Children's Hospital Corp. v. George Washington University

750 F. Supp. 2d 239, 2010 U.S. Dist. LEXIS 97221, 2010 WL 3703226
CourtDistrict Court, D. Massachusetts
DecidedSeptember 16, 2010
DocketCivil Action 07-11985-DPW
StatusPublished
Cited by4 cases

This text of 750 F. Supp. 2d 239 (Children's Hospital Corp. v. George Washington University) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Children's Hospital Corp. v. George Washington University, 750 F. Supp. 2d 239, 2010 U.S. Dist. LEXIS 97221, 2010 WL 3703226 (D. Mass. 2010).

Opinion

MEMORANDUM AND ORDER

DOUGLAS P. WOODLOCK, District Judge.

This diversity suit involves a dispute over the performance of a multi-year study supervised by Children’s Hospital Corporation (“Children’s”). The National Institutes of Health (“NIH”) provided Children’s with a grant to research the molecular antecedents of brain damage in extremely premature newborns. Children’s subcontracted parts of the study to cooperating institutions, including the George Washington University (“GW”), whose task was to analyze blood samples gathered from newborns. Children’s makes several claims related to breach of contract and allegations of misrepresentation while GW submits parallel counterclaims. The matter is before me on cross-motions for partial summary judgment.

I. BACKGROUND

A. The Proposed Study

In October 2000, Children’s filed a grant application for a study of the causes of brain damage in extremely low gestational age newborns (“ELGANs”), who have a higher risk of such damage and developmental disorders than other infants (the “Study”). The Study was to investigate what factors, or antecedents, were related to the brain damage observed in ELGANs. One hypothesis to be tested was that these antecedents include certain proteins such as cytokines and growth factors — often referred to as “biomarkers” or “analytes.”

The research design required the collection, through parental consent, of one to two drops of blood from ELGANs born at participating hospitals. The blood would be collected on filter paper, then frozen for later analysis. The challenge for the Study was how to adequately analyze the blood samples given that they consisted only of one or two drops. The Study therefore proposed use of a technology called recycling immunoaffinity chromatography (“RIAC”). The more general process of immunoaffinity chromatography *243 takes a liquid sample and runs it through a column filled with small beads, each of which is coated with an antibody specific to the biomarker under investigation. When the liquid passes through the column, the biomarker in the blood sample adheres to its corresponding antibody on the beads. A solvent then passes through the column to release both the biomarker and the antibody from the beads. After the bio-marker is collected, a detection system measures the sample and calculates the quantity of the biomarker present in the sample. The process requires the disposal of any liquid left over from the sample after passing through the column.

By contrast, the RIAC method permits recycling the liquid sample that remains after passing through the column. The excess liquid can run through additional columns, each with beads coated with antibodies that correspond to other biomarkers. This allows a small blood sample to be tested for a large number of biomarkers. The process could also be automated, which would accelerate the analysis. Children’s wanted to use the RIAC method to test ELGAN blood samples for particular biomarkers, thereby gaining more information from the limited size of the samples.

The principal investigator on the Study was Dr. Alan Levitón, a researcher at Children’s. Dr. Levitón submitted a grant proposal to the NIH on behalf of Children’s in order to obtain funding for the ELGAN Study. The grant, which the NIH ultimately approved, was a “consortium agreement,” under which the grant recipient (here, Children’s) would enter into separate agreements with various “cooperating institutions” (here, GW) to undertake discrete elements of the Study. In relevant part, the ELGAN grant application contemplated that Children’s would subcontract with GW to “provide ultra-micro analytical services for the measurement of analytes of interest in blood spots .... by recycling immunoaffinity chromatography.”

B. Children’s Agreement with GW

GW, as part of the consortium, contracted with Children’s to perform the analysis of biomarkers in the collected blood samples. The parties identify several documents that, taken together, form the contract at issue in this matter. The contract consists of the “General Terms and Conditions,” the “Purchase Order” and subsequent modifications, the NIH Grants Policy Statement, and Children’s original NIH Grant Application. The Purchase Order and subsequent modifications, signed by Children’s and GW, specify the budget for GW’s portion of the Study for a given period of time. The Purchase Order incorporates by reference the General Terms and Conditions and the NIH Grants Policy Statement. The General Terms and Conditions is a form document used by Children’s for grant subcontractors to define terms and establish basic provisions such as equipment purchase and employee status. The NIH Grants Policy Statement outlines the relationship between the NIH and the recipient and between the NIH and cooperating institutions, or subawardees, like GW. The NIH Grant Application describes the scope of GW’s proposed participation in the Study.

GW’s particular obligations under the Study are subject to dispute, as will be discussed in greater detail in Part III.A.1. Generally, however, the “Budget Justification” section of the NIH Grant Application describes the expected scope of the investigation: “The current proposal requires chromatographic separation of up to 100 biomarkers per sample on 10,000 samples (1 million individual analytes).” (emphasis added). Dr. Benjamin Dickens, the Pro *244 ject Director for GW’s portion of the Study, was to use the RIAC method, requiring at least three years to complete the analysis: “Since the instruments can not be running 24 hours a day ... this project will require 100% effort on all three machines for a minimum of full three years (1068 days).” This would require the use of three RIAC machines, Dr. Dickens’s services, as well as the assistance of two technicians.

C. GW’s Performance

The execution of the Study began in September 2001. GW maintains that, as of January 2005, Children’s had not authorized GW to analyze any ELGAN blood spots. At that time, Dr. Dickens informed Children’s that completion of the blood-spot analysis would require another 2.7 years. Dr. Levitón viewed this time period as “impractical” given that Boston Medical Center intended to apply for another NIH grant to fund a follow-on study (“EL-GAN 2”). The NIH ultimately did not award the grant for ELGAN 2.

In November 2005, Dr. Thomas McElrath of Children’s contacted Dr. Raina Fichorova at Brigham and Women’s Hospital about using a non-RIAC technology, Meso Scale Discovery (“MSD”), to detect cytokines in blood spots. In April 2006, Dr. Levitón asked Dr. Fichorova for information about what the MSD platform would be capable of doing with respect to a “wish list” of proteins.

For reasons that are disputed by the parties, Dr. Dickens had only completed analysis of sixty analytes in 954 samples by April 2006. The parties also dispute whether Dr. Dickens demonstrated acceptable inter-assay variability, i.e., that if the same experiment was performed twice, the same result would occur, within an acceptable margin of error.

As Children’s grew concerned about Dr. Dickens’s execution of the Study, it arranged for an audit of the laboratory on May 31, 2006. The auditor, Dr.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Pittner v. Selene Finance, LP
D. Massachusetts, 2021
Selfridge v. Jama
172 F. Supp. 3d 397 (D. Massachusetts, 2016)
Hayes v. CRGE Foxborough, LLC
167 F. Supp. 3d 229 (D. Massachusetts, 2016)

Cite This Page — Counsel Stack

Bluebook (online)
750 F. Supp. 2d 239, 2010 U.S. Dist. LEXIS 97221, 2010 WL 3703226, Counsel Stack Legal Research, https://law.counselstack.com/opinion/childrens-hospital-corp-v-george-washington-university-mad-2010.