GUINAN v. A.I. duPONT HOSPITAL FOR CHILDREN et al
Filing
80
MEMORANDUM AND ORDER THAT THE MOTION OF DEFTS NUMED,INC. AND ALLEN J. TOWER FOR SUMMARY JUDGMENT ON THE COMPLAINT OF MOLLY GUINAN IS GRANTED AS TO COUNTS I (NEGLIGENCE), COUNT II (FRAUD AND INTENTIONAL MISREPRESENTATION), COUNT III (ASSAULT AND BATTE RY), COUNT IV (STRICT PRODUCTS LIABILITY), AND COUNT V (BREACH OF EXPRESS AND IMPLIED WARRANTY; AND THE MOTION OF DEFTS NUMED, INC. AND ALLEN J. TOWER FOR SUMMARY JUDGMENT ON THE COMPLAINT OF MOLLY GUINAN IS DENID AS TO COUNT VI (MEDICAL MONITORING). ( SIGNED BY HONORABLE R. BARCLAY SURRICK ON 2/6/09. ) 2/9/09 ENTERED AND COPIES MAILED, E-MAILED AND FAXED BY COUNSEL.(gn, )
IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA
MOLLY GUINAN v. A.I. DUPONT HOSPITAL FOR CHILDREN, et al.
: : : : : :
CIVIL ACTION NO. 08-0228
SURRICK, J. MEMORANDUM & ORDER
FEBRUARY 6 , 2009
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
For purposes of this opinion, we refer to Molly Guinan as "Plaintiff"; A.I. duPont Hospital for Children, the Nemours Foundation, the Nemours Cardiac Center, and the Nemours Delaware Institutional Review Board as the "Institutional Defendants"; Doctors William Norwood and John Murphy as the "Medical Defendants"; Allen Tower and NuMed Inc. as "NuMed"; and all the Defendants together as "Defendants." This Memorandum and Order follows a Memorandum and Order (hereinafter, "First Memorandum") which granted summary judgment in favor of the Medical Defendants and the Institutional Defendants as to all causes of action in the Complaint except Count VI (medical monitoring).
1
(Count V); and medical monitoring (Count VI). In February 2007, we granted the Medical Defendants' motion to dismiss certain theories of negligence under the Plaintiff's first cause of action; 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").) After a scheduling conference in January 2008, it was agreed that the named plaintiffs' cases would be tried separately. (See Doc. No. 1.) B. Plaintiff's 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, Plaintiff's 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 Plaintiff's 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 Plaintiff's 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").
2
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, 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"). (Doc. No. 33, Ex. K at 150-52 (hereinafter, "J. Guinan Dep.").) At CHOP, Plaintiff's 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 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").) 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
3
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 3334.) 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.
4
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).
5
21 U.S.C. § 360j(b). NuMed sent the CP stent used in Plaintiff's 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 not "pertinent." (See id.) Tower, who is not a doctor, did not understand what the Fontan procedure was when he sent the CP stent to Dr. Murphy, and he did not think it was NuMed's place to tell doctors what they could or could not do with the CP stent. (Id. at 25.) When Plaintiff developed PLE and plastic bronchitis after her Fontan was completed, her mother became dissatisfied with the treatment Plaintiff was receiving. 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").) Plaintiff's mother also contacted the FDA, which began an investigation into the use of the CP stent by the Medical Defendants. Over the course of several months, the FDA communicated with all Defendants to develop a series of remedial measures, which included, among other things, a recall of the CP stent, removing it from all institutions that had it on hand. (See Doc. No. 33, Ex. V at 2.)
6
The FDA's investigation culminated in the government bringing an information charging that NuMed and Tower violated 21 U.S.C. §§ 331(a) and 331(a)(1) by marketing an adulterated device (i.e., a device without premarket approval, see 21 U.S.C. § 351(f)(1)(B)). (See Doc. No. 33, Ex. EEE.) NuMed and Tower, in his individual capacity, pled guilty to two misdemeanor counts of introducing an adulterated device into interstate commerce in violation of 21 U.S.C. § 331(a). (See Doc. No. 33, Ex. UU (hereinafter, "Tower Plea Agreement" and "NuMed Plea Agreement").) As part of their plea agreements, NuMed and Tower agreed to pay a criminal fine of $2,293,451.00 and to perform a community service in the form of paying approximately $2 million to fund a clinical study of the CP stent for the indicated use of coarctation of the aorta administered by The Johns Hopkins University. (See Tower Plea Agreement at 2-3.) In addition to paying for the clinical study, Tower and NuMed agreed to supply CP stents for the study free of charge and, if FDA approves the CP stent, to supply it to health care providers who request it for treatment of coarctation of the aorta free of charge. (Id. at 3-4.) 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
7
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 must apply the law of the forum state. 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)). "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., 203 A.2d 796, 805-06 (Pa. 1964); see also Hanover Ins. Co. v. Ryan, No. 06-2650,
8
2007 U.S. Dist. LEXIS 92646, at *9-12 (E.D. Pa. Dec. 17, 2007) (explaining Griffith). Griffith requires a court 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. Where there is no conflict, the court can refer interchangeably to the laws of the pertinent states in discussing the law applicable to the case. On Air Entm't Corp. v. Nat'l Indem. Co., 210 F.3d 146, 149 (3d Cir. 2000) (citing Lucker Mfg. v. Home Ins. Co., 23 F.3d 808, 813 (3d Cir. 1994)). If the court determines that a conflict does exist, it then must move 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." Hanover, 2007 U.S. Dist. LEXIS 92646, at *12. The pertinent states in this case are: (a) Pennsylvania, the forum state; (b) Delaware, where the medical procedure occurred; (c) New Jersey, Plaintiff's residence; and (d) New York, NuMed's state of incorporation. Unless otherwise noted, we will apply Delaware law in this case because (1) both parties rely on Delaware law in their memoranda; (2) to the extent that there is no conflict of laws, the laws of the states whose law would be potentially applicable can be applied interchangeably; and, (3) most importantly, to the extent that a conflict exists, the parties have agreed that, under Pennsylvania's choice of law analysis, Delaware has the greatest interest. See Smith v. Cont'l Cas. Co., No. 07-1214, 2008 U.S. Dist. LEXIS 76818, at *22-23 (M.D. Pa. Sep. 30, 2008) ("The parties to this action have not explicitly addressed the choice of law question, but they have relied on Pennsylvania law in their submissions and seem to agree that Pennsylvania law governs the insurance contract at issue. Accordingly, to the extent that the
