Courts and Commentators on the Use of Relative Risks to Infer Specific Causation

Below, I have collected some of the case law and commentary on the issue of using relative and attributable risks to satisfy plaintiff’s burden of showing, more likely than not, that an exposure or condition caused his or her disease or injury.


Radiation

Johnston v. United States, 597 F. Supp. 374, 412, 425-26 (D. Kan. 1984)

Allen v. United States, 588 F. Supp. 247 (1984), rev’d on other grounds, 816 F.2d 1417 (10th Cir. 1987)

In re TMI Litig., 193 F.3d 613, 629 (3d Cir. 1999)(rejecting “doubling dose” trial court’s analysis), amended, 199 F.3d 158 (3d Cir. 2000)

In re Hanford Nuclear Reservation Litig., 1998 WL 775340, at *8 (E.D.Wash. Aug. 21, 1998), rev’d, 292 F.3d 1124, 1136-37 (9th Cir. 2002)


Swine Flu- GBS Cases

Cook v. United States, 545 F. Supp. 306, 308 (N.D. Cal. 1982)(“Whenever the relative risk to vaccinated persons is greater than two times the risk to unvaccinated persons, there is a greater than 50% chance that a given GBS case among vaccinees of that latency period is attributable to vaccination, thus sustaining plaintiff’s burden of proof on causation.”)

Padgett v. United States, 553 F. Supp. 794, 800 – 01 (W.D. Tex. 1982) (“From the relative risk, we can calculate the probability that a given case of GBS was caused by vaccination. . . . [A] relative risk of 2 or greater would indicate that it was more likely than not that vaccination caused a case of GBS.”);

Manko v. United States, 636 F. Supp. 1419, 1434 (W.D. Mo. 1986)(relative risk of 2, or less, means exposure not the probable cause of disease claimed), aff’d in relevant part, 830 F.2d 831 (8th Cir. 1987)


IUD Cases – Pelvic Inflammatory Disease

Marder v. G.D. Searle & Co., 630 F. Supp. 1087, 1092 (D.Md. 1986) (“In epidemiological terms, a two-fold increased risk is an important showing for plaintiffs to make because it is the equivalent of the required legal burden of proof—a showing of causation by the preponderance of the evidence or, in other words, a probability of greater than 50%.”), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987)(per curiam)


Bendectin cases

Lynch v. Merrill-National Laboratories, 646 F.Supp. 856 (D. Mass. 1986)(granting summary judgment), aff’d, 830 F.2d 1190, 1197 (1st Cir. 1987)(distinguishing between chances that “somewhat favor” plaintiff and plaintiff’s burden of showing specific causation by “preponderant evidence”)

DeLuca v. Merrell Dow Pharm., Inc., 911 F.2d 941, 958-9 (3d Cir. 1990)

Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1321 (9th Cir.)(“Daubert II”)(holding that for epidemiological testimony to be admissible to prove specific causation, there must have been a relative risk for the plaintiff of greater than 2) (“For an epidemiological study to show causation under a preponderance standard . . . the study must how that children whose mothers took Bendectin are more than twice as likely to develop limb reduction birth defects as children whose mothers did not.”), cert. denied, 516 U.S. 869 (1995)

DePyper v. Navarro, 1995 WL 788828 (Mich. Cir. Ct. Nov. 27, 1995)

Oxendine v. Merrell Dow Pharm., Inc., 1996 WL 680992 (D.C. Super. Ct. Oct. 24, 1996)

Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 716 (Tex. 1997) (holding, in accord with the weight of judicial authority, “that the requirement of a more than 50% probability means that epidemiological evidence must show that the risk of an injury or condition in the exposed population was more than double the risk in the unexposed or control population”); id. at at 719 (rejecting isolated statistically significant associations when not consistently found among studies)


Silicone Cases

Hall v. Baxter Healthcare, 947 F.Supp. 1387, 1392, 1397, 1403-04 (D. Ore. 1996)(discussing relative risk of 2.0)

