The opinion of the court was delivered by: FRANCIS CAIAZZA, Chief Magistrate Judge
MAGISTRATE JUDGE'S REPORT AND RECOMMENDATION
It is respectfully recommended that the Defendant's Motions to
Exclude the Testimony of the Plaintiff's Expert Witnesses (Docs.
53 & 55) be granted. Based on the Plaintiff's failure to proffer
admissible expert testimony regarding causation, moreover,
summary judgment should be entered in favor of the Defendant.
The Plaintiff Joseph W. Fabrizi ("Mr. Fabrizi" or "the
Plaintiff") filed this action against Rexall Sundown, Inc.
("Rexall" or "the Defendant") in state court. See generally
Compl., attached to Notice of Removal (Doc. 1). Rexall
manufactured and distributed an herbal supplement, St. John's
Wort, allegedly taken by Mr. Fabrizi. See generally Compl. at ¶
3. The Plaintiff claims that his ingestion of the supplement
caused him to develop cataracts in both eyes, resulting in
various physical and mental injuries. See generally id. at ¶¶
5-6. The Plaintiff brings claims sounding in negligence, strict
liability, and breach of warranty. See id., Counts I-III.
The Defendant removed the case to federal court on the basis of
diversity jurisdiction. See generally Notice of Removal. As
discovery wound down, Defense counsel raised for the first time
the Plaintiff's need to introduce expert testimony regarding
causation. Cf. generally Def.'s Br. in Supp. of 1st Mot. for
Summ. J. (Doc. 10) at 1 (under Pennsylvania law, product
liability claim presenting "no obvious causal relationship" must
be supported by expert testimony regarding causation) (citations
omitted). Since that time, and multiple requests for summary
judgment later, the expert issue has taken center stage in this
litigation. The Plaintiff's efforts to secure expert testimony,
and the nature and content of the opinions obtained, may be
summarized as follows.
Before filing suit, Mr. Fabrizi asked his treating
ophthalmologist, E. Ronald Salvitti, M.D. ("Dr. Salvitti"),
whether his cataracts could be attributed to his ingestion of St.
John's Wort. See Pl.'s Dep. Tr. (excerpts attached as
unnumbered Ex. to Doc. 54) at 62-63. Dr. Salvitti responded that
he could not say, "with reasonable [medical] certainty[,] that
[Mr. Fabrizi's] condition was related to use of" the supplement.
See Dep. Tr. of Dr. Salvitti (excerpts attached as unnumbered
Ex. to Doc. 54) at 6; see also Dr. Salvitti's Ltr. to Pl. dated
Aug. 21, 2000 ("[a]s you know, there are other medications,
genetic factors and certain types of medical illnesses that
contribute to the development of cataracts[,] . . . and probably
more commonly, cataracts are seen without explanation in
approximately 80% of patients").*fn1
After filing suit, Plaintiff's counsel employed the services of
Christopher V. Lamperski, M.D. ("Dr. Lamperski"). Dr. Lamperski
is a board-certified medical internist who, since July 2001, has
acted full time as a medical consultant in legal cases. See
generally Aff. of Dr. Lamperski (Doc. 43) at ¶ 1 & Ex. A
thereto; Dep. Tr. of Dr. Lamperski at 54.*fn2 In a report
dated December 14, 2001, Dr. Lamperski purported to opine, "with
a reasonable degree of medical certainty, that Mr. Fabrizi's
cataracts were caused or accelerated by [his] ingestion of St.
John's Wort." See Dr. Lamperski's Report at 3.
Dr. Lamperski has neither examined nor interviewed the
Plaintiff. See generally Dep. Tr. of Dr. Lamperski at 16, 20.
Nor has he spoken to Mr. Fabrizi's treating ophthalmologist(s)
regarding the subject matter of this case. See id. at 21.
Rather, Dr. Lamperski has formed his opinions based on a review
of the treating physicians' records, his discussions with
Plaintiff's counsel, and his review of medical literature, "hard
cop[y]" and "on-line," regarding "anecdotal reports" of premature
cataract development in St. John's Wort users. See id. at 58;
see also generally Dr. Lamperski's Report at 3. More recently,
Dr. Lamperski has claimed heavy reliance on the "clinical trial
data," opinions, and his consultation with the Plaintiff's second
expert, Joan E. Roberts, Ph.D. ("Dr. Roberts").
Dr. Roberts is an organic chemist who specializes in the study
of "ocular toxicity" and "phototoxicity." See generally Dep.
