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Guinan v. A.I. duPont Hospital for Children

February 6, 2009

MOLLY GUINAN
v.
A.I. DUPONT HOSPITAL FOR CHILDREN, ET AL.



The opinion of the court was delivered by: R. Barclay Surrick, Judge

SURRICK, J.

MEMORANDUM & ORDER

Presently before the Court are the Motion of Defendant William I. Norwood, M.D., Ph.D., for Summary Judgment Pursuant to Rule 56 of the Federal Rules of Civil Procedure (Doc. No. 20), the Motion for Partial Summary Judgment to Dismiss the First Cause of Action (Doc. No. 21), the Motion for Partial Summary Judgment to Dismiss Count II of the Complaint Alleging Fraud and Intentional Misrepresentation and Punitive Damages Claim (Doc. No. 22), the Joint Motion of Defendants for Summary Judgment or Alternatively for Partial Summary Judgment on Medical Monitoring Claim Set Forth in Count VI (Doc. No. 23), and the Institutional Defendants' Motion for Partial Summary Judgment (Doc. No. 24). For the following reasons, Defendants' Motions will be granted in part and denied in part.

I. BACKGROUND

Plaintiff is one of several infants who had a controversial procedure to correct a congenital heart defect performed on her by doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware.*fn1 Plaintiff was born with Down Syndrome and a combination of three heart defects: tetralogy of Fallot, complete common atrioventricular canal defect, and severe pulmonary stenosis.*fn2 These defects are uncommon but well-known congenital cardiac malformations that accompany Down Syndrome. The defects' primary effect on Plaintiff was to prevent her right ventricle from performing its function of receiving deoxygenated blood from the right atrium and pumping that blood to the pulmonary artery for oxygenation in the lungs. This, in turn, resulted in Plaintiff having insufficiently oxygenated blood, giving Plaintiff's skin a bluish or purple color.

Defendant Dr. Norwood decided that a shunting procedure known as the Fontan procedure was the most appropriate treatment for Plaintiff's condition. (Doc. No. 33, Ex. YY at 38 (hereinafter, "Norwood Dep."); (Doc. No. 20, Ex. A ¶¶ 2, 4 (hereinafter, "Norwood Decl.").) In Plaintiff's case, the Fontan procedure modified the physiology of her heart to "allow blood to bypass [her] non-functioning right ventricle and go directly and passively to the lungs to be oxygenated." (Norwood Decl. ¶ 5.) When Plaintiff was born on March 12, 2001, achieving the so-called Fontan physiology required two open heart surgeries, the Hemi-Fontan and the Fontan completion ("Surgical Completion"), respectively. (See Norwood Decl. ¶¶ 6-10.) Dr. Norwood performed a Hemi-Fontan on Plaintiff two months after she was born, on May 14, 2001. (Id. ¶ 4.) The sequence of events that precipitated the instant lawsuit began with the second surgery. Plaintiff was scheduled to have a Surgical Completion of her Fontan on May 9, 2002.

However, instead of having her Fontan completed, Plaintiff had her atrioventricular valves repaired. There is disagreement with regard to the goal of the second surgery. On one hand, Plaintiff's parents thought that Dr. Norwood was going to perform the Surgical Fontan, and it was not until after the surgery was over that Plaintiff's parents discovered that the Fontan had not been completed. (See Doc. No. 33, Ex. L Vol. I at 101 (hereinafter, K. Guinan Dep. Vol. I").) On the other hand, Dr. Norwood indicates that, prior to the surgery, it was apparent that Plaintiff had developed "severe leakage of her atrioventricular valves, [which] obviat[ed] for the moment the second stage of her Fontan procedure." (Id. ¶ 12; see also Norwood Dep. at 47 (noting that completing the Fontan and repairing Plaintiff's atrioventricular valve at the same time was not "the most favorable way of dealing with [Plaintiff's] physiology"); Doc. No. 33, Ex. F at 3 (consent form signed by Plaintiff's father describing surgical procedure as "repair mitral valve").) In any event, the May 9, 2002, surgery did not result in Plaintiff receiving a Fontan completion.

