GOLDBERG, District Judge.
In March of 2008, Plaintiff, Army Joe Leake, II, suffered acute liver failure which necessitated an immediate liver transplant. Plaintiff alleges that this illness was the result of his work as a painter on a naval cargo ship and has sued Defendant, the United States of America, under the Jones Act, 46 U.S.C. § 30104, and maritime law.
Presently before the Court are Defendant's Motions to Exclude the Reports and Testimony of Plaintiff's causation experts, Dr. Jeffery A. Handler, Dr. Kay Washington and Dr. Rudy Rai. Because we conclude that these experts have failed to offer reliable opinions that will assist the trier of fact regarding the cause of Plaintiff's injury, Defendant's motions will be granted. Further, as the exclusion of this evidence precludes Plaintiff from establishing causation, we also grant Defendant's motions for summary judgment as to each of Plaintiff's claims.
Unless otherwise indicated, the following facts are undisputed.
Plaintiff worked aboard the United States Naval Ship GILLILAND as an Able Bodied Seaman, intermittently, from 2005 until March 1, 2008. From at least November 19, 2007 to December 16, 2007, and thereafter from January 8, 2008 to February 29, 2008, Plaintiff worked overtime chipping and painting the cargo hold of the ship. During the last week of February 2008, Plaintiff also spent three hours painting the laundry room and four days painting a stairwell on the ship. (Def.'s State. Facts, Doc. No. 29, Ex. 1, ¶¶ 1-4; Pl.'s Resp. State. Facts, Doc. No. 32, Ex. 4, ¶¶ 1-4.)
On March 3, 2008, Plaintiff began feeling ill, and on March 5, 2008, he was admitted to the hospital and diagnosed with acute liver failure. Plaintiff underwent a liver transplant on March 10, 2008. Although the transplant was successful, Plaintiff alleges that he has suffered several physical and mental complications. (Def.'s State. Facts, Doc. No. 29, Ex. 1, ¶¶ 8-13; Pl.'s Resp. State. Facts, Doc. No. 34, Ex. 4, ¶¶ 8-13; Compl. ¶ 13.)
Plaintiff contends that his exposure to chemicals in the paints and thinners he used aboard the ship caused his liver failure.
Federal Rule of Evidence 702 governs the admissibility of expert testimony, and states:
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The current version of Rule 702 "embodies a trilogy of restrictions on expert testimony: qualification, reliability and fit." Schneider v. Fried, 320 F.3d 396, 404 (3d Cir.2003). In evaluating whether an expert opinion is admissible, the district court acts as a gatekeeper, excluding opinion testimony that does not meet these requirements. Id.
An expert's opinion is reliable if it is based upon "`methods and procedures of science' rather than subjective belief or unsupported speculation." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 742-43 & n. 7 (3d Cir.1994) (quotation omitted.) In considering whether an expert's method is reliable, courts should consider: (1) whether it is based upon testable hypotheses; (2) subject to peer review; (3) the known or potential error rate; (4) the existence and maintenance of standards controlling the technique's operation; (5) whether it is generally accepted; (6) the relationship of the method to other methods that have been deemed reliable; (7) the expert's experience or qualification with the technique or method; (8) non-judicial uses the method has been put to; and (9) all other relevant factors. Id. The reliability requirement is not to be applied "too strictly" and is satisfied as long as the expert has "good grounds" for his or her opinion. Holbrook v. Lykes Bros. S.S. Co., 80 F.3d 777, 784 (3d Cir.1996).
There also must be a "valid scientific connection" or fit, between the facts of the case and the expert's opinion. Daubert, 509 U.S. at 591, 113 S.Ct. 2786; Holbrook, 80 F.3d at 777. This requirement ensures that the opinion is relevant and will "aid the jury in resolving a factual dispute." Id.
Finally, we recognize that Rule 702 is to be interpreted liberally in favor of admissibility, since "[v]igorous cross-examination, presentation of contrary evidence,
In toxic tort cases, a plaintiff must demonstrate that the substance at issue is capable of causing the observed harm (general causation), and that the substance actually caused the harm suffered by the plaintiff (specific causation).
In light of these causation standards, Defendants contend that Plaintiff's experts have failed to offer "good grounds" to support a reliable opinion as to general or specific causation. Plaintiffs disagree and assert that the causation opinions of Drs. Handler, Washington and Rai are sufficiently reliable.
