Photo of Bexis

Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”).  That approach originally led us to 21 U.S.C. §337(a), the FDCA’s “no private enforcement” provision, which we later successfully repurposed to support preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

It also led to reliance on other limitations on negligence per se in other states.  We’ve already discussed Kentucky’s limitation of negligence per se to claimed violations of state, as opposed to federal, enactments.  We also had success with legislative intent arguments in Florida and Wisconsin, and with a licensing statute argument in Virginia.  Now, it turns out that some anti-negligence per se seeds we planted in Texas found some fertile ground.

In Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334 (Tex. Dist. June 7, 1999), aff’d on other grounds, 2000 WL 991697 (Tex. App. July 20, 2000), a Texas trial judge in a Bone Screw case rejected FDCA-based negligence per se allegations every which way but loose.  “The pertinent question is whether the duties set forth in the federal law are analogous to those set forth in the local tort law.”  Baker, 1999 WL 811334, at *8 (quoting Johnson v. Sawyer, 47 F.3d 716, 729 (5th Cir. 1995)).  Thus, under Texas law, Baker held that the plaintiff:

must do more than simply denominate his claim for violations of the FDCA as a negligence per se claim.  [He] must demonstrate that the regulations in question establish suitable standards of conduct under preexisting, independent Texas tort law.

Id.  The plaintiff in Baker could not do so.  FDCA-based negligence per se flunked the criteria for allowing use of negligence per se established in Perry v. S.N., 973 S.W.2d 301 (Tex. 1998).

First, “the FDCA does not establish the sole duty of a manufacturer.”  Baker, 1999 WL 811334, at *9 (footnote omitted).  “While the FDCA is more precise than these general concepts, it varies significantly from common law negligence.  The Court in Perry cautioned against applying negligence per se if it causes a “great change” in the law.  Id.  “[A]bsence of a corresponding common law duty weighs against adopting negligence per se in the FDCA regulations.”  Id.  “[T]he [FDA’s] regulations do not merely serve to define more precisely what conduct breaches the common law duty.  To the contrary, a new and more stringent duty would be imposed.”  Id.

Second, FDA regulations do not “clearly define[] the prohibited conduct.”  Id. at *10 (quoting Perry).  That was particularly true of claims alleging off-label promotion:

This factor weighs against the imposition of tort liability.  The FDCA, MDA, and FDA guidelines are not clear about prohibited conduct. . . .  Therefore, it is difficult for a manufacturer to know exactly when the activities are promotional or scientific/educational.

Id. (quote from FDA guidance document omitted).

Third, negligence per se in Texas is improper where it would convert negligence into “liability without fault.”  Id.  Under the FDCA “the manufacturer’s acts may result in [FDA enforcement] if no scienter is shown.”  Id.  In product liability cases:

the negligence per se theory is surplusage if [plaintiff] prevails on . . . common law negligence or strict liability claims.  If [plaintiff] cannot succeed on either of these issues, an issue is raised as to the culpability of Defendant’s conduct. . . .  Therefore, applying negligence per se may create liability without fault that causes injury.


Fourth, “the only inquiry for the jury” in FDCA-based negligence per se “is whether the defendant violated the statute and, if so, whether this was a proximate cause of plaintiff’s injuries.”  Id. (citation omitted).  Thus, any FDCA violation could impose liability “without regard to the condition of the device itself (assuming provable causation).  The device could be absolutely safe (i.e., free from defects and not tainted by negligence), but [defendant] would still be liable.  Id.  This type of liability violated Perry’s rejection of negligence per se where it “would impose ruinous liability disproportionate to the seriousness of the defendant’s conduct.”  Id.

Fifth, a relevant factor “is whether [plaintiff’s] injury is a direct or indirect result of the violation of the statute.”  Baker, 1999 WL 811334, at *11.  “This factor also supports” rejection of negligence per se because an alleged FDCA violation “does not prove that the device was unsafe and therefore caused [plaintiff’s] injury.”  Id.  The claimed liability:

is too attenuated to impose liability automatically through a per se cause of action.  It may be an unreasonably dangerous and defective device, a manufacturer’s negligence, or the negligence of a learned intermediary that would directly cause plaintiff’s injury in this type of case, but it is not a failure to follow administrative regulations.


