In this post we discuss something that most definitely is not near and dear to our hearts. In fact it’s just the opposite. We hate it. And if you defend FDA-regulated manufacturers, you should hate it too – unless you enjoy hearing your client called a criminal, or worse. The “it,” of course, is negligence per se based upon claims that the defendant somehow violated the Food, Drug & Cosmetic Act (“FDCA”).
Pull up a cyberchair and pay attention because we’re going to explain some ways of defeating such claims – as a matter of law – that you probably haven’t considered.
First, a little bit on why FDCA-based negligence per se is so dangerous and difficult a cause of action to deal with. The obvious danger from such claims is the effect on a jury when the plaintiff’s counsel stands up and accuses your client of breaking the law – not just any law but the law overseen by the omniscient Food and Drug Administration (“FDA”); the law intended by Congress to keep us safe from adulterated drugs and misbranded medical devices. You may cue the violins now. Anyway, take it from those of us who have been on the receiving end. The atmosphere in the courtroom is not exactly the best if you’re defense counsel.
The less obvious danger from FDCA-based negligence per se claim is that there doesn’t have to be anything wrong with the product. In both negligence and strict liability, a successful cause of action requires either breach of duty (negligence) or product defect (strict liability) before the case can get to the jury. That requires a detailed investigation of the product and how it was made, and almost invariably expert testimony. It’s not all that easy for the plaintiff to prove, and it can be quite an expensive proposition.
Negligence per se, on the other hand, does away with this requirement because the violation of law substitutes for a finding either breach or defect. Under negligence per se, if a jury finds that your client broke the law, then there can be liability even if there was nothing intrinsically wrong with the product – a scary proposition for defendants, and the Holy Grail for plaintiffs.
The biggest legal problem defendants face with FDCA-based negligence per se is that the Restatement has never restated everything it should with respect to negligence per se. The Second Restatement conditions negligence per se liability on violation of an enactment that met four “purposes”:

(a) to protect a class of persons which includes the one whose interest is invaded, and
(b) to protect the particular interest which is invaded, and
(c) to protect that interest against the kind of harm which has resulted, and
(d) to protect that interest against the particular hazard from which the harm results.

Restatement (Second) of Torts §286 (1965) (emphasis added). The black letter of the Third Restatement, concerning product liability is even less precise:

In connection with liability for defective design or inadequate instructions or warnings. . .a product’s noncompliance with an applicable product safety statute or administrative regulation renders the product defective with respect to the risks sought to be reduced by the statute or regulation[.]

Restatement (Third) of Torts: Products Liability §4 (1997) (emphasis added).
The problem with both of these formulations is that they fail to address (at least in the black letter) all of the legal prerequisites for negligence per se – and the elements they choose to “restate” are absurdly easy for FDCA violation claims to satisfy. The FDCA’s a safety statute, right? Sure, perhaps the classic example of such an act. Thus it protects consumers of prescription medical products from personal injury, and since the Act covers both warnings and design it’s equally easy to say that the “particular hazard” causing injury is within the statute’s scope as well.
Right? It’s very easy to answer “yes,” and some courts have done so – with little or no thought to the consequences. Thus, in Ezagui v. Dow Chemical Corp., 598 F.2d 727, 733 (2d Cir. 1979), the court took all of a paragraph to conclude that an FDCA violation could serve as the basis for negligence per se under New York law. Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 460 (4th Cir. 1960), devoted two paragraphs to a similar holding under Virginia law.
Under most state’s laws, however, the answer isn’t as cut and dried as the Ezagui and Eutsler courts make it out to be. There are other elements of negligence per se – those not found in the Restatement formulations – that defendants can use to defeat FDCA-based claims. Here they are, in a nutshell:
(1) Negligence per se is improper where it is inconsistent with the legislative intent of the enactment that was allegedly violated.
(2) Negligence per se is improper where it would impose novel duties that are not analogous to any existing common-law duty.
(3) Negligence per se is improper in some jurisdictions where only a regulation, and not a statute, was violated. It is improper everywhere where the alleged transgression involved something that lacks full force of law.
(4) Negligence per se is improper where the allegedly violated statute is vague or imprecise.
(5) Negligence per se is improper where the allegedly violated statute only required that the defendant obtain a license of some sort.
Legislative Intent – The most important of these additional elements of negligence per se is that of legislative intent. One has to look deep into the comments of the Restatement to find it, but it’s there: when “the legislature has indicated no intention that it [a statutory provision] shall be so applied” in a tort suit, courts “treat the provision as inapplicable.” Restatement (Second) of Torts §286, comment d (1965), see Restatement (Third) of Torts, Products Liability §4, comment d (1997) (“purpose” is to be taken “into account in determining whether noncompliance. . .renders the product defective”). Most states have adopted some sort of legislative purpose limitation on the use of negligence per se. The language used by the New York Court of Appeals is representative:

[W]e must, most importantly, determine the consistency of [negligence per se] with the purposes underlying the legislative scheme. For, the Legislature has both the right and the authority to select the methods to be used in effectuating its goals, as well as to choose the goals themselves.

