Opinion
993 EDA 2024 2213
05-22-2024
ERNEST CARANCI and CARMELA CARANCI, Plaintiffs, v. MONSANTO COMPANY, et al., Defendants.
OPINION
Abbe F. Fletman, J.
Defendant Monsanto Company ("Monsanto") appeals this Court's orders of September 22, 2023, denying (in part) its motion to exclude the testimony of Timur Durrani, M.D. under Frye v. United States, 293 F. 1013 (D.C. Cir. \923)(followed in Grady v. Frito-Lay, Inc., 839 A.2d 1038 (Pa. 2003)) and denying its motion for summary judgment on failure-to-warn claims due to federal preemption. This Court adopts by reference the February 27, 2024, Opinion of the Honorable James Crumlish, III, on the issue of federal preemption. Opinion, Trial Court Docket ("Dkt.") at 2/27/24. Accordingly, this opinion focuses on the motion to exclude Dr. Durrani's testimony.
Because this Court neither abused its discretion in denying in part the motion to exclude Dr. Durrani nor erred in concluding that the failure-to-warn claims are not preempted, this Court respectfully requests the Superior Court affirm the orders of September 22, 2023.
PROCEDURAL HISTORY
On June 29, 2021, plaintiffs Ernest Caranci and Carmela Caranci commenced this products liability action against Monsanto with the fding of a complaint. Compl., generally, Dkt. at 6/29/21. The Carancis alleged that Ernest Caranci developed non-Hodgkin lymphoma ("NHL") from his use of Roundup brand herbicide products designed, marketed, sold, and manufactured by Monsanto. See, e.g., id. at ¶ 10, 56, 160-62, 172.
While the June 29, 2021, complaint also named Bayer AG, S&H Hardware & Supply Co., Perm Hardware, Inc., and Perm Hardware Two, Inc. as defendants, only Monsanto remained by the time summary judgment motions were decided. In their short-form complaint, the Carancis maintained their claims only against Monsanto, Penn Hardware, Inc., and Perm Hardware Two, Inc. See generally Short-Form Complaint, Dkt. at 1/31/23. Counsel for the parties later stipulated to discontinue all claims against the Penn Hardware defendants, which the Court approved on August 14, 2023. Stipulation, Dkt. at 8/14/23.
On August 5, 2022, following establishment of the Roundup mass tort program and pursuant to Case Management Order No. 2, plaintiffs' liaison counsel filed a long-form complaint containing allegations equally applicable to all Roundup plaintiffs. Long-Form Complaint, Global Dkt. at 8/5/22; Order, Global Dkt. at 8/10/22. The long-form complaint alleges that two of the ingredients of Roundup, the chemical glyphosate and surfactants known as polyethoxylated tallow amines, cause NHL. Long-Form Complaint ¶¶ 32-37, 113-114, Global Dkt. at 8/5/22.
This case is one of several hundred similar cases now pending in the Philadelphia Court of Common Pleas and coordinated for pre-trial purposes under the caption In Re: Roundup Products Liability Litigation, May Term 2022 No. 0550. Order, Docket No. 220500550 ("Global Dkt.") at 5/10/22. At the time the relevant orders were entered, Judge Fletman oversaw the pretrial proceedings in the case as the Team Leader for the Mass. Tort Program.
Case Management Order No. 2 authorizes the filing of a long-form complaint on the global docket by liaison counsel. Order, Global Dkt. at 8/10/22.
On January 31, 2023, the Carancis filed a short-form complaint pursuant to Case Management Order No. 4, incorporating the general allegations of the long-form complaint and maintaining their claims against Monsanto for (1) strict liability design defect, (2) strict liability failure-to-warn, (3) negligence, (4) negligent design, (5) negligent marketing, and (6) breach of implied warranties. Short-Form Complaint at ¶ 11, Dkt. at 1/31/23.
