Worthy v. Collagen Corp.

• Decision Date: 31 October 1995
• Docket Number: No. 05-94-01574-CV,05-94-01574-CV
• Citation: 921 S.W.2d 711
• Parties: Prod.Liab.Rep. (CCH) P 14,412 Tempie Fortson WORTHY, Appellant, v. COLLAGEN CORPORATION, Appellee.
• Court: Texas Court of Appeals

Page 711

921 S.W.2d 711

Prod.Liab.Rep. (CCH) P 14,412

Tempie Fortson WORTHY, Appellant, v. COLLAGEN CORPORATION, Appellee.

No. 05-94-01574-CV.

Court of Appeals of Texas Dallas.

Oct. 31, 1995.

Opinion on Denial ofRehearing Feb. 12, 1996.

Michael M. Essmyer, Essmyer & Tritico, L.L.P., Houston, Clinard J. Hanby, The Woodlands, John M. O'Quinn, O'Quinn Kernesky McAninch & Laminack, Houston, for Appellant.

Joe W. Redden, Jr., Beck Redden & Secrest, Houston, for Appellee.

Before MALONEY, MORRIS and DEVANY, JJ.

OPINION

MORRIS, Justice.

This summary judgment case presents an unanswered question of law. We decide whether the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act preempt claims brought under the Texas Deceptive Trade Practices Act for damages allegedly resulting from an injection of a cosmetic material known as Zyderm.

In two points of error, Tempie Fortson Worthy complains about the trial court granting summary judgment in favor of Collagen Corporation (Collagen). She contends the trial court erred in concluding that the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA) preempt her claims against Collagen. In considering her points of error, however, we first must address whether Worthy has presented a sufficient record for us to review the trial court's judgment with respect to every claim she alleged against Collagen during this litigation. We conclude she has not. Worthy has presented a record sufficient for us to review only her claims asserted under the Texas Deceptive Trade Practices Act (DTPA). Therefore, we next address whether the MDA's specific preemption provision, as a matter of law, preempts Worthy's DTPA claims. We conclude it does. We do so after deciding that a regulation promulgated by the Food and Drug Administration (FDA) is inconsistent with congressional intent expressed in the MDA and, therefore, is not controlling. Accordingly, we affirm the trial court's judgment.

FACTUAL AND PROCEDURAL HISTORY

In February 1991, Worthy was injected with a cosmetic device known as Zyderm. Zyderm is a collagen implant material manufactured and distributed by Collagen. Worthy complained that she suffered injuries caused by the injected material. In October 1992, Worthy filed her original petition alleging various causes of action against Collagen. Collagen filed a motion for summary judgment urging that the MDA preempted Worthy's claims. In August 1993, the trial court granted Collagen an interlocutory summary judgment ordering that Worthy take nothing by the claims alleged in her original petition against Collagen.

Following rendition of the judgment, Worthy filed two amended petitions. In her second amended petition, Worthy alleged new causes of action against Collagen solely under the DTPA. These claims were not the subject of the interlocutory summary judgment. Collagen moved for summary judgment with respect to the DTPA claims asserting that the MDA also preempts those claims. In June 1994, the trial court granted Collagen a second and final summary judgment concluding that federal law preempted all claims asserted by Worthy, including those asserted in her second amended petition. Worthy perfected her appeal to this Court.

Initially, Worthy filed the original transcript of the case in this Court. The only petition contained in the original transcript was Worthy's second amended petition. Worthy later filed a motion for leave to file a supplemental transcript containing her original petition. In her motion, Worthy urged that the original petition was material to this appeal because it set forth the causes of action that were the subject of the trial court's first summary judgment. By signed order, this Court granted Worthy's motion. Nonetheless, a supplemental transcript containing Worthy's original petition was never filed.

