Barrett/NCAHF LOSE Again In California
Ilena Rose
EXCERPTS:
"Having reviewed and considered all these matters, and
having considered and weighed the evidence presented by the Plaintiff in its
case in-chief, as well as the evidence adduced through cross-examination of
the Plaintiff's witnesses, the Court hereby grants Defendants motion and
directs that judgment shall be entered in favor of the Defendant, and
against Plaintiff, as set forth below."
"In addition, Dr. Sampson admitted to having done absolutely no investigation
concerning Defendants' specific products. He admitted to no real knowledge
as to their ingredients and acknowledged that he had not seen any of the
products prior to the trial."
C. Credibility of Plaintiff's experts
"Furthermore, the Court finds that both Dr. Sampson and Dr. Barrett are
biased heavily in favor of the Plaintiff and thus the weight to be accorded
their testimony is slight in any event....
...Based on this fact alone, the Court may infer that Dr.
Barrett and Sampson are more likely to receive fees for testifying on behalf
of NCAHF in future cases if the Plaintiff prevails in the instant action and
thereby wins funds to enrich the litigation fund described by Dr. Barrett.
It is apparent, therefore, that both men have a direct, personal financial
interest in the outcome of this litigation. Based on all of these factors,
Dr. Sampson and Dr. Barrett can be described as zealous advocates of the
Plaintiff's position, and therefore not neutral or dispassionate witnesses
or experts. In light of these affiliations and their orientation, it can
fairly be said that Drs. Barrett and Sampson are themselves the client, and
therefore their testimony should be accorded little, if any, credibility on
that basis as well.
~~~~~~~~~~~
IN THE SUPERIOR COURT OF CALIFORNIA
IN AND FOR THE COUNTY OF LOS ANGELES
NATIONAL COUNCIL AGAINST HEALTH FRAUD, INC.,
Plaintiff
v.
KING BIO PHARMACEUTICALS, INC.; FRANK J. KING, JR.; and DOES 1-50,
Defendants ________________________________
CASE NO. BC 245271
Assigned for all purposes to Judge Haley J. Fromholz, Dept. 20
REVISED STATEMENT OF DECISION
Pursuant to the Court's order dated December 3, 2001 Defendants King Bio
Pharmaceutical, Inc. and Dr. Frank J. King, Jr. hereby submit the following
proposed revised statement of decision which incorporates the Court's
revisions to that document.
I. Overview of Proceedings
The trial in this action was held commencing on October 22, 2001 in Dept. 20
of the above-entitled court, Hon. Haley J. Fromholz, Judge, presiding.
Plaintiff National Council Against Health Fraud, Inc. ("Plaintiff" or
"NCAHF") was represented by Morse Mehrban, Esq. Defendants King Bio
Pharmaceutical, Inc. and Dr. Frank J. King, Jr. ("Defendants") were
represented by Scott D. Pinsky, Esq.
Following opening statements by the parties, Defendants moved for a non-suit
pursuant to Code of Civil Procedure § 631.8 on the grounds that the
Plaintiff had not identified in its opening statement evidence sufficient to
establish a prima facie case. The Court heard argument by counsel for the
parties on Defendants' motion and denied the motion without prejudice.
Thereafter, NCAHF presented its case, which began with the testimony of two
proffered experts, Wallace I. Sampson, M.D. and Stephen Barrett, M.D.
Plaintiff also offered brief testimony by its counsel, Mr. Mehrban, and
called Defendant Frank J. King as a witness. By stipulation of the parties,
the expert witness designated by Defendants, Jacquelyn J. Wilson, M.D., was
called by Defendants to testify out of order and during the presentation of
the Plaintiff's case due to scheduling reasons. Cross examination was
permitted as to all of the above witnesses. In addition to the foregoing
evidence, both sides filed extensive trial briefs and supplemental trial
briefs both prior to and during the course of the trial, and also submitted
further authorities during the course of the proceedings for the Court's
consideration.
