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Hess v. A.I. Dupont Hospital for Children

March 5, 2009

MARK AARON HESS, BY AND THROUGH HIS PARENT AND NATURAL GUARDIAN, MARK HESS
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. 10), the Motion for Partial Summary Judgment to Dismiss the First Cause of Action (Doc. No. 11), the Motion for Partial Summary Judgment to Dismiss Count II of the Complaint Alleging Fraud and Intentional Misrepresentation and Punitive Damages Claim (Doc. No. 12), the Motion of Defendants for Summary Judgment on Medical Monitoring Claim Set Forth in Count VI (Doc. No. 13), and the Institutional Defendants' Motion for Partial Summary Judgment (Doc. No. 14). For the following reasons, Defendants' Motions will be granted in part and denied in part.

I. BACKGROUND*fn1

A. Plaintiff's Medical History

Plaintiff was born on January 8, 2002, with a congenital heart defect known as Hypoplastic Left Heart Syndrome ("HLHS").*fn2 HLHS is characterized by an underdevelopment of the left side of the heart, preventing circulation of oxygenated blood to the body. Babies born with HLHS cannot survive unless they receive a course of treatment that entails three procedures. The first procedure, called the "Norwood Procedure," modifies the heart's physiology so that the right ventricle, which normally pumps deoxygenated blood to the pulmonary arteries for oxygenation, pumps oxygenated blood to the body. The second and third procedures, respectively called the "Hemi-Fontan" and "Fontan Completion," create a physiology that allows deoxygenated blood to flow to the lungs without first going to the heart. In the Hemi-Fontan procedure, the superior vena cava, which receives deoxygenated blood from the upper body, is redirected to the pulmonary arteries. In the Fontan Completion, the inferior vena cava, which receives deoxygenated blood from the lower body, is redirected to the pulmonary arteries.

Plaintiff was born at a hospital in Tupelo, Mississippi. When it became apparent that Plaintiff had HLHS, the doctors informed Plaintiff's parents that Plaintiff had a "slim chance" of survival. (Doc. No. 11, Ex. D at 54 (M. Hess Dep.).) The doctors presented Plaintiff's parents with three options. (Id.) They could take no action and allow Plaintiff to pass away; they could put his name on a heart transplant list and hope that an acceptable transplant became available in time; or they could take him to a hospital at the University of Michigan for the Norwood Procedure. (Id. at 54-55.) Plaintiff's parents elected the last option and Plaintiff had the Norwood Procedure performed in Michigan six days after his birth. (Doc. No. 22, Ex. 2 at 2 (hereinafter, "Weber Report").) Following the Norwood Procedure, Plaintiff suffered several complications including seizures and a grade II intraventricular bleed. (Id.)

For reasons that are not entirely clear, Plaintiff's parents decided to transfer him to the A.I. duPont Hospital in Wilmington, Delaware. (See Doc. No. 11, Ex. E at 62 (hereinafter, "A. Hess Dep.") (implying that Dr. Norwood was the only doctor who would operate on Plaintiff); Doc. No. 18, at 4 (stating that Plaintiff was transferred from the Michigan Hospital to the duPont Hospital because he "experienc[ed] some medical difficulties...").) On July 10, 2002, Dr. Norwood performed a Hemi-Fontan procedure on Plaintiff. (Weber Report at 2.) Following the Hemi-Fontan procedure, Plaintiff experienced complications including a pneumothorax, brief episodes of supraventricular tachycardia, mild tricuspid and neoarctic valve insufficiency, and atrial flutter. (Id.) These complications necessitated at least one additional hospitalization and two follow-up procedures: an ablation procedure and an electrophysiology study. (Id.)

Sometime during 2002, the Medical Defendants determined that the Fontan Completion procedure could be accomplished by implanting a Cheatham Platinum covered stent ("CP stent") via catheterization. The benefit of such a procedure was that it avoided the risks attendant with a open-heart surgery. According to Dr. Norwood, the catheterization procedure "accomplish[es] the identical physiological and structural result as [the surgical procedure], but avoid[s] open heart surgery in the infant." (Doc. No. 11, Ex. C ¶ 9 (Norwood Aff.).)

