Thursday, February 12, 2009

Defeating FDCA-Based Negligence Per Se On State-Law Grounds

We’ve been keeping an eye on some interesting litigation in the District of Columbia, Iacangelo v. Georgetown University, C.A. No. 05-2086 (PLF). It’s not even a drug or device case, but rather a suit against a hospital and some doctors over their off-label use of certain "substances" in a medical procedure that went awry. We’re not entirely clear from the opinion whether the stuff involved were considered drugs or devices (we suspect devices, but weren’t that motivated to research the point). We know that the plaintiffs alleged that they were “injected into [the] brain.” Id. at *1.

What makes Iacangelo different from the vast majority of medical malpractice litigation is that the plaintiffs did not sue as much for malpractice as over what they claimed were violations by the doctors of the Food, Drug and Cosmetic Act (“FDCA”).

The case first came to our attention when the District Court excluded an expert witness for the plaintiffs who offered opinions on what was, and was not, legal under the FDCA. We posted about that here.

Well, Iacangelo is back again, and as interesting as ever.

The new opinion, Iacangelo, v. Georgetown University, ___ F. Supp.2d ___, 2009 WL 250478 (D.D.C. Feb. 3, 2009), grants summary judgment against plaintiff’s negligence per se claim based upon claimed FDCA violations. As we’ve discussed before, “negligence per se” is one way that plaintiffs in medical device product liability litigation try to package the kinds of “parallel violation” claims that they argue gets them around the preemption ruling in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). If Levine comes down the right way, we would expect to see similar efforts on the drug side.

So any case that throws out an FDCA-based negligence per se claim as a matter of law is sure to grab our attention as we prepare for what might well be a preemption-dominated landscape in our area of practice.

So what happened in Iacangelo and why?

The off-label use in the case occurred in a therapeutic rather than research setting. That means that the doctors used the drugs the way they did only to try to cure one particular patient, and not to study the drug's safety or effectiveness in that use. Thus the doctors and hospital never applied for an Investigational Drug Exemption (“IDE”), did not set up an Institutional Review Board, nor established any of the other trappings of an FDA-regulated clinical study.

Plaintiffs tried to turn that into a tort. They alleged that the defendants violated the FDCA in conducting off-label use outside of the IDE context and alleged that this violation constituted negligence per se. Iacangelo, 2009 WL 250478, at *1. The defendants moved for judgment on the pleadings against this claim, but the magistrate said no. Iacangelo v. Georgetown University, 580 F. Supp.2d 111, 119-20 (Mag. D.D.C. 2008). The defendants appealed to the Article III judge.

And won (actually the procedure was considerably more complicated, but not in anything that matters to what we want to discuss).

Here’s how that happened.

The plaintiffs based their negligence per se action on the defendants’ use of “adulterated” or “misbranded” drugs/devices – the alleged violation solely being related to their off-label use. They alleged nothing intrinsically wrong with the substances in question. The defendants were liable for “adulterated” or “misbranded” products because they supposedly: (1) introduced them into interstate commerce, (2) used them together, (3) received them from interstate commerce, (4) created an unapproved “new” drug/device by using them together, and/or (5) ignored the FDA labeling. 2009 WL 250478, at *2-3.

Without getting into any preemption arguments, the court held that these allegations did not state a cause of action for two reasons.

We dealt with the first reason for dismissal before: that the standard set by the particular FDCA section the plaintiff relied upon was too open-ended to provide a common-law legal standard. The District of Columbia, like most states, requires that the allegedly violated statute set out a standard more specific than the usual negligence “reasonableness” standard:


[W]e conclude that the trial court’s modified instruction was not error because [the provision] is too general a statute to be the subject of a negligence per se instruction. A statute or regulation offered to establish a standard for negligence per se purposes must not merely repeat the common law duty of reasonable care, but must set forth ‘specific guidelines to govern behavior. [A] negligence per se instruction [is] improper because [the] generality of [the] regulation. . .did not differ significantly in particulars from the common law standard of reasonable care in the circumstances.
Chadbourne v. Kappaz, 779 A.2d 293, 296 (D.C. 2001) (citations omitted).

