Colombini v Westchester County Health Care Corp.

[*1] Colombini v Westchester County Health Care Corp. 2009 NY Slip Op 51555(U) [24 Misc 3d 1222(A)] Decided on July 6, 2009 Supreme Court, Westchester County Jamieson, J. Published by New York State Law Reporting Bureau pursuant to Judiciary Law § 431. This opinion is uncorrected and will not be published in the printed Official Reports.

Decided on July 6, 2009
Supreme Court, Westchester County

John Colombini As Administrator of the Estate of MICHAEL COLOMBINI, Deceased, and JOHN COLOMBINI and BARBRA COLOMBINI, Individually, Plaintiffs,

against

Westchester County Health Care Corporation, JIAN HOU, M.D., UNIVERSITY IMAGING MEDICAL CORPORATION AND MEDICAL ASSOCIATES, P.C., VALHALLA ANESTHESIA ASSOCIATES, P.C., NEW YORK MEDICAL COLLEGE, MARY NADLER, R.N., PATRICIA LAURIA, PAUL DANIELS AND GENERAL ELECTRIC COMPANY, and TERENCE MATALON, M.D., Defendants.



11101/2002



Attorneys for Plaintiffs, Kramer, Dillof, Livingston & Moore; Attorneys for Defendants, Schiavetti, Corgan, Soscia, DiEdwards and Nicholson, LLP and Heidell, Pittoni, Murphy & Bach, LLP

Linda S. Jamieson, J.

In this long-standing, complex action arising from the tragic death of Michael Colombini on July 29, 2001, discovery has finally been completed, and the parties have made three motions: (1) GE seeks summary judgment dismissing it from the action entirely, as well as to stay the trial of the action until its motion has been resolved; (2) plaintiffs seek to reinstate their claim for punitive damages against GE; and (3) all defendants but GE (the "Other Defendants") seek (a) to dismiss the claims for punitive damages against University Imaging and Medical [*2]Associates, P.C. ("UIMA")[FN1], Paul Daniels, Patricia Lauria and Terence Matalon, M.D.; (b) to dismiss all claims against Paul Daniels and New York Medical College; and (c) to dismiss all claims of emotional distress brought by John Colombini.

As a threshold matter, plaintiffs argue that the Other Defendants' motion should be denied because it is untimely. The Court rejects this argument. The Court, pursuant to CPLR §§ 2001 and 2004, has the power to overlook any possible untimeliness. The Court notes that it entertained many telephone calls from counsel on this case requesting repeated extensions of time for these voluminous summary judgment motions, and granted every request. It is not going to penalize anyone on procedural grounds, and leave open issues which can and should be decided now.

GE's Motion for Summary Judgment

Plaintiffs have four causes of action against GE (1) negligence, because GE allegedly owned, controlled and/or maintained the MRI facility at the hospital; (2) negligent design and manufacturing of the MRI machine, as well as the negligent failure to warn; (3) breach of warranty; and (4) strict products liability.

A.Federal Preemption

I.Background

As its first argument, GE claims that all of these causes of action are preempted by a Federal statute, the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 360(a)(1)(c) (the "MDA"). The United States Supreme Court has ruled, in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), that certain state law claims are preempted by the MDA's preemption clause, which states that

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a). Riegel held that this preemption clause bars state law claims challenging the safety and effectiveness of a medical device marketed in a form that received what is called "premarket approval" from the Food and Drug Administration [*3]("FDA"). Premarket approval is a "rigorous process," requiring a manufacturer to

submit what is typically a multivolume application [which] includes, among other things, full reports of all studies and investigations of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a "full statement" of the device's "components, ingredients, and properties and of the principle or principles of operation"; "a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device"; samples or device components required by the FDA; and a specimen of the proposed labeling. . . . The FDA spends an average of 1,200 hours reviewing each application, and grants premarket approval only if it finds there is a "reasonable assurance" of the device's "safety and effectiveness." The agency must "weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.

Riegel, 128 S. Ct. at 1004 (citations omitted). Only certain devices undergo the premarket approval procedure, those devices that are classified as Class III — as the MRI machine at issue here initially was classified.

Once the Class III device undergoes the premarket approval process and is approved, the MDA forbids the manufacturer to make, without FDA permission, certain changes in design specifications, manufacturing, labeling or other aspects that affect the safety or effectiveness of the device. Mitaro v. Medtronic, Inc., 23 Misc 3d 1122(A), 2009 WL 1272398 (Sup. Ct. West. Co. April 9, 2009) (Nicolai, J.) (on motion to dismiss, dismissing claims for strict liability for failure to warn, strict liability for defective design, negligence, breach of implied warranty, among others, based on preemption). Any claim brought under state law that would impose requirements "different from, or in addition to" the requirements set forth in the MDA and the premarket approval are preempted. "In deciding whether the product liability claims at issue . . . imposed requirements different from, or in addition to' those set forth under the federal regulatory regime, the [Riegel] court stated: State tort law that requires a manufacturer's [medical devices] to be safer, but hence [potentially] less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.'" Mullin v. Guidant Corp., —A.2d—, 2009 WL 1272327 (Conn. App. Ct. May 12, 2009) (claims [*4]under state law were preempted by MDA) (quoting Riegel).[FN2]

The only causes of action that are not preempted by the MDA are those claims that that "would not create requirements that are different from or in addition to the federal requirements," but instead parallel the federal requirements. Id. That is to say, the only claims that are allowed are those in which the manufacturer did not comply with the FDA requirements. See generally Mitaro, 2009 WL 1272398 at *2; Mullin, 2009 WL 1272327 at *5. Once the FDA has approved the design, manufacturing process, and labeling of the device, any finding of negligence under state common law would necessarily impose requirements different from those imposed by the FDA. This is what is preempted. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008) (dismissing claims for common law negligence and breach of warranty).

