Montoya v. Mentor Corp.

• Citation: 122 N.M. 2,1996 NMCA 67,919 P.2d 410
• Decision Date: 29 May 1996
• Docket Number: No. 16407,16407
• Parties: , Prod.Liab.Rep. (CCH) P 14,678 Abel MONTOYA and Joann Montoya, Plaintiffs-Appellants, v. MENTOR CORPORATION, Defendant-Appellee, and St. Joseph Health Care System, and John Does 1-5, Defendants.
• Court: Court of Appeals of New Mexico

Page 410

919 P.2d 410

122 N.M. 2, Prod.Liab.Rep. (CCH) P 14,678

Abel MONTOYA and Joann Montoya, Plaintiffs-Appellants, v. MENTOR CORPORATION, Defendant-Appellee and St. Joseph Health Care System, and John Does 1-5, Defendants.

No. 16407.

Court of Appeals of New Mexico.

May 29, 1996.

Carolyn N. Merchant, Carolyn N. Merchant, P.C., Albuquerque, David B. Martinez, Eaton, Martinez & Hart, P.C., Albuquerque, for Appellants.

Paul E. Houston, Steven M. Jakob, Sager, Curran, Sturges & Tepper, P.C., Albuquerque, B. Frank Davis, Howard B. Kaplan, Bernard, Cassisa & Elliott, Metairie, LA, for Appellees.

OPINION

APODACA, Chief Judge.

¶1 Plaintiffs Abel and Joann Montoya appeal the trial court's order granting summary judgment and dismissing their complaint alleging product liability claims against Defendant Mentor Corporation. The trial court ruled that the Medical Device Amendments of 1976, 21 U.S.C. Sections 360c-3601 (1994) (the MDA), preempted Plaintiffs' causes of action. We disagree, reverse the trial court, and remand for trial.

I. FACTUAL AND PROCEDURAL BACKGROUND

¶2 This appeal arose as a result of injuries suffered by Plaintiff Abel Montoya and allegedly caused by a medical implant. In January 1986, a device known as the Angelchik prosthesis, manufactured and sold by Defendant, was implanted in Mr. Montoya by Dr. Oberdorfer at St. Joseph Hospital, as treatment for a hiatal hernia. The Angelchik is a C-shaped silicone-filled device encased in a silicone shell. A Dacron strip surrounds the silicone shell and is laminated with silicone on the outer surface to make the strip a smooth surface. The device was secured around Mr. Montoya's esophagus at the gastroesophageal junction with the strip of Dacron. The device is designed to be placed unsecured in this motile area of the gut so that it moves whenever the person breathes, talks, swallows, eats, and digests food.

¶3 With the passage of time, the device bled silicone, and the movement of the device caused silicone debris to be released into Mr. Montoya's abdominal cavity, causing damage to adjacent organs, an inflammatory reaction, adhesions, and immunodeficiency. As the silicone wore off the outer surface of the Dacron strip, an abrasive surface was left, causing irritation. As a result of that irritation, the device became surrounded by dense scar tissue, and eventually it migrated into Mr. Montoya's stomach. The device had to be surgically removed in December of 1986, at which time the damage to Mr. Montoya's internal organs was repaired. He developed serious complications from the surgery, and, since the removal of the device, his condition has worsened. We will develop additional facts in the discussion.

¶4 Plaintiffs' complaint against Defendant specifically alleged claims of strict products liability, negligence in products liability, negligence per se, and strict liability for a peculiar risk or ultrahazardous activity. Defendant's answer raised the affirmative defense of federal preemption. Defendant's motion for summary judgment contended that, under any state of facts, Plaintiffs could not recover because all of Plaintiffs' claims were preempted by federal law and regulations governing medical devices. The trial court agreed and granted summary judgment.

II. DISCUSSION

A. Standard Of Review

¶5 The relevant facts are not disputed. In reviewing the grant of summary judgment in a case where there are no disputed issues of material fact, this Court considers whether the trial court correctly interpreted the relevant law. Bybee v. City of Albuquerque, 120 N.M. 17, 18, 896 P.2d 1164, 1165 (1995).

B. General Preemption Principles

¶6 The principle of federal preemption of state law arises directly from Article VI of the United States Constitution. Article VI states 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. VI, cl. 2. Under this constitutional authority, Congress may preempt state law. Whether a federal law preempts state law is ultimately a question of congressional intent. Hawaiian Airlines v. Norris, 512 U.S. 246, ----, 114 S.Ct. 2239, 2243, 129 L.Ed.2d 203 (1994).

