Lawsuits Against the FDA Update (July, 1995)

By John Hammell
Political Coordinator for The Life Extension Foundation

In April we reported on three lawsuits that have been filed in US federal courts to challenge FDA censorship of free expression. On July 6th, NHA (Nutritional Health Alliance), announced the filing of another first amendment suit against the FDA. We will first fill you in on progress towards filing our own lawsuit, and then we will fill you in on the cases we discussed in April, plus the suit just filed by NHA.

Life Extension Foundation will soon be filing suit against the FDA for their obstruction of the importation of unapproved drugs for personal use. Up to a three month supply of such drugs as deprenyl, hydergine, and piracetam can be imported for personal use under FDA's RPM Part 9 Chapter 9-71. The FDA has acted arbitrarily and capriciously in denying these products to some citizens, while allowing others to import them. The FDA allows AIDS Buyer's Clubs to import unapproved drugs, while denying cancer, multiple sclerosis, and other patients the same rights. By working through members of Congress, three Foundation members were successful in getting detained products back even when they were on the so called "import alert list." While we don't think anyone should have to go to all this trouble, we also feel that their success in getting detained products back raises grave doubts as to the legality of the broad powers the FDA is claiming.

Several months ago we hired an attorney in California who was going through the process of contacting potential plaintiffs for our suit when he became too ill to be able to conduct business. Considering that he had drafted a complaint and was close to being able to file the suit when he became ill this was a disappointment to us. We are very happy about how things turned out because in his place we have managed to secure the services of William Moore, Jr., of Savannah, Georgia. Many people consider him the most experienced anti-FDA attorney in the country.

Moore is an expert in the art of "forum shopping," which is selecting the best place possible in which to file the suit. The ideal place for us to launch our legal assault would be a port city with a customs house (for ease of subpoenaing FDA employees), that is near Moore's home (so we don't have to pay him a lot for traveling), which is also near a plaintiff's home. Some aspects of forum shopping can't be discussed here. We are hoping to file our suit in Charleston, SC because it meets our criteria. If we are not able to file it there, anywhere along the southeast coast from Virginia to Florida would be suitable.

In the December 26, 1994 issue of Fortune Magazine, "according to Robertson Stephens, the San Francisco investment firm, some $270 billion, or 30% of the total US health care spending, relates to treatment of disorders of the brain and spinal cord. In comparison, heart disease lays claim to $117 billion and cancer, $100 billion. One reason for the disparity is that whereas heart disease and cancer tend to kill their victims, neurological disorders are usually chronic ailments that require long term care and medication."

Karen Anderson, an MS patient from Georgia, damn near fell out of her chair upon hearing in a college Marketing lecture that Fortune magazine had chosen Betaseron "medical profit item of the year."

Anderson has no side effects on calcium EAP, and it only costs her $5./day. Betaseron, on the other hand is highly toxic, costs an average of $10. / day. Berlex, its marketer, and Chiron, the manufacturer, made a combined profit of $70,000,000. on the sale of Betaseron in their first year! No wonder Fortune magazine considers this to be a great investment! By blocking the importation of calcium EAP, it appears that the FDA is protecting the interests of Berlex and Chiron. Upon checking the PDR for warnings, contraindications, adverse reactions, and precautions, I found that the fine print goes on by the page, including warnings that is causes tachycardia, peripheral vascular disorder, hemorrhaging, suicidal ideation, flu like symptoms, and vomiting.

Thus it is obvious that the treatment of multiple sclerosis and other neurological diseases is big business. We feel that this is the reason why the FDA has an automatic import alert on Dr. Nieper's calcium EAP. They do not want this unpatentable combination of calcium, magnesium, potassium and a mineral transporter competing with Chiron's "Betaseron," the only FDA approved drug for multiple sclerosis.