Case Management Order No. 4 directs individual plaintiffs, who already had started Roundup cases, to file their short-form complaints, which incorporate and supplement the long-form complaint for a specific plaintiff, no later than January 31, 2023. Order, Global Dkt. at 12/21/22.
On July 12, 2023, Monsanto moved for summary judgment. Defendant Monsanto Company's Motion for Summary Judgment, Dkt. at 7/12/23. Monsanto argued, in relevant part, that (1) the Carancis failed to present admissible expert testimony on causation as shown in their contemporaneously filed motion to exclude Dr. Durrani, and (2) the Carancis' failure-to-warn claims are preempted by the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"). Id. at 8, 9-14; see also Defendants' Motion to Exclude Testimony of Timur Durrani, M.D., Dkt. at 7/12/23.
Though Monsanto's motion for summary judgment referenced all five of its filed motions to exclude expert testimony, its April 30, 2024, Statement of Errors Complained of on Appeal raised only the motion pertaining to Dr. Durrani.
On August 9, 2023, the Carancis filed their responses to the summary judgment motion and the motion to exclude Dr. Durrani's testimony. Plaintiffs' Opposition to Defendant Monsanto Company's Motion for Summary Judgment, Dkt. at 8/9/23; Plaintiffs' Opposition to Defendants' Motion to Exclude the Testimony of Dr. Timur Durrani, Dkt. at 8/9/23. On August 16, 2023, Monsanto filed its replies. Defendants Monsanto Company and Philadelphia Building Materials Ltd.'s Motion for Summary Judgment, Dkt. at 8/16/23; Defendant's Reply in Support of Motion to Exclude Testimony of Timur Durrani, M.D., Dkt. at 8/16/23.
On September 11, 2023, the Court heard oral argument on the motions. See Notes of Testimony ("N.T.") 9/11/23 at 4-36 (summary judgment), 57-73 (motion to exclude Dr. Durrani). On September 22, 2023, this Court denied Monsanto's motion for summary judgment. Order, Dkt. at 9/25/23. The Court also denied the motion to exclude Dr. Durrani to the extent the motion raised a challenge under Frye v. United States, 293 F. 1013 (D.C. Cir. 1923)(followed in Grady v. Frito-Lay, Inc., 839 A.2d 1038 (Pa. 2003), and dismissed the remaining grounds in the motion to exclude without prejudice to raise them before the trial court. Order, Dkt. at 9/25/23.
In October 2023, the case proceeded to a three-week jury trial that resulted in a verdict for the Carancis and a total award of $175 million. Trial Worksheet, Dkt. at 10/30/23. On March 27, 2024, after denial of post-trial relief, Monsanto timely filed a notice of appeal challenging, in relevant part, this Court's September 22, 2023, order denying summary judgment. Notice of Appeal ¶ 1, Ex. B, Dkt. at 3/27/24.
On April 30, 2024, Monsanto timely filed a Statement of Errors Complained of on Appeal. See Defendant Monsanto Company's Statement of Errors Complained of on Appeal ("Statement of Errors"), Dkt. at 4/30/24. Monsanto raised two purported errors by this Court in its pretrial rulings: (1) denying Monsanto's motion to exclude Dr. Durrani's testimony, and (2) concluding that the Carancis' failure-to-warn claims are not preempted under FIFRA. Id. at ¶¶ 4-6, 15.
FACTS
Dr. Durrani is a medical doctor certified in family medicine, general preventative medicine and public health, occupational medicine, and medical toxicology. Motion to Exclude Durrani, Ex. A at 3 ("Durrani Report"). In a report produced during pre-trial proceedings, Dr. Durrani offered opinions on two issues: (1) general causation, i.e., the carcinogenic potential of glyphosate and glyphosate-based herbicide formulas such as Roundup, and (2) specific causation, i.e., whether Mr. Caranci's exposure to Roundup was a substantial contributing factor in causing his NHL. Durrani Report at 2.