After the surgery, Plaintiff's attending physician, cardiologist Dr. Samuel Gidding, informed Plaintiff's parents that the Fontan had not been completed but that the procedure could be completed in the catheter lab. (Id. at 101.) Completing the Fontan in the catheter lab involved a relatively new procedure that entailed a cardiologist employing a covered stent via catheter to complete the Fontan procedure intravascularly ("Catheterization Fontan").*fn3 (See Norwood Decl. ¶ 9; see also, e.g., Doc. No. 33, Ex. DDD at 72 (hereinafter, "Mullins Dep.") (describing some benefits of catheterization over open heart surgery).) The theoretical advantage of such a procedure was that it avoided the risks that accompany open-heart surgery. The parties present very different versions of what occurred from this point forward in Plaintiff's treatment. However, the following facts are not in dispute.

On October 14, 2002, cardiologist Dr. Murphy implanted a Cheatham Platinum covered stent ("CP stent") in Plaintiff. The CP stent was manufactured by NuMed, Inc., a New York corporation that is one of the few developers of pediatric medical devices in the United States. (See Mullins Dep. at 34-38.) The CP stent had not been approved by the Food and Drug Administration when Dr. Murphy implanted the CP stent in Plaintiff. On the day Plaintiff had the procedure performed, Plaintiff's father signed a consent form provided by the Hospital that described the procedure as "Transcatheter placement of intravascular stent: Covered stent completion of cavopulmonary connection." (Doc. No. 25, Ex. 5 at 2 (hereinafter, "duPont Consent Form"); (Doc. No. 33, Ex. K at 283 (hereinafter, "J. Guinan Dep.").)

About a month after the procedure, Plaintiff developed symptoms of a cold. (J. Guinan Dep. at 85.) Plaintiff's mother contacted Dr. Gidding about the symptoms and he advised that she and Plaintiff's father monitor Plaintiff's blood oxygen saturation. (Id. at 86-87.) Plaintiff's symptoms gradually became worse, requiring several trips to the hospital. (See generally id. at 90-121.) Plaintiff was eventually diagnosed with protein losing enteropathy ("PLE") and plastic bronchitis, both rare and potentially life-threatening conditions.

Dissatisfied with the responsiveness and general conduct of the doctors in the Nemours Cardiac Center, Plaintiff's parents started bringing her to the Pediatric Intensive Care Unit at the A.I. duPont Hospital, which is separate from the Nemours Cardiac Center. (See id. at 140-41.) In May 2003, Plaintiff's parents decided to transfer Plaintiff to the care of Dr. Jack Rychik, Dr. Thomas Spray, and Dr. Jonathan Rome at the Children's Hospital of Philadelphia ("CHOP"). (Id. at 150-52.) Plaintiff's PLE eventually dissipated, but her plastic bronchitis remained. (See id. at 169.)

Dr. Rychik determined that he would not remove the CP stent. Rather, he determined that the best course of treatment for Plaintiff's plastic bronchitis was to leave the CP stent in and fenestrate, or create a hole in, it. (See Doc. No. 25, Ex. 21 at 22 (hereinafter, "Rome Dep.") ("[T]he decision to fenestrate was based on the fact that we didn't identify other specific things to fix, if you will."); K. Guinan Dep. Vol. I at 186-87; J. Guinan Dep. at 160.) Fenestration is a known, although not widely agreed upon, procedure intended to lower pressure in the venous system and thereby alleviate PLE and plastic bronchitis, which sometimes accompany the increased venous pressure associated with Fontan physiology. (See Norwood Dep. at 64-66, 78-79; see also Cheatham Dep. at 64-65; Doc. No. 25, Ex. 22 at 54 (hereinafter, "Jacobs Dep.") ("[S]ome centers feel that fenestration is useful and they try to do it. Other centers feel that it's never useful.").) Although Dr. Rychik and Dr. Rome had limited experience dealing with the CP stent and general experience performing fenestrations and working with Gore-Tex, they came to the conclusion that the Gore-Tex material that covered the stent might close back up if it were fenestrated. (Rome Dep. at 33-35; J. Guinan Dep. at 164, 292.) They conveyed this concern to Plaintiff's parents, who elected to proceed with the fenestration with that knowledge. (J. Guinan Dep. at 164; Doc. No. 33, Ex. L Vol. II at 108 (hereinafter, "K. Guinan Dep. Vol. II").) Prior to the procedure, Dr. Rychik and Dr. Rome determined that Plaintiff's pulmonary artery was narrowing and needed a stent to hold it open. (Rome Dep. at 23.) Plaintiff's parents consented to having a second (non-CP) stent placed in the artery to address the narrowing. (J. Guinan Dep. at 158; K. Guinan Dep. Vol. I at 190-91.)