Pick v. American Medical Systems, Inc., 958 F. Supp. 1151, 1160 (E.D.La. 1997) (noting, in penile implant case, that “any” increased risk suggests that the exposure “may” have played some causal role)

In re Breast Implant Litigation, 11 F. Supp. 2d 1217, 1226 -27 (D. Colo. 1998)(relative risk of 2.0 or less shows that the background risk is at least as likely to have given rise to the alleged injury)

Barrow v. Bristol-Myers Squibb Co., 1998 WL 812318 (M.D. Fla. Oct. 29, 1998)

Allison v. McGhan Med. Corp., 184 F.3d 1300, 1315n.16, 1316 (11th Cir. 1999)(affirming exclusion of expert testimony based upon a study with a risk ratio of 1.24; noting that statistically significant epidemiological study reporting an increased risk of marker of disease of 1.24 times in patients with breast implants was so close to 1.0 that it “was not worth serious consideration for proving causation”; threshold for concluding that an agent more likely than not caused a disease is 2.0, citing Federal Judicial Center, Reference Manual on Scientific Evidence 168-69 (1994))

Grant v. Bristol-Myers Squibb, 97 F. Supp. 2d 986, 992 (D. Ariz. 2000)

Pozefsky v. Baxter Healthcare Corp., No. 92-CV-0314, 2001 WL 967608, at *3 (N.D.N.Y. August 16, 2001) (excluding causation opinion testimony given contrary epidemiologic studies; noting that sufficient epidemiologic evidence requires relative risk greater than two)

In re Silicone Gel Breast Implant Litig., 318 F. Supp. 2d 879, 893 (C.D. Cal. 2004)

Norris v. Baxter Healthcare Corp., 397 F.3d 878 (10th Cir. 2005) (discussing but not deciding specific causation and the need for relative risk greater than two; no reliable showing of general causation)

Barrow v. Bristol-Meyers Squibb Co., 1998 WL 812318, at *23 (M.D. Fla., Oct. 29, 1998)

Minnesota Mining and Manufacturing v. Atterbury, 978 S.W.2d 183, 198 (Tex.App. – Texarkana 1998) (noting that “[t]here is no requirement in a toxic tort case that a party must have reliable evidence of a relative risk of 2.0 or greater”)


Asbestos

Washington v. Armstrong World Indus., Inc., 839 F.2d 1121 (5th Cir. 1988)(affirming grant of summary judgment on grounds that there was insufficient evidence that plaintiff’s colon cancer was caused by asbestos)

Lee v. Johns Manville Corp., slip op. at 3, Phila. Cty. Ct. C.P., Sept. Term 1978, No. 88 (123) (Oct. 26, 1983) (Forer, J.)(entering verdict in favor of defendants on grounds that plaintiff had failed to show that his colo rectal cancer had been caused by asbestos exposure after adducing evidence of a relative risk less than two)

Primavera v. Celotex Corp., Phila. Cty. Ct. C.P., December Term, 1981, No. 1283 (Bench Op. of Hon. Berel Caesar, (Nov. 2, 1988) (granting compulsory nonsuit on the plaintiff’s claim that his colorectal cancer was caused by his occupational exposure to asbestos)

Grassis v. Johns-Manville Corp., 248 N.J.Super. 446, 455-56, 591 A.2d 671, 676 (App. Div. 1991)

Landrigan v. Celotex Corp., 127 N.J. 404, 419, 605 A.2d 1079 (1992)

Caterinicchio v. Pittsburgh Corning Corp., 127 N.J. 428, 605 A.2d 1092 (1992)

In re Joint E. & S. Dist. Asbestos Litig., 758 F. Supp. 199 (S.D.N.Y. 1991), rev’d sub nom. Maiorano v. Owens Corning Corp., 964 F.2d 92 (2d Cir. 1992)

Maiorana v. National Gypsum, 827 F. Supp. 1014, 1043 (S.D.N.Y. 1993), aff’d in part and rev’d in part, 52 F.3d 1122, 1134 (2d Cir. 1995)

Jones v. Owens-Corning Fiberglas Corp., 288 N.J. Super. 258, 266, 672 A.2d 230, 235 (App. Div. 1996)

Keene Corp. v. Hall, 626 A.2d 997 (Md. Spec. Ct. App. 1993)(laryngeal cancer)

In re W.R. Grace & Co., 355 B.R. 462, 483 (Bankr. D. Del. 2006) (requiring showing of relative risk greater than two to support property damage claims based on unreasonable risks from asbestos insulation products).


