, e.g., chronic fatigue syndrome, fibromyalgia, leaky gut syndrome, metabolic syndrome, cardiovascular disease, inflammatory bowel disease, eczema, rhinitis, allergy-responsive asthma, and peripheral artery disease.  FDA also concluded that such products were drugs based upon therapeutic claims, e.g., “[A] medical food formulated to nutritionally support the management of conditions associated with metabolic syndrome and cardiovascular diseases including hypercholesterolemia, hypertriglyceridemia, and hypertension.”

This warning letter and the existence of the new draft guidance indicate that medical food enforcement has become a priority for FDA.  Medical food companies are not safe just because the new medical food guidance is only a draft.

The post FDA Enforcing Draft Medical Food Guidance appeared first on Emord Blog.

Notably, FDA’s draft guidance greatly restricts the universe of diseases manageable by “medical food” products.  For example, FDA clarified that medical foods cannot be used to manage disease or conditions that can theoretically be managed by modifying the normal diet alone.  FDA specifically identified diabetes, classical nutrient deficiency diseases (e.g., scurvy and pellagra) that result from essential nutrient deficiencies, and pregnancy as diseases or conditions that medical foods cannot be used to manage.  The agency, however, will allow inborn errors of metabolism (IEMs), including inherited biochemical disorders in which a specific enzyme defect interferes with normal metabolism of protein, fat, or carbohydrate, to be managed with medical foods when the medical food is required in addition to dietary modification to maintain sufficient levels of essential nutrients that are reduced by modifying the normal diet.

The problem with FDA’s approach is that it eliminates beneficial products from the marketplace, requiring them to either proceed through the drug approval process or be marketed as dietary supplements with limited structure/function claims, thus depriving consumers of valuable information that can improve their health.  Although some diseases and conditions that have special nutritional requirements can be managed through diet modifications alone, not all consumers are willing or able to make drastic diet modifications.  If FDA’s new position stands, companies could resort to the DSHEA’s health claims provisions to spread information concerning a nutrient’s relationship with certain disease states.

The agency asked for written comments on the draft guidance by October 15, 2013.   Please contact us for information about the commenting process.

The post FDA Issues Draft Medical Food Guidance appeared first on Emord Blog.

CONTACT: Bethany Kennedy (602-334-4415)

Washington, D.C.— The Martindale-Hubbell legal rating service issued today a newswire press release.^[1]  In it, Martindale-Hubbell announces that based on interviews with lawyers and judges, it has reaffirmed in 2013 the AV Preeminent (highest in legal ability and ethics) rating it originally awarded Jonathan W. Emord in 1996.  Nominations for the rating must come from peers and follows a detailed peer review process.  The rating is the highest Martindale-Hubbell bestows on lawyers, based on the professional judgment of peers.

The Martindale-Hubbell rating service includes the following in its press release issued today:

The Martindale-Hubbell^® AV Preeminent^® rating is the highest possible rating for an attorney for both ethical standards and legal ability. This rating represents the pinnacle of professional excellence. It is achieved only after an attorney has been reviewed and recommended by their peers – members of the bar and the judiciary. Congratulations go to Jonathan W. Emord who has achieved the AV Preeminent^® Rating from Martindale-Hubbell^®.

The post PRESS RELEASE: JONATHAN W. EMORD’S AV PREEMINENT® (HIGHEST IN LEGAL ABILITY AND ETHICS) RATING REAFFIRMED BY MARTINDALE-HUBBELL appeared first on Emord Blog.

FOR IMMEDIATE RELEASE: July 30, 2013

CONTACT: Bethany Kennedy (602-334-4415)

EMORD ANNOUNCES FIRST AMENDMENT HALL OF FAME

Washington, D.C.—Today the Washington, D.C. based constitutional and administrative law firm Emord and Associates, P.C. announced its posting of an online First Amendment Hall of Fame.  The posting presents the names, photographs, and biographies of the 9 people most responsible for 8 successful First Amendment lawsuits brought by the firm against FDA censorship of nutrient-disease claims for dietary supplements.  See www.emord.com (First Amendment Hall of Fame).  “These people have made legal history, prevented FDA from censoring vital nutrient-disease information in the market, established the qualified health claims regime at FDA through their victories, and have helped reduce the incidence of neural tube defects, sudden death heart attacks, and cancer all around the world,” said Emord & Associates’ principal Jonathan Emord.  “They have courageously championed the cause of liberty,” he said, “and they are richly deserving of our gratitude and respect.”

The inductees into the First Amendment Hall of Fame are Durk Pearson and Sandy Shaw; Dr. Julian M. Whitaker, M.D.; Dr. Joel D. Wallach, DVM, ND; Ray Hamel; Peter Hamel; Gretchen DuBeau; Dr. Alexander Schauss, PhD, FACN; and Dr. Richard Kleinberger, PharmD.  On September 5 and 6, 2014, at the Hyatt Regency in Cambridge, Maryland, each of these individuals will be formally inducted into the Hall of Fame and will receive awards in recognition of their achievements.