9
law of a state other than Pennsylvania could control the resolution of the present motion, the issue has been waived by the parties."); see also Mellon Bank, N.A., v. Aetna Bus. Credit Inc., 619 F.2d 1001, 1005 n.1 (3d Cir. 1980) (finding that the parties had waived any objection to the application of Pennsylvania law where the parties "proceeded at the trial and appellate level as if Pennsylvania law applied . . . [and] [n]o objection was raised below or on appeal . . ."); Sofia v. McWilliams, No. 01-5394, 2003 U.S. Dist. LEXIS 5622, at *50-51 (E.D. Pa. Mar. 31, 2003) (applying New Jersey law because the parties implicitly agreed that New Jersey law applied when they based their arguments exclusively on New Jersey law; the parties did not brief the issue; the choice of law would not impact the result; and there was no perceivable reason to apply another state's law); Textile Biocides v. Avecia Inc., 52 Pa. D. & C.4th 244, 260 & n.10 (Pa. Ct. Com. Pl. 2001) (allowing the parties to agree on choice of law "as long as the state whose law is chosen bears a reasonable relationship to the transaction and the chosen law does not affect the court's subject matter jurisdiction or violate public policy"). NuMed argues that "if there is any conflict in the laws of Pennsylvania, New Jersey, New York and Delaware, the Court should apply Delaware law . . . ." (Doc. No. 25 at 16-17.) Similarly, Plaintiff states that "Delaware has the greatest interest in this case, given that the medical treatment giving rise to these claims was rendered in Delaware." (Doc. No. 33 at 32.) We agree with the parties that Delaware's interests in this matter are stronger than the interests of the other states and that Delaware law should apply where conflicts exist.2 Delaware has the greater interest because the complained-of conduct occurred in Delaware, including the purported misrepresentations, and
Indeed, we have determined on several occasions that Delaware law applies to the nexus of facts and legal claims that form the basis of this case. (See First Memorandum at 1016; see also No. 04-cv-4862, E.D. Pa., Doc. Nos. 50, 151.) 10
2
Delaware has a demonstrable interest in regulating health care practice and policies within its borders. We will not, however, apply Delaware law to the "piercing the corporate veil" issue, which must be considered in light of Plaintiff's claims against Allen Tower as an individual. Pennsylvania courts apply the internal affairs doctrine, which "holds that courts look to the law of the state of incorporation to resolve issues involving the internal affairs of a corporation." See Banjo Buddies, Inc. v. Renosky, 399 F.3d 168, 179 n.10 (3d Cir. 2005) (citing, inter alia, CTS Corp. v. Dynamics Corp. of Am., 481 U.S. 69, 89-93 (1987)). "Pennsylvania has adopted the `internal affairs' doctrine by statute." Banjo Buddies, 399 F.3d at 179 n.10 (citing 15 Pa. Cons. Stat. § 4145(a); In re Estate of Hall, 731 A.2d 617, 622 (Pa. Super. Ct. 1999)); see also United States v. Funds Held ex rel. Wetterer, 210 F.3d 96, 106 (2d Cir. 2000) (finding that "[q]uestions relating to the internal affairs of corporations . . . are generally decided in accordance with the law of the place of incorporation"); McDermott Inc. v. Lewis, 531 A.2d 206, 215 (Del. 1987) (holding that Delaware recognizes the internal affairs doctrine). NuMed is incorporated in the state of New York. Accordingly, we will apply the law of New York to the issue of piercing the corporate veil. III. LEGAL ANALYSIS A. Negligence (Count I)
Plaintiff's negligence claims against NuMed include failure to test, failure to warn, and negligence per se based on violation of the FDCA. (See Doc. No. 33 at 42-65.) In the First Memorandum, we determined that Plaintiff's medical negligence and informed consent claims against the Medical Defendants and the Institutional Defendants failed because Plaintiff had not
11
met her burden of producing expert testimony on the essential element of causation. See 18 Del. C. § 6853(e); see also O'Donald v. McConnell, 858 A.2d 960, 960 (Del. 2004) (granting defendant's summary judgment motion because plaintiff had not produced medical expert testimony regarding causation); Burkhart v. Davies, 602 A.2d 56, 59 (Del. 1991), cert. denied, 504 U.S. 912 (1992) (holding medical expert testimony on the defendant's deviation from the standard of care and the causal connection between that deviation and plaintiff's alleged injury are essential elements of medical negligence claims). In the First Memorandum, we analyzed Plaintiff's negligence claims against the Medical Defendants and the Institutional Defendants under the framework of Delaware's Health Care Malpractice Insurance and Litigation Act (the "Health Care Act"), 18 Del. C. §§ 6801 et seq. Plaintiff's negligence claims against NuMed are not governed by the Health Care Act because NuMed is not a health care provider under the Act's terms. See 18 Del. C. § 6801(5) ("`Health care provider' means a person, corporation, facility or institution licensed by this State pursuant to Title 24, excluding Chapter 11 thereof, or Title 16 to provide health care or professional services or any officers, employees or agents thereof acting within the scope of their employment . . . ."). Nevertheless, Plaintiff's negligence claim against NuMed cannot survive summary judgment. The prescriptions of the Health Care Act notwithstanding, in order to withstand summary judgment, all tort plaintiffs in Delaware must produce medical expert testimony regarding causation when their claims are for bodily injury. Rayfield v. Power, 840 A.2d 642, 642 (Del. 2003) ("With a claim for bodily injury, the causal connection between the defendant's alleged negligent conduct and the plaintiff's alleged injury must be proven by the direct testimony of a competent medical expert.") (footnote omitted); Money v. Manville Corp. Asbestos Disease
12
