Gonzales v. Surgidev Corp., 21703

Citation1995 NMSC 36,899 P.2d 576,120 N.M. 133
Decision Date25 May 1995
Docket NumberNo. 21703,21703
Parties, Prod.Liab.Rep. (CCH) P 14,311 Enrique GONZALES and Berlin Padilla, as Personal Representative of the Estate of Ricardo Garduno, deceased, Plaintiffs-Appellees, and Cross-Appellants, v. SURGIDEV CORPORATION, a corporation, Jock Morrison, M.D., and Holy Cross Hospital, Defendants-Appellants, and Cross-Appellees.
CourtSupreme Court of New Mexico

FROST, Justice.

Defendant-Appellant Surgidev Corp. appeals from a judgment for compensatory and punitive damages entered against it in a products liability action. Plaintiffs-Appellees Enrique Gonzales and Ricardo Garduno sued Surgidev for personal injuries that resulted from implantation of intraoccular lenses manufactured by Surgidev. Surgidev appealed to the Court of Appeals, alleging five errors that mandate reversal: (1) Plaintiffs' state law claims were preempted by federal law, (2) the trial court erred in not including the Food and Drug Administration on the verdict form, (3) the trial court erred in admitting several pieces of evidence, (4) the trial court erred in submitting the issue of punitive damages to the jury, and (5) bailiff and jury misconduct warrant a new trial. Plaintiffs cross-appealed, alleging that the trial court abused its discretion in refusing to award Plaintiffs prejudgment interest. The Court of Appeals certified this case to us under N.M.S.A.1978, Section 34-5-14(C) (Repl.Pamp.1990), to consider whether federal preemption divests the state courts of subject matter jurisdiction in this case. We note jurisdiction to decide all the issues raised on appeal, Collins ex rel. Collins v. Tabet, 111 N.M. 391, 404 n. 10, 806 P.2d 40, 45 n. 10 (1991), and affirm the trial court on each claim in both the appeal and cross-appeal.


In May 1985 Enrique Gonzales and Ricardo Garduno received treatment for cataracts from Dr. Jock Morrison in Taos. As part of the treatment, Dr. Morrison removed the natural lens from one eye of each patient and replaced it with an intraoccular lens manufactured by Surgidev. In 1985 an ophthalmologist could remove the natural lens and implant an intraoccular lens by one of two procedures, by intracapsular cataract extraction (ICCE) or by extracapsular cataract extraction (ECCE). The procedures differ in the method used for extracting the natural lens. The natural lens is surrounded by a capsule that helps the lens keep its shape. In the ICCE procedure, the lens capsule is entirely removed when the lens is extracted. In the ECCE procedure, the lens is extracted from inside the capsule but the rear wall of the capsule (the posterior capsule) is left in place to retain the natural barrier between the fluids in the rear of the eye and in the front of the eye.

In addition to the choice of implantation procedures, there were also two main categories of lenses an ophthalmologist could choose from, anterior chamber lenses, which are placed in front of the iris and pupil, and posterior chamber lenses, which are placed behind the iris and pupil in the space that the natural lens occupied before removal. The intraoccular lens that Dr. Morrison implanted in both patients was a Surgidev Style 10 intraoccular lens (Style 10), which was an anterior chamber lens. In addition, the Style 10 lens employed closed loops as mounts on either side of the lens that support the lens and hold it in place.1 Dr. Morrison used the ICCE procedure to implant the Style 10 lens in both Gonzales and Garduno. As a result of complications both Gonzales and Garduno went blind in the eye containing the Style 10 implant. Dr. Morrison did not have either Gonzales or Garduno sign an informed consent form before implantation.

The Food and Drug Administration (FDA) is responsible for regulating intraoccular lenses under the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360c-k (1988). Under the regulatory scheme developed in the late-1970s, an intraoccular lens moves through three stages as it gains approval as being safe and effective. The first stage is called "core" status in which the implant is approved as an investigational device and may be sold for testing in humans on a limited basis. The manufacturer is required to conduct extensive monitoring of the core patients over the course of one year.

