{ "id": 1352896, "name": "HAROLD WEILAND, Plaintiff-Appellant, v. TELECTRONICS PACING SYSTEMS, INC., Defendant-Appellee", "name_abbreviation": "Weiland v. Telectronics Pacing Systems, Inc.", "decision_date": "1998-12-11", "docket_number": "No. 1\u201495\u20142736", "first_page": "175", "last_page": "190", "citations": [ { "type": "official", "cite": "302 Ill. App. 3d 175" } ], "court": { "name_abbreviation": "Ill. App. Ct.", "id": 8837, "name": "Illinois Appellate Court" }, "jurisdiction": { "id": 29, "name_long": "Illinois", "name": "Ill." }, "cites_to": [ { "cite": "520 U.S. 1112", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 11658058, 11658029, 11657965, 11658001, 11657910, 11658044, 11658077, 11657919 ], "year": 1997, "opinion_index": 0, "case_paths": [ "/us/520/1112-07", "/us/520/1112-05", "/us/520/1112-03", "/us/520/1112-04", "/us/520/1112-01", "/us/520/1112-06", "/us/520/1112-08", "/us/520/1112-02" ] }, { "cite": "524 U.S. 954", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 11219968, 11220289, 11220164, 11220135, 11220334, 11220206, 11220112, 11220018, 11220243, 11220083, 11219899, 11219996, 11220061 ], "year": 1998, "opinion_index": 0, "case_paths": [ "/us/524/0954-02", "/us/524/0954-12", "/us/524/0954-09", "/us/524/0954-08", "/us/524/0954-13", "/us/524/0954-10", "/us/524/0954-07", "/us/524/0954-04", "/us/524/0954-11", "/us/524/0954-06", "/us/524/0954-01", "/us/524/0954-03", "/us/524/0954-05" ] }, { "cite": "522 U.S. 862", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 11505921, 11506019, 11505990, 11506056, 11506120, 11505963, 11505900, 11506253, 11506158, 11506287, 11506226, 11506198, 11505944, 11506079 ], "year": 1997, "pin_cites": [ { "parenthetical": "state law claim for failure to warn of risk of toxic shock syndrome related to use of tampons, a class II device, preempted by MDA" } ], "opinion_index": 0, "case_paths": [ "/us/522/0862-02", "/us/522/0862-06", "/us/522/0862-05", "/us/522/0862-07", "/us/522/0862-09", "/us/522/0862-04", "/us/522/0862-01", "/us/522/0862-13", "/us/522/0862-10", "/us/522/0862-14", "/us/522/0862-12", "/us/522/0862-11", "/us/522/0862-03", "/us/522/0862-08" ] }, { "cite": "522 U.S. 1075", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 11598816, 11598530, 11598789, 11598982, 11598440, 11598728, 11599176, 11598923, 11598482, 11598578, 11599093, 11598870, 11598679, 11598620 ], "year": 1998, "pin_cites": [ { "parenthetical": "state law claims preempted by MDA for pacemaker marketed under investigational exception to PMA process" } ], "opinion_index": 0, "case_paths": [ "/us/522/1075-09", "/us/522/1075-03", "/us/522/1075-08", "/us/522/1075-12", "/us/522/1075-01", "/us/522/1075-07", "/us/522/1075-14", "/us/522/1075-11", "/us/522/1075-02", "/us/522/1075-04", "/us/522/1075-13", "/us/522/1075-10", "/us/522/1075-06", "/us/522/1075-05" ] }, { "cite": "523 U.S. 1020", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 11510146, 11510212, 11510309, 11510120, 11509993, 11509963, 11510283, 11510253, 11510029, 11510067, 11510165, 11510230, 11510009 ], "year": 1998, "opinion_index": 0, "case_paths": [ "/us/523/1020-07", "/us/523/1020-09", "/us/523/1020-13", "/us/523/1020-06", "/us/523/1020-02", "/us/523/1020-01", "/us/523/1020-12", "/us/523/1020-11", "/us/523/1020-04", "/us/523/1020-05", "/us/523/1020-08", "/us/523/1020-10", "/us/523/1020-03" ] }, { "cite": "230 A.D.2d 77", "category": "reporters:state", "reporter": "A.D.2d", "case_ids": [ 316187 ], "weight": 2, "year": 1997, "pin_cites": [ { "parenthetical": "claims not preempted because PMA process is not specific federal regulation" }, { "parenthetical": "claims not preempted because PMA process is not specific federal regulation" } ], "opinion_index": 0, "case_paths": [ "/ad2d/230/0077-01" ] }, { "cite": "552 N.W.2d 679", "category": "reporters:state_regional", "reporter": "N.W.2d", "year": 1996, "pin_cites": [ { "page": "684", "parenthetical": "claims not preempted because premarket approval process not specific requirement applicable to particular device" } ], "opinion_index": 0 }, { "cite": "217 Mich. App. 705", "category": "reporters:state", "reporter": "Mich. App.", "case_ids": [ 1558239 ], "year": 1996, "pin_cites": [ { "page": "718", "parenthetical": "claims not preempted because premarket approval process not specific requirement applicable to particular device" } ], "opinion_index": 0, "case_paths": [ "/mich-app/217/0705-01" ] }, { "cite": "116 S. Ct. 2579", "category": "reporters:federal", "reporter": "S. Ct.", "year": 1996, "opinion_index": 0 }, { "cite": "135 L. Ed. 2d 1094", "category": "reporters:federal", "reporter": "L. Ed. 2d", "year": 1996, "opinion_index": 0 }, { "cite": "518 U.S. 1033", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 1729699, 1729636, 1730180, 1730117, 1729831, 1729829, 1729938, 1730165, 1730134, 1729627, 1729788, 1729919 ], "year": 1996, "opinion_index": 0, "case_paths": [ "/us/518/1033-07", "/us/518/1033-12", "/us/518/1033-01", "/us/518/1033-08", "/us/518/1033-06", "/us/518/1033-10", "/us/518/1033-04", "/us/518/1033-03", "/us/518/1033-05", "/us/518/1033-09", "/us/518/1033-02", "/us/518/1033-11" ] }, { "cite": "67 F.3d 1453", "category": "reporters:federal", "reporter": "F.3d", "case_ids": [ 7416606 ], "year": 1995, "opinion_index": 0, "case_paths": [ "/f3d/67/1453-01" ] }, { "cite": "940 P.2d 1386", "category": "reporters:state_regional", "reporter": "P.2d", "year": 1997, "pin_cites": [ { "parenthetical": "state strict liability claims not preempted by MDA because they did not establish additional or different requirements specific to medical devices" } ], "opinion_index": 0 }, { "cite": "86 Wash. App. 898", "category": "reporters:state", "reporter": "Wash. App.", "case_ids": [ 1279027 ], "year": 1997, "pin_cites": [ { "parenthetical": "state strict liability claims not preempted by MDA because they did not establish additional or different requirements specific to medical devices" } ], "opinion_index": 0, "case_paths": [ "/wash-app/86/0898-01" ] }, { "cite": "149 Or. App. 641", "category": "reporters:state", "reporter": "Or. App.", "case_ids": [ 1180382 ], "weight": 2, "opinion_index": 0, "case_paths": [ "/or-app/149/0641-01" ] }, { "cite": "964 S.W.2d 753", "category": "reporters:state_regional", "reporter": "S.W.2d", "case_ids": [ 11850818 ], "year": 1998, "pin_cites": [ { "parenthetical": "\"distinguishing\" its supreme court's decision in Worthy, 967 S.W.2d at 376, cited above, and ruling that state law claims regarding pacemaker not preempted by MDA because defendant failed to show conflict between state and federal requirements" } ], "opinion_index": 0, "case_paths": [ "/sw2d/964/0753-01" ] }, { "cite": "117 S. Ct. 1695", "category": "reporters:federal", "reporter": "S. Ct.", "year": 1997, "opinion_index": 0 }, { "cite": "137 L. Ed. 2d 822", "category": "reporters:federal", "reporter": "L. Ed. 2d", "year": 1997, "opinion_index": 0 }, { "cite": "685 A.2d 110", "category": "reporters:state_regional", "reporter": "A.2d", "case_ids": [ 466658, 7346974 ], "year": 1996, "pin_cites": [ { "parenthetical": "failure to warn, strict liability, and breach of warranty claims preempted" } ], "opinion_index": 0, "case_paths": [ "/pa/546/0400-01", "/a2d/685/0110-01" ] }, { "cite": "546 Pa. 400", "category": "reporters:state", "reporter": "Pa.", "case_ids": [ 466658 ], "year": 1996, "pin_cites": [ { "parenthetical": "failure to warn, strict liability, and breach of warranty claims preempted" } ], "opinion_index": 0, "case_paths": [ "/pa/546/0400-01" ] }, { "cite": "57 Cal. Rptr. 2d 763", "category": "reporters:state", "reporter": "Cal. Rptr. 2d", "opinion_index": 0 }, { "cite": "50 Cal. App. 4th 580", "category": "reporters:state", "reporter": "Cal. App. 4th", "case_ids": [ 4673055 ], "opinion_index": 0, "case_paths": [ "/cal-app-4th/50/0580-01" ] }, { "cite": "63 Cal. Rptr. 2d 879", "category": "reporters:state", "reporter": "Cal. Rptr. 2d", "year": 1997, "pin_cites": [ { "page": "888" } ], "opinion_index": 0 }, { "cite": "54 Cal. App. 4th 1474", "category": "reporters:state", "reporter": "Cal. App. 4th", "case_ids": [ 215788 ], "year": 1997, "pin_cites": [ { "page": "1489" } ], "opinion_index": 0, "case_paths": [ "/cal-app-4th/54/1474-01" ] }, { "cite": "118 S. Ct. 374", "category": "reporters:federal", "reporter": "S. Ct.", "year": 1997, "opinion_index": 0 }, { "cite": "139 L. Ed. 2d 291", "category": "reporters:federal", "reporter": "L. Ed. 2d", "year": 1997, "opinion_index": 0 }, { "cite": "522 U.S. 952", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 11548066, 11548515, 11548099, 11548556, 11548430, 11548304, 11548241, 11548210, 11548180, 11548344, 11548601, 11548282, 11548123, 11548381 ], "year": 1997, "opinion_index": 0, "case_paths": [ "/us/522/0952-01", "/us/522/0952-12", "/us/522/0952-02", "/us/522/0952-13", "/us/522/0952-11", "/us/522/0952-08", "/us/522/0952-06", "/us/522/0952-05", "/us/522/0952-04", "/us/522/0952-09", "/us/522/0952-14", "/us/522/0952-07", "/us/522/0952-03", "/us/522/0952-10" ] }, { "cite": "695 A.2d 511", "category": "reporters:state_regional", "reporter": "A.2d", "case_ids": [ 11967100 ], "year": 1997, "pin_cites": [ { "page": "517", "parenthetical": "claims for negligence, strict liability, and breach of warranty preempted by MDA" } ], "opinion_index": 0, "case_paths": [ "/a2d/695/0511-01" ] }, { "cite": "516 U.S. 400", "category": "reporters:federal", "reporter": "U.S.", "case_ids": [ 323164 ], "weight": 3, "year": 1996, "pin_cites": [ { "parenthetical": "resolving split of authority contrary to state court's ruling" }, { "parenthetical": "resolving split of authority contrary to state court's ruling" }, { "parenthetical": "resolving split of authority contrary to state court's ruling" } ], "opinion_index": 0, "case_paths": [ "/us/516/0400-01" ] }, { "cite": "268 Ill. App. 3d 561", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 381912 ], "year": 1994, "pin_cites": [ { "page": "563-64", "parenthetical": "court must look to federal decisions for guidance and interpretation of federal acts to prevent erosion of rights conferred under federal law and to achieve uniformity; but where split of authority existed among federal courts, court chose to follow prior state case law" } ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/268/0561-01" ] }, { "cite": "144 Ill. App. 3d 616", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 3501201 ], "year": 1986, "pin_cites": [ { "page": "620", "parenthetical": "decisions of federal courts are controlling upon appellate court in interpretation of federal statute" } ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/144/0616-01" ] }, { "cite": "38 Ill. 2d 31", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 2860497 ], "year": 1967, "pin_cites": [ { "page": "34", "parenthetical": "in construing federal statutes, court looks to federal decisions" } ], "opinion_index": 0, "case_paths": [ "/ill-2d/38/0031-01" ] }, { "cite": "9 Ill. 2d 505", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 5320009 ], "year": 1956, "pin_cites": [ { "page": "507", "parenthetical": "decisions of federal courts are controlling upon court in interpretation of federal statue" } ], "opinion_index": 0, "case_paths": [ "/ill-2d/9/0505-01" ] }, { "cite": "11 Ill. 2d 186", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 2785293 ], "weight": 2, "year": 1957, "pin_cites": [ { "page": "200" }, { "page": "199-200", "parenthetical": "rights created under federal statute are governed, not by state law, but by decisions of federal courts, in order that federal act be given uniform application" } ], "opinion_index": 0, "case_paths": [ "/ill-2d/11/0186-01" ] }, { "cite": "15 U.S.C. \u00a7 1261", "category": "laws:leg_statute", "reporter": "U.S.C.", "year": 1988, "pin_cites": [ { "page": "et seq." } ], "opinion_index": 0 }, { "cite": "94 C 5477", "category": "reporters:state", "reporter": "Cow.", "year": 1998, "opinion_index": 0 }, { "cite": "176 F.R.D. 158", "category": "reporters:specialty", "reporter": "F.R.D.", "case_ids": [ 103435 ], "year": 1998, "opinion_index": 0, "case_paths": [ "/frd/176/0158-01" ] }, { "cite": "118 S. Ct. 2372", "category": "reporters:federal", "reporter": "S. Ct.", "year": 1998, "opinion_index": 0 }, { "cite": "141 L. Ed. 2d 740", "category": "reporters:federal", "reporter": "L. Ed. 2d", "year": 1998, "opinion_index": 0 }, { "cite": "967 S.W2d 360", "category": "reporters:state_regional", "reporter": "S.W.2d", "case_ids": [ 11832545 ], "weight": 3, "year": 1998, "pin_cites": [ { "page": "376", "parenthetical": "citing Mitchell and then concluding that federal requirements on product were sufficiently specific to have preemptive effect" }, { "page": "376", "parenthetical": "claims brought under state consumer protection law preempted by MDA" }, { "page": "376" } ], "opinion_index": 0, "case_paths": [ "/sw2d/967/0360-01" ] }, { "cite": "945 F. Supp. 7", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 5625988 ], "year": 1996, "pin_cites": [ { "parenthetical": "MDA did not completely preempt state law tort claims regardless of which approval process device underwent" } ], "opinion_index": 0, "case_paths": [ "/f-supp/945/0007-01" ] }, { "cite": "965 F. Supp. 49", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 479502 ], "year": 1997, "pin_cites": [ { "parenthetical": "PMA process is not a \"specific federal requirement\" so as to preempt state law claims" } ], "opinion_index": 0, "case_paths": [ "/f-supp/965/0049-01" ] }, { "cite": "111 F.3d 782", "category": "reporters:federal", "reporter": "F.3d", "case_ids": [ 11914143 ], "year": 1997, "pin_cites": [ { "parenthetical": "no preemption where state law claim predicated on general duties applicable to every manufacturer" } ], "opinion_index": 0, "case_paths": [ "/f3d/111/0782-01" ] }, { "cite": "19 F. Supp. 2d 625", "category": "reporters:federal", "reporter": "F. Supp. 2d", "case_ids": [ 11678499 ], "year": 1998, "pin_cites": [ { "parenthetical": "state law claim for negligent design preempted by MDA for device marketed under investigational exception" } ], "opinion_index": 0, "case_paths": [ "/f-supp-2d/19/0625-01" ] }, { "cite": "966 F. Supp. 839", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 11977437 ], "year": 1997, "pin_cites": [ { "parenthetical": "strict liability, negligent design and failure to warn claims preempted by MDA for device marketed under investigational