Comp. Trust Fund, 596 A.2d 1372, 1377 (Del. 1991) ("The plaintiff always has the burden of proving by competent evidence that there was a reasonable probability of a causal connection between each defendant's negligence and the plaintiff's injury. When the issue of causation is presented in a context which is not a matter of common knowledge, such a reasonable probability can only be proven by the testimony of a competent expert witness."); Cann v. Dunner, No. 07C-02-15, 2008 Del. Super. LEXIS 424, at *7 (Del. Super. Ct. Nov. 13, 2008) (holding that plaintiff had failed to establish a prima facie case of negligence, entitling defendant to summary judgment, where plaintiff had not produced expert testimony connecting the automobile accident allegedly caused by defendant to plaintiff's claimed soft tissue injuries). Plaintiff has not produced expert testimony linking any of NuMed's alleged deviations from the standard of care to the cognizable legal injuries that she claims. Plaintiff contends that she has satisfied her burden regarding causation. (Doc. No 33 at 33-42.) She asserts that there is ample evidence to find causation and cites to two paragraphs in the report of her expert, pediatric cardiologist Dr. Paul Grossfeld: As far as [Plaintiff's] future is concerned, given the fact that the CP stent implanted in her on October 14, 2002, was not safe for use in humans[3] [sic] that the Cheatham platinum stent has never been shown to be safe or effective for use of stent based Fontan completion, and there was no original plan for long term care and follow up of this implanted device, I find that Molly's future is truly unknown. There is nothing in the deposition of Allen Tower or Dr. Cheatham that would indicate that they have any knowledge as to what the safety and effectiveness of the [CP] stent will be in the future. [Plaintiff] has already had two additional procedures to fenestrate the stent which was never meant to be fenestrated in order to deal with her protein losing enteropathy and plastic bronchitis. Clearly, her future is unknown and relies upon the physicians at [CHOP] to continue in their attempts to At his deposition, Dr. Grossfeld revised the statement in his report that the CP stent was "not safe for use in humans." He testified that the statement should have been that the safety of the stent was unknown. (See Doc. No. 25, Ex. 6 at 286-89 (hereinafter, "Grossfeld Dep.").) 13
3
manage this unknown and unapproved device implanted in [Plaintiff's] heart. (Doc. No. 33 at 34, 40 (quoting Doc. No. 33, Ex. WW (hereinafter, "Grossfeld Report")).) However, it is clear from the text of Dr. Grossfeld's report that he offers no opinion regarding the causal connection between the catheterization procedure or the CP stent and Plaintiff's claimed injuries. Without adequate medical expert testimony on causation, Plaintiff's negligence claims fail. NuMed is entitled to summary judgment. See Rayfield, 840 A.2d at 642; Money, 596 A.2d at 1377. B. Fraud and Intentional Misrepresentation (Count II)
In Count II of her Complaint, Plaintiff alleges that "Defendants committed common law fraud in intentionally misrepresenting the risks of undergoing the stent implantation and the complete truth behind the history of the NuMED Stent." (Compl. ¶ 102.) Plaintiff requests compensatory and punitive damages on this claim. NuMed moves for summary judgment on Plaintiff's fraud and intentional misrepresentation claim, arguing that NuMed did not make any factual misrepresentation or conceal any material fact and that NuMed did not engage in intentionally deceptive conduct toward Plaintiff. (Doc. No. 25 at 34-37.) Furthermore, NuMed argues that there is no evidence to support Plaintiff's demand for punitive damages. (Id. at 3738.) Intentional misrepresentation, or common-law fraud, requires that (1) the defendant falsely represented or omitted facts that the defendant had a duty to disclose; (2) the defendant knew or believed that the representation was false or made the representation with a reckless indifference for the truth; (3) the defendant intended to induce the plaintiff to act or refrain from acting; (4) the plaintiff acted in justifiable reliance on the representation; and (5) the plaintiff was injured by its reliance. ABRY Partners V, L.P., v. F&W Acquisition LLC, 891 A.2d 1032, 1050 (Del. Ch. 2006). "In 14
addition to overt representations, fraud may also occur through deliberate concealment of material facts, or by silence in the face of a duty to speak." H-M Wexford LLC v. Encorp., Inc., 832 A.2d 129, 144 (Del. Ch. 2003). NuMed asserts that Plaintiff cannot establish the first element of a common-law fraud claim, that is, that NuMed falsely represented or omitted facts that it had a duty to disclose. (Doc. No. 25 at 35.) First, NuMed argues that under the "learned intermediary" doctrine, it was only required to warn Plaintiff's physicians about the regulatory status of the CP stent or any risks associated with the stent. (Id. (citing Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974)).) Second, NuMed argues that since no NuMed representative spoke with Plaintiff's family until one year after the procedure, NuMed clearly cannot be said to have affirmatively misrepresented any fact. (Id. at 36 (citing J. Guinan Dep. at 231-32, 298-303; K. Guinan Dep. Vol I. at 246-51, Vol. II. at 122-27).) Finally, NuMed argues that "[t]o the extent that Guinan's fraud and intentional misrepresentation claim is based on the NuMED consent form, that form clearly states that the CP Stent is not FDA-approved." (Id. at 36 n.23.) Plaintiff responds that NuMed deliberately concealed a material fact and that NuMed's silence in the face of its duty to speak shows that NuMed is culpable of fraud. (Doc. No. 33 at 66.) Furthermore, Plaintiff argues that "[t]he `learned intermediary' rule is inapplicable here, because, as an exception to the Rule, the manufacturer, Numed, has failed to follow Federal regulations, namely, facts material to the use, and the substance of the information given to the doctors." (Id. at 55.) "The learned intermediary doctrine provides for an exception to the general rule that the manufacturer of a drug [or medical device] owes a duty to warn the consumer directly concerning risks associated with the drug [or medical device]." Lacy v. G.D. Searle & Co., 567
15
A.2d 398, 399 (Del. Sup. Ct. 1989) (brackets in original). The doctrine provides that in circumstances where (1) ethical drugs or medical devices that can be prescribed or installed only by a physician are involved and (2) a physician prescribes the drug or installs the medical device after having evaluated the patient, the manufacturer of the drug or device owes the patient only the duty to warn the physician and to provide the physician with adequate product instructions. Talley v. Danket Med., Inc., 179 F.3d 154, 163 (4th Cir. 1999); see also, e.g., Dyer v. Danek Med., Inc., 115 F. Supp. 2d 732, 740 (N.D. Tex. 2000) (applying "the learned intermediary doctrine, under which manufacturers need only warn the ultimate user's physician"); Minisan v. Danek Med., Inc., 79 F. Supp. 2d 970, 978 (N.D. Ind. 1999) ("[U]nder the Learned Intermediary Doctrine, manufacturers of prescription medical products have a duty only to warn phsycians, rather than patients, of the risks associated with the use of the product."). Courts reason that [f]or physician-prescribed drugs and medical devices, the physician is in the best position to understand the patient's needs and assess the risks and benefits of a particular course of treatment. The manufacturer, on the other hand, generally has no ability to assess the suitability of its product for a particular patient in a particular situation. Manufacturers of ethical drugs (i.e., drugs administrable only by a doctor's prescription) and medical devices make products which, while generally beneficial when used properly in the right circumstances, are often inherently dangerous when used improperly or in improper circumstances. The manufacturer lacks precisely the patient-specific information the physician possesses and uses to determine if, when, and how an ethical drug or device should be used. In addition, practical realities support the learned intermediary doctrine because it is virtually impossible in many cases for a manufacturer to directly warn each patient. While a manufacturer can enclose warnings with the product, when the product is applied directly by the physician . . . there is no practical way that the manufacturer could ensure that the patient receives the written warnings. Talley, 179 F.3d at 163 (internal quotes, citations omitted). This reasoning certainly makes sense in the context of this case, where Plaintiff could not have obtained independent access to the CP stent, where the Medical Defendants had to order the CP stent from NuMed by prescription, and 16
where the Medical Defendants inserted the CP stent into Plaintiff during a medical procedure. See, e.g., Lacy, 567 A.2d at 401 ("The rationale supporting the learned intermediary doctrine is even stronger when applied to the IUD, as opposed to an oral contraceptive, because not only must the physician order the IUD for his patient, but the physician must also fit the IUD in place. Thus, the patient is required to rely on her physician's expertise whenever an IUD is used."). Plaintiff argues that the learned intermediary rule should not apply here because there was no warning insert or physician guidance provided by NuMed, and therefore a question of fact exists. (Doc. No. 33 at 59.) Plaintiff supports her position by devoting three full pages of her brief to a block quote from a Delaware Superior Court case. (See Doc. No. 33 at 56-59 (quoting O'Brien-Hastings v. Howmedica Corp., 1996 Del. Super. LEXIS 211, at *4-7 (Del. Super. Ct. May 15, 1996)).) This extended quotation serves as Plaintiff's legal analysis of the learned intermediary doctrine. The O'Brien court refused to apply the learned intermediary doctrine because there existed a question of fact as to "whether the actual content of the warning [provided by the medical device manufacturer to the doctor] was sufficient in light of the degree of harm that a patient could suffer . . . ." O'Brien, 1996 Del. Super. LEXIS 211, at *8. NuMed argues that Plaintiff has not pointed to any "evidence that NuMED failed to provide adequate training and instructions to Dr. Murphy, to the extent that any such training or instructions were necessary." (Doc. No. 25 at 26.) Plaintiff responds that "there is ample evidence that defendants actively concealed a material fact the CP stent was purely experimental and not approved for anything . . . ." (Doc. No. 33 at 69.) Plaintiff states that although NuMed knew that doctors were using the CP stent for Fontan completion (Id. at 67 (citing Tower Dep. at 16)), NuMed "did not provide any
17
information with regard to using the CP stent for fontan completion." (Doc. No. 33 at 69 (emphasis in original).) In support of this assertion, Plaintiff quotes from Allen Tower's deposition: Q: What information did you know that Dr. Murphy had that said using this stent, your Cheatham platinum, the CP covered stent in a Fontan completion context was safe to use? He got nothing from NuMED on that and in my mind he learned about this from Cheatham and from other doctors that were doing Fontan completions throughout the world.
A:
(Tower Dep. at 65 (cited in Doc. No. 33 at 69).) Tower's response did not indicate that NuMed "did not provide any information with regard to using the CP stent for fontan completion." (Doc. No. 33 at 69 (emphasis in original).) Rather, Tower's answer indicates that NuMed did not assure the doctors that the CP stent was safe to use in the Fontan completion. Tower's deposition does not provide a basis upon which to conclude that NuMed misrepresented or failed to disclose the status and risks of the CP stent. Plaintiff also argues that "Defendants' silence in the face of his duty to speak, yes a Duty to Warn, . . . shows that defendants are culpable of fraud, who by this omission fail to reveal that which it was their duty to disclose, in order to prevent statements actually made by Drs. Murphy and Gidding from being misleading." (Doc. No. 33 at 66.) It is difficult to determine exactly what Plaintiff is trying to communicate here. If Plaintiff is arguing that NuMed's fraud occurred when NuMed failed to disclose to the Medical Defendants that the CP stent was not FDAapproved, and that this omission caused the doctors to make misleading statements to Plaintiff's parents, Plaintiff has presented no evidence to support the proposition that NuMed concealed either the regulatory status or risks of the CP stent from the doctors, or that it failed to disclose
18
that information. In fact, the record reflects that it was NuMed's practice to include a NuMed consent form with the CP stent when it was mailed to doctors upon receiving a prescription order. (See, e.g., LaFlesh Dep. at 50 ("With each CP stent that was shipped out was an informed consent form . . . . [e]xplaining the device.").) The NuMed consent form, titled "Use of the Investigational NuMED Cheatham Platinum (CP) Stent Adult/Parent Consent Form," states in pertinent part: The NuMED Cheatham Platinum (CP) stent has been developed over the past two years and remains in the investigational stage. NuMED, Hopkinton, New York, has helped with the development and manufacturing of the stent and has agreed to allow its use in you or your child. Because the CP stent has not been approved by the United Stated [sic] Food and Drug Administration (FDA), we would like to maintain appropriate records regarding the clinical effectiveness and safety of the stent. (Doc. No. 25, Ex. 4.) The form describes the composition of the CP stent and the catheterization procedure. (Id.) The form then lists potential risks, discomforts and complications that could result from the catheterization, the balloon valvuloplasty or angioplasty, or the use of a stent. (Id.) There is a factual dispute regarding whether or not Plaintiff's parents saw or signed the NuMed consent form. NuMed says that Plaintiff's father signed the form and submits a signed form as evidence. (Doc. No. 25 at 6 n.3; id., Ex. 4.) Plaintiff's father insists that he did not see or sign the form. (K. Guinan Dep. Vol. I at 87-88, 113, 117, 228; see also J. Guinan Dep. 173, 283-85.) In any event, Plaintiff points to no evidence suggesting either that the doctors did not see this consent form, which states explicitly that the device was not FDA-approved, or that the doctors did not receive additional information about the device. Plaintiff cannot create a genuine issue of material fact with a conclusory assertion that there was no warning insert and no physician guidance. She must point to facts in the record. Despite Plaintiff's statement that there is "ample evidence" to show that NuMed concealed the fact that the CP stent was not 19
