RALEIGH v. ALCON LABORATORIES INC., 1-09-1790.

• Decision Date: 06 August 2010
• Docket Number: No. 1-09-1790.,1-09-1790.
• Citation: 343 Ill.Dec. 206,403 Ill.App.3d 863,934 N.E.2d 530
• Parties: William RALEIGH, Plaintiff-Appellant, v. ALCON LABORATORIES, INC., and West Suburban Medical Center, Defendants-Appellees.
• Court: United States Appellate Court of Illinois

403 Ill.App.3d 863
934 N.E.2d 530
343 Ill.Dec. 206

William RALEIGH, Plaintiff-Appellant,
v.
ALCON LABORATORIES, INC., and West Suburban Medical Center, Defendants-Appellees.

No. 1-09-1790.

Appellate Court of Illinois,First District, Fifth Division.

Aug. 6, 2010.

934 N.E.2d 531

COPYRIGHT MATERIAL OMITTED.

934 N.E.2d 532

Michael T. Mullen, Richard J. Schroeder, Paul B. Episcope, LLC, Chicago, IL, for Plaintiff-Appellant.

Anderson, Rasor Partners, LLP, C. Kinnier Lastimosa, Sedgwick, Detert, Moran & Arnold, LLP, Chicago, IL, Deborah E. Lewis, S. Vance Wittie, Sedgwick, Detert, Moran & Arnold, LLP, Dallas, TX, for Defendants-Appellees.

934 N.E.2d 533

Justice LAVIN delivered the opinion of the court:

403 Ill.App.3d 865

343 Ill.Dec. 209

This appeal involves the medical and legal sequellae from a cataract surgery in which an intraocular lens was implanted in a suburban man's eye almost 10 years ago. On October 11, 2000, plaintiff William Raleigh, D.D.S., underwent surgery on his right eye at the West Suburban Medical Center (West Suburban) in Oak Park, Illinois. Dr. Scott Rosen, an ophthalmologist, performed the procedure and implanted an ACRYSOF® intraocular lens (the ACRYSOF® Lens), developed, designed, and manufactured by Alcon Laboratories, Inc. (Alcon), in plaintiff's eye. While there were no complications during the surgery, plaintiff later experienced pain and vision problems in the eye. Weeks later, a rare fungus, phaeoacremonium rubrigenum, was found in plaintiff's right eye, requiring the surgical removal of the eye. In the trial court, plaintiff alleged that the product manufacturer should be held strictly liable, arguing that the lens in question was infected when it entered the stream of commerce, while simultaneously alleging that West Suburban should be held liable under the theory of res ipsa loquitur, arguing that the hospital was in exclusive control of the instrumentality that injured the plaintiff. After lengthy discovery and motion practice, the trial court entered dispositive orders in favor of the defendants and this appeal followed. For reasons elucidated below, we affirm in all respects.

BACKGROUND ACRYSOF ®

An intraocular lens is defined in section 886.3600(a) of the Code of Federal Regulations (21 C.F.R. § 886.3600(a) (2000)) as a “device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.” Intraocular lenses are classified as Class III medical devices requiring premarket approval prior to being commercially distributed. 21 C.F.R. §§ 886.3600(b), (c) (2000).

On May 28, 1993, Alcon submitted a premarket approval application for ACRYSOF® to the United States Food and Drug Administration (the FDA). Alcon's application included design, manufacturing and labeling specifications, full reports of all known studies and investigations of ACRYSOF®'s safety and effectiveness, a statement of ACRYSOF®'s components, properties, and its principles of operation, and a description of the methods, controls, and facilities used in

403 Ill.App.3d 866

manufacturing ACRYSOF®. On December 22, 1994, the FDA notified Alcon that it had approved ACRYSOF® as a premarket-approved Class III medical device subject to certain conditions described in its approval letter. ACRYSOF® remains on the market as such today.

Alcon manufactured the ACRYSOF® Lens in August 2000 and shipped it to West Suburban on September 14, 2000. In its motion for summary judgment, Alcon included an affidavit from Sandra Budden, the regulatory compliance manager at Alcon, stating that it was her opinion that Alcon complied with the federal manufacturing specifications and processes during the manufacture of the ACRYSOF® Lens, and that it was not defective at the time it left Alcon's manufacturing facility. Alcon's manufacturing documents demonstrate that Alcon complied with the FDA manufacturing specifications for sterilization, air and surface microbiological environmental testing, and packaging. The ACRYSOF® Lens was 1 of 5,176 intraocular lenses from Batch No. 002296 that met manufacturing specifications for release in August 2000. There were no other complaints of fungal contamination from Batch No. 002296.