II.The Approval Process for the MRI Machine

In 1983, the MRI machine at issue here was classified as a Class III device, and GE began the premarket approval process. The completed application was submitted to the FDA in May 1984. In December 1984, the FDA issued a letter to GE, called an "Approvable Letter," which stated that GE's application was on track to be approved, if certain amendments to the application were made. After some negotiation, GE made the requested changes, and in April 1985, the FDA approved the MRI machine as a Class III medical device under the MDA. GE submitted various supplements and reports to the FDA over the next several years, as required.

In 1986, however, GE, along with other MRI machine manufacturers, sought to have their machines reclassified from Class III devices to Class II devices. In July 1988, the FDA reclassified GE's MRI machine as a Class II device. The reclassification letter specifically noted that "all currently marketed devices have undergone premarket approval." See July 28, 1988 Letter from the FDA to GE, Exhibit K to GE's motion.

Plaintiffs make much of the reclassification, stating that their claims

survive preemption from the time MRI scanners were reclassified from Class III to Class II medical devices in July of 1988. This is because once the device was reclassified as Class II, GE was no longer bound by any PMA requirements and conditions. . . . [*5]Upon reclassification as a Class II device, the restrictions on manufacturers of MRI scanners were no different than those on devices that entered the market through the 501(k) substantial equivalence process. . . . Since PMA approval and the accompanying restraints or requirements are negated once the device is reclassified, there can be no preemption after reclassification. . . .

Gaier Affirmation of December 14, 2007 ("Gaier December Aff.") at pp. 86, 91. The Court disagrees with plaintiffs' conclusion.[FN3] Rather, this Court finds that the fact of having gone through the "rigorous" premarket approval process is determinative. Once a device has undergone premarket approval, it is already in an "approved form [that the FDA has determined] provides a reasonable assurance of safety and effectiveness." Riegel, 128 S. Ct. at 1007.

As the Court held in Rousseau v. Depuy Ortho., Inc., 2006 WL 3716061, the only decision that either party cites on this issue, it is not the present classification of the device at issue that is the primary factor in determining whether claims are preempted under the MDA, but "the process the product underwent in order to obtain FDA approval." Id. at *8 ("the approval process is key to the preemption analysis.") (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S. Ct. 2240 (1996)).

Moreover, there is case law to support the proposition that if the particular device in question had already been put into commerce during the time that the device was classified as a Class III device, the Court should analyze the preemption using the Class III status, regardless of its later reclassification. See Scott v. Pfizer Inc., 249 F.R.D. 248, 254 fn.8 (E.D.Tex. 2008) (treating bone cement as Class III rather than Class II because the cement at issue in the case was manufactured and distributed during the time of the Class III classification). See also Southard v. Temple Univ. Hosp., 781 A.2d 101 (Pa. 2001) (analyzing device as Class III even though it was reclassified to [*6]Class II after the events had occurred). In the instant case, the FDA did not reclassify the MRI machine from Class III to Class II until July 1988.[FN4] The contract between GE and Westchester Medical Center was executed in mid-1986 — at a time when the machine was a Class III device. While apparently the machine was upgraded in 1997, according to plaintiffs, "the bore of the magnet remained the same" — presumably the same as it was when the machine was a Class III device. See Gaier December Aff. at ¶ 84. Based on the reasoning in Scott, then, the reclassification of the device is irrelevant.

Therefore, because the MRI machine at issue here did go through the premarket approval process — which, as the Riegel Court stated "is federal safety review," 128 S. Ct. at 1007 — and was expressly approved, the fact that the FDA later determined that the device was less risky than previously thought does not negate the approval, or the preemption.[FN5] The additional fact that the core part of the device was manufactured at a time when it was classified as a Class III device bolsters this conclusion.

III.The Specific Claims Here

Just because the Court has determined that federal preemption applies to the MRI machine does not mean that all of plaintiffs' claims are preempted. Rather, the Court must analyze each of the claims set forth in the complaint to determine whether any of them are parallel claims that are not preempted. The claims plaintiffs bring against GE are, as listed above, negligence, because GE allegedly owned, controlled and/or maintained the MRI facility at the hospital; negligent design and manufacturing of the MRI machine, as well as the negligent failure to warn; breach of warranty; and strict products liability. Another Supreme Court in Westchester County has already found that the MDA preempts, among others, claims for failure to warn; claims for design defects; claims for negligent design, testing, manufacturing, distribution and marketing; and [*7]claims for breach of implied warranty.[FN6] See Mitaro v. Medtronic, Inc., 23 Misc 3d 1122(A), 2009 WL 1272398 (Sup. Ct. West. Co. April 9, 2009) (Nicolai, J.). This Court agrees.

