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Conway v. A.I. Dupont Hospital for Children

January 6, 2009

TEAGUE CONWAY
v.
A.I. DUPONT HOSPITAL FOR CHILDREN, ET AL.



The opinion of the court was delivered by: 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. 116), the Institutional Defendants' Motion for Partial Summary Judgment (Doc. No. 117), the Motion for Partial Summary Judgment to Dismiss the First Cause of Action (Doc. No. 118), and the Motion for Partial Summary Judgment to Dismiss Count II of the Complaint Alleging Fraud and Intentional Misrepresentation and Punitive Damages Claim (Doc. No. 119). For the following reasons, Defendants' Motions will be granted.

I. BACKGROUND*fn1

This case arises out of the medical treatment received by Teague*fn2 Conway ("Plaintiff") at the A.I. Dupont Hospital in Wilmington, Delaware. Plaintiff was born on January 16, 2001, with Hypoplastic Left Heart Syndrome ("HLHS"), "[a] congenital heart disorder marked by underdevelopment of the left ventricle (lower chamber of heart), deformity of the aorta, narrowing of the aortic valve, and narrowing of the mitral valve." Matthew Bender & Co., 3-H Attorneys' Dictionary of Medicine 5914 (2005). Babies born with HLHS inevitably die shortly after birth unless they receive medical attention. (See Doc. No. 119, Ex. A ¶ 1.) The standard treatment for HLHS involves three separate open-heart surgical procedures that restructure the aorta so that the right side of the heart does the work of the underdeveloped left side. (Id. ¶ 2.) The first procedure, called the "Norwood Procedure," allows oxygenated blood to be pumped from the right side of the heart to the body. (Id. ¶ 3.) The second and third procedures achieve the goal of allowing unoxygenated blood from the upper and lower body to go directly to the lungs for oxygenation, bypassing the heart. (Id.) These are called, respectively, the "HemiFontan" and "Fontan Completion" procedures. (Id. ¶ 4.) The first procedure was performed on Plaintiff on January 17, 2001. (Id. ¶ 11.) The second procedure was performed on Plaintiff on June 19, 2001. (Id.)

Sometime in 2002, Defendants Murphy and Norwood determined that the Fontan Completion procedure could be achieved via catheterization*fn3 of a device known as the Cheatham Platinum covered stent ("CP stent").*fn4 (See generally Doc. No. 117, Ex. D at 1-5 (hereinafter the "March 30, 2004, Letter").)*fn5 The use of the stent would avoid the necessity of the third open-heart surgery required by the Fontan Completion procedure. (Doc. No. 119, Ex. A ¶ 6.) The doctors believed that the CP stent procedure would "accomplish the same physiological and anatomical outcome" as the surgery, with the difference being that instead of a pediatric heart surgeon opening an infant's chest and connecting veins and arteries with a Gore-tex patch, an interventional cardiologist would implant the CP stent using a less invasive catheterization process. (Id. ¶¶ 7-9.)

In April 2002, Dr. Murphy began implanting the CP stent in his patients. (March 30, 2004, Letter at 8.) He obtained the CP stents from NuMed, Inc., a New York-based medical device manufacturer.*fn6 The CP stent had not been approved by the FDA; however, NuMed was in the process of seeking FDA approval. (Id. at 3, 6-7.) During the period spanning April 2002 to May 2003, Dr. Murphy implanted the CP stent in sixteen patients. (Id. at 8-12.) On June 26, 2003, Dr. Murphy received a letter from NuMed informing him that it was recalling the CP stent, that the stent was not to be used except on an emergency or compassionate use basis, and that Dr. Murphy should provide NuMed with background information on each CP stent he implanted, including consent forms and follow-up data. (Id. at 13.)

Shortly thereafter, Dr. Murphy sought NuMed's assistance with obtaining FDA approval for compassionate use of the CP stent in twenty patients. (Id.) Dr. Murphy notified the Hospital's Institutional Review Board ("IRB") of his pending requests on July 11, 2003. (Id. at 17.) The March 30, 2004, Letter states that this was the Hospital's first notification about use of CP stent and that, up to that time, it did not know that Dr. Murphy had already implanted the CP stent into patients.*fn7 (Id. at 17-18.)

On October 30, 2003, Dr. Murphy sent a compassionate use application for use of the CP stent in Plaintiff to the Regulatory Affairs department of NuMed, which forwarded it to the FDA. (See Doc. No. 119, Ex. D.) The application contained two consent forms signed by Plaintiff's parents, Chris and Kristen Conway. It also included an IRB memorandum addressed to Dr. Murphy informing him of the IRB's procedures surrounding an application for compassionate use, and a letter from Dr. Norwood expressing his belief that use of the CP stent was the "safest and most effective way of saving this boy's life." (Id.) On November 10, 2003, the FDA granted the compassionate use application. (March 30, 2004, Letter at 20; Doc. No. 118, Ex. K.) On December 4, 2003, Plaintiff underwent a transcatheter completion of the Fontan procedure. (March 30, 2004, Letter at 20.) He was discharged from the hospital in early January 2004. (Id. at 21.)