Following the close of Plaintiff's presentation of evidence, Defendants
renewed their motion for judgment pursuant to Code of Civil Procedure §
631.8. The Court again heard argument by counsel for the parties on
Defendants' motion. The Court also considered and weighed the evidence
presented by the above-stated witnesses for the parties. Moreover, the Court
considered the various trial briefs and supplemental trial briefs and
supporting authorities submitted and argued by the parties on the issues
before the Court. Having reviewed and considered all these matters, and
having considered and weighed the evidence presented by the Plaintiff in its
case in-chief, as well as the evidence adduced through cross-examination of
the Plaintiff's witnesses, the Court hereby grants Defendants motion and
directs that judgment shall be entered in favor of the Defendant, and
against Plaintiff, as set forth below. The reasons for the Court's ruling
are as follows.
II. Plaintiff's claims and elements thereof
Plaintiffs' claims are brought principally under certain provisions of the
Cal. Business and Professions ("B & P") Code, specifically B & P Code §§
17200, 17500 and 17508. Sections 17500 and 17508 of the Code prohibit false
or misleading advertising. A violation of these false advertising
prohibitions may also constitute a separate, parallel violation of the
unfair business practices bar under B & P Code § 17200. Section 17200 also
permits an action based on any business practice that is unlawful,
fraudulent or unfair. The principal allegations in the Complaint and the
focus of the Plaintiff's evidence at trial indicate that the primary
violation of law alleged by NCAHF against the Defendants is false
advertising, i.e. some form of false, deceptive or misleading statements or
representations in the labeling or advertising used by Defendants in
marketing their products. The plaintiff did not strongly assert that the
Defendants have violated the other prongs of B & P Code § 17200, which
prohibit business practices that are unlawful, fraudulent or unfair.
Plaintiff did make an attempt to argue that the evidence adduced at trial
could be viewed as supporting a finding that Defendants' actions were
unlawful, fraudulent or unfair within the meaning of § 17200. But the only
evidence offered by Plaintiff concerned the alleged falsity of Defendant's
advertising.
Although Plaintiff did not present evidence specifically pertaining to the
labeling of Defendants' products, there was no dispute between the parties
that the labels affixed to Defendants' products contained substantively the
same information as was contained in the advertising which formed the basis
for the Plaintiff's claims. The parties further agreed that the products in
question are homeopathic drugs regulated under numerous provisions of
federal and state law. See 21 U.S.C. §§ 321 et seq.; B & P Code §§ 13 and
4025; Cal. Health & Safety Code §§ 11014, 109985, 111225 and 111235.
Plaintiff also admitted that there is no evidence of a violation of such
state or federal drug laws by Defendants; Plaintiff offered no evidence or
legal authority respecting any such possible violation. Plaintiff further
did not dispute that Defendants' products fall squarely within the
definition of legal, non-prescription homeopathic "drugs" under both federal
and state laws. Id.
Nonetheless, Plaintiff argued and attempted to offer testimony to the effect
that the claims stated in Defendants' advertising are scientifically
unsupportable and is therefore allegedly false.
III. Burden of proof
The Plaintiff's initial trial brief argued that the burden of proof in this
action should be shifted to the Defendants, citing several California and
federal administrative cases. The Plaintiff's trial brief seemed implicitly
to concede that the Plaintiff could not meet its burden of proof--i.e. the
establishment of Defendants' liability by a preponderance of the evidence-if
the burden were not so shifted to Defendants. The Defendants filed a
supplemental brief responding to the Plaintiff's arguments and asserted that
the burden lies with NCAHF and that the cases it cited to the contrary are
inapposite or do not govern in California. The Court finds that the
authorities cited by the Plaintiff do not support Plaintiff's position on
this issue. There appears to be no case in California to support the
shifting of the burden of proof to the Defendant in a case of this type. The
burden of establishing each element of its claims therefore lies with
Plaintiff NCAHF. Cal. Evid. Code § 500.
In a subsequent, supplemental brief, the Plaintiff next argued that even if
the burden lies initially with the plaintiff in a false advertising case,
only slight evidence is required to then shift the burden to the defendant.
This argument was based on several federal appellate opinions from appeals
of administrative hearings before the U.S. Federal Trade Commission. No
authority was presented to suggest that these decisions are applicable to
the issues at bar, namely who has the burden of proof and to what degree in
a civil action brought in state Court. Since Plaintiff has failed to
demonstrate through appropriate authorities that the burden of proof is in
any way transferred or modified by any of the authorities it cited, the
Court finds that the burden is on the Plaintiff NCAHF to prove its case by
establishing each element of its various causes of action by a preponderance
of the evidence.