To analyze general causation, Dr. Durrani performed a literature review considering "all relevant data" contained in the scientific literature and applied the Bradford Hill criteria to interpret the results of studies and assess their weight. Id. at 5-6. The Bradford Hill criteria include nine viewpoints used to analyze human epidemiologic evidence and determine whether a causal relationship can be deduced. Walsh Est. of Walsh v. BASF Corp., 234 A.3d 446, 451 (Pa. 2020). The criteria are (1) consistency of association, (2) strength of association, (3) specificity, (4) temporality, (5) biological gradient, (6) biologic plausibility, (7) coherence, (8) experimental evidence, and (9) analogy. Durrani Report at 6. Dr. Durrani reported that this method "is commonly taught in schools of public health and is an accepted methodology when determining causal associations [.]" Id.
Dr. Durrani's general causation assessment included review of glyphosate evaluations performed by the International Agency for Research on Cancer and the United States Environmental Protection Agency; mechanistic studies; animal studies; epidemiological case-control studies; the Agricultural Health Study analysis of glyphosate (a cohort study); and meta-analyses of scientific literature on glyphosate. See Durrani Report at 15, 17, 18, 22, 33-36, 37. After reviewing the literature, Dr. Durrani analyzed each of the nine Bradford Hill criteria, found that all criteria except number nine (analogy) supported a causal relationship, and concluded that glyphosate and glyphosate formulations (including Roundup) "can cause NHL in humans." Id. at 47-51,57.
Dr. Durrani then used differential diagnosis methodology to analyze whether Roundup was a substantial factor in causing Mr. Caranci's NHL. Id. at 7, 55-56. In performing this analysis, Dr. Durrani "considered the factors that research has shown may increase one's likelihood of developing NHL and further ruled out any additional potential alternative causes" including age, sex, body weight, ethnicity, family history, exposure to other chemicals, radiation exposure, weakened immune system, autoimmune diseases, and relevant infections. Id. at 55.
Dr. Durrani determined whether to include Roundup as a risk factor based on his general causation analysis and on the number of eight-hour "exposure days" to Roundup that Mr. Caranci experienced over his lifetime. Id. at 53-54. Dr. Durrani applied threshold levels of eight-hour "exposure days" he found in his search of peer-reviewed scientific literature. Id. at 7 n.3, 33-36. Three epidemiological case control studies analyzing glyphosate and NHL revealed by Dr. Durrani's literature review compared the strength of association between glyphosate and NHL with the number of "exposure days" that subjects experienced. Id. at 33-36 (citing McDuffie 2001, Eriksson 2008, and Pahwa 2019). The McDuffie and Pahwa studies found that subjects who experienced at least two exposure days per year had a stronger association with NHL than those with lower exposures, and the Eriksson study found a similarly increased association for subjects that experienced 10 exposure days during a lifetime. Id. at 33, 34, 35.
The citations for these studies are:
• McDuffie H.H., et al., Non-Hodgkin 's Lymphoma and Specific Pesticide Exposures in Men: Cross-Canada Study of Pesticides and Health, Cancer Epidemiology, Biomarkers & Prevention: A Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology, Nov. 2001, Volume 10, Issue 11, Pages: 1155-63, PMID: 11700263;
• Eriksson M., et al., Pesticide Exposure as Risk Factor for Non-Hodgkin's Lymphoma Including Histopathological Subgroup Analysis, International Journal of Cancer, Oct. 2008, Volume 123, Issue 7, Pages: 1657-63, doi: 10.1002/ijc.23589; and
• Pahwa M., et al., Glyphosate Use and Associations with Non-Hodgkin Lymphoma Major Histological Sub-Types: Findings from the North American Pooled Project, Scandinavian Journal of Work, Environment & Health, Jun. 2019, Volume 45, Issue 6, Pages: 600-609; doi: 10.5271/sjweh.3830.Durrani Report at 49.
