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June 2, 2004.


The opinion of the court was delivered by: FRANCIS CAIAZZA, Chief Magistrate Judge



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 aforementioned research,
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 concluded:
The results we obtained in simplified model systems can provide clues to investigate the effects of hypericin on lens properties in physiological conditions.
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 her research:
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. . . .
Q. Okay.
A. Something I'm developing. . . .
Q. When you say you're developing this ocular fluorometry, is it perfected . . . yet?
A. The technique of ...

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