How does plaintiff-side stealth preemption work? Well, the common law of most states holds that a warning is inadequate/defective/negligent when the defendant knows or should have known about a risk caused by the drug, but didn’t warn. Common-law causation standards are a little harder to characterize in one sentence, but they tend to require “but for” causation – that an injury would not have occurred but for a plaintiff’s use of a product. A lot of states also tack on some version of “substantial factor” causation, so that in addition to being a but for cause, the product must also be a “substantial factor” in bringing about the claimed harm. In either case, causation requires proof to a "more likely than not" standard.
Plaintiffs lose a lot of cases on the defect and causation elements of state tort law. If they get the chance, they’ll try to replace these traditional state-law standards with something looser that they might be able to find in an FDA regulation. So, if an FDA regulation even arguably sets a less stringent standard for duty or causation than the common law, we expect to find some expert from the other side trying to sneak that regulatory standard into the case. They are rarely, if ever, honest about the stunt they’re trying to pull – it amounts to arguing that the FDA standard preempts state common law.
Sometimes the effort is even more blatant. Plaintiffs have been known to try to get the judge to do their stealth preemption dirty work for them, such as by arguing that a court applying state law should take “judicial notice” of the purported FDA regulatory standard. And we’re talking about otherwise routine inadequate warning claims, here, not something more exotic like negligence per se.
There are plenty of examples, but probably the regulations that are most abused (now that fraud on the FDA claims are by and large a thing of the past) in this fashion are the FDA’s causation standards for when drug manufacturers need to update labeling. These regulations in and of themselves are perfectly okay. The FDA being able to act on less-than-certain risk information is a good thing. We want to see the Agency nip possible threats to the public health in the bud. So we wouldn’t want the FDA to have to wait for the kind of evidence needed to prove a common-law tort case. Thus, for drugs approved after June 30, 2001, the FDA requires that drug warnings be changed “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). For drugs approved before then, the FDA’s administrative standard demands that drug warnings be revised “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. §201.80(e). In either case, the FDA’s regulatory regime isn’t constrained by common-law concepts of defect or legal cause.
That’s what the FDA wants. That’s what we want the FDA to be able to do. But what the FDA can demand as a regulatory matter simply ain’t what the common-law requires. Case after case has made this quite clear. “The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one.” In re Agent Orange Product Liability Litigation, 597 F. Supp. 740, 781 (E.D.N.Y.1984), aff’d in pertinent part, 818 F.2d 145 (2d Cir.1987). As far as we know there’s no state in the country – not even West Virginia – that imposes liability in a tort case when causation has “not. . .been definitely established” or “need not have been proved.”
What’s expressed in §§201.57(c) and §201.80(e) are FDA standards, not common-law standards. Unless plaintiffs allege and prove some sort of claim of negligence per se, whether or not a manufacturer should have changed a warning sooner under an FDA regulatory standard that prophylactically dispenses with causation to protect society has nothing to do with common-law tort liability. And negligence per se, particularly in the context of the FDCA – which we shout until we’re blue in the face does not permit private enforcement of regulatory violations – is a difficult claim to maintain. Negligence per se raises a host of legal problems that we’ve discussed here, here, here, and here (among other places). What we’re kvetching over in this post are plaintiffs seeking to interject FDA regulations with their lax causation standards into an ordinary common-law tort cases, typically alleging inadequate warnings or some related informational failing.
Defendants should be vigilant against plaintiffs’ stealth preemption attempts either through the back door (some sort of expert opinion) or through the front door (asking the judge to instruct the jury) where the upshot will cause jury confusion as to what standard: common-law or FDA, applies. It’s been widely recognized that less stringent administrative standards – particularly causation-related standards – aren’t applicable in common-law cases. The FDA doesn’t have to wait until causation is “more likely than not,” but tort plaintiffs do:
In [its] statement, the FDA did not purport to have drawn a conclusion about causation. Instead, the statement merely states that possible risks outweigh the limited benefits of the drug. This risk-utility analysis involves a much lower standard than that which is demanded by a court of law. A regulatory agency such as the FDA may choose to err on the side of caution.Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1201 (11th Cir. 2002). That the FDA can compel manufacturers to act before causation is proven doesn’t mean that either a plaintiff’s expert or a jury should be allowed to follow the same lax standards in product liability litigation. The “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.” Soldo v. Sandoz Pharmaceuticals Corp., 244 F.Supp.2d 434, 543 (W.D. Pa. 2003). “Although evidence of an association may. . .be important in the scientific and regulatory contexts. . ., tort law requires a higher standard of causation.” Newton v. Roche Laboratories, Inc., 243 F. Supp.2d 672, 677 (W.D. Tex. 2002).