Dr. Durrani calculated Mr. Caranci's exposure as between 41 and 61 days over his lifetime, exceeding the thresholds found in the literature. Id. at 52-54. Dr. Durrani based this calculation on deposition testimony and an interview of Mr. Caranci and detailed the spraying times in his report. Id. at 51-52. After reviewing Mr. Caranci's medical history and ruling out other risk factors for NHL, Dr. Durrani concluded that Roundup caused or was a substantial factor in causing Mr. Caranci's NHL. Id. at 54-58.
STANDARD OF REVIEW
"When reviewing a trial court's grant or denial of a Frye motion, an abuse of discretion standard applies." Walsh Est. of Walsh v. BASF Corp., 234 A.3d at 456; see also Betz v. Pneumo Abex, LLC, 44 A.3d 27, 54 (Pa. 2012). "An abuse of discretion exists when the trial court has rendered a judgment that is manifestly unreasonable, arbitrary, or capricious, has failed to apply the law, or was motivated by partiality, prejudice, bias, or ill will." Risperdal Litig. W. C. v. Janssen Pharm., Inc., 174 A.3d 1110, 1117 (Pa. Super. 2017)(citations and quotations omitted).
DISCUSSION
Monsanto contends the Court erred in failing to grant its motion to exclude Dr. Durrani based on his use of "exposure days" to conclude that Roundup caused Mr. Caranci's NHL. Statement of Errors at ¶¶ 4-6; see also N.T. 9/11/23 at 58-65. For the following reasons, the Court did not abuse its discretion in denying Monsanto's motion under Frye.
A. The Frye Rule in Pennsylvania.
Rule 702 of the Pennsylvania Rules of Evidence permits expert witnesses to give opinion testimony if (a) the expert's scientific, technical, or other specialized knowledge is beyond that of the average layperson, (b) such knowledge will help the trier of fact, and (c) "the expert's methodology is generally accepted in the relevant field." Pa.R.E. 702 (emphasis added). Subsection (c) of Rule 702 echoes Pennsylvania's adoption of the Frye standard for expert testimony, allowing admission of novel scientific evidence only if "the methodology that underlies the evidence has general acceptance in the relevant scientific community." Grady v. Frito-Lay, Inc., 839 A.2d 1038, 1044 (Pa. 2003)(citing Frye, j«pra)(emphasis added).
A challenge under Frye entails a two-step process:
First, the party opposing the evidence must show that the scientific evidence is "novel" by demonstrating "that there is a legitimate dispute regarding the reliability of the expert's conclusions." [...] If
the moving party has identified novel scientific evidence, then the proponent of the scientific evidence must show that "the expert's methodology has general acceptance in the relevant scientific community" despite the legitimate dispute.Com. v. Foley, 38 A.3d 882, 888 (Pa. Super. 2012)(citations omitted). Once the evidence is deemed novel, then "the trial court's proper function [is] to ensure that the expert has applied a generally accepted scientific methodology to reach his or her scientific conclusions." Walsh, 234 A.3d at 458. In so deciding, the court is guided by relevant scientists, the experts in the case, and other evidence of general acceptance. Id.
Critically, in deciding a Frye challenge, the trial court "may not go further to attempt to determine whether it agrees with the expert's application of those methodologies or whether the expert's conclusions have sufficient factual support. Id. The court accordingly "may not question the merits of the expert's scientific theories, techniques or conclusions" or "assess whether it considers those theories, techniques and/or conclusions to be accurate or reliable[.]" Id. Indeed, whether an opinion is "in accordance with [the] generally accepted methodology to rely upon" certain studies or whether it is appropriate to "rely upon articles with limiting language" are "scientific judgments] that must be guided by the experts, not a trial court." Id.