934 N.E.2d 534

343 Ill.Dec. 210

The Surgical Procedure at West Suburban

Plaintiff's surgery, performed by Dr. Rosen, lasted approximately 30 minutes. Approximately 20 minutes into the surgery, the ACRYSOF® Lens was removed from its sealed packaging and placed on a plastic dish, still wrapped in sterile material. The ACRYSOF® Lens was then removed using forceps. Dr. Rosen then placed the ACRYSOF® Lens in plaintiff's right eye using the forceps. The eye was then sutured and covered with a patch and plaintiff was discharged. Within 24 hours of the surgery, plaintiff informed Dr. Rosen that he was having difficulty seeing out of the eye and experiencing pain. On November 5, 2000, Dr. Frank LaFranco performed a vitrectomy procedure, during which fluid was removed from the eye. A culture performed on the fluid revealed the presence of the aforementioned fungus.

Deposition Testimony Presented to the Trial Court

Dr. Rosen testified that he had performed approximately 6,000 cataract surgeries prior to plaintiff's procedure. Fungal endophthalmitis, he testified, is very rare and occurs in “significantly less than one percent” of cataract surgeries. No other patients that he performed cataract surgery on that day developed any type of infection in the eye. There was nothing unusual noted about the storage or handling of the ACRYSOF® Lens by West Suburban. Dr. Rosen used approximately 10 surgical instruments and 9 ophthalmic solutions during and after the procedure. Dr. Rosen testified that any of these

403 Ill.App.3d 867

instruments or solutions could have been sources of plaintiff's infection.

Dr. LaFranco testified that “something that occurred in the operating room was the cause of this infection, whether it was a nonsterile instrument, a nonsterile fluid, a nonsterile [intraocular lens], and nonsterile surgeon's finger.” Dr. LaFranco had “no way of knowing” that the infection occurred in the operating room, but it was his “belief is that this organism was put into Mr. Raleigh's eye in the operating room.” Dr. LaFranco had no opinion to a reasonable degree of medical certainty as to the source of the fungus. Dr. LaFranco testified that the fungus “is such a rare organism [he] would speculate that its cause was not the normal breakdown of sterile technique.”

Dr. Michael Bergman, plaintiff's expert, testified that “human error was involved in one way or the other. [E]nvironmental molds should not be contaminating prosthetic devices.” Assuming that the ACRYSOF® Lens was contaminated by the forceps used during the procedure, Dr. Bergman believed that West Suburban deviated from the standard of medical care in the manner in which it sterilized the forceps, stating that “either the sterilization of the instrument was a problem or the ventilation in the unit was a problem. Neither of which is probable but either of which could have happened.” Dr. Bergman opined that because the infection predominantly originated in the posterior chamber, “the problem began nearby which would incriminate, number one, the lens and its manufacturing or postmanufacturing packaging, or two * * * the forceps.”

Another expert for plaintiff, Dr. Michael Rinaldi, testified that the most likely source of the fungus was the ACRYSOF® Lens, but acknowledged that other sources included the operating suite personnel, ophthalmic solutions used during the procedure, the surgical instruments, and the operating room environment. Dr. Rinaldi testified that a fungal infection is a risk of cataract surgery that does not necessarily mean that someone was negligent.

934 N.E.2d 535

343 Ill.Dec. 211

The Pleadings and the Trial Court's Dispositive Rulings

On January 20, 2009, plaintiff filed his amended complaint, alleging two counts against each defendant. ¹ As to Alcon, plaintiff alleged state law claims for strict product liability (count I) and negligence

403 Ill.App.3d 868

(count II), asserting that the ACRYSOF® Lens contained the fungus which caused his infection at the time it was manufactured and prior to the time it was placed into the stream of commerce. As to West Suburban, plaintiff alleged a count for medical negligence (count III) and a count under the doctrine of res ipsa loquitur, alleging that West Suburban was in exclusive control of all potential sources of the fungus that led to and caused plaintiff's subsequent injuries (count IV). On May 15, 2009, the trial court entered two orders, the first order granting Alcon's motion for summary judgment as to counts I and II, and the second granting West Suburban's motion for summary judgment on count III and its motion to dismiss count IV pursuant to section 2-615 of the Code of Civil Procedure ( 735 ILCS 5/2-615 (West 2000)). On June 12, 2009, plaintiff filed a timely notice of appeal.

Plaintiff submits three issues on appeal. First, plaintiff contends that the trial court erred in dismissing count IV of his complaint because he established that he was injured while under the exclusive control of West Suburban and that the injuries would not have occurred in the absence of negligence as required by the doctrine of res ipsa loquitur. Next, plaintiff contends that the trial court erred in granting West Suburban's motion for summary judgment when the uncontradicted evidence established that West Suburban's conduct was negligent and that its negligence caused injury to him. Third, plaintiff contends that the trial court erred in granting Alcon's motion for summary judgment when the uncontradicted evidence established that a product manufactured by Alcon caused injury to him.

ANALYSIS Res Ispa Loquitur

Plaintiff first contends that the trial court erred in dismissing count IV of his complaint because he established that he was injured while under the exclusive control of West...