Dr. Handler, Plaintiff's expert toxicologist, concluded that "[g]iven Plaintiff's employment and the activities he was involved with just before he became symptomatic,... exposure to chemicals in the
As we understand Drs. Handler and Washington's opinions in lay-person's terms, they concluded that Plaintiff's exposure to the chemical compounds in the paints and thinners he used aboard the GILLILAND caused his liver failure to occur in two stages. They explain that initially, one of these chemicals, most specifically MAK, was incorporated into Plaintiff's liver over the course of his first several weeks working with the paints and thinners, resulting in the formation of protein adducts and antibodies. The formation of these adducts and antibodies prepared Plaintiff's liver for an autoimmune response in defense of a subsequent exposure. Thereafter, during his final week aboard the GILLILAND, Plaintiff was again exposed to MAK in a manner sufficient to trigger a severe autoimmune response. Handler explains that this type of second exposure could cause "severe hepatitis" in a "small subset of individuals" due to the presence of the antibodies, generated from the first exposure. (Handler Rpt. at 3-5; Washington Rpt. at 3-4.)
In reaching these conclusions, Drs. Handler and Washington primarily relied upon: (1) the temporal relationship between Plaintiff's exposure and his injury; (2) the "pattern of injury" to Plaintiff's liver, which, in their view, showed signs of an "immune-mediated" response; (3) a 1984 study which reported that the exposure of rats to radioactive labeled MAK caused the incorporation of the radioactivity into three unidentified liver proteins; (4) "precedent" describing the immune-mediated reaction that occurs following "halothane" exposure; and (5) a differential diagnosis, which is "a standard scientific technique which identifies the cause of a medical problem by eliminating the likely causes until the most probable one is isolated."
In support of this position, Plaintiff primarily relies upon Heller v. Shaw Industries, Inc., 167 F.3d 146 (3d Cir.1999). See (Pl.'s Resp., Doc. No. 33, at 17, 23-26.) In Heller, the United States Court of Appeals for the Third Circuit held that it is not necessary for a medical expert to "cite published studies on general causation in order to reliably conclude that a particular object caused a particular illness." 167 F.3d at 154-55. The Court concluded that a strong "temporal relationship between an injury and a causal event" could obviate the need for a published study demonstrating a link between a substance and an injury.
Plaintiff contends that the temporal analysis and differential diagnosis performed by his experts satisfies Heller and that any scientific studies offered in support of their opinions was "merely icing on the cake[.]" (Pl.'s Resp., Doc. No. 33, at 12.) Plaintiff urges that there is a strong temporal relationship between exposure and injury in this case. He points out that it is undisputed that he was exposed to paints and thinners from, at least, November 19, 2007 to December 16, 2007 and January 8, 2008 to February 29, 2008, and that he began feeling ill on March 3, 2008. (Def.'s State. Facts, Doc. No. 29, Ex. 1, ¶¶ 2-5, 13, 15; Pl.'s Resp. State. Facts, Doc. No. 32, Ex. 4, ¶¶ 2-5, 13, 15.) In Plaintiff's view, this sequence of events supports the opinions of Drs. Handler, Washington and Rai, which provide that Plaintiff's exposure to "toxins" prior to February 25, 2008 "primed" him for an immune-mediated response and that his subsequent exposure during the last week of February 2008 brought about the immune-mediated response that caused his liver failure in early March.
Plaintiff also points to the testimony of his liver transplant surgeon, Dr. Robert A. Fisher, M.D., as supportive of this temporal analysis. Dr. Fisher testified that the period of time between Plaintiff's exposure to "some form of a toxin" in the paints and thinners and the onset of his symptoms was consistent with the impact of immune-mediated responses in rabbits.
We note several weaknesses in Plaintiff's arguments. First, although Plaintiff's experts contend that there is a temporal relationship between Plaintiff's exposure and injury, they do not point to any scientific evidence to suggest that the pattern or timing of his exposure was "sufficient" to "prime" him for an
Most importantly, however, we do not read Heller to hold that even a strong temporal relationship between exposure and injury, in and of itself, is sufficient to establish a reliable general causation opinion. Heller instructs that a district court must consider the "analytical gap" between the scientific data and the expert's opinion in determining whether a temporal connection and differential diagnosis provide "good grounds" for the opinion. Id. at 155-56, 158 ("We repeat that all of these reliable methods for making a diagnosis cannot sanitize an otherwise untrustworthy conclusion") (quotation omitted.) Thus, while a definitive study on general causation is not a prerequisite to the admissibility of an expert opinion, the scientific data an expert relies upon is not, as Plaintiff characterizes it, "merely icing on the cake." Rather, the district court must determine whether the "gap" between the scientific data and the opinions offered is simply too great to assist the trier of fact. For the following reasons, we conclude that the scientific evidence relied upon by Plaintiff's experts in support of their general causation opinion fails to pass muster under Heller and Daubert, even in light of their reliance upon temporal proximity and a differential diagnosis.
