The opinion of the court was delivered by: Pollock, J.
On certification to the Superior Court, Appellate Division, whose opinion is reported at 301 N.J. Super. 7 (1997).
This appeal presents two issues. The first is whether the statute of limitations, N.J.S.A. 2A:14-2, bars a patient's claim for lack of informed consent against an ophthalmologist who implanted an intraocular lens in the patient's eye, the hospital at which the implantation took place, and the manufacturer of the intraocular lens. The second issue is whether federal law preempts the patient's state-law claims against the manufacturer of the intraocular lens, American Medical Optics ("AMO").
In November 1983, defendant, Dr. Frederick Newman, performed cataract surgery on plaintiff, Eleanor Baird, and implanted an intraocular lens in her left eye. The Food and Drug Administration ("FDA") had approved the lens pursuant to an Investigational Device Exemption, in which AMO, in association with Valley Hospital and Dr. Newman, was conducting a clinical investigation of the lens.
After her surgery, Baird experienced multiple complications and underwent further treatment, including additional surgery. On February 6, 1992, Baird sued Dr. Newman, AMO, and Valley Hospital.
The Law Division granted summary judgment for all defendants. The Appellate Division reversed and remanded the matter to the Law Division. We granted certification. 151 N.J. 467 (1997). We modify the judgment of the Appellate Division and remand the matter to the Law Division.
Because the matter arises on defendant's motion for summary judgment, we assume the truth of plaintiff's version of the facts and give plaintiff the benefit of all inferences that those facts support. Brill v. Guardian Life Ins. Co. of America, 142 N.J. 520 (1995); Judson v. People Bank & Trust Co., 17 N.J. 6 (1954).
In 1983, Baird, who was sixty-one years old, experienced blurred vision in her left eye. On September 23, 1983, she consulted Dr. Newman, an ophthalmologist. After an examination, Dr. Newman informed Baird that she had a posterior subcapsular cataract that needed surgical removal and replacement with an implant. On the same day, Baird signed a four-page consent form.
On November 8, 1983, Dr. Newman performed the cataract removal at Valley Hospital. Dr. Newman inserted American Medical Optics ACPC-55 intraocular lens into Baird's left eye.
The 1976 Medical Device Amendments ("MDA" or "Act"), 21 U.S.C. 360c to 360k, 379, 379a, to the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. 301 to 395, authorizes the FDA to regulate the use of intraocular lenses ("IOLs"). At the time of Baird's surgery, the FDA had not approved AMO's IOL for general marketing to the public under the Pre-Market Approval ("PMA") application process. 21 U.S.C. 360e. Instead, the FDA had granted AMO an Investigational Device Exemption ("IDE") for its IOL.
An IDE permits a manufacturer to conduct a clinical investigation and exempts the manufacturer from certain MDA requirements. 21 C.F.R. § 812.1. Pursuant to FDA regulations, Valley Hospital established an Institutional Review Board to monitor AMO's investigational study. 21 C.F.R. § 56.102g. Dr. Newman was an "investigator" in the study, meaning that he conducted the clinical investigation of AMO's IOL. He implanted the IOL in Baird's eye pursuant to that investigation.
In a clinical investigation of a device subject to an IDE, the FDA requires that the consent of a participating patient be informed. 21 C.F.R. §§ 50.1 to -.27. To satisfy that requirement, the investigator must describe the experimental nature of the treatment, its risks and benefits, and alternative courses of treatment. 21 C.F.R. § 50.25. Under most circumstances, moreover, the patient must sign an informed consent form. 21 C.F.R. § 50.27.
The consent form that Baird signed was entitled "Informed Consent for Cataract Operation and/or Implantation of Intraocular Lens." Previously, the FDA had found that this form satisfied the FDA's minimum standards for obtaining informed consent. The Consent Form described alternative treatments to IOLs, discussed the fact that the operation was part of a clinical investigation by the FDA to research the safety and efficacy of IOLs, explained the nature of the procedure, and outlined its risks and potential complications. *fn1
In her deposition, Baird admitted that she signed the consent form, but she did not recall reading it. She said that Dr. Newman did not explain the consent form, that she did not know she was participating in an investigational study, or that the FDA had not approved the lens for general marketing to the public. Baird also stated that she was unaware of the availability of other IOLs that the FDA had fully approved. Notwithstanding the cataract in Baird's left eye, nothing in the record suggests that she could not read the form. Although Dr. Newman does not recall the details of his conversation with Baird, he avers that "his practice was to explain to the patient the nature of a cataract, cataract surgery, and of an intraocular lens." He also would explain the types of intraocular lenses, as well as the risks and prognosis of surgery.
Dr. Newman also told Baird that, following the cataract surgery, she should expect to stay overnight at Valley Hospital. After surgery, however, Dr. Newman informed Baird of "complications," and she remained in the hospital for three days.
Baird's eyesight worsened, and she returned to Dr. Newman's office numerous times. She stated that "I was in a lot of pain, I just knew there was something not right." She thought Dr. Newman "was a good doctor," and continued to consult him after the surgery, but never asked him the cause of her difficulties. Because of Baird's complications, on March 9, 1984, Dr. Newman performed laser surgery on her left eye at the New York Eye and Ear Infirmary. Baird continued to experience problems with her left eye, including photophobia (an unusual intolerance to light), intermittent pain, and severe eye infections. She stated that after laser surgery her eyesight was "terrible," and was worse than before laser surgery.