The trial court in Lake v. Kardjian, 2008 WL 5244823 (Sup. Ct. Madison Co. Dec. 17, 2008) came to a similar conclusion. In that case, the Court dismissed claims for breach of duty to warn, breach of warranty, strict liability and negligence. The Lake Court also held that the failure of the manufacturer to report certain incidents involving the device at issue — much the same as plaintiffs claim here — does not deprive the manufacturer of the benefits of preemption. The Court held that claims that state that by failing to report incidents, a manufacturer violated the MDA "are impliedly preempted by federal law, because enforcement . . . is the sole province of the federal government." 2008 WL 5244823 at *2. See also Horowitz v. Stryker Corp., - F.Supp.2d -, 2009 WL 436406 (E.D.NY Feb. 20, 2009) (dismissing claims for negligent and defective manufacturing, defective design, breach of implied and express warranties and failure to warn, among others, all based on preemption); Parker v. Stryker Corp., 2008 WL 4716879 (D. Colo. Oct. 22, 2008) (dismissing claims for failure to warn, defective design, negligence and breach of warranties, among others); Despain v. Bradburn, 2008 WL 1067202 (Ark. April 10, 2008). The Riegel decision also clearly states that claims for strict product liability are preempted. 128 S.Ct at 1007.

To sidestep the issue of preemption, plaintiffs claim that they have a parallel claim that is allowed. They argue repeatedly that both piped-in oxygen systems and metal detectors are mandatory requirements that GE failed to comply with here, thus violating its PMA application. In support of this contention, plaintiffs cite only to certain pages of the November 10, 1983 Hazard Analysis that GE submitted to the FDA along with its initial application. These pages list these items as "minimum requirements," and, with respect to the piped-in oxygen, the comment is "TBD," presumably meaning "to be determined." See Exhibit D to GE's motion at pp. 2-00899-900. Yet this 1983 document (which is not the final approval from the FDA, but instead the first round of applications) goes on to state, under the heading "Corrective Action" that "Warning signs [must be] installed," and that "Oxygen [must be] made available in the clinic area." Id. at p. 2-00909. Although, obviously, the [*8]hazards of ferrous objects and lack of oxygen were conditions that were required to be addressed, plaintiffs cite to no document from the FDA which specifically mandates piped-in oxygen or metal detectors as the only solutions to the problems. Plaintiffs therefore have not demonstrated that they have any parallel claims that are not subject to preemption.

It is thus clear that all of the claims plaintiffs allege, except for the first cause of action, for negligence based on GE's alleged ownership, operation, management, maintenance and control of the MRI center and adjacent areas (which the Court will address below) are preempted by the MDA. All of those claims are dismissed.

B.The Negligence Claim Against GE

Plaintiffs' first cause of action is for negligence against GE (and the Other Defendants as well) because GE allegedly "operated, managed, maintained and controlled" the MRI center, including the "MRI testing area, hallways and adjacent storage areas," jointly with several of the other defendants. This claim must be dismissed. The Court finds, as a matter of law, that GE did not operate, manage, maintain or control those premises (although, as discussed below, it did service and maintain the MRI machine itself).

Plaintiffs' own motion papers admit that in the initial agreement between the parties, the lease agreement between GE and WMC Imaging Associates (the "buyer"), the lease expressly states that "Buyer is fully responsible for control of access to and all operations and protocols at the Magnetic Resonance site," and that "Buyer shall indemnify" GE "from any claim or loss directly or indirectly attributable to the magnetic or electric fields created by the Magnetic Resonance System." See Gaier December Aff. at ¶ 70; plaintiffs' Exhibit V at p. 9, ¶ 7 (emphasis added). The next paragraph of the lease goes on to state that "Buyer is responsible for preparing . . . a site" for the installation of the MRI device. Id. at ¶ 8. This paragraph also has an indemnification provision to protect GE.

Thereafter, the parties entered into a series of service agreements. While GE was responsible for the maintenance and repair of the MRI machine, it had no responsibility for the machine's surroundings. Although the copy provided is difficult to read, it appears that the service agreement in effect at the time of the tragedy states that Westchester Medical Center was responsible to "provide a suitable location for the Equipment and maintain the Site and environment . . . and provide a secure and protected area." See Exhibit M to GE's motion at p. 10 (marked "1 of 3").

Plaintiffs' papers appear to concede that GE did not have [*9]any direct ownership, control, management or maintenance responsibility for the entire MRI facility, as the Complaint alleges. Rather than list each and every sentence in the papers or exhibits which tends to show this, a few examples will suffice. First, plaintiffs admit that "GE did not directly supervise or operate the facility. . . ." Gaier December Aff. at ¶ 229. Instead, "UIMA was responsible for the administration, supervision and day-to-day operation and management of the MRI facility. . . ." Gaier Affirmation of February 28, 2008 (the "Gaier February Aff.") at ¶ 28. See also id. at ¶ 33 (UIMA's responsibilities for the MRI center include "employing safe practices in the operation of the facility, and training and educating personnel with regard to safety in the facility."). Plaintiffs also concede that when Westchester Medical Center decided to install a piped-in oxygen system, GE "was not involved in the plan or design of the system" — presumably because GE did not operate, control, maintain or manage the suite. Id. at ¶ 91.

The Decision of the Appellate Division in this case further supports GE's position. In that decision, the Appellate Division said that the MRI facility was "administered and supervised by the defendant [UIMA], pursuant to a contract with the defendant Westchester County Healthcare Corporation." Colombini v. Westchester Co. Healthcare Corp. at al., 24 AD3d 712, 714, 808 NYS2d 705 (2d Dept. 2005). The Decision held that

The conditions in the MRI suite were the responsibility of UIMA pursuant to the MRI services contract with WCHCC, by which UIMA agrees to provide administrative, supervisory, and teaching services necessary for the conduct of all phases of the MRI operation.'

