The opinion of the court was delivered by: LESLIE G. FOSCHIO
The parties executed a consent to proceed before the undersigned on January 24, 1994.
Plaintiff, Jennie Petix, filed this diversity action on July 30, 1992, alleging two causes of action for negligence, and under the doctrine of strict products liability. Plaintiff is a New York resident, Defendant Kabi Pharmacia Ophthalmics, Inc. ("Kabi") is a California corporation, and Defendant Intermedics, Inc. is a Delaware corporation. Plaintiff's claims arise out of a surgical procedure wherein an intraocular lens was implanted into her right eye following diagnosis of a cataract.
On December 1, 1993, Defendants filed a motion for summary judgment on the ground that federal law preempted Plaintiff's claims. Plaintiff filed opposition papers on February 14, 1994. Defendants filed a reply memorandum on March 22, 1994. Oral argument was held on March 30, 1994. Thereafter, Plaintiff filed a supplemental memorandum of Law on April 8, 1994, and a sur-reply memorandum was filed by Defendants on May 3, 1994.
Discovery in the matter has been stayed pending the resolution of this motion.
For the reasons as set forth below, Defendants' motion for summary judgment is GRANTED.
In 1981, Defendants introduced the Pharmacia Intermedics Ophthalmics model 024 (Hessburg) anterior chamber intraocular lens into the market for use in relation to cataract surgery.
This lens was introduced after the federal Food and Drug Administration ("FDA") granted an Investigational Device Exemption ("IDE")
under the Medical Device Amendments to the federal Food and Drug Cosmetic Act. The FDA classified the intraocular lens as a Class III medical device, a classification which is the most heavily regulated, and which required pre-market approval by the FDA. Pursuant to federal regulations, specifically, 21 C.F.R. 813, such intraocular lenses were to be tested on cataract patients who gave their informed consent for the lenses to be used.
Plaintiff, Jennie Petix, was admitted to Kenmore Mercy Hospital in Kenmore, New York on January 15, 1984 after a diagnosis of a cataract in her right eye. Petix was scheduled for a cataract extraction of her right eye, along with an intraocular lens implantation, with the surgery to take place on January 16, 1984.
Prior to the surgery, at the office of Dr. Sara R. Sirkin, a Buffalo ophthalmologist, Petix was provided with an informed consent form. The form specifically stated as follows:
The United States Food and Drug Administration, in response to congressional mandate, is requiring an extensive clinical investigation of intraocular lenses to establish facts about safety and efficacy. I understand I have been asked to take part in this study because Dr. Sara R. Sirkin considers me a candidate. I understand the study involves a minimum of one-year observation of the results of my surgery whether a lens is implanted or not. The purpose of this observation is to compare in a similar group of patients the differences, if any, in eyes with and without lens implantations. Information about the results of my surgery will be made available to the Food and Drug Administration. The hospital will comply with requests for reports concerning my eye surgery and follow-up examinations and procedures when reports are requested by participants in the study. Efforts to maintain confidentiality regarding my case will be made, but the hospital cannot guarantee confidentiality. If for any reason I wish to decline participation in the study, I may do so without affecting my future care. It is estimated that 50,000 individuals will receive intraocular lenses as patients in this study.
The informed consent form also indicated that the results of the surgery could not be guaranteed, and set forth specific complications of lens implantations. Petix executed the consent on January 5, 1984.
Dr. Sirkin performed Petix's surgery on January 16, 1984, and inserted an Intermedics Model 024 anterior chamber intraocular lens into Petix's right eye. The surgery was initially successful. Following the surgery, Dr. Sirkin completed a "Lens Accountability Form" which provided the manufacturer, Intermedics Intraocular, Inc., with the type of lens used, and the name, address, and social security number of the patient in whom the lens was implanted.
After the introduction of the Intermedics Model 024 lens into the market, studies were reported indicating that complications could occur from the use of the lens after the standard one-year post-operative follow-up period of the pre-market studies. Several members of the medical community recommended the discontinuation of the close-looped anterior chamber intraocular lenses, of which the Intermedics Model 024 was a type. In May, 1987, the Intermedics Model 024 anterior chamber intraocular lens was voluntarily withdrawn from the market by Intermedics Intra Ocular, Inc. for "marketing reasons."
Subsequent to the withdrawal of the lens from the market, Petix began experiencing visual difficulty in her right eye, and her vision then deteriorated significantly. Dr. Sirkin diagnosed Petix with having pseudophakos bulbous keratopathy in her right eye, and blindness later resulted. In July, 1990, Petix had the lens extracted from her eye as part of a corneal transplant. At the time that the instant motion was filed, Petix was scheduled to have her right eye removed as a result of the continuing deterioration. Petix was never informed by the manufacturer of the withdrawal of the lens from the market, nor was she told ...