The section that plaintiffs relied upon was 21 U.S.C. §331. But the court found that §331 merely prohibited “adulteration” and “misbranding” without going into any detail about what that means. It wasn’t enough that §331 “governed behavior.” Rather, it didn’t govern behavior any more than telling somebody they had to get a license:


The principal problem with plaintiffs’ attempt to base claims of negligence per se on §331 is that §331 simply sets forth – in prohibitory terms – the basic requirement of the FDCA and its implementing regulations that FDA approval is required for commercial distribution. . . . That basic requirement does not embody a substantive standard of care, but rather an administrative requirement aimed at furthering the FDCA’s regulatory goals.
2009 WL 250478, at *4 (footnote omitted) (citing Talley v. Danek Medical, Inc., 179 F .3d 154, 161 (4th Cir. 1999); King v. Danek Medical, Inc., 37 S.W.3d 429, 456-60 (Tenn. App. 2000)). Thus, for common-law purposes, §331 is simply “an administrative requirement – not a substantive standard of care that can support plaintiffs' negligence per se claim.” 2009 WL 250478, at *4.

This ruling falls about midway between the “mere licensing statute” and “too general” defenses to negligence per se that we discussed in our prior post. With respect to the first (licensing) aspect of the court’s ruling, in addition to the cases cited in Iacangelo, a number of other FDCA-based negligence per se claims have met the same fate: Knoth v. Smith & Nephew Richards, 195 F.3d 355, 358 (8th Cir. 1999); Lillebo v. Zimmer, Inc., 2005 WL 388598, at *4-5 (D. Minn. Feb. 16, 2005); Barnett v. Mentor H/S, Inc., 133 F. Supp.2d 507, 511-12 (N.D. Tex. 2001), affirmed mem., 31 Fed. Appx. 156 (5th Cir. Dec. 13, 2001); Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1310, 1321 (N.D. Okla. 2000) (and several adjacent identical opinions with the same name); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *7 (S.D. Cal. June 13, 2000); Holland v. Smith & Nephew Richards, Inc., 100 F. Supp.2d 53, 56 (D. Mass. 1999); Minisan v. Danek Medical, Inc., 79 F. Supp.2d 970, 978 (N.D. Ind. 1999); Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 828 (N.D. Ind. 1999); Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d. 1351, 1361 (N.D. Ga. 1999); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 257 (E.D.N.Y. 1999); Baker v. Smith & Nephew Richards, Inc., 1999 WL 1129650, at *6 (N.D. Ga. Sept. 30, 1999); Johnson v. Smith & Nephew Richards, Inc., 1999 WL 1117105, at *2 (N.D. Okla. Sept. 30, 1999); Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *15-16 & n.9 (D. Neb. Aug. 16, 1999); Bell v. Danek Medical, Inc., 1999 WL 335612, at *4 (E.D. La. May 24, 1999); Lester v. Danek Medical, Inc., 1999 WL 1061973, at *4 (M.D.N.C. Apr. 16, 1999); Clark v. Danek Medical, Inc., 1999 WL 613316, at *2 (W.D. Ky. Mar. 29, 1999); Richardson v. Smith & Nephew Richards, Inc., 1998 WL 1166780, at *5 (Mag. E.D.N.C. Sept. 22, 1998), adopted, 1999 WL 1132962 (E.D.N.C. Jan. 10, 1999); Kirkman v. Sofamor, S.N.C., 1998 WL 666706, at *4 (W.D.N.C. July 21, 1998); United States v. Barr Laboratories, Inc., 812 F. Supp. 485, 486 (D.N.J. 1993); Flynn v. Biomet, Inc., 1993 WL 540570, at *9 (E.D. Va. July 23, 1993); United States v. 789 Cases of Latex Surgeons’ Gloves, 799 F. Supp. 1275, 1286 (D.P.R. 1992); Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001); Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 837 (Neb. 2000); Bish v. Smith & Nephew Richards, Inc., 2000 WL 1294324, at *5 (Tenn. App. Aug. 23, 2000), appeal denied (Tenn. Oct. 29, 2001); 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).