exception" } ], "opinion_index": 0, "case_paths": [ "/f-supp/966/0839-01" ] }, { "cite": "937 F. Supp. 181", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 7652675 ], "year": 1996, "pin_cites": [ { "parenthetical": "state common law claims for negligence and strict products liability preempted by MDA for device marketed under investigational exception" } ], "opinion_index": 0, "case_paths": [ "/f-supp/937/0181-01" ] }, { "cite": "118 S. Ct. 166", "category": "reporters:federal", "reporter": "S. Ct.", "year": 1997, "pin_cites": [ { "parenthetical": "state law claim for failure to warn of risk of toxic shock syndrome related to use of tampons, a class II device, preempted by MDA" } ], "opinion_index": 0 }, { "cite": "139 L. Ed. 2d 110", "category": "reporters:federal", "reporter": "L. Ed. 2d", "year": 1997, "pin_cites": [ { "parenthetical": "state law claim for failure to warn of risk of toxic shock syndrome related to use of tampons, a class II device, preempted by MDA" } ], "opinion_index": 0 }, { "cite": "107 F.3d 737", "category": "reporters:federal", "reporter": "F.3d", "case_ids": [ 7641853 ], "year": 1997, "opinion_index": 0, "case_paths": [ "/f3d/107/-847-01" ] }, { "cite": "109 F.3d 1243", "category": "reporters:federal", "reporter": "F.3d", "case_ids": [ 834196 ], "year": 1997, "pin_cites": [ { "parenthetical": "state law claims related to device marketed under investigational exception preempted to extent would impose greater requirement than those already imposed by FDA" } ], "opinion_index": 0, "case_paths": [ "/f3d/109/1243-01" ] }, { "cite": "118 S. Ct. 850", "category": "reporters:federal", "reporter": "S. 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TELECTRONICS PACING SYSTEMS, INC., Defendant-Appellee." ], "opinions": [ { "text": "JUSTICE GREIMAN\ndelivered the opinion of the court:\nPlaintiff Harold Weiland brought suit against defendant Telectronics Pacing Systems, Inc., alleging claims for breach of warranty and product liability regarding two pacemakers implanted into his body. The circuit court granted summary judgment to the defendant on the claims because it determined that those claims were preempted by the Medical Device Amendments of 1976 (MDA) (21 U.S.C.A. \u00a7\u00a7 360c through 360k (West Supp. 1998)) to the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C.A. \u00a7 301 et seq. (West Supp. 1998)). Plaintiff appealed.\nFor the reasons that follow, we affirm.\nOn July 26, 1993, plaintiff filed a third amended complaint against Telectronics Proprietary, Ltd. (TPL), Telectronics Pacing Systems, Inc. (TPSI), and Alexian Brothers Medical Center, Inc. (Alexian), alleging breach of warranty and product liability claims against each defendant and loss of consortium for plaintiffs wife. According to the complaint, prior to January 1991, plaintiff suffered from a heart ailment. He sought treatment from Alexian and was diagnosed with heart disease. In January 1991, a pacemaker, model 8222, was surgically implanted into plaintiff. The pacemaker was designed and manufactured by TPL and sold to its distributor, TPSI, which in turn sold it to Alexian. Plaintiff alleged that the pacemaker malfunctioned, causing him to suffer various physical problems as well as general mental and psychological distress. The pacemaker was removed and a new pacemaker, model 1230, was implanted. This pacemaker was also manufactured by TPL, sold to TPSI, and resold to Alexian.\nPlaintiff alleged that TPSI impliedly warranted that the pacemakers were merchantable and fit for the particular purpose for which they were intended and that they failed to meet those warranties. He further alleged that the two pacemakers were defective in design and construction, the defective condition existed at the time they left TPSI\u2019s possession, and the pacemakers were defective when they were sold to Alexian and, ultimately, to plaintiff. Plaintiff claimed that as a result of the defect he suffered adverse cardiac reaction, mental and physical pain, and psychological strain and anguish. He underwent surgical procedures to have the pacemakers removed and replaced with related devices.\nPlaintiffs complaint noted that on December 31, 1991, the Department of Health and Human Services\u2019 Food and Drug Administration issued a recall of the model 8222 pacemaker.\nOn October 12, 1993, TPL was dismissed from the case without prejudice. Plaintiff later stipulated to the dismissal of the claims against Alexian with prejudice.\nOn July 6, 1995, the circuit court granted summary judgment to TPSI on the claims against it, counts II and V of the third amended complaint. During the hearing on the motion, the court stated that it found the claims preempted by federal law \u201cin that they seek to impose requirements on the manufacturer that relate to the safety and effectiveness of a class III device that are different from and in addition to the requirements imposed by the medical device amendment[s].\u201d\nPlaintiff now appeals this ruling, arguing that the claims are not preempted by the MDA. The matter was held in abeyance pending resolution of Haudrich v. Howmedica, Inc., 267 Ill. App. 3d 630 (1994), in the Illinois Supreme Court, pending resolution of Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996), in the Supreme Court of the United States, and pending resolution of a petition for certiorari for Kernats v. Smith Industries Medical Systems, Inc., 283 Ill. App. 3d 455 (1996), appeal denied, 169 Ill. 2d 569 (1996), cert. denied, 520 U.S. 1208, 139 L. Ed. 2d 631, 118 S. Ct. 684 (1998). The Illinois Supreme Court decided Haudrich without reaching the issue of whether the Medical Device Amendments of 1976 preempted state claims. See Haudrich v. Howmedica, Inc., 169 Ill. 2d 525 (1996) (preemption issue waived by failure to raise to court below). The Supreme Court\u2019s decision in Medtronic and this court\u2019s ruling in Kernats are discussed below.\nSummary judgment is appropriate where the pleadings, affidavits, depositions, and admissions on file show there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Busch v. Graphic Color Corp., 169 Ill. 2d 325, 333 (1996). The standard of review is de novo. Busch, 169 Ill. 2d at 333.\nThe outcome of this case involves the interpretation of the MDA as well as several decisions interpreting the MDA, including Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996); Kernats v. Smith Industries Medical Systems, Inc., 283 Ill. App. 3d 455 (1996), appeal denied, 169 Ill. 2d 569 (1996), cert. denied, 520 U.S. 1208, 139 L. Ed. 2d 631, 118 S. Ct. 684 (1998), and Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), cert. denied, 523 U.S. 1020, 140 L. Ed. 2d 467, 118 S. Ct. 1300 (1998).\nPlaintiff contends the circuit court erred in determining that the MDA preempted his claims for breach of implied warranty and product liability, and relies on this court\u2019s opinion in Kernats, which appears on point with regard to the preemption of his claims. Defendant argues, however, that this court should reconsider Kernats because it misconstrued the United States Supreme Court decision in Medtronic and, in light of subsequent federal decisions, hold these claims preempted by the MDA.