United States District Court, W.D. Pennsylvania
June 2, 2004.
JOSEPH W. FABRIZI, Plaintiff,
REXALL SUNDOWN, INC., d/b/a, SUNDOWN VITAMINS, Defendant.
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 ocular fluorometry is perfected.
The use of it to determine hypericin in the eye is
undergoing at the moment.
Q. That's something you haven't perfected yet?
A. It's something that I am presently working
on. . . .
See Dep. Tr. of Dr. Roberts at 43-45.
Lest there remain any doubt, Dr. Roberts later made clear that
the opinions offered here in no way rely upon her continuing
efforts to identify the fluorescence of hypericin in the human
eye. See id. at 208 ("We're [currently] developing it and it's
patentable, . . . so I'm not going to discuss it . . . [or] rely
on [it in this case]."). Similarly Dr. Roberts has admitted that,
at all relevant times,*fn4 she has neither completed nor
in vitro studies testing whether human
alpha-crystalline, when soaked in hypericin and
exposed to light, evidenced light-induced damage,
see id. at 97-99 (studies on human cells were" a
work in progress");
in vitro fluorometry studies indicating that
hypericin does in fact bind to human lenses, see
id. at 180;
in vivo studies, in humans or animals, confirming
that the ingestion of St. John's Wort leads to the
presence of hypericin in the eye, see id. at 45-46,
49-50, 51-52, 82-84, 236-37;
in vivo studies, in humans or animals, confirming
that the ingestion of St. John's Wort leads to the
development or acceleration of cataracts, see id.
at 141-42, 181; or
test(s) confirming that hypericin is, or at any
time has been, present in Mr. Fabrizi's eyes, see
id. at 43, 55, 139, 180.
Defense counsel filed the instant Motions, seeking to exclude
the opinions and testimony of Drs. Roberts and Lamperski under
Federal Rule of Evidence 702 and Daubert. See generally Def.'s
Mots. (Docs. 53 & 55). The parties stipulated that the Daubert
hearing would be conducted "upon the depositions" and affidavits
of the expert witnesses, "without [live] testimony from either
expert." See Pl.'s Stip. (Doc. 64) at ¶¶ 5-6; see also Def.'s
Stip. (Doc. 62) (stating essentially same).
On May 12, 2003, counsel appeared before the undersigned to
participate in a Daubert hearing, which proceeded in accordance
with the parties' stipulation. On March 11, 2004, the parties
were invited to engage in a second round of oral argument.
Having carefully considered the parties' positions, as stated
during the Daubert hearing, at oral argument, and in their
briefing, the undersigned now is prepared to offer
recommendations regarding the Plaintiff's expert evidence.
A. General Standards Applicable Under Rule 702/Daubert,
Under Pennsylvania Law, and Within the Context of Toxic Tort
Federal Rule of Evidence 702 ("Rule 702"), which governs the
admissibility of expert testimony, provides:
If scientific, technical, or other specialized
knowledge will assist the trier of fact to understand
the evidence or to determine a fact in issue, a
witness qualified as an expert by knowledge, skill,
experience, training, or education, may testify
thereto in the form of an opinion or otherwise, if
(1) the testimony is based upon sufficient facts or
data, (2) the testimony is the product of reliable
principles and methods, and (3) the witness has
applied the principles and methods reliably to the
facts of the case.
As the Court of Appeals for the Third Circuit recently has
Rule 702 embodies a trilogy of restrictions on expert
testimony: qualification, reliability and fit. . . .
Qualification refers to the requirement that the
witness possess specialized expertise. We have
interpreted this requirement liberally, holding that
a broad range of knowledge, skills, and training
[may] qualify an expert. . . .
Secondly, the testimony must be reliable; it must be
based on the methods and procedures of science rather
than on subjective belief or unsupported
speculation[, and] the expert must have good grounds
for his on her belief. In sum, Daubert holds that
an inquiry into the reliability of scientific
evidence under Rule 702 requires a determination as
to its scientific validity.
Finally, Rule 702 requires that the expert testimony
must [`] fit['] the issues in the case. In other
words, the expert's testimony must be relevant for
the purposes of the case and must assist the trier of
fact. . . . Rule 702's helpfulness standard requires
a valid scientific connection to the pertinent
inquiry as a precondition to admissibility.