With respect to the vagueness point, a number of other negligence per se claims based upon alleged “adulteration”/”misbranding” have also been found wanting based upon the vagueness of the statutory standard. Baraukas v. Danek Medical, Inc., 2000 WL 223508, at *4 n.2 (M.D.N.C. Jan. 13, 2000); Shanks v. Upjohn Co., 835 P.2d 1189, 1200-01 (Alaska 1992) (“adulteration” under state “little FDCA” statute); Goodman v. Wenco Foods, Inc., 423 S.E.2d 444, 452 (N.C. 1992) (same); In re Shigellosis Litigation, 647 N.W.2d 1, 10-11 (Minn. App. 2002), review denied (Minn. Aug. 20, 2002); Jones v. GMRI, Inc., 551 S.E.2d 867, 873 (N.C. App. 2001), cert. dismissed, 559 S.E.2d 787 (N.C. 2002) (same as Goodman).

The second state-law ground upon which the Iacangelo court dismissed the FDCA-based negligence per se claim was causation. Nothing in the pleadings suggested that the claimed statutory violation caused or contributed to the plaintiff’s injury. In short, it didn’t matter whether the use was on or off-label – the injury would have been the same. “Mere” lack of FDA approval didn’t have anything to do with the plaintiff being injured. 2009 WL 250478, at *4.


Here, the statutory violation at issue is the use of “adulterated” and/or “misbranded” devices. Plaintiffs therefore would have to show that the mere fact that defendants used “adulterated” and/or “misbranded” devices contributed to [plaintiff’s] injuries. This they cannot do. . . . [I]t is no more logical to infer a causal connection between [these products’] unapproved status and [plaintiff’s] injuries than it is to infer a causal connection between a driver’s lack of a drivers license and injuries he causes while driving.
Id. (citing, inter alia, Talley, 179 F.3d at 161).

Iacangelo thus highlights another inherent problem in many of the “parallel violation” claims that we can expect to see so much of should preemption do away with our opponents’ real claims. Causation in the context of negligence per se is a two step process, a lot like warning defect causation under the learned intermediary rule. Before a plaintiff can even get to the broad causation question of “did the drug/device cause the injury?” s/he must first establish that the violation – the negligence per se equivalent of a defect – caused the injury. In a lot of cases, especially off-label use cases where the violation only concerns regulatory status and not the product’s actual condition, proof that the violation caused any injury will be very difficult.

Finally, a word to the wise for our fellows. If the plaintiffs get pushed heavily into “parallel violation” claims as a result of preemption (knock on wood), we’re going to find ourselves in some new territory. Negligence per se is not something most of us (save yours truly and other Bone Screw veterans) have really had to deal with all that much. We’re going to find ourselves looking at a lot of unfamiliar cases involving car crashes, building fires, and the like. That’s where negligence per se came from – and where, we think, it belongs.

But to win negligence per se cases, it’s critical to know what the defenses are, because they vary from state to state and they aren't evident from the Restatement formulation. Some states, for instance, allow negligence per se only for violations of statutes, and not for administrative regulations, such as Title 21 of the Code of Federal Regulations. These are things that a lot of us haven’t had to think about before, so it behooves us to start now. Every time a plaintiff comes up with a new cause of action, it’s our job to respond with the new defenses.

So while we’re waiting for something new and exciting to come out of the Supreme Court in Wyeth v. Levine, it might be a good idea to crack a book and read up on something old and stodgy like negligence per se.

2 comments:

Ted Heise said...

Interesting case from a regulatory perspective. This court document https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2005cv2086-33 indicates that the injected substance was "a combination of Histoacryl and Lipiodal" intended to embolize (block blood flow into) a pathological vascular structure. Poking around on the internet a bit, it looks as if the Histoacryl is a cyanoacrylate glue of some sort, and the Lipiodal is a contrast agent. Individually these are probably a device and a drug, respectively; however, together they might be considered a device. Contrast agents are in sort of a gray area--they are not metabolized in their medical function, but are regulated as drugs, presumably because they are systemically administered. I suppose one might argue that together they are a combination product, but devices are commonly combined with opacifying agents and it seems most reasonable (to me) to consider it a device. The contrast portion really has no drug action, further supporting device status.

dr said...
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