FDA-approved, Plaintiff has failed to locate this evidence is in the record for the Court. After our own review of the record, it is apparent that, as the record stands, Plaintiff cannot establish the first element of the intentional misrepresentation claim. The second element of a common law fraud claim requires Plaintiff to show that NuMed acted with a reckless indifference for the truth. ABRY Partners, 891 A.2d at 1050. Plaintiff does not offer any additional evidence on this element. Moreover, the fact that NuMed, as a practice, sent doctors a copy of the NuMed consent form along with the CP stent is inconsistent with the allegation that NuMed acted with an intent to deceive. Finally, as discussed above and in the First Memorandum, Plaintiff has produced no evidence that NuMed's actions caused Plaintiff's injuries. Even if we determine that Plaintiff had established that NuMed made false representations or failed to disclose material facts to the Medical Defendants and Plaintiff's parents, NuMed would still be entitled to summary judgment on this claim because Plaintiff has not established that she suffered injuries as a result of her reliance on NuMed's misrepresentations. For these same reasons Plaintiff's negligent misrepresentation claims suffer the same fate. A negligent misrepresentation, or equitable fraud, claim must "satisfy all the elements of common-law fraud with the exception that plaintiff need not demonstrate that the misstatement or omission was made knowingly or recklessly." H-M Wexford, 832 A.2d at 144. As discussed, Plaintiff has not met her burden with regard to the first and last elements of an intentional misrepresentation claim. These same elements must be established to survive summary judgment on a negligent misrepresentation claim. Accordingly, we will grant Defendant's Summary Judgment Motion as to Plaintiff's negligent misrepresentation claim.
20
Finally, Plaintiff cannot establish a claim for punitive damages. There must be compensatory damages in order for there to be punitive damages. See, e.g., Pipher v. Burr, 1998 Del. Super. LEXIS 26, at *14 (Del. Super. Jan. 29, 1998) ("[W]here compensatory damages are not available, punitive damages are also not available."); Franklin Inv. Co. v. Smith, 383 A.2d 355, 358 (D.C. 1978) ("[P]unitive damages may not be awarded where there is no basis for an award of compensatory damages."). C. Assault and Battery (Count III)
Count III of Plaintiff's Complaint states a claim of assault and battery. (Compl. ¶¶ 10607.) Plaintiff alleges that "Defendants failed to inform [Plaintiff] . . . of the risks and alternatives to of [sic] all treatment, care, therapy and procedures performed so as to afford [Plaintiff] . . . the opportunity to make an informed decision . . . ." (Id. ¶ 107.) In Delaware, informed consent claims sound in negligence, not battery. See, e.g., 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.") Under the Health Care Act, informed consent is defined as the 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) (emphasis added). Plaintiffs bringing an informed consent claim must establish the following: 21
(1) The injury alleged involved a nonemergency 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. Id. § 6852(a) (emphasis added). Clearly, the Health Care Act places the burden of obtaining informed consent on health care providers, not manufacturers. See id. NuMed is not a health care provider. See id. § 6801(5). Therefore NuMed had no duty to obtain informed consent from Plaintiff. Plaintiff argues, however, that NuMed inserted itself into and participated in the informed consent process and therefore is not entitled to summary judgement on the assault and battery claims. (Doc. No. 33 at 80.) Plaintiff appears to argue that by enclosing an informed consent form with the CP stent, NuMed has created a voluntary duty to obtain informed consent directly from Plaintiff. Plaintiff does not support this argument with citation to legal authority. However, to the extent that Plaintiff is arguing that NuMed has the same duty as the Medical Defendants to obtain informed consent, our analysis in the First Memorandum explains why NuMed is entitled to summary judgment. NuMed's summary judgment motion on the assault and battery claim must be granted. D. Strict Products Liability (Count IV)
Count IV of the Complaint is a claim based on a theory of strict products liability. NuMed seeks summary judgment on the claim. In support thereof, NuMed advances three arguments. First, NuMed contends that under Delaware law, Article 2 of the Uniform Commercial Code preempts strict products liability claims and, consequently, "Delaware does not recognize a cause of action in strict products liability." (Doc. No. 25 at 43.) Second, NuMed
22
contends that under Delaware law, strict liability principles do not apply to prescription medical devices like the CP stent. (Id.) Finally, NuMed contends that even if Delaware recognized Plaintiff's strict products liability claim as a cause of action, Plaintiff has not shown that the CP stent was defective in design or manufacture and has not shown that NuMed failed to warn. Thus, NuMed contends that Plaintiff has not shown the necessary elements of a strict liability claim. (Id. at 44.) In response to NuMed's contention that Article 2 of the UCC preempts strict products liability claims under Delaware law, Plaintiff argues that NuMed relied on several cases that did not involve a Class III medical device like the CP stent. (Doc. No. 33 at 81.) The cases involved a shower door, a peanut jar, and an air compressor. See Miley v. Harmony Mill Ltd., 803 F. Supp. 965, 967 (D. Del. 1992) (shower door); DiIenno v. Libbey Glass Div., Owens-Illinois, Inc., 668 F. Supp. 373, 376 (D. Del. 1987) (peanut jar); Amoroso v. Joy Mfg. Co., 531 A.2d 619, 621 (Del. Super. Ct. 1987) (air compressor). Plaintiff argues that unlike a shower door, peanut jar, or air compressor, the CP stent is an "abnormally dangerous product" such that "Delaware would apply strict liability." (Doc. No. 33 at 81.)4 In response to NuMed's contention that strict liability principles do not apply to prescription medical devices, Plaintiff again argues that the CP stent is an "abnormally dangerous product" and, "as such, Delaware would apply strict liability." (Id. at 82.) Finally, in response to NuMed's contention that Plaintiff has not shown the necessary elements of a strict liability claim even if Delaware recognized such a claim, Plaintiff argues that "there is ample evidence of defective design / manufacture" and "NuMed Plaintiff did not mention the other cases on which NuMed relied for the same proposition. See Matter of L.B. Trucking, Inc., 163 B.R. 709, 718 (Bankr. D. Del. 1994) (damaging herbicidal chemicals); Cline v. Prowler Indus. of Md., Inc., 418 A.2d 968, 980 (Del. 1980) (exploding propane heater). 23