Id. at 714-715. The only aspect of responsibility that GE had, according to the Appellate Division decision, is for manufacturing and maintaining the "MRI machine in which the accident occurred" — not the MRI suite, the MRI center, or its hallways and adjacent facilities. Id. at 715.

There is, therefore, no basis for holding GE responsible for the alleged negligent operation, management, maintenance and control of the "MRI testing area, hallways and adjacent storage areas. . . ." Complaint at ¶ 101.[FN7] This is particularly true since, according to plaintiffs, "there was no one in the entire hospital other than UIMA employees who had responsibility for safety within the MRI facility." Gaier February Aff. at ¶ 35. See also id. at ¶ 37. Accordingly, this cause of action is [*10]dismissed as against GE.

Plaintiffs' Motion to Reinstate the

Punitive Damages Claims Against GE

As GE has been dismissed from the action in its entirety, plaintiffs' request to reinstate the punitive damages claim against GE has become moot. In any event, plaintiffs have set forth no facts that show, with clear and convincing evidence, see Camillo v. Geer, 185 AD2d 192, 587 NYS2d 306 (1st Dept. 1992), that GE has acted with "exceptional misconduct which transgresses mere negligence, as when the wrongdoer has acted maliciously, wantonly, or with a recklessness that betokens an improper motive or vindictiveness . . . or has engaged in outrageous or oppressive intentional misconduct or with reckless or wanton disregard of safety or rights." Sharapata v. Town of Islip, 56 NY2d 332, 335, 352 NYS2d 347, 349 (1982) (quotes and citations omitted). Therefore, even if this Court did not dismiss GE from the case, there is no basis for punitive damages against GE.

The Motion of the Other Defendants

The Other Defendants seek to dismiss the claims for punitive damages against UIMA, Paul Daniels, Patricia Lauria and Dr. Terence Matalon; to dismiss all claims against Mr. Daniels and the New York Medical College; and to dismiss the claim for emotional distress of John Colombini.

The Claims Against Paul Daniels

and the New York Medical College

A.Paul Daniels

Paul Daniels was not the main technician assigned to work on the MRI scan of Michael Colombini. According to Patricia Lauria, who was the main technician assigned to the scan, Mr. Daniels was only to do the filming while she did the scanning. Ms. Lauria testified that she thought that Mr. Daniels would have checked the oxygen tanks that morning upon his arrival, but she did not know for sure whether he had done so. Ms. Lauria testified that she herself did not check the oxygen levels in the computer room on the day of the accident (despite her having advised Dr. Hou, the physician doing the scan, that the oxygen was ready).

It is clear that it was not Mr. Daniels' regular responsibility to change the oxygen tanks in the computer room. Rather, he was only shown how to change the oxygen tanks in the event of an emergency. Mr. Daniels also testified at his deposition that on the few occasions when he had had to change [*11]the oxygen tanks prior to the accident at issue, no patient had been in the scanner.

On the day of the accident, according to plaintiffs' papers, Dr. Hou told Ms. Lauria more than once at the outset that he needed oxygen for Michael Colombini. Ms. Lauria told Dr. Hou, in sum and substance, that the oxygen was set. She also testified that she checked the flow meter before leaving the MRI room for the console room. Once in the console room, approximately a minute later, Ms. Lauria saw Dr. Hou motioning for her, and opened the door to the console room to hear Dr. Hou calling for oxygen. Ms. Lauria then asked Mr. Daniels for his help with the oxygen. Because the oxygen level appeared to be a bit lower than normal, Mr. Daniels suggested that they switch the tanks. Since Ms. Lauria apparently did not know how to change the tanks, Mr. Daniels made the switch. The scanner room was unattended while they were doing so.

It was not until they had finished switching the tanks that Mr. Daniels heard the commotion arising from the accident. It is undisputed that Mr. Daniels and Ms. Lauria never saw Dr. Hou open the door to the MRI room,[FN8] never heard Dr. Hou's urgent call for oxygen, or witnessed Mary Nadler hand Dr. Hou the ferrous oxygen cannister. With these facts undisputed, it is evident that Mr. Daniels had no direct or immediate involvement in the accident that resulted in Michael's death.

The parties differ on the issue of whether Mr. Daniels had any indirect involvement in, and responsibility for, the accident. Plaintiffs claim that Mr. Daniels was responsible for the accident because he (along with UIMA and Ms. Lauria) was responsible "not only for the events that happened on the morning of July 27, 2001, but for the circumstances and conditions that led to those events." Gaier February Aff. at ¶ 28.[FN9] This Court [*12]disagrees. Despite their many arguments in all of their motion papers, and their myriad exhibits, plaintiffs have not shown that Mr. Daniels did have such responsibility.

