The opinion of the court was delivered by: WILLIAM J. HIBBLER, District Judge
MEMORANDUM OPINION AND ORDER
On November 13, 2002, relator, Sanford Gross, filed a qui
tam action against Defendants, AIDS Research Alliance-Chicago,
Roberta Luskin-Hawk, Thomas Klein, Ross Slotten, Neel French, Patricia
Dixon, and Catholic Health Partners (collectively, "Defendants"),
alleging that they violated the False Claims Act ("FCA"),
31 U.S.C. § 3729, et seq. Defendants moved to dismiss the complaint, and
Gross subsequently withdrew it. On April 15, 2003, Gross filed an amended
complaint, which Defendants again moved to dismiss. Upon Defendants'
motion, this Court dismissed Gross's amended complaint without prejudice for failing
to meet the pleading requirements of Federal Rule of Civil Procedure
("FRCP") 9(b). See United States ex rel Gross v. AIDS Research
Alliance-Chicago, et al, No. 01 C 8182, 2003 WL 22508153 (N.D. Ill.
Nov. 3, 2003) (hereinafter Gross 7). After obtaining leave from
the Court, Gross filed a second amended complaint on November 24, 2003.
Currently pending before this Court is Defendants' Motion to Dismiss
Gross's Second Amended Complaint pursuant to Federal Rule of Civil
Procedure 9(b), 12(b)(1), and 12(b)(6). For the reasons explained below,
Defendants' motion is GRANTED.
Beginning in December 1998, Gross participated as a patient in a
year-long study jointly sponsored by the Food and Drug Administration
("FDA") and the National Institutes of Health ("NIH") to investigate the
effectiveness of a combination of drugs on HIV patients ("the Study").
NIH awarded Defendant AIDS Research Alliance-Chicago ("AIDS Research
Alliance") approximately $3,700,000 to conduct the Study. The remaining
Defendants worked with AIDS Research Alliance in the administration and
oversight of the Study. Defendants were required to adhere to a number of
federal regulations, namely 21 C.F.R. § 50, 56, and 312, and
45 C.F.R. § 46 and 74, which are aimed at protecting the rights and
safety of human subjects involved in clinical investigations and
research. Gross alleges that Defendants did not comply with these
regulations because they failed to monitor the administration of the
Study, maintain adequate records, and refrain from scientific misconduct.
In addition, Gross alleges that Defendants' failures were reckless and/or
Defendant AIDS Research Alliance is a private, not-for-profit
501(c)(3) organization. AIDS Research Alliance was the site of the Study
and admits, for the purposes of this motion, that it was responsible for submitting to the government certain written
reports as part of its compliance with the research grant, such as
Financial Service Requests and PHS Form 398.*fn1 Gross alleges that AIDS
Research Alliance, in violation of Study regulations, failed to record or
report the adverse effects Gross experienced as a participant in the
Study from April 1999 to December 1999. Furthermore, Gross claims that
AIDS Research Alliance mismanaged the Study by allowing Gross's insurance
carrier to be billed for Study-related expenses, losing files of Study
participants and records of the Study, and instructing Gross to vary the
daily dose amount of the Study drug while never requesting Gross's daily
dose records of the drug.
Defendant Catholic Health Partners ("CHP") is a health network of
hospitals, research institutes, and satellite medical offices. CHP acted
as the Institutional Review Board for the Study and was responsible for
preparing and submitting initial and continuing review records and
consent forms to the government to certify of its compliance with the
Study's regulations. Gross cites misconduct on the part of CHP and the
other Defendants for allowing his viral load to increase unchecked during
the Study and failing to inform him of the increase.
Defendant Roberta Luskin-Hawk was a Principal Investigator of the Study
and a member of the administrative staff of AIDS Research Alliance and
the faculty of CHP. As Principal Investigator, Luskin-Hawk was
responsible for submitting to the government a DAIDS Investigator of
Record Agreement, PHS Form 398, PHS Form 2590, and FDA Form 1572.*fn2
However, Gross alleges that Luskin-Hawk falsely certified compliance with
the Study's regulations when she omitted the adverse effects of the Study in her submissions to the
government. Gross also claims that Luskin-Hawk mismanaged the Study by
allowing Gross's insurance carrier to be billed for Study-related
expenses and losing control of Study records.