¶7 There is a strong presumption against preemption. Consideration of preemption issues begins with the " 'assumption that the historic police powers of the States [are] not to be superseded by ... [a] Federal Act unless that [is] the clear and manifest purpose of Congress.' " Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 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)). There is thus a reluctance to preempt state laws relating to health and safety matters because those matters have been the exclusive concern of the states. See New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., --- U.S. ----, ----, 115 S.Ct. 1671, 1680, 131 L.Ed.2d 695 (1995); Hillsborough County, Fla. v. Automated Medical Labs, Inc., 471 U.S. 707, 715, 105 S.Ct. 2371, 2376, 85 L.Ed.2d 714 (1985). There is also a presumption against preemption if it would deny an injured party all judicial remedies, especially in the face of congressional silence. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251-52, 104 S.Ct. 615, 622-23, 78 L.Ed.2d 443 (1984).

¶8 "[P]re-emption will not lie unless it is 'the clear and manifest purpose of Congress.' " CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664, 113 S.Ct. 1732, 1737, 123 L.Ed.2d 387 (1993) (quoting Rice, 331 U.S. at 230, 67 S.Ct. at 1152). Thus, our focus in this appeal is to determine Congress' intent. When Congress has considered the issue of preemption and has included in the legislation a provision expressly addressing the issue, it is unnecessary to infer congressional intent to preempt state law. Cipollone, 505 U.S. at 517, 112 S.Ct. at 2618. "Congress' enactment of a provision defining the pre-emptive reach of a statute implies that matters beyond that reach are not pre-empted." Id. Consequently, because, as noted below, Congress has enacted a preemption provision for the MDA, "we need only identify the domain expressly pre-empted" by the statute. Id.

C. The MDA Regulatory Scheme

¶9 In 1976, Congress enacted the MDA in response to the public outcry following the injuries suffered by women using the Dalkon Shield contraceptive device. See Ministry of Health, Province of Ontario, Can. v. Shiley Inc., 858 F.Supp. 1426, 1434 (C.D.Cal.1994). It had become clear that the pace of the medical device industry had far surpassed the ability of the Food and Drug Administration (FDA) to control it. Id. at 1434. As a result, Congress sought "to assure the reasonable safety and effectiveness of medical devices intended for human use." H.R.Conf.Rep. No. 1090, 94th Cong., 2d Sess. reprinted in 1976 U.S.C.C.A.N. 1070, 1103.

¶10 The MDA gave the FDA broad regulatory power over medical devices. It set up a classification system requiring the FDA to assign a particular device to one of three statutory categories. Regulation of a particular device by the FDA depends on the class of the device. The regulatory scheme reflects the wide range of hazards associated with products classified as medical devices. Class I devices consist of simple, relatively risk-free products not requiring extensive regulation to protect the public health and safety, such as tongue depressors and elastic bandages. 21 U.S.C. § 360c(a)(1)(A). Class II devices present greater risks and require some regulation regarding performance standards and guidelines for their use. 21 U.S.C. § 360c(a)(1)(B). Examples of these devices are syringes, tampons, and hearing aids. Class III devices present the greatest risk because they are implanted into consumers' bodies and are therefore subject to the most extensive regulation by the FDA. 21 U.S.C. § 360c(a)(1)(C). Among this class of devices are pacemakers, intraocular lenses, and the device at issue in this appeal.

¶11 With two exceptions, which are unimportant here, Class III devices require an extensive premarket approval process before being placed on the market. The approval process requires the device's manufacturer to obtain approval from the FDA for the device's design, manufacturing process, and advertising. 21 U.S.C. § 360e(c)(1); 21 C.F.R. § 814.20(b)(2)-(12) (1994). Once a device has been approved for marketing, federal regulations prohibit the device from being "manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the [premarket] approval order for the device." 21 C.F.R. § 814.80. This " 'premarket approval process is designed to provide a "reasonable assurance of ... safety and effectiveness" for medical devices [that] are too dangerous or unknown to permit less regulation.' " King v. Collagen Corp., 983 F.2d 1130, 1131 (1st Cir.), cert. denied, 510 U.S. 824, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993) (quoting 21 U.S.C. § 360c(a)(1)(C)).

¶12 The device in question went through the premarket approval process in 1979 when it was developed by Heyer-Schulte Corporation. Once the device was approved by the FDA, Heyer-Schulte sold the product to Defendant. Defendant was required to provide additional information to the FDA in order to receive approval to change the labeling of the device. Defendant received approval to market the device from the FDA in 1984.

D. Preemption Under The MDA

1. Interpretation By Other Jurisdictions

¶13 The MDA contains an express preemption provision that provides:

(a) General rule

Except as provided in subsection (b) of this section, 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...