September 3, 1996
SARAH KERNATS, A MINOR, BY CYNTHIA KERNATS, HER MOTHER AND NEXT FRIEND, CYNTHIA KERNATS, INDIVIDUALLY, AND ANDREW KERNATS, PLAINTIFFS-APPELLANTS,
SMITH INDUSTRIES MEDICAL SYSTEMS, INC., D/B/A CONCORD/PORTEX, INC., A FOREIGN CORPORATION, DEFENDANT-APPELLEE, AND HOWARD GRUNDY, M.D., EVANGELICAL HEALTH SYSTEMS, D/B/A CHRIST HOSPITAL AND MEDICAL CENTER, AN ILLINOIS CORPORATION, HIGH TECH MEDICAL PARKS DEVELOPMENT CORPORATION, AN ILLINOIS CORPORATION, HIGH TECHNOLOGY, INC., AN ILLINOIS CORPORATION, CARMENCITA GALVEZ, M.D., SOUTHWEST OBSTETRICS AND GYNECOLOGY LTD., AN ILLINOIS CORPORATION, DEFENDANTS. JOYCE OSHODI, INDIVIDUALLY AND AS MOTHER AND NEXT FRIEND OF KENNETH OSHODI, A MINOR, PLAINTIFFS-APPELLANTS, V. SMITH INDUSTRIES MEDICAL SYSTEMS, INC., D/B/A CONCORD/PORTEX, INC., A FOREIGN CORPORATION, DEFENDANT-APPELLEE, AND MICHAEL REESE HOSPITAL AND MEDICAL CENTER, AN ILLINOIS CORPORATION, NORMAN GINSBERG, M.D., EUGENE PERGAMENT, M.D., DR. MELTZER, ALAN CADKIN, M.D., BETH FINE, DIAGNOSTIC ULTRASOUND, P.C., ASSOCIATION FOR WOMEN'S HEALTH CARE, LTD., PRENATAL GENETIC PROGRAM OF ILLINOIS, INC., COOK UROLOGICAL INC., A WHOLLY OWNED SUBSIDIARY OF COOK INC., DEFENDANTS. MARY SUSAN WILLIAMS, AS MOTHER AND NEXT FRIEND OF JOHN CALVIN WILLIAMS, A MINOR, PLAINTIFF-APPELLANT, V. SMITH INDUSTRIES MEDICAL SYSTEMS, INC., D/B/A CONCORD/PORTEX, INC., A FOREIGN CORPORATION, ALAN CADKIN, M.D., AND ILLINOIS MASONIC MEDICAL CENTER, DEFENDANTS-APPELLEES, AND DIAGNOSTIC ULTRASOUND, P.C., NORMAN GINSBURG, M.D., INDIVIDUALLY AND AS AN EMPLOYEE, AGENT, AND/OR OSTENSIBLE AGENT OF ASSOCIATION FOR WOMEN'S HEALTH CARE, LTD., PRENATAL GENETIC PROGRAM OF ILLINOIS, INC., DEFENDANTS.
Appeal from the Circuit Court of Cook County. Honorable Joseph N. Casciato, Judge Presiding. Honorable Robert V. Boharic, Judge Presiding. Honorable Jennifer Duncan-Brice, Judge Presiding.
Released for Publication October 4, 1996.
Presiding Justice Hartman delivered the opinion of the court. DiVITO and Burke, JJ., concur.
The opinion of the court was delivered by: Hartman
PRESIDING JUSTICE HARTMAN delivered the opinion of the court:
This action involves three consolidated appeals. Plaintiffs in all three cases filed suit against defendant Smith Industries Medical Systems, Inc., d/b/a Concord/Portex, Inc., to recover damages for injuries allegedly caused by a medical product that it manufactured, distributed, and sold. In all cases, the circuit court entered summary judgment in favor of defendant on the ground that plaintiffs' claims were preempted by the Medical Device Amendments of 1976 (the "MDA") (21 U.S.C. §§ 360c-3601 (1988)) to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301-395 (1988)). Plaintiffs in all three cases appeal those judgments. *fn1
Following oral argument in this appeal, the parties successfully moved that this court await the ruling of the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. , 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996) (Medtronic), which involved issues similar to those presented in this case: whether plaintiffs' state law tort claims are preempted by the MDA.