Tr. of Dr. Roberts at 12. Stated more plainly, Dr. Roberts
"studies the biological effects of . . . toxic agents in the
eye." See id. at 11. In a report dated May 28, 2002, she
opined, "within a reasonable degree of scientific certainty, that
ingestion" of the active ingredient in St. John's Wort,
hypericin, "coupled with exposure to sunlight leads to the . . .
formation of cataracts in humans." See Dr. Roberts' Report
(attached as unmarked Ex. to Doc. 56) at 2. She also purports to
opine, based on medical data/history of an unknown origin, "that
the development of Mr. Fabrizi's cataracts was caused by his
ingestion of St. John's Wort." See id. at 3.*fn3
Dr. Roberts' general theory of causation is as follows. When
St. John's Wort is ingested by a human being, hypericin enters
the bloodstream and finds its way into either the person's
"aqueous," i.e., the "fluid that surrounds" and "feeds the
lens," or the lens of the eye itself. See generally Dep. Tr. of
Dr. Roberts at 183, 236. Once present in "those components of the
eye," the hypericin absorbs "UV and visible" light introduced
through the environment. See generally id. 67, 183. A reaction
between hypericin and the light occurs, disrupting "the orderly
arrangement of . . . protein fibers in the lens[es] and caus[ing
them] to be[come] clouded." See generally id. at 17; cf. also
generally id. at 242. It is through this process that cataracts
allegedly are formed. Cf. generally id. at 17, 20.
In support of this theory, Dr. Roberts relies on her
participation in two research studies. Results of both studies
were published in the year 2000, and Plaintiff's counsel has
attached the articles to Mr. Fabrizi's brief in opposition to the
Daubert Motion (Doc. 58). See K.L. Schey, S. Patat, C.F.
Chignell, M. Datillo, R.H. Wang & J.E. Roberts, Photooxidation
of Lens α-Crystallin by Hypericin (Active Ingredient in St.
John's Wort), PHOTOCHEMISTRY & PHOTOBIOLOGY, 72(2): 200-203
(2000); A. Sgarbossa, N. Angelini, D. Gioffre', T. Youssef, F.
Lenci & J.E. Roberts, The Uptake, Location and Fluorescence of
Hypericin in Bovine Intact Lens, 21 CURRENT EYE RESEARCH (No. 2)
at 597-601 (2000).
Both of the studies were conducted in vitro, which means "in
cell or using tissue." See generally Dep. Tr. of Dr. Roberts at
83, 173; cf. also generally Schering Corp. v. FDA,
51 F.3d 390, 398 n. 11 (3d Cir.) ("[i]n vitro studies are conducted in
an artificial environment such as in laboratory test tubes," and
they "do not measure [drug] absorption"; "[i]n vivo studies are
conducted in [living beings]"), cert. denied, 516 U.S. 907
(1995). In the first study alpha-crystalline, "the main protein
in the lens that keeps its integrity," was extracted from calf
lenses and soaked in a solution containing pure hypericin. See
generally Dep. Tr. of Dr. Roberts at 153, 154, 160. Irradiation
of the solution resulted in "light-induced damage to [the
alpha]-crystallin." See Photooxidation Article at 203. These
findings, coupled with the conclusion hypericin "has . . .
[chemical] properties" that "should enable it to cross
blood/ocular barriers," led the authors to warn that exposure to
the substance, in combination with light, "could lead to the
formation of cataracts . . . in vivo." See id.
The second study posed that, given the results of the
it is essential to determine clinically whether
hypericin reaches the human eye and whether it can be
phototoxic to ocular tissues. This can be determined
in humans, non-invasively, using in vivo
fluorescence spectroscopy and imaging. To that end, . . .
[the researchers] developed a model system to
determine the fluorescence characteristics of
hypericin when bound to [bovine] ocular tissue.
See Fluorescence Article at 597.
The researchers again soaked calf lens matter, this time intact
lenses, in hypericin solution. See generally id., "Methods"
section. After a period of "incubat[ion]," instruments used to
measure fluorescence "confirmed that [the] hypericin [did] bind
to the ocular tissues." Based on these results, the scientists
The results we obtained in simplified model systems
can provide clues to investigate the effects of
hypericin on lens properties in physiological
Hypericin could in fact bind to lens protein[,] thus
increasing the retention time of [the substance] in
the eye and possibly altering [alpha]-crystallin
properties. . . . Therefore, ophthalmologists may use
a slit-lamp or scanning fluorometry to monitor the
uptake of hypericin in the eyes of patients using St.
John's Wort. . . .
See id., "Conclusions" section.
At her deposition, Dr. Roberts clarified the practical
implications of the second study, as well as the current state of
Q. Was ocular fluorometry used to detect hypericin in
Mr. Fabrizi's eyes?
A. I have no idea.
Q. Is that a staining technique?
A. No. . . . The eye is clear. You can look through
the eye. One of the techniques that I am developing
is ocular fluorometry. Fluorometry refers to
fluorescence. Fluorescence means the compound lights
up. . . . [Like] fluorescent paint, when you paint
something and you put a light on it and it lights
up[,] that's fluorescence. . . .
Well, because the eye is clear, you can pass a
fluorometer, that is an instrument that measures
fluorescence, through the eye to pick up . . .
anything that is fluorescent. It is used in
ophthalmological examinations all the time, and . . .
the whole purpose of . . . the fluorescence [study]
was to determine the exact fluorescence that an
ophthalmologist might look at in a human eye. . . .
A. Something I'm developing. . . .
Q. When you say you're developing this ocular
fluorometry, is it perfected . . . yet?
A. The technique of ...