Pharmaceutical Cases

Ambrosini v. Upjohn, 1995 WL 637650, at *4 (D.D.C. 1995)

Ambrosini v. Labarraque, 101 F.3d 129, 135 (D.C. Cir. 1996)(Depo-Provera, birth defects)

Miller v. Pfizer, 196 F. Supp. 2d 1062, 1079 (D. Kan. 2002) (acknowledging that most courts require a showing of RR > 2, but questioning their reasoning), aff’d, 356 F. 3d 1326 (10th Cir. 2004)

Smith v. Wyeth-Ayerst Laboratories Co., appears to recognize that risk and cause are distinct concepts. 278 F. Supp. 2d 684, 691 (W.D.N.C. 2003) (“Epidemiologic data that shows a risk cannot support an inference of cause unless (1) the data are statistically significant according to scientific standards used for evaluating such associations; (2) the relative risk is sufficiently strong to support an inference of ‘more likely than not’; and (3)  the epidemiologic data fits the plaintiff’s case in terms of exposure, latency, and other relevant variables.”)

Burton v. Wyeth-Ayherst Laboratories, 513 F. Supp. 2d 719 (N.D. Tex. 2007)

In re Bextra and Celebrex Marketing Sales Practices and Prod. Liab. Litig., 524 F. Supp. 2d 1166, 1172 (N.D. Calif. 2007)(observing that epidemiologic studies “can also be probative of specific causation, but only if the relative risk is greater than 2.0, that is, the product more than doubles the risk of getting the disease”)

In re Viagra Products Liab. Litigat., 572 F. Supp. 2d 1071, 1078 (D. Minn. 2008)(noting that some but not all courts have concluded relative risks under two support finding expert witness’s opinion to be inadmissible).


Toxic Tort Cases

In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 836 (E.D.N.Y. 1984) (“A government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship.  A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him. … This means that at least a two-fold increase in incidence of the disease attributable to Agent Orange exposure is required to permit recovery if epidemiological studies alone are relied upon.”), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988)

Sanderson v. Int’l Flavors & Fragrances, Inc., 950 F. Supp. 981, 998 n. 17,  999-1000, 1004 (C.D.Cal.1996) (more than a doubling of risk is required in case involving aldehyde exposure and claimed multiple chemical sensitivities)

Wright v. Willamette Indus., Inc., 91 F.3d 1105 (8th Cir. 1996)(“Actions in tort for damages focus on the question of whether to transfer money from one individual to another, and under common-law principles (like the ones that Arkansas law recognizes) that transfer can take place only if one individual proves, among other things, that it is more likely than not that another individual has caused him or her harm.  It is therefore not enough for a plaintiff to show that a certain chemical agent sometimes causes the kind of harm that he or she is complaining of.  At a minimum, we think that there must be evidence from which the factfinder can conclude that the plaintiff was exposed to levels of that agent that are known to cause the kind of harm that the plaintiff claims to have suffered. See Abuan v. General Elec. Co., 3 F.3d at 333.  We do not require a mathematically precise table equating levels of exposure with levels of harm, but there must be evidence from which a reasonable person could conclude that a defendant’s emission has probably caused a particular plaintiff the kind of harm of which he or she complains before there can be a recovery.”)

