                             UNITED STATES DISTRICT COURT
                             FOR THE DISTRICT OF COLUMBIA

____________________________________
                                    )
FELICE I. IACANGELO, et al.,        )
                                    )
                  Plaintiffs,       )
                                    )
      v.                            )                 Civil Action No. 05-2086 (PLF)
                                    )
GEORGETOWN UNIVERSITY, et al.,      )
                                    )
                  Defendants.       )
____________________________________)


                          MEMORANDUM OPINION AND ORDER

               This matter is before the Court on defendants’ objections to Magistrate Judge

Alan Kay’s report and recommendation of September 17, 2008 (“Report”).1


                                       I. BACKGROUND

               In this diversity action, plaintiffs assert claims based on medical treatment

provided to Karyn Kerris. Plaintiffs’ allegations center on three embolization procedures

performed on Ms. Kerris between 1998 and 1999 by Dr. Vance Watson at Georgetown

University Hospital. Those procedures involved two substances – Histoacryl and Lipiodol –

which were injected into Ms. Kerris’ brain to treat a defect known as arteriovenous

malformation. Plaintiffs claim that after the third embolization, Ms. Kerris “became very



       1
                The papers submitted in connection with this matter include: Defendants’
Objections to the Magistrate Judge’s Proposed Findings and Recommendations (“Defs. Obj.”);
Plaintiffs’ Opposition to Defendants’ Objections to Magistrate Judge Kay’s September 17, 2008
Report and Recommendation (“Pls. Opp.”); defendants’ reply; and plaintiffs’ sur-reply.
Plaintiffs’ objections to Magistrate Judge Kay’s report and recommendation are not discussed
because, as explained below, the Court addressed plaintiffs’ objections in a prior opinion.
lethargic and then stopped eating, communicating or showing signs of being awake . . . [and]

ultimately became and remains catatonic.” Pls. Opp. at 2 (internal quotation marks omitted).

               Plaintiffs brought suit on October 24, 2005. According to defendants,

               [p]laintiffs have two basic theories of liability. First, Plaintiffs
               allege that embolization itself should not have been attempted at
               all. . . . Plaintiffs [also] assert that it was . . . negligence per se for
               Dr. Watson to use Histoacryl and Lipiodol, because [those
               substances] were not FDA approved (Counts VII and VIII) and
               Georgetown allegedly should have submitted an investigation
               device exemption (IDE) application to the FDA before using them
               (Count IX).

Defs. Obj. at 5.

               On February 14, 2008, defendants filed a motion (1) seeking judgment on the

pleadings or dismissal with respect to Counts VI, VII, VIII and IX of plaintiffs’ Second Amended

Complaint, and (2) asking the Court to strike certain allegations in the Second Amended

Complaint. The undersigned referred that motion to Magistrate Judge Alan Kay for a report and

recommendation pursuant to Local Civil Rule 72.3(a). On September 17, 2008, Magistrate

Judge Kay recommended that this Court grant defendants’ motion for judgment on the pleadings

with respect to Count VI (a free-standing claim for punitive damages), Count VII (a negligence

per se claim based on violations of 21 U.S.C. § 360c, a provision of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. § 301, et seq. (“FDCA”), and 21 C.F.R. § 812.20, a regulation intended

to implement the investigational device exemption of the FDCA) and Count IX (a negligence per

se claim based on violations of 21 C.F.R. § 812.20). Magistrate Judge Kay further recommended

that this Court deny without prejudice defendants’ motion with respect to Count VIII (a

negligence per se claim based on violations of 21 U.S.C. § 331, another provision of the FDCA)



                                                    2
and deny without prejudice defendants’ motion to strike.

               On September 27, 2008, plaintiffs filed objections to the Report.2 Three days

later, the Court issued a Memorandum Opinion rejecting all of plaintiffs’ objections and adopting

and approving Magistrate Judge Kay’s Report. In that Memorandum Opinion, the Court

observed that “[d]efendants have not, at this writing, filed objections to the Report, and their time

to do so has expired. . . . The Court therefore assumes that they accept Magistrate Judge Kay’s

recommendations [including his recommendation not to dismiss Count VIII].” Iacangelo v.

