|
|
by Scott Tips January 2002, Whole Foods Magazine |
|
In a stunning move, California attorney Scott Pinsky gutted the entire case that the so-called National Council Against Health Fraud ("NCAHF") had put forward against homeopathic manufacturer King Bio Pharmaceuticals and left that case terminally bleeding on the courtroom floor. Recognizing that NCAHF had no evidence whatsoever, the Los Angeles County Superior Court trial judge stepped in and delivered the coup de grace by granting Pinsky's motion for nonsuit and dismissing NCAHF's case against King Bio on October 26, 2001. No mercy was asked for and none was given. It is a war with which many of you in the industry have long been familiar. NCAHF, through its president Stephen Barrett, has for many years been crusading against any and all complementary health and medical practices. Chiropractors, homeopaths, herbalists, Chinese traditional medicine practitioners, and others have all been targeted by Barrett and his NCAHF. Barrett seems to be especially enraged by homeopaths and their homeopathic remedies. The King Bio case was an attempt by NCAHF to accomplish by litigation what it had failed to do through the Food and Drug Administration (FDA), that is, to shut down homeopathy in America. Years ago, NCAHF members had lobbied FDA to re-write its regulations so as to essentially eliminate homeopathic drugs from the marketplace. This effort failed, so NCAHF turned to the courts to make policy itself through litigation. The NCAHF lawsuit against King Bio and its president, Dr. Frank King, Jr. alleged that the defendants had violated various California statutes prohibiting false advertising and unfair business practices based on the false advertising. Essentially, NCAHF's legal position was that there is virtually no credible evidence to support the claims associated with any homeopathic drug. Therefore, NCAHF argued, all of King Bio's homeopathic remedies must be useless and the associated advertising false. It did not matter to NCAHF that it had never sampled King Bio's products, that it had never tested them, or even seen one of them at all. In fact, the very first time that NCAHF had even set eyes on any of the defendant's products was on the first day of trial! No, to NCAHF, the defendant's products were tainted because NCAHF disbelieved in the theories upon which homeopathic remedies are based. As defendants' attorney, Scott Pinsky, said in his opening statement, "this is . . . a lawsuit founded upon theory and intolerance alone." So how did Mr. Pinsky and his clients win this case? First of all, it helps that you are in the right. Second, it takes good lawyering. Third, a smart Judge who understands the law is also important. But, in the end, the legal arguments carried the day along with the complete absence of any real evidence offered by NCAHF. Pinsky correctly pointed out that Federal law defines "drugs" to include homeopathic remedies and that every one of the defendant's ingredients was duly listed in the FDA-recognized Homeopathic Pharmacopoeia of the United States, which is itself published by the respected Homeopathic Pharmacopoeia Convention of the United States. Pinsky then added that the FDA mandates that all drug purveyors follow certain guidelines in labeling and marketing their products, especially an "indication" that identifies the conditions that each drug is known to affect. For homeopathic drugs, these indications may be taken from the reference work known as the Materia Medica. (The Materia Medica, for those unfamiliar with it, is a comprehensive compilation of empirical reports prepared by medical doctors about homeopathic remedies.) The Materia Medica is accepted by the FDA and others as authoritative on the question of the effects of homeopathic remedies; so, defendants contended that since King Bio's products had been labeled and advertised in a way entirely consistent with the Materia Medica, its products were being lawfully sold and advertised under Federal and State law. NCAHF had to agree, but still claimed that the defendants' advertising was false and misleading. To support its position, it presented as expert witnesses Wallace J. Sampson, M.D. and Stephen Barrett, M.D. Dr. Sampson's testimony was very general in nature and upon cross-examination, he had to admit that he had no experience or training in homeopathic medicine or drugs. The best expertise that he could muster on the topic was to claim that he taught a university course on "alternative medicine." That did not impress the trial judge at all, particularly when Sampson admitted that he had done absolutely no investigation into defendant's specific products. The court ruled that Dr. Sampson's testimony did not support NCAHF's claims. Dr. Barrett's testimony was evidently more amusing. Climbing into the stand, Barrett lugged with him a notebook to which he constantly referred during his testimony. Even when asked about his educational credentials, he had to peer into his notebook for the answer. When the judge challenged him on this by telling him to answer the question and not to look at his notebook, Barrett retorted with "Oh, yes, I do." The notebook, it turned out, contained all of Barrett's testimony that he had scripted with his attorney before the trial. Needless to say, as with any witness on the stand, he was forced to turn those notes over to opposing counsel for counsel's review. (The moral of this portion of the story is to never take to the stand anything you do not want opposing counsel to see.) In the end, Barrett's testimony was limited to the sole issue of FDA's treatment of homeopathic drugs. But, as with Dr. Sampson's previous testimony, Barrett had to admit that he had no particular training in homeopathic medicine or drugs, although he claimed that he had read extensively on the subject. However, notwithstanding his readings and conversations with FDA agents, Dr. Barrett was rejected by the Court as an expert witness. Moreover, Pinsky's cross-examination of Barrett uncovered the fact that Barrett and Sampson were both financially interested in the outcome of the case because his witness fees came from the proceeds of suits such as this one. The Court determined that both Barrett and Sampson were not neutral or dispassionate witnesses or experts, and were even themselves the client for which they testified. So, in the end, the Court dismissed both men's testimony as having little, if any, credibility. Defense witness, Dr. Jacquelyn Wilson, M.D., on the other hand, was well-received by the Court. Her background and credentials in homeopathy and homeopathic drug usage were extensive and refreshingly real. The Court accepted her testimony as credible and persuasive on the fact that the defendant's products complied with all applicable FDA laws and regulations. Dr. Frank King, King Bio's president, was also called to the stand and he testified as to the actions that he had taken to comply with all applicable Federal and State laws. Importantly, he showed that he had retained and consulted with experienced regulatory counsel practicing in the field of food-and-drug law and that he had also hired a medical doctor to consult on FDA-compliance issues. In the end, this case went well for King Bio and homeopathy because King Bio was well represented by legal counsel and stuck to its guns by not caving in to any of plaintiff's demands to settle before trial. With the risk of major damages looming over their heads, defendants must have been tempted to try to rid themselves of the case before trial. But they did not. Sometimes the best way out is to just go through. That was certainly the case here. Above all, though, this court victory shows the rest of us that homeopathy is actually very defensible in court. It also reveals NCAHF to be the "paper tiger" that it really is.
|
|