Sheehy v. Big Flats Community Day, Inc., 541 N.E.2d 18, 21 (N.Y. 1989). “Where a statute creates legal duties and provides a particular means for their enforcement, the designated remedy excludes all others.” Gammill v. United States, 727 F.2d 950, 953 n.3 (10th Cir. 1984). Most other states’ law contains similar statements if one digs hard enough. This point becomes critical because the FDCA contains express language that forbids anyone but the government itself from seeking to prosecute violations of the act: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). In the context of a product liability action, the Supreme Court held that §337(a) means no private enforcement of purported violations, because it “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions” and is “clear evidence that Congress intended that the [statute] be enforced exclusively by the Federal Government.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 352 (2001).There are other federal statutes that likewise contain language that in one way or another restricts their usage in private tort actions, most notably OSHA. Courts considering whether violations of those statutes could support negligence per se claims have predominately (but not unanimously) held that they cannot. E.g., Elliott v. S.D. Warren Co., 134 F.3d 1, 4 (1st Cir. 1998); Myers v. United States, 17 F.3d 890, 901 (6th Cir. 1994); Albrecht v. Baltimore & Ohio Railroad Co., 808 F.2d 329, 332-33 (4th Cir. 1987).The same rationale – that Congress did not intend private enforcement of the FDCA – has also been used to preclude Lanham Act claims asserting FDCA violations as the predicate act under that statute. E.g., PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997); Mylan Laboratories, Inc. v. Matkari, 7 F.3d at 1130, 1139 (4th Cir. 1993); Sandoz Pharmaceuticals v. Richardson-Vicks, 902 F.2d 222, 231 (3d Cir. 1990).The defense that private actions alleging FDCA violations as negligence per se fail as contrary to congressional intent has been successfully employed to defeat such claims. The Supreme Court of Illinois held:

[T]he instant plaintiffs seek to premise a private cause of action in State court upon defendant’s alleged violation of Federal legislation. Therefore, to determine whether a cause of action. . .exists, we examine whether such a cause of action has been recognized by the Federal courts or whether recognizing such a cause of action comports with Federal legislative intent. This inquiry forecloses plaintiff’s cause of action. Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act.

Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 355-56 (Ill. 1996). Accord, e.g., In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 789-90 (3d Cir. 1999); In re Shigellosis Litigation, 647 N.W.2d 1, 10 (Minn. App. 2002); Bish v. Smith & Nephew Richards, Inc., 2000 WL 1294324, at *3 (Tenn. App. Aug. 23, 2000); Osburn v. Danek Medical, Inc., 520 S.E.2d 88, 93 (N.C. App. 1999), aff’d, 542 S.E.2d 215 (N.C. 2000); Friedlander v. HMS-PEP Products, Inc., 485 S.E.2d 240, 242 (Ga. App. 1997); Scott v. CIBA Vision Corp., 44 Cal. Rptr. 2d 902, 912 (Cal. App. 1995); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 594 (W.D. Tex. 2002) ; Alexander v. Smith & Nephew, P.L.C., 98 F. Supp. 2d 1299, 1308 (N.D. Okla. 2000); Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353, 1361 (M.D. Fla. 1999); Cali v. Danek Medical, Inc., 24 F.Supp.2d 941, 954 (W.D. Wis. 1998); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1516 (S.D. Fla. 1990).Typical of these decisions is the recent opinion in Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp.2d 1023, 1027 (D. Kan. 2006), which addressed a negligence per se claim under Kansas law. In Kansas, legislative intent was one of the elements of negligence per se. “[T]he tort of negligence per se in Kansas is limited to violations of a statute where the legislature intended to create an individual right of action for injury arising out of a statutory violation.” Id. at 1028. Because congress did not exhibit any such intent in the FDCA, “a violation of the FDCA cannot give rise to a negligence per se claim.” Id. The Vanderwerf opinion is well researched and references numerous other courts that reached the came conclusions under various states’ laws.
Novel duties – Some states only allow negligence per se where the duty being imposed is parallel to some already-recognized common-law duty. Texas is chief among these jurisdictions. Statutes “do not. . .automatically create duties cognizable under local tort law. The pertinent question is whether the duties set forth in federal law are analogous to those set forth in the local tort law.” Johnson v. Sawyer, 47 F.3d 716, 729 (5th Cir. 1995). Rejection of novel negligence per se duties has occurred the FDCA context. “[T]he negligence per se doctrine does not create new causes of action. Rather, it recognizes a legislatively created standard of care to be exercised where there is an underlying common-law duty.” Talley v. Danek Medical, Inc., 179 F.3d 154, 158 (4th Cir. 1999). Accord Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1017 (8th Cir. 2004); King v. Danek Medical, Inc., 37 S.W.3d 429, 460 (Tenn. App. 2000); Bish, 2000 WL 1294324, at *2; Hackett, 246 F. Supp.2d at 594; Alexander, 98 F. Supp.2d at 1321; Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *9 (Tex. Dist. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex App. July 20, 2000).
Administrative regulations – While the Restatement, and most states, permit negligence per se for violations of administrative regulations, a number of states – including some of the largest, do not. See Elliott v. City of New York, 747 N.E.2d 760, 763-64 (N.Y. 2001); Chambers v. St. Mary’s School, 697 N.E.2d 198, 202-03 (Ohio 1998); Harwood v. Glacier Electric Cooperative, Inc., 949 P.2d 651, 656 (Mont. 1997); Price v. Sinnott, 460 P.2d 837, 840 (Mont. 1969); Town of Kirklin v. Everman, 29 N.E.2d 206, 206-07 (Ind. 1940); Ridgecrest Retirement & Healthcare v. Urban, 135 S.W.3d 757, 763 (Tex. App. 2004); McKinney v. H.M.K.G. & C., Inc., 123 S.W.3d 274, 280-281 (Mo. App. 2003); California Service Station & Automobile Repair Ass’n v. American Home Assurance Co., 73 Cal. Rptr. 2d 182, 188 (Cal. App. 1998), Murray v. Briggs, 569 So. 2d 476, 480 (Fla. App. 1990); La. Civ. Code Art. 2317(D).
Less Than Administrative Regulations – Many times, however, the FDA provides substantive content to the Act through means less formal than administrative regulations having the force of law – particularly “guidances,” but also proposals for regulations that remain in “draft” form indefinitely. The Restatements explicitly limit negligence per se to statutes or regulations. Restatement (Third), Products Liability §4; Restatement (Second) of Torts §§285-288C (1965). Nor does any state that we are aware of allow negligence per se for the “violation” of something, such as a guidance or a draft that lacks full force of law. A few representative cases rejecting negligence per se where what was supposedly violated was only advisory, or otherwise lacked legal force are: Gatter v. Nimmo, 672 F.2d 343, 347 (3d Cir. 1982); Flechsig v. United States, 991 F.2d 300, 304 (6th Cir. 1993); Jacobo v. United States, 853 F.2d 640, 641 (9th Cir. 1988); Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 931 (Utah 2003); Smith v. Pulaski County, 501 S.E.2d 213, 214 (Ga. 1998).
Vagueness – Whether FDCA-related negligence per se lies for purported violations of administrative regulations – or even less – is particularly important because the most frequently invoked sections of the Act are rather broad and vague as to what constitutes, for example, adulteration or misbranding. To the extent that these sections are given more precise substantive content, that precision is found in the Agency’s regulations. Negligence per se is generally not permitted where the statutory standard that the defendant allegedly violated is vague or non-specific.

Implicit in virtually all discussions of negligence per se is the unspoken assumption that the regulation in question establishes a clear minimum standard of care. If the regulation fails to do so, the reason for applying the doctrine fades. An ambiguous or contradictory regulatory standard defeats the certainty on which the rule of per se liability rests. Persons affected are deprived of a sure standard upon which they may fashion their affairs.