Georgetown Univ., Civil Action No. 05-2086, Memorandum Opinion at 2 n.2 (D.D.C. Sept. 30,

2008). On October 1, 2008, defendants filed a motion for reconsideration of the Court’s

September 30, 2008 Memorandum Opinion, arguing that it was issued prematurely because

defendants’ time to object to the Report had not yet expired. See Defendants’ Motion for

Reconsideration of the September 30, 2008 Memorandum Opinion Adopting and Approving

Report and Recommendation of Magistrate Judge Kay at 1. Defendants simultaneously filed

their objections to Magistrate Judge Kay’s Report, in which they objected only to Magistrate

Judge Kay’s recommendation to retain Count VIII.

               On October 10, 2008, the Court acknowledged that it had issued the September

30, 2008 decision prematurely. See Iacangelo v. Georgetown Univ., Civil Action No. 05-2086,

Memorandum Opinion and Order at 3 (D.D.C. Oct. 10, 2008). The Court therefore announced

that it would consider defendants’ objections to Magistrate Judge Kay’s Report (and plaintiffs’



       2
              Plaintiffs objected to Magistrate Judge Kay’s recommendation to dismiss Count
VI and Count VII. See generally Plaintiffs’ Objections to Magistrate Judge Kay’s September 17,
2008 Report and Recommendation. They also disagreed with Magistrate Judge Kay’s
recommendation to dismiss Count IX, but offered no separate argument respecting that count.

                                                 3
responses thereto) and, if necessary, modify its September 30, 2008 decision accordingly. Those

objections, plaintiffs’ opposition to them, defendants’ reply, and plaintiffs’ sur-reply are now

before the Court.

               When a party files written objections to any part of the magistrate judge’s

recommendation with respect to a dispositive motion, the Court considers de novo those portions

of the recommendation to which objections have been made, and “may accept, reject, or modify

the recommended disposition.” FED. R. CIV. P. 72(b)(3).


                                        II. DISCUSSION

               As noted above, Count VIII of plaintiffs’ Second Amended Complaint sets forth a

claim of negligence per se based on certain provisions of the FDCA. See Second Amended

Complaint ¶¶ 60-68. Count VIII hinges on the idea that defendants acted negligently – i.e.,

violated a substantive standard of care – by obtaining and using devices that the FDCA defines as

“adulterated” or “misbranded.” Plaintiffs point to the following specific provisions of the FDCA

as the basis for their negligence per se claim in Count VIII:

               The following acts and the causing thereof are prohibited:

                       (a) The introduction or delivery for introduction into
                       interstate commerce of any food, drug, device, or cosmetic
                       that is adulterated or misbranded.

                       (b) The adulteration or misbranding of any food, drug,
                       device, or cosmetic in interstate commerce.

                       (c) The receipt in interstate commerce of any food, drug,
                       device, or cosmetic that is adulterated or misbranded, and
                       the delivery or proffered delivery thereof for pay or
                       otherwise.



                                                 4
                                                     ***

                       (g) The manufacture within any Territory of any food, drug,
                       device, or cosmetic that is adulterated or misbranded.

                                                     ***

                       (k) The alteration, mutilation, destruction, obliteration, or
                       removal of the whole or any part of the labeling of, or the
                       doing of any other act with respect to, a food, drug, device,
                       or cosmetic, if such act is done while such article is held for
                       sale (whether or not the first sale) after shipment in
                       interstate commerce and results in such article being
                       adulterated or misbranded.

21 U.S.C. § 331(a), (b), (c), (g) and (k). According to plaintiffs, defendants violated these

provisions, and thereby committed negligence per se, because they

               (a) introduced and or caused introduction of, Histoacryl and
               Lipiodol, both adulterated and misbranded devices, into interstate
               commerce,

               (b) adulterated both Histoacryl and Lipiodol by mixing and/or
               compounding the two devices together,

               (c) received a misbranded and adulterated device,

               (d) manufactured a “new” Class III adulterated and misbranded
               device when they mixed Histoacryl with Lipiodol,

               (e) ignored the warnings and/or destroyed the labeling on the Class
               III device Histoacryl.