On January 13, 2003, Dr. Murphy performed a Fontan Completion on Plaintiff using a catheter and two CP stents. (Weber Report at 2.) Before the procedure, Plaintiff's mother signed two consent forms: one provided by NuMed Inc., the CP stent's manufacturer; and one provided by the Hospital. (See Doc. No. 11, Exs. F, G (hereinafter, "NuMed Consent Form" and "duPont Consent Form," respectively).) The NuMed Consent Form informed Plaintiff's parents, inter alia, that the CP stent "ha[d] been developed over the past two years and remains in the investigational stage..." and that the CP stent "ha[d] not been approved by the United States Food and Drug Administration (FDA)...." (NuMed Consent Form at 1.) The CP stent is a Class III medical device under the Food, Drug & Cosmetics Act, 21 U.S.C. §§ 301 et seq.,and the Medical Device Amendments, 21 U.S.C. §§ 360 et seq. See 21 U.S.C. § 360c(a)(1)(C). As a Class III device, the CP stent could not be sold or marketed by NuMed without obtaining premarket approval from the FDA. See 21 U.S.C. §§ 331, 351, 360e. The FDA permitted the Medical Defendants to implant the CP stent in Plaintiff on a compassionate use basis. (See Doc. No. 19 at 14-15; id. Ex. 7.)*fn3

After the catheter completion of the Fontan, Plaintiff experienced complications including two small areas of right to left shunting within the stent and a hemothorax (an accumulation of blood in the pleural cavity) that required removal. (Weber Report at 2.) Three days after being discharged from the hospital, Plaintiff was readmitted to treat dehydration and an atrial flutter. (Id.) Plaintiff was discharged three days later. (Id.) He was readmitted two weeks after that to address a decrease in his blood's oxygen saturation, at which time his doctors observed an additional right to left shunt in the stent. (Id.) After several days of observation at the hospital, Plaintiff was discharged. (Id.)

Plaintiff currently suffers from a blood platelet disorder known as idiopathic thrombocytopenia purpura ("ITP"). It is not clear whether Plaintiff had ITP at birth, whether he developed it sometime after birth but before his Fontan Completion, or whether he developed it after his Fontan Completion. However, Plaintiff concedes that the ITP is unrelated to the CP stent or treatment he received from the Medical Defendants. (Doc. No. 22 at 6 (acknowledging that Plaintiff "does have an unrelated blood platelet disorder, for which he has had much intense medical care and supervision").) Complications resulting from the ITP have resulted in Plaintiff making numerous hospital visits from November of 2004 through July of 2006. (Id.) ITP limits the physical activities in which Plaintiff, who is now seven years old, can engage. For instance, he is not permitted to participate in his school's physical education classes. (A. Hess Dep. at 8.) Despite these limitations, Plaintiff's mother testified that he is doing "amazingly" well. (Id. at 94; see also id. at 7-8.)

B. Procedural History

Plaintiff brought this lawsuit in 2004 as one of three named plaintiffs to a class action. See Complaint, Conway v. A.I. duPont Hosp. for Children, No. 04-4862 (E.D. Pa. Oct. 15, 2004). The Complaint alleged a number of torts arising out of the use of the CP stent. Id.

In February of 2007, we dismissed several claims against the Medical Defendants for failure to state claims upon which relief may be granted. See Conway v. A.I. duPont Hosp. for Children, No. 04-4862, 2007 WL 560502 (E.D. Pa. Feb. 14, 2007) (Conway I). Under the broad scope of negligence alleged in Count I of the Complaint, we dismissed the plaintiffs' failure to warn, failure to perform adequate testing, and negligent marketing and design theories as alleged against the Medical Defendants. Id. at *3-5. We determined that the plaintiffs' failure to warn claim amounted to an informed consent theory. Id. at *4. We also determined that, to the extent that the plaintiffs' failure to warn theory was based on products liability, there was no legal authority "that would require a surgeon to provide his patient with the same warnings prior to surgery that would be required of the manufacturer of a product." Id. Similarly, we determined that the Medical Defendants did not have a duties with regard to the testing and design of the CP stent. Id. at *5-6. We dismissed the plaintiffs' assault and battery claim against the Medical Defendants because the Complaint alleged what amounted to an informed consent claim, which in Delaware sounds in negligence and not battery. Id. at *8. Finally, we dismissed the plaintiffs' strict products liability and express and implied warranty claims against the Medical Defendants because professionals are not normally liable under these theories and the plaintiffs alleged no facts that would require a deviation from the normal rule. Id. at *9-10 (citing and discussing Golt v. Sports Complex, Inc., 644 A.2d 989, 993 (Del. Super. Ct. 1994) with regard to strict liability and Coleman v. Garrison, 349 A.2d 8, 11 (Del. 1975), rev'd on other grounds, Garrison v. Med. Ctr. of Del. Inc., 571 A.2d 786 (Del. 1989) with regard to express and implied warranties).

On April 13, 2007, a Stipulation was filed dismissing all class action allegations in the Complaint with prejudice. See Stipulation and Order, Conway v. A.I. duPont Hosp. for Children, No. 04-4862 (E.D. Pa. Apr. 13, 2004). On January 11, 2008, we issued an order that the cases of the three named plaintiffs were to be tried separately and issued separate civil action numbers.