Could this have anything to do with the trouble Karen Anderson and other MS patients are having importing Calcium EAP? On Calcium EAP, Karen has no side effects and the cost of her treatment is only about $5.00/ day. If she were taking Betaseron, she would be paying twice that, or $3,500./ year for a highly toxic drug that is nowhere near as effective as Calcium EAP. Betaseron caused MS patient and registered Nurse Joyce Johnston to go into cardiac arrest while working in a hospital. If they had not been able to fibrillate immediately to restart her heart, and to put her on a respirator in the ER, she would have died. Is it morally proper for the FDA to approve a highly dangerous drug like Betaseron while suppressing a safe, effective, non toxic product like Calcium EAP? You already know the answer.

Joyce Johnston, a registered nurse and MS patient was on Betaseron and it caused her to go into cardiac arrest while she was working in the hospital. They had to fibrillate to restart her heart and put her on a respirator in the ER. Johnston almost died. Following that, she went on calcium EAP, was doing quite well, but the FDA detained her shipment and never responded when her doctor wrote a certified letter in her behalf informing them that Betaseron had almost killed her, but that she was doing very well on calcium EAP.

Most of our potential plaintiffs suffer from multiple sclerosis, and are patients of Dr. Niepers. If we win this case and set the needed precedent, all of you who've had products seized will then be in a position to jointly sue the FDA for damages. If you have multiple sclerosis or cancer and want more information about Dr. Nieper's treatment methods, call the Brewer Science Library at 608-647-6513, and speak with Lillian Hanke. For information about Americans for Medical Freedom call Jack Haney at 303-220-5020.

In April we reported that the Washington Legal Foundation filed suit against the FDA on June 13, 1994 in US District Court in the District of Columbia. WLF argues that the FDA's restrictions on information regarding unapproved (or off label) uses of FDA approved drugs and medical devices violate the first amendment rights of both the providers of the products and the recipients of the information. In one particularly egregious case, the FDA blocked a manufacturer from distributing an authoritative textbook to doctors because it contained truthful information regarding off label uses

of the manufacturer's cancer drugs. WLF also seeks to stop the FDA from blocking educational seminars sponsored by drug companies in which this sort of information is presented. The FDA is preventing doctors from receiving vital information about recognized off label uses of drugs and devices.

In our last report we were waiting to see if the Judge would dismiss the case, however in March the Judge ruled in favor of WLF, agreeing that the case should proceed to a trial. Both sides are in Discovery now, and a trial is expected to occur in March 1996. The Washington Legal Foundation has a superb track record of defending our constitutional freedoms in court, and a victory here would help anyone involved in first amendment disputes with the FDA including dietary supplement companies. All of these legal challenges combined may be more than the FDA has bargained for. I predict some major victories on the horizon. For information about the Washington Legal Foundation call 202-588-0302.

The second case we reported on in April was the National Council for Improved Health's first amendment lawsuit against the FDA. The suit charges that the FDA has misused and violated the food additive portion of the Food Drug and Cosmetic Act with intent to destroy the marketplace for amino acids, herbs, and other nutrient products such as Co-enzyme Q-10. It also charges that the FDA's classification of nutrients as "drugs" is in violation of the Act, the intent of Congress, the Constitution, and thousands of years of safe use of these products. A hearing was held in January, but Judge Greene has yet to make a decision as of July 6th. His delay could partially be the result of a need to carefully review all aspects of the case due to the momentousness of any decision. Kirk Dilling, counsel for NCIH recently presented Judge Greene with the brief of Rubin v. Coors, the Supreme Court decision which ruled that Coors was allowed to list the alcohol content of their beer on the label on the grounds that it was a true statement. (This was over BATF's objection that such listing on beer would cause "strength wars" between beer companies in which they'd vie with each other to sell the beer with the highest alcohol content. Coors argued successfully that wine and liquor companies were allowed to list alcohol contents and theirs is higher than beers, so they should be allowed to follow suit. The Supreme Court agreed. This decision will have a major impact in all first amendment lawsuits against the FDA (such as the one just filed by NHA - described below, and in H.R. 1951 The Food and Dietary Supplement Consumer Information Act which was just introduced by Representatives Pallone and Hastert.) For more information on the NCIH's lawsuit contact them at 800-533-7255 and ask for Mike Byrd.