\nThe MDA classifies medical devices into three categories based on the risk they pose to the public. See 21 U.S.C.A. \u00a7 360c (West Supp. 1998); see generally Medtronic, 518 U.S. at 476-77, 135 L. Ed. 2d at 710, 116 S. Ct. at 2246; Kernats, 283 Ill. App. 3d at 459-60. Class III devices, which are at issue here, present \u201ca potential unreasonable risk of illness or injury\u201d and are subject to the most stringent MDA controls. 21 U.S.C.A. \u00a7 360c(a)(1)(C) (West Supp. 1998). To market a class III device, a manufacturer must provide the FDA with a \u201creasonable assurance\u201d that the device is both safe and effective. 21 U.S.C.A. \u00a7 360e(d)(2) (West Supp. 1998). Manufacturers must obtain premarket approval (PMA) through a rigorous process that requires them to submit detailed information regarding the safety and efficacy of their medical devices. See Medtronic, 518 U.S. at 477, 135 L. Ed. 2d at 710-11, 116 S. Ct. at 2246-47.\nExceptions to the PMA requirement allow some class III devices to reach the marketplace without PMA review. A \u201cgrandfather\u201d provision allows pre-1976 medical devices to remain on the market until such time as the FDA initiates and completes the requisite PMA. See 21 U.S.C.A. \u00a7 360e(b)(1)(A) (West Supp. 1998); 21 C.F.R. \u00a7 814.1(c)(1) (1998). The MDA also allows devices that are \u201csubstantially equivalent\u201d to preexisting devices to avoid the PMA process. See 21 U.S.C.A. \u00a7 360e(b)(1)(B) (West Supp. 1998); see generally Medtronic, 518 U.S. at 478, 135 L. Ed. 2d at 711, 116 S. Ct. at 2247. Under the \u201csubstantially equivalent\u201d exception, manufacturers must submit to a limited form of review known as \u201cpremarket notification,\u201d which allows the device to be marketed without further regulatory analysis if the FDA decides that it is \u201csubstantially equivalent\u201d to a preexisting device. Plaintiff does not suggest that the devices here are under the \u201csubstantial equivalent\u201d exception.\nBecause the pacemakers implanted into plaintiff fall under class III, defendant was required to provide a \u201creasonable assurance\u201d that the device was both safe and effective. Defendant asserts that the two pacemakers at issue here underwent the PMA review process. With this background, we must decide whether the MDA preempts plaintiffs claims.\nThe supremacy clause of the United States Constitution provides that the laws of the United States \u201cshall be the supreme Law of the Land *** any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.\u201d U.S. Const., art. VI, cl. 2. Where state law conflicts with federal law, the state law is \u201c \u2018without effect.\u2019 \u201d Busch, 169 Ill. 2d at 334, quoting Maryland v. Louisiana, 451 U.S. 725, 746, 68 L. Ed. 2d 576, 595, 101 S. Ct. 2114, 2128 (1981).\nWhen analyzing a preemption question, there is an assumption that a federal law will not supersede the historic police powers of the states unless the purpose of Congress is clear and manifest. Kernats, 283 Ill. App. 3d at 460-61, citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 120 L. Ed. 2d 407, 422, 112 S. Ct. 2608, 2617 (1992); Medtronic, 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250. Unless there is an express congressional command, state law is preempted if that law actually conflicts with federal law or if federal law so thoroughly occupies the legislative field as to make reasonable the inference that Congress left no room for the states to supplement it. Kernats, 283 Ill. App. 3d at 461, citing Cipollone, 505 U.S. at 516, 120 L. Ed. 2d at 423, 112 S. Ct. at 2617.\nSection 360k(a) of the MDA contains a preemption provision, which provides, in pertinent part:\n\u201c[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement\u2014\n(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and\n(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.\u201d 21 U.S.C.A. \u00a7 360k(a) (West Supp. 1998).\nIn Medtronic, the Supreme Court interpreted this section with respect to state-law claims involving a pacemaker marketed as a device that was \u201csubstantially equivalent\u201d to products already on the market and not a device that underwent the full PMA process to which the pacemakers here were subjected. Medtronic, 518 U.S. at 480, 135 L. Ed. 2d at 712, 116 S. Ct. at 2248. When the pacemaker failed, the Lohrs sued Medtronic for breach of its duty to use reasonable care in the design, manufacture, assembly and sale of the pacemaker, as well as for failing to warn and adequately instruct as to the pacemaker\u2019s tendency to fail. Their strict liability claim alleged that the device was in a defective condition and unreasonably dangerous at the time of sale. A deeply divided Supreme Court held that none of the Lohrs\u2019 claims were preempted by the MDA. Medtronic, 518 U.S. at 503, 135 L. Ed. 2d at 726, 116 S. Ct. at 2259. Because of the several concurring and dissenting opinions in that case, the precise precedence of Medtronic is difficult to discern.\nAll nine Justices agreed that the claims alleging negligent design were not preempted by the MDA\u2019s substantial equivalency requirement, which was employed on the pacemaker in that case. This notification process, observed Justice O\u2019Connor, merely determines whether the device in question is the substantial equivalent of another device already on the market. It places no \u201crequirement\u201d on the device. Medtronic, 518 U.S. at 513, 135 L. Ed. 2d at 733, 116 S. Ct. at 2264 (O\u2019Connor, J., concurring in part & dissenting in part, joined by Rehnquist, C.J., & Scalia & Thomas JJ.).\nJustice Stevens, with Justices Kennedy, Souter, Ginsberg, and Breyer, also held that the claims alleging negligent manufacturing and failure to warn were not preempted despite federal manufacturing and labeling requirements for medical devices. Medtronic, 518 U.S. at 497-502, 135 L. Ed. 2d at 723-26, 116 S. Ct. at 2256-58. The Court found those federal requirements to be general requirements and not \u201cspecific\u201d so as to trigger the preemption section.\nThe Medtronic Court disagreed as to whether a state common law duty is or can be a \u201crequirement\u201d that would invoke the preemption section. Justice Stevens, with Justices Kennedy, Souter, and Ginsberg, stated that the argument that all common law actions were \u201crequirement [s],\u201d and thus preempted, was \u201cimplausible.\u201d Medtronic, 518 U.S. at 486-87, 135 L. Ed. 2d at 716, 116 S. Ct. at 2251. If that were the case, the Justices concluded, this section would have in effect granted complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation to provide for the safety and effectiveness of medical devices. Medtronic, 518 U.S. at 487, 135 L. Ed. 2d at 716-17, 116 S. Ct. at 2251. The Justices did not believe that was Congress\u2019 intent. They concluded that the Court need not determine whether common law actions are never \u201crequirements\u201d within the meaning of section 360k and it would be \u201crare\u201d for such an action to have the effect of establishing substantive requirements for a specific device. Medtronic, 518 U.S. at 502-03, 135 L. Ed. 2d at 726, 116 S. Ct. at 2259.