To meet the "minimal threshold" necessary to qualify as "an expert opinion rather than merely an opinion expressed by an expert," the proffered expert "must point to, rely on or cite some scientific authority - whether facts, empirical studies, or the expert's own research - that the expert has applied to the facts at hand and which supports the expert's ultimate conclusion." Snizavich v. Rohm and Haas Co., 83 A.3d 191, 197 (Pa. Super. 2013). Thus, expert testimony may be excluded under Frye if the trial court is "unable to discern a coherent methodology supporting" a novel theory (such as the broad opinion that "any exposure" to asbestos is a substantial factor in causing disease while also concluding the disease is dose-responsive). Betz, 44 A.3d at 53 (Pa. 2012). Expert testimony also may be excluded if the expert fails to cite to "any documented scientific authority" supporting the conclusion, Snizavich 83 A.3d at 197; if the expert's conclusion is based on unpublished recalculations of federal regulatory data to reach a conclusion opposite to that of extensive published scientific studies, Blum ex rel. Blum v. Merrell Dow Pharm., Inc., 764 A.2d 1, 3, 4 n.5 (Pa. 2000); or if the expert reaches their conclusion "without any reference to outside sources on which he might predicate his findings" and "denie[s] reliance on any documented scientific authority[.]" Checchio By and Through Checchio v. Frankford Hosp.- Torresdale Div., 717 A.2d 1058, 1061 (Pa. Super. 1998).
B. Dr. Durrani applied a generally accepted methodology in analyzing whether Roundup caused Mr. Caranci's NHL.
In this case, Monsanto failed to demonstrate that Dr. Durrani's use of "exposure days" in his specific causation opinion resulted from a novel methodology that is not generally accepted in the scientific community. Rather, this Court concluded that Dr. Durrani based his "exposure days" analysis on published epidemiological literature revealed in his literature review, and that he used this data consistent with the related studies to analyze whether Roundup could be included in his differential diagnosis analysis.
Dr. Durrani first performed a literature review and applied the nine Bradford Hill criteria to determine whether Roundup can cause NHL. See generally Durrani Report; see also Durrani Report at 47-51. The Braford Hill criteria were originally published in 1965 by Sir Austin Bradford Hill as a basis to determine whether a causal relationship existed between smoking and lung cancer. Walsh, 234 A.3d at 451 n.3. The criteria are well established and were used by EPA's Office of Pesticide Programs in its 2017 analysis of glyphosate. Walsh, 234 A.3d at 451-52 (noting that, according to expert report, Bradford Hill criteria are "are widely accepted in the relevant scientific community, including by scientific bodies (e.g., the World Health Organization) and in modern textbooks on epidemiology, occupational and environmental medicine, and toxicology"); see also Ex. DD to Plaintiffs' Opposition to Defendant Monsanto Company's Motion for Summary Judgment (December 12, 2017 Revised Glyphosate Issue Paper from EPA's Office of Pesticide Programs), Dkt. at 8/9/23.
Dr. Durrani then applied differential diagnosis to determine the most likely cause of Mr. Caranci's NHL. (Durrani Report at 55.) Differential diagnosis is not novel. Stange v. Janssen Pharm., Inc., 179 A.3d 45, 55 (Pa. Super. 2018)("There is nothing scientifically novel about using differential diagnosis[. ...] Certainly differential diagnosis is a generally accepted methodology.") The method involves "ruling in all identifiable known causes of (and risk factors for) [the disease in question] and then ruling out those for which there is inadequate evidence." Walsh, 234 A.3d at 453 (citing causation expert's testimony, brackets in original).
Dr. Durrani ruled in Roundup (along with several other factors) based on his general causation opinion and his conclusion that Mr. Caranci experienced sufficient "exposure days" to warrant Roundup's inclusion. (Durrani Report at 47-51, 51 -57.) Dr. Durrani derived the "exposure days" metric from the thresholds found in the peer-reviewed McDuffie, Eriksson, and Pahwa studies identified in his literature review on general causation. (Id. at 7, 33-36, 51-54.) Dr. Durrani applied the threshold "exposure days" values in a manner consistent with those studies to analyze whether Roundup could be ruled in for the differential diagnosis. (Id. at 33-26, 51-54.) Accordingly, this Court determined that Dr. Durrani's methodology did not warrant exclusion under Frye.
