A lot of things about that recent Gadolinium opinion ticked us off. But one of the lowest of many low points was when the court ruled a causation opinion based upon FDA adverse event reports (“AERs”) was admissible in a civil trial because the FDA used AERs to assess causation administratively. In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334, at *9-11 (N.D. Ohio May 4, 2010). Never mind that the FDA’s administrative standards (and agency standards generally) are a far cry from those used in civil litigation.
Anyway, as we pointed out in the Gadolinium post, a lot of other courts have taken a more sensible – not to mention scientifically valid – approach to AERs and have excluded them, or opinions based upon them, from evidence. Heck, even Gadolinium wouldn’t let the plaintiffs’ experts base their opinions “based on AERs alone.” 2010 WL 1796334, at *11. For this reason we’ve decided to make exclusions of AERs from evidence (on grounds other than notice) our latest “cheat sheet.”
Before get to the cases, however, we’ll also supply links to some relevant FDA documents.
(1) the FDA’s 1996 Annual Adverse Experience Drug Report, in which the agency states that AERs “may not be used to calculate incidences or estimates of drug risk”;
(2) the FDA’s 2003 Pharmaceutical Safety Assessments Analysis, which characterized causation assessments based upon AERs as “dubious,” “inefficient,” and “low quality”;
(3) the FDA’s 2005 Guidance for Industry Good Pharmacovigilance Practices & Pharmacoepidemiologic Assessment, which discusses the “reporting biases” underreporting issues plaguing AERs.
(4) the FDA’s current website description of its adverse event reporting system, discussing the “limitations” of AERs and how they “cannot be used to calculate the incidence of an adverse event in the U.S. population.”
(5) the Department of Justice’s recent amicus brief in Bruesewitz v. Wyeth in which it states that even the stricter regime of “voluntary” adverse vaccine event reporting “alone” isn’t enough to establish anything scientific. Br. at 21-22.
(6) the FDA’s current website description of its MAUDE system of medical device reporting, which acknowledges “limitations,” such as “potential submission of incomplete, inaccurate, untimely, unverified or biased data,” and that “the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.”
(7) Due to poor data quality, even the FDA’s own attempt to use artificial intelligence to probe for causation information in its FAERS drug adverse event database proved to be a failure that “did not generate outputs accurate enough for deployment.” Engstrom, et al., “Government by Algorithm: Artificial Intelligence in Federal Administrative Agencies,” at 55-56 & nn. 36, 53 (2020).
Here goes. It’s the usual format: a list of cases, similar to our scorecards, but only including those cases we would consider citing in support of a motion to exclude. Like the scorecards, this cheat sheet will be updated periodically.
- Wolf v. Procter & Gamble Co., 555 F. Supp. 613 (D.N.J. Dec. 22, 1982) (tampon). Excluding AERs from evidence. AERs are inadmissible hearsay. Pre-Daubert case.
- Richardson v. Richardson-Merrell, Inc., 649 F. Supp. 799 (D.D.C. Dec. 19, 1986) (Bendectin). Excluding AERs from evidence and as a basis for expert opinion. AERs “are neither exceptions to the hearsay rule nor data reasonably relied upon by experts in the field of making determinations of causality.” Richardson was affirmed on other grounds. Richardson v. Richardson-Merrell, Inc., 857 F.2d 823 (D.C. Cir. 1988). Pre-Daubert case.
- Hagaman v. Merrell Dow Pharmaceuticals, 1987 WL 342949 (D. Kan. June 26, 1987) (Bendectin). Excluding AERs from evidence. AERs “are often incomplete, in that they often do not indicate whether other drugs are being taken, or whether other drugs might have caused the reported health problem.” Many “have been prompted by contemplated or existing litigation.” Pre-Daubert case.
- Martinkovic v. Bangash, 1987 WL 28400 (N.D. Ill. Dec. 18, 1987) (DTP vaccine). AERs excluded as evidence of causation, although admissible for purposes of notice. “[A]necdotal reports of alleged adverse reactions are not admissible to prove the truth of the matter” and are hearsay for that purpose. Pre-Daubert case.
- Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 788 P.2d 1293 (Idaho June 8, 1989) (Bendectin). Affirming exclusion of AERs from evidence. AERs “are anecdotal in nature and should not form the basis for any conclusions, expert or otherwise” and are inadmissible hearsay. Pre-Daubert case.
- Peters v. Johnson & Johnson Products, Inc., 783 S.W.2d 442 (Mo. App. Jan. 23, 1990) (tampon). Affirming exclusion of AERs from evidence. AERs are inadmissible hearsay as “unsolicited letters and unsubstantiated reports from alleged . . . users do not stand as to their trustworthiness.” Pre-Daubert case.
- DeLuca v. Merrell Dow Pharmaceuticals, Inc., 791 F. Supp. 1042 (D.N.J. April 29, 1992) (Bendectin). Excluding expert opinion based upon AERs. AERs “are unreliable for determining causation” because they “ADRs have inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions.” They are “not of a type of data that are reasonably relied upon by experts . . . to make a determination of [a] causal relationship.” DeLuca was affirmed without opinion: 6 F.3d 778 (3d Cir. 1993). Pre-Daubert case.
- Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441 (D.V.I. March 3, 1994) (Primatine). Excluding expert opinion based upon “[a]necdotal reports of the claimed adverse experiences” and AERs “filed with manufacturers or regulatory authorities.” “[S]uch data represent anecdotal information of chance associations, do not purport to assess cause and effect and have no epidemiological significance.” Pre-Daubert case.
- Sprague v. Upjohn Co., CA No. 91-40035-NMG (D. Mass. May 13, 1994) (Halcion). Excluding expert opinion based upon AERs. AERs are “not a scientifically valid or accepted methodology for making a determination of causation or relative drug safety.” Pre-Daubert case. We don’t have a copy of this opinion, but would like one.
- Casey v. Ohio Medical Products, 877 F. Supp. 1380 (N.D. Cal. Feb. 28, 1995) (Halothane). Excluding expert report based upon a study that was based upon foreign AERs. The foreign AERs “simply describe reported phenomena without comparison to the rate at which the phenomena occur,” “do not isolate and exclude potentially alternative causes,” and “do not investigate or explain the mechanism of causation.”
- Reynolds v. Warthan, 896 S.W.2d 823 (Tex. App. March 17, 1995) (Kwell). Affirming exclusion of AERs from evidence on grounds of danger of jury confusion. AERs “did not establish a causal link between [the product] and the reported symptoms; rather, they created a suspicion without any medical proof.” “[S]ubmission of [an AER] does not necessarily constitute an admission that the drug caused the adverse reaction.”
- Haggerty v. Upjohn Co., 950 F. Supp. 1160 (S.D. Fla. Dec. 6, 1996) (Halcion). Excluding expert opinion based upon AERs and “anecdotal case reports appearing in medical literature.” Due to the “the inherent bias in the” AERs, they “cannot be relied upon to form causation opinions.” Haggerty was affirmed without opinion: 158 F.3d 588 (11th Cir. 1998).
- Lopez v. Wyeth-Ayerst Laboratories, 1996 WL 784566 (N.D. Cal. Dec. 13, 1996) (non-swine flu vaccine). Excluding expert report based upon “case reports,” which were probably AERs, absent evidence that the reports “isolate and exclude other potential causes.” Lopez was affirmed in a non-precedential opinion. Lopez v. Wyeth-Ayerst Laboratories, Inc., 1998 WL 81296 (9th Cir. 1998) (“anecdotal reports . . . do not attempt to isolate causes and are not intended to reach conclusions as to causation”) (in table at 139 F.3d 905).
- Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. Dec. 18, 1996) (breast implants). Excluding expert opinion based upon “case reports or collections of case reports” which sound like AERs. “[C]ase reports and case studies are universally regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls.”