That 2014 event is entitled “Rekindling Liberty’s Sacred Fire,” borrowed from George Washington’s statement to that effect at the end of his First Inaugural address on April 30, 1789.  It occurs on the 20^th anniversary of the founding of Emord & Associates in 2004.  The emcee for the program is Kate Obenshain, Fox News Contributor, former Chairman of the Republican Party of Virginia, and Vice President of the Young America’s Foundation.  Keynote speakers include Richard Thornburgh, former Attorney General of the United States and former Governor of Pennsylvania; Bay Buchanan, former Treasurer of the United States, Fox News Analyst, and former policy advisor to the Romney campaign; and Tammy Bruce, Fox News Commentator, New York Times best-selling author, and radio talk show host.  More information will be available about the event in the near future.

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The post Press Release – Emord Announces First Amendment Hall of Fame appeared first on Emord Blog.

In 2004, Karen Bartlett took sulindac, a generic, prescription-only non-steroidal anti-inflammatory drug manufactured by Mutual Pharmaceutical, for her painful shoulder.  A few weeks after Bartlett took the drug, she developed an acute case of toxic epidermal necrolysis, which left her extremely disfigured, disabled, and almost blind.  Sulindac’s label did not warn about toxic epidermal necrolysis as a possible side effect because the brand name drug, Clinoril, did not warn about it.  Under federal law, generic manufacturers are prohibited from making unilateral changes to a drug’s composition and labeling, including warnings; a generic drug’s composition and labeling must be consistent with the brand name drug.  In 2005, however, FDA recommended changing all non-steroidal anti-inflammatory labeling to contain a more explicit toxic epidermal necrolysis warning.

Bartlett sued Mutual Pharmaceutical under a state law requiring manufacturers to ensure that their products are not unreasonably dangerous, and a jury awarded her $21 million for her design-defect claim.  The Fifth Circuit affirmed, but the U.S. Supreme Court reversed that decision.   In Mutual Pharmaceutical Co., Inc. v. Bartlett, the Court held that state law design-defect claims based upon the adequacy of a drug’s warnings are preempted by federal law.  The Court reasoned that it was impossible for Mutual Pharmaceutical to comply with state law requiring it to strengthen its warnings or change sulindac’s composition and federal law requiring it to not alter sulindac’s warnings and composition.  Thus, the Court concluded that the state law is “without effect.”

Despite the Court’s holding, it claimed that it was not unsympathetic to Bartlett’s situation.  The Court stated:

This case arises out of tragic circumstances. A combination of factors combined to produce the rare and devastating injuries that respondent suffered: the FDA’s decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent’s physician to prescribe sulindac despite its known risks, and Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs’ compositions or their warnings. Respondent’s situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed.

As it now stands, Bartlett and countless others injured because of generic manufacturers’ design defects have no remedy.  The availability of a remedy should not turn upon whether the drug at issue is brand name or generic.  Generic manufacturers must be held liable for their dangerous products, regardless of whether they are FDA approved, in order for consumers to be adequately protected.

The post Supreme Court Further Immunizes Generic Drug Manufacturers from Liability appeared first on Emord Blog.

Although she was at death’s door, Sarah almost did not receive a lung transplant because of an arbitrary and capricious rule that prohibited children under the age of 12 from getting adult lungs unless the lungs were first offered to and refused by adults and adolescents on the waiting list.  The rule effectively limited the pool of eligible organs to pediatric lungs, which are much rarer than adult lungs.  It is unclear why the cutoff for adult lungs was set at 12 years.

When Sarah’s parents became aware of the rule, they requested an exception.    Kathleen Sebelius, the U.S. Secretary of Health and Human Services, acknowledged that it was an “incredibly agonizing situation,” but declined to intervene and suspend the rule.  Similarly, the Organ Procurement and Transplantation Network (“OPTN”) voted 14-0 to not suggest emergency changes to existing rules.

As a result of this utter lack of compassion and common sense, it took a federal district judge, Michael Baylson, to rule that Sarah was eligible for adult lungs. Judge Baylson has since added a second child with cystic fibrosis, Javier Acosto, to the adult waiting list.

It is sad that it took a judge to intervene.  How many children perished because of the arbitrary rule is unknown.  Thanks to Sarah’s parents, who refused to accept no for an answer, children waiting for lung transplants will be treated equitably with adults for the time being.

For the next year, OPTN is allowing doctors to submit a request to a national review board to have a child under the age of 12 put on the adult waiting list, and the board has seven days to approve the request.  The temporary policy change expires next July unless it is made permanent.

The post Secretary Sebelius and OPTN Failed to Intervene for Sick Girl appeared first on Emord Blog.