DISCUSSION

Record on Appeal

An appellant bears the burden to present an appellate court with a sufficient record showing reversible error. TEX.R.APP.P. 50(d); Bayoud v. Bayoud, 797 S.W.2d 304, 313 (Tex.App.--Dallas 1990, writ denied); Nix v. Fraze, 752 S.W.2d 118, 120 (Tex.App.--Dallas 1988, no writ). Even where an appellant properly requests that all necessary items be included in the appellate record, an appellant still has the duty to be certain that everything material to her appeal is actually received by the appellate court. Bayoud, 797 S.W.2d at 313; Nix, 752 S.W.2d at 120. By failing to bring forth a sufficient record to show reversible error, an appellant waives any right to complain of the alleged error on appeal. See Sunwest Reliance Acquisitions Group, Inc. v. Provident Nat'l Assurance Co., 875 S.W.2d 385, 388 (Tex.App.--Dallas 1993, no writ).

In this case, the trial court rendered the two summary judgments at different times based upon different pleadings: Worthy's original petition and her second amended petition. The appellate record contains only Worthy's second amended petition. Worthy represented at oral argument that her second amended petition did not allege any of the causes of action raised in her original petition. A review of the second amended petition confirms that it contains claims solely under the DTPA.

As Worthy expressly claimed in her motion to file a supplemental transcript, her original petition is material to this appeal because it sets forth the causes of action that the trial court decided in its first summary judgment. Without Worthy's original petition, we are unable to determine what causes of action the trial court concluded to be preempted in its first summary judgment. We conclude, therefore, that we have an insufficient record to review the trial court's judgment on those claims alleged by Worthy in her original petition. Because Worthy did not provide a sufficient record, she has waived her right to complain of any error involving the issues resolved in the first summary judgment. We affirm, therefore, the trial court's take nothing judgment on the claims alleged by Worthy in her original petition.

We do have within the appellate record Worthy's second amended petition alleging claims under the DTPA. We also have Collagen's motion for summary judgment challenging the DTPA claims in addition to Worthy's response to Collagen's motion and the trial court's final judgment concluding that the DTPA claims are preempted by federal law. Therefore, we have a sufficient record to review the trial court's final summary judgment to the extent it decided the claims raised in Worthy's second amended petition. Consequently, our review is limited to the DTPA claims raised in Worthy's second amended petition as challenged by Collagen in its second motion for summary judgment, which Collagen designated as a "supplemental" motion. ¹

The DTPA Claims

The United States Congress enacted the FDCA, delegating to the FDA the authority to promulgate regulations to enforce the FDCA. ² In 1976, Congress enacted the MDA, amending the FDCA and granting the FDA comprehensive regulatory authority over certain medical devices. See Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. §§ 360c-360l (West Supp.1995). The MDA requires the FDA to classify medical devices intended for human use into one of three classes: class I, II, or III. 21 U.S.C.A. § 360c(b)(1). A class III medical device is subjected to an extensive and rigorous premarket approval process. See 21 U.S.C.A. § 360e. The MDA requires premarket approval for class III medical devices because such devices present "a potential unreasonable risk of illness or injury." 21 U.S.C.A. § 360c(a)(1)(C)(ii)(II). Once premarket approval has been given, 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 (1993). It is undisputed that Zyderm, a material designed to be injected into the human body, is a class III medical device that received premarket approval.

The manner and extent to which a medical device is federally regulated leads to the question of whether a state may also regulate the device or whether the federal statute and regulations preempt, or in effect prevent, such state regulation. Significantly, the MDA contains a specific preemption provision. Section 360k(a) of the MDA states:

[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--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any matter included in a requirement applicable to the device under this chapter.

21 U.S.C.A. § 360k(a). Although the MDA's preemption provision has been addressed by courts in many other jurisdictions, no Texas appellate court has addressed the effect of the preemption provision on a claim asserted under the DTPA. After reviewing the relevant statutory and regulatory provisions, as well as case law from other jurisdictions, we conclude that section 360k(a) preempts Worthy's DTPA claims.

The scope of the MDA preemption provision is addressed in certain FDA regulations. Among these regulations is section 808.1(b). It states that the "requirements" referenced in section 360k(a) that are subject to preemption include state statutes, ordinances, regulations, and court decisions. 21 C.F.R. § 808.1(b). Section 808.1(d) sets forth examples of various state requirements that, in the opinion of the FDA, are not preempted. See 21 C.F.R. § 808.1(d). Among the examples listed is "State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electric codes, and the Uniform Commercial Code (warranty of fitness))...