- In re Norplant Contraceptive Products Liability Litigation, 1997 WL 80527 (E.D. Tex. Feb. 19, 1997) (Norplant). AERs excluded from evidence on the basis of jury confusion and waste of time. AERs are only “marginally probative” because “the FDA requires [defendant] to submit all adverse events reported to it without regard to whether there is any proven causal connection.”
- Saari v. Merck & Co., 961 F. Supp. 387 (N.D.N.Y. March 11, 1997) (hepatitis B vaccine). AER about plaintiff’s case excluded from evidence. It was “was simply a report of what plaintiff told [the reporting doctor] about what she believed was her reaction to the vaccine.” Reporting physician could not testify since in the AER he “neither confirmed nor den[ied] that there is any [causal] relationship.”
- Golod v. La Roche, 964 F. Supp. 841 (S.D.N.Y. May 20, 1997) (Tegison). AERs excluded from evidence of causation, although admissible for purposes of notice. “[T]he reports may not be sufficiently reliable or relevant to be admissible on the issue of causation, [but] are relevant to [defendant’s] awareness.”
- Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d. 706 (Tex. July 9, 1997) (Bendectin). Reversing admission of expert opinion based on “case reports” (which in other Bendectin cases included AERs). “[P]hysicians following scientific methodology” would not “rely on case reports to determine whether a substance is harmful.” “[A]necdotal . . . evidence accomplishes no more than a false appearance of direct and actual knowledge of a causal relationship.”
- Willert v. Ortho Pharmaceutical Corp., 995 F. Supp. 979 (D. Minn. Feb. 25, 1998) (Floxin). Excluding expert opinion based on “case reports” (which might be AERs) and other “anecdotal” evidence. “[T]hey simply describe reported phenomena without comparison to the rate at which the phenomena occur,” “do not isolate and exclude potentially alternative causes,” and “do not investigate or explain the mechanism of causation.”
- In re Breast Implant Litigation, 11 F. Supp.2d 1217 (D. Colo. June 3, 1998) (breast implants). Technically this case shouldn’t be here because it doesn’t involve FDA AERs, but other anecdotal evidence (an expert’s individual clinical experience). But it comes up so often – and cites several AER cases – that we’re including it. “[C]ase reports. and case studies universally are regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls.”
- Allison v. McGhan Medical Corp., 184 F.3d 1300 (11th Cir. Aug. 18, 1999) (breast implants). Affirming exclusion of expert opinion based on “case reports” (which might be AERs). “Case reports and case studies are universally regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls.”
- Revels v. Novartis Pharmaceuticals Corp., 1999 WL 644732 (Tex. App. Aug. 26 1999) (non-precedential), review denied (Tex. June 29, 2000) (Parlodel). Affirming exclusion of expert opinion based upon AERs. “[A] study of case reports alone is a scientifically invalid manner in which to form an expert opinion.”
- Brumbaugh v. Sandoz Pharmaceuticals Corp., 77 F. Supp. 2d 1153 (D. Mont. Sept. 27, 1999) (Parlodel). Excluding expert opinion based upon AERs. AERs “do not demonstrate a causal link but instead represent coincidence.” Their “most significant analytical defect is that they don’t isolate and investigate the effects of alternative causation.”
- Linnen v. A.H. Robins Co., 2000 WL 16769 (Mass. Super. Dec. 14, 1999) (Phentermine). Excluding expert opinion based on “between ten and twenty case reports” that sound like AERs. “[C]ase reports alone are not considered reliable scientific evidence of causation.”
- Nelson v. American Home Products Corp., 92 F. Supp.2d 954 (W.D. Mo. March 24, 2000) (Cordarone). Excluding expert opinion based upon AERs and possibly other case reports. AERs “do not demonstrate a causal link sufficient for admission to a finder of fact in court.”
- Robinson v. Astra Pharmaceutical Products, Inc., 765 So.2d 378 (La. App. March 31, 2000) (Citanest). AERs were “wholly irrelevant” because they were not substantially similar to the plaintiff’s situation.
