The opinion of the court was delivered by: McLaughlin, J.
Robert and Tracie Daddio bring this medical negligence action under Delaware law seeking damages for the death of their son, Michael Daddio. Michael died approximately twenty months after undergoing pediatric cardiac surgery to correct his congenital heart defects at the A.I. duPont Hospital for Children (the "duPont Hospital") in Wilmington, Delaware. The defendants are the Nemours Foundation, which owns and operates the Nemours Cardiac Center at the duPont Hospital, and Dr. William I. Norwood, the pediatric heart surgeon who operated on Michael. The plaintiffs state two claims against the defendants. First, they claim that Michael received negligent care and treatment from the defendants, which resulted in his death. Second, they claim that they did not give their informed consent to a procedure Michael underwent.*fn1
This case came to this Court in September 2008, following an appeal in a related case, Svindland, et al. v. The Nemours Foundation, et al., Civ. A. No. 05-417. After that appeal, both the Svindland case and this case were transferred to the undersigned. The Court held a status conference with the parties in September 2008, at which time the parties informed the Court that the case was all but ready for trial, and that a limited number of issues remained to be decided, including the admissibility of testimony from the plaintiffs' expert witness, Dr. Robert L. Hannan. Following the September 2008 conference, the defendants filed a motion to preclude certain testimony by Dr. Hannan under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and Rule 702 of the Federal Rules of Evidence.
The Court held a hearing on this motion and other evidentiary motions on March 11, 2009. At that hearing, at which the plaintiffs did not offer testimony from Dr. Hannan, plaintiffs' counsel explained that they were uncertain as to Dr. Hannan's theory of causation. Rather than decide the motion, the Court allowed the plaintiffs the opportunity to attempt to clarify their position at a later date.
Following the March 11, 2009, hearing, the plaintiffs filed various additional submissions with the Court, including an affidavit from Dr. Hannan, attempting to clarify their theory of the case. Throughout the period following the hearing, and up until the pretrial conference on June 24, 2009, at which new counsel for the plaintiffs appeared, the Court understood the plaintiffs' theory of causation to be something other than what they now argue it to be.
At the final pretrial conference, the Court continued to express concern about the reliability of Dr. Hannan's testimony. Accordingly, the Court allowed the plaintiffs yet another opportunity to present testimony from Dr. Hannan at a special hearing on July 7, 2009. Following a hearing with Dr. Hannan on that date, the parties agreed to postpone trial so that the plaintiffs might have a final opportunity to clarify their position on the scope and content of Dr. Hannan's expert testimony, and so that the defendants might have the opportunity to respond.
The defendants continue to argue that Dr. Hannan's testimony is not reliable under Daubert and Rule 702 - both the theories that they originally moved to preclude and the theories since argued by new counsel for the plaintiffs. They have also since filed a motion for summary judgment on the basis that the plaintiffs have not provided any other evidence of causation to support their medical negligence or informed consent claims.
Upon consideration of the various filings submitted to the Court since September 2008, and having heard from Dr. Hannan himself, the Court concludes that Dr. Hannan's proposed testimony, as it has been presented to the Court, is not supported by reliable scientific data and methods. The Court will grant the defendants' Daubert motion and will preclude Dr. Hannan from presenting testimony that any of the defendants' alleged acts of negligence caused Michael Daddio's injuries. The Court will also grant the defendants' motion for summary judgment, and will enter judgment for the defendants on the plaintiffs' medical negligence and informed consent claims.
I. Factual Background and Procedural History
Michael Daddio was born on June 5, 2001, with multiple congenital heart defects, including a condition known as Hypoplastic Left Heart Syndrome ("HLHS"). To survive, Michael needed three surgical procedures to alter the flow of blood through his heart. The first of these surgeries is commonly referred to as the "Norwood procedure." The second is commonly referred to as the "hemi-Fontan" procedure. The third is known as the "Fontan" or "Fontan completion" procedure.
On June 7, 2001, Dr. Norwood performed the first of three scheduled surgeries to correct Michael's heart defects. A second surgery 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 approximately twenty months later, on July 23, 2003.
Prior to both of Michael's surgeries, 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. In their operative complaint, the plaintiffs asserted that Dr. Norwood's cooling technique was negligent, as was the manner in which he used circulatory arrest. See Am. Compl. ¶ 32. They did not identify any other ways in which Dr. Norwood's conduct was negligent.
