Worthy v. Collagen Corp.

921 S.W.2d 711, 1996 Tex. App. LEXIS 699, 1995 WL 654413

• Court: Court of Appeals of Texas
• Decided: February 12, 1996
• Docket: 05-94-01574-CV
• Status: Published

Opinions

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. § 360e(b)(1). A class III medical device is subjected to an extensive and rigorous pre-market 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)), or to unfair trade practices in which the requirements are not limited to devices.” 21 C.F.R. § 808.1(d)(1) (emphasis added). Worthy relies on this language in the federal regulations to support her contention that section 360k(a) does not preempt her DTPA claims.

In particular, focusing on the language of section 808.1(d)(1), Worthy argues section 360k(a) does not preempt her claims under the DTPA because the DTPA is a state requirement of “general applicability” that is not “limited to devices.” Therefore, urging the FDA’s interpretation of the statute, she contends her causes of action should survive. Based upon the following analysis, we disagree.

The FDA’s interpretation of the MDA is controlling only if it is not “inconsistent with clearly expressed congressional intent.” Hillsborough County v. Automated Medical Lab., Inc., 471 U.S. 707, 714, 105 S.Ct. 2371, 2376, 85 L.Ed.2d 714 (1985). If the intent is clear, this Court, as well as the FDA, must give effect to the unambiguously expressed intent of Congress. Chevron, U.S.A, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-43, 104 S.Ct. 2778, 2781-82, 81 L.Ed.2d 694 (1984). We conclude Congress’s intent is clear. We also conclude the FDA’s interpretation of section 360k(a) as set forth in section 808.1(d)(1) is inconsistent with that intent and, therefore, is not controlling.

In section 808.1(d)(1), the FDA interprets section 360k(a) to preempt only those state requirements that are limited specifically to medical devices. See 21 C.F.R. § 808.1(d)(1). Section 360k(a) states, however