Osman v Ophthalmic Innovations Intl., Inc.

[*1] Osman v Ophthalmic Innovations Intl., Inc. 2004 NY Slip Op 51405(U) Decided on October 29, 2004 Supreme Court, New York County 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 This opinion is uncorrected and will not be published in the printed Official Reports.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 October 29, 2004
Supreme Court, New York County

NAHLA OSMAN, Plaintiff,

against

OPHTHALMIC INNOVATIONS INTERNATIONAL, INC., EAST SIDE OPHTHALMOLOGY, P.C., HERBERT L. GOULD and MILES A. GALIN, Defendants.



122651/00

Stanley L. Sklar, J.

Defendant Ophthalmic Innovations International, Inc. ("OI") moves for an order granting it summary judgment dismissing plaintiff Nahla Osman's "cause of action" (See, Notice of motion).

This case involves claims of injury to Osman's eyes as a result of the implantation by codefendant Dr. Herbert Gould of phakic anterior chamber intraocular lenses, (model ACN-60A) manufactured by OI, which lenses were never approved by the FDA for any purpose. Such lenses are class III medical devices under FDA regulations. Plaintiff, who was in her early 30's at the time the lenses were implanted, had the lenses removed and suffers from, inter alia, deformed and degenerated corneas, impaired vision, deformed pupils, light sensitivity, burning and pain in both eyes and underwent thus far one corneal transplant. She also underwent two laser surgeries by Dr. Gould in an attempt to correct her vision after the implantations. The lenses in issue were designed (See, Gould EBT, p 233) by codefendant Miles Galin, M.D., an ophthalmologist, who in July 1997 had his New York medical license revoked for, inter alia, practicing medicine fraudulently [ See, Matter of Galin v. De Buono, 259 AD2d 788 (3rd Dept, 1999), lv. to app. den. 812]

OI's predecessor was founded in 1989 by one Richard Aguilera and his partner, Sam Cobb. In March 1995 OI was sold to a group of investors including Dr. Galin, several of his associates, and an entity called Majestic Securities, which apparently was owned by Dr. Galin's son. The 1995 deal "gave Dr. Galin and his associates a controlling interest in OI ." Gannon aff. in opp., exh F; See also, Galin EBT, pp 19-20 Aguilera stayed on as Vice President of Operations. Dr. Galin was OI's paid consultant and received royalties on products for which he held patents. At that time OI was involved in manufacturing intraocular lenses which were used in cataract surgery to replace a person's natural lens. OI had CE approval with respect to such lenses outside the United States, a process allegedly analogous to FDA pre-market approval ("PMA") (See, 21 USC § 360 e) Around that time OI began the process of seeking CE approval [*2]for phakic lenses, which were to be used to correct patients' visions without the removal of their natural lens, thereby hopefully obviating the need for glasses or contact lenses. In about 1996 OI received CE approval for phakic lenses. In 1996 and 1997 OI shipped in excess of 500 phakic lenses to Dr. Galin at his office in Manhattan. Of these about 160 were unfinished samples, and the rest were finished. It is claimed that two of the finished lenses were the ones ultimately implanted into Osman's eyes. Why they were sent to Dr. Galin is the subject of dispute.

In February 1997 Osman first consulted Dr. Gould, who practiced "under" Herbert Gould, M.D., P.C., regarding whether she was a candidate for Lasik surgery to correct her myopia. Osman had worn contact lenses but found that they irritated her eyes. Dr. Gould had an office on the same floor as Dr. Galin's, and their offices were connected by an interior door (See, Gould EBT, p 32; Osman EBT, p 12) Dr. Gould advised Osman that she was not a Lasik candidate because she was too myopic, but recommended the implantation of phakic lenses, which lenses he had obtained without charge from Dr. Galin (Gould EBT, p 67) Dr. Galin examined Osman and told her that she was the "perfect candidate for the implant." Osman EBT, pp 32-33

