Guinan v. A.I. Dupont Hosp. for Children

Decision Date06 February 2009
Docket NumberNo. 08-0228.,08-0228.
Citation597 F.Supp.2d 485
PartiesMolly GUINAN v. A.I. DUPONT HOSPITAL FOR CHILDREN, et al.
CourtU.S. District Court — Eastern District of Pennsylvania

John M. Hudgins, IV, Weinberg Wheeler Hudgins Gunn & Dial LLC, Atlanta, GA, David J. Creagan, David E. Edwards, White and Williams LLP, Nicholas R. Gimbel, McCarter and English, L.L.P., Sara Petrosky, Suzanne N. Pritchard, McCann and Geschke, P.C., Philadelphia, PA, for A.I. duPont Hospital for Children, et al.

MEMORANDUM & ORDER

SURRICK, District Judge.

Presently before the Court is the Motion of Defendants Numed, Inc. and Allen J. Tower For Summary Judgment on the Complaint of Molly Guinan. (Doc. No. 25.) For the following reasons, the motion will be granted in part and denied in part.1

I. BACKGROUND
A. Procedural History

On October 15, 2004, Plaintiff, along with two other individuals, filed against Defendants on behalf of themselves and those similarly situated. The Complaint alleges six causes of action: negligence (Count I); Fraud and Intentional Misrepresentation (Count II); Assault and Battery (Count III); Strict Products Liability (Count IV); breach of express and implied warranty (Count V); and medical monitoring (Count VI). In February 2007, we granted the Medical Defendants' motion to dismiss certain theories of negligence under the Plaintiffs first cause of action; Plaintiffs third cause of action for assault and battery; Plaintiffs fourth cause of action for strict products liability; and Plaintiffs 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").) After a scheduling conference in January 2008, it was agreed that the named plaintiffs' cases would be tried separately. (See Doc. No. 1.)

B. Plaintiffs Medical Treatment

Plaintiff was born on March 12, 2001, with Down Syndrome and a combination of heart defects. As part of her treatment for these heart defects, Plaintiffs doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, implanted a stent in her heart that was not approved by the Food and Drug Administration. The Medical Defendants used this stent, known as the Cheatham Platinum covered stent ("CP stent"), in the second step of a two-step process known as the Fontan procedure. The first step of the procedure, the Hemi-Fontan, was intended to redirect unoxygenated blood from the upper half of Plaintiffs body to her lungs for oxygenation, bypassing her non-functioning right ventricle. (Doc. No. 20, Ex. A ¶ 5 (hereinafter, "Norwood Decl.").) The second step of the procedure, the Fontan completion, was intended to redirect unoxygenated blood from the lower half of Plaintiffs body to her lungs. (Id. ¶ 7.) A traditional Fontan completion ("Surgical Completion") is an open heart surgery. (Id.) Some time prior to treating Plaintiff, the Medical Defendants determined that the Surgical Completion could be achieved through a less invasive catheterization procedure using the CP stent ("Catheterization Fontan").

On October 14, 2002, cardiologist Dr. Murphy implanted a CP stent in Plaintiff. After the procedure, Plaintiff developed protein losing enteropathy ("PLE") and plastic bronchitis, both rare and potentially life-threatening conditions. Plaintiff's parents were dissatisfied with the Medical Defendants' treatment in response to these conditions, and in May 2003, Plaintiffs 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"). (Doc. No. 33, Ex. K at 150-52 (hereinafter, "J. Guinan Dep.").)

At CHOP, Plaintiffs doctors determined that fenestrating—i.e., putting a hole in— the CP stent was the best treatment for Plaintiff's plastic bronchitis, her PLE having dissipated on its own. (See Doc. No. 25, Ex. 21 at 22 (hereinafter, "Rome Dep.").) The doctors at CHOP believed 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 Plaintiffs 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").) On December 17, 2004, Dr. Rychik used a catheter to fenestrate the CP stent in Plaintiff. (J. Guinan Dep. at 169.) In February, 2006, Drs. Rychik and 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.) Plaintiff's parents consented, and Dr. Rychik performed the procedure. (See K. Guinan Dep. Vol. II at 116-20; J. Guinan Dep. at 292-94.) Plaintiff continues to suffer from plastic bronchitis, which, combined with other physiological and developmental issues that accompany Down Syndrome, necessitates ongoing medical supervision.