Since the Bone Screw litigation concluded, other courts applying Texas law have followed Baker’s thorough analysis.  In Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591 (W.D. Tex. 2002), involving a drug rather than a device, plaintiff asserted negligence per se based on purported FDCA violations “by providing inaccurate information in their warnings, informational materials and package inserts.”  Id. at 594.  Starting, as Baker did, with Johnson v. Sawyer, Hackett recognized that “[c]ourts are not required to find negligence per se from a violation of a federal statute, particularly where the violation would not give rise to liability under state common law.”  Id.  “Because the FDCA does not provide for a private cause of action, many courts have held plaintiffs cannot seek to enforce it through negligence per se tort actions.”  Id. (citing three Bone Screw cases).  Hackett adopted Baker’s rationale.  “The Court finds the Baker Court’s application of the Perry factors persuasive and declines to create a new cause of action, particularly in a case where the Plaintiff has been so lackadaisical in pursuing his novel theory of liability.”  Id. (citations omitted).

Baker was also persuasive in Jackson v. Kim, 2004 WL 6040969 (E.D. Tex. Sept. 27, 2004):

Because the [statute] does not provide for a private cause of action, this Court is not inclined to enforce such standards through negligence per se tort actions. . . .  [O]ne Texas court has held the FDCA and FDA regulations do not give rise to a negligence per se cause of action under the standard . . . established in Perry. . . .  The Court finds the Baker Court’s application of the Perry factors persuasive and declines to create a new cause of action.

Id. at *4.  Without citing Hackett, Kim reached a virtually identical result – even though Kim was not an FDCA-based case, but rather a Fair Debt Collection Practices Act case.  See Bruce v. Nationstar Mortgage, 2015 WL 728028, at *4 (N.D. Tex. Feb. 19, 2015); Bent v. Mackie Wolfe Zientz & Mann, P.C., 2013 WL 4551614, at *6 (N.D. Tex. Aug. 28, 2013); Thompson v. Hughes, Watters & Askanase, LLP, 2013 WL 4441979, at *9 (N.D. Tex. Aug. 20, 2013) (all dismissing FDCPA cases for similar reasons).

In Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007), another prescription drug case, plaintiffs primarily pursued warning claims, but those claims failed to overcome the Texas statutory presumption of adequacy in Tex. Civ. Prac. & Rem. C. §82.007(a)(1).  2007 WL 4042757, at *2-3.  Holland made short work of an FDCA-based negligence per se, based on prior precedent.  “Texas courts also refuse to recognize a cause of action for negligence per se based on violations of the Food and Drug Cosmetic Act (“FDCA”) and FDA regulations.”  Id. at 3 (citing Hackett).

More recently, in a generic drug case that (like the Bone Screw litigation) involved claims concerning off-label use, Monk v. Wyeth Pharmaceuticals, Inc., 2017 WL 2063008 (W.D. Tex. May 11, 2017), rejected FDCA-based negligence per se as inconsistent with Texas law.  Following Baker, Hackett, and Holland, Monk dismissed the negligence per se allegations.

[U]nder the applicable factors set forth by the Texas Supreme Court, the FDCA and FDA regulations did not give rise to a cause of action for negligence per se under Texas law . . . .  The Court is persuaded by the cases cited by Defendants, and agrees that Texas law likely does not recognize a cause of action for negligence per se based solely on the violation of the FDCA and FDA regulations.

Id. at *8 (citations omitted).  Monk rejected several arguments in favor on FDCA-based negligence per se.  First, the action failed as a matter of law.  “[A]ll of these cases, despite being postured as summary judgment decisions, conducted a legal (not factual) analysis of negligence per se claims.”  Id.  Non-Texas cases (primarily the infamous Oklahoma Howard decision) weren’t “binding in any respect” and were “countered by other out-of-circuit decisions that reach the opposite result.”  2017 WL 2063008, at *8.  Finally, while another judge had let FDCA-based negligence per se claims survive dismissal, negligence per se was “never analyzed” so those orders were “not an affirmation of the validity of these claims.”  Id.

Finally, several weeks ago, we saw Sweezey v. C.R. Bard, Inc., 2020 WL 1237394 (N.D. Tex. Mar. 12, 2020), which disposed of a negligence per se claim against a medical device manufacturer on the same basis, that “’Texas courts . . . refuse to recognize a cause of action for negligence per se based on violations of the FDCA and FDA regulations.”  Id. at *1. Since the plaintiff in Sweezey “d[id] not dispute that his negligence per se claim is based on Defendants’ alleged violations of the FDCA and FDA regulations . . ., the Court grant[ed] summary judgment as to Plaintiff’s negligence per se claim.”  Id. (citing Monk, Jackson, Hackett, and Baker).

It’s hard for a defendant to “win” a mass tort because of the mass.  But plaintiffs (or their counsel) will think twice if they think that their litigation is producing precedents that will negatively impact future cases.  From Buckman on down, that was how the Bone Screw litigation was litigated, and the fate of FDCA-based negligence per se claims in Texas is one more example that Bone Screw was a defense win.