IV. Analysis and evaluation of evidence
The Court now reviews the evidence presented by the parties.
A. Wallace I. Sampson, M.D.
Dr. Sampson was offered apparently to testify concerning the scientific
method generally, standards of clinical medical research the nature of
homeopathic medical science, and the nature of the information upon which
much of homeopathic science may be said to rest. The thrust of his testimony
appeared directed to the conclusion that the evidence supporting claims of
efficacy for homeopathic drugs does not meet the standard that he believes
applies to valid clinical studies. In this regard, his testimony was largely
an attempt to discredit the group of reference sources known as "Materia
Medica," which resources the U.S. FDA recognizes as a significant source of
information concerning homeopathic drugs.
All of Dr. Sampson's testimony was quite general in nature and he did not
provide any specific facts that would tend to support any particular finding
as to Defendants' products. Dr. Sampson, a retired medical doctor with an
oncology specialty, has had only limited involvement in clinical research
studies. He has little expertise in research methodology and does not
instruct in that area. He is not an expert in pharmacology. He admitted to
having had no experience with or training in homeopathic medicine or drugs.
He was unfamiliar with any professional organizations related to homeopathy,
including the Homeopathic Pharmacopeia Convention of the United States,
which group is responsible for designation and de-designation of such drugs
as "official" drugs recognized by the U.S. Food and Drug Administration. He
thus does not have expertise as to the drug products that are the sole
products at issue in this case. While he stated that he teaches a university
course on "alternative medicine," Dr. Sampson admitted that the course does
not instruct on how such methods may be practiced, but rather is a course
designed to highlight the criticisms of such alternative practices.
Therefore, the Court finds that Dr. Sampson has relatively thin credentials
to opine on the general questions of the proper standards for clinical or
scientific research or other methods of obtaining valid evidence about the
efficacy of drugs. The Court further finds that Dr. Sampson lacks experience
in the field of homeopathic drugs, which renders his testimony of little or
no weight in this case.
In addition, Dr. Sampson admitted to having done absolutely no investigation
concerning Defendants' specific products. He admitted to no real knowledge
as to their ingredients and acknowledged that he had not seen any of the
products prior to the trial. He admitted that he was aware of no tests ever
performed on Defendants' products by anyone. In view of the foregoing, Dr.
Sampson did not show that the evidence in the Materia Medica as it relates
to the ingredients in Defendants' products is invalid. Accordingly, the
Court finds that the testimony of Dr. Sampson did not show that there is no
valid scientific or medical evidence to support the claims associated with
Defendants' products, even according to his own standards.
B. Stephen Barrett, M.D.
Dr. Barrett was offered on several issues by the Plaintiff, but the Court
found that there was substantial overlap on the issues that he and Dr.
Sampson were asked to address. Thus, in order to avoid duplicative or
cumulative evidence (see Cal. Evidence Code §§ 352, 411, 723), Dr. Barrett's
testimony was limited by the Court to the sole issue of FDA treatment of
homeopathic drugs. The relevancy of this issue was questionable at best,
since the Plaintiff had previously asserted that its case did not depend on
or seek to establish any violation of federal food and drug laws or
regulations. Nevertheless, Plaintiff elicited testimony from Dr. Barrett on
his experience with the FDA as it relates to regulation of homeopathic
drugs.
Dr. Barrett was a psychiatrist who retired in or about 1993, at which point
he contends he allowed his medical license to lapse. Like Dr. Sampson, he
has no formal training in homeopathic medicine or drugs, although he claims
to have read and written extensively on homeopathy and other forms of
alternative medicine. Dr. Barrett's claim to expertise on FDA issues arises
>from his conversations with FDA agents, his review of professional
literature on the subject and certain continuing education activities.
As for his credential as an expert on FDA regulation of homeopathic drugs,
the Court finds that Dr. Barrett lacks sufficient qualifications in this
area. Expertise in FDA regulation suggests a knowledge of how the agency
enforces federal statutes and the agency's own regulations. Dr. Barrett's
purported legal and regulatory knowledge is not apparent. He is not a
lawyer, although he claims he attended several semesters of correspondence
law school. While Dr. Barrett appears to have had several past conversations
with FDA representatives, these appear to have been sporadic, mainly at his
own instigation, and principally for the purpose of gathering information
for his various articles and Internet web-sites. He has never testified
before any governmental panel or agency on issues relating to FDA regulation
of drugs. Presumably his professional continuing education experiences are
outdated given that he has not had a current medical licence in over seven
years. For these reasons, there is no sound basis on which to consider Dr.