This case was originally assigned to the Honorable Berle M. Schiller of the United States District Court for the Eastern District of Pennsylvania.*fn2 Judge Schiller was also the trial judge assigned to another case brought against Dr. Norwood and the Nemours Foundation, Svindland, et al. v. The Nemours Foundation, et al., Civ. A. No. 05-417.
Upon agreement of the parties, these two cases were consolidated for the purposes of discovery with other cases filed against the defendants. Pursuant to a stipulation filed by the parties, Judge Schiller would decide discovery issues that were common to all cases; other disputes would be decided by whichever judge was sitting as the trial judge. See Svindland Docket No. 20; Daddio Docket No. 21.
A. Dr. Hannan's Report and Deposition
By letter dated September 28, 2006, Dr. Hannan expressed his criticisms of Dr. Norwood's treatment of Michael Daddio. See Defs.' Daubert Mot. Ex. B. In this letter, he opined that Dr. Norwood made unnecessary and experimental modifications to Michael's hemi-Fontan procedure, thus leading to a 59-minute period of circulatory arrest and aortic cross-clamping, which, according to Dr Hannan, led to "increased pleural effusions." He also concluded that Dr. Norwood was negligent because he cooled Michael Daddio "rapid[ly]." Dr. Hannan further concluded that there was insufficient "protection of the myocardium which was a cause of the right ventricular failure and poor functioning of Michael's heart." Id. at 2, 6.
Dr. Hannan also explained that he believed that Dr. Norwood was negligent in failing to ligate Michael's "azygous vein" and in failing to timely address Michael's "pulmonary artery stenosis." According to Dr. Hannan, "[a]ny increase in pressure to the venous pathways will cause and increase pleural effusions." Dr. Hannan explained that "[t]here was a known RPA stenosis prior to the surgery," and the conditions of both the RPA and the azygous vein "raise[d] the venous pressures, which was the major cause of the chronic pleural effusions." He also stated that in this case, "[t]he LPA stenosis caused an increase in pressure in the SVC and the PA which caused the effusions, and caused desaturations by shunting blood through the azygous [vein]." Dr. Hannan concluded that Michael's heart could not tolerate these conditions and Michael eventually suffered right ventricular failure "due to a combination of all of these factors." Id. at 3-4, 6.
Dr. Hannan's deposition in the Daddio case took place on October 23, 2006. See Daddio Docket No. 136 Ex. C. At his deposition, Dr. Hannan was questioned about his experience with performing hemi-Fontan procedures. Dr. Hannan explained that he does not perform the hemi-Fontan procedure, but rather, that he performs a procedure called the "Bidirectional Glenn." He also explained that there are ways in which a stage two operation can be done without utilizing circulatory arrest. See id. at 9-10.
Dr. Hannan was also questioned about the incidence of pleural effusions as a side effect of procedures to correct HLHS. Dr. Hannan acknowledged that there is a range of effusions that is generally accepted among pediatric cardiothoracic surgeons. He explained that pleural effusions, generally, can result from the third-stage Fontan procedure. He also acknowledged, however, that it would be fair to say that there is a reported rate of effusions following a stage two procedure. Dr. Hannan further acknowledged that pleural effusions can occur in a stage two or a stage three procedure absent negligence, and that he has had patients develop pleural effusions after a stage two procedure. See id. at 16-18, 21.
Dr. Hannan was further questioned about the cause or causes of postoperative pleural effusions. Dr. Hannan stated that the "prolonged" period of circulatory arrest Michael underwent failed to sufficiently protect his myocardium. He stated that there is a "well-documented relationship" in the literature between prolonged aortic cross-clamping or circulatory arrest and postoperative pleural effusions. Id. at 34.*fn3 He also stated that "[e]levated pulmonary artery pressures can lead to the effusions," and that "people believe" that "elevated SVC or pulmonary artery pressures" and "elevated venous pressures," cause pleural effusions. He admitted, however, that "people don't completely understand why effusions form." Id. at 49-50.
