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Faye Cafferty and Doane Cafferty v. Cayuga Medical Center; Arleo Eye Institute; Robert Arleo M.D.; and

February 8, 2011

FAYE CAFFERTY AND DOANE CAFFERTY, PLAINTIFFS,
v.
CAYUGA MEDICAL CENTER; ARLEO EYE INSTITUTE; ROBERT ARLEO M.D.; AND ALCON LABORATORIES, INC., DEFENDANTS.



The opinion of the court was delivered by: Neal P. McCurn, Senior District Judge

Memorandum, Decision and Order

I. Introduction

This personal injury action was removed to this court, which has jurisdiction pursuant to 28 U.S.C. § 1332. By their complaint, plaintiffs, Faye Cafferty ("Mrs. Cafferty") and her husband, Doane Cafferty (collectively, "Plaintiffs"), set forth seven causes of action stemming from injuries which allegedly occurred due to the negligence of defendants Cayuga Medical Center ("CMC"); Arleo Eye Institute and Robert Arleo, M.D. (collectively, "Dr. Arleo"); and Alcon Laboratories, Inc. ("Alcon") (collectively, "Defendants"). In her complaint, Mrs. Cafferty asserts claims of negligence against all defendants, including a separate cause of action based on the doctrine of res ipsa loquitur. In addition, Mrs. Cafferty alleges a claim for breach of implied warranty of merchantability against Alcon*fn1 and a claim for medical malpractice based on lack of informed consent against Dr. Arleo. All claims are pursuant to New York common law.

Prior to the close of discovery, Alcon filed a motion to dismiss the complaint as against it for failure to state claims upon which relief may be granted pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure based on federal preemption of certain of the claims, as well as a motion to stay discovery pending resolution of that motion. See Dkt. No. 20. Discovery is now complete. Consequently, Alcon's motion to stay discovery is denied as moot. Alcon thereafter filed a motion for summary judgment against Plaintiffs seeking dismissal of all claims against it, based on, among other things, the same federal preemption argument it set forth in its earlier motion to dismiss. See Dkt. No. 57. Accordingly, the motion to dismiss need not be separately decided, as the issues it presents will be addressed with the motion for summary judgment.

Also pending is a motion for summary judgment by Plaintiffs against all defendants as to the issue of res ipsa loquitur, see Dkt. No. 52 as well as a cross motion for summary judgment by Alcon against Plaintiffs on that same issue, see Dkt. No. 69. Defendants CMC and Dr. Arleo have also filed separate motions for summary judgment against Plaintiffs. See Dkt. Nos. 56 and 53, respectively. Papers in opposition to each motion as well as reply papers have been filed. Decision regarding the pending motions is rendered on the papers submitted without oral argument.

II. Legal Standard

A motion for summary judgment shall be granted "if 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 a judgment as a matter of law." Fed. R. Civ. P. 56(c). See also United Transp. Union v. Nat'l R.R. Passenger Corp., 588 F.3d 805, 809 (2d Cir. 2009). "In ruling on a motion for summary judgment, the district court may rely on any material that would be admissible or usable at trial." Major League Baseball Props., Inc. v. Salvino, Inc., 542 F.3d 290, 309 (2d Cir. 2008) (internal quotation and citation omitted).

The movant has the burden to show that no genuine factual dispute exists. See Vermont Teddy Bear Co., Inc. v. 1-800 Beargram Co., 373 F.3d 241, 244 (2d Cir. 2004) (citing Adickes v. S. H. Kress & Co., 398 U.S. 144, 157, 90 S.Ct. 1598 (1970)). Moreover, when the court is deciding a motion for summary judgment, it must resolve all ambiguities and draw all reasonable inferences in the non-movant's favor. See id.

When deciding whether a material issue of fact is in dispute, the court is cognizant that "[a] fact is material when it might affect the outcome of the suit under governing law." Tracy v. Freshwater, 623 F.3d 90, 95 (2d Cir. 2010) (internal citation omitted). Also, a material fact is genuinely in dispute "if 'the evidence is such that a reasonable jury could return a verdict for the nonmoving party.'" Bessemer Trust Co., N.A. v. Branin, 618 F.3d 76, 85 (2d Cir. 2010) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510 (1986)).