Second Amended Complaint ¶ 65.

               Relying principally on Cabiroy v. Scipione, 767 A.2d 1078, 1080-81 (Pa. Sup. Ct.

2001), Magistrate Judge Kay concluded that the cited provisions of 21 U.S.C. § 331 could

support plaintiffs’ negligence per se claim in Count VIII because those provisions set forth a

discernible standard of care. See Report at 13. Having reviewed the papers considered by


                                                 5
Magistrate Judge Kay, Magistrate Judge Kay’s Report, both parties’ objections to Magistrate

Judge Kay’s Report, all of the filings by the parties relating to defendants’ objections, and the

relevant case law, the Court concludes that it must reject Magistrate Judge Kay’s conclusion with

respect to Count VIII. The provisions of Section 331 on which plaintiffs base Count VIII cannot

support a negligence per se claim for two reasons: (1) those provisions do not set forth a

substantive standard of care the violation of which amounts to the violation of a duty in tort, and

(2) plaintiffs cannot demonstrate a causal relationship between the unapproved status of

Histoacryl and Lipiodol and Ms. Kerris’ injuries.


                                       A. Negligence Per Se

               “As a general rule, the plaintiff in a negligence action bears the burden of proving

the applicable standard of care, a deviation from that standard by the defendant, and a causal

relationship between that deviation and the plaintiff’s injury.” McNeil Pharmaceutical v.

Hawkins, 686 A.2d 567, 577 (D.C. 1996) (citation and internal quotation marks omitted). The

doctrine of negligence per se represents a “slight variation[] on this general rule.” Id. at 578. In

some cases, that doctrine permits a plaintiff to “rely on a statute or regulation as proof of the

applicable standard of care.” Id. In the District of Columbia,

               [t]he “general [negligence per se] rule” . . . is that “where a
               particular statutory or regulatory standard is enacted to protect
               persons in the plaintiff’s position or to prevent the type of accident
               that occurred, and the plaintiff can establish his relationship to the
               statute, unexplained violation of that standard renders the
               defendant negligent as a matter of law.” Richardson v. Gregory,
               281 F.2d 626, 629 (D.C. Cir. 1960). . . . If a party charged with
               statutory or regulatory negligence produces competent evidence
               tending to explain or excuse his or her violation of the statutory or
               regulatory standard, the jury is properly instructed, upon proper


                                                  6
               request of the party, that the violation is evidence of negligence but
               not negligence as a matter of law.

Ceco Corp. v. Coleman, 441 A.2d 940, 945 (D.C. 1982) (some citations omitted); see also Joy v.

Bell Helicopter Textron, Inc., 999 F.2d 549, 557 (D.C. Cir. 1993) (same). In addition, the statute

or regulation in question must impose specific duties on the defendant. See id. at 558.

Ultimately, “[t]he decision to adopt from a statute a standard of care to be applied in determining

common law negligence is purely a judicial one, for the court to make.” McNeil Pharmaceutical

v. Hawkins, 686 A.2d at 579; see also Rong Yao Zhou v. Jennifer Mall Restaurant, Inc., 534

A.2d 1268, 1274 (D.C. 1987).


                               B. No Substantive Standard of Care

               Plaintiffs argue that Section 331 sets forth a substantive standard of care and

therefore supports Count VIII because Section 331 “obviously governs behavior.” Pls. Opp. at 7.

The question before the Court, however, is not whether Section 331 “governs behavior.” It

surely does – as does almost every statute and regulation. The question before the Court is

whether Section 331 embodies “a legislative judgment as to the standard of care” applicable to

this case, and thus whether the violation of the cited provisions of Section 331 amounts to the

violation of a duty giving rise to an action in tort. Talley v. Danek Medical, Inc., 179 F.3d 154,

161 (4th Cir. 1999). The Court concludes that the answer to that question is “no.”

               The principal problem with plaintiffs’ attempt to base claims of negligence per se

on Section 331 is that Section 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 [and use of Class III medical devices like Histoacryl and Lipiodol].”