See Schneider v. Fried, 320 F.3d 396
, 404 (3d Cir. 2003)
(numerous citations and internal quotations omitted).
Superimposed upon these standards is Pennsylvania's law
regarding causation. "Proof of causation is a necessary element
in a products liability action," regardless of whether the
plaintiff's claims sound in negligence, strict product liability,
misrepresentation, or breach of warranty. See Soldo v. Sandoz
Pharm. Corp., 244 F. Supp.2d 434, 524 (W.D. Pa. 2003) (Lee, J.)
(citations omitted); see also generally Steamfitters Local
Union No. 420 Welfare Fund v. Philip Morris, Inc., 171 F.3d 912,
937 (3d Cir. 1999) (in Pennsylvania, "strict liability,
negligence, and breach-of-warranty claims . . . each require a
proximate connection between the defendant['s] conduct and the
plaintiff['s] injur[y]") (citations omitted), cert. denied,
528 U.S. 1105 (2000).
Pennsylvania law makes clear, moreover, that "unequivocal
medical testimony is necessary to establish the causal connection
in cases where there is no obvious . . . relationship between the
accident and the injury." In re Paoli R.R. Yard PCB Litig.,
2000 WL 1279922, *2 (E.D. Pa. Sept. 6, 2000) (citations omitted);
accord Niklaus v. Vivadent, Inc., U.S.A., 767 F. Supp. 94, 96
(M.D. Pa. 1991) (internal quotations and numerous citations
omitted), aff'd, 986 F.2d 1409 (3d Cir. 1993) (table). This
standard corresponds with Pennsylvania's requirement that the
plaintiff's injury "did, with a reasonable degree of medical
certainty, [flow] from the [complained of] act." Niklaus,
767 F. Supp. at 96 (citation and internal quotations omitted,
emphasis in original); accord In re Paoli, 2000 WL 1279922 at
*2 (citing and quoting Niklaus).
Relatedly, the Third Circuit Court in the seminal case of In
re Paoli R.R. Yard PCB Litigation recognized that Pennsylvania's
"reasonable degree of medical certainty" standard is both "a rule
of admissibility" and "part of the plaintiff's burden of proof."
See id., 35 F.3d at 751. Thus, a defendant is entitled to
summary judgment "when the plaintiff['s] expert" is unable to
"testify that [the] plaintiff's [injury] was caused by [the
defendant's product] with a reasonable degree of medical
certainty." See id. at 752; see also Heller v. Shaw Indus.,
Inc., 167 F.3d 146, 153 n. 4 (3d Cir. 1999) ("in a diversity
case . . ., state rules on the degree of certainty required of an
expert's opinion apply" and, "[i]n Pennsylvania, a doctor can
give an opinion on the cause of a plaintiff's illness [only] if
he or she can do so with a reasonable degree of medical
certainty") (citing Paoli).
Finally, and of particular significance here, are the standards
of causation applicable in toxic tort cases. "[T]o meet [his]
causation burden, [the] plaintiff must first establish that" the
substance in question "is capable of causing" in humans the
injury alleged; this is known as "general causation." See
Soldo, 244 F. Supp.2d at 524-25 (citations omitted). Then the
plaintiff "must . . . establish that, in [his] particular case,"
the substance "did in fact cause" the injury he alleges, i.e.,
"specific causation." See id.; see also, e.g., Paoli, 35
F.3d at 752 (to sustain "traditional [toxic] tort claims, . . .
plaintiffs must show that they were exposed to the chemicals
released by the defendants, that these chemicals can cause the
types of harm they suffered, and that the chemicals in fact did
cause them harm") (emphasis added); In re Breast Implant
Litig., 11 F. Supp.2d 1217, 1224 (Colo. 1998) ("[c]ausation
in toxic tort cases is discussed in terms of general and specific
causation") (citation omitted).
It is with the foregoing standards in mind that the District
Court should analyze the admissibility of the Plaintiff experts'
B. The Testimony and Opinions of Dr. Roberts Should Be
Excluded Under the Aforementioned Standards.
Dr. Roberts' research and opinions most obviously go to the
question of whether St. John's Wort generally is capable of
causing cataracts in humans, so "general causation" is the
logical starting point for the court's analysis. Cf. Soldo,
244 F. Supp.2d at 524-25. In this regard, all of Dr. Roberts'
opinions flow directly from her animal studies, a topic addressed
at length in Paoli.