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. In re Seroquel Products Liability Litigation, 601 F. Supp.2d 1313, 1315 (M.D. Fla. 2009). “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.” Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp.2d 1347, 1370 (N.D. Ga. 2001). The court in McClain v. Metabolife International, Inc., discussed the inapplicability of FDA regulatory standards to tort cases at some length:
[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.401 F.3d 1233, 1249 (11th Cir. 2005) (emphasis added). We’ve deliberately left a couple of good secondary source citations in this quote, so you’ll have them – other citations are omitted.
The Reference Manual on Scientific Evidence explains that
[p]roof of risk and proof of causation entail somewhat different questions because risk assessment frequently calls for a cost-benefit analysis. The agency assessing risk may decide to bar a substance or product if the potential benefits are outweighed by the possibility of risks that are largely unquantifiable because of presently unknown contingencies. Consequently, risk assessors may pay heed to any evidence that points to a need for caution, rather than assess the likelihood that a causal relationship in a specific case is more likely than not.Margaret A. Berger, “The Supreme Court’s Trilogy on the Admissibility of Expert Testimony,” in Reference Manual On Scientific Evidence, 33 (Federal Judicial Center, 2d. ed. 2000). Obviously, in a toxic tort case the court must focus on assessing causation, not on a cost-benefit analysis for restricting the sale and use of a drug. . . .
Public health guidelines, however, should not be interpreted as predicting exact levels at which effects would occur in a given individual.
Because a number of protective, often “worst-case” assumptions ... are made in estimating allowable exposures for large populations, these criteria and the resulting regulatory levels. . .generally overestimate potential toxicity levels for nearly all individuals. Furthermore, because these guidelines are intended to be protective of all individuals in a population, including the very young, the very old, and other potentially "sensitive" individuals, the theoretical risks from exposure at the guideline range level is likely to be substantially over-estimated for the large majority of individuals in the population.[David Eaton, “Scientific Judgment and Toxic Torts--A Primer in Toxicology for Judges & Lawyers,” 12 J.L. & Policy 1,] 34-35 [(2003)].
In Glastetter v. Novartis Pharmaceuticals Corp., the court similarly held that the FDA’s willingness to act in situations where the data is inconclusive is not probative of common-law liability:
[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.107 F. Supp.2d 1015, 1036 (E.D. Mo. 2000) (emphasis original). The Eighth Circuit, in affirming, agreed. “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.” Glastetter v. Novartis Pharmaceuticals Corp., 252 F.3d 986, 991 (8th Cir. 2001).
An FDA determination that a drug should be recalled because its safety “had not been proven” is not probative in a civil suit where it’s the plaintiff’s affirmative burden to prove that the drug was unsafe.
[P]laintiffs’ reliance on the position taken by the Food and Drug Administration with respect to [the drug] is misplaced. The methodology employed by a government agency results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances. The agencies’ threshold of proof is reasonably lower than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm.Hollander v. Sandoz Pharmaceuticals Corp., 95 F. Supp.2d 1230, 1239 (W.D. Okla. 2000), aff’d in pertinent part, 289 F.3d 1193 (10th Cir. 2002); accord Dunn v. Sandoz Pharmaceuticals Corp., 275 F. Supp.2d 672, 684 (M.D.N.C. 2003) (FDA “risk benefit analysis” “does not demonstrate” causation in any particular plaintiff). Allegations that an FDA-regulated product’s safety or efficacy have “not been proven” does not establish a common-law claim. “[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.” In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *13 (D.N.J. July 10, 2009); accord In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 2009 WL 1703285, at *5 (C.D. Cal. June 17, 2009) (“have not been proven” allegations are an improper “FDA approval” standard). That the FDA sees fit to require warning changes before causation is established does not permit a court or jury, bound by common-law standards, to impose such a duty where common-law causation requirements are not met.