On December 17, 2004, Dr. Rychik used a catheter to fenestrate the CP stent and to implant a stent in Plaintiff's pulmonary artery. (J. Guinan Dep. at 169.) In February, 2006, Dr. Rychik and Dr. Rome discovered that the fenestration in Plaintiff's CP stent was only allowing a "relatively small amount of blood" to pass through it. (Rome Dep. at 24.) Dr. Rychik suggested enlarging the fenestration in a procedure that would result in an extremely small stent sitting in the fenestration at a right angle to the CP stent. (Id. at 25.) Stents are sometimes used in the same way when cardiologists fenestrate surgically-completed Fontan physiology. (See id. at 34-35.) Plaintiff's parents agreed, and Dr. Rychik performed the procedure. (See K. Guinan Dep. Vol. II at 116-20; J. Guinan Dep. at 292-94.)

Plaintiff currently has three stents in her body. (J. Guinan Dep. at 287-88.) She has the CP stent, which completes her Fontan physiology; a non-CP stent that prevents her pulmonary artery from narrowing; and a non-CP stent holding the fenestration of the CP stent open. (Id.) In February 2007, the doctors at CHOP did an echocardiogram that showed that the fenestration was still open. (Id. at 293; Rome Dep. at 28-30.) However, Plaintiff's plastic bronchitis persists. (J. Guinan Dep. at 293; Rome Dep. at 29.) A take-down Fontan procedure remains a last resort for treating Plaintiff's plastic bronchitis. (Doc. No. 33, Ex. SS at 2; J. Guinan Dep. at 294.) Plaintiff's cardiothoracic surgeon at CHOP, Dr. Spray, believes that returning Plaintiff's heart to a Hemi-Fontan physiology might alleviate the pulmonary cast formations associated with plastic bronchitis because Plaintiff did not have that problem in the interim between her Hemi-Fontan procedure and the completion of the Fontan. (See Doc. No. 33, Ex. SS at 2.)

While there is little or no dispute over these facts, a number of events and circumstances concerning Plaintiff's medical treatment by the Medical Defendants and the Institutional Defendants are contested.

One factual dispute between the parties concerns whether Plaintiff's parents signed a consent form provided by NuMed or were otherwise informed of the details of the CP stent and the nature of the Catherization Fontan prior to the surgery. (Doc. No. 25, Ex. 4 (hereinafter, "NuMed Consent Form").) The guardians of most, if not all, of the other patients at the Nemours Cardiac Center who had the Catheterization Fontan using the CP stent signed a NuMed Consent Form indicating that the device was investigational and not FDA-approved. Plaintiff's parents contend that they never signed this form. (K. Guinan Dep. Vol. I at 87-88, 113, 117, 228; see also J. Guinan Dep. 173, 283-85.) Moreover, they contend that they were not informed in any way by the Medical Defendants that the CP stent was not FDA-approved or that the Catheterization Fontan was an innovative procedure with a limited track record. (See K. Guinan Dep. Vol. I at 112-17; J. Guinan Dep. 75-77.)

As mentioned above, factual disputes exist over how Dr. Norwood performed the May 9, 2002, procedure. In addition to the discrepancies between what the parties believed to be the purpose of the surgery, disagreement remains over how Dr. Norwood performed the surgery. Specifically, during the course of the surgery, Dr. Norwood placed a Gore-Tex collar in Plaintiff's inferior vena cava. (Norwood Decl. ¶ 14.) Dr. Norwood contends that the placement of the Gore-Tex collar "markedly simplified the Fontan circuit if it was to be completed surgically and it could potentially be used to provide an anchor within the heart if [Plaintiff's parents elected] non-surgical Fontan completion . . . . The placement of the collar did not commit to either Completion Fontan approach, rather it simplified both." (Id.) As with the dispute over whether Plaintiff's parents viewed, signed, or were informed of the contents of the NuMed Consent Form, the issues surrounding Plaintiff's May 9, 2002 procedure concern the extent to which Medical Defendants informed Plaintiff's parents as to Plaintiff's course of treatment.