After the final CP stent procedures performed by Dr. Murphy, the IRB and the Hospital conducted an investigation that resulted in the March 30, 2004, Letter. At about that time, Plaintiff's parents contacted Dr. Jack Rychik, a pediatric cardiologist at the Children's Hospital of Philadelphia ("CHOP") who is now Plaintiff's doctor. Plaintiff was experiencing pleural effusions and a significant amount of fluid build-up in his abdomen and Plaintiff's parents wanted "an additional opinion and . . . some additional thoughts" on how to treat Plaintiff for effusions that he was experiencing. (Doc. No. 146 at 9 (hereinafter the "Rychik Deposition")) Plaintiff was transferred to CHOP under the care of Dr. Rychik. At his deposition, Dr. Rychik testified that "[e]ffusions are collections of fluid in potential spaces that exist between tissue planes within the body. One can see effusions around the lung or around the heart or sometimes in the abdomen, and that's referred to as ascites." (Id. at 9-10.) When Dr. Rychik examined Plaintiff, he determined that Plaintiff had pleural effusions (fluid build-up around the lungs) and "a significant amount of ascites." (Id. at 10.) Dr. Rychik testified that he had experience treating pleural effusions and ascites following Fontan Completion procedures. He noted that "the presence of effusions can be a common phenomenon" after a Fontan Completion, stating "[i]t's not a rare or unusual phenomenon at all." (Id. at 12.)

Dr. Rychik determined that the best treatment for Plaintiff would be to conduct what is known as a "take-down" of the Fontan. (Id. at 13.) Dr. Rychik explained the procedure as follows:

In order to define [a take-down of the Fontan], one perhaps has to explain what the Fontan is and the step that one takes to achieving the Fontan operation. In the Fontan, the veins that drain blood from the lower part of the body are connected to the pulmonary arteries in some fashion. And there are a number of different modifications for this. The step prior to the Fontan operation is one in which the veins from the top part of the body connect to the pulmonary arteries, the superior vena cava.

And in a take-down from a Fontan to a previous step, one goes back to reestablishing connection between the inferior vena cava and the heart, turning that blood back away from the lung to the heart itself. (Id. at 13-14.) Dr. Thomas Spray, a cardiothorasic surgeon at the CHOP, performed the take-down of the Fontan on Plaintiff. After the take-down, Plaintiff had a "relatively rapid" recovery, including abatement of the pleural effusions and, eventually, of the ascites. (Id.) Plaintiff went on to have a Fontan Completion procedure, in which Dr. Spray surgically implanted a Gore-tex patch in Plaintiff's chest. (Id. at 21.) As of September 2008, Plaintiff, who was then 6 years old, was "doing very well" and there were no future surgeries planned. (Id at 27.)

Plaintiff has filed the instant law suit alleging, inter alia, medical negligence, lack of informed consent, and fraud against the Defendants.

II. LEGAL STANDARD

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); Woods v. Bentsen, 889 F. Supp. 179, 184 (E.D. Pa. 1995).

B. Choice of Law

Federal courts sitting in diversity must apply the law of the forum state. 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)). "This general rule embraces the application of choice of law principles." 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 Electric Mfg. Co., 313 U.S. 487 (1941)). Thus, we apply Pennsylvania's choice of law rules.

Pennsylvania uses an interest analysis to determine choice of law. See Griffith v. United Airlines Inc., 65 A.2d 796 (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) (explaining Griffith). Griffith requires courts to engage in a two-step inquiry. See Cipolla v. Shaposka, 267 A.2d 854 (Pa. 1970); Hanover, 2007 U.S. Dist. LEXIS 92646 at *11. First, a court must examine whether a conflict exists between the laws of the competing states. Hanover, 2007 U.S. Dist. LEXIS 92646 at *11. If the court determines that a conflict exists, it then must move on to the second step of "weigh[ing] the interests of each state in the resolution of the dispute, and determin[ing] which state has greater contacts with the dispute." Id. at *12.

There are substantial conflicts between the law of Delaware and the law of Pennsylvania with regard to Plaintiff's medical malpractice and fraud claims. In several areas, Delaware law, including the Health Care Malpractice Insurance and Litigation Act (the "Health Care Act"), 18 Del. C. § 6801 et seq., imposes different burdens on plaintiffs than does Pennsylvania law. For instance, Pennsylvania requires expert testimony that a defendant's conduct was a "substantial factor" in causing the harm suffered. See Winschel v. Jain, 925 A.2d 782, 789 (Pa. Super. Ct. 2007). Delaware, however, requires expert testimony that the defendant's conduct was the "but for" cause of the harm suffered, a more rigorous standard. See Spicer v. Osunkoya, No. 04-218, 2008 Del. Super. LEXIS 257, at *3 (Del. Super. Ct. 2008). In addition, Delaware informed consent claims sound in negligence. In Pennsylvania, informed consent claims sound 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.") with Fitzpatrick v. Natter, No. 1-2007, 2008 Pa. LEXIS 2266, at *32 n.13 (Pa. Dec. 17, 2008) ("An informed consent action . . . sounds in battery rather than in negligence."). Plaintiff's fraud claim is also subsumed by Delaware's Health Care Act, rendering it, in essence, a negligence claim.