Dougherty v. Santa Fe Marine, Inc., 698 F.2d 232, 235 (5th Cir. 1983). Accord, e.g., In re TMI, 67 F.3d 1103, 1115 (3d Cir. 1995); Ridge v. Cessna Aircraft Co., 117 F.3d 126, 131 (4th Cir. 1997); Parra v. Atchison, Topeka & Santa Fe Railway Co., 787 F.2d 507, 509 (10th Cir. 1986); Young v. Commonwealth DOT, 744 A.2d 1276, 1279 (Pa. 2000); Perry v. S.N., 973 S.W.2d 301, 307-08 (Tex. 1998); Shahtout v. Emco Garbage Co., 695 P.2d 897, 899 (Or. 1985); Griglione v. Martin, 525 N.W.2d 810, 812 (Iowa 1994); Rains v. Bend of the River, 124 S.W.3d 580, 590-591 (Tenn. App. 2003).For this reason, quite a few attempts to assert FDCA-based negligence per se have failed because the standard allegedly set by the FDCA (or similar state “little FDCA” statutes) was impermissibly vague. Talley, 179 F.3d at161; Shanks v. Upjohn Co., 835 P.2d 1189, 1200-01 (Alaska 1992); Goodman v. Wenco Foods, Inc., 423 S.E.2d 444, 452 (N.C. 1992); Messer Griesheim Industries, Inc. v. Eastman Chemical Co., 194 S.W.3d 466, 483 (Tenn. App. 2005); Shigellosis Litigation, 647 N.W.2d at 10-11; King, 37 S.W.3d at 458; Jones v. GMRI, Inc., 551 S.E.2d 867, 873 (N.C. App. 2001); McNeil Pharmaceutical v. Hawkins, 686 A.2d 567, 582 (D.C. App. 1996); Baraukas v. Danek Medical, Inc., 2000 WL 223508, at *4 n.2 (M.D.N.C. Jan. 13, 2000).
Licensing Statutes – Almost all states refuse to hold unlicensed persons – usually, but not always, somebody driving a car – automatically liable on an negligence per se theory simply because they lacked the necessary licenses. See R.P. Davis, “Lack of Proper Automobile Registration or Operator’s License as Evidence of Operator’s Negligence,” 29 A.L.R.2d 963 §5 (1953 & Supps.) (collecting cases). Some representative non-drivers-license cases reaching the same result are: Cooper v. Eagle River Memorial Hospital, Inc., 270 F.3d 456, 461 (7th Cir. 2001); Beaver Valley Power Co. v. National Engineering & Contracting Co., 883 F.2d 1210, 1221-22 (3d Cir. 1989); Flint City Nursing Home, Inc. v. Depreast, 406 So. 2d 356, 357-60 (Ala. 1981); Lingle v. Dion, 776 So.2d 1073, 1077 (Fla. App. 2001); Leal v. Hobbs, 538 S.E.2d 89, 93 (Ga. App. 2000); Business Men’s Assurance Co. v. Graham, 891 S.W.2d 438, 455-56 (Mo. App. 1994); Turek v. Saint Elizabeth Community Health Center, 241 Neb. 467, 488 N.W.2d 567, 571-72 (Neb. 1992); Leahy v. Kenosha Memorial Hospital, 348 N.W.2d 607, 612-13 (Wis. App. 1984).Likewise, negligence per se claims seeking to hold defendants automatically liable because their products allegedly lacked the necessary marketing approvals from the FDA have also failed.

The administrative requirement [of] approv[al] by the FDA. . .is only a tool to facilitate administration of the underlying regulatory scheme. Because it lacks any independent substantive content, it does not impose a standard of care, the breach of which could form the basis of a negligence per se claim. Its breach is analogous to the failure to have a drivers license.

Talley, 179 F.3d at 161. Accord Knoth v. Smith & Nephew Richards, 195 F.3d 355, 358 (8th Cir. 1999); King, 37 S.W.3d at 457-58; Lillebo v. Zimmer, Inc., 2005 WL 388598, at *4-5 (D. Minn. Feb. 16, 2005); Alexander, 98 F. Supp.2d at 1321; Holland v. Smith & Nephew Richards, Inc., 100 F. Supp.2d 53, 56 (D. Mass. 1999); Johnson v. Smith & Nephew Richards, Inc., 1999 WL 1117105, at *2 (N.D. Okla. Sep. 30, 1999); Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *15-16 (D. Neb. Aug. 16, 1999); Bell v. Danek Medical, Inc., 1999 WL 335612, at *4 (E.D. La. May 24, 1999); Flynn v. Biomet, Inc., 1993 WL 540570, at *9 (E.D. Va. July 23, 1993).One of us has written a book – well, both of us have written books, but only one on this topic – that addressed these negligence per se issues in considerably greater detail. Anyone interested in learning more about these defenses to FDCA-related negligence per se can find about that book here.