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Iacangelo v. Georgetown University

February 3, 2009

FELICE I. IACANGELO, ET AL., PLAINTIFFS,
v.
GEORGETOWN UNIVERSITY, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Paul L. Friedman United States District Judge

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").*fn1

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 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) and deny without prejudice defendants' motion to strike.

On September 27, 2008, plaintiffs filed objections to the Report.*fn2 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' 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 ΒΆΒΆ 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 ...


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