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December 14, 1992

D. DUANE HUNSAKER and LOUISE V. HUNSAKER, his wife, Plaintiffs,


The opinion of the court was delivered by: RAMBO


Before the court is Defendant's motion for summary judgment. The issue has been fully briefed and is now ripe for consideration.


 The following facts are undisputed by the parties; any contested points will be noted by the court: In June of 1980, plaintiff Duane Hunsaker began treatment with Dr. Byron Chong for cataracts. On August 23, 1982, as part of this treatment, Dr. Chong performed an intracapsular cataract extraction *fn1" on Mr. Hunsaker's left eye, surgery which entailed removing his natural eye lens which was clouded over by the cataract. Dr. Chong then implanted an intraocular lens ("IOL") in front of Mr. Hunsaker's natural iris. This lens, a Surgidev Style 10, was designed, manufactured and sold by Defendant. On December 20, 1983, Mr. Hunsaker underwent additional surgery, this time extracapsular cataract extraction and had an IOL implanted in his right eye. Again, the lens was a Surgidev Style 10 manufactured by Defendant.

 Defendant asserts that both surgeries were part of a clinical investigation approved and monitored by the Food and Drug Administration ("FDA") and that plaintiff Duane Hunsaker consented to participating in this study. Defendant's supporting brief at 2.

 Plaintiffs allege that these lenses were defective, resulting in severe and permanent disabling injuries to Mr. Hunsaker -- total and irreparable vision loss in his right eye, and a substantial loss of vision in his left eye which required a corneal transplant. They also allege that Defendant knew that such defects existed prior to the implant of its IOL in Mr. Hunsaker's eye.

 Plaintiffs brought the captioned action on negligence and strict liability theories; a claim for punitive damages was also included. Defendant asserts that all the claims are preempted by federal law and therefore summary judgment should be entered against Plaintiffs.


 I. Summary Judgment

 The court will consider this motion under the accepted standards for the award of summary judgment under Federal Rule of Civil Procedure 56. The Third Circuit has recently summarized those standards in a concise and helpful way:

Summary judgment may be entered if "the pleadings, deposition[s], answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c) . An issue is "genuine" only if the evidence is such that a reasonable jury could return a verdict for the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 91 L. Ed. 2d 202, 106 S. Ct. 2505, [248,] . . . (1986); Equimark Comm. Finance Co. v. C.I.T Financial Serv. Corp., 812 F.2d 141, 144 (3d Cir. 1987). If the evidence is "merely colorable" or "not significantly probative" summary judgment may be granted. Anderson, 106 S. Ct. at 2511; Equimark, 812 F.2d at 144. Where the record, taken as a whole, could not "lead a rational trier of fact to find for the nonmoving party, summary judgment is proper." Matsushita Elec. Indus. Co. v. Zenith Radio, 475 U.S. 574, 106 S. Ct. 1348, 89 L. Ed. 2d 538 . . . (1986).

 Hankins v. Temple Univ., 829 F.2d 437, 440 (3d Cir. 1987). The parties' burdens in summary judgment may be described in the following way: Once the moving party has shown an absence of evidence to support the claims of the nonmoving party, the nonmoving party must do more than simply sit back and rest on the allegations of the complaint. She must "go beyond the pleadings and her own affidavits, or by the 'depositions, answers to interrogatories, and admissions on file' and designate 'specific facts showing that there is a genuine issue for trial.'" Celotex Corp. v. Catrett, 477 U.S. 317, 324, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986). If the nonmovant bears the burden of persuasion at trial, "the party moving for summary judgment may meet its burden by showing that the evidentiary materials of record, if reduced to admissible evidence, would be insufficient to carry the nonmovant's burden at trial." Chipollini v. Spencer Gifts, Inc., 814 F.2d 893, 896 (3d Cir. 1987).

 II. Preemption

 A. Introduction

 The Supremacy Clause of the United States Constitution provides that "this Constitution, and the Laws of the United States which shall be made in Pursuance thereof . . . shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art IV, cl. 2. This clause has been interpreted as providing for federal preemption of state law in three situations:

(1) Congress may pass a statute that by its express terms preempts a state law,
(2) Congress, though not expressly stating, may imply that it is preempting state law by occupation of an entire field of regulation, so that no room is left for supplementary state regulation,
(3) Congress may speak neither expressly nor impliedly of preemption, nonetheless state law is preempted to the extent it actually conflicts with federal law; such a conflict occurs when
(a) compliance with both state and federal law is impossible or,
(b) when state law stands as an impediment to a federal purpose.

 Abbot v. American Cyanamid Co., 844 F.2d 1108, 1111 (4th Cir.), cert. denied, 488 U.S. 908, 102 L. Ed. 2d 248, 109 S. Ct. 260 (1988) (citing Michigan Canners and Freezers Ass'n v. Agric. Mktg. and Bargaining Bd., 467 U.S. 461, 469, 104 S. Ct. 2518, 81 L. Ed. 2d 399 (1984)) (emphasis added). See also Cipollone v. Liggett Group, Inc., 505 U.S. , 112 S. Ct. 2608, 120 L. Ed. 2d 407, 423 (1992).

 Analysis of preemption issues must "start with the assumption that the historic police powers of the States [are] not to be superseded by [federal law] unless that [is] the clear and manifest purpose of Congress." Cipollone, 120 L. Ed. 2d at 422. (citing Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947)). There is a strong presumption against preemption when "Congress does not expressly state its intent," Abbott, 844 F.2d at 1112 (citing Maryland v. Louisiana, 451 U.S. 725, 68 L. Ed. 2d 576, 101 S. Ct. 2114 (1981)); when regulations pertain to health or safety issues, Abbott, 844 F.2d at 1112 (citing Hillsborough County v. Automated Med. Labs, 471 U.S. 707, 715, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985)); when there is no federal remedy for the plaintiff's injury, Abbot, 844 F.2d at 1112 (citing Silkwood v. Kerr-McGee, Corp., 464 U.S. 238, 251, 78 L. Ed. 2d 443, 104 S. Ct. 615 (1984), reh'g denied, 465 U.S. 1074, 79 L. Ed. 2d 754, 104 S. Ct. 1430 (1984), cert. denied, 476 U.S. 1104, 90 L. Ed. 2d 356, 106 S. Ct. 1947 (1986)); or in ambiguous cases. Cipollone, 120 L. Ed. 2d at 432 (Blackmun, J., concurring). Moreover, the comprehensive nature of regulations is less likely than the comprehensive nature of a statute from which to infer federal preemption, since regulations must ordinarily be comprehensive and detailed in nature. Abbot, 844 F.2d at 1112 (citing Hillsborough, 471 U.S. at 718).

 The Medical Device Amendments ("MDA") were added to the Food, Drug, and Cosmetic Act ("FDCA") in 1976 and are codified at 21 U.S.C. § 360c et seq. They were enacted "to assure that medical devices . . . meet the requirements of safety and effectiveness before they are put in widespread use throughout the United States." S. Rep. No. 33, 94th Cong., 1st Sess. 2 (1975), reprinted in 1976 U.S.C.C.A.N. 1071.

 These amendments both set forth requirements regarding the safety of medical devices and limit the power of states to regulate such devices. 21 U.S.C. § 360k(a), provides:

No state or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement --
(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and
(2) which relates to the safety and effectiveness of the device or to any other matter included in a requirement ...

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