Dr. Hannan also criticized Dr. Norwood's handling of Michael's azygous vein and pulmonary artery stenosis. According to Dr. Hannan, Michael should have had pulmonary artery angioplasty and occlusion of his azygous vein "much sooner." The purpose of occluding the azygous vein is to prevent the vein from decompressing the pulmonary arteries and reducing effective pulmonary artery blood flow. In this case, Dr. Hannan stated that he "suspected" that failing to address Michael's azygous vein made him "bluer" and "increased the volume in the inferior vena cava." According to Dr. Hannan, closing the vein may not "materially change" SVC pressures, "but one of the treatments of recurrent effusions is taking collaterals out... of the picture." See id. at 35, 37, 39, 50.
With respect to pulmonary artery angioplasty, Dr. Hannan stated that, although Michael received that procedure six months after his surgery, he should have had it "weeks after surgery... based on his pleural effusions." According to Dr. Hannan, Dr. Norwood's failure to perform the procedure sooner had an impact on Michael's pulmonary artery pressures, and "[e]levated pulmonary artery pressures can lead to the effusions." Dr. Hannan also stated, however, that postoperative pressures are "immaterial" in the setting of "recurrent" pleural effusions. Id. at 41, 47, 49, 50, 52.
When asked whether there was an improvement when the azygous vein was excluded and a stent was placed in the left pulmonary artery, Dr. Hannan responded, "I don't know. I'd have to look at the cath sheet. Again, the [postoperative] pressures are relatively immaterial in this situation." Id. at 52.
B. The Svindland Trial and Appeal
In May 2007, the Svindland case proceeded to trial. At trial, the Svindlands concentrated on two issues. They claimed that Dr. Norwood only cooled Ian Svindland 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.
Following a jury verdict for the defendants, the plaintiffs appealed. The Daddio case was stayed pending that appeal. In August 2008, the United States Court of Appeals for the Third Circuit vacated the jury verdict in Svindland, in part, because it could not discern 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 presented on appeal, and instead remanded the case for decision on these issues and for a new trial. After the Court of Appeals vacated the jury verdict in Svindland, both the Svindland case and the Daddio case were reassigned to the undersigned.
D. Proceedings in Svindland and Daddio
After the Svindland Appeal The Court held an on-the-record status conference on September 16, 2008, to isolate the issues for decision in both cases 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. At the conference, counsel agreed that the only motion that had not been addressed by the Svindland appeal and which had not been decided by Judge Schiller in the Daddio case was a prior version of the defendants' Daubert motion to preclude Dr. Hannan from testifying that Michael's pleural effusions were caused by the length of time for which he was cooled or for which he underwent circulatory arrest. See Daddio Docket No. 77. See generally Daddio Docket No. 127 at 23-40.*fn4
In describing the Daddio case to the Court, counsel for the plaintiff explained that "Daddio is a cooling case," and that the plaintiffs' theory of causation was that "cooling damaged parts of [Michael's] body... through lack of oxygen, during the cooling process." See id. at 12. Counsel further explained that, with respect to cooling, "there's not a definite relationship,... but because it's oxygen deprivation, the organs of the baby sort of choose which needs it most, and so there may be varying kinds of organ damage." Id. at 13.
Shortly after the conference, the parties filed various evidentiary motions in both cases. Both sides filed motions related to certain subpoenas that the plaintiffs served on the Children's Hospital of Philadelphia ("CHOP") and Dr. James Goin, a statistician at CHOP, to obtain the raw data that served as the basis for publications of two studies done at CHOP (the "CHOP data"). The defendants moved for a protective order over the CHOP data. The plaintiffs responded by moving to compel CHOP and Dr. Goin to produce the data. These data, according to the plaintiffs, constituted the only available set of data in existence from which the relationship of cooling duration to postoperative outcomes could be analyzed. See Daddio Docket No. 127 at 26-27; see also Daddio Docket No. 143 at 110.
The defendants also filed a motion in the Daddio case under Daubert v. Merrell Dow Pharmaceuticals and Federal Rule of Evidence 702 to preclude certain evidence and certain testimony by Dr. Hannan. See Daddio Docket No. 129. In their motion, the defendants asked the Court to preclude the plaintiffs from offering expert testimony or other evidence that pleural effusions are caused by, or related to, the duration of cooling or circulatory arrest during open-heart surgery.