Barrett qualified as an expert on the issues he was offered to address.
Moreover, there was no real focus to his testimony with respect to any of
the issues in this case associated with Defendants' products.
C. Credibility of Plaintiff's experts
Furthermore, the Court finds that both Dr. Sampson and Dr. Barrett are
biased heavily in favor of the Plaintiff and thus the weight to be accorded
their testimony is slight in any event. Both are long-time board members of
the Plaintiff; Dr. Barrett has served as its Chairman. Both participated in
an application to the U.S. FDA during the early 1990s designed to restrict
the sale of most homeopathic drugs. Dr. Sampson's university course presents
what is effectively a one-sided, critical view of alternative medicine. Dr.
Barrett's heavy activities in lecturing and writing about alternative
medicine similarly are focused on the eradication of the practices about
which he opines. Both witnesses' fees, as Dr. Barrett testified, are paid
from a fund established by Plaintiff NCAHF from the proceeds of suits such
as the case at bar. Based on this fact alone, the Court may infer that Dr.
Barrett and Sampson are more likely to receive fees for testifying on behalf
of NCAHF in future cases if the Plaintiff prevails in the instant action and
thereby wins funds to enrich the litigation fund described by Dr. Barrett.
It is apparent, therefore, that both men have a direct, personal financial
interest in the outcome of this litigation. Based on all of these factors,
Dr. Sampson and Dr. Barrett can be described as zealous advocates of the
Plaintiff's position, and therefore not neutral or dispassionate witnesses
or experts. In light of these affiliations and their orientation, it can
fairly be said that Drs. Barrett and Sampson are themselves the client, and
therefore their testimony should be accorded little, if any, credibility on
that basis as well.
D. Dr. Frank J. King, Jr.
Plaintiff called Defendant King, who is also president of Defendant King Bio
Pharmaceuticals, Inc., pursuant to Evidence Code § 776. Dr. King testified
to the actions he took to assure his and his company's compliance with all
applicable laws, state and federal. These actions included the retention of
and consultation with experienced regulatory counsel practicing in the area
of FDA compliance. He also testified that he and his company hired a medical
doctor to consult on FDA compliance issues. These and others steps were
taken by the Defendants to be sure that their products and their labeling
complied with federal and other laws and regulations. Dr. King's testimony,
therefore, did nothing to support Plaintiff's case against him and his
company.
E. Jacquelyn J. Wilson, M.D.
Dr. Wilson testified for the Defendants. She is a board certified medical
practitioner with particular experience in homeopathic medicine and serves
on the faculty of the U.C. San Diego medical school. Dr. Wilson testified
that she has trained in homeopathic medicine and received certification to
practice in the field from at least one state agency. She lectures and
consults on the subject of homeopathy and is a member of the Homeopathic
Pharmacopeia Convention of the United States, in which capacity she helps
designate official homeopathic drugs recognized by the U.S. FDA. She has
treated many patients using homeopathic drugs. Based on this background, Dr.
Wilson is, unlike Drs. Barrett and Sampson, qualified as an expert on issues
relating to homeopathy generally. On these issues, she testified that the
Materia Medica contain several types of valid scientific evidence respecting
the effectiveness of homeopathic drugs, even when this evidence is evaluated
under the methodological standards testified to by Dr. Sampson. She also
testified about the general manner in which homeopathic drugs are recognized
and regulated by the FDA. Dr. Wilson further explained through her testimony
that, according to FDA guidance in this area, the "indications" (i.e., drug
effects) that must be placed on the label or package of any homeopathic drug
may be taken from the Materia Medica.
With respect to the products at issue in this case, Dr. Wilson is the only
expert who investigated and evaluated any of the Defendants' products and
their ingredients. Based on her review and general knowledge of the field,
she offered her opinion that all of the ingredients in Defendants' products
are listed in the Homeopathic Pharmacopeia of the United States, which is
the federally approved reference guide for all officially recognized
homeopathic drugs. She also testified that all of Defendants' labeling was
consistent with the information respecting drug indications found in the
Materia Medica. Based thereon, Dr. Wilson concluded, the Defendants'
products complied with all applicable FDA laws and regulations.