4
has not been able to provide sufficient evidence that the CP stent was safe for use in humans to obtain any sort of FDA approval." (Id. at 82, 89.) Plaintiff also argues that there is evidence that NuMed failed to warn. (Id. at 89.) With respect to the issue of whether Delaware recognizes strict products liability claims, we conclude that it does not. The Delaware Supreme Court recognized nearly thirty years ago that the doctrine of strict liability in tort is not applicable in Delaware in cases involving sales of allegedly defective goods. See Cline v. Prowler Indus. of Md., Inc., 418 A.2d 968, 980 (Del. 1980) (en banc). In Cline, the plaintiff sued the manufacturer and installer of a propane heater after the heater exploded, causing injury. Id. at 970. The plaintiff's complaint contained counts based on the doctrine of strict tort liability, breach of warranty under the Uniform Commercial Code, and negligence. Id. The trial court refused to instruct the jury on strict tort liability, and the jury found in favor of the defendants on the remaining breach of warranty and negligence claims. Id. at 970. On appeal, the Delaware Supreme Court affirmed the trial court's refusal to instruct the jury on strict liability, concluding that "by the [adoption of the UCC,] the General Assembly preempted the field of the law of products liability . . . as to sales." Id. at 979. The court reasoned that while other state courts have held that the adoption of the UCC does not preempt the application of the strict liability doctrine, those courts have so held because those states have made and preserved a distinction between the contractual nature of a UCC claim and the tort nature of a strict liability claim. Id. The court distinguished Delaware because Delaware law has melded the two claims together through its adoption of the UCC. Id. Under Delaware's adoption of the UCC, a plaintiff's recovery can be affected by manufacturer's notice of the defect, the existence of disclaimers, and the applicable statute of limitations. Id. at 974. The
24
court reasoned that the creation of a parallel cause of action in strict liability tort would be tantamount to a judicial repeal of those UCC provisions: The General Assembly's choice to make the Code nearly coextensive with the coverage under [Restatement (Second) of Torts] § 402A, at least with respect to privity and the scope of injury, suggests clearly, we think, that it intended that products liability remedies in sales cases be treated within the confines of sales warranty law and that there be no remedy therefor outside the Code. Id. at 979. The court therefore concluded that the application of strict tort liability to sales transactions would constitute impermissible judicial legislation. Id. at 971. Since Cline, Delaware state and federal courts applying Delaware law have consistently declined to recognize causes of action grounded on strict products liability. See, e.g., Johnson v. Hockessin Tractor, Inc., 420 A.2d 154, 156 (Del. 1980) (noting that "the doctrine of strict tort liability has been preempted in this State in sales cases by the General Assembly's adoption of the Uniform Commercial Code"); LeJeune v. Bliss-Salem, Inc., 85 F.3d 1069, 1072 (3d Cir. 1996) ("Applying Delaware law, we can immediately dispose of Appellants' product liability claim. Appellants' claim fails because Delaware does not recognize strict products liability."); Baylis v. Red Lion Group, Inc., 214 Fed. App'x 193, 196 n.6 (3d Cir. 2007) (unpublished opinion) (noting that under Delaware law, the UCC preempts common law strict liability in cases of sales of goods); Nationwide Mut. Fire Ins. Co. v. Sears Roebuck & Co., No. 07-0153, 2008 WL 613145, at *2 (D. Del. Mar. 5, 2008) (dismissing strict liability claim "[b]ecause Delaware does not recognize a claim for strict liability"); DiIenno, 668 F. Supp. at 376 (rejecting strict liability claim and noting that "[i]f [the plaintiff] is to recover in this action it can only be under the UCC breach of warranty theory she alleges . . . in her complaint"); Sellon v. Gen. Motors Corp., 571 F. Supp. 1094, 1102 (D. Del. 1983) ("In cases decided after Cline, Delaware
25
state and federal decisions have unanimously declined to recognize a cause of action in strict tort liability in cases involving sales transactions."); Middlesex Mut. Assur. Co. v. Del. Elec. Signal Co., No. 07C-12-005, 2008 WL 4216145, at *5 (Del. Super. Ct. Sept. 11, 2008) (noting same); Gunzl v. CJ Pony Parts, No. 07C-10-169, 2008 WL 755272, at *2 n.10 (Del. Super. Ct. Mar. 20, 2008) ("Under Delaware law, a claim of strict liability based on sales is governed by the [UCC] and not by tort law. Thus, [the plaintiff] can only recover damages for a breach of an implied or express warranty where there is privity between the parties, notice is established, and the applicable statute of limitations has not run."); Thompson v. Reinco, Inc., No. 01C-04-076, 2004 WL 1426971, at *1 n.1 (Del. Super. Ct. Jun. 15, 2004) (noting that "the doctrine of strict liability is preempted in Delaware by the [UCC] in sales cases"); Smith v. DaimlerChrysler Corp., No. 94C-12-002, 2002 WL 31814534, at *2 (Del. Super. Ct. Nov. 20, 2002) ("In Delaware, the doctrine of strict liability has been preempted by the UCC in sales cases, which Plaintiff concedes."); Evans v. FMC Corp., No. 89C-AU27, 1991 WL 165901, at *1 (Del. Super. Ct. 1991) (noting that "the theory of strict products liability is not available in Delaware as a basis for recovery when the sale is governed by the UCC"). Plaintiff contends that Cline and its progeny do not apply to bar strict liability claims where the allegedly defective product is "abnormally dangerous" and presents "a high degree of harm."5 (Doc. No. 33 at 81.) In support of this argument, Plaintiff relies on Bell v. Celotex Plaintiff also states that she is "confused as to [D]efendants' citations to stand for [sic], `Furthermore, Delaware like many other states refused to apply strict liability principles to any product claims concerning a prescription medical device.'" (Doc. No. 33 at 80-81.) Plaintiff's confusion is evident. The issue is whether Delaware recognizes strict products liability claims like the one at issue. NuMed relies on a line of legal authority for the proposition that Delaware does not recognize such claims. Plaintiff appears to be confused by NuMed's inference that since Delaware generally does not recognize strict liability claims outside of the UCC, Delaware does not recognize strict liability claims in this context. Plaintiff therefore draws factual 26