The allegations and undisputed facts in all three cases are essentially the same. In each case, the mother underwent chorionic villus sampling ("CVS") during her pregnancy. CVS is a medical procedure performed during the first trimester of pregnancy to obtain a sample of fetal tissue which is subsequently analyzed by geneticists for genetic abnormalities. Defendant manufactured, distributed, and sold the CVS catheter used in each CVS procedure. Plaintiffs allege that the CVS procedure caused the minors to be born with limb abnormalities.
Plaintiffs in all three appeals asserted identical theories of liability: (1) strict products liability based on the allegedly defective design and manufacture of the CVS catheter, failure to warn, and inadequate instructions; (2) breach of express and implied warranties; and (3) common law negligence based on failure to warn, inadequate testing, and negligent design of the CVS catheter. *fn2
The CVS catheters involved received Food and Drug Administration (FDA) premarket approval on August 9, 1990. The catheter is used in obtaining chorionic tissue samples making possible prenatal diagnosis of genetic abnormalities. 55 Fed. Reg. 42779 (1990). On August 17, 1990, the FDA granted defendant additional premarket approval for the warning label on the CVS catheter.
Defendant successfully moved for summary judgment in all three cases, based upon asserted MDA preemption of plaintiffs' state law claims. The circuit courts found no just reason to delay enforcement or appeal of the orders pursuant to Supreme Court Rule 304(a) (155 Ill. 2d R.304(a)). Plaintiffs timely filed notices of appeal from those respective orders. We consolidated the cases for purposes of appeal.
Summary judgment properly may be entered if the pleadings, exhibits, affidavits and depositions on file disclose no genuine issue of material fact entitling the movant to judgment as a matter of law. Dudek, Inc. v. Shred Pax Corp., 254 Ill. App. 3d 862, 868, 626 N.E.2d 1204, 193 Ill. Dec. 653 (1993); Bernard v. Sears, Roebuck & Co., 166 Ill. App. 3d 533, 534, 519 N.E.2d 1160, 116 Ill. Dec. 945 (1988). The principal issue, that of preemption, is a question of law which will be examined under a de novo standard of review. Zoeller v. Augustine, 271 Ill. App. 3d 370, 374, 648 N.E.2d 939, 208 Ill. Dec. 17 (1995); American Health Care Providers, Inc. v. County of Cook, 265 Ill. App. 3d 919, 923, 638 N.E.2d 772, 202 Ill. Dec. 904 (1994).
The MDA comprehensively regulates medical devices. The FDA is authorized to classify medical devices intended for human use into three categories based on the degree of regulation necessary to assure safety and effectiveness. See 21 U.S.C. § 360c. See generally Medtronic, 116 S. Ct. at 2246.
Class I devices, such as tongue depressors, are subject only to general controls on manufacturing processes because they pose little threat to public health and safety. 21 U.S.C. § 360c(a)(1)(A); Stamps v. Collagen Corp., 984 F.2d 1416, 1418 (5th Cir. 1993). Class II devices, such as bone-conduction hearing aids, for which "general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device," are subject to special controls. 21 U.S.C. § 360c(a)(1)(B); 21 C.F.R. § 874.3300 (1995). Class III devices, applying to the CVS catheter in this case, present "a potential unreasonable risk of illness or injury," and are subject to the most stringent MDA controls. 21 U.S.C. § 360c(a)(1)(C).
In order to market a Class III device, a manufacturer must provide the FDA with a "reasonable assurance" that the device is both safe and effective. Medtronic, 116 S. Ct. at 2246, citing 21 U.S.C. § 360e(d)(2). This is accomplished by obtaining premarket approval (PMA), a rigorous process that requires manufacturers to submit to the FDA detailed information regarding the safety and efficacy of their medical devices. Medtronic, 116 S. Ct. at 2246-47.
As part of the PMA application for a Class III device, a manufacturer must submit a bibliography of all reports concerning the device's safety and effectiveness, an outline of the device's components and properties, a description of the manufacturing process, safety data, samples of the device, copies of all proposed labeling, and any other information the FDA requests. 21 U.S.C. § 360e(c)(1). See also 21 C.F.R. § 814.20 (1995). The application is referred to a panel of qualified experts for study and submission of a report and recommendation respecting approval. 21 U.S.C. § 360e(c)(2). The FDA retains the right to withdraw its approval if it finds that a device previously approved is unsafe or ineffective. 21 U.S.C. § 360e(e).
Two important exceptions to the PMA requirement allow Class III devices to reach the marketplace without PMA review. First, a grandfather 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. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1) (1995). Second, the MDA allows devices that are "substantially equivalent" to preexisting devices to avoid the PMA process in order to permit ...
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