In their opposition to the defendants' Daubert motion, the plaintiffs disavowed that their theory of negligence was based on the amount of time that Michael Daddio was cooled prior to his November 9, 2001, surgery. Instead, they stated that Dr. Norwood was negligent because he improperly modified Michael's hemi-Fontan procedure, thus leading to a longer period of circulatory arrest than was necessary. See Daddio Docket No. 136 at 4. Dr. Hannan, according to the plaintiffs, would testify not to a relationship between cooling time and pleural effusions, but rather, to a causal link between the length of circulatory arrest - or rather, "aortic cross-clamping" - and pleural effusions.
Id. at 4. In their opposition to the defendants' Daubert motion, the plaintiffs further stated that increased "cross-clamp" time "leads to" pleural effusions and that the medical literature identifies it as "a significant contributing factor." Id. at 2 & n.2.
E. March 11, 2009, Hearing and Post-Hearing Briefing
On March 11, 2009, the Court held a conference with the parties for the purpose of hearing oral argument on all pending evidentiary motions, including the defendants' Daubert motion in the Daddio case.*fn5 At the hearing, the plaintiffs reaffirmed the position taken in their opposition to the defendants'
Daubert motion - that Dr. Hannan would not testify to a link between cooling duration and pleural effusions, but rather, that he would draw a connection between the duration of circulatory arrest and pleural effusions. See id. at 138, 146-49.
Although the plaintiffs admitted that Dr. Hannan would not testify that cooling caused Michael Daddio's pleural effusions, at the same time, however, counsel for the plaintiffs stated that cooling was not completely out of the case, in that cooling "made a contribution" to the outcome. Id. at 163. Counsel further stated, however: "I'm not clear... in my own mind in terms of the scientific part of how [Dr. Hannan is] saying that the rapid cooling... also... may have had an effect." Id. at 165. Counsel further attempted to explain that "inadequate" or "bad cooling" may lead to organ damage, "and the fact that pleural effusions have occurred... could be an indication that the kidneys or the heart has been affected." Id. at 166-67 (emphasis added).
The plaintiffs did not present any witnesses at the March 11 hearing. Instead, they asked the Court to refrain from ruling on the pleural effusions motion until they had the opportunity to submit an additional affidavit from Dr. Hannan. The Court stated that the plaintiffs could file an additional opposition to the defendants' Daubert motion, after they had more time to clarify for themselves their theory of causation.
After the hearing, the plaintiffs filed an additional opposition to the defendants' Daubert motion, in which they further attempted to explain Dr. Hannan's theories of negligence and causation. They explained that "rapid cooling remains an issue in this case, although we are not contending that rapid cooling caused the onset of the pleural effusions that ultimately led to Michael Daddio's death.... In the present case the issue is not the method used for cooling but the cross-clamp time, and Plaintiff [sic] has provided the court with medical literature that supports the fact that prolonged circulatory arrest causes pleural effusions." Daddio Docket No. 142 at 1. The plaintiffs attached various articles to this filing, two of which they had not produced prior to the March 11 hearing.
The defendants filed a reply brief in support of their Daubert motion on March 26, 2009. See Daddio Docket No. 145. In response, the plaintiffs submitted an additional affidavit from Dr. Hannan. See Daddio Docket No. 146.*fn6 In this affidavit, Dr. Hannan explained that "[b]ypass, crossclamping and DHCA procedures all increase the risk of end organ damage and are intrinsically related," and that "[c]onsequently, studies showing that the longer these procedures last the more likely they are to cause organ damage and pleural effusions are applicable to each." He also explained that every authoritative medical reference recommends limiting the duration of DHCA to the shortest time necessary to perform the necessary surgery; there is, however, no magic period of time (e.g. 60 minutes) in which there is no injury from DHCA.
Id. In his affidavit, Dr. Hannan did not comment on any specific aspect of Michael Daddio's hemi-Fontan operation. Nor did he identify or purport to rely on any data from Michael's medical records identifying any documented organ damage.
F. Plaintiffs' Motions for Consolidation and Recusal
On April 21, 2009, plaintiffs' counsel filed a motion to consolidate the Svindland and Daddio cases with each other and with six other cases pending in this district. See Svindland Docket No. 172. The basis for the motion was that, in each and every surgery in these cases, "the Defendants' method of cooling violated the applicable standards of care, thereby, resulting in harm" to the patients whose surgeries were at issue. Id. at 5. According to the plaintiffs, the cases contained a common issue of law and fact - whether Dr. Norwood engaged in negligent conduct by cooling the ...