Raleigh v. Alcon Laboratories

CourtAppellate Court of Illinois
DecidedAugust 6, 2010
Docket1-09-1790 Rel
StatusPublished

This text of Raleigh v. Alcon Laboratories (Raleigh v. Alcon Laboratories) is published on Counsel Stack Legal Research, covering Appellate Court of Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Raleigh v. Alcon Laboratories, (Ill. Ct. App. 2010).

Opinion

FIFTH DIVISION August 6, 2010

No. 1-09-1790

WILLIAM RALEIGH, ) Appeal from the ) Circuit Court of Plaintiff-Appellant, ) Cook County. ) v. ) No. 06 L 5695 ) ALCON LABORATORIES, INC., and ) WEST SUBURBAN MEDICAL CENTER, ) The Honorable ) Elizabeth Budzinski, Defendants-Appellees. ) Judge Presiding.

JUSTICE LAVIN delivered the opinion of the court:

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 1-09-1790

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

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

2 1-09-1790

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.

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

3 1-09-1790

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 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

4 1-09-1790

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.

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