\nJustice Breyer wrote separately, stating that ordinarily section 360k(a) preempted state requirements embodied in a state statute, rule, regulation, or other administrative action, and it would also preempt a similar requirement that takes the form of a standard of care or behavior imposed by a state law tort action. Medtronic, 518 U.S. at 504-05, 135 L. Ed. 2d at 727, 116 S. Ct. at 2260 (Breyer, J., concurring in part & dissenting in part).\nJustice O\u2019Connor, with Chief Justice Rehnquist and Justices Scalia and Thomas, determined that section 360k(a) preempted any state common law action that would impose a requirement \u201cdifferent from, or in addition to\u201d a requirement under the FDCA. Medtronic, 518 U.S. at 509, 135 L. Ed. 2d at 730, 116 S. Ct. at 2262 (O\u2019Connor, J., concurring in part & dissenting in part, joined by Rehnquist, C.J., & Scalia & Thomas, JJ.), (with Breyer\u2019s concurrence, this would make a majority of Justices agreeing on this point). These Justices also disagreed with Stevens on the issue of whether the negligent manufacturing and failure to warn claims were preempted by section 360k(a), concluding that \u201c[s]ome, if not all, of the Lohrs\u2019 common-law claims regarding the manufacturing and labeling of Medtronic\u2019s device would compel Medtronic to comply with requirements different from, or in addition to, those required by the FDA.\u201d Medtronic, 518 U.S. at 513, 135 L. Ed. 2d at 733, 116 S. Ct. at 2264 (O\u2019Connor, J., joined by Rehnquist, C.J., & Scalia & Thomas, JJ.).\nThis court discussed Medtronic in Kernats, 283 Ill. App. 3d at 461-64, recognizing that the Medtronic decision was divided as to whether state common law damages actions could ever be preempted by the MDA. The plaintiff in Kernats alleged various claims related to a medical device, a CVS catheter, that had undergone PMA review and obtained FDA approval for its safety and effectiveness. This court concluded that the PMA process was a specific federal requirement. Kernats, 283 Ill. App. 3d at 465.\nThe Kernats court then looked to the nature of the state requirements and stated that the Medtronic Court \u201cheld that common-law claims challenging the manufacturing and labeling of medical devices were not preempted by the MDA because they were simply \u2018general obligations\u2019 imposed by the state on manufacturers; they were not state requirements specifically developed \u2018with respect to\u2019 medical devices.\u201d Kernats, 283 Ill. App. 3d at 465, quoting Medtronic, 518 U.S. at 501-02, 135 L. Ed. 2d at 725-26, 116 S. Ct. at 2258. The court determined that the claims based on the manufacture of the CVS catheter, the failure to warn and inadequate instruction, and the claims for defective design and inadequate testing arose from \u201cgeneral obligations\u201d applicable to all manufacturers and were \u201cnot the sort of state requirement that section 360k was intended to preempt.\u201d Kernats, 283 Ill. App. 3d at 465-66. Therefore, the court found no preemption for those claims despite the PMA review.\nAs to claims for breach of express and implied warranties, which the Medtronic Court did not address, the Kernats court noted that the FDA regulations provide, as an example of a permissible general requirement, that the Uniform Commercial Code (UCC) (810 ILCS 5/2\u2014314, 2\u2014315 (West 1994)) warranty of fitness is not preempted. Kernats, 283 Ill. App. 3d at 466, citing 21 C.F.R. \u00a7 808.1(d)(1) (1995). The court concluded that because these state requirements were of \u201cgeneral applicability,\u201d and not \u201cspecifically developed \u2018with respect to\u2019 medical devices,\u201d they also did not fall \u201cwithin the purview of section 360k.\u201d Kernats, 283 Ill. App. 3d at 466-67.\nBased on the Kernats analysis, plaintiff in this case contends that his claims were not preempted by the MDA despite the fact that the devices went through the PMA process. He states that because the federal regulations point to the UCC warranty of fitness as an example of a permissible general requirement and because the UCC\u2019s requirements are of \u201cgeneral applicability\u201d and not specifically developed with respect to medical devices, they would not appear to fall within section 360k. Likewise, because the plaintiffs claims for defects in design and construction are based on common law \u201cgeneral obligations\u201d that apply to all manufacturers, and are not specifically established for medical devices, those claims would also not appear to be preempted by the MDA.\nDefendant urges this court to \u201crevisit\u201d Kernats and follow the seventh circuit\u2019s subsequent ruling in Mitchell, 126 F.3d 902, as well as other cases decided after Medtronic holding that state law claims are preempted when a device has gone through PMA review. Defendant contends that because Medtronic did not address a medical device that had gone through the full PMA review process, the decision did not specifically answer the question in this case, and he argues that the precedential value of Medtronic is very limited by the various opinions in that decision.\nIn Mitchell, 126 F.3d 902, the seventh circuit addressed the question of preemption with regard to a medical device that had undergone the PMA process and concluded that the plaintiffs\u2019 state claims were preempted under the MDA. The Mitchells filed a complaint, alleging counts of strict liability, negligence, fraud, mislabeling, misbranding, adulteration and breach of warranty, related to collagen injections Ms. Mitchell received. Mitchell, 126 F.3d at 906. The Mitchell court stressed the factual distinction from Medtronic because the product in Mitchell had been subjected to full PMA review. Mitchell, 126 F.3d at 907.\nThe Mitchell court discussed the disagreement among the Justices in Medtronic, recognizing the difficult situation created by Medtronic and stating:\n\u201c[A]lthough we have an obligation to be absolutely faithful to the holdings of the Supreme Court of the United States, the holding in Medtronic contains several ambiguities that impair our ability to perceive with absolute clarity the path that the Court has chosen for us to follow.\n*** Like the majority of courts that already have had to deal with this quandary, we believe that the Medtronic disposition must be read as acknowledging that at least some state-based common law causes of action must be considered \u2018requirements\u2019 as that term is employed in the MDA.\u201d Mitchell, 126 F.3d at 910.\nThe Mitchell court determined that the Mitchells\u2019 strict liability claims were preempted by the PMA process for a class III medical device, stating:\n\u201cApproval by the FDA constitutes approval of the product\u2019s design, testing, intended use, manufacturing methods, performance standards and labeling. The FDA\u2019s determination is specific to the product. A state court judgment premised on a contrary determination, as a finding of liability based on the Mitchells\u2019 strict liability claim necessarily would be, would constitute *** a requirement \u2018different from, or in addition to,\u2019 the standard required by federal authority.