Parenteau v. Johnson & Johnson Orthopedics, Inc.
Decision Date | 29 June 1994 |
Docket Number | Civ. No. 93-521-SD. |
Citation | 856 F. Supp. 61 |
Court | U.S. District Court — District of New Hampshire |
Parties | Robert PARENTEAU; Theresa Parenteau v. JOHNSON & JOHNSON ORTHOPEDICS, INC. |
Roger B. Phillips, Concord, NH, for plaintiffs.
Charles R. Parrott, Boston, MA, for defendant.
In this diversity action, plaintiffs Robert and Theresa Parenteau assert claims against defendant Johnson & Johnson Orthopedics, Inc., for (1) strict liability, (2) negligence, (3) breach of implied warranty, and (4) loss of consortium. Said claims are based upon the alleged defective design of a knee prosthesis manufactured by defendant with which Robert Parenteau was fitted during knee replacement surgery in July 1988.
Presently before the court is defendant's motion for summary judgment, to which plaintiffs object.
Defendant moves for summary judgment on the ground that plaintiffs' claims are preempted by the Medical Device Amendments of 1976 to the Food, Drug and Cosmetics Act of 1938, 21 U.S.C. § 301, et seq. (the "MDA").
On July 14, 1988, Robert Parenteau underwent total left knee replacement surgery. During this procedure, plaintiff's left knee was allegedly replaced by a total knee prosthesis designed, manufactured, and sold by defendant. Complaint ¶¶ 7-9.
Plaintiff alleges that during the fourteen-month period following surgery he experienced pain, discomfort, and swelling in his left knee. Id. ¶¶ 10-11.
Id. ¶ 12. Plaintiff's left knee prosthesis was subsequently removed and replaced. This action followed.
Under Rule 56(c), Fed.R.Civ.P., summary judgment is appropriate "if the pleadings, depositions, 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."
"The nonmoving party bears the burden of placing at least one material fact into dispute after the moving party shows the absence of material fact." Mendes v. Medtronic, Inc., 18 F.3d 13, 15 (1st Cir.1994) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S.Ct. 2548, 2554, 91 L.Ed.2d 265 (1986)). In determining whether the nonmoving party has met this burden, the court construes the evidence and draws all reasonable inferences in the nonmoving party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 2513-14, 91 L.Ed.2d 202 (1986).
The Supremacy Clause provides that federal law "shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. "State laws that conflict with federal laws and regulations, therefore, are preempted." King v. Collagen Corp., 983 F.2d 1130, 1133 (1st Cir.) (citing, e.g., Malone v. White Motor Corp., 435 U.S. 497, 98 S.Ct. 1185, 55 L.Ed.2d 443 (1978)), cert. denied, ___ U.S. ___, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993).
"Consideration of issues arising under the Supremacy Clause `starts with the assumption that the historic police powers of the States are not to be superseded by ... Federal Act unless that is the clear and manifest purpose of Congress.'" Cipollone v. Liggett Group, Inc., ___ U.S. ___, ___, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). The court interprets the MDA in light of this "presumption against preemption." Id., ___ U.S. at ___, 112 U.S. at 2618.
21 U.S.C. § 360k(a) (Supp.1994).
"The fact that Congress included section 360k in the MDA implies that matters beyond its reach are not preempted." King, supra, 983 F.2d at 1134. Therefore, to determine the extent to which plaintiffs' state law claims are preempted by section 360k(a), the court "need only identify the preemptive reach of the statute's express language." Mendes v. Medtronic, Inc., supra, 18 F.3d at 16 (citing Cipollone, supra, ___ U.S. at ___, 112 S.Ct. at 2628 (plurality); id., at ___, 112 S.Ct. at 2625 (Blackmun, J., concurring in part and dissenting in part)).
The FDA's regulations interpreting section 360k(a) "are given controlling weight unless they are arbitrary, capricious, or manifestly contrary to the statute." See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 844, 104 S.Ct. 2778, 2782, 81 L.Ed.2d 694 (1984).
21 C.F.R. § 808.1(b). The FDA regulations further provide King, supra, 983 F.2d at 1134. See also Slater v. Optical Radiation Corp., 961 F.2d 1330, 1331 (7th Cir.) (, )cert. denied, ___ U.S. ___, 113 S.Ct. 327, 121 L.Ed.2d 246 (1992).
