                              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’ Motion in Limine No. 1 to Exclude

References to Alleged FDCA Violations or FDA Approval Status (“Mot.”). As the defendants

point out, see Mot. at 1, the Court has already ruled that neither the federal statutes nor the

regulations cited by the plaintiffs establish a standard of care applicable in this case. See

Iacangelo v. Georgetown Univ., 595 F. Supp. 2d 87, 91 (D.D.C. 2009); 580 F. Supp. 2d 111,

113, 117-19 (D.D.C. 2008). For substantially the same reasons provided by the defendants in the

motion, see Mot. at 2-3, those rulings necessarily mean that the statutes and regulations in

question are not relevant to Count I of plaintiffs’ second amended complaint, which alleges

negligence/medical malpractice. As a result, the plaintiffs may not refer to or in any way rely

upon the Food, Drug, and Cosmetic Act (“FDCA”) or any related regulation — or any alleged

violation thereof — in an attempt to demonstrate that the defendants are liable as to Count I.

This means that the plaintiffs may not argue or present evidence to the effect that defendants

were negligent because (1) they did not obtain premarket approval or an investigational device
exemption (“IDE”) for their use of Histoacryl, or (2) Histoacryl was “misbranded” or

“adulterated.”

                 The relationship of the laws in question to plaintiffs’ lack of informed consent

claim, described in in Count II of their second amended complaint, is more complicated. It is

undisputed that the substances used to treat Karyn Kerris were at the time not approved by the

FDA for commercial marketing. See Mot. at 5-6. The defendants point out that some courts

have ruled that a drug or device’s lack of FDA approval is not material information that must be

revealed to a patient during the informed consent process, and so is not relevant to a claim based

on lack of informed consent. See id. at 6. While a handful of state courts have so held, however,

neither the United States Court of Appeals for the District of Columbia Circuit nor the District of

Columbia Court of Appeals has addressed the matter. A jury may well conclude that a device’s

lack of FDA approval would be material information that a reasonable person would want to

know before giving or declining to give consent for use of such a device in a medical procedure.

The plaintiffs therefore may inform the jury that the device or devices used to treat Ms. Kerris

were not FDA-approved and were not available for commercial sale in the United States. They

may not, however, refer to those devices as “illegal,” “misbranded,” or “adulterated,” as none of

those terms relate to FDA-approval status, and each is inflammatory and likely to unfairly

prejudice the defendants before the jury.




                                                  2
             For the foregoing reasons, it is hereby

             ORDERED that Defendants’ Motion in Limine No. 1 to Exclude References to

Alleged FDCA Violations or FDA Approval Status is GRANTED in part and DENIED in part.

             SO ORDERED.


                                           /s/_______________________________
                                           PAUL L. FRIEDMAN
                                           United States District Judge
DATE: December 31, 2010




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