5
Corporation, No. 79C-DE-125. 1988 WL 7623, at *2 (Del. Super. Ct. Jan. 19, 1988) (unpublished opinion). In Bell, the plaintiffs alleged that they were exposed to asbestos in the course of their work. Id. The plaintiffs brought a strict liability claim against their employer, alleging that Delaware should apply strict liability considerations to a tort claim involving asbestos as an abnormally dangerous product. Id. The court rejected the plaintiffs' argument that the abnormally dangerous nature of the product removed the case from the purview of Cline and its progeny. In doing so, the court attached in an appendix an opinion issued in another case, In re Asbestos Litigation, No. 79C-DE-125 (Sep. 30, 1985), for the proposition that "the sale of a product containing an inherently dangerous substance d[oes] not remove that sale from the line of cases which have found strict liability to be inapplicable to sales." Id. at *3 (citations omitted). In the attached case, the court noted its concern that the plaintiffs relied on cases decided before Cline, observing that: It is indeed baffling why plaintiffs argue such cases in light of recent Delaware decisions, which plaintiffs either misread or chose to ignore, holding that the legislative enactment of the Uniform Commercial Code . . . prevents "the extension of the doctrine of strict tort liability to the law of sales." Id. at *6 (citations omitted). The court elaborated that Cline definitively stated that the doctrine of strict liability does not apply to the sale of abnormally dangerous products: It is deserving of special mention that in [previous cases], the plaintiffs, like the plaintiffs in the instant case, asserted that despite Cline, strict liability applies to the sale of "inherently dangerous products." The plaintiffs argued that the inherently dangerous propensities of a product remove it from the purview of Cline. However, the Court definitively stated [that the UCC] applies to sales transactions in goods, making no distinction as to type of goods, i.e., inherently hazardous, or non-hazardous. Even if this Court took judicial notice that "Drain Snake," which distinctions between the CP stent and the products involved in the legal authorities that NuMed cited. We fail to see how the factual distinctions that Plaintiff makes affect the Delaware Supreme Court's reasoning in Cline. 27
contains almost 90% sulfuric acid, is hazardous . . . the nature of the transaction, i.e., sale of a product, does not change. In view of the holding in Cline, the doctrine of strict tort liability does not apply to the sale of an inherently dangerous product. Id. at *7; see also Franchetti v. Intercole Automation, Inc., 523 F. Supp. 454, 457 (D. Del. 1981) ("Although the precise holding of Cline does not apply to this case, it is clear that the Court's rationale was considerably broader than its holding."). The court in In re Asbestos Litigation was "compelled," sua sponte, to sanction the plaintiffs reasoning that "as a result of the position taken by counsel for the plaintiffs regarding an action in tort for strict liability, measured against the backdrop of well-settled Delaware law, counsel have swelled the record and caused unnecessary expense." Id. The court therefore ordered the plaintiffs' counsel to pay "all reasonable costs to include reasonable attorneys fees . . . to any and all defense counsel of record who incurred actual expenses and/or billable time in this regard." Id. Here, Plaintiff relies on Bell and its attached case, In re Asbestos Litigation for the very proposition that the Delaware courts rejected twenty years ago. Indeed, the court was "baffled" by the plaintiff's argument in light of well-settled case law. Id. at *6. We are similarly baffled. Plaintiff's reliance on Bell is even more troubling in light of Plaintiff's contradictory position at an earlier, consolidated stage of this litigation. In responding to the medical providers' motion to dismiss Plaintiff's strict liability claim, Plaintiff maintained that "Delaware is one of only a handful of states that has not adopted Section 402A of the Restatement. Instead, Delaware recognizes strict products liability for design defects under Article 2 of the [UCC]." (No. 04-4862, Doc. No. 34 at 17-18.) For that proposition, Plaintiff cited Beattie v. Beattie, a case that recognizes and applies the rule from Cline that "the [UCC] preempt[s] strict liability in `sale of goods' transactions." 786 A.2d 549, 554 (Del. Super. Ct. 2001). Thus, Plaintiff has long
28
recognized that the UCC and not the Restatement provides the applicable rule of law. Plaintiff's counsel certainly should have been aware based on her own legal arguments, if nothing else that in Delaware the UCC preempts strict liability in sale of goods transactions.6 See Beattie, 786 A.2d at 554. We agree with NuMed that under Delaware law, it is well-settled that the doctrine of strict liability is preempted by the UCC in sales cases. See Nationwide Mut., 2008 WL 613145, at *2; DiIenno, 668 F. Supp. at 376; Sellon, 571 F. Supp. at 1102; Middlesex, 2008 WL 4216145, at *5; Gunzl, 2008 WL 755272, at *2 n.10; Thompson, 2004 WL 1426971, at *1 n.1; Evans, 1991 WL 165901, at *1. Plaintiff's attempt to distinguish the instant case based on the alleged "abnormally dangerous" nature of the CP stent is inconsistent with the reasoning that the Delaware Supreme Court set forth in Cline. See 418 A.2d at 980. Delaware courts have repeatedly rejected distinctions like the one that Plaintiff now makes. See, e.g., Bell, 1988 WL 7623, at *2; In re Asbestos Litig., No. 90C-10-72, 1993 WL 603386, at *2 (Del. Super. Ct. 1993) ("The law in Delaware is well-settled on this issue: the doctrine of strict liability in tort has no application to the sale of a product. This is true even where it is alleged that the product is inherently dangerous.") (citations omitted); Hammond v. Colt Indus. Operating Corp., 565 A.2d 558, 562 (Del Super. Ct. 1989) (noting that, since Cline, "Delaware courts have refused to extend strict liability to cases involving the sale of a product even where it is alleged that the product is inherently dangerous"). We are satisfied that the "abnormally dangerous" nature of a
