The opinion of the court was delivered by: McLaughlin, J.
The plaintiffs in these medical malpractice cases are the parents of infants who died at some point after undergoing open-heart surgery at the A.I. duPont Hospital for Children ("the duPont Hospital"). The defendants that remain are the Nemours Foundation, which operated the Nemours Cardiac Center at the duPont Hospital, and William I. Norwood, M.D. ("Dr. Norwood"), who performed the surgeries.*fn1 The plaintiffs allege, among other things, that the technique used by Dr. Norwood to cool the children prior to their surgeries violated the standard of care and thus constitutes malpractice.
This memorandum concerns three pretrial evidentiary motions filed by the parties. First, the defendants have moved, in the Svindland case, to preclude the plaintiffs from introducing evidence related to the morbidity and mortality rates of Dr. Norwood's patients, of other patients treated at the duPont Hospital, or of any other patients that are not Ian Svindland. Second, the defendants have moved for a protective order related to subpoenas that the plaintiffs directed to the Children's Hospital of Philadelphia ("CHOP") and Dr. James Goin, a statistician at CHOP, to obtain certain raw data underlying publications of studies done at CHOP (the "CHOP data"). Third, the plaintiffs have moved to compel CHOP and Dr. Goin to produce the CHOP data.*fn2 For the reasons herein stated, the defendants' motions are granted and the plaintiffs' motion is denied.
I. Background and Procedural Posture
Ian Svindland was born with a congenital heart defect known as a ventricular septal defect ("VSD"). A VSD is a hole in the wall separating the two pumping chambers of the heart. Dr. Norwood operated on Ian on June 25, 2003. After six hours of surgery, Ian's heart began to fail, and after eighteen hours, he was placed on a heart-lung bypass machine for support. Ian's heart continued to fail, and eventually, other organs did as well. Ian died on July 14, 2003.
Michael Daddio was also born with congenital heart defects, including "hypoplastic left heart syndrome." On June 7, 2001, Dr. Norwood performed the first of three scheduled surgeries to correct Michael's heart defects. The second was performed on November 9, 2001. At some point after the second surgery, Michael developed persistent pleural effusions, which are liquid buildups surrounding the lungs. Michael died on July 23, 2003.
During the surgeries on both infants, Dr. Norwood utilized a technique known as "deep hypothermic circulatory arrest" ("DHCA"), in which the body is cooled to a certain temperature, blood is removed and stored, and the surgeon operates in a bloodless field on a heart that does not beat. Cooling serves the purpose of reducing the amount of oxygen required by the body's organs in the absence of blood flow.
These cases were initially assigned to the Honorable Berle M. Schiller of the Eastern District of Pennsylvania. Upon agreement of the parties, these two cases were consolidated with other cases filed against the defendants for the purposes of discovery. Pursuant to a stipulation filed by the parties, Judge Schiller would sit as the "discovery judge," and the parties would agree which, if any, disputes would be heard before Judge Schiller as the discovery judge, and which would be heard by Judge Schiller as the trial judge for the Svindland and Daddio cases. See Svindland Docket No. 20; Daddio Docket No. 21.
The Svindland case proceeded to trial in May 2007. Prior to trial, the parties filed several evidentiary motions relating to the exclusion of certain data and expert testimony. The plaintiffs also sought to enforce subpoenas for the CHOP data. The Court precluded the plaintiffs from presenting evidence at trial related to the mortality of Dr. Norwood's patients or other patients of the duPont Hospital. It also quashed the subpoenas related to the CHOP data.
At trial, the Svindlands concentrated on two issues. They claimed that Dr. Norwood only cooled Ian for six minutes, which was not long enough to protect Ian's organs, and ultimately caused his death. They also claimed that the information given to them in order to constitute informed consent did not acquaint them with the mortality risks for Ian's operation.
The jury ruled for the defendants. It found that Dr. Norwood was negligent. However, the jury also found that the Svindlands' proof was not adequate to establish that Dr. Norwood's cooling technique proximately caused Ian's death. The jury also found no lack of informed consent.
The plaintiffs appealed the jury verdict to the United States Court of Appeals for the Third Circuit, challenging several of the Court's rulings, including orders quashing the subpoenas for the CHOP data and precluding the plaintiffs from introducing mortality evidence. The Court of Appeals vacated the jury verdict, in part, because it could not determine on the record before it the rationale for some of the Court's evidentiary rulings. See Svindland v. The Nemours Foundation, 287 F. App'x 193, 195 (3d Cir. 2008). The Court of Appeals did not reach the merits of the legal issues that were presented on appeal, and instead remanded the case for decision on these evidentiary issues and for a new trial.*fn3
The Daddio case has not yet proceeded to trial. Although the case was set to be tried in July 2007, it did not proceed as scheduled. After the Court of Appeals vacated the jury verdict in Svindland, both cases were reassigned to the undersigned judge.
The Court held an on-the-record status conference with the parties on September 16, 2008, to isolate the issues for decision in light of the Svindland appeal and to discuss schedules for the retrial of the Svindland case and for the trial of the Daddio case. See Svindland Docket No. 145; Daddio Docket No. 127. After that conference, the Court issued scheduling orders setting trial dates in both cases, as well as schedules for the filing of pretrial motions. See Svindland Docket No. 149; Daddio Docket No. 131.
Shortly after the conference, the parties filed various evidentiary motions. These include: (1) the defendants' motion to preclude the plaintiffs from introducing comparative morbidity or mortality data at trial ("Defs.' Mot. to Preclude," Svindland Docket No. 148); (2) the defendants' motion for a protective order relating to the subpoenas of the CHOP data ("Defs.' Mot. for P.O.," Svindland Docket No. 147; Daddio Docket No. 130); and (3) the plaintiffs' motion to compel the production of the CHOP data (Svindland Docket No. 150).
The parties' motions concern two sets of data. The first set of data includes evidence of morbidity and mortality rates for the patients of Dr. Norwood, the surgeon in this case, and for other patients at the duPont hospital and at other hospitals who have undergone the types of cardiac surgery at issue. The second set of data consists of raw data that served as the basis for two publications of studies done at CHOP. As the Court understands it, the plaintiffs seek this latter evidence so that their expert can independently analyze the data and further evaluate whether the cooling technique used by Dr. Norwood created a heightened risk of adverse outcomes. The Court will address each set of data in turn.
A. Morbidity and Mortality Data
The defendants' motion to preclude mortality data pertains to two forms of evidence. First, the defendants argue that the testimony of the plaintiffs' expert, Dr. Robert L. Hannan, is inadmissible under Daubert because it is based on scientifically unreliable data and methods. Second, the defendants seek to preclude the defendants from introducing any evidence of morbidity or mortality rates more generally. Such evidence, they argue, is irrelevant, unreliable, prejudicial, and based on hearsay. The Court agrees with the defendants, and will grant the defendants' motion to preclude the plaintiffs from introducing either form of evidence at trial.
1. The Admissibility of Dr. Hannan's Testimony
The defendants expect that the plaintiffs will try to introduce expert testimony to prove that Dr. Norwood's mortality rate was "too high" and that it was caused by his cooling technique. This testimony will come from the plaintiffs' expert witness, Dr. Robert L. Hannan. As the Court understands it, Dr. Hannan will compare data from the Delaware Health Statistics Center (the "DHSC data") to data from Children's Hospital Boston (the "Boston data"). The Court finds that Dr. Hannan's testimony and report comparing these data are inadmissible under Daubert.
The defendants argue that Dr. Hannan's testimony is inadmissible under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), for three reasons: (1) the DHSC data are unreliable; (2) the Boston data are unreliable; and (3) the method ...