The Paoli Court first discussed animal studies
hypothetically, as a vehicle to explain Rule 702's "fit"
Rule 702 requires that the expert's testimony must
assist the trier of fact. . . . [Thus], admissibility
depends in part on the proffered connection between
the scientific research . . . and particular disputed
factual issues in the case. . . .
For example, animal studies may be methodologically
acceptable to show that chemical X increases the risk
of cancer in animals, but they may not be
methodologically acceptable to show that chemical X
increases the risk of cancer in humans. Daubert
explains that, `[f]it' is not always obvious, and
scientific validity for one purpose is not
necessarily scientific validity for other, unrelated
purposes. . . . Thus, even if an expert's proposed
testimony constitutes scientific knowledge, his or
her testimony will be excluded if it is not
scientific knowledge for purposes of the case. . . .
Rule 702's `helpfulness' standard requires a valid
scientific connection to the pertinent inquiry as a
precondition to admissibility. . . .
[Thus], in order for animal studies to be admissible
to prove causation in humans, there must be good
grounds to extrapolate from animals to humans, just
as the methodology of the studies must constitute
good grounds to reach conclusions about the animals
themselves. Thus, the requirement of reliability, or
`good grounds,' extends to each step in an expert's
analysis all the way through the step that connects
the work of the expert to the particular case.
See id., 35 F.3d at 742-43 (citations and most internal
quotations omitted, emphasis added).
Consistent with Paoli, courts addressing animal studies
commonly have identified the "extrapolation" inquiry as an
important, if not threshold, determination for the purposes of
both "fit" and "reliability." See id. at 742-43, 779-81; see
also, e.g., General Elec. Co. v. Joiner, 522 U.S. 136, 144-46
(1997) (affirming exclusion of evidence where there was no
"expla[nation] how and why the experts could have extrapolated
their opinions from . . . seemingly far-removed animal studies"
to humans; "[a] court may conclude that there is simply too great
an analytical gap between the data and the opinion proffered")
(citations omitted); Soldo, 244 F. Supp.2d at 546 ("[t]o ensure
that the expert's . . . animal studies [are] reliable, there must
be a scientifically valid link such as supporting human data
between the sources or studies consulted and the conclusion
reached") (citations and internal quotations omitted); see also
id. at 548 (same inquiry related to "fit"); In re Diet Drugs,
2001 WL 454586, *15 (E.D. Pa. Feb. 1, 2001) (evidence unreliable
where plaintiff fails to explain reliance on "animal studies far
removed from circumstances of [the] plaintiff's exposure")
Paoli presents a good example of a case where sufficient
grounds for extrapolation existed. Among other things, the Third
Circuit Court emphasized that:
the animal studies in question were supported by
human" occupational studies" and, "when there is a
concordance of animal data and human data, it
strengthens the reliability of each";
the "defendants' own experts based their opinions
partly on animal studies[,] showing that they [we]re
at least relevant to assessing causation in humans";
"animal studies [we]re particularly valuable with
respect to assessing health effects of [the chemical
in question], because humans and monkeys ha[d] shown
similar sensitivity" to a related chemical compound;
the "EPA ha[d] relied on animal studies to draw
conclusions about the effects of [the chemical] on
See id. at 779-80.
None of these "good grounds" for extrapolation are present in
the instant case. Thus far, there are no human studies to
corroborate Dr. Roberts' in vitro animal testing and, thus,
there exists no "concordance of animal data and human data" to
"strengthen the reliability of each." Compare Paoli with
discussion supra (noting lack of human studies). The Defendant
has failed to validate Dr. Roberts' efforts by offering competing
animal studies. See id. Dr. Roberts has not demonstrated a
"similar sensitivity" between bovines and human beings to
hypericin or St. John's Wort. Cf. Dep. Tr. of Dr. Roberts
(providing no basis to conclude that metabolic processes of
species would result in similar sensitivity to ingested
hypericin).*fn5 Nor has the Plaintiff shown that the EPA, or
any other governmental body, has relied on animal studies to draw
conclusions regarding the effects of St. John's Wort on the human
As just seen, none of the earmarks of reliability and fit
identified in Paoli are present in this case. To the contrary,
the record on the whole reveals science that has taken the most
preliminary (if arguably promising) steps towards establishing a
causal connection between St. John's Wort and cataracts.