Defendants Thomas Klein, Ross Slotten, and Neel French were the
participating physicians in the Study and responsible for submitting to
the government a DAIDS Investigator of Record Agreement, FDA Form 1572,
CPCRA Form 704, and Study records.*fn3 Gross alleges that these
Defendants, like Luskin-Hawk, falsely certified compliance with the
Study's regulations because they failed to include the adverse effects of
the Study in their reports to the government. Gross claims that these
Defendants also mismanaged the Study by losing files of Study
participants, failing to keep track of Gross while he was a Study
participant, and conducting incomplete examinations of Study
Defendant Patricia Dixon was the Research Clinician and Nurse
Coordinator for the Study and responsible for submitting to the
government CPCRA Form 704 and Study records.*fn4 Gross alleges that
Dixon falsely certified compliance with the Study's regulations when she
failed to record or report the adverse effects of the Study experienced
by Gross. He alleges that Dixon also mismanaged the Study by allowing
Gross's insurance carrier to be billed for Study-related expenses, losing
files of Study participants, conducting incomplete examinations of Study
participants, and instructing Gross to vary the daily dose amount of the
According to Gross, despite the aforementioned violations, Defendants
certified their compliance with the applicable federal regulations.
Therefore, Gross contends that Defendants' failure to comply with the regulations in addition to their false
certification of compliance amount to a false claim under the FCA.
II. PROCEDURAL BACKGROUND
A. The Court's Rulings In Gross I
Earlier in this litigation, this Court considered Defendants' Motion to
Dismiss Gross's (first) Amended Complaint. The Court determined that
Defendants were entitled to dismissal because Gross's complaint failed to
meet the requisite level of specificity required under FRCP 9(b) to state
a claim under the False Claims Act ("FCA"). Gross I, 2003 WL
22508153, at *2. The Court stated: "[i]n order to meet the requirements
of FRCP 9(b), a plaintiff must plead the `who, what, when and where of
the fraud." Id. (quoting United States ex rel. Garst v.
Lockheed-Martin Corp., 328 F.3d 374, 376 (7th Cir. 2003)).
Accordingly, Gross was required to "plead `the identity of the person
making the representation, the time, place and content of the
misrepresentation and the method by which the misrepresentation was
communicated.'" Gross I, 2003 WL 22508153, at* 1 (quoting
Uni-Quality, Inc. v. Infotronx, Inc., 974 F.2d 918, 923 (7th
Upon review of his complaint, the Court found that Gross failed to meet
these requirements in the following ways. First, in his Amended
Complaint, Gross made the conclusory allegation that Defendants knowingly
failed to submit required forms to the government in order to maintain
their funding. The Court found these allegations deficient under the
heightened pleading standards of FRCP 9(b) because Gross did not allege
any specific facts concerning the dates Defendants submitted these forms.
See Gross, 2003 WL 22508153, at *2. In addition, Gross
insufficiently alleged that Defendants, in their administration of the
Study, failed to comply with the governing regulations because Gross did
not precisely detail what the failures were, who committed them, and on what date. Id. at *3. Gross also failed to plead
sufficient facts to demonstrate that Defendants had a motive to deceive
the government when they certified compliance with the Study's
regulations. Id. The Court found Gross's conclusory allegation
that Defendants knowingly certified compliance insufficient to meet the
pleading requirements of FRCP 9(b). On these grounds, the Court dismissed
Gross's FCA claims against the individual Defendants. In addition, the
Court dismissed Gross's claim that Defendants conspired to submit a false
claim, because he failed to plead even the contours of the alleged
conspiracy. Therefore, the Court granted Defendants' Motion to Dismiss
Gross's (first) Amended Complaint.
The Court dismissed Gross's Amended Complaint without prejudice, and
Gross subsequently obtained leave from the Court to file a second amended
complaint against Defendants. In his Second Amended Complaint, Gross
attempts to address the deficiencies ...