- In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Products Liability Litigation, 2001 WL 454586 (E.D. Pa. Feb. 1, 2001) (fen-phen). Excluding expert opinion based upon AERs. AERs “are universally recognized as insufficient and unreliable evidence of causation.”
- Glastetter v. Novartis Pharmaceuticals Corp., 252 F.3d 986 (8th Cir. June 8, 2001) (Parlodel). Affirming exclusion of expert opinion based upon AERs. Mere “case reports” suffer from numerous flaws and are “not scientifically valid proof of causation.” The trial court opinion is at Glastetter v. Novartis Pharmaceuticals Corp., 107 F. Supp.2d 1015 (E.D. Mo. 2000).
- Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1046 (S.D. Ill. Sept. 12, 2001) (Parlodel). Excluding expert opinion based upon AERs and published case reports. AERs “make little attempt to isolate or exclude possible alternative causes, lack adequate controls, and lack any real analysis.”
- Cloud v. Pfizer, Inc., 198 F. Supp. 2d 1118 (D. Ariz. Nov. 21, 2001) (Zoloft). Excluding expert opinion based upon AERs and “retrospective case reports.” Such items “are merely compilations of occurrences, and have been rejected as reliable scientific evidence supporting an expert opinion.”
- Hollander v. Sandoz Pharmaceuticals Corp., 289 F.3d 1193 (10th Cir. May 10, 2002) (Parlodel). Affirming exclusion of expert opinion based upon AERs and other case reports. AERs “contain only limited information” and are “unreliable evidence of causation.” The trial court opinion is at Hollander v. Sandoz Pharmaceuticals Corp., 95 F. Supp.2d 1230 (W.D. Okla. 2000) (“case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation”).
- Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194 (11th Cir. June 24, 2002) (Parlodel). Affirming exclusion of expert opinion based upon AERs. Such case reports “are merely accounts of medical events” and “reflect only reported data, not scientific methodology.” They do “not by themselves provide reliable proof of causation.” The trial court opinion is at Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp.2d 1347 (N.D. Ga. 2001) (case reports “cannot establish general causation”).
- Newton v. Roche Laboratories, Inc., 243 F. Supp.2d 672 (W.D. Tex. Dec. 5, 2002) (Accutane). Excluding expert opinion based upon AERs. “[M]any other courts have soundly rejected case reports as an acceptable basis for causation.”
- Soldo v. Sandoz Pharmaceuticals Corp., 244 F. Supp.2d 434 (W.D. Pa. Jan. 13, 2003) (Parlodel). Excluding expert opinion based upon AERs. AERs “do not demonstrate a causal link but instead represent coincidence. Case reports and ADEs are compilations of occurrences, and have been rejected as reliable scientific evidence supporting expert opinion so as to meet the requirements set forth in Daubert.”
- Dunn v. Sandoz Pharmaceuticals Corp., 275 F. Supp. 2d 672 (M.D.N.C. Aug. 4, 2003) (Parlodel). Excluding expert opinion based upon AERs. AERs “are not controlled studies, and they cannot be verified through peer review. [AERs] often do not include information about the patient’s medical history, family medical history, use of other medications or drugs, or other information that would be necessary to determine whether causation between the use of the drug and the reported adverse effect can be established. [AERs] are not scientific proof of causation.”
- Swallow v. Emergency Medicine of Idaho, P.A., 67 P.3d 68 (Idaho April 2, 2003) (Cipro). Excluding expert opinion based upon AERs. AERs are “based solely upon the temporal relationship between the administration of [the drug] and the adverse . . . event.” “There was no showing as to what percentage of . . . patients are represented by these ten events, nor . . . that these ten events were statistically significant. In other words, there is no showing that [the AERs are] a greater incidence of such events than would be expected to occur by chance.”
- Freeman v. Hoffman-Laroche, Inc., 2004 WL 5382304 (Neb. Dist. March 18, 2004) (Accutane). Further discovery of AER files denied. AERs “do not constitute valid scientific proof of medical causation and therefore, has little relevance in a product liability case.”