Although Dr. Roberts on occasion has appeared inclined to
overstate the implications of her research, the tentative nature
of her findings are apparent from the language of her
publications. For example, while her Expert Report claims to
opine "within a reasonable degree of scientific certainty" that
ingestion of St. John's Wort accelerates the formation of
cataracts, her conclusions in the literature are stated with
markedly less confidence. See, e.g., Photooxidation Article at
200 ("hypericin can induce changes in lens protein that could
lead to the formation of cataracts"); id. at 203 (chemical
properties of hypericin "should enable it to cross blood/ocular
barriers"); and id. ("hypericin induces changes in lens
proteins in vitro and this could lead to the formation of
cataracts . . . in vivo") (emphases added); see also, e.g.,
Fluorescence Article at 597 and Dep. Tr. of Dr. Roberts at
43-45 (stating "it is essential to determine clinically whether
hypericin reaches the human eye and whether it can be phototoxic
to ocular tissues," discussing "develop[ment of] a model system,"
but admitting that ocular fluorometry could not yet detect
presence of hypericin in human eye); cf. also Fluorescence
Article at 600 (positing that hypericin "binding might occur . . .
in physiological conditions") (emphasis added).
Consistent with the foregoing, Defense counsel elicited the
following concessions during Dr. Roberts' deposition, ones that
are particularly damaging under Rule 702:
Q. Just to clarify, Doctor, am I correct in stating
that . . . what you know to this point in time is . . .
St. John's Wort may or possibly can cause
cataracts in humans?
Q. You're not saying that [it] actually does; is
A. You're right.
Q. You need to do more studies to be able to confirm
that . . .?
A. That's correct.
See Dep. Tr. of Dr. Roberts at 141 (emphasis added).
By Dr. Roberts' own admission, her current research is
insufficient to support a theory of general causation to any
reasonable degree of certainty. See discussions supra; see
also generally Paoli, 35 F.3d at 742 (Rule 702 does not permit
expert testimony based on "subjective belief or unsupported
speculation") (citation omitted). If and when further studies are
available to effectively close the gaps identified above, such an
opinion one day may be admissible. Compare, e.g., discussion
supra at n. 5 (noting distinction between soaking of bovine
ocular matter in hypericin solution and human beings' ingestion
and metabolism of St. John's Wort such that hypericin may, or may
not, end up in human eye) with Diet Drugs, 2001 WL 454586 at
*15 (rejecting expert opinion based on "animal studies far
removed from circumstances of [the] plaintiff's exposure")
(emphasis added). On the record presented here, however, that day
has not yet come.
In light of the inadmissibility of Dr. Roberts' opinions
regarding general causation, the court need not reach the issue
of specific causation. See Soldo, 244 F. Supp.2d at 525
("[i]f [the] plaintiff has not demonstrated sufficiently reliable
evidence of general causation, [his] claims fail and there is no
need to consider specific causation") (citations omitted). Even
were the court to do so, however, Dr. Roberts' "opinions"
regarding Mr. Fabrizi specifically are inadequate.
First, Plaintiff's counsel has failed to demonstrate Dr.
Roberts' qualification to testify regarding specific causation.
The Third Circuit Court faced a similar scenario in Heller,
where a "certified industrial hygienist" purported to opine on
the causation of the plaintiffs' specific injuries:
[The industrial hygienist has] opined . . . that the
illness[es] suffered by the [plaintiffs] were caused
by their prolonged exposure to the [chemicals]
measured in their home and emitted by the . . .
[defendant]. . . . We . . . are doubtful that a
non-medical expert such as [the hygienist] is
qualified to testify as to the cause of someone's
illness. . . .
While [the hygienist] was knowledgeable about studies
on [the relevant chemicals] and illness, . . . he is
not a physician and did not examine the [plaintiffs]
nor discuss with them their symptoms or their medical
histories. Thus, whatever his qualifications for
testifying about the source and level of [chemicals]
in the [plaintiffs'] house . . ., his qualification
to offer an opinion on the ultimate cause of the
[plaintiffs'] illnesses is another matter.
See id., 167 F.3d at 159 & n. 9 (emphasis added).
The Heller Court's observations are entirely consistent with
Pennsylvania law,*fn6 and they apply here with equal force.