The same sort of misplaced reliance upon administrative standards in common-law cases has also received significant attention in environmental and chemical exposure cases. Agencies like OSHA and EPA routinely set exposure standards that could never hold up in a common-law tort case. One of the first cases after Daubert recognized the fundamental difference between agency standards and the common law in an environmental exposure case when it rejected an expert’s attempt to import agency causation standards into a common-law tort case:
We are also unpersuaded that the “weight of the evidence” methodology these experts use is scientifically acceptable for demonstrating a medical link. . . . Regulatory and advisory bodies. . .utilize a “weight of the evidence” method to assess the carcinogenicity of various substances in human beings and suggest or make prophylactic rules governing human exposure. This methodology results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances. The agencies’ threshold of proof is reasonably lower than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm.Allen v. Pennsylvania Engineering Corp., 102 F.3d 194, 198 (5th Cir. 1996) (emphasis added). Thus, “the fact that an agency, ex ante, sets a[ ]standard. . .does not compel, or even necessarily support, the ex post conclusion that [plaintiff’s condition] was caused by” exposure in excess of that standard. Sutera v. Perrier Group, Inc., 986 F. Supp. 655, 664 (D. Mass. 1997).
[S]ubstances are regulated because of what they might do at given levels, not because of what they will do. . . . The fact of regulation does not imply scientific certainty. It may suggest a decision to err on the side of safety as a matter of regulatory policy rather than the existence of scientific fact or knowledge. . . . The mere fact that substances to which [plaintiff] was exposed may be listed as carcinogenic does not provide reliable evidence that they are capable of causing brain cancer, generally or specifically, in [plaintiff’s] case.Valentine v. PPG Industries, Inc., 821 N.E.2d 580, 597-98 (Ohio App. 2004), aff’d, 850 N.E.2d 683 (Ohio 2006). Accord Parker v. Mobil Oil Corp., 857 N.E.2d 1114, 1122 (N.Y. 2006) (“standards promulgated by regulatory agencies as protective measures are inadequate to demonstrate legal causation”); 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); Baker v. Chevron USA, Inc., ___ F. Supp.2d ___, 2010 WL 99272, at *11 (S.D. Ohio Jan. 6, 2010) (“[t]he mere fact that Plaintiffs were exposed to [the product] in excess of mandated limits is insufficient to establish causation”); 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"); 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”); Cano v. Everest Minerals Corp., 362 F. Supp.2d 814, 825 (W.D. Tex. 2005) (that the product “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); 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); 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).
The FDA itself rejects stealth attempts by plaintiffs to preempt the common law with looser agency regulatory standards. More than 30 years ago the Agency intended 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) (discussing requirements for patient package inserts). “[L]abeling is not intended to define the duty or set the standard of care manufacturers, physicians, pharmacists, or other dispensers owe to the patient who uses the product.” Id. A bit more recently, the FDA drew the same regulatory/common law distinction we've just finished writing about:
Rather, as a consumer protection agency, FDA has determined that this additional warning is necessary to ensure that these. . .drug products continue to be safe and effective. . . . 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.67 Fed. Reg. 72555, 72556 (FDA Dec. 6, 2002) (citing Glastetter, Agent Orange, and Hollander).
Thus, attempts to replace common-law requirements for defect, duty, or causation with looser FDA regulatory standards intended solely to safeguard the general public health should be stoutly resisted. Allowing experts, or worse the court itself, to start spouting FDA regulatory standards that are at odds with the common law can only confuse the jury as to what the relevant legal standard really is. There are good reasons why the FDA can ignore strict proof of defect or causation in carrying out its regulatory responsibilities. There are no good reasons for letting plaintiffs avoid well-established common-law standards when they are before a court of law, and not part of an administrative proceeding.