- Skibniewski v. American Home Products Corp., 2004 WL 5628157 (W.D. Mo. April 1, 2004) (fen-phen). AERs excluded from evidence. AERs “cannot be used to establish causation,” and “are hearsay and do not fall within an exception.”
- In re Meridia Products Liability Litigation, 328 F. Supp.2d 791 (N.D. Ohio July 7, 2004) (Meridia). Excluding expert opinion on comparative drug risk based upon AERs. AERs “do not screen out alternative causes for the adverse event and often lack analysis,” are “not scientifically valid proof of causation” and are “irrelevant to establish a material issue of fact.”
- McClain v. Metabolife International, Inc., 401 F.3d 1233 (11th Cir. March 2, 2005) (ephedrine). Reversing admission of expert opinion based upon AERs. AERs “reflect complaints called in by product consumers without any medical controls or scientific assessment.” “Uncontrolled anecdotal information offers one of the least reliable sources to justify opinions about both general and individual causation.”
- Ryman v. Sec’y of Dep’t of Health & Human Services, 65 Fed. Cl. 35 (2005) (hepatitis B vaccine). Affirming a trier of fact’s rejection of expert causation testimony. Finding “several difficulties” with reliance upon adverse event reports: “First, the reports can be filed by anyone. Second, the quantity and quality of information obtained in the reports is often insufficient to make an informed decision as to whether a causal link exists between the vaccination and the injury. Third, the reports may be biased towards pre-existing notions of adverse events. Fourth, the respondent’s expert . . . testified that VAERS reports ‘offer very little information regarding causality.’”
- Heckstall v. Pincus, 797 N.Y.S.2d 445 (N.Y.A.D. June 16, 2005) (Bupropion). Excluding expert opinion based upon AERs. AERs are “unverified listings and reporting of adverse reactions . . . [and] “are not generally accepted in the scientific community on questions of causation.”
- Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440 (D.N.J. Dec. 13, 2005) (Lotronex). Excluding AERs from evidence. AERs are not FDA conclusions and thus have no guarantees of genuineness. AERs “may not be sufficiently reliable or relevant to be admissible on the issue of causation.”
- Pauley v. Bayer Corp., 2006 WL 463866 (Pa. C.P. Jan. 26, 2006) (Baycol). Excluding AERs from evidence. AERs are “not the product of laboratory research or any type of controlled study,” but “merely the compilation of experiential reports.” They “are not proof of the data they contain, and do not directly bear upon the adequacy of label warnings.” Pauley was affirmed in a non-citable memorandum opinion. Pauley v. Bayer Corp., 2009 WL 1654592 (Pa. Super. June 12, 2009) (“the court’s limitation on the use of the AERs data at trial was appropriate, because it was anecdotal, not scientific”) (in table at 981 A.2d 331).
- Leathers v. Pfizer, Inc., 233 F.R.D. 687, 694 (N.D. Ga. March 10, 2006) (Lipitor). Excluding expert opinion based upon AERs. AERs “reflect only reported data, not scientific methodology . . . with little or no patient history, description or course of treatment, or reasoning to exclude other possible causes.”
- Ervin v. Johnson & Johnson, Inc., 2006 WL 1529582 (S.D. Ind. May 30, 2006) (Remicade). Excluding expert opinion based upon AERs. AERs “do little more than establish a temporal association between an exposure to a drug and a particular occurrence.” Ervin was affirmed: Ervin v. Johnson & Johnson, Inc., 492 F.3d 901 (7th Cir. 2007), without any specific discussion of AERs.
- Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006) (Itrel implantable neurological electrical pulse generator). Affirming exclusion of expert opinion based upon MDRs. An inference of defect cannot be drawn from the number of complaints. MDRs “invite rank speculation and are not demonstrably relevant to the failure of the individual unit.”