F. Documentary and physical evidence
Apart from testimonial evidence, Plaintiff offered no documentary or other
evidence to support its claims. The principal exhibit offered by NCAHF was a
collection of Internet web-page downloads from the Defendants' web-site,
admitted in evidence without objection. These documents established only
what Defendants' claims were, not the alleged falsity of those claims.
Plaintiff offered no evidence pertaining to the specific products in
question.
V. Findings of fact/Conclusions of law
A. False advertising
With respect to the false advertising claims brought under B & P Code
§§ 17200 and 17508, a finding for Plaintiff under these sections requires
that the Plaintiff show by a preponderance of the evidence that each of the
Defendants made false or misleading statements in advertising or labeling as
to one or more of their products. Moreover, it must be shown that the
defendants knew, or through the exercise of reasonable diligence should have
known, that the statements were false. With respect to these claims, the
Court finds that the Plaintiff has failed to prove that Defendants made any
false or misleading statements or representations in connection with any
advertising or labeling of its products. Furthermore, the Plaintiff failed
to show that either of the Defendants knew or should have known that any of
their statements were untrue, false or misleading.
Because the Court has found that there was no false statement or
representation shown, it follows that Plaintiff has also failed to establish
a claim under
B & P Code § 17200. The necessity of a false or misleading statement is no
different under these two provisions. The Plaintiff argues that a different
scienter standard applies under § 17200, and that strict liability applies.
This argument does not aid the Plaintiff, since the Court finds that there
is no showing of a false or misleading statement in the first place, thus
the Court need not reach the issue of knowledge or intent.
B. "Unlawful" business practice
The Court finds that under the evidence adduced at trial there is no basis
for a finding that Defendants violated the unlawful activity prong of B & P
Code § 17200.
C. "Unfair" business practice
The parties disputed the appropriate standard for determining whether
Defendants' activities were "unfair" within the statute's meaning. It has
been interpreted in a number of cases. The case offered by Defendants,
Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co. (1999)
20 Cal.4th 163, 187, appears to apply more to actions involving alleged
competitive injury, rather than harm to consumers. Plaintiff asserts that
the correct standard should be taken from People v. Casa Blanca Convalescent
Homes, Inc. (1984) 159 Cal.App.3d 509, 530. Under Casablanca, unfairness may
exist if it is shown that a practice offends public policy established by
statute, common law or otherwise, or is shown to be immoral, unethical,
oppressive, unscrupulous, or causes substantial injury to consumers.
There is uncertainty as to the continued validity of the opinion in Casa
Blanca in light of the Cell-Tech decision. Cel-Tech was the Supreme Court's
first case directly addressing the definition of "unfair" in the context of
B & P Code § 17200, (20 Cal.4th at 184), and it analyzed and apparently
rejected the definitions arrived at in prior decisions by several
intermediate appellate rulings, including Casa Blanca. 20 Cal.4th at 184-85.
As to these earlier decisions, the Cel-Tech court wrote: "We believe these
definitions are too amorphous and provide too little guidance to courts and
businesses." Id. at 185. In light of this decisions, this Court may be
unable to rely on the test advanced by Plaintiff from Casa Blanca. But even
under the standard articulated in that case-which Plaintiff advances-none of
the above offenses were proved by Plaintiff's evidence.
D. "Fraudulent" business practice
The Court also finds that there is no basis for a finding that Defendants
violated the fraudulent activity prong of B & P Code § 17200. The Plaintiff
failed to show that any of the Defendants' labeling or advertising was
likely to mislead a reasonable person. Committee On Children's Television v.
General Foods Corp. (1983) 35 Cal. 3d 197.
VI. Remaining issues raised by party requesting statement of decision
The foregoing resolves the majority of issues raised in the Defendants'
Request for Statement of Decision, filed October 22, 2001. With respect to
the remaining issues, the Court holds:
A. Federal preemption/state court jurisdiction
Defendants asserted in their trial brief and argument that the fact of U.S.