                                                 7
Defs. Obj. at 7.3 That basic requirement does not embody a substantive standard of care, but

rather an administrative requirement aimed at furthering the FDCA’s regulatory goals. In other

words:

               The administrative requirement that a given device be approved by
               the FDA before being marketed – as opposed to a specific
               substantive requirement that a device be safe and effective – 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.

Talley v. Danek Medical, Inc., 179 F.3d at 161. See also King v. Danek Medical, Inc., 37 S.W.

3d 429, 456-60 (Tenn. Ct. App. 2000) (same); Morton v. George Washington Univ., No. 99-

4599, Order at 9 (D.C. Sup. Ct. Nov. 30, 2001) (rejecting negligence per se claims for use of

unapproved devices based on 21 U.S.C. § 331, 21 U.S.C. § 360c and 21 C.F.R. § 812.20;

characterizing those provisions as “administrative in nature” and concluding that they do not “set


         3
               The FDCA classifies devices as Class I, II or III devices.

               A Class III device is subject to the statutory requirement of pre-
               market approval. . . . A Class III device that is introduced, or
               delivered for introduction, into interstate commerce without such
               approval violates the statute because it is [“adulterated” under 21
               U.S.C. § 351 and “misbranded” under 21 U.S.C. § 352] . . . .

               The status of a device as unapproved and uncleared . . . does not
               necessarily mean that the device is unsafe, defective, or
               unreasonably dangerous. It means simply that the FDA has not yet
               concluded that the device should be approved or cleared. Many
               lawfully marketed medical products have “off-labeled uses”
               (unapproved and uncleared) that the medical community is
               satisfied are safe and effective and to which the FDA has no
               objection.

Baker v. Smith & Nephew Richards, Inc., No. 95-58737, 1999 WL 811334, at *6 (Tex. D. Ct.
1999).

                                                 8
forth a standard of conduct, the breach of which would constitute negligence per se”). Thus,

Count VIII must be dismissed because 21 U.S.C. § 331 reflects an administrative requirement –

not a substantive standard of care that can support plaintiffs’ negligence per se claim.


                                     C. No Causal Relationship

                Plaintiffs’ attempt to base negligence per se claims on alleged violations of 21

U.S.C. § 331 suffers from another flaw. An essential element of any negligence claim is proof

that the alleged breach of duty at issue proximately caused the harm at issue. Thus, to succeed on

negligence per se claims, “plaintiffs must prove that the statutory violation was the proximate

cause of their injuries.” Rong Yao Zhou v. Jennifer Mall Restaurant, Inc., 534 A.2d at 1277

(emphasis added). 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 Ms. Kerris’ injuries. This they

cannot do. As plaintiffs acknowledge, Histoacryl and Lipiodol were deemed “adulterated”

and/or “misbranded” not because of any affirmative determination of dangerousness or

impropriety, but merely because they lacked FDA approval. As a result, it is no more logical to

infer a causal connection between Histoacryl’s and Lipiodol’s unapproved status and Ms. Kerris’

injuries than it is to infer a causal connection between a driver’s lack of a drivers license and

injuries he causes while driving. See KEETON ET AL., PROSSER & KEETON ON TORTS § 36, at

223-24 (5th ed. 1984) (observing that “[w]hen a car is driven without a license, the act of driving

the car certainly causes a collision; the absence of the license, or the existence of the statute, of

course does not”). In short, plaintiffs have not shown and cannot show “that the breach of the



                                                   9
FDA approval requirement proximately caused” the injuries to Ms. Kerris. Talley v. Danek

Medical, Inc., 179 F.3d at 161; see also id. (“If the quality or proper labeling of the device, rather

than its formal approval, were at issue, then causation might [be] a question of fact. But that [is]

not the circumstances here.”). Accordingly, it is hereby

               ORDERED that the Court’s Memorandum Opinion of September 30, 2008 is

modified in the manner set forth in this Memorandum Opinion and its Order of Judgment of

September 30, 2008 is amended to provide that Count VIII of plaintiff’s Second Amended

Complaint is DISMISSED.

               SO ORDERED.
                                                       /s/
                                                       PAUL L. FRIEDMAN
DATE: February 3, 2009                                 United States District Judge




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