- Dellinger v. Pfizer Inc., 2006 WL 2057654 (W.D.N.C. July 19, 2006) (Neurontin). Excluding expert opinion based upon AERs. AERs “are not scientific proof of causation.” “[M]any courts have recognized that adverse drug reaction case reports and other regulatory reports fail to test a causal hypothesis and therefore cannot support a causation opinion.”
- Sutherland v. Matrixx Initiatives, Inc., 2006 WL 6617000 (N.D. Ala. Nov. 7, 2006) (Zicam). Excluding expert opinion based upon “case reports,” which may not have been FDA-reported AERs. “[A]s is always true of case reports, there are inherent methodological concerns about their significance.” “Anecdotal hearsay cannot fill the gap.”
- Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp.2d 1316 (M.D. Ala. Dec. 27, 2006) (Zicam). Excluding expert opinion based upon AERs. AERs are “are even less persuasive than case reports” because they are “[u]ncontrolled anecdotal information.”
- Salden v. Matrixx Initiatives, Inc., 2007 WL 850239 (E.D. Mich. March 16, 2007) (Zicam). Excluding expert opinion based upon a “case report,” not an FDA-submitted AER, as “merely an anecdotal observation” lacking “confirmatory research.”
- Wyatt v. Matrixx Initiatives, Inc., 2007 WL 7238402 (N.D. Ala. March 30, 2007) (Zicam). Excluding expert opinion based upon “case reports,” probably not true AERs, as “anecdotal evidence, not evidence that has been vigorously tested using scientific methodology.”
- In re: Accutane Products Liability Litigation, 2007 WL 1288354 (M.D. Fla. May 2, 2007) (Accutane). Excluding AERs from evidence. AERs “reflect nothing more than an assessment of a possible relationship, not an actual relationship.”
- Goldstein v. Centocor, 2007 WL 7428597 (S.D. Fla. May 14, 2007) (Remicade). Excluding AERs from evidence. MedWatch reports are hearsay. They are not business records because their submission is purely voluntary. Nor are they reliable because voluntary reporting is subject to various biases. They are not adoptive admissions, because a reporting manufacturer does not vouch for their truth. AERs are “uncontrolled anecdotal information” not sufficient to base an expert opinion, and their prejudice outweighs their probative value because they give a one-sided view of risks with no corresponding admission of beneficial uses of the drug.
- In re: Accutane Products Liability Litigation, 511 F. Supp.2d 1288 (M.D. Fla. June 15, 2007) (Accutane). Excluding expert opinion based upon AERs and case reports. “The reports are unreliable as proof of causation because, in general, the events were not observed in such a way as to rule out coincidence or other potential causes.”
- In re Baycol Products Litigation, 532 F. Supp.2d 1029 (D. Minn. July 16, 2007) (Baycol). Excluding expert opinion on comparative drug risk based upon AERs. “[T]he limitations inherent in AER data” preclude any rate of error analysis and “no evidence has been submitted to demonstrate that such an analysis is generally accepted.”
- In re Viagra Products Liability Litigation, 572 F. Supp.2d 1071 (D. Minn. 2008) (Viagra). Excluding expert opinion based upon 10 case reports and one rechallenge. “The difficulty with case reports is distinguishing between association and causation.” One rechallenge among millions of prescriptions is a “paucity.”
- Rose v. Matrixx Initiatives, Inc., 2009 WL 902311 (W.D. Tenn. March 31, 2009) (Zicam). Excluding expert opinion based upon ten “case reports,” which are not technically AERs. The reports are “mere accoun[ts] of medical events,” “reflect only reported data, not scientific methodology,” and while they “may bolster true toxicological data, they are not, standing alone, sufficient to establish general causation.”
- Gibson v. Sanofi-Aventis U.S., LLC, 2009 WL 3490454 (W. D. Ky. Oct. 27, 2009) (Ambien). Excluding expert opinion based upon “a collection of case reports,” which sound like AERs, as “wholly inadequate.”
