Iacangelo v. Georgetown University

CourtDistrict Court, District of Columbia
DecidedMay 7, 2010
DocketCivil Action No. 2005-2086
StatusPublished

This text of Iacangelo v. Georgetown University (Iacangelo v. Georgetown University) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Iacangelo v. Georgetown University, (D.D.C. 2010).

Opinion

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. ) ____________________________________)

OPINION

This matter came before the Court on plaintiffs’ motion to disqualify Williams &

Connolly, LLP (“W&C”) as counsel for the defendants on the ground that Williams &

Connolly’s representation of both defendant Georgetown University Hospital and defendant

Dr. Vance E. Watson in this case is tainted by a conflict of interest. Both the case and the issue

itself are complicated and involve many filings, depositions and assertions of fact supported by

competing affidavits and declarations, all of which the Court has carefully considered.1 Because

1 The documents reviewed by the Court in reaching its decision include the following: plaintiffs’ Second Amended Complaint [Docket No. 101] (“Compl.”); plaintiffs’ Motion to Disqualify Defendants’ Counsel (“Mot.”); defendants’ Opposition to Plaintiffs’ Motion to Disqualify Defendants’ Counsel (“Opp.”); Opp., Ex. C (Transcript of December 14, 2007 Deposition of Dr. Vance Wilson) (“Dec. 14, 2007 Watson Dep.”); Opp., Ex. D (Transcript of May 31, 2007 Deposition of Dr. Watson) (“May 31, 2007 Watson Dep.”); Opp., Ex. E (Transcript of July 26, 2007 Deposition of Sheila Zimmet) (“July 23, 2007 Zimmet Dep.”); Transcript of June 26, 2007 Status Conference (“June 27, 2007 Tr.”); defendants’ Response to Alleged Conflict of Interest Issues [Docket No. 173] (“Defs.’ Resp.”); Affidavit of Defendant Vance E. Watson, M.D. [Docket No. 177] (“Watson Affid.”); Iacangelo v. Georgetown Univ., Civil Action No. 05-2086, Memorandum Opinion and Order (D.D.C. June 27, 2007) (“June 27, 2007 Mem. Op. & Order”); id., Memorandum Opinion and Order (D.D.C. July 16, 2009) (“July 16, 2009 Mem. Op. & Order”). the Court concluded that most of plaintiffs’ claims and contentions lack merit, it issued an Order

on March 26, 2010, denying the motion to disqualify. This Opinion explains the reasons

underlying that Order, and also discusses the one area where W&C may have a waivable conflict

of interest that has not yet been waived by Dr. Watson and the process by which that waiver may

be accomplished.

I. BACKGROUND

A. The Medical Treatment at Issue

This is a medical malpractice case concerning the care provided to Karyn A.

Kerris, the daughter of plaintiffs Felice Iacangelo and Cicily Iacangelo, by defendant Dr. Vance

Watson and Georgetown University Hospital (“Georgetown”). Ms. Kerris suffers from a

bithalmic arteriovenous malformation (“AVM”), an abnormal tangle of veins and arteries in her

brain through which blood does not flow properly. See Compl. ¶ 8. In 1998 and 1999, Dr.

Watson attempted to treat this condition by utilizing a process known as “embolization,” which

involves using a glue-like substance to seal abnormal blood vessels off from healthy ones. See

id. ¶¶ 8-9. As part of the embolization process, Dr. Watson combined two substances that would

be applied to the AVM: Histoacryl, a glue, and Lipiodol, a poppyseed-oil mixture containing

material that is visible in X-rays. Id. ¶ 9. Dr. Watson’s treatment was not successful, and Ms.

Kerris subsequently experienced damage to her brain that has incapacitated her. Id. ¶¶ 11-12.

Plaintiffs claim that at the time of the embolizations, Dr. Watson’s combination of

Histoacryl and Lipiodol was a “Class III[] medical device that had not been approved [by the

FDA] and was thus illegal.” Compl. ¶ 10(c). They further allege that Dr. Watson should have

2 obtained an investigational device exemption (“IDE”) from the FDA and submitted to

supervision by an institutional review board (“IRB”) before combining and using the two

substances in Ms. Kerris’ brain. Id. ¶¶ 10(d), (j). In addition, at the time of the embolizations,

Histoacryl was allegedly “the subject of a trade alert and had been seized by the FDA prior to its

use on” Ms. Kerris. Id. ¶ 10(k).

The defendants claim that they followed proper procedures in obtaining and using

Histoacryl. There is deposition testimony that in 1994, several years before treating Ms. Kerris,

Dr. Watson consulted Sheila Zimmet, a lawyer employed by Georgetown, about the use of

Histoacryl. Defs.’ Resp. at 6. The exact content of that discussion between Dr. Watson and Ms.

Zimmet is unclear, but it is reasonably certain that (1) Ms. Zimmet informed Dr. Watson that he

did not require the approval or the supervision of the IRB in order to perform the embolizations

on Ms. Kerris, id.; and (2) Dr. Watson properly inferred from Ms. Zimmet’s comments and

demeanor that his use of Histoacryl was permissible, even though Histoacryl was not yet

FDA-approved. See Defs.’ Resp. at 7; Dec. 14, 2007 Watson Dep. at 350.

Dr. Watson consulted Ms. Zimmet again in 1998 to learn “how best to achieve

prompt importation of Histoacryl.” Defs.’ Resp. at 7. Dr. Watson had already spoken with a

U.S. Customs agent about the issue and had “been provided with language to be used” in a letter

to be presented to the FDA, known as a “letter of need.” Id. Ms. Zimmet recommended that Dr.

Watson send the letter to the FDA by fax so that it would arrive at the agency before the

Histoacryl shipment went through Customs. Id. Dr. Watson successfully obtained the Histoacryl

and used it in treating Ms. Kerris, giving rise to the current lawsuit.

3 B. Plaintiffs’ Claims

Plaintiffs’ most recent amended complaint included, among its other claims, three

counts of negligence per se by Dr. Watson and Georgetown. Plaintiffs claimed that Dr. Watson

had violated 21 U.S.C. § 360c(a)(II) and 21 C.F.R. § 812.20(a)(2) by obtaining and using

unapproved “artificial embolization devices” without obtaining an IDE from the FDA. Compl.

¶¶ 45-59; 69-72. According to plaintiffs, Dr. Watson also breached 21 U.S.C. §§ 331(a)-(c), (g)

and (k) by receiving and combining Histoacryl and Lipiodol, two allegedly “adulterated and

misbranded devices.” Id. ¶¶ 60-68. Plaintiffs argued that by allegedly violating these laws, Dr.

Watson had necessarily breached his duty to Ms. Kerris, causing her injuries. The Court

disagreed with that argument and dismissed plaintiffs’ negligence per se claims in Orders issued

on September 30, 2008 and February 4, 2009. Iacangelo v. Georgetown Univ., Civil Action

No. 05-2086, Order and Judgment (D.D.C. Sept. 30, 2008) [Docket No. 125]; id., Memorandum

Opinion and Order (D.D.C. Feb. 4, 2009) [Docket No. 145]. There remain five still-viable

claims for relief in plaintiffs’ amended complaint: negligence, lack of informed consent, breach

of warranty, fraud, and breach of fiduciary obligations. Compl. Counts I-V. Currently pending

before the Court is a motion by defendants for partial summary judgment on the plaintiffs’

informed consent, breach of warranty, and fraud claims. See Defendants’ Motion for Summary

Judgment on Counts II-IV of the Second Amended Complaint [Docket No. 143].

4 C. The Conflict-of-Interest Issue

The possibility that Williams & Connolly might have a conflict of interest in this

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