Drs. Galin and Gould collaborated on patients receiving phakic lenses. (Id, 34-40, 136, 231, 235) and evidently between the two of them and other doctors apparently working for Dr. Galin implanted unapproved phakic lenses in about 160 people (See, Aguilera EBT, p 107) Dr. Gould testified (EBT, p 49) that he did about twelve implants between 1996 and 1998. Dr. Galin also sent some of the unapproved lenses to at least one other physician in the U.S. who implanted them in his patients. Dr. Gould had Dr. Galin see all the patients whose phakic lenses were to be implanted by Dr. Gould (Gould EBT, p 76) Dr. Galin and his staff performed all the preliminary work and follow-up work for phakic patients that Dr. Gould "did". Ibid. Osman's deposition testimony confirms Dr. Galin's extensive involvment with her care. See, Osman, EBT pp 32-33, 72-73, 75, 77, 161, 230, 233, 245, 246, 250-251, 258-259, 261, 265, 266-267 According to Osman, Dr. Gould and Galin "were the same" because when she saw Dr. Gould Dr. Galin would see her so she assumed they were working together. Osman EBT p 311, 138

On some of the printed results of tests performed on Osman Dr. Galin was listed as the physician (See, motion, exh J) Dr. Galin would see and speak to the patient himself and would in conjunction with Dr. Gould explain the risks and benefits of the procedure. Gould EBT, p 186, 206, 77 Dr. Galin would sometimes assist in the implant surgery but most of the time the assistant was provided by Dr. Galin and was evidently working for or employed by him, or was a fellow training under him. Id 29, 77-78

Dr. Gould was allegedly unaware that Dr. Galin's license had been revoked in 1997, and claims he first learned of the revocation in the fall of 2000 from a newspaper article. Gould EBT, p 79 Dr. Galin continued to be involved in Osman's care after his license revocation. Dr. Gould who practiced at the locale in issue since 1992 admittedly however was aware in 1997 or 1998 that Dr. Galin was involved in a criminal trial in California [Gould EBT, pp 79-82; See generally, US v Galin, 217 F3d 847 (9th Cir, 2000)] at which time Dr. Galin was seeing Osman (Id, p 82). Dr. Gould also testified before a New Jersey grand jury investigating Dr. Galin in the spring of 2000 [Id 80-82; See generally, US v East Side Ophthalmology, 1996 WL 384891 (SDNY) and US v. East Side Ophthalmology, 1996 WL 31843 (1996) which indicate that a grand jury investigation into Dr. Galin and others associated with East Side was [*3]commenced in 1994 and that a search pursuant to warrants was conducted of East Side's office on December 27 and 28, 1995]

Dr. Gould testified (EBT 49-50) that he assisted Dr. Galin on several occasions when Dr. Galin implanted lenses between 1996 and 1998, and also as a "courtesy" performed implants on Dr. Galin's patients during that period. Dr. Galin invoked his Fifth Amendment privilege as to whether Osman was his patient and whether he treated her. Galin EBT, p 14 Dr. Gould did not maintain complete records on Osman because some were maintained by Dr. Galin. Id 83; Osman EBT, p 238 The surgical suite used by Dr. Gould was Dr. Galin's and/or East Side Ophthalmology, P.C's[FN1]. Dr. Gould did not have many of the records regarding the implant procedure he performed on Osman's right eye in March 1997 and assumed that the records, including the informed consent and the surgical notes were in Dr. Galin's notes or records. Id, 123-132 Dr. Gould also did not maintain an operative report for the implant he performed on the left eye in January, 1998 since he claims the record was left in Dr. Galin's operating room facility. Id, 162 Dr. Gould did not remember if Dr. Galin was present during the first implant procedure but testified that he may have been assisted by a Dr. Baron who worked for or with Dr. Galin. Id, 133-134. Osman testified (EBT, p 34) that during the first implant there was "a Dr. Douglas Buxton; I'm not quite sure of his last name" present in the surgical room as well as a woman prepping her. She further testified that during the second implant procedure, besides Dr. Gould, "[t]here were other people in there, but I don't know who they were". Id, p 268