- Ranes v. Adams Laboratories, Inc., 778 N.W.2d 677 (Iowa Feb. 5, 2010) (PPA). Affirming exclusion of expert opinion based upon AERs and published case reports. “[C]ase reports are merely accounts of medical events. They reflect only reported data, not scientific methodology.” “[T]he methodology used by the expert becomes suspect when it is only supported by case reports of limited use to the medical field.”
- Smith v. Pfizer Inc., 2010 WL 1754443 (M.D. Tenn. April 30, 2010) (Neurontin). Excluding AERs from evidence. AERs are not probative of causation as they have “inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions.”
- Hendrix v. Evenflo Co., Inc., 609 F.3d 1183 (11th Cir. June 22, 2010) (child restraint system). Affirming exclusion of expert testimony. “Case studies and clinical experience, used alone and not merely to bolster other evidence, are also insufficient to show general causation.”
- Kilpatrick v. Berg, Inc., 613 F.3d 1329 (11th Cir. Aug. 12, 2010) (pain pump). Affirming that case study was an unreliable basis for expert testimony because it did not contain statistical analysis and did not draw medically valid conclusions. The excluded expert “acknowledged that case reports . . . are ‘way down at the very bottom as far as medical strength of an article’ and cannot establish medical causation,” because of a “multitude of factors that could have caused” the alleged injuries.
- Toni’s Alpacas, Inc. v. Evans, 2010 WL 3730382 (D. Colo. Sept. 16, 2010) (fiber supplement). Rejecting anecdotal reports as foundation for proof of causation, since they do not isolate and exclude alternative causes and lack controls.
- In re Zicam Cold Remedy Marketing, Sales Practices, & Products Liability Litigation., 2011 WL 798898 (D. Ariz. Feb. 24, 2011) (Zicam). The FDA’s “AERs data and the agency’s reports are not admissible bases” for expert causation opinions. Such reports “reflect complaints called in by product consumers without any medical controls or scientific assessment,” and are “uncontrolled anecdotal information [which] is not the foundation of a reliable causation methodology.”
- In re Denture Cream Products Liability Litigation 795 F. Supp.2d 1345 (S.D. Fla. June 13, 2011) (Fixodent). Expert testimony on general causation was unreliable because there was “no evidence that Plaintiffs’ experts or the case reports they rely on [were] systematic in considering other plausible hypotheses and excluding background risk.” AERs are “unreliable, as a general matter,” due to “inconsistencies in case definition,” which “limit[ed] the evidentiary value of the case reports to support an inference of causation.”
- In re Aredia & Zometa Products Liability Litigation, 483 F. Appx. 182 (6th Cir. June 5, 2012) (bisphosphonate drugs). Affirming grant of summary judgment. Expert testimony was properly excluded as unreliable because general causation expert admitted that he could not “establish causation [based on 2] case reports, but simply a ‘very close association.’”
- Rhodes v. Bayer Healthcare Pharmaceutical, Inc., 2013 WL 1289050 (W.D. La. Mar. 26, 2013) (Avelox). Granting Daubert motion to exclude expert testimony because “reliance on adverse event reports is also unimpressive, as such reports do not demonstrate the requisite degree of reliability.”
- Klein v. TAP Pharmaceutical Products, Inc., 518 F. Appx. 583 (9th Cir. May 14, 2013) (Lupron). Affirming exclusion of adverse event reports, as they “were hearsay reports of uncertain reliability, lacking information relevant to causation.”
- Trainer v. Sec’y of Health & Human Services, 2013 WL 4505803 (Fed. Cl. July 24, 2013) (hepatitis A vaccine). Finding “no causal link” between” the product and the alleged harm where the claimant attempted to rely on case reports and anecdotal evidence because “there are too many unknown variables that make such raw information inherently unreliable.”
- Berman v. Stryker Corp., No. 11 C 1309, 2013 WL 5348324 (N.D. Ill. Sept. 24, 2013) (prosthetic knee). Reliance on Manufacturer and User Facility Device Experience (“MAUDE”) medical device adverse event reports alone was inappropriate basis to infer causation are because “such reports can contain inaccurate and non-validated data,” and “[d]enominator data are missing which makes evaluation of the incidence or prevalence of reported events impossible.”