FDA regulation requires dismissal of the Plaintiff's claims insofar as
federal law preempts an action under state law, particularly where the
result of the state court action could impose requirements on Defendants'
labeling practices that might vary from federal requirements. Defendants
also argue that their compliance with federal drug laws and regulations
constitutes a complete defense to Plaintiff's state law claims. Also,
Defendants assert the doctrine of state court abstention. Federal preemption
is asserted as Defendants' Tenth Affirmative Defense; presumably the other
jurisdictional arguments are subcategories of this defense. In view of the
findings above on the issues of liability, the Court finds that it need not
reach these jurisdictional questions, and therefore it makes no ruling on
those matters.
The Court notes, however, that the Plaintiff argued on the question of
burden that it is placed in an unreasonable position by being forced to
assemble proof of the alleged falsity of a drug manufacturer's
advertisements, since (as Plaintiff argues) the creation of that evidence is
costly and difficult. As noted above, Plaintiff has failed to support its
argument on the burden of proof. In any event, however, its argument more
logically leads to the conclusion of state court abstention. The complexity
necessarily involved in the development and interpretation of clinical tests
and trials of drug products suggest strongly that questions of enforcement
and regulation of drug advertising and labeling requirements should be
brought before the agency possessing the expertise and experience most
needed to resolve medical and scientific issues involved in drug regulation.
That agency, obviously, is the U.S. FDA.
Furthermore, the Court notes that the logical end-point of Plaintiff's
burden-shifting argument would be to permit anyone with the requisite filing
fee to walk into any court in any state in the Union and file a lawsuit
against any business, casting the burden on that defendant to prove that it
was not violating the law. Such an approach, this Court finds, would itself
be unfair.
B. Is Plaintiff is a proper party to assert these claims?
Defendants sought a determination as to whether Plaintiff adequately
represented the interests of the People of California. As no liability was
found and therefore no relief is to be awarded, the Court need not reach
this issue.
C. Is equitable relief is warranted where there is a remedy at law?
Defendants sought a determination as to whether Plaintiff is entitled to
equitable relief where there is an adequate remedy at law. For reason
previously noted, the Court does not reach this issue.
Dated: December 17, 2001 /s/ Judge Haley J. Fromholz
Judge of the Superior Court
Ilena Rose
<pjm...@gil.com.au> wrote:
**Are alternative supporters all entirely happy that any old fraud or
**charlatan can peddle any old snake oil to anyone?
You obviously missed the content of the Ruling.
The Judge clearly illustrated that these old frauds and charletans were
not "experts" and had no viable cause of action against the defendent ...
who had complied to the rules required.
Perhaps a re-reading might illustrate that the Quack Regime pays itself to
further its slanted viewpoint ... and for way too many years, have
pretended to be experts in matters in which they have a clear and
profitable agenda.
"Dr. Barrett's purported legal and regulatory knowledge is not apparent."
The Doctors Sue fabricated a case against this defendent, hired themselves
as "experts" ... yet fortunately, fooled no one but themselves in this
case.
Another victim of these homeopathic lawsuits contacted me after being sued
... he let me know how Barrett was pushing him to "settle" and even
admitted something like they intended to use any monies collected to go
after his "competitors."
He refused.
Peter Bowditch
>Another victim of these homeopathic lawsuits contacted me after being sued
>... he let me know how Barrett was pushing him to "settle" and even
>admitted something like they intended to use any monies collected to go
>after his "competitors."
Careful, Ilena. You just admitted to being part of a conspiracy.
-------------------------------------
Peter Bowditch pet...@ratbags.com
Mad - Quintessence of the Loon http://www.ratbags.com/loon
Bad - The Millenium Project http://www.ratbags.com/rsoles
Sad - Full Canvas Jacket http://www.ratbags.com/ranters
Ilena Rose
pet...@ratbags.com wrote:
**il...@san.rr.com (Ilena Rose) wrote:
**
**>Another victim of these homeopathic lawsuits contacted me after being sued
**>... he let me know how Barrett was pushing him to "settle" and even
**>admitted something like they intended to use any monies collected to go
**>after his "competitors."
**
**Careful, Ilena. You just admitted to being part of a conspiracy.
**
in your hallucinations.
i merely re-iterated a phone conversation, Desperado.