Dr. Gould did have a consent form for the 1998 implant procedure, which form he stated "we" used in the operating room. Id, 165 That form failed to reveal that the lens was not FDA approved or that the procedure was part of a study. Id, p 166 The form did not comply with the federal regulations applicable to informed consent pertaining to research on a human subjects (See, 21 CFR § 50.20 et. seq.) nor did it comply with the New York State counterparts (See, Public Health Law §§ 2441, 2442). Osman testified that Dr. Gould thought the implant procedure was fairly safe and that he did not stress risks. Osman EBT, pp 271-272, 278

Dr. Gould, according to Osman, first told her that the lenses were not FDA approved during her last visit and further told her that such approval meant nothing and was just a formality. He also told her, in response to her inquiry of whether nonapproved lenses were legal, that the FDA had nothing to do with the private practice of medicine. Id 279 It appears according to the medical chart (motion, exh J) that the last visit occurred on June 29, 2000.

That Dr. Gould believed at that visit or believes now, as he asserted at his deposition (See, Gould EBT, pp 45-46, 68), that the FDA has nothing to do with the practice of medicine and only deals with the manufacturer, is undercut by other portions of his deposition testimony (See, e.g. pp 139-140), including his experiences of being affiliated with various hospitals and doing investigational studies there (See, EBT, pp 166-168; 21 CFR § 50.20 et. seq. dealing with the informed consent of human subjects). But such assertions are principally undermined by the fact that Dr. Gould was presumably aware before Osman's visit of June 29, 2000 of the fact that the FDA learned that the lenses shipped to Dr. Galin had been implanted in [*4]patients, conducted an investigation and had letters sent to all of the patients in New York whose lenses had come from Dr. Galin. As Dr. Gould testified "we did send- all the patients were sent [warning] letters from the FDA". EBT, p 215, See also Id, pp 213-217, 223-224 Dr. Gould testified that he personally was not asked to report Osman's condition to the FDA, that he did not have to fill out adverse events reports with regard to the lenses but that Galin said he would do it. Id 223 Gould was to report everything to Galin who would then pass it on to OI. Id 223-224

The letter that was ultimately sent to Osman was dated June 30, 2000, the day after Dr. Gould last saw plaintiff, and informed her that the lenses were not FDA approved. Presumably Dr. Gould was aware that there was an FDA investigation, before he last saw plaintiff, and that the letter to Osman was forthcoming.

The June 30, 2000 letter which was received by Osman was on OI letterhead but was signed by East Side Opthalamology. The letter specifically advised Osman that the lenses were never approved for sale or for investigational use by the FDA, that the FDA asked "us" to contact every patient to so advise patients and to let them know that complications can occur and that long term follow-up is necessary. Osman was further falsely advised in the letter that she had not experienced any complications as of her March 2, 2000 (See, Gould EBT, p 190-191) visit and that she should call East Side, whose phone number was provided, for a free appointment or that she should see her local ophthalmologist.

It is not entirely clear on this record when the FDA started its investigation into OI's shipment of unapproved lenses to Dr. Galin and the implantation of such lenses into patients in the United States, but it appears that the FDA first received a complaint on October 14, 1997 from a physician stating that he had surgically removed three refractive intraocular lenses from Dr. Galin's patients and that he (the reporting physician) believed that Dr. Galin had implanted them without obtaining an approved investigational device exemption ("IDE") from the FDA. See, Gannon aff., exh E

Generally a class III medical device must go through a rigorous pre-market approval process with the FDA "to provide reasonable assurance of its safety and effectiveness" [(21 USC §§ 360 c (a)(1)(C)(ii); 360 e)] unless the device is substantially equivalent to a device on the market before the May 28, 1976 effective date of the Medical Device Amendments to the Federal Food Drug and Cosmetics Act ("FD& C Act") (which is not claimed here) or the device is subject to an IDE (See, 21 USC § 360 j (g)).

