Confusing Regulatory and Litigation Standards for Showing Causation – More on Chantix


Before denying Pfizer’s Rule 702 challenges to the plaintiffs’ expert witnesses’ opinion testimony, the Chantix MDL court handed Pfizer a significant victory by holding that the company’s 2009 warnings were adequate as a matter of law.  In re Chantix Products Liab. Litig., 2012 U.S. Dist. LEXIS 101780, *21 (Jul. 23, 2012). The MDL court assessed warnings in the full context of the learned intermediary setting, in which the prescribing physicians are the intended audience for the warnings. The court held that when the warning addresses the particular injury sustained by the plaintiff, the warning is adequate.  Id. at *29-30 n.10. See Michelle Yeary, “Chantix Warnings Adequate As a Matter of Law” (July 31, 2012).

Perhaps the MDL Court felt that it needed to level the playing field by denying the defendant’s Rule 702 motions.  In any event, I seem to be not alone in expressing dismay over the glib pronouncements of the Chantix MDL court’s Rule 702 opinionSee David Oliver, “Of Mice and Monkeys and Men” (Aug. 30, 2012) (noting the court’s indulgence in the extreme assumption that causation in one mammalian species justifies an inference that it will cause in others, including humans).

In “Open Admissions for Expert Witnesses in Chantix Litigation (Sept. 1, 2012),” I detailed much that went wrong in the gatekeeping in the Chantix litigation.  Unfortunately, I only scratched at the surface.


One of the more stunning aspects of the Chantix opinion is its holding that the plaintiffs’ expert witnesses need present opinions no more rigorous and warranted than would be required to justify FDA action.  Memorandum Opinion and Order at 22-23, In re Chantix (Varenicline) Prod. Liab. Litig., MDL No. 2092, Case 2:09-cv-02039-IPJ Document 642 (N.D. Ala. Aug. 21, 2012)[hereafter cited as Chantix].  As I noted in the earlier post, this holding against the overwhelming weight of precedent on the issue.  Judge Johnson relied heavily upon the Supreme Court’s decision in Matrixx Initiatives, but that decision carefully distinguished causal judgments in civil actions from regulatory action, at least for a while, before the Court conflated them in dictum.

To be sure, Judge Johnson, in the Chantix litigation, is not the first federal judge to conflate regulatory decision making with the sufficiency and reliability needed to establish medical causation in civil litigation.  Judge Rakoff, confusing statistical significance probability with posterior probability attached to the causation issue, reached a similar conclusion in the Ephedra MDL.  See In re Ephedra Prods. Liab. Litig., 393 F. Supp. 2d 181, 189 (S.D.N.Y. 2005) (relying upon FDA ban despite “the absence of definitive scientific studies establishing causation”).

The FDA could not be clearer that its labeling requirements do not bear on the civil tort standards of liability and causation.  Back in 1979, the FDA stated that its “[l]abeling requirements will not affect adversely the civil tort liability of manufacturers, physicians, pharmacists, and other dispensers of prescription drug products.”  44 Fed. Reg. 40016, 40023 (FDA July 6, 1979) (addressing patient package inserts)
In terms of modifying drug warnings, the FDA requires that manufacturers address potential adverse events “as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.” 21 C.F.R. § 201.57(c)(6)(i) (stating requirement for medications approved after June 30, 2001).  For medications approved before July 1, 2001, the FDA requires that warnings be modified “as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” Id. at § 201.80(e).  See also “Labeling of Diphenhydramine Containing Drug Products for Over-the-Counter Human Use,” 67 Fed. Reg. 72,555, at 72,556 (Dec. 6, 2002) (“FDA’s decision to act in an instance such as this one need not meet the standard of proof required to prevail in a private tort action. . .. To mandate a warning or take similar regulatory action, FDA need not show, nor do we allege, actual causation.”)(citing Agent Orange, Glastetter, and Hollander).


Matrixx Initiatives, Inc. v. Siracuso, ___U.S. ___, 131 S. Ct. 1309, 1320 (2011) (regulatory and administrative agencies “may make regulatory decisions … based on post-marketing evidence that gives rise to only a suspicion of causation.)(internal citation omitted)

IUD v. API, 448 U.S. 607, 656 (1980)(“agency is free to use conservative assumptions in interpreting the data on the side of overprotection rather than underprotection.”)