The third first amendment lawsuit we reported on in April was the Mineral Resources International , a business trust; Trace Minerals Research, a business trust (Petitioners) v. The US Dept. of Human Services; Donna E. Schalala, Secretary; United States Food and Drug Administration; David A. Kessler, Commissioner of Food and Drugs, FDA, United States of America.

It was incorrectly stated last time that this suit had been filed by Durk Pearson and Sandy Shaw. In fact, their attorney, Jonathan Emord argued the case, and Durk and Sandy were present in the courtroom, but it was not their case. Theirs will be a similar case, filed in the 9th Circuit Court of Appeals in San Francisco, and I just received word from Sandy that oral arguments will be heard on August 15th. Petitioners in the 9th Circuit case are Durk Pearson and Sandy Shaw, American Preventive Medical Association, Citizens for Health, and the National Health Federation. The defendants are identical to those listed above from the 10th circuit case.

Sandy told me that the 10th circuit court ruled that it didn't have jurisdiction to hear an appeal on Trace Minerals case, so they wriggled out of it. The court also claims that Trace Minerals did not exhaust all remedies by not petitioning the FDA to be allowed to make claims on their products. It will be much more difficult for the 9th circuit court to adopt this kind of tactic on August 15th because unlike the 10th circuit court which does not allow the presentation of evidence, the 9th circuit hearing will be more formal, with the plaintiffs prepared to present thousands of pages of scientific articles which prove numerous valid health claims on dietary supplements: claims which the FDA has steadfastly denied

On July 6th, the Nutritional Health Alliance just filed a first amendment suit against the FDA in Federal District Court in the Southern District of New York seeking a declaratory judgment that provisions of the Nutrition Labeling and Education Act (NLEA), and FDA implementing regulations, are invalid under the first amendment to the US Constitution in that they constitute a "prior restraint" of constitutionally protected speech. NHA reports that the suit was filed by the NY law firm of Bass and Ullman, and attacks that portion of the NLEA unchanged by the Dietary Supplement Health and Education Act, which prohibits manufacturers and marketers of dietary supplement products from using truthful non misleading information to inform the public of the relationship between the consumption of dietary supplement products and the prevention of disease and other health related conditions, unless such information has been authorized in advance by the FDA.

The FDA, under the NLEA, acts as a governmental censor, deciding what the American people can read and learn about the consumption of dietary supplement products and their health and well being. This action brought by NHA is complementary to the Food and Dietary Supplement Consumer Information Act, H.R. 1951, legislation introduced by Congressmen Pallone and Hastert, which is part of a total and coordinated campaign for health freedom. Gerald Kessler, NHA's President, stated that "The NHA has filed this case as part of its continuing campaign for health freedom and freedom of speech." Mr. Kessler further stated that, "We must continue to the fight for the right of the dietary supplement industry to make truthful and non misleading health claims and for the right of the American public to receive information which is crucial to their health and well being."

(The information on HR 1951 and on the lawsuit filed by NHA was reprinted with permission from NHA)

If you've had a product detained by the FDA, and want to join our class action suit, send your paperwork to: John Hammell 1534 Polk St. Hollywood, FL 33020. You should also attempt to get your seized product back from the FDA by going through your 2 Senators and Congressmen. Three Foundation members succeeded by going that route, although it was difficult. It is important that you educate your elected officials. They are in Washington to serve you, but they may not do what you want unless you educate them and request their assistance. You need to find out who handles constituent case work involving the FDA. It may be someone in DC, or someone in a Senators or Congressman's state or district office. The key thing to state is that the FDA has been acting arbitrarily and capriciously in detaining some people's products, but not others. When pressured by Congress they have released detained products even when they were on the so called "import alert list." The key thing is to refer them to the FDA's RPM Part 9, Chapter 9-71 which allows you to import any unapproved drug provided its for personal use and is no more than a 90 day supply. The FDA will attempt to buffalo your Congressman. Don't let them! Tell them that 3 LEF members got detained products returned to them, even in cases when the products were on the import alert list because their Senators and Congressmen got behind them and backed their constitutional rights. Don't let your elected officials give you the brush off. Be persistent! Along with this, join our lawsuit.