At some point evidently during the fall of 1997 or sometime soon thereafter OI advised the FDA that Dr. Galin had been implanting the lenses. See, Aguilera aff. of 3/12/04 OI met with the FDA. In July and August 1999 the FDA inspected Dr. Galin's office, reviewed his records and found that he had allowed 157 patients to participate in an investigational study under his supervision in his office without an FDA IDE[FN2], without obtaining proper informed consents, and without following the FDA procedures regarding investigational studies, including but not limited to maintaining appropriate records, submitting reports of adverse events to the [*5]FDA or to OI, and checking on investigators' qualifications. See, motion, exh L; Gannon aff. in opp. exh F; 21 CFR Part 812 The FDA also found that Dr. Galin had distributed these lenses to physicians outside the U.S. OI was advised by the FDA in September 1999 that the exportation of the lenses was a violation of the FD&C Act, and that the distribution and implantation of the lenses without an IDE caused them to be misbranded under section 502 (o) and adulterated under section 501 (f) of the Act. (See, 21 USC §§ 321 (n), 331, 351, 352) The FDA also found that the lenses had been sold or offered for sale within the meaning of the Act notwithstanding that they were given free of charge to Dr. Galin. See, Gannon aff. in opp. ehx E According to the FDA and a memo prepared for OI by its consultant Dr. Galin had persuaded OI to ship him several types of lenses under the rational that he was entitled to receive them under a practice of medicine exemption. Ibid.; Gannon aff. in opp. exh D Relying on that advice OI began shipping the lenses to Dr. Galin in April 1996 until November 1997. Ibid. According to the FDA, Aguilera, after attending an FDA video conference in the fall of 1997, had doubts about Dr. Galin's advice. Ibid

The FDA after receiving complaints from several physicians, who had removed the lenses from five patients, who had them implanted in Dr. Galin's facility with about "81 complications/ injurious events" (Gannon aff. in opp. Exh E),and from another doctor who removed such a lens from a patient at Dr. Galin's office who was developing cataracts, and after discovering that OI had observed problems involving the lenses from Dr. Galin's patients' records, informed OI on November 11, 1999 that patient notification needed to be conducted, which OI agreed to do. After meeting with the FDA, OI reorganized its management, installed a new president and chairman of the board (CEO) and rearranged shareholders' voting rights so that Dr. Galin could "no longer directly or indirectly control company policy". Gannon aff. in opp. exhs. F and E

OI now seeks an order granting it summary judgment dismissing Osman's "cause of action". See, notice of motion The affirmation in support of the motion asserts that the "cause of action" sounds in strict products liability. See, Tzimorotas aff. §§ 2-3 No copy of the complaint has been provided by OII or by any other party on this application.

OII maintains that plaintiff Nahla Osman's strict liability claim is without merit because it never sold the lenses to Dr. Galin or to Dr. Gould. At oral argument OI's attorney narrowed the issue to whether there was any intent by OI to introduce the lenses into the stream of commerce in the United States, which according to OI was not the case here. OI further claims that Osman will be unable to prove that the lenses were defective. OI further maintains that any failure to warn claim is barred by the "learned intermediary exception". OI also asserts that Galin's decision to provide the lenses to Dr. Gould and Drs. Galin's and Gould's decision to implant the lenses into Osman's eyes were superseding causes of Osman's injuries which absolve OI of any liability. OI further asserts that Dr. Gould used bad surgical technique which damaged Osman's corneas and/or inappropriately determined that she was a candidate for the lenses, which she allegedly was not because her interior chambers were of inadequate depth in light of the severity of her myopia. OI asserts that these acts of negligence on the part of Dr. Gould were a superseding cause of Osman's injuries. Finally, although the notice of motion referred only to "a cause of action", as did the beginning of OI's counsel's moving affirmation, the end of such affirmation alleges that there can be no cause of action based on fraudulent misrepresentation [*6]because there was no communication between OI and Osman. The wherefore cause of the moving affirmation then seeks dismissal of the "complaint".