\u201d Mitchell, 126 F.3d at 913.\nThe court also determined that the Mitchells\u2019 negligence claims must be considered preempted to the extent that they alleged that Collagen was negligent despite its adherence to the standards required by the FDA in its PMA for the product. \u201cA state court judgment premised on a determination that such a specific allegation is true would necessarily conflict with the determination of the FDA that its requirements rendered the product safe and effective.\u201d Mitchell, 126 F.3d at 913.\nThe court found the Mitchells\u2019 claims for breach of an implied warranty were preempted because an implied warranty claim is based on the accepted standards of design and manufacture of the products. The court stated:\n\u201cIn the case of a product that has gone through the PMA process, these criteria are set by the FDA. A state judgment for breach of implied warranty that rested on allegations about standards other than those permitted by the FDA would necessarily interfere with the PMA process and, indeed, supplant it.\u201d Mitchell, 126 F.3d at 915.\nIn addition to Mitchell, several cases after Medtronic have held state law claims are preempted where the device in question underwent PMA review, rather than being marketed under an exception to that process. See Easterling v. Cardiac Pacemakers, Inc., 986 F. Supp. 366 (E.D. La. 1997) (state law claims for negligence and strict liability related to pacemaker despite manufacturer\u2019s adherence to FDA PMA requirements preempted by MDA); Richman v. W.L. Gore & Associates, Inc., 988 F. Supp. 753 (S.D.N.Y. 1997) (state law claims for breach of implied warranty and tort claims preempted by MDA for medical device that underwent PMA approval except for claims based on failure to meet PMA requirements); Lake v. Telectronics Pacing Systems, Inc., 1 F. Supp. 2d 84 (D. Mass. 1998) (state law claims for negligence and breach of warranty against manufacturer of pacemaker preempted where pacemaker went through PMA review). See also Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090 (6th Cir. 1997), cert. denied, 522 U.S. 1075, 139 L. Ed. 2d 751, 118 S. Ct. 850 (1998) (state law claims preempted by MDA for pacemaker marketed under investigational exception to PMA process); Chambers v. Osteonics Corp., 109 F.3d 1243 (7th Cir. 1997) (state law claims related to device marketed under investigational exception preempted to extent would impose greater requirement than those already imposed by FDA); Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir. 1997), cert. denied, 522 U.S. 862, 139 L. Ed. 2d 110, 118 S. Ct. 166 (1997) (state law claim for failure to warn of risk of toxic shock syndrome related to use of tampons, a class II device, preempted by MDA); Berish v. Richards Medical Co., 937 F. Supp. 181 (N.D.N.Y. 1996) (state common law claims for negligence and strict products liability preempted by MDA for device marketed under investigational exception); Chmielewski v. Stryker Sales Corp., 966 F. Supp. 839 (D. Minn. 1997) (strict liability, negligent design and failure to warn claims preempted by MDA for device marketed under investigational exception); Lewis v. Intermedics Intraocular, Inc., 19 F. Supp. 2d 625 (E.D. La. 1998) (state law claim for negligent design preempted by MDA for device marketed under investigational exception).\nThere have been some contrary decisions. See Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997) (no preemption where state law claim predicated on general duties applicable to every manufacturer); Lakie v. SmithKline Beecham, 965 F. Supp. 49 (D.D.C. 1997) (PMA process is not a \u201cspecific federal requirement\u201d so as to preempt state law claims). See also Comeau v. Heller, 945 F. Supp. 7 (D. Mass. 1996) (MDA did not completely preempt state law tort claims regardless of which approval process device underwent).\nIn Lake, 1 F. Supp. 2d 84, the District Court in Massachusetts addressed the preemption of state law claims for negligence and breach of warranty related to the manufacturing of pacemaker, model 1230, which appears to be the same model number at issue in this case. The court held those claims preempted, stating:\n\u201c{Medtronic] did not address the separate issue of whether approval through the more rigorous PMA process has the effect of imposing specific federal requirements on the device, for purposes of the preemption clause. [Citation.] Circuit courts have varied as to whether it does, but a majority seem to conclude that, where safety is a primary concern, the PMA process does impose specific federal requirements. [Citations.] Some state courts have come to the same conclusion. [Citations.]\nThis seems the better view, and this Court will follow it in this case. With regard to the 1230 pacemaker, specific federal requirements are imposed by reason of the PMA approval given by the FDA.\u201d Lake, 1 F. Supp. 2d at 86-87.\nThe court next examined whether the state common law causes of action created requirements different from or in addition to the requirements imposed by the PMA. The court noted that Medtronic does not provide a clear answer on this question, but concluded, based on Mitchell and Papike, that the causes of action do impose requirements so as to be preempted. Lake, 1 F. Supp. 2d at 87.\nSeveral courts have relied on Mitchell when finding state law claims preempted by the MDA. See Easterling, 986 F. Supp. at 372 (relying on Mitchell and stating that state claims, even those based upon general duty of care, are preempted if they have effect of imposing requirements on device that are different from, or in addition to, federal requirements); Richman, 988 F. Supp. at 758 (citing Mitchell and deciding to follow majority of courts that have considered the issue and determined that the PMA process constitutes a type of specific federal requirement that can have preemptive effect); Touchet v. Ace Medical Co., No. 96\u20143534 (E.D. La. August 14, 1998) (citing Mitchell and holding state law claims preempted by MDA for device approved under investigational exception); Worthy v. Collagen Corp., 967 S.W2d 360, 376 (Tex. 1998) (citing Mitchell and then concluding that federal requirements on product were sufficiently specific to have preemptive effect) cert. denied, 524 U.S. 954, 141 L. Ed. 2d 740, 118 S. Ct. 2372 (1998); but see In re Orthopedic Bone Screw Products Liability Litigation, 176 F.R.D. 158 (3rd Cir. 1998) (disagreeing with Mitchell and ruling that after Medtronic the MDA would not preempt a state law claim for fraudulent misrepresentation to the FDA by a manufacturer during the approval process for a device approved under the substantial equivalent exception and not approved after full PMA review). Most notably, defendant points out that the United States District Court for the Northern District of Illinois recently followed Mitchell in Rogerson v. Telectronics Co., No. 94 C 5477 (N.D. Ill. August 25, 1998), and ruled that the MDA preempted state law claims for strict liability, negligence, and implied warranty for a pacemaker that underwent full PMA review.