Finally, there are factual disputes surrounding the treatment Plaintiff received when her PLE and plastic bronchitis first began manifesting themselves in December 2002 or January 2003. At her deposition, Plaintiff's mother described her dissatisfaction with the Medical Defendants' and Institutional Defendants' treatment of her daughter. (See J. Guinan Dep. at 98-145.) That dissatisfaction led Plaintiff's mother to file several formal complaints with A.I. duPont Hospital and its Institutional Review Board. (See Doc. No. 33, Ex. JJ at 21 (hereinafter, "March 30, 2004 Letter").) It was these complaints that first made the Institutional Defendants aware of the fact that the Medical Defendants were using the CP stent. This prompted an internal review process within the A.I. duPont Hospital. (See id. at 18.)

This lawsuit was originally filed as a class action. Plaintiff was one of the named plaintiffs representing a class of patients who had received Catheterization Fontans with CP stents at the A.I. duPont Hospital for Children in Wilmington, Delaware. In February 2007, we granted the Medical Defendants' motion to dismiss. Specifically, we dismissed certain theories of negligence under the Plaintiff's first cause of action. We also dismissed Plaintiff's third cause of action for assault and battery, Plaintiff's fourth cause of action for strict products liability, and Plaintiff's fifth cause of action for breach of express and implied warranty. (See No. 04-cv-4862, E.D. Pa., Doc. No. 50 (hereinafter, "February 14, 2007 Memorandum and Order").) In April 2007, the parties stipulated that all class action allegations in the Complaint would be dismissed and that the request for class certification would be withdrawn. After a scheduling conference in January 2008, an Order was entered upon request of counsel directing that separate civil action numbers be assigned to each of the named plaintiffs and directing that the cases be tried separately. (See Doc. No. 1.)

II. LEGAL STANDARDS

A. Summary Judgment

Summary judgment is appropriate when "the pleadings, the discovery, and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986); Fed. Home Loan Mortgage Corp. v. Scottsdale Ins. Co., 316 F.3d 431, 443 (3d Cir. 2003). Only facts that might affect the outcome of a case are "material." Anderson, 477 U.S. at 248. The moving party bears the burden of identifying the absence of a genuine issue of material fact, which it may satisfy by "showing" the court that there is an absence of evidence supporting the non-moving party's case. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 325 (1986); UPMC Health Sys. v. Metro. Life Ins. Co., 391 F.3d 497, 502 (3d Cir. 2004). All reasonable inferences from the record are drawn in favor of the non-movant. Knabe v. Boury Corp., 114 F.3d 407, 410 n.4 (3d Cir. 1997).

Although the movant has the initial burden of demonstrating the absence of genuine issues of material fact, the non-movant must then establish the existence of each element on which it bears the burden of proof. See Watson v. Eastman Kodak Co., 235 F.3d 851, 857-58 (3d Cir. 2000). Plaintiffs cannot avert summary judgment with speculation or by resting on the allegations in the pleadings, but rather must present competent evidence from which a jury could reasonably find in their favor. Ridgewood Bd. of Educ. v. N.E. for M.E., 172 F.3d 238, 252 (3d Cir. 1999); see also Fin. Software Sys., Inc., v. Lecocq, No. 07-3034, 2008 U.S. Dist. LEXIS 41699, at *6 (E.D. Pa. May 27, 2008).

B. Choice of Law

Federal courts sitting in diversity jurisdiction must apply the law of the forum state, including its choice of law principles. See, e.g., Thabault v. Chait, 541 F.3d 512, 521 (3d Cir. 2008) (citing Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938); Pennsylvania v. Brown, 373 F.2d 771, 777 (3d Cir. 1967)); First State Underwriters Agency of New England Reinsurance Corp. v. Travelers Ins. Co., 803 F.2d 1308, 1316 (3d Cir. 1986) (citing Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487 (1941)). Pennsylvania courts use a two-step interest analysis to determine choice of law. See Griffith v. United Airlines Inc., 203 A.2d 796, 806-07 (Pa. 1964); see also Hanover Ins. Co. v. Ryan, No. 06-2650, 2007 U.S. Dist. LEXIS 92646, at *9-12 (E.D. Pa. Dec. 17, 2007) (discussing Griffith). A court must first examine whether a conflict exists between the laws of the competing states. Hanover, 2007 U.S. Dist. LEXIS 92646 at *11. If a conflict exists, then the court must "weigh the interests of each state in the resolution of the dispute, and determine which state has greater contacts with the dispute." Id. at *12.