In opposing the motion plaintiff's counsel indicates that he was under the belief that the motion although unclear, was seeking dismissal of only the strict products liability cause of action (See, Gannon aff. in opp. § 3) rather than the negligence, breach of implied and express warranties, and fraudulent misrepresentation causes of action which were allegedly pleaded in the complaint, which as noted above has not been provided here. In light of the inconsistencies in the initial moving papers and the confusion caused by them, and the lack of the complaint [See, CPLR 3212 (b)], the motion shall be entertained solely to extent that OI seeks dismissal of the strict products liability cause of action.

OI's claim that such cause of action can not stand because there was no sale by it of the lenses to Dr. Galin or to Dr. Gould is unavailing. A sale is unnecessary. As noted previously the FDA rejected OI's claim that a sale was needed. OI must establish as a matter of law that it did not intend to place the lenses into the stream of commerce. See, Delaney v. Towmotor Corp., 339 F 2nd 4 (2d Cir, 1964) OI has failed to do that. While it claims that it never placed the lenses into the stream of commerce because it merely shipped some of the lenses which were unfinished to Dr. Galin's Upper East Side office to perform animal experiments (See, oral argument transcript, p 11) and shipped others to him which were allegedly finished products so that Dr. Galin could conduct clinics outside the U.S. to teach other doctors how to implant them (See, Aguilera aff. of 3/12/04), as previously noted there is evidence which indicates that OI shipped the lenses to Dr. Galin, who allegedly exerted some control over the company, because he convinced OI that as a practicing physician he was exempt from the FDA requirements. I further note that it is dubious that some of the lenses were shipped to Dr. Galin for animal experiments because the FDA's regulation requires any investigational device which is shipped only for animal research to have on its label [presumably meaning the label on the device itself or on its immediate package (See, 21 CFR 812.5 (a)] the statement "CAUTION- Device for investigational use in laboratory animals or other tests that do not involve human subjects". 21CFR 812.5 ( c) There is no claim here that the lenses in issue or their immediate packages contained any such warnings. OI merely relies in its initial moving papers on shipping invoices pertaining to the bulk shipment of lenses. See, motion, exhs G, M Those invoices in any event do not contain the requisite language. In light of the foregoing OI has failed to establish that it did not introduce the lenses into the stream of commerce.

OI has also failed to establish that Galin's decision to furnish the lenses to Dr. Gould was a superseding cause of Osman's injuries which exonerates OI. As noted previously there is evidence which suggests that the lenses were provided to Dr. Galin because he convinced OI that there was a practice of medicine exemption. Thus a jury could find that it was foreseeable to OI that Dr. Galin might provide such lenses to other physicians who would also be beneficiaries of the alleged exemption. Thus the causative chain was not necessarily broken by Dr. Galin supplying the lenses to Dr. Gould.

In addition, the relationship between Galin and Dr. Gould is unclear on this record. Galin invoked his Fifth Amendment privilege with respect to almost all relevant lines of inquiry at his deposition, including his relationship to Dr. Gould and both of their relationships to codefendant East Side Ophthalmology, P.C., and as to whether Osman was his (Dr. Galin's) [*7]patient and whether he treated her.

The evidence presented on this motion raises an issue as to whether Dr. Galin and Dr. Gould held themselves out to plaintiff as joint venturers in connection with the treatment rendered to plaintiff so as to make each vicariously liable for the other's torts. See, Ruane v Cooper, 127 AD2d 524 (1st Dept, 1987); lv. to app. dsmd., 70 NY2d 693 If they were joint venturers, the link between OI and Dr. Gould's actions are not particularly attenuated. Here, it appears that Osman went to Dr. Gould for treatment of her myopia but that the implants and subsequent treatment were rendered jointly as part of collaborative effort to investigate the lens. As noted previously Osman was seen by them interchangeably, and testified that Drs. Galin and Gould "were the same". Indeed the letter she received notifying her that the lenses were not FDA approved was signed not by Dr. Gould but by East Side Ophthalmology, P.C. which told her to come to it for a free appointment, rather than to Dr. Gould.