First Circuit

In re Neurontin Mktg., Sales Practices, and Prod. Liab. Litig., 612 F. Supp. 2d 116, 136 (D. Mass. 2009) (‘‘It is widely recognized that, when evaluating pharmaceutical drugs, the FDA often uses a different standard than a court does to evaluate evidence of causation in a products liability action. Entrusted with the responsibility of protecting the public from dangerous drugs, the FDA regularly relies on a risk-utility analysis, balancing the possible harm against the beneficial uses of a drug. Understandably, the agency may choose to ‘err on the side of caution,’ … and take regulatory action such as revising a product label or removing a drug from the marketplace ‘upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-like-than-not standard used to assess tort liability.’’’)(internal citations omitted)

Sutera v. Perrier Group of Am., Inc., 986 F. Supp. 655, 667 (D. Mass. 1997)

Second Circuit

Mancuso v. Consolidated Edison Co., 967 F. Supp. 1437, 1448 (S.D.N.Y. 1997) (“recommended or prescribed precautionary standards cannot provide legal causation”; “[f]ailure to meet regulatory standards is simply not sufficient” to establish liability)

In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y.1984)(“The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one.”), aff’d in relevant part, 818 F.2d 145 (2d Cir.1987), cert. denied sub nom. Pinkney v. Dow Chemical Co., 484 U.S. 1004  (1988)

Third Circuit

Gates v. Rohm & Haas Co., 655 F.3d 255 (3d Cir. 2011) (‘‘plaintiffs could not carry their burden of proof for a class of specific persons simply by citing regulatory standards for the population as a whole’’)

In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *13 (D.N.J. July 10, 2009)(“[T]here is a clear and decisive difference between allegations that actually contest the safety or effectiveness of the Subject Drugs and claims that merely recite violations of the FDCA, for which there is no private right of action.”)

Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434, 543 (W.D. Pa. 2003) (“FDA is a regulatory agency whose mandate is to control which drugs are marketed in the United States and how they are marketed. FDA ordinarily does not attempt to prove that the drug in fact causes a particular adverse effect.”)

O’Neal v. Dep’t of the Army, 852 F. Supp. 327, 333 (M.D. Pa. 1994) (administrative risk figures are “appropriate for regulatory purposes in which the goal is to be particularly cautious [but] overstate the actual risk and, so, are inappropriate for use in determining” civil liability)

Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441, 1464 (D.V.I.) (“assumption[s that] may be useful in a regulatory risk-benefit context … ha[ve] no applicability to issues of causation-in-fact”), aff’d, 46 F.3d 1120 (3d  Cir. 1994)

Fourth Circuit

Meade v. Parsley, No. 2:09-cv-00388, 2010 U.S. Dist. LEXIS 125217, * 25 (S.D.W. Va. Nov. 24, 2010) (‘‘Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concludes that the FDA-mandated [black box] warnings cannot establish general causation in this case.’’)

Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672, 684 (M.D.N.C. 2003) (FDA “risk benefit analysis” “does not demonstrate” causation in any particular plaintiff).

Fifth Circuit

Johnson v. Arkema Inc., 2012 WL ______ (5th Cir. June 20, 2012) (per curiam) (affirming exclusion of expert witness who relied upon regulatory pronouncements; noting the precautionary nature of such statements, and the absence of specificity for the result claimed at the exposures experienced by plaintiff)

Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198-99 (5th Cir. 1996)(“Scientific knowledge of the harmful level of exposure to a chemical, plus knowledge that the plaintiff was exposed to such quantities, are minimal facts necessary to sustain the plaintiffs’ burden in a toxic tort case”; regulatory agencies,  charged with protecting public health, employ a lower standard of proof in promulgating regulations than that used in tort cases)

Cano v. Everest Minerals Corp., 362 F. Supp. 2d 814, 825 (W.D. Tex. 2005) (noting that a product that “has been classified as a carcinogen by agencies responsible for public health regulations is not probative of” common-law specific causation);

Burleson v. Glass, 268 F.Supp. 2d 699, 717 (W.D. Tex. 2003) (“the mere fact that [the product] has been classified by certain regulatory organizations as a carcinogen is not probative on the issue of whether [plaintiff’s] exposure . . . caused his . . . cancers”), aff’d, 393 F.3d 577 (5th Cir. 2004)

Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672, 677, 683 (W.D. Tex. 2002) (“Although evidence of an association may. . .be important in the scientific and regulatory contexts. . ., tort law requires a higher standard of causation.”)(FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events)

Molden v. Georgia Gulf Corp., 465 F. Supp. 2d 606, 611 (M.D. La. 2006) (“regulatory and advisory bodies make prophylactic rules governing human exposure based on proof that is reasonably lower than that appropriate in tort law”)

Sixth Circuit

Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244, 252-53 (6th Cir. 2001)(exposure above regulatory levels is insufficient to establish causation)

Stites v Sundstrand Heat Transfer, Inc., 660 F. Supp. 1516, 1525 (W.D. Mich. 1987) (rejecting use of regulatory standards to support claim of increased risk, noting the differences in goals and policies between regulation and litigation)

Baker v. Chevron USA Inc., 680 F. Supp. 2d 865, 880 (S.D. Ohio 2010) (“[t]he mere fact that Plaintiffs were exposed to [the product] in excess of mandated limits is insufficient to establish causation”; rejecting Dr. Dahlgren’s opinion and its reliance upon a “one-hit” or “no threshold” theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer, a theory that may be accepted for purposes of setting regulatory standards, but as reliable scientific knowledge; ‘‘regulatory agencies are charged with protecting public health and thus reasonably employ a lower threshold of proof in promulgating their regulations’’)