It is appropriate to remind counsel of their obligations to the Court. See Fed. R. Civ. P. 11(b)(2) (providing that "[b]y presenting to the court a pleading, written motion, or other paper, . . . an attorney . . . certifies that . . . the . . . legal contentions are warranted by existing law or by a non-frivolous argument for extending, modifying, or reversing existing law or for establishing new law"). 29
6
product does not remove it from the rule set forth in Cline, and the doctrine of strict liability does not apply in this case.7 Summary judgment in favor of NuMed on Count IV will be granted.8 E. Breach of Express and Implied Warranty (Count V)
Count V of the Complaint alleges breach of express and implied warranties. The Delaware UCC provides for three types of warranties arising from the sale of goods: (1) express warranties, see 6 Del. C. § 2-313 (2009); (2) implied warranties of merchantability, see 6 Del. C. § 2-314 (2009); and (3) implied warranties for a particular purpose, see 6 Del. C. § 2-315 (2009). NuMed contends that it is entitled to summary judgment on Plaintiff's express warranty claim since "Plaintiff has not identified any express warranty about the stent made by NuMed." (Doc. No. 25 at 53.) NuMed contends that it is entitled to summary judgment on Plaintiff's implied warranty of merchantability claim since "Plaintiff has presented no evidence that the CP stent implanted in her was defective in any way[, n]or has she offered any expert testimony showing that the stent was defective or demonstrating that the stent caused any injury to Plaintiff." (Id. at 54.) Finally, NuMed contends that it is entitled to summary judgment on Plaintiff's implied warranty for a particular purpose claim since "[t]here is no evidence that the CP stent was unfit
Although Count IV of the Complaint cites the Restatement (Second) of Torts Section 402A, we agree with the parties that Section 402A does not apply to Plaintiff's claim against NuMed. (See Doc. No. 25 at 43; No. 04-4862, Doc. No. 35 at 17-18.) Instead, Article 2 of the UCC provides the governing framework. (Id.) See Franchetti, 523 F. Supp. at 457 (noting that the UCC provides "a right of recovery [that is] nearly as coextensive as strict tort liability" and that "[t]he scope of that recovery reflects the legislature's understanding that there would be no remedy beyond negligence in products liability cases involving sales transactions outside of the [UCC]"). Even if Section 402A applied, we are satisfied that, for the reasons mentioned infra, Plaintiff has failed to present evidence that the CP stent was defective to subject NuMed to liability. We note that NuMed elected not to file a motion to dismiss Count IV under Federal Rule of Civil Procedure 12(b)(6). 30
8
7
or unsafe for the purposes for which it was manufactured, nor that it was defective or unreasonably dangerous." (Id.) Plaintiff attempts to survive summary judgment on all three claims. Plaintiff responds that there is sufficient evidence to support a claim for breach of an express warranty, since: NuMed has described the CP stent as "custom," when there is no indicia [sic] of a "custom device," a product that could be obtained for use in an approved manner, and [Plaintiff] relied upon that bargain. What [Plaintiff] received, [sic] was an unapproved experimental device that noone [sic] is using for fontan [sic] completion. (Doc. No. 33 at 94.) Plaintiff argues that there is sufficient evidence to support a claim of breach of the implied warranty of merchantability, since "NuMed sold the CP stents, which were "defective" and "not merchantable" for Fontan completion. (Id. at 96.) Finally, Plaintiff argues that there is sufficient evidence to support a claim of breach of the implied warranty for a particular purpose, since "Numed and Allen Tower had reason to know that this CP stent . . . would be used by Defendants Murphy and Norwood, and for what purpose [i.e., a Fontan completion]." (Id. at 97.) Thus, Plaintiff argues that "there is an implied warranty that the CP stent was fit for that purpose." (Id. at 98.) Plaintiff alleges that NuMed breached this warranty because "the stent is not used for fontan [sic] completion in the United States, or Canada" and "NuMed was never able to prove to the FDA that the CP stent was safe and effective for use." (Id.) 1. Breach of Express Warranty
Plaintiff's express warranty claim is governed by Delaware statute. See 6 Del.C. § 2-313.9 The statute provides that "a seller creates an express warranty by making (1) an
9
The statute, 6 Del. C. § 2-313, provides that:
(1) Express warranties by the seller are created as follows: 31
affirmation of fact or promise; (2) to the buyer; (3) which relates to the goods; and (4) becomes part of the basis of the bargain." Harris v. Dependable Used Cars, Inc., No. 96C-10-023, 1997 WL 358302, at *4 (Del. Super. Ct. Mar. 20, 1997). The statute is "identical to Section 2-313(1) and (2) of the Uniform Commercial Code." Bell Sports, Inc. v. Yarusso, 759 A.2d 582, 592 (Del. 2000). The Delaware Supreme Court has noted that "[t]he official commentary to that section under the UCC indicates that the drafters intended its warranty provisions to be construed and applied liberally in favor of a buyer of goods." Id. (citing UCC § 2-313 cmt. 1 (1977) ("Express warranties rest on `dickered' aspects of the individual bargain, and go so clearly to the essence of that bargain that words of a disclaimer in a form are repugnant to the basic dickered terms."); UCC § 2-313 cmt. 3 ("In actual practice affirmations of fact made by a seller about the goods during a bargain are regarded as part of the description of those goods; hence no particular reliance on such statements need be shown in order to weave them into the fabric of the agreement."); UCC § 2-313 cmt. 4 ("[A] contract is normally a contract for a sale of something describable and described. A clause generally disclaiming `all warranties, express or implied' (a) Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise. Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description. Any sample or model which is made part of the basis of the bargain creates an express warranty that the whole of the goods shall conform to the sample or model.
(b) (c)
(2) It is not necessary to the creation of an express warranty that the seller use formal words such as "warrant" or "guarantee" or that he have a specific intention to make a warranty, but an affirm
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?