For several of Plaintiff's claims the choice of Delaware law is potentially outcome determinative. We will therefore conduct the choice of law analysis.*fn4

1. Negligence: Medical Negligence and Informed Consent

Plaintiff articulates two different theories of negligence: (1) medical negligence premised on malpractice; and (2) lack of informed consent. A conflict exists between the laws of Pennsylvania, Delaware, and New Jersey with regard to both theories of negligence arising from the provision of medical services. We address each in turn.

There are conflicts between the law of Delaware and the laws of Pennsylvania and New Jersey with regard to Plaintiff's medical negligence claims. Pennsylvania and New Jersey both require courts to apply a "substantial factor" test to issues of causation in medical malpractice cases. See Winschel v. Jain, 925 A.2d 782, 789 (Pa. Super. Ct. 2007); Verdicchio v. Ricca, 843 A.2d 1042, 1058 (N.J. 2004). In contrast, Delaware courts apply a "but for" test to issues of causation in medical malpractice cases. See Spicer v. Osunkoya, No. 04-218, 2008 Del. Super. LEXIS 257, at *3 (Del. Super. Ct. 2008). Thus, a conflict exists with regard to Plaintiff's medical negligence claims.

In addition, informed consent in Delaware and New Jersey sounds in negligence. Informed consent in Pennsylvania sounds in battery. Compare Brzoska v. Olson, 668 A.2d 1355, 1366 (Del. 1995) ("If a health care provider violates his . . . duty of care in obtaining the consent of the patient by failing to disclose all relevant information (risks) that a reasonable person would deem significant in making a decision to have the procedure, the action should be pleaded in negligence -- not battery."), and Acuna v. Turkish, 930 A.2d 416, 425 (N.J. 2007) ("The informed consent doctrine has evolved from a concept originally sounding in battery to a firmly established principle of negligence involving the duty of care a doctor owes his patient.") (citing Howard v. Univ. of Med. & Dentistry of N.J., 800 A.2d 73, 77-78 (N.J. 2002), with Fitzpatrick v. Natter, 961 A.2d 1229, 1242 n.13 (Pa. 2008) ("An informed consent action . . . sounds in battery rather than in negligence."). Moreover, since informed consent in New Jersey and Delaware is based on negligence, there is a conflict between Delaware and New Jersey law. In Delaware, a plaintiff claiming a lack of informed consent needs to establish that the absence of informed consent was the "but for" cause of his injuries. In New Jersey, the same plaintiff would need to establish that the absence of informed consent was a "substantial factor" in causing his injuries.

Pennsylvania's sole interest with regard to Plaintiff's negligence-based claims is in its role as the forum state. New Jersey's interest is that Plaintiff is its citizen. Delaware, by contrast, has a number of different interests that dictate that Delaware law should apply. Plaintiff intentionally travelled from New Jersey to Delaware to receive treatment. This weighs heavily in favor of applying Delaware law. See, e.g., Blakesley v. Wolford, 789 F.2d 236, 243 (3d Cir. 1986) ("[I]t is only fair that the law of the state to which the patient has voluntarily travelled, and in which the doctor has chosen to conduct the operation, be applied to adjudicate the respective rights duties, and obligations between the parties."). The complained-of conduct occurred in Delaware, and Delaware has a strong interest in regulating the activity within its borders. See Svindland v. A.I. Dupont Hosp. for Children of the Nemours Found., No. 05-0417, 2006 U.S. Dist. LEXIS 80601, at *6 (E.D. Pa. Nov. 3, 2006) (looking to where medical treatment occurred as one factor in Griffith analysis); see also 42 Pa. Cons. Stat. § 5101.1(b) ("[A] medical professional liability action may be brought against a health care provider for a medical professional liability claim only in the county in which the cause of action arose."). Delaware also has an interest maintaining the predictability of its regulations so that health care professionals practicing within its borders know what standards govern their conduct.

2. Fraud and Negligent Misrepresentation

Delaware and New Jersey have significantly curtailed, if not eliminated outright, causes of action for fraud and misrepresentation based on a doctor's failure to inform a patient of risks or concerns associated with medical treatment. See 18 Del. C. ยง 6801(7) (defining medical negligence as "any tort or breach of contract based on health care or professional services rendered, or which should have been rendered, by a health care provider to a patient"); Howard, 800 A.2d at 81-82 (disallowing cause of action for fraud where it "would circumvent the ...


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