\nWhen analyzing the scope of preemption of a federal act, the Illinois Supreme Court has held that \u201cdecisions of the Federal courts interpreting a Federal act *** are controlling upon Illinois courts, \u2018in order that the act be given uniform application.\u2019 \u201d Busch, 169 Ill. 2d at 335 (holding plaintiff\u2019s wrongful death claim preempted by Federal Hazardous Substances Act (15 U.S.C. \u00a7 1261 et seq. (1988)), quoting Bowman v. Illinois Central R.R. Co., 11 Ill. 2d 186, 200 (1957); see Elgin, Joliet & Eastern Ry. Co. v. Industrial Comm\u2019n, 9 Ill. 2d 505, 507 (1956) (decisions of federal courts are controlling upon court in interpretation of federal statue); Bowman v. Illinois Central R.R. Co., 11 Ill. 2d 186, 199-200 (1957) (rights created under federal statute are governed, not by state law, but by decisions of federal courts, in order that federal act be given uniform application); Boyer v. Atchinson, Topeka & Santa Fe Ry. Co., 38 Ill. 2d 31, 34 (1967) (in construing federal statutes, court looks to federal decisions); Golden Bear Family Restaurants, Inc. v. Murray, 144 Ill. App. 3d 616, 620 (1986) (decisions of federal courts are controlling upon appellate court in interpretation of federal statute); see also Hiles v. Norfolk & Western Ry. Co., 268 Ill. App. 3d 561, 563-64 (1994) (court must look to federal decisions for guidance and interpretation of federal acts to prevent erosion of rights conferred under federal law and to achieve uniformity; but where split of authority existed among federal courts, court chose to follow prior state case law), rev\u2019d, 516 U.S. 400, 134 L. Ed. 2d 34, 116 S. Ct. 890 (1996) (resolving split of authority contrary to state court\u2019s ruling).\nUnder Mitchell and what appears to be a majority of other federal court decisions, plaintiffs claims would be preempted because a determination by a state court as to a product defect or as to its fitness or merchantability would be \u201cdifferent from, or in addition to\u201d the federal approval of these pacemakers. Plaintiff contends that this court should not follow Mitchell, because it and the other cases following it improperly interpreted Medtronic and therefore they should not be considered binding on this court, and that this court should follow Kernats.\nWe agree with the Kernats court that PMA approval creates a specific federal regulation and follow that portion of its ruling.. We disagree, however, with the Kernats court as to whether the state law claims create requirements different from or in addition to the federal requirements so as to find preemption. A majority of the federal courts, including the seventh circuit, have interpreted the MDA PMA to preempt the type of state law claims presented in this case. While there are some decisions to the contrary, the prevailing view of the federal courts at this time is that the state law claims impose requirements different from or in addition to the federal requirements and we will follow this view.\nWe observe that since Medtronic several state courts have found state law claims involving devices that had undergone PMA review preempted by the MDA. See, e.g., Worthy, 967 S.W.2d at 376 (claims brought under state consumer protection law preempted by MDA); Fry v. Allergan Medical Optics, 695 A.2d 511, 517 (R.I. 1997) (claims for negligence, strict liability, and breach of warranty preempted by MDA) cert. denied, 522 U.S. 952, 139 L. Ed. 2d 291, 118 S. Ct. 374 (1997); Steele v. Collagen Corp., 54 Cal. App. 4th 1474, 1489, 63 Cal. Rptr. 2d 879, 888 (1997) (stating that claim relating to safety and effectiveness of device preempted to extent it sought to impose requirements different from or in addition to federal requirement resulting from PMA process; refusing to follow prior ruling in Armstrong v. Optical Radiation Corp., 50 Cal. App. 4th 580, 57 Cal. Rptr. 2d 763\n(1996), that found no preemption); Green v. Dolsky, 546 Pa. 400, 685 A.2d 110 (1996) (failure to warn, strict liability, and breach of warranty claims preempted) cert. denied sub nom. Collagen Corp. v. Green, 520 U.S. 1112, 137 L. Ed. 2d 822, 117 S. Ct. 1695 (1997); but see Herring v. Telectronics Pacing Systems, Inc., 964 S.W.2d 753 (Tex. Ct. App. 1998) (\u201cdistinguishing\u201d its supreme court\u2019s decision in Worthy, 967 S.W.2d at 376, cited above, and ruling that state law claims regarding pacemaker not preempted by MDA because defendant failed to show conflict between state and federal requirements), rev. denied (August 25, 1998); Mears v. Marshall, 149 Or. App. 641, 944 P.2d 984\n(1997) (no preemption for failure to warn, negligent manufacturing, defective design, and breach of warranty claims where state requirement was only general duty); Wutzke v. Schwaegler, 86 Wash. App. 898, 940 P.2d 1386 (1997) (state strict liability claims not preempted by MDA because they did not establish additional or different requirements specific to medical devices).\nIn affirming the lower court, we note that the Kernats court did not have the benefit of many of the federal cases cited above, which provide analysis of the federal statutes involved as well as further review of the Supreme Court\u2019s reasoning in Medtronic. In light of these additional developments in the federal case law, we hold plaintiffs state law claims are preempted by the MDA.\nFor the aforementioned reasons, we affirm the judgment and ruling of the circuit court.\nAffirmed.\nCAMPBELL, EJ., concurs.\nWe also note that two state courts, relying on a pre-Medtronic case, Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir. 1995), cert. denied, 518 U.S. 1033, 135 L. Ed. 2d 1094, 116 S. Ct. 2579 (1996), have found no preemption. See Walker v. Johnson & Johnson Vision Products, Inc., 217 Mich. App. 705, 718, 552 N.W.2d 679, 684 (1996) (claims not preempted because premarket approval process not specific requirement applicable to particular device); Sowell v. Baush & Bomb, Inc., 230 A.D.2d 77, 656 N.Y.S.2d 16 (1997) (claims not preempted because PMA process is not specific federal regulation). However, because Kernats determined that the PMA process was a specific federal requirement, these cases are not useful in analyzing the issue at hand.", "type": "majority", "author": "JUSTICE GREIMAN" }, { "text": "JUSTICE ZWICK,\ndissenting:\nI dissent. The United States Supreme Court has spoken directly on this point in Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996), and this court, in a case involving virtually identical facts to those presented here, found no preemption of state common law causes of action. See Kernats v. Smith Industries Medical Systems, Inc., 283 Ill. App. 3d 455, 669 N.E.2d 1300 (1996). Accordingly, I would reverse the finding of preemption and the entry of summary judgment in favor of the defendant.\nThe majority acknowledges that when considering a preemption question, we must begin with the assumption that the historic police powers of the states are not to be superseded by a federal law unless that was the clear and manifest purpose of Congress. Kernats, 283 Ill. App. 3d at 460, citing Medtronic, Inc., 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250; Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 120 L. Ed. 2d 407, 422, 112 S. Ct. 2608, 2617 (1992). This approach recognizes the \u201chistoric primacy of state regulation of matters of health and safety.