While plaintiffs certainly have many arguments to support their position that UIMA was, at least in part, responsible for the accident, see Colombini v. Westchester Co. Healthcare Corp. at al., 24 AD3d 712, 714-715, 808 NYS2d 705 (2d Dept. 2005), their arguments with respect to Mr. Daniels are much weaker. See Anesthesia Assocs. of Mt. Kisco, LLP v. Northern West. Hosp. Center, 2009 WL 324047 at *4 (2d Dept. Feb. 10, 2009). Plaintiffs rely entirely on the testimony of Ms. Lauria (a co-defendant with a significantly greater involvement in the events of the day), who claims that the MRI technicians were responsible for safety within the MRI facility. She also claimed that Mr. Daniels supervised her, but at the same time said that he had the same responsibilities that she had. Aside from plaintiffs' speculation as to Mr. Daniels' being a supervisor who was responsible for safety conditions, there is simply no real evidence to support plaintiffs' theory. Rendon v. Castle Realty, 28 AD3d 532, 813 NYS2d 479 (2d Dept. 2006) ("a motion for summary judgment may not be defeated by a response based on surmise, conjecture and suspicion.") (internal quotes omitted). See also RCD Building, L.L.C. v. Park Slope Condos., L.L.C., 14 Misc 3d 1215(A), 836 NYS2d 489, 2007 WL 64266 at *4 (Sup. Ct. Kings Co. 2007) ("Such speculative testimony fails to viably raise a triable factual issue. . . .").

Indeed, it is clear that Mr. Daniels had no formal responsibility for overseeing any aspect of the MRI facility, was not a doctor or a trained safety specialist, and, in fact, was only a technician with minimal safety training at best.[FN10] See Gaier February Aff. at pp. 20-21. According to plaintiffs' papers, Ms. Lauria stated that she never conducted regular inspections of the MRI suite, and Mr. Daniels testified that he believed that any object outside the scanner room was safe. Id. at ¶ 46. Traci Chiapetta, a technical aide, testified that "Mr. Daniels and Ms. Lauria only instructed her that no metal objects were allowed in the scanner room." Id. Despite plaintiffs' allegations concerning what Mr. Daniels knew or should have known, they do not set forth any evidence showing either Mr. [*13]Daniels or Ms. Lauria were responsible for instructing Ms. Chiapetta, or anyone else, on safety issues, or for otherwise overseeing safety at the facility.

Thus, plaintiffs have set forth no evidence to demonstrate that (1) Mr. Daniels had any responsibility, express or otherwise, for the area outside the scanner room, (the scanner room being his usual workspace), or (2) that Mr. Daniels was present in the immediate area at the time of the accident such that he could have prevented it. Mr. Daniels was only secondarily involved in the scan of Michael Colombini, Ms. Lauria being the primary technician, and, in this Court's view, cannot bear any legal responsibility for the tragedy. See generally James v. Pathmark, Inc., 17 Misc 3d 1139(A), 856 NYS2d 24, 2007 WL 4336416 (Sup. Ct. Kings Co. 2007) (cause of action against security guard brought by injured third party was dismissed where guard owed no duty to third party). Accordingly, all causes of action against Mr. Daniels, including the claim for punitive damages, are dismissed.

B.New York Medical College

With respect to New York Medical College ("NYMC"), the only evidence the Other Defendants submit in support of their motion to dismiss it from the action is an affidavit of Thomas Martin, the General Counsel, dated November 10, 2003. It is the exact same affidavit that NYMC submitted on the first motion for summary judgment — indeed, it is the exact same affidavit that the Appellate Division found "did not establish its prima facie entitlement to judgment as a matter of law. . . ."[FN11] Colombini , 24 AD3d at 716, 808 NYS2d 705. While the Court believes that it is quite likely that NYMC was not "involved in the training or education of individuals involved in the incident," id., that is not the standard the Court must apply here. Rather, on a motion for summary judgment, the Court needs to construe evidence in a light most favorable to the non-moving party, rather than make assumptions in movants' favor. Insurance Co. of NY v. Central Mutual Ins. Co., 47 AD3d 469, 472, 850 NYS2d 56, 58 (1st Dept. 2008). Accordingly, based on the evidence before it at this time, the Court must deny the Other Defendants' motion to dismiss NYMC.

John Colombini's Claim for Negligent

Infliction of Emotional Distress [*14]

Mr. Colombini seeks damages for negligent infliction of emotional distress. This issue was the subject of a prior motion for summary judgment brought by the Other Defendants, which this Court denied. The Appellate Division upheld that determination, finding that plaintiffs had "raised a triable issue as to whether [Mr. Colombini] came within the zone of foreseeable danger when he entered the room to help extricate his son from the MRI machine, with the attendant circumstances surrounding the endeavor." Colombini, 24 AD3d at 716, 808 NYS2d 705 (emphasis added).

Plaintiffs argue that the determination by the Appellate Division that they had raised a triable issue of fact is law of the case, and cannot be addressed by this Court. Plaintiffs are mistaken. The doctrine of the law of the case "is a rule of practice, an articulation of sound policy that, when an issue is once judicially determined, that should be the end of the matter as far as Judges . . . are concerned;" stated differently, "[t]he doctrine " applies only to legal determinations that were necessarily resolved on the merits in the prior decision.'" Oyster Bay Assocs. Ltd. Partnership v. Town Bd. of Town of Oyster Bay, 21 AD3d 964, 966, 801 NYS2d 612 (2d Dept. 2005) (citations omitted) (emphasis added). See also Shatzkin v. Village of Croton-on-Hudson, 51 AD3d 903, 858 NYS2d 362 (2d Dept. 2008) (prior order was not law of the case where it did not reach the merits of the motions); Meekins v. Town of Riverhead, 20 AD3d 299, 798 NYS2d 133 (2d Dept. 2005). Here, the only thing the Appellate Division determined was that there was a triable issue as to whether Mr. Colombini came within the zone of foreseeable danger in order to pursue a claim for negligent infliction of emotional distress. The Appellate Division did not resolve the issue on the merits.