Dr. Roberts has never interviewed the Plaintiff, examined him, or
seen his medical records. And although her Expert Report claims
to state an opinion regarding specific causation, she repeatedly
has disavowed the requisite knowledge and expertise to offer the
same. See, e.g., Dep. Tr. of Dr. Roberts at 11-12 (admitting
lack of qualification to treat or diagnose patients); id. at 15
(not qualified to treat cataracts); and id. at 250 (declining
Plaintiff counsel's invitation to review Mr. Fabrizi's medical
records, stating "I would prefer not to evaluate medical records
. . . [because] I'm not an M.D."); see also, e.g., In re Diet
Drugs, 2000 WL 962545, *5 (E.D. Pa. Jun. 28, 2000) (Supreme
Court "has made clear that a person, although qualified as an
expert in one area of expertise, may be precluded from offering
opinions beyond that area of expertise") (citation
For all of these reasons, Dr. Roberts' opinions are
inadmissible and they cannot sustain the Plaintiff's burden
C. The Testimony and Opinions of Dr. Lamperski Likewise Are
As to general causation, Dr. Lamperski in large part
piggy-backs on the opinions of Dr. Roberts. See Aff. of C.
Lamperski at ¶¶ 8-9 (claiming "particular" reliance on
"clinical trial data and consultation with Dr. Joan
Roberts").*fn8 The only other source identified is "the
anecdotal reports of premature cataract development in patients
taking St. John's [W]ort." See Dr. Lamperski's Report at 3.
Obviously, Dr. Lamperski cannot establish general causation
through the inadmissible opinions and testimony of Dr. Roberts.
See discussion supra; cf. also generally Robinson v. Ford
Motor Co., 967 F. Supp. 482, 487 n. 2 (M.D. Ala. 1997) (expert
testimony that "simply parrots the opinion of another does not
assist the trier of fact, and thus, is inadmissible under
Rule 702"), aff'd, 144 F.3d 56 (11th Cir. 1998). As to anecdotal
reports, neither the Plaintiff nor his expert has demonstrated
that such "evidence" is an acceptable and/or sufficient basis for
showing causation. The case law is uniformly to the contrary.
See, e.g., Soldo, 244 F. Supp.2d at 542 ("reliance on
anecdotal case reports to support [an expert's] causation
opinion is contrary to both good scientific practice and the
Daubert case law") (citations omitted); Newton v. Roche Labs.,
Inc., 243 F. Supp.2d 672, 681 n. 1 (W.D. Tex. 2002) (anecdotal
reports "are universally regarded as an insufficient scientific
basis for a conclusion regarding causation" because they "do not
isolate and exclude potentially alternative causes, . . . do not
investigate or explain the mechanism of causation," and "lack
controls") (numerous citations omitted).
Dr. Lamperski has failed to offer admissible opinions or
testimony regarding general causation, and this conclusion
obviates the need to reach specific causation. See discussion
supra. Even reaching the issue, however, the Plaintiff's expert
evidence again comes up short.
Initially, the undersigned questions whether an internist like
Dr. Lamperski is qualified to offer opinions regarding ocular
injury. At least some Pennsylvania precedent would demand
specific medical "expert[ise]" in the "diagnosi[s] . . . and . . .
caus[ation] of injuries to the eye." See, e.g., Niklaus,
767 F. Supp. at 96; In re Paoli, 2000 WL 1279922 at *2 (citing
Niklaus and holding same); see also Dep. Tr. of C. Lamperski
at 11-12 (admitting he was not an ophthalmologist and that, if
patient required treatment of eye disease, he would refer patient
to said specialist). Even assuming a more liberal standard
applies, Dr. Lamperski's lack of specific expertise in
ophthalmology undermines the reliability of his testimony
regarding specific causation. See generally Elcock v. Kmart
Corp., 233 F.3d 734, 749 (3d Cir. 2000) ("an expert's level of
expertise may affect the reliability of [his] opinion")
(citations and internal quotations omitted).
Relatedly, Dr. Lamperski's opinions are in direct contradiction
to those of treating ophthalmologist Dr. Salvitti, who has
concluded that the Plaintiff's causation theory cannot be
established to a reasonable degree of medical certainty. See
generally discussion supra. This gives the District Court good
grounds for rejecting Dr. Lamperski's opinions based on "lack[of]
foundation and . . . unreliab[ility]." See Washington v.
Armstrong World Indus., Inc., 839 F.2d 1121, 1123-24 (5th Cir.
