Opinion
Civil Action No. 01-289.
June 2, 2004 Report and Recommendation Adopted June 24, 2004
MAGISTRATE JUDGE'S REPORT AND RECOMMENDATION
I. 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.
II. REPORT
BACKGROUND
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").
Mr. Fabrizi's cataracts initially were detected by Dr. Richard Stout, an ophthalmologist who in 1996 performed laser surgery on the Plaintiff to correct moderate nearsightedness. Cf. generally Expert Report of C. Lamperski, M.D. dated Dec. 14, 2001 (attached as Ex. A to Doc. 59) at 1 (noting "photorefractive keratectomy" ("PRK") performed by Dr. Stout in 1996); cf. also website at http://www.eyemdlink.com/EyeProcedure.asp?EyeProcedureID=7 (PRK "is a procedure in which the surface of the cornea is reshaped by an ophthalmologist using an Excimer laser"). Upon discovering the cataracts, Dr. Stout referred the Plaintiff to Dr. Salvitti, who performed surgery to remove the cataracts and treated him thereafter. See generally Pl.'s Dep. Tr. at 63; Dep. Tr. of Dr. Salvitti at 5. The Plaintiff never sought Dr. Stout's opinion regarding whether his cataracts may have been caused by St. John's Wort. See Pl.'s Dep. Tr. at 63 ("I don't think I ever saw [Dr. Stout] after . . . he referred me to Dr. Salvitti").
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. 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.
The full deposition transcripts of the Plaintiff's two experts, Dr. Lamperski and Joan E. Roberts, Ph.D., have been submitted for the court's consideration. The transcripts have not been docketed, but are contained in the case file.
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.
Dr. Roberts never examined the Plaintiff or his medical records. See, e.g., Dep. Tr. of Dr. Roberts at 9-10, 25-27. Presumably, then, her opinion regarding the cause of Mr. Fabrizi's cataracts, specifically, was based on information and representations provided by Plaintiff's counsel. Cf. id. at 26.
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 -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 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, she has neither completed nor relied upon:
As referenced below, the parties have stipulated to the court's adjudication of the Daubert Motions based on the Plaintiff experts' deposition testimony. See generally Stips. filed at Docs. 62 64. Even absent such stipulation, the court must draw the line somewhere in terms of the ever-developing courses of study referenced by Dr. Roberts. Moreover, in light of the vast expenditures of time, effort, and resources thus far regarding experts, any request by Plaintiff's counsel to "update" or otherwise supplement the record should be summarily denied. See generally discussion supra; cf. also generally Mem. Order dated July 30, 2002 (Doc. 44) at 4-5 (noting, as early as July 2002, that Plaintiff "ha[d] been somewhat less than timely in prosecuting his case and [his counsel] ha[d] engaged in questionable posturing" regarding experts).
• 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.
ANALYSIS A. General Standards Applicable Under Rule 702/ Daubert, Under Pennsylvania Law, and Within the Context of Toxic Tort Litigation.
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 explained:
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' testimony.
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" requirement:
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") (citations omitted).
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; and
• the "EPA ha[d] relied on animal studies to draw conclusions about the effects of [the chemical] on humans."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). 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 eye.
Dr. Roberts did testify that, although the eyes of "monkeys and primates" would be the best comparators, cow eyes biologically "are very close to humans." See id. at 87. While this similarity may justify the decision to soak bovine cells/lenses in hypericin in a test tube or petri dish, it does not show the type of "similar sensitivity" contemplated inPaoli. See discussion supra in text; see also discussion infra (concluding that in vitro data here presents too great an analytical gap to support Dr. Robert's theory of general causation).
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?
A. Yes.
Q. You're not saying that [it] actually does; is that correct?
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, 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 omitted).
See, e.g., discussion supra (Pennsylvania law requires "unequivocal medical testimony" of causation, offered to "a reasonable degree of medical certainty") (citations omitted, emphasis added); Niklaus, 767 F. Supp. at 96 (in case involving eye injury, expert must be capable of "offer[ing] expert medical testimony" regarding "diagnosi[s]" and "caus[ation] of . . . injuries to the eye") (emphasis added).
To be clear, the District Court need not hold that Dr. Roberts' lack of qualification extends to the issue of general causation. Cf. generally, e.g., Genty v. Resolution Trust Corp., 937 F.2d 899, 917 (3d Cir. 1991) ("[m]edical doctors . . . are not the only experts qualified to render an opinion as to the harm [generally] caused by exposure to toxic chemicals").
For all of these reasons, Dr. Roberts' opinions are inadmissible and they cannot sustain the Plaintiff's burden regarding causation.
C. The Testimony and Opinions of Dr. Lamperski Likewise Are Inadmissible.
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"). 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.
Although Dr. Lamperski more generally has claimed reliance on "learned publications and treatises," neither he nor Plaintiff's counsel has identified any other research supporting their theory of general causation. See id.; cf. also Dep. Tr. of Dr. Roberts at 243 ("[m]y work is the first indication that [hypericin is] phototoxic in the eye").
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 (citingNiklaus 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") (emphasis added).
Dr. Lamperski's opinions are further called into question by the circumstances through which they have come to be offered. It suffices to say that, when a physician who has never examined the plaintiff renders opinions solely for the purpose of advancing a lawsuit, said opinions will be met with at least some degree of skepticism under the law. Cf. generally, e.g., Watkins v. Telsmith, Inc., 121 F.3d 984, 991 (5th Cir. 1997) ( Daubert inquiry "evaluat[es] whether the expert is a hired gun or a person whose opinion in the courtroom will withstand the same scrutiny that it would among his professional peers") (citation omitted, emphasis added); Braun v. Lorillard Inc., 84 F.3d 230, 235 (7th Cir.) ( Daubert discourages "the hiring of reputle scientists . . . to testify for a fee to propositions that they have not arrived at through the methods . . . they use when they are doing their regular professional work rather thanbeing paid to give an opinion helpful to one side in a lawsuit") (emphasis added), cert. denied, 519 U.S. 992 (1996);Soldo, 244 F. Supp.2d at 527-28 ("[e]xpert opinions generated as the result of litigation have less credibility than opinions generated as the result of academic research or other forms of `pure' [science]"; "[w]e may not ignore the fact that a scientist's normal work place is the lab or field, not the courtroom or the lawyer's office") (citations and internal quotations omitted).
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 cause.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.
The Paoli Court contemplated that, based on the specific facts of a given case, "a doctor does not always have to employall of [the specified] techniques in order for [his] differential diagnosis to be reliable." See id. at 759 (emphasis added). The burden in this regard, however, remains with the expert, as he must "offer[a] . . . good explanation as to why his or her conclusion[s] remain reliable" in the absence of the standard techniques. See id. at 760. Dr. Lamperski has offered no such explanation here. His reliance on other physicians' treatment records alone is particularly troubling, moreover, given the contrary opinions of primary treating ophthalmologist Dr. Salvitti.
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 Summary Judgment.
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.
CONCLUSION
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, 2004.