Now that discovery has been completed, however, the Court determines that there are no issues of fact that would warrant a trial on this claim.

It was established, in Bovsun v. Sanperi, 61 NY2d 219, 473 NYS2d 357 (1984), that a plaintiff may recover damages for a "serious and verifiable" "emotional disturbance," id. at 231, 473 NYS2d at 363, "using an objective test of whether the plaintiff was unreasonably threatened with bodily harm by the conduct of the defendant. . . in consequence of the observation of the serious injury or death of a member of his or her immediate family . . . ." Id. at 230-231, 473 NYS2d at 362. The Appellate Division has amplified this, stating that

the circumstances under which recovery may be had for purely emotional harm are extremely limited and, thus, a cause of action seeking such recovery must generally be premised upon a breach of a duty owed directly to the plaintiff which either endangered the plaintiff's physical safety or caused the plaintiff fear for his [*15]or her own physical safety.

Peter T. v. Children's Village, Inc., 30 AD3d 582, 819 NYS2d 44 (2d Dept. 2006) (emphasis added). See also Shaw v. QC-Medi New York, Inc., 10 AD3d 120, 778 NYS2d 791 (4th Dept. 2004) (emotional distress claim rejected where defendants owed no duty to mother of victim who knew of her daughter's suffering, and whose medical condition was exacerbated by nurses' indifferent care); Graber v. Bachman, 27 AD3d 986, 987, 812 NYS2d 659, 660 (3d Dept. 2006) ("plaintiff was required to show a breach of a duty owed to her which unreasonably endangered her physical safety, or caused her to fear for her own safety."). Here, plaintiffs do not allege that defendants owed any duty to Mr. Colombini. See Complaint, ¶¶ 164-167; Gaier February Aff. at ¶¶ 139-143. For this reason alone, the cause of action for negligent infliction of emotional distress should be rejected.

The cause of action falls short for two additional reasons. First, there is no proof that Mr. Colombini really feared for his own safety. While the Court understands and is sympathetic to Mr. Colombini's fear for Michael's safety in the tragic moments following the accident, Mr. Colombini did not mention his own safety in his testimony at the 50-H hearing, only that he was, understandably, "nervous" for the safety of his son ("things sounded a little frantic on the other side. I proceeded to go in the room to see what was going on. I felt very nervous at the time."). Transcript of 50-H Hearing at p. 78, Exhibit H to Gaier February Aff.[FN12]

More significantly, there is no evidence in Mr. Colombini's sworn testimony, including the portion of the deposition transcript submitted to the Court by plaintiffs in their opposition papers, that he has suffered any genuine and serious mental distress stemming from his fear of injury to himself. Nor have plaintiffs presented any expert testimony on the subject. See Graber, 27 AD3d at 987, 812 NYS2d at 660 (where plaintiff proffered only her own affidavit and bill of particulars indicating that she suffered from emotional distress, claim for negligent infliction of emotional distress was rejected because "in the absence of expert proof, more was required."); Stamm v. PHH Vehicle Management Servs., LLC, 32 AD3d 784, 822 NYS2d 240 [*16](1st Dept. 2006) (claim denied because plaintiff failed to establish that he suffered serious emotional distress). See generally Dankner v. Steefel, 47 AD3d 867, 850 NYS2d 618, 619 (2d Dept. 2008) (claims for intentional and reckless infliction of emotional distress rejected where there was no expert testimony in support of claim for emotional distress).

As discovery has been complete for some time now, "no amount of additional discovery would fortify [Mr. Colombini] with facts necessary to oppose summary judgment, since information regarding the type of harm he suffered was in his sole possession." Gaylord v. Fiorilla, 28 AD3d 713, 714, 813 NYS2d 534, 536 (2d Dept. 2006). Accordingly, Mr. Colombini's claim for negligent infliction of emotional distress must be dismissed.

The Motion to Dismiss the Punitive Damages

Against Ms. Lauria, UIMA and Dr. Matalon

In order to prevail on a claim for punitive damages, plaintiffs must show that defendants' conduct "evinced a high degree of moral turpitude and demonstrated such wanton dishonesty as to imply a criminal indifference to civil obligations." Huang v. Sy, 62 AD3d 660, 878 NYS2d 398, 401 (2nd Dept. 2009). The Appellate Division, in this case, held that "Punitive damages are recoverable in actions where a party engages in willful or wanton conduct evincing a deliberate intention to harm or an utter indifference or conscious disregard for the safety of others." Colombini, 24 AD3d at 715, 808 NYS2d 705 (finding that while Dr. Hou may have been "negligent, there is nothing in his conduct which elevated his acts or omissions to the level of gross negligence as would warrant the imposition of punitive damages."). See also Marlowe v. Ferrari of Long Island, Inc., 61 AD3d 645, 646, 876 NYS2d 165, 166 (2nd Dept. 2009) (dismissing punitive damages claim where plaintiff failed to show that the "alleged conduct was so gross, wanton, or willful, or of such high moral culpability, as to warrant an award of such damages."); DiDomenico v. Long Beach Plaza Corp., 60 AD3d 618, 620, 875 NYS2d 133, 136 (2nd Dept. 2009) ("The conduct alleged by the plaintiffs did not demonstrate a malicious intent or a high degree of moral culpability, was not so flagrant as to transcend mere carelessness, and did not constitute willful or wanton negligence or recklessness.").

