The opinion of the court was delivered by: LIFLAND
Plaintiff Nancy Rutigliano initiated this action in 1990 against various manufacturers and distributors of carbonless carbon paper ("CCP") forms. Rutigliano alleges that she has developed a condition called "formaldehyde sensitization" from exposure to formaldehyde released from CCP she handled in the course of her employment at Metro Fuel Oil Company ("Metro") in Ridgefield, New Jersey from January 1984 through December 1985. Formaldehyde sensitization, she claims, is a severe and permanent disability which requires her to live and work in environments free of formaldehyde, a ubiquitous chemical in today's society.
The Court heard oral argument on November 27, 1995. The parties have submitted copious medical information and deposition testimony in conjunction with this motion, which the Court has reviewed at length. Neither party requested that the Court conduct an evidentiary hearing. Nor did the Court judge that such a hearing would enhance its ability to decide this motion, given the completeness of the written record presented to the Court. As the Third Circuit has noted:
Evaluating the reliability of scientific methodologies and data does not generally involve assessing the truthfulness of the expert witness and thus is often not significantly more difficult on a cold record.
In re Paoli R.R. Yard PCB Lit., 35 F.3d 717, 749 (3d Cir. 1994), cert. denied, sub nom General Elec. Co. v. Ingram, 131 L. Ed. 2d 134, 115 S. Ct. 1253 (1995). Accordingly, the Court proceeds to consider this matter on the written record, in light of counsel's written and oral arguments.
Plaintiff has alleged that she contracted "formaldehyde sensitization" as a result of handling carbonless carbon paper manufactured by defendants during the course of her employment at Metro Fuel Oil Company. Dr. Panitz offers testimony that use of CCP can cause formaldehyde sensitization, that Rutigliano suffers from formaldehyde sensitization, and that this sensitization was caused by defendants' CCP. However, she has failed to demonstrate that her conclusions are supported by "good science," as required by the evidentiary analysis set forth by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993), and subsequent case law. The Court will not allow a jury to hear her testimony. As this leaves plaintiff without admissible evidence that her alleged injury was caused by defendants' products, the Court will also grant summary judgment in favor of defendants. The Court need not reach the admissibility of Dr. Godish's testimony, which does not include an opinion as to causation, and the case will be dismissed in its entirety.
Dr. Panitz is an occupational physician who works primarily as a consultant and expert witness in litigation matters. She does not have specialized knowledge in the fields of immunology, toxicology or dermatology. She first diagnosed plaintiff with formaldehyde sensitization in 1990, and has coordinated and interpreted plaintiff's medical testing since that time. She does not treat plaintiff herself. Dr. Panitz has neither visited nor tested any of plaintiff's present or previous home or work environments.
Formaldehyde is a naturally-occurring chemical that is nearly ubiquitous in our society. Formaldehyde is present in automobile exhaust, cigarette smoke (both primary and secondary), building materials, glues and many other common products. It is one of over fifty chemicals employed in the production of CCP. "Formaldehyde sensitization," according to Dr. Panitz, is an allergic condition that may result from short-term, high-dose exposure to formaldehyde or from long-term, low-dose exposure. When a sensitized person is exposed to formaldehyde, even at very low levels, she may experience any of a panoply of symptoms, including tight throat, rhinitis, skin rash, headache, fatigue and depression. Plaintiff argues that her formaldehyde sensitization is so severe that she cannot work in an office, in a retail operation, or outdoors.
Plaintiff has asserted claims of failure to warn, strict liability, negligence and gross negligence. Causation is a fundamental element of each of plaintiff's claims. See, e.g., Habecker v. Copperloy Corp., 893 F.2d 49, 54 (3d Cir. 1990); Restatement (Second) of Torts (1965) § 430. Plaintiff's case requires expert testimony to satisfy her burden with respect to both general causation and specific causation. See DeLuca by DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F.2d 941, 958 (3d Cir. 1990) (testimony must be able to support a jury finding both (i) that the drug can produce birth defects and (ii) that the drug more likely than not caused the birth defects in this particular case), on remand 791 F. Supp. 1042 (D.N.J. 1992), aff'd, 6 F.3d 778 (3d Cir. 1993), cert. denied, 114 S. Ct. 691 (1994); see In re Agent Orange Product Liability Lit., 611 F. Supp. 1223, 1250 (E.D.N.Y. 1985) (to prove specific causation, plaintiff's expert must first prove general causation and then exclude other possible causes for the plaintiff's injury), aff'd, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234, 108 S. Ct. 2898 (1988). In this case, "general causation" addresses whether formaldehyde found in defendants' carbonless carbon paper is capable of causing sensitization in persons handling that paper in the course of their work. "Specific causation" addresses whether formaldehyde from defendants' CCP did cause Rutigliano's symptomatology.
If plaintiff's expert opinion evidence regarding causation is inadmissible or insufficient to sustain a jury verdict in her favor, summary judgment must be granted to defendants. Fed. R. Civ. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986); Goodman v. Mead Johnson & Co., 534 F.2d 566, 573 (3d Cir. 1976), cert. denied, 429 U.S. 1038, 97 S. Ct. 732, 50 L. Ed. 2d 748 (1977).
Where, as here, essential elements of plaintiff's case are entirely dependent upon expert testimony, the trial judge must act as a "gatekeeper" to ensure that all expert testimony or evidence to be heard at trial is not only relevant, but also reliable. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 2795, 125 L. Ed. 2d 469 (1993). The Supreme Court and the Court of Appeals for the Third Circuit have set forth non-exclusive guidelines to shape the gatekeeper's analysis under the relevant rules of evidence: Rules 702, 703 and 403. The crucial portion of the analysis in the case at bar relates to the standards established under Rule 702.
Federal Rule of Evidence 702 requires that expert opinion testimony be rendered by a qualified expert, based upon reliable data and methodology. The testimony must be relevant to the case at hand. The Rule 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.
The three requirements established by Rule 702 are often referred to as qualification, reliability and fit. See Paoli, 35 F.3d at 741-42. Although defendants assert that Dr. Panitz's testimony fails to satisfy any of these requirements, the Court finds that the most critical flaws in her testimony lie in the unreliability of her diagnostic method, which renders her opinion as to both general and specific causation inadmissible. As Dr. Panitz's testimony falters on the reliability prong of the Rule 702 test, the Court will not reach the issues of qualification and fit.
Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a), whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.
113 S. Ct. at 2796. The Court explained that the "overarching subject is the scientific validity--and thus the evidentiary relevance and reliability"--of the principles that underlie a proposed submission. Id. Daubert listed five non-exclusive factors for consideration when determining reliability. Id. at 2796-97. The Court of Appeals expanded this list in Paoli. 35 F.3d at 742 n. 8. When determining reliability, the Court may consider the following aspects of an expert's methodology:
(1) Whether the method consists of a testable hypothesis.
(2) Whether the method has been peer reviewed.
(3) The known or potential rate of error of the method.
(4) The standards controlling the technique's operation.
(5) The general acceptance of the method.
(6) The relation of the technique to ...