- DeGidio v. Centocor Ortho Biotech, Inc., 3 F. Supp.3d 674 (N.D. Ohio Mar. 11, 2014) (Remicade). Excluding expert testimony under Daubert, where there was “no question that plaintiffs’’ experts based their general-causation opinions solely on case reports” because “[c]ase reports make little attempt to screen out alternative causes for a patient’s condition,” and simply describe phenomena without comparison to background rates, either “in the general population or in a defined control group; do not isolate and exclude potentially alternative causes; and do not investigate or explain the mechanism of causation.
- Wirt v. Sec’y of Health & Human Services, No. 11–118V S, 2014 WL 1911421 (Fed. Cl. Apr. 18, 2014) (HPV vaccine). Adverse event data alone, “without the opinion of a medical expert and/or medical records showing a causal connection between vaccination and injury, is not proof of a causal connection,” and is insufficient to establish that a product caused a particular disease.
- Schenone v. Zimmer, Inc., 2014 WL 12619911 (M.D. Fla. Aug. 27, 2014) (hip implant). ADEs excluded as insufficiently similar other incidents and unduly prejudicial.
- Chapman v. Procter & Gamble Distributors, LLC, 766 F.3d 1296 (11th Cir. Sept. 11, 2014) (Fixodent). Affirming exclusion of causation testimony because reliance on “generalized case reports, hypotheses, and animal studies are insufficient proof of general causation,” because such information “could mislead the jury by causing it to consider testimony that was insufficient by recognized primary methodologies to prove using [denture cream] causes myelopathy.”
- In re Incretin Mimetics Products Liability Litigation, 2014 WL 4987877 (S.D. Cal. Oct. 6, 2014). (Incretin-based diabetes drugs). Denying generalized discovery of AER databases. AERs lack medical controls and scientific assessment, and are too unreliable to justify the expense of production as relevant to causation.
- In re Denture Cream Products Liability Litigation, 2015 WL 392021 (S.D. Fla. Jan. 28, 2015) (Fixodent). Case studies are not a reliable basis for an expert opinion on causation.
- In re Byetta Cases, 2015 WL 7184655, slip op. (Cal. Super. Nov. 13, 2015) (Byetta). ADEs are unvalidated, and even plaintiff lawyers can submit them. They are not particularly useful to establish causation.
- In re Mirena IUD Products Liability Litigation, 202 F. Supp.3d 304 (S.D.N.Y. Aug. 26, 2016) (Mirena). Case reports are not reliable evidence of causation. Affirmed 713 F. Appx. 11 (2d Cir. Oct. 24, 2017).
- Hale v. Bayer Corp., 2017 WL 1425944 (S.D. Ill. April 21, 2017) (Aleve). ADEs are too unreliable to serve as the basis of an expert opinion.
- Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. May 8, 2017) (Eliquis). ADEs do not require causation. An adverse event, standing alone, says nothing about causation. FDA voluntary reporting does not collect systematic data. Reporting rates say little about actual incidence of risk.
- In re Mirena Ius Levonorgestrel-Related Products Liability Litigation (No. II), 341 F. Supp.3d 213 (S.D.N.Y. Oct. 24, 2018) (Mirena). Adverse event reports cannot establish causation. primarily serve a more limited function, as a tool to generate hypotheses. Precedent has hesitated to base causation or even an epidemiological association on adverse event data. Collections of adverse event reports are often inherently skewed by the reporting impulses of those, including lawyers, who choose to make reports.
Gayle v. Pfizer, Inc., ___ F. Supp.3d ___, 2020 WL 1685313, at *5 (S.D.N.Y. April 7, 2020) (Lipitor). Adverse event reports must be submitted whether or not the submitter believes the event was caused by the product. FDA expressly disclaims causation. Neither adverse event reports standing alone, nor analyses based on such reports can be “newly acquired information” under the FDA CBE regulation.