It should also be noted that, pursuant to Local Rule 7.1(a)(3), the court deems admitted any statement of material fact that is not specifically controverted by the opposing party. See N.D.N.Y. R. 7.1(a)(3).

III. Factual Background

On October 12, 2005, Mrs. Cafferty underwent eye surgery performed by Dr. Arleo at a CMC facility, during which products manufactured by Alcon were used. Thereafter, Mrs. Cafferty presented with certain symptoms and was later diagnosed with Toxic Anterior Segment Syndrome ("TASS") in her left eye.

TASS is an inflammation that occurs when unwanted material gains access to the anterior chamber of the eye, causing a toxic reaction. In this case, Mrs. Cafferty underwent clear lens extraction of the left eye with implantation of an intraocular lens. She thereafter presented with symptoms that each expert in this case agrees are consistent with TASS.*fn2

While all of the experts agree that there are many possible causes of TASS, they also agree that in the majority of TASS cases, its exact cause is often difficult to identify and in Mrs. Cafferty's case, the specific cause of her TASS is unknown. Drs. Armesto and Mamalis agree that TASS is related to an unwanted material gaining access to the anterior segment of the eye. Dr. Armesto states in his report that TASS occurs when a toxic substance enters the eye at the time of surgery. Dr. Mamalis states in his report that the material gains access either during surgery or immediately after, but at his deposition, Dr. Mamalis agreed that TASS occurs during a surgical procedure, and that Mrs. Cafferty's TASS arose from her surgery. Later, by affidavit, Dr. Mamalis clarified that "while TASS frequently results from a toxic substance introduced during surgery, it can also develop due to a toxic material introduced in either pre-operative or post operative settings. TASS does not necessarily always occur because of a toxic substance introduced into the anterior segment of the eye during surgery while the opthalmic surgeon is present." Aff. of Nick Mamalis, M.D., April 22, 2010, ¶ 7, Dkt. No. 66-1.

While Dr. Mamalis testified that his review of the medical records in this case do not reveal a specific cause of Mrs. Cafferty's TASS, he also explained that it is not uncommon to be unable to identify the exact cause of TASS. According to Dr. Mamalis, most TASS cases arise from one of two main sources: (1) cleaning and sterilization of opthalmic instruments and (2) fluids, solutions, medications and products used during the surgery. Because TASS does not present itself until 24-48 hours after surgery, it is difficult to identify a specific cause because by that time, the instruments used during surgery have been cleaned and sterilized and the medications or solutions used during surgery are disposed of, preventing the discovery of direct evidence of contamination.

Here, none of the experts were able to identify a specific cause of Mrs. Cafferty's TASS based on the medical records and the video recording of the surgery. In fact, several of the experts commented that the surgery was performed in an "expert" (Dr. Armesto) and "very competent and efficient" (Dr. Milstein) manner, "without any complications or breaches in technique" (Dr. Mamalis). Dr. Armesto opined that it is likely that one of the two main sources of TASS outlined by Dr. Mamalis caused Mrs. Cafferty's TASS. However, he noted that the records he reviewed did not contain a complete comprehensive analysis of every solution, substance, product or cleaning process in her case.

IV. Discussion

A. Pre-emption

Alcon argues that Plaintiffs' causes of action for negligence and breach of warranty regarding its ReSTOR lens and DisCoVisco are pre-empted by the Medical Devices Amendments to the Federal Food, Drug and Cosmetic Act and must be dismissed. Because Plaintiffs have withdrawn the breach of warranty claim, the court need not address the pre-emption issue in that regard.

The Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., requires approval by the Food and Drug Administration ("FDA") for the introduction of new drugs into the market. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 1002 (2008). The Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. ยง 301c et seq., "imposed a regime of detailed oversight," changing the then existing regulatory landscape wherein states were left to supervise the introduction of new medical devices ...


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