In determining that MAK is capable of causing Plaintiff's injury, Drs. Handler and Washington initially drew upon a 1984 study, performed by Phillip W. Albro, et al. ("Albro Study"), which demonstrated that radioactively labeled MAK "caused incorporation of the radioactivity into 3 unidentified liver proteins as well as into DNA, urea and cholesterol."
To bridge to gap between the Albro study and liver failure in humans, Drs. Handler and Washington state that the pattern of injury seen in Plaintiff's liver is consistent with that seen following exposure to the compound halothane, which is used as a general anesthetic. We recognize that there is precedent in scientific literature that exposure to halothane can result in the development of protein adducts and antibodies in the liver, which upon subsequent exposure, can facilitate an immune-mediated response that causes liver failure. (Handler Rpt. at 4; Washington Rpt. at 3-4; Rai Depo. pp. 39-40.) Importantly, however, MAK, the substance at issue here, is chemically unrelated to halothane. In our view, reliance by Plaintiff's experts on science involving an entirely unrelated substance does not meet Daubert's requirements of a "valid scientific connection" between the facts and the opinion. Daubert, 509 U.S. at 591, 113 S.Ct. 2786.
It is worth repeating that Plaintiff's experts have not pointed to any scientific evidence or an example from their clinical experience to suggest MAK, like halothane, is capable of giving rise to an immune-mediated response or liver failure. Although Dr. Handler noted that "immune-based hepatotoxicity linked to protein adduct formation has been observed with other chemicals such as tienilic acid... and minocycline[,]" (Handler Resp. Rpt. at 3), there is no basis set forth in any of Plaintiff's expert opinions that suggests MAK may fall within the same category as these "other chemicals" or impact the liver in a similar manner. Indeed, it is telling that in response to Defendant's argument that there is no scientific evidence to suggest that MAK may give rise to an "immune response" or acute liver failure, Plaintiff is only able point to the expert opinions offered in connection with this case. (Def.'s State. Facts, Doc. No. 29, Ex. 1, ¶¶ 18-19; Pl.'s Resp. State. Facts, Doc. No. 32, Ex. 4, ¶¶ 18-19); see Heller 167 F.3d at 158-59 ("[T]he District Court could, however, properly consider the fact (rather than requiring it as a prerequisite to admissibility) that [the expert] relied on few, if any, studies linking exposure to the [chemical at issue] ... to the illness"). Although an expert may extrapolate from existing scientific data, "nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert."
Plaintiff's experts attempt to downplay the lack of scientific support for their opinions by pointing out the "rare," "unpredictable" and "idiosyncratic" nature of immune-based hepatotoxicity.
Lastly, we reject Plaintiff's contention that his experts have provided reliable general causation opinions based upon their "properly performed differential diagnoses." (Pl.'s Resp., Doc. No. 33, at 11-13) (citing Heller v. Shaw Industries, Inc., 167 F.3d 146, 155 (3d Cir.1999). In performing a differential diagnosis, "a physician begins by `ruling in' all scientifically plausible causes of the plaintiff's injury." Glastetter v. Novartis Pharmaceuticals Corp., 252 F.3d 986, 989 (8th Cir.2001). Thus, it is "assume[d] that general causation has been proven for a list of possible causes[,]" such that the physician can identify the probable cause by process of elimination. In re Rezulin Products, 2004 WL 2884327 **3-4 (S.D.N.Y. Dec. 10, 2004) (collecting cases); Soldo v. Sandoz Pharmaceuticals Corp., 244 F.Supp.2d 434, 524-25 (W.D.Pa.2003).
A properly performed differential diagnosis, therefore, is built upon a reliable general causation finding — it does not establish general causation. Because the temporal analysis and scientific evidence offered by Plaintiff's experts are insufficient to suggest that MAK, or any other toxin in the paints and thinners, is capable of causing acute liver failure, we are unable to conclude that their differential diagnoses provide "good grounds" in support of a general causation opinion.
Defendants also filed two motions for partial summary judgment, seeking dismissal of Plaintiff's negligence and seaworthiness claims (Doc. No. 29) and his maintenance and cure claim (Doc. No. 30). Plaintiff concedes that all of his claims are
For the reasons set forth above, Defendant's motions to exclude the expert testimony of Drs. Handler, Washington and Rai are granted. Defendant's motions for summary judgment as to each of Plaintiff's claims are also granted.
An appropriate order follows.