Eighth Circuit

Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015, 1036 (E.D. Mo. 2000) (“[T]he [FDA’s] statement fails to affirmatively state that a connection exists between [the drug] and the type of injury in this case.  Instead, it states that the evidence received by the FDA calls into question [drug’s] safety, that [the drug] may be an additional risk factor. . .and that the FDA had new evidence suggesting that therapeutic use of [the drug] may lead to serious adverse experiences.  Such language does not establish that the FDA had concluded that [the drug] can cause [the injury]; instead, it indicates that in light of the limited social utility of [the drug for the use at issue] and the reports of possible adverse effects, the drug should no longer be used for that purpose.”) (emphasis in original), aff’d, 252 F.3d 986, 991 (8th Cir. 2001) (FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events; “methodology employed by a government agency results from the preventive perspective that the agencies adopt”)(“The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like-than-not standard used to assess tort liability . . . . [Its] decision that [the drug] can cause [the injury] is unreliable proof of medical causation.”)

Wright v.Williamette Indus., Inc., 91 F.3d 1105, 1107 (8th Cir. 1996)

Nelson v. Am. Home Prods. Corp., 92 F. Supp. 2d 954, 958 (W.D. Mo. 2000) (FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events)

National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp. 2d 942, 961 (E.D.Ark. 1998), aff’d, 191 F.3d 858 (8th Cir. 1999)

Junk v. Terminix International Co., 594 F. Supp. 2d 1062, 1071 (S.D. Iowa 2008) (“government agency regulatory standards are irrelevant to [plaintiff’s] burden of proof in a toxic tort cause of action because of the agency’s preventative perspective”)

Ninth Circuit

Lopez v. Wyeth-Ayerst Labs., Inc., 1998 WL 81296, at *2 (9th Cir. Feb. 25, 1998) (FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events)

Tenth Circuit

Hollander v. Shandoz Pharm. Corp., 95 F. Supp. 2d 1230, 1239 (W.D. Okla. 2000) (distinguishing FDA’s threshold of proof as lower than appropriate in tort law), aff’d in relevant part, 289 F.3d 1193, 1215 (10th Cir. 2002)

Mitchell v. Gencorp Inc., 165 F.3d 778, 783 n.3 (10th Cir. 1999) (state administrative finding that product was a carcinogen was based upon lower administrative standard than tort standard)

In re Breast Implant Litig., 11 F. Supp. 2d 1217, 1229 (D.Colo. 1998)

Eleventh Circuit

Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1201 (11th Cir. 2002)(FDA may take regulatory action, such as revising warning labels or withdrawing drug from the market ‘‘upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standard used to assess tort liability’’)(“A regulatory agency such as the FDA may choose to err on the side of caution. Courts, however, are required by the Daubert trilogy to engage in objective review of the evidence to determine whether it has sufficient scientific basis to be considered reliable.”)

McClain v. Metabolife Internat’l, Inc., 401 F.3d 1233, 1248-1250 (11th Cir. 2005)(ephedra)( “[U]se of FDA data and recommendations raises a more subtle methodological issue in a toxic tort case. The issue involves identifying and contrasting the type of risk assessment that a government agency follows for establishing public health guidelines versus an expert analysis of toxicity and causation in a toxic tort case.’’)

Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347, 1370 (N.D. Ga. 2001)(“The standard by which the FDA deems a drug harmful is much lower than is required in a court of law.  The FDA’s lesser standard is necessitated by its prophylactic role in reducing the public’s exposure to potentially harmful substances.”)

In re Seroquel Products Liab. Litig., 601 F. Supp. 2d 1313, 1315 (M.D. Fla. 2009)(noting that administrative agencies “impose[] different requirements and employ[] different labeling and evidentiary standards” because a “regulatory system reflects a more prophylactic approach” than the common law)


New York

Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 450, 857 N.E.2d 1114, 1122, 824 N.Y.S.2d 584 (N.Y. 2006) (“standards promulgated by regulatory agencies as protective measures are inadequate to demonstrate legal causation”)

In re Bextra & Celebrex, 2008 N.Y. Misc. LEXIS 720, *20, 239 N.Y.L.J. 27 (2008) (characterizing FDA Advisory Panel recommendations as regulatory standard and protective measure).


Valentine v. PPG Industries, Inc., 821 N.E.2d 580, 597-98 (Ohio App. 2004), aff’d, 850 N.E.2d 683 (Ohio 2006).


Betz v. Pneumo Abex LLC, 44 A. 3d 27 (Pa. 2012).


Exxon Corp. v. Makofski, 116 S.W.3d 176, 184-85 (Tex. App. 2003)

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