Even if Dr. Galin was not in an joint venture with Dr. Gould it still appears that he was one of the doctors who was in some measure responsible for her having the lenses implanted since among other things he examined her before the implant procedures and informed her she was a candidate for the procedures. Also, accordingly to Dr. Gould, Dr. Galin participated in explaining the risks and benefits of the procedure, provided the operating suite and surgical assistant, allegedly kept at least some of the medical records and was involved in the patient's follow-up care. Thus that Dr. Galin provided the lenses to Dr. Gould does not entitle OI to relief on this motion.

I have also considered the balance of grounds raised by OI for dismissal of the strict liability cause of action, namely that plaintiff will not be able to prove that the lenses were defective, that the informed intermediary doctrine bars Osman's claims against OI and that as a matter of law Dr. Gould's bad surgical technique and his decision to implant ill-fitting lenses were superseding causes of Osman's injuries which exonerate OI, and find them unavailing.

The burden in the first instance of proving that the lenses were not defective is on the movant OI, not on Osman. Also, as further noted previously the FDA advised OI that the lenses were misbranded as well as adulterated under the FD&C Act. See, Medtronic v. Lohr, 518 US 470, 495-497 (1996); See also, Id, O'Connor, J. concurring in part and dissenting in part, at p 513; Rexrode v America Landing Press CO, 674 F 2d 826, Fn 18 (10th Cir, 1982); cert. den., 459 US 862 (1982); NYPJI (3rd Ed) vol 1A § 2:141, comments, p 687

OI has not established that the information provided in terms of labeling and package inserts was adequate so as to exonerate it pursuant to the informed intermediary doctrine. Aguilera at his deposition was equivocal as to what materials, if any, other than the bulk shipping invoices, accompanied the lenses implanted into Osman's eyes. See, Aguilera EBT, pp 74-77, 89-91, 100 The moving affirmations of Aguilera and his counsel say nothing about labels or package inserts and only talk about invoices. This motion was made long after this case was placed on the trial calendar and as noted by plaintiff's counsel in his opposing affirmation no instruction labels or product inserts were produced by OI during the course of discovery. See, Gannon aff. in opp. § 14

It is readily apparent that neither the lenses nor their immediate container contained the requisite labeling applicable to investigational devices or to investigational devices shipped solely for research on or with laboratory animals. See, 21 CFR 812.5 (a), (b), ( c) Dr. [*8]Gould testified that he was unaware of any restrictions that OI put on the implantation of the lenses he used. EBT pp 65-66 He further testified that were no warnings or labels on the package that the lenses were solely for animal research; nor was he ever told so by Dr. Galin. Id 69-70 Also, he never saw any invoices so limiting the use of the lenses. Id 71

Whether and to what extent OI provided package inserts that one would generally expect to find with respect to any class III device, covering topics such as indications, contraindications, surgical criteria, and risks has not been established by OI on this motion. OI's attempt via its reply affirmation to supply for the first time additional information about package inserts (which was never provided during discovery) is unavailing. Dannasch v. Bifulco, 184 AD2d 415 (1st Dept, 1992)

Even if OI provided information about surgical criteria, Dr. Gould's deposition raises issues as to whether such criteria would have been appropriate. Specifically Dr. Gould, as a result of conducting his joint study with Dr. Galin (See, Gould EBT pp 40, 136, 231, 235), his getting surgical parameters from Dr. Galin, who designed the lens, as to, inter alia, the anterior chamber depth needed to accommodate the lens (Id, pp 55-56, 233, 201), and having Dr. Galin's staff measure his patients (Id, 76) to ensure that they met the criteria, determined, after patients began developing corneal complications, that the parameters were incorrect and that the lenses were inappropriate for highly myopic patients who did not have an anterior chamber of a greater depth because the thicker peripheral edges of the lenses would come in contact with the cornea thereby causing damage over time (Id, 198-199, 202). Dr. Gould, who became a paid consultant for OI in 1998 or 1999 (Id, 59-61), testified that he reported the problems with the lens to a Shirley Garvey who had been retained by OI for an FDA submission (Id, 62-63, 134-135, 199). As a result, in 2000 a greater chamber depth was made a standard procedure (albeit with respect to a newer model of lens that OI was developing in lieu of the type of lenses received by Osman). As a result of Dr. Gould informing Garvey of the complications encountered by Dr. Gould, OI also thinned the edges of its phakic lenses (Id, 225) and informed doctors as to which patients would be more appropriate surgical candidates in terms of the severity of their myopia (Ibid). It is not clear on this record when the technology used by OI to thin the lenses became available. Dr. Gould testified, possibly inconsistently, that "to his knowledge the lens was as thin as possible with the available technology (EBT, p 203), but then testified that once notified of the problem, OI was able to make the lenses thinner (Id, 225)."