Regardless of whether the essential elements of fraud are the same in Pennsylvania and Delaware, the Health Care Act creates a conflict between the two in the context of medical malpractice actions.

The existence of a difference between Delaware and Pennsylvania laws requires us to engage in the second step of the Griffith analysis, which is straightforward in this case. There is no doubt that Delaware's interests in this matter are stronger than Pennsylvania's and that Delaware law should apply to Plaintiff's negligence theories. The reasons for this have been discussed by the several federal courts and Pennsylvania courts that have applied Delaware negligence law to the malpractice claims of Pennsylvania residents when those residents, as Plaintiff did here, intentionally traveled to Delaware for the allegedly negligent medical care. 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.").

Delaware has the greater interest because the complained-of conduct occurred in Delaware, including the purported misrepresentations, and Delaware has a demonstrable interest in regulating health care practice and policies 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). 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. Finally, Delaware has an interest in that Defendants are its citizens. By contrast, Pennsylvania has an interest as the forum state and an interest in that Plaintiff is its citizen. Clearly, Delaware law applies here.*fn8

III. LEGAL ANALYSIS

Delaware's Health Care Act governs the outcome of this case. See 18 Del. C. § 6801, et seq. "Chapter 68 of Title 18 was enacted with the purpose of providing an atmosphere in which the number of suits and claims of malpractice, as well as the size of judgments and settlements, would be reduced thereby reducing the cost and/or maintaining the availability of medical malpractice insurance for health care providers." Miller v. Spicer, 822 F. Supp. 158, 172 (D. Del. 1993).*fn9 The Health Care Act creates a statutory scheme that imposes rigid requirements on plaintiffs seeking to bring tort claims arising from the provision of medical services. Specifically, as it pertains to this matter, the Health Care Act defines the terms "medical negligence" and "informed consent," and it sets out evidentiary standards with which plaintiffs must comply. These definitions and requirements limit the theories of recovery that are available to plaintiffs.

Medical negligence is defined in the Health Care Act as:

[A]ny 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.

The standard of skill and care required of every health care provider in rendering professional services or health care to a patient shall be that degree of skill and care ordinarily employed in the same or similar field of medicine as defendant, and the use of reasonable care and diligence. 18 Del. C. § 6801(7). In order to establish a claim for medical negligence, a plaintiff must present "expert medical testimony . . . as to the alleged deviation from the applicable standard of care in the specific circumstances of the case and as to the causation of the alleged personal injury or death . . . ."*fn10 18 Del. C. § 6853(e). This requirement is an essential element of a medical negligence claim. See Burkhart v. Davies, 602 A.2d 56, 59 (Del. 1991), cert. denied, 504 U.S. 912 (1992) ("As a result of the [section 6853] statutory mandate, the production of expert medical testimony is an essential element of a plaintiff's medical malpractice case . . . .").

Informed consent is a subset of medical negligence that the Health Care Act defines as:

[T]he consent of a patient to the performance of health care services by a health care provider given after the health care provider has informed the patient, to an extent reasonably comprehensible to general lay understanding, of the nature of the proposed procedure or treatment and of the risks and alternatives to treatment or diagnosis which a reasonable patient would consider material to the decision whether or not to undergo the treatment or diagnosis. 18 Del. C. § 6801(6); see also Patten v. Freedman, No. 61, 1989 Del. Super. LEXIS 222, at *7-8 (Del. Super. Ct. May 18, 1989) ("An action based on lack of informed consent is an action for malpractice, and malpractice is defined by a negligence standard. The conclusion follows that an action for malpractice based on lack of informed consent is a negligence action."). Plaintiffs bringing an informed consent claim must establish the following:

(1) The injury alleged involved a non-emergency treatment, procedure or surgery; and

(2) The . . . health care provider did not supply information regarding such treatment, procedure or surgery to the extent customarily given to patients, or other persons authorized to give consent for patients by other licensed health care providers in the same or similar field of medicine as the defendant.

18 Del. C. ยง 6852(a). Because informed consent claims in Delaware sound in negligence, not battery, the requirements imposed by section 6852(a) are in addition to the Health Care Act's other requirements regarding medical negligence claims. See Valentine v. Mark, No. 12-244, 2004 Del. Super. LEXIS 352, at *8 (Del. Super. Ct. Oct. 20, 2004) (reasoning that because the Informed Consent Statute can be found under the Medical Negligence chapter of the Delaware Insurance Code, other requirements under the chapter applied to informed ...


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