McDaniel v. CSX Transp., Inc., 955 S.W.2d 257, 264 (1997) (doubling of risk is relevant but not required as a matter of law)

Lofgren v. Motorola, 1998 WL 299925 *14 (Ariz. Super. 1998) (TCE, cancer)

Berry v. CSX Transp., Inc., 709 So. 2d 552 (Fla. D. Ct.App. 1998)(solvents, toxic encephalopathy)

Bartley v. Euclid, Inc., 158 F.3d 261 (5th Cir. 1998)

Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 591-92 (D.N.J.2002) (‘‘the threshold for concluding that an agent was more likely than not the cause of an individual’s disease is a relative risk greater than 2.0’’), aff’d, 68 F. App’x 356 (3d Cir. 2003)

Ferguson v. Riverside School Dist. No. 416, 2002 WL 34355958 (E.D. Wash. Feb. 6, 2002)(No. CS-00-0097-FVS)

Daniels v. Lyondell-Citgo Refining Co., 99 S.W.3d 722, 727 (Tex. App. – Houston [1st Dist.] 2003)

Graham v Lautrec Ltd., 2003 WL 23512133 (Mich. Cir. Ct., July 24, 2003)

Theofanis v. Sarrafi, 791 N.E.2d 38,48 (Ill. App. 2003)(reversing and granting new trial to plaintiff who received an award of no damages when experts testified that relative risk was between 2.0 and 3.0)(“where the risk with the negligent act is at least twice as great as the risk in the absence of negligence, the evidence supports a finding that, more likely than not, the negligence in fact caused the harm”).

Cano v. Everest Minerals Corp., 362 F. Supp. 2d 814, 846 (W.D. Tex. 2005)(relative risk less than 3.0 represents only a weak association)

Mobil Oil Corp. v. Bailey, 187 S.W.3d 263, 268 (Tex. App. – Beaumont 2006)

Cook v. Rockwell Internat’l Corp., 580 F. Supp. 2d 1071, 1088-89 (D. Colo. 2006)

In re Lockheed Litig. Cases, 115 Cal. App. 4th 558 (2004), rev’d in part, 23 Cal. Rptr. 3d 762, 765 (Cal. App. 2d Dist. 2005), cert. dismissed, 192 P.3d 403 (Cal. 2007)

Watts v. Radiator Specialty Co., 990 So. 2d 143 (Miss. 2008)(“The threshold for concluding that an agent was more likely than not the cause of an individual’s disease is a relative risk greater than 2.0.”)

Henricksen v. Conocophillips Co., 605 F. Supp. 2d 1142, 1158 (E.D. Wash. 2009) (noting that under Circuit precedent, epidemiologic studies showing low-level risk may suffiicent to show general causation but are sufficient to show specific causation only if relative risk exceeds two) (excluding plaintiff‘s expert witness’s testimony because epidemiologic evidence iis “contradictory and inconsistent”)

George v. Vermont League of Cities and Towns, 2010 Vt. 1, 993 A.2d 367, 375 (2010)

City of San Antonio v. Pollock, 284 S.W.3d 809, 818 (Tex. 2009) (holding testimony admitted insufficient as matter of law).


ACADEMIC COMMENTATORS

Michael Dore, “A Commentary of the Use of Epidemiological Evidence in Demonstrating Cause-in-Fact,” 7 Harv. Envt’l L.Rev. 429, 431-40 (1983)

Bert Black & David E. Lilienfeld, Epidemiologic Proof in Toxic Tort Litigation, 52 Fordham L. Rev. 732, 767 – 69 (1984)

David E. Lilienfeld & Bert Black, “The Epidemiologist in Court,” 123 Am. J. Epidemiology 961, 963 (1986)(a relative risk of 1.5 allows an inference of attributable risk of 33%, which means any individual case is less likely than not to be causally related)

Powell, “How to Tell the Truth With Statistics: A New Statistical Approach to Analyzing the Bendectin Epidemiological Data in the Aftermath of Daubert v. Merrell Dow Pharmaceuticals,” 31 Houston L. Rev. 1241, 1310 (1994) (“The plaintiff who wishes to reach the jury on the issue of causation must submit a statistical analysis indicating that exposure to the drug in question more likely than not caused the birth defects in question.  To support a finding of causation, the meta-analysis summary odds ratio must exceed two.”)

