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Guinan v. A.I. Dupont Hospital for Children

February 6, 2009


The opinion of the court was delivered by: Surrick, J.


Presently before the Court is the Motion of Defendants Numbed, 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.*fn1


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 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").

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 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 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.)

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.)


A. Summary Judgment

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

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

B. Choice of Law

Federal courts sitting in diversity 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, 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 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.*fn2 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.

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.


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 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 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*fn3 [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 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 37-38.)

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 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, Numbed, 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 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 ...

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