A.UIMA

The Appellate Division has already held that the MRI facility was

administered and supervised by the defendant [UIMA]. . . [and that] the conditions in the MRI suite were the responsibility of UIMA pursuant to the MRI services contract with WCHCC, by which UIMA agrees to provide administrative, supervisory, and teaching [*17]services necessary for the conduct of all phases of the MRI operation.'

Colombini, 24 AD3d at 714-715, 808 NYS2d 705. This means that UIMA was ultimately responsible for the safety of the MRI facility, including the training of personnel regarding safe practices and procedures. As the supervisor of the MRI suite, UIMA was also responsible for ensuring that ferrous oxygen tanks and other dangerous objects were nowhere near the scan room.

While the Court is certain that nothing in UIMA's actions or inactions was "gross, wanton, or willful, or of such high moral culpability" as to warrant punitive damages, Marlowe, 61 AD3d at 646, 876 NYS2d at 166, plaintiffs make many claims which may indicate UIMA's "utter indifference or conscious disregard for the safety of others." Colombini, 24 AD3d at 715, 808 NYS2d 705. Plaintiffs' papers are replete with instances which show that UIMA spent no time in training its staff on safety protocols, and had no way of even monitoring safety conditions. These contentions do raise questions of fact sufficient to defeat UIMA's motion for summary judgment on this issue. Accordingly, the Court allows plaintiffs' claim for punitive damages to proceed to trial with respect to UIMA.

B.Patricia Lauria and Terence Matalon

Patricia Lauria was an MRI technician who received no training in MRI safe practices and procedures when she began working at the MRI facility. See Gaier February Aff. at ¶ 102 ("Neither Ms. Lauria nor Mr. Daniels received any training regarding safety procedures when they began working for UIMA."). While she knew that ferrous objects should not be brought into the scan room, Ms. Lauria was never instructed on any proper procedures for excluding ferrous objects from outside the scan room.

Despite all of the testimony and evidence to the contrary, plaintiffs insist that Ms. Lauria (along with Paul Daniels) "had primary responsibility for safety within the [MRI] suite," id. at ¶ 100, because she had testified that the MRI technicians were the "gatekeepers" who would keep a "watchful eye" to make sure that no one came into the scan room with metal objects.[FN13] Yet this interpretation overly amplifies Ms. Lauria's role. She was an MRI technician, with minimal safety training, who had a limited job to do. She had no supervisory role, no authority and [*18]no responsibility over anything other than the scan room (which, in actuality, was controlled by the doctor using it at the time). To say, as plaintiffs do, that Ms. Lauria was "absolutely reckless," with a "conscious disregard for safety" to support an award of punitive damages, see Gaier February Aff. at ¶ 105, is, to this Court, entirely without merit. While Ms. Lauria should have spoken up about the oxygen canisters she had noticed, or even moved them herself, it was simply not her responsibility to rearrange the MRI suite or to oversee its safety protocols. For these reasons, Ms. Lauria cannot be subject to punitive damages under applicable law. (Indeed, the cases plaintiffs cite are not on point because in each case the party at issue had a greater level of supervisory responsibility than Ms. Lauria plainly had here.)

Nor does Ms. Lauria's conduct on the date of the accident subject her to punitive damages. The evidence does not show that Ms. Lauria deliberately or even negligently ignored settled protocols when she only checked the flow meter, rather than checking the oxygen supply. See Gaier February Aff. at ¶ 112. There simply were no protocols in place for Ms. Lauria to have failed to follow.

Further, by "abandoning" the scanner and console room, as plaintiffs phrase it, id. at ¶ 113, Ms. Lauria did not do the "unthinkable" — rather, she and Mr. Daniels did what they thought was needed to rectify the situation. Whether Ms. Lauria was negligent in leaving the room to check the oxygen after Dr. Hou indicated there was a problem is a matter for trial; however, it is clear to this Court that under no circumstances did Ms. Lauria's behavior "demonstrate a malicious intent or a high degree of moral culpability, [and it] was not so flagrant as to transcend mere carelessness, and did not constitute willful or wanton negligence or recklessness." DiDomenico, 60 AD3d at 620, 875 NYS2d at 136.

Accordingly, plaintiffs' claim for punitive damages against Ms. Lauria is dismissed.

With respect to Dr. Matalon, while he was the Director of the Department of Radiology, and the president of UIMA, plaintiffs themselves admit that he "had no experience supervising MRI facilities . . . and did not view himself as having taken on any supervisory responsibilities with respect to the MRI facility. . . ." Gaier February Aff. at ¶ 41. Instead, Dr. Ellen Panageas, the medical director of the MRI facility, was the supervising doctor — up until the time that she left the facility (about six weeks before the accident occurred, thus leaving the facility with no direct supervision). Plaintiffs state that

UIMA and Dr. Matalon are guilty of gross misconduct and conscious disregard for safety in failing to have a designated safety [*19]officer responsible for overseeing and supervising safety in the MRI facility, and in failing to have a medical director of the MRI to provide supervision during the six weeks leading up to the incident in this case.

Gaier February Aff. at ¶ 117 (emphasis added). Although Dr. Matalon, as the Director of the Department of Radiology, was responsible for issuing policies and procedures (and, by extension, failing to review and update them), plaintiffs set forth not one case to suggest that being Director of the Department of Radiology is sufficient to warrant a claim for punitive damages.

Similarly, plaintiffs cite no case that would demonstrate that Dr. Matalon, who admittedly had no involvement in the scan at issue, and who was merely the president of UIMA, would have any liability for punitive damages purely on the basis of his role as an officer. The Court will not opine on whether there is enough evidence here to find Dr. Matalon liable to plaintiffs at all — that is for the trial — but there is certainly no basis for punitive damages against him.