\u201d Medtronic, Inc., 518 U.S. at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250.\nWriting separately, Justice Stevens found it \u201cunpersuasive\u201d and \u201cimplausible\u201d that Congress would have intended to preclude state courts from affording state consumers any protection from injuries resulting from a defective medical device. Medtronic, Inc., 518 U.S. at 487, 135 L. Ed. 2d at 716, 116 S. Ct. at 2251 (opinion of Stevens, J.). Such an interpretation would have barred most, if not all, relief for persons injured by defective medical devices. Medtronic, Inc., 518 U.S. at 487, 135 L. Ed. 2d at 716, 116 S. Ct. at 2251 (opinion of Stevens, J.). Justice Stevens correctly observed that the MDA was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common law actions. Medtronic, Inc., 518 U.S. at 489, 135 L. Ed. 2d at 718, 116 S. Ct. at 2252 (opinion of Stevens, J.). Justice Stevens further noted that preemption of all state common law causes of action would have the \u201cperverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order \u2018to provide for the safety and effectiveness of medical devices intended for human use.\u2019 \u201d Medtronic, Inc., 518 U.S. at 487, 135 L. Ed. 2d at 716-17, 116 S. Ct. at 2251 (opinion of Stevens, J.).\nJustice Stevens concluded that Congress did not intend for the MDA to provide a sweeping preemption of traditional common law remedies against manufacturers and distributors of defective devices. Medtronic, Inc., 518 U.S. at 491, 135 L. Ed. 2d at 719, 116 S. Ct. at 2253 (opinion of Stevens, J.). Such a sweeping interpretation would require far greater interference with state legal remedies, producing a serious intrusion into state sovereignty while simultaneously wiping out the possibility of remedy for injured persons. Medtronic, Inc., 518 U.S. at 488-89, 135 L. Ed. 2d at 717-18, 116 S. Ct. at 2252 (opinion of Stevens, J.). Like Justice Stevens, I do not believe that Congress \u201cclearly signaled its intent to deprive States of any role in protecting consumers from the dangers inherent in many medical devices.\u201d Medtronic, Inc., 518 U.S. at 489, 135 L. Ed. 2d at 718, 116 S. Ct. at 2252 (opinion of Stevens, J.).\nIn construing the preemption provision contained in section 360k(a), the Supreme Court held the MDA dictates that preemption occur only where there is a conflict between a specific state requirement and a federal requirement applicable to the same device. Medtronic, Inc., 518 U.S. at 498-99, 135 L. Ed. 2d at 723-24, 116 S. Ct. at 2257. Thus, the Supreme Court defined a two-part inquiry to decide the preemption issue.\nFirst, the \u201cspecific\u201d federal requirements must be reviewed; if found \u201capplicable to the device\u201d in question, the requirements will preempt state law only if they are \u201cspecific counterpart regulations\u201d or \u201cspecific\u201d to a \u201cparticular device.\u201d Medtronic, Inc., 518 U.S. at 500, 135 L. Ed. 2d at 725, 116 S. Ct. at 2257. Second, the \u201cparticular\u201d state requirements must be examined. In order to be preempted, state requirements must, \u201cwith respect to\u201d medical devices, be \u201cdifferent from, or in addition to\u201d federal requirements, and relate \u201cto the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.\u201d Medtronic, Inc., 518 U.S. at 500, 135 L. Ed. 2d at 724, 116 S. Ct. at 2257. State requirements of \u201cgeneral applicability\u201d are not preempted except where they have \u201cthe effect of establishing a substantive requirement for a specific device.\u201d 21 C.F.R \u00a7 808.1(d)(6)(ii) (1995); Medtronic, Inc., 518 U.S. at 499, 135 L. Ed. 2d at 724, 116 S. Ct. at 2257.\nIn Kernats, the court employed this analysis to claims arising from use of a class III device and determined that the PMA process is a specific federal requirement. Kernats, 283 Ill. App. 3d at 465. The court then examined the second prong of the analysis: whether the corresponding state requirement was \u201cspecifically developed \u2018with respect to\u2019 medical devices.\u201d Kernats, 283 Ill. App. 3d at 465, citing Medtronic, Inc., 518 U.S. at 501, 135 L. Ed. 2d at 725, 116 S. Ct. at 2258. The court concluded that the plaintiffs\u2019 claims based on defective design and inadequate testing allege that defendant defectively designed and failed to adequately test the device. Although these allegations related to the specific medical device at issue, they emanated from general duties applicable to every manufacturer; the legal duty owed to the plaintiffs was the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Kernats, 283 Ill. App. 3d at 465-66, citing Medtronic, Inc., 518 U.S. at 501, 135 L. Ed. 2d at 725, 116 S. Ct. at 2258. The court concluded that the plaintiffs\u2019 common law tort claims, based upon general liability principles, were not preempted by the MDA.\nUpon consideration of the plaintiffs\u2019 claims for breach of implied warranties of merchantability and fitness, the court noted that the FDA regulations specifically provide, as an example of a permissible general requirement, that the Uniform Commercial Code warranty of fitness is not preempted. Kernats, 283 Ill. App. 3d at 466-67, citing 21 C.F.R. \u00a7 808.1(d)(1) (1995); Medtronic, 518 U.S. at 497, 135 L. Ed. 2d at 724, 116 S. Ct. at 2257. Because these state requirements are clearly of \u201cgeneral applicability,\u201d and not \u201cspecifically developed \u2018with respect to\u2019 medical devices,\u201d they do not fall within the purview of section 360k. Therefore, those claims were not preempted by the MDA.\nIn my view, the State of Illinois has an obligation to protect the rights of its citizens to recover for injuries caused by defectively manufactured goods, of whatever type, and we are obligated to follow the precedent defined by the United States Supreme Court and to adhere to the prior holdings of this court where they control the issues at hand. I would, therefore, reverse the finding of preemption by the trial court.", "type": "dissent", "author": "JUSTICE ZWICK," } ], "attorneys": [ "Carponelli & Krug, of Chicago (Stephen P. Carponelli, Albert M.T. Finch III, and Gregory J. Chinlund, of counsel), for appellant.", "Paul E. Chronis, of McDermott, Will & Emery, of Chicago, and Feldman, Gale & Weber, P.A., of Miami, Florida (Michael J. Weber, of counsel), for appellee." ], "corrections": "", "head_matter": "HAROLD WEILAND, Plaintiff-Appellant, v. TELECTRONICS PACING SYSTEMS, INC., Defendant-Appellee.\nFirst District (5th Division)\nNo. 1\u201495\u20142736\nOpinion filed December 11, 1998.\nZWICK, J., dissenting.\nCarponelli & Krug, of Chicago (Stephen P. Carponelli, Albert M.T. Finch III, and Gregory J. Chinlund, of counsel), for appellant.\nPaul E. Chronis, of McDermott, Will & Emery, of Chicago, and Feldman, Gale & Weber, P.A., of Miami, Florida (Michael J. Weber, of counsel), for appellee." }, "file_name": "0175-01", "first_page_order": 193, "last_page_order": 208 }