After the manufacturer has followed over 500 patients for one year without seeing significant adverse results, the implant may be upgraded to "adjunct" status. During the adjunct phase, the intraoccular lens is still considered investigational, but the manufacturer may distribute the lens for more widespread use. The reporting requirements are relaxed under adjunct status, but the manufacturer is still not allowed to claim that the lens is safe or effective. At all times during both the core and adjunct phase, the implanting doctor is required to get the patient's signature on an informed consent form which explains that the lens has not been approved and is still investigational. However, during the core and adjunct phases, the manufacturer is not required to place any labelling on the product's packaging.

If the investigations conducted under core and adjunct status demonstrate that the intraoccular lens is functional and safe, the manufacturer can apply for premarket approval from the FDA. Premarket approval means that the lens is no longer investigational and the manufacturer may advertise to the public that the lens is a safe and effective product and sell it without restrictions. In order to receive premarket approval, the manufacturer must submit its data from the core and adjunct monitoring to the Ophthalmic Device Panel (Panel), a panel consisting mostly of ophthalmologists, which examines the data and gives its recommendation to the FDA. The manufacturer must also submit proposed labelling for the product for inclusion with the final approved product.

Surgidev began manufacturing the Style 10 lens in 1978 under core status. The lens was elevated to adjunct status in 1980. In 1981 and 1982, Surgidev submitted to the Panel its testing data for the Style 10 lens. The Panel subsequently recommended that the FDA grant the Style 10 premarket approval on condition that Surgidev include in its labelling notice of the differences between insertion of the Style 10 by the ICCE procedure and by the ECCE procedure. However, a manufacturer is not required to provide labelling for an intraoccular lens until the FDA has actually granted premarket approval for the lens. Despite several years of negotiations between the FDA and Surgidev, the FDA never gave the Style 10 premarket approval. Therefore, Surgidev was never required to label the Style 10. In 1986, in response to growing concerns in the medical community, the FDA demoted all closed-loop anterior chamber lenses to core status, including the Style 10. Despite rapidly declining sales and mounting criticism, Surgidev continued to market the Style 10 under core status through 1987. The Style 10 lens was last sold in the United States in early 1988.

Gonzales and Garduno sued Surgidev, claiming that the Style 10 lens was defectively designed and that Surgidev had failed to adequately warn the medical community about dangers associated with implanting the Style 10 lens by the ICCE procedure. The jury returned a verdict for Gonzales and Garduno for compensatory damages of $434,990.18 and $45,000 respectively and awarded them each $350,000 in punitive damages.

Surgidev appealed to the Court of Appeals on several grounds that are addressed below. As one of its numerous bases for appeal, Surgidev raised for the first time the question of federal preemption of state tort actions by the Medical Device Amendments, 21 U.S.C. § 360k. The Court of Appeals certified to this Court the question whether federal preemption is an issue of subject matter jurisdiction which may be raised for the first time on appeal. NMSA 1978, § 34-5-14(C)(2) (Repl.Pamp.1990) (certification of question of substantial public interest). Although only this question was certified for review, we have jurisdiction to review all the issues raised in this appeal and in Plaintiffs' cross-appeal. Collins ex rel. Collins v. Tabet, 111 N.M. 391, 404 n. 10, 806 P.2d 40, 45 n. 10 (1991).


The first point we address is Surgidev's claim that Medical Device Amendments, 21 U.S.C. § 360k(a), expressly preempts all state tort claims based on defective-product liability, including those asserted by Gonzales and Garduno. However, Surgidev did not raise federal preemption during the trial and addressed this issue for the first time on appeal. Thus, before we examine the merits of this claim, we must first consider the threshold question whether this argument may be raised for the first time on appeal.

Surgidev argues that express federal preemption of a state claim deprives the state court of subject matter jurisdiction. It is well settled that subject matter jurisdiction cannot be waived and may be raised for the first time on appeal. Chavez v. County of Valencia, 86 N.M. 205, 209, 521 P.2d 1154, 1158 (1974); SCRA 1986, 1-012(H)(3) (Repl.Pamp.1992).

However, as we noted in Sundance Mechanical & Utility Corp. v. Atlas, 109 N.M. 683, 689, 789 P.2d 1250, 1256 (1990), a failure to state a cause of action in the complaint does not deprive the trial court of subject matter jurisdiction. Subject matter jurisdiction is the power to adjudicate the general questions involved in the claim and is not dependent upon the state of facts which may appear in a particular case, or the ultimate existence of a valid cause...

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