In sum, the Court grants the motion to dismiss the punitive damages as against all moving defendants except for UIMA.

Conclusion

All claims against GE and Paul Daniels are dismissed. The claims for punitive damages as against Mr. Daniels, Ms. Lauria, and Dr. Matalon are also dismissed. Additionally, the claims for emotional distress on behalf of Mr. Colombini are dismissed.

The foregoing constitutes the decision and order of the Court.

Dated:White Plains, New York

July __, 2009

____________________________

Hon. Linda S. Jamieson

Justice of the Supreme Court

To:Kramer, Dillof, Livingston & Moore

217 Broadway

New York, New York 10007

Schiavetti, Corgan, Soscia,

DiEdwards and Nicholson, LLP

709 Westchester Avenue, Suite 205

White Plains, New York 10604 [*20]

Heidell, Pittoni, Murphy & Bach, LLP

99 Park Avenue

New York, New York 10016

Footnotes

Footnote 1:UIMA was sued under the name of University Imaging Medical Corporation and Medical Associates, P.C.

Footnote 2:There have not been many New York decisions arising from Riegel as of yet and, therefore, when appropriate, this Decision and Order cites to decisions from other states. See generally All Seasons Resorts, Inc. v. Abrams, 68 NY2d 81, 506 NYS2d 10 (1986); People v. Perez, 18 Misc 3d 582 (Sup. Ct. Bronx Co. 2007).

Footnote 3:Plaintiffs argue that preemption was revoked when the classification changed. This Court disagrees. The section of the MDA concerning classification specifically states that upon reclassification, any regulation or requirement in effect may be revoked. 21 USCA § 360c(e)(1). There is no argument in this case that any regulations or requirements involving the device at issue here were expressly revoked upon reclassification. Plaintiffs claim that when the MRI machine was reclassified, the FDA "revoked the requirements that accompanied PMA approval . . . ." Gaier Reply Affirmation at ¶ 12. However, this is not what the letter reclassifying the device states. See Letter of July 28, 1988, Exhibit K to GE's motion. Plaintiffs' statement regarding the revocation is no more than an assumption.

Footnote 4:As an aside, the Court notes that many of the reports of incidents listed in plaintiffs' papers occurred before the FDA reclassified the device from Class III to Class II. See Gaier December Aff. at pp. 12-14.

Footnote 5:If it were the case that devices that had received premarket approval and later were reclassified as Class II were not protected under the MDA's preemption clause, there would be no reason for any manufacturer to ever seek reclassification — and indeed, some manufacturers might seek to have their devices re-reclassified as Class III to obtain the benefits of preemption under the MDA.

Footnote 6:While the recent New York cases of Mitaro and Lake, infra, do state that express warranty claims may not be preempted by the MDA, a review of the Complaint here shows that plaintiffs do not allege a breach of any express warranties made specifically to plaintiffs by GE. See Exhibit A to GE's motion at pp. 24-26.

Footnote 7:The Court notes that there is no argument that the MRI machine itself malfunctioned or otherwise operated in any way other than its intended function.

Footnote 8:Plaintiffs' statement that Mr. Daniels and Ms. Lauria "left [Dr. Hou] standing at the open door to the scanner room" when "they abandoned the scanner room to change the oxygen supply" is, at best, disingenuous, since there is no evidence to suggest that Dr. Hou had opened the door before they left to change the tanks. Gaier February Aff. at ¶ 63.

Footnote 9:For example, plaintiffs make statements like "a jury could certainly find that Mr. Daniels is lying [about not having been told about the 1997 incident in which two ferrous oxygen canisters were pulled into the scanner]," and then go on to state, as if it logically flows, that "the evidence thus clearly establishes an issue of fact as to whether UIMA, Mr. Daniels and Ms. Lauria knowingly permitted an extremely dangerous situation to exist with respect to the ferrous oxygen bottles being stored in close proximity to the scanner room door." Gaier February Aff. at ¶ 60. However, the issue before this Court on this summary judgment motion is not whether Mr. Daniels knew that ferrous oxygen bottles could be dangerous around an MRI machine, but whether Mr. Daniels had any responsibility or oversight regarding such a situation.

Footnote 10:The fact that Mr. Daniels' safety training was inadequate is certainly an issue, but the fact that his training was inadequate does not mean that he is responsible for the accident.

Footnote 11:The Court finds it significant that not only did the Other Defendants not bother to obtain a new affidavit, but they also did not even address plaintiffs' arguments about the old affidavit in their Reply Affirmation.

Footnote 12:It was not until more than two years later that Mr. Colombini gave an affidavit in which he stated that he was "concerned and apprehensive about [his] own safety, as well as that of [his] child." Exhibit J to Gaier February Aff. At his deposition several months later, Mr. Colombini said that he was "very fearful" of the noise he heard, and that "the fear [he] felt was it sounded like something that could either explode or cause a fire. It was just — that's what it sounded like - danger." Exhibit I to Gaier February Aff. at pp. 38, 83.

Footnote 13:A review of Ms. Lauria's deposition testimony reveals that she viewed her role as the gatekeeper of the consult or console room and scan room, rather than the overall MRI suite, which is how plaintiffs interpret her testimony. See Exhibit A to Motion of the Other Defendants at pp. 71-72.