Linda Bailey, et al., “Reference Guide on Epidemiology,” in Reference Manual on Scientific Evidence at 121, 168-69 (Federal Judical Ctr. 1st ed. 1994) (“The threshold for concluding that an agent was more likely the cause of a disease than not is a relative risk greater than 2.0 … .  A relative risk greater than 2.0 would permit an inference that an individual plaintiff’s disease was more likely than not caused by the implicated agent.”)

Ben Armstrong & Gilles Theriault, “Compensating Lung Cancer Patients Occupationally Exposed to Coal Tar Pitch Volatiles,” 53 Occup. Envt’l Med. 160 (1996)

Philip E. Enterline, “Toxic Torts:  Are They Poisoning Scientific Literature?” 30 Am. J. Indus. Med. 121 (1996)

Joseph V. Rodricks & Susan H. Rieth, “Toxicological Risk Assessment in the Court:  Are Available Methodologies Suitable for Evaluating Toxic Tort and Product Liability Claims?,” 27 Reg. Toxicol. & Pharmacol. 21, 25-30 (1998)

Michael Green et al., “Reference Guide on Epidemiology,” in Reference Manual on Scientific Evidence 333, 381, 383 (Federal Judicial Center ed., 2d ed. 2000), available at http://www.fjc.gov ( “[E]pidemiology addresses whether an agent can cause a disease, not whether an agent did cause a specific plaintiff’s disease.  * * *  Nevertheless, the specific causation issue is a necessary legal element in a toxic substance case. The plaintiff must establish not only that the defendant’s agent is capable of causing disease but also that it did cause the plaintiff’s disease.  Thus, a number of courts have confronted the legal question of what is acceptable proof of specific causation and the role that epidemiologic evidence plays in answering that question. This question is not a question that is addressed by epidemiology. Rather, it is a legal question a number of courts have grappled with.”) (“[t]he civil burden of proof is described most often as requiring the fact finder to believe that what is sought to be proved is more likely true than not true. The relative risk from epidemiologic studies can be adapted to this 50% plus standard to yield a probability or likelihood that an agent caused an individual’s disease.”)

David W. Barnes, “Too Many Probabilities:  Statistical Evidence of Tort Causation,” 64 Law and Contemp. Problems 191, 206 (2001) (criticizing the uncritical use of a relative risk greater than two to signify the probability, but acknowledging that sometimes a credible, precise RR, greater than 1.0, will be too small to support specific causation, such as the RR of 1.24 seen in the Allison case)

Russellyn S. Carruth & Bernard D. Goldstein, “Relative Risk Greater than Two in Proof of Causation in Toxic Tort Litigation,” 41 Jurimetrics 195 (2001) (criticizing the use of a relative risk of two benchmark, but acknowledging that when a disease has multiple causes and a substantial base rate in the general population, “there is no objective means to determine if a particular person’s disease was caused by some other environmental exposure, or by a non-environmental cause.”)

Richard W. Clapp & David Ozonoff, “Environment and Health:  Vital Intersection or Contested Territory?” 36 Am. J. L. & Med. 189, 210 (2004)( incorrectly describing the meaning of a confidence interval:  “A relative risk of 1.8, with confidence interval of 1.3 to 2.9 could very likely represent a true relative risk greater than 2.0, and as high as 2.9 in 95 out of 100 repeated trials.”)

Erica Beecher-Monas, Evaluating Scientific Evidence 58, 67 (N.Y. 2007)(“No matter how persuasive epidemiological or toxicological studies may be, they could not show individual causation, although they might enable a (probabilistic) judgment about the association of a particular chemical exposure to human disease in general.”)(“While significance testing characterizes the probability that the relative risk would be the same as found in the study as if the results were due to chance, a relative risk of 2 is the threshold for a greater than 50 percent chance that the effect was caused by the agent in question.”)(incorrectly describing significance probability as a point probability as opposed to tail probabilities)

Andrew W. Jurs, “Daubert, Probabilities and Possibilities and the Ohio Solution:  A Sensible Approach to Relevance Under Rule 702 in Civil and Criminal Applications,” 41 Akron L. Rev. 609, 637 (2008)(acknowledging that relative risks less than 2.0 invite jury speculation about individual, specific causation)

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