Dr. Newman then referred Baird to Dr. James Bastek, a retinal specialist. According to Baird, she "was having a lot of pain, you know, and I had those infections, but my eye always hurt me and it would swell." She could see only a slight amount of light through her left eye.
On June 5, 1984, when Dr. Bastek first saw Baird, he diagnosed pseudopathic vitritis of her left eye and cystoid macular edema. Vitritis is an inflammation of the fluid that collects in the back of the lens of the eye. Cystoid macular edema is a cystic degeneration of the retina that may occur after cataract extraction. Dr. Bastek advised Baird that a vitrectomy would most likely be needed, but that he would first administer Kenalog injections to increase her vision. A vitrectomy is a procedure involving the removal of the contents of the vitreous chamber and replacement with a sterile saline solution. Kenalog is the trade name for a synthetic glucuosteroid. Dr. Bastek referred Baird back to Dr. Newman and asked her to return in one month.
Baird, however, left Dr. Newman's care on August 9, 1984. Although Dr. Newman expected her to return to him for additional treatment, Baird stopped seeing Dr. Newman "[b]ecause I wasn't getting any results in my eyesight and I figured all those operations, I didn't want to go through any more operations because it wasn't making my eyesight any better, it was just steadily getting worse." She felt "very disillusioned" about "[t]he whole thing."
Dr. Bastek performed the vitrectomy on Baird's left eye on April 15, 1985. Her eyesight, however, did not improve. Dr. Bastek continued to treat Baird for several months after the surgery, seeing her for the last time on June 6, 1985. Although Dr. Bastek expected her to return to him, she never did. After leaving Dr. Bastek's care, Baird consulted three other ophthalmologists between 1989 and 1993.
On or about March 24, 1991, Baird saw in the Bergen Record an advertisement placed by her attorney's law firm. The advertisement referred to eye injuries from cataract surgery. Baird concluded that her problems following the implantation of the IOL in 1983 were similar to the problems described in the advertisement. On contacting the law firm, she claimed she learned for the first time that the FDA had not approved AMO's IOL for general marketing to the public.
Other portions of her testimony reveal that she was aware that the lens was the cause of her problems. At her deposition, Baird testified, "I had nothing, but problems from the first day I went to that hospital and even after I had the vitrectomy it just seemed to get worse and worse." She also indicated that she "just knew" that the IOL Dr. Newman implanted in her eye was the source of her problems because of the infections and the need for additional surgery. Baird started to think that Dr. Newman's surgery was the source of her problems right after he performed the cataract surgery. As Baird stated, "I felt that my problems started right from the very beginning when he first did my cataract surgery. I hadn't had any problem like that before." At the Lopez hearing, see Lopez v. Swyer, 62 N.J. 267 (1973), Baird also indicated that, even before she saw the newspaper advertisement, "I felt that [my problems with my eyesight] must have been caused by the lens because I didn't have that problem before, the infection and all that I had after the surgery."
Baird's complaint alleged that both Dr. Newman and Valley Hospital failed to obtain her informed consent to the cataract surgery. She did not allege claims for medical malpractice or battery against the doctor or the hospital. Baird also asserted claims against AMO for product-liability, breach-of-warranty, fraudulent misrepresentation, failure-to-warn, and failure to obtain her informed consent.
On April 20, 1994, the Law Division decided motions for summary judgment filed by defendants AMO and Dr. Newman. It granted AMO's motion for summary judgment, reasoning that 21 U.S.C. 360k preempted common-law claims against manufacturers of IOLs to which the FDA has granted IDEs. The court denied Dr. Newman's motion for summary judgment based on federal preemption. Dr. Newman then moved for summary judgment based on the applicable statute of limitations, N.J.S.A. 2A:14-2. At the Conclusion of a Lopez hearing, the Law Division ruled that the statute of limitations barred Baird's complaint. The court found that Baird was "fully aware" that she suffered damages as a result of the 1983 cataract surgery; that a person of reasonable diligence would have known that her damages were caused by the fault of another; that her cause of action accrued by 1985 at the latest; and, consequently, that the statute tolled at least no later than 1987.
Finally, on May 12, 1994, Valley Hospital filed a motion for summary judgment. It argued, among other things, that the physician, not the hospital, has the duty to obtain a patient's informed consent to a particular procedure. On July 8, 1994, the Law Division granted Valley Hospital's motion, concluding that Valley Hospital did not have a duty to obtain Baird's informed consent.
The Appellate Division reversed the summary judgment in favor of all three defendants. 301 N.J. Super. 7 (App. Div. 1997). Relying on Lombardo v. Borsky, 298 N.J. Super. 658 (App. Div.), certif. granted, 150 N.J. 28 (1997), and appeal dismissed, 153 N.J. 44 (1998), the Appellate Division held that the statute of limitations did not bar Baird's informed consent claim against Dr. Newman. The court reasoned that Baird had not learned of the investigational status of AMO's IOL until 1991. Id. at 11. Next, the Appellate Division concluded that a more complete factual record was necessary to resolve Baird's informed consent claim against Valley Hospital. Id. at 12. Finally, relying on Medtronic v. Lohr, U.S. , 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996), the Appellate Division reversed the lower court's dismissal of Baird's complaint against AMO. Id. at 18. The Appellate Division read Medtronic to hold that the MDA preempts state common-law claims only to the extent that the FDA has adopted a regulation inconsistent with or ...