The foregoing evidence raises issues as to whether surgical criteria information, even if provided, was adequate and perhaps as to whether the lenses were defective because they were too thick, thereby rebutting OI's expert's claim that Dr. Gould was negligent in his assessment of Osman as an appropriate candidate for surgery, which claimed negligence forms the basis for OI's claim that such negligence was a superseding cause of Osman's injury.

I note that while there are some entries in Dr. Gould's chart which appear to be overwritten with respect to Osman's anterior chamber depth, that simply raises issues of fact for trial.

OI's claim that Osman's corneal damage may have been due to excessive intraoperative trauma is bald, conclusory and speculative and in any event appears to be undercut by Dr. Gould's claim that the corneal damage only appeared long after the surgery as a result of the edges of the lenses coming into contact with the corneas and causing them injury over time. [*9]Gould EBT, pp 141, 179, 184-et seq.

Even assuming arguendo that Dr. Gould was negligent in his assessment of Osman as a phakic implant candidate or in his surgical technique, the issue of whether an act is a superseding cause of an injury is usually for the trier of fact. McCann v City of New York, 205 AD2d 668 (2d Dept, 1994) Moreover, an intervening act which is a normal consequence of a situation created by a defendant can not constitute a superseding cause absolving that defendant. Lynch v. Bay Ridge Assoc. 72 NY2d 632, 636-637 (1988); Boltax v Joy Day Camp, 67 NY2d 617 (1986) Here if a jury finds that defective lenses were improperly placed by OI into the stream of commerce it could find that it was foreseeable that a physician would implant them negligently and without obtaining a patient's informed consent.

OI has not established that its lenses were otherwise safe. OI's expert bases his opinion that such lenses were safe on a statistical analysis conducted by Aguilera related to the sale of lenses outside of the U.S. and "international complaints". However a review of Aguilera's findings as set forth in two charts (motion , exh K) reveal that they pertain to 15 different models of lenses which are lumped together. Of the 4171 phakic lenses sold by OI only about 352 were model ACN-60A, and sales of such lenses appear to have ceased in 1997. As noted by Aguilera in his affidavit (¶ 8) appended to his counsel's reply affirmation "[i]t would be unfair for the court to consider guidelines pertaining to a different lens as having any bearing on ACN lenses". Moreover Aguilera does not state how he obtained his numbers or indicate whether there were mandatory adverse reporting requirements outside the U.S. In any event it is obvious from East Side's letter to Osman on OI letterhead which stated that she suffered no complications that OI's data collecting process was less than ideal. Also FDA documents (See, Gannon aff. in opp., ehx E, F) show that OI's own "information revealed several types [of] problems that may have been associated with the IOLS." Further, Dr. Gould testified that there were patients of his and Dr. Galin's who had problems and complications that were corneal. EBT pp 191, 196-198

In light of the foregoing OI's motion to dismiss the strict liability cause of action is denied.

Settle order.

Dated: October 29, 2004

J.S.C. Footnotes

Footnote 1: East Side is presumably the corporate entity under which Dr. Galin practiced, but since he invoked the Fifth Amendment with respect to most questions posed at his deposition, it is unclear on this record.

Footnote 2: It is questionable whether even had Dr. Galin sought to conduct a legitimate study he would have been permitted to be a clinical investigator, in light of his alleged financial interest in OI and the lenses he developed. See, 21 CFR Part 54 which deals with financial disclosure by clinical investigators.