C. NuMed and the CP Stent

The CP stent was created by Dr. John Cheatham and NuMed's president, chief executive officer, and sole shareholder, Allen Tower. (See generally Doc. No. 33, Ex. G at 30-40 (hereinafter, "Cheatham Dep.").) The two began collaborating together in the mid-1990s to develop a stent specifically intended for treatment of cardiac problems in children. (Id. at 33-34.) In its original form, which took shape in 1997, the stent was bare and made out of platinum. By 2002, when the Medical Defendants implanted it in Plaintiff, the CP stent was made of platinum with gold welds and covered in Gore-Tex. (See id. at 52-53.)

It is uncontested that the CP stent is a Class III medical device under the Food, Drug & Cosmetics Act ("FDCA"), 21 U.S.C. §§ 301 et seq. and the Medical Device Amendments ("MDA"), 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. In 1997, NuMed contacted the FDA to arrange to have the CP stent classified as a humanitarian use device ("HUD"), which is "a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year." See 21 C.F.R. § 814.3(n). A HUD classification allows a device manufacturer to obtain a humanitarian device exemption to the regular premarket approval requirements for Class III devices under the FDCA. See 21 U.S.C. § 360j(m). On May 10, 2000, NuMed obtained HUD approval for the first version of the CP stent from the FDA. (Doc. No. 25, Ex. 13 at 31-32 (hereinafter, "LaFlesh Dep.").)

Over the next year NuMed pursued an HDE so that it could market and sell the device. The FDA refused NuMed's requests in July 2000 and January 2001. (Id. at 37-42.) NuMed withdrew its HDE application in March 2001 and indicated to the FDA that it intended to file for an investigational device exemption ("IDE"). See 21 U.S.C. §§ 360j(g), 360bbb(c); 21 C.F.R. §§ 812.1 et seq. During this time period, the CP stent was being tested in animals and modified. (LaFlesh Dep. at 62-63.) NuMed was also seeking approval to sell the device in Europe from the European Union. (Id. at 80-81.)

Over the course of the FDA approval process, NuMed was providing the CP stent to doctors under what NuMed believed to be the custom device exemption to the premarket approval requirements of the FDCA. (Doc. No. 25, Ex. 11 at 20 (hereinafter, "Tower Dep.").) The custom device exemption removes devices that "in order to comply with the order of an individual physician[,] ... necessarily deviate[ ] from an otherwise applicable performance standard or requirement prescribed by or under section [21 U.S.C. § 360e]" from the FDCA's premarket approval requirements if two conditions are met:

(1) the device is not generally available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and

(2) such device—

(A) (i) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated) and is to be made in a specific form for such patient, or

(ii) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated), and

(B) is not generally available to or generally used by other physicians or dentists (or other specially qualified persons so designated).

21 U.S.C. § 360j(b). NuMed sent the CP stent used in Plaintiffs Catheterization Fontan to Dr. Murphy under what it believed was a custom device exemption to the FDCA. (LaFlesh Dep. at 138.)

The Medical Defendants first approached NuMed at a medical convention in Chicago in 2001 or 2002. (Tower Dep. at 5-6, 26-28.) They expressed interest in using the CP stent for doing transcatheter completions of the Fontan procedure. (Id. at 27.) At the time, Allen Tower believed that NuMed could provide the Medical Defendants with the CP stent if they wrote a prescription for a specific patient. (Id. at 20.) Tower believed that if the doctor wrote a prescription and NuMed shipped the paperwork that it had worked on with the FDA "to get the right wording," then what the Medical Defendants did with the CP stent was...

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