The first step in determining whether plaintiffs' claims are preempted by section 360k(a) is to "outline the federal Food, Drug, and Cosmetic Act's requirements applicable to the device." Mendes, supra, 18 F.3d at 16. The court must then "scrutinize plaintiff's claims, to determine whether the successful litigation of any of them would `establish or continue in effect' a `different' or `additional' requirement." Id. (quoting 21 U.S.C. § 360k(a)); see also King, supra, 983 F.2d at 1134 ( ).
The knee prosthesis in question is a Class II medical device.2 As a Class II device, the knee prosthesis is subject to certain general controls regarding, inter alia, labeling, reporting, and manufacturing. 21 U.S.C. § 360c(a)(1)(A)-(B); 21 C.F.R. § 860.3(c)(1)(2). Class II devices may also "be subject to recommendations, guidelines, post-marketing surveillance, the development of patient registries, and even the promulgation of specific performance standards, should the FDA deem them a sufficient health hazard as to require strict product specifications or warnings." Stamps v. Collagen, 984 F.2d 1416, 1418 (5th Cir.) (citing see 21 U.S.C. § 360c(a)(1)(B)), cert. denied, ___ U.S. ___, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993); see also 21 C.F.R. § 860.3(c)(2).
The knee prosthesis is subject to 21 C.F.R. § 888.3560, entitled "Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis," which provides:
21 C.F.R. § 888.3560.
The court finds that the purpose of this regulation is to classify knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prostheses as Class II medical devices. See 21 C.F.R. § 888.1(a)(b). Other than this identification and classification regulation, the parties have not identified, nor has this court discovered, any other specific FDA requirements applicable to the knee prosthesis at issue.
Plaintiffs' claims of strict liability, negligence, breach of implied warranty, and loss of consortium are each based upon plaintiffs' contention that the Class II knee prosthesis with which Robert Parenteau was fitted in 1988 was defectively designed.
Defendant asserts that plaintiffs' claims are preempted under section 360k(a) because said claims, if successfully litigated, would create "requirements...
To continue reading
Request your trial-
Burgstahler v. AcroMed Corp.
...Corp., 867 F.2d 243, 246 (5th Cir.1989); Ginochio v. Surgikos, Inc., 864 F.Supp. 948, 953 (N.D.Cal.1994); Parenteau v. Johnson & Johnson Orthopedics, Inc., supra, 856 F.Supp. at 64-65; Brown v. Medtronic, Inc., supra, 852 F.Supp. at 721; Mulligan v. Pfizer, Inc., 850 F.Supp. 633, 635-37 (S.......
-
National Bank of Commerce of El Dorado v. Kimberly-Clark Corp.
...in the class II regulatory context is limited to the realm in which the FDA has acted. See, e.g., Parenteau v. Johnson & Johnson Orthopedics, Inc., 856 F.Supp. 61, 63-64 (D.N.H.1994); Brown v. Medtronic, Inc., 852 F.Supp. 717, 721 (S.D.Ind.1994); Mulligan v. Pfizer, Inc., 850 F.Supp. 633, 6......
-
Rosci v. AcroMed, Inc.
...867 F.2d 243, 246 (5th Cir.1989); Ginochio v. Surgikos, Inc., 864 F.Supp. 948, 953 (N.D.Cal.1994); Parenteau v. Johnson & Johnson Orthopedics, Inc., 856 F.Supp. 61, 64-65 (D.N.H.1994); Brown v. Medtronic, Inc., 852 F.Supp. 717, 721 (S.D.Ind.1994); Mulligan v. Pfizer, Inc., 850 F.Supp. 633, ......
-
Dow v. Baxter Healthcare Corp., Civ. A. No. 94-30099-MAP.
...Lohr v. Medtronic, 56 F.3d 1335 (11th Cir. 1995), cited in Talbott. This court agrees with the case of Parenteau v. Johnson & Johnson Orthopedics, Inc., 856 F.Supp. 61 (D.N.H.1994) that "preemption does not apply when the FDA has issued no regulations or other requirements specific to the p......
-
Preemption of State Tort Claims Under the Medical Device Amendments
...for Class II devices do not rise to the level to cause preemption under the MDA"); Parenteau v. Johnson & Johnson Orthopedics, Inc., 856 F.Supp. 61, 65 (D.N.H. 1994) ("the general controls to which all Class II devices are subject, do not regulate the design of the knee prosthesis at issue"......