(See Doc. No. 1.) Prior to the plaintiffs' request to have their cases tried separately, it became apparent that Plaintiff's parents disagreed over whether they should pursue this litigation. On April 12, 2007, Plaintiff's father filed a petition to be appointed Plaintiff's guardian ad litem. See Petition of Mark Hess for Appointment of Guardian Ad Litem for Minor Plaintiff, Conway v. A.I. duPont Hosp. for Children, No. 04-4862 (E.D. Pa. Apr. 12, 2007). Plaintiff's mother had written a letter to Dr. Norwood expressing gratitude to Dr. Norwood for saving Plaintiff's life and disavowing the lawsuit. (See Doc. No. 11, Ex. B.) Plaintiff's father believed that pursuing litigation was in Plaintiff's best interest. On April 17, 2007, after a hearing we appointed Plaintiff's father, Mark Hess, as Plaintiff's guardian ad litem. See Order, Conway v. A.I. duPont Hosp. for Children, No. 04-4862 (E.D. Pa. Apr. 17, 2007).

Recently, we have ruled on summary judgment motions in the related cases of Teague Conway and Molly Guinan. On January 6, 2009, we granted summary judgment in favor of the Defendants on all outstanding claims in the Teague Conway case. See Conway v. A.I. duPont Hosp. for Children, No. 04-4862, 2009 WL 57016, at *16-17 (E.D. Pa. Jan. 6, 2009) (Conway II). Teague Conway had developed ascites, pleural effusions (conditions characterized by fluid build up in the abdomen and lungs, respectively), and protein losing enteropathy (or "PLE," a condition marked by lose of serum protein through the walls of the intestine) after the completion of the Fontan procedure. Id. at *2-3. Teague Conway's parents moved him from A.I. duPont Hospital in Wilmington, Delaware, to the Children's Hospital of Philadelphia ("CHOP"), where his new physicians performed the take-down of his Fontan, which entailed removing the CP stent. Id. at *3. The physicians observed a thrombus (a blood clot) lodged in the CP stent. Id. at *7. We granted the Defendants' motions for summary judgment because Teague Conway did not provide medical expert testimony establishing a causal connection between the use of the CP stent and the PLE, ascites, or thrombus as required by Delaware law. See id. at *5-7, *10-12.

One month later, we granted summary judgment in favor of the Defendants on all claims except for the medical monitoring claim in the Molly Guinan case. See Guinan v. A.I. duPont Hosp. for Children, No. 08-0228, 2009 WL 307019 (E.D. Pa. Feb. 6, 2009) (Guinan I); Guinan v. A.I. duPont Hosp. for Children, No. 08-0228, 2009 WL 311113 (E.D. Pa. Feb. 6, 2009) (Guinan II). Molly Guinan developed PLE and plastic bronchitis (a condition where protein is lost through the lungs) after the completion of her Fontan. Guinan I, 2009 WL 307019, at *2. We granted the Medical Defendants and Institutional Defendants' summary judgment motions regarding medical negligence and informed consent for the same reason as in the Teague Conway case: Molly Guinan did not produce medical expert testimony establishing a causal connection between the use of the CP stent and her PLE and plastic bronchitis as required by Delaware law. Id. at *10-15. We denied the Medical Defendants and Institutional Defendants' motion for summary judgment on Molly Guinan's medical monitoring claim (see medical monitoring discussion infra).*fn4 See id. at *16-18. In Guinan II, we addressed NuMed's motion for summary judgment, dismissing all outstanding claims against NuMed CEO Allen Tower and dismissing all claims except the medical monitoring claim against NuMed. See Guinan II, 2009 WL 311113, at *25-26.

II. LEGAL STANDARDS

A. Summary Judgment

A moving party is entitled to summary judgment 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). Where the non-moving party bears the burden of proof at trial, the moving party may identify an absence of a genuine issue of material fact by "showing" the court that there is no evidence in the record 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). Once the moving party carries this initial burden, the non-moving party must set forth specific facts showing that there is a genuine issue for trial. See Fed. R. Civ. P. 56(e)(2) (stating that "an opposing party may not rely merely on allegations or denials in its own pleading; rather, its response must... set out specific facts showing a genuine issue for trial"); see also Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (noting that the nonmoving party "must do more than simply show that there is some metaphysical doubt as to the material facts"); Watson v. Eastman Kodak Co., 235 F.3d 851, 857-58 (3d Cir. 2000) (explaining that once the movant has demonstrated an absence of a genuine issue of material fact, the non-movant must then establish the existence of each element on which it bears the burden of proof); Ridgewood Bd. of Educ. v. N.E. for M.E., 172 F.3d 238, 252 (3d Cir. 1999) ...


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