United States v. Catholic Healthcare West

445 F.3d 1147, 2006 WL 1008963
CourtCourt of Appeals for the Ninth Circuit
DecidedApril 18, 2006
Docket03-16937
StatusPublished
Cited by1 cases

This text of 445 F.3d 1147 (United States v. Catholic Healthcare West) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Catholic Healthcare West, 445 F.3d 1147, 2006 WL 1008963 (9th Cir. 2006).

Opinion

B. FLETCHER, Circuit Judge:

Dr. Patricia Haight and the organization In Defense of Animals (collectively “Relators”) appeal the dismissal of their complaint for lack of subject matter jurisdiction under the False Claims Act’s “public disclosure” jurisdictional bar, 31 U.S.C. § 3730(e)(4). We reverse.

I.

Relators brought this qui tam action under the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-33, against Catholic Healthcare West and Dr. Michael Berens (collectively “Defendants”). The Relators allege that Berens submitted a fraudulent grant application to the National Institutes of Health (“NIH”). Based on this application, he was awarded over $700,000 in grant money.

Defendant Berens is a research scientist at Barrow Neurological Institute, a division of Catholic Healthcare West. Berens is the primary researcher on a project that uses beagle dogs to research glioma, a form of malignant brain tumor. The study is designed to develop a large animal model for studying glioma and then extrapolate any knowledge gained to treat glioma in humans. Berens attempted to develop the model by injecting glioma tumor cells into the flanks of gestating beagle puppies. This procedure had to be done during gestation to prevent the immune systems of the puppies from rejecting the gliomal cells and was designed to cause tumors to develop after the puppies were born, which could then be transplanted into their brains. Initially, Berens’ research was privately funded. Later he sought public funding. Berens’ first grant application to the NIH was rejected, but his second application was approved, resulting in an award of over $700,000 in grant money.

*1149 Relator Haight is an experimental psychologist and the Southwest Regional Director of In Defense of Animals. Haight performed extensive research on Berens’ study and uncovered the fraud alleged in the complaint. Haight began investigating Berens’ research at the request of a student and community members who were protesting animal research conducted at Barrow and Arizona State University (“ASU”). She first identified the funding source for Berens’ study — the National Institute of Neurological Disorders and Strokes, an institute within the larger NIH — and requested documents relating to the study pursuant to the Freedom of Information Act (“FOIA”). She was subsequently informed that she could obtain the documents from her FOIA request directly from Barrow, where Berens’ study was being performed, so she walked down personally to obtain them. The documents she obtained because of her FOIA request included the 1997 grant application and continuation forms, and a paper and paper abstract by Berens.

Haight then requested documents from ASU, where the project had formerly been housed, including animal care records and minutes from the Institutional Animal Care and Use Committee (“IACUC”) meetings, where animal research projects are vetted. In response to this request, Haight received protocols submitted to ASU by Berens starting in 1990, animal care records, IACUC minutes, and correspondence between Berens. and IACUC concerning Berens’ withdrawal of the project from ASU in 1997.

Becoming concerned about the efficacy of the project, Haight arranged to tour the ASU facility where the dogs had been housed and the Veterans Administration hospital to which the dogs were transferred when Berens’ project ceased to have the support of ASU. She also interviewed numerous individuals who provided information about Berens’ research, including Edward Castaneda, Chairman of the IACUC at ASU; Ted Brandon, Director of ASU’s Animal Care Program; Neal DeNardo, ASU Veterinarian; Ronald Barr, Assistant Vice Provost for Research at ASU and IACUC member; Tol Chesko, IACUC member; Joan McGregor, ASU faculty member; and graduate student Clare Rhodes. In conjunction with her tour of the VA facility, Haight interviewed Jedd Nelson, Director of Animal Care. Haight contacted Geoffrey Pilkington, Professor of Experimental Neuro-oncology at King’s College of London, who was listed as a consultant to Berens’ project on the NIH application. Haight also met with Joan Rankin Shapiro, Vice President for Research at Barrow Neurological Institute.

In the course of these discussions and tours, Haight learned what she believes to be the truth about Berens’ research. First, she learned from DeNardo and Brandon that Berens’ research has produced little, if any, scientific results. Many of the pups died, were aborted, or were born with congenital defects, and those that were born healthy did not develop the expected subcutaneous tumors. This assessment of the project was supported by Shapiro, who told Haight that throughout the ten years that the project had been ongoing, only three pups had developed tumors, and one of those tumors was so small that it could not be seen until after the pup was killed. Second, she learned that Berens’ competency to perform the complicated surgery on the prenatal pups was questionable and that the researchers could not identify gross anatomical landmarks when attempting to inject the pups’ flanks with gliomal cells. Shapiro stated that because the uterus of the beagle is murky, it became necessary to “inject everything we think we can see” when attempting to implant the cells in the *1150 pups’ flanks. Third, she learned that while Berens had officially withdrawn his project from ASU, he had done so under pressure from the university’s IACUC to terminate the project because of its failure to' produce meaningful results after ten years of attempts. Fourth, she learned that none of the dogs temporarily housed at the VA Hospital after the project was terminated at ASU had developed subcutaneous tumors. Fifth, she discovered from Dr. Pilkington that he was surprised to have been listed as a consultant for the project and that he had not, as stated in the grant application, agreed to provide any dogs for the project.

The Relators challenge an array of allegedly fraudulent or misleading statements. The Relators’ allegations are as follows:

1. Relators challenge the indications of success stated in the grant application, specifically that:
a. “successful allotolerant pups had been achieved in four separate litters”;
b. “4 out of 5 pups in one litter developed tumors”;
c. “one in four litters yielded at least one pup with a subcutaneous tumor”;
d. “there were subcutaneous tumors in up to 80% of the pups.”
2. Relators challenge the assertions in the grant application that the researchers have “achieved the technical and surgical skills necessary for realizing the desired outcome,” that they can identify gross anatomical landmarks, and that the cells were embedded in the desired locations.
3. Relators challenge the projections in the grant application as to the number of tumors the researchers would create.
4.

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Related

United States v. Catholic Healthcare West
445 F.3d 1147 (Ninth Circuit, 2006)

Cite This Page — Counsel Stack

Bluebook (online)
445 F.3d 1147, 2006 WL 1008963, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-catholic-healthcare-west-ca9-2006.