Monsanto's arguments that Dr. Durrani's analysis is not generally accepted based on alleged "flaws" are inconsistent with Pennsylvania law. Monsanto argues that the McDuffie, Eriksson, and Pahwa studies fail to adjust for use of other pesticides. (Statement of Errors at ¶ 5.) In so arguing, Monsanto asks the Court to assume the role of the expert and make scientific judgments on the significance of the limitations presented by scientific studies. Walsh 234 A.2d at 458. Such scientific judgments fall within the scope of Dr. Durrani's expertise and are properly addressed by contrary expert testimony and cross examination. Indeed, Monsanto presented expert reports from industrial hygienists Joshua Schaeffer, Ph.D. and Matthew Call criticizing Dr. Durrani's analysis and highlighting these concerns. (Motion to Exclude Durrani at Exs. C, D.) It is not this Court's role under Frye to resolve a dispute between scientists where both positions find support in scientific literature and result from an established and generally accepted methodology. Monsanto's argument that Dr. Durrani should have been precluded under Frye for failure to quantify the actual "dose" of glyphosate that Mr. Caranci experienced is inapposite in this context. (Statement of Errors at f 5.) To borrow from asbestos cases - which involve similar aerial exposures to a toxic product over many years with a latent injury arising years or decades after the first exposure - Pennsylvania courts have repeatedly rejected a quantification requirement because it would impose "an impossible burden of proof on plaintiffs. See Rost v. Ford Motor Co., 151 A.3d 1032, 1052 (Pa. 2016)(rejecting requirement of quantification in asbestos cases where there "is substantial doubt whether such quantification is possible" as doing so would "have the effect of creating an impossible burden of proof," and leaving comparison of multiple asbestos products to jury); Andaloro v. Armstrong World Industries, Inc.,199 A.2d 71, 86 (Pa. Super. 2002)(rejecting argument that plaintiff must quantify number of asbestos fibers attributable to a given defendant); Junge v. Garlocklnc, 629 A.2d 1027, 1029 (Pa. Super. 1993)(noting that Pennsylvania imposes "no requirement" on an asbestos plaintiff to "prove through an industrial hygienist, or any other kind of opinion witness, how many asbestos fibers are contained in the dust emissions from" a specific product). The Court finds this rationale persuasive in the current context. This matter involves allegations of latent injuries allegedly caused by aerial exposure to Roundup and that arise only after years or decades of regularly spraying Roundup. To require plaintiffs to specify their precise dosage would similarly impose an impossible burden of proof
Finally, Monsanto's argument that Dr. Durrani failed to adequately address other risk factors for NHL (age, obesity, sex, ethnicity, "natural cell replication errors," and exposure to benzene) is unavailing. Statement of Errors at 1 6. Dr. Durrani considered age, sex, body weight, ethnicity, family history, exposure to benzene and other chemicals, radiation exposure, weakened immune system, autoimmune diseases, and relevant infections. Durrani Report at 55-56. That Dr. Durrani did not reach the same conclusion as Monsanto's experts merely speaks to the weight of his testimony, not its admissibility under Frye. See Walsh v. BASF Corp., 191 A.3d 838, 845 (Pa. Super. 2018)(noting that differing conclusions and absence of treatise on point speak to weight of expert testimony, not admissibility), off d sub nom. Walsh Est. of Walsh v. BASF Corp., 234 A.3d 446 (Pa. 2020).
Accordingly, this Court did not abuse its discretion in denying Monsanto's motion to exclude Dr. Durrani under Frye.
CONCLUSION
For the foregoing reasons, this Court respectfully requests that the Superior Court affirm its orders of September 22, 2023.