1988) (holding same where physician "never actually examined [the
plaintiff] but merely relied on examinations performed by
[treating] physicians who reached different conclusions")
Finally, Dr. Lamperski's opinions regarding specific causation
are lacking in substance under Rule 702. In essence, Dr.
Lamperski purports to have conducted a "differential diagnosis"
to exclude all potential causes of Mr. Fabrizi's cataracts other
than St. John's Wort. Compare Paoli, 35 F.3d at 758
(differential diagnosis "is a [widely accepted] method that
involves assessing causation with respect to a particular
individual" through "an attempt to rule out alternative causes")
with, e.g., Dr. Lamperski's Report at 2 ("[n]one of the other
long-established potential causes of cataract formation appear to
apply in Mr. Fabrizi's case"). Dr. Lamperski admitted in his
deposition, however, that the only information he possessed
regarding the Plaintiff was a handful of treatment records from
other physicians. See Dep. Tr. of C. Lamperski at 20, 23. This
is insufficient under the law.
As the Paoli Court explained:
We agree . . . that [the] performance of physical
examinations, taking of medical histories, and
employment of reliable laboratory tests all provide
significant evidence of a reliable differential
diagnosis, and that their absence makes it much
less likely that a differential diagnosis is
reliable. We reach this conclusion in part based on
the [fact] . . . that these techniques are generally
accepted as a standard part of differential
diagnosis, and that such techniques significantly
reduce the likelihood of erroneous results. . . .
Moreover, performance of standard diagnostic
techniques provides prima facie evidence that a
doctor has considered [alternate] causes and has
attempted to test his or her initial hypothesis as to
See id., 35 F.3d at 758-59 (emphasis added).
Here, the proffered expert has engaged in none of the standard
techniques of differential diagnosis. Dr. Lamperski candidly
admits to never having seen or interviewed Mr. Fabrizi.
Obviously, then, he has not conducted physical examination(s),
taken the Plaintiff's medical history, or employed reliable
laboratory tests in support of his opinions. Cf. id. Rather,
Dr. Lamperski relies on the treatment records of other
physicians, at least one of whom has expressly rejected the
Plaintiff's theory of specific causation. See discussion
supra regarding Dr. Salvitti. Under the circumstances, the
proposed expert "has engaged in few [if any] standard diagnostic
techniques," and he has offered "no good explanation as to why
his . . . conclusion remain[s] reliable." See Paoli,
35 F.3d 760-61.*fn10
Dr. Lamperski's opinions regarding causation, both general and
specific, should be excluded under Rule 702 and Daubert.
D. Given the Plaintiff's Failure to Proffer Admissible Expert
Testimony Regarding Causation, the Defendant Is Entitled to
Where a plaintiff fails to present admissible expert testimony
regarding causation, courts routinely have granted summary
judgment in favor of the defendant. See, e.g., Heller, 167
F.3d at 165 (affirming entry of summary judgment based on "the
total lack of causation evidence absent the [proffered but
inadmissible] expert testimony"); Soldo, 244 F. Supp.2d at
576-77 (granting summary judgment because, "[i]n the absence of
expert testimony, [the] plaintiff has failed to demonstrate that
[the Defendant's product] can and did cause her [injury]").
Technically, the Defendant's most recent Motion for Summary
Judgment (Doc. 28) was denied without prejudice pending
resolution of the Daubert Motions. See generally Order dated
Feb. 4, 2003 (Doc. 61). In light of the recommendations above,
however, requiring the Defendant to renew its request for summary
judgment would be a matter of mere formality.
The Plaintiff has been afforded ample opportunity to present
expert testimony and opinions regarding general and specific
causation. All the evidence he has submitted fails under
Rule 702 and Daubert, and any request to further pursue expert testimony
would be unjustified. See discussion supra at n. 4.
Accordingly, summary judgment should be entered in favor of the
Defendant on each of the Plaintiff's claims.
The Defendant's Motions to Exclude the Testimony of the
Plaintiff's Expert Witnesses (Docs. 53 & 55) should be granted,
and summary judgment should be entered in favor of the Defendant.
In accordance with the Magistrates Act,
28 U.S.C. § 636(b)(1)(B) and (C), and Rule 72.1.4(B) of the Local Rules for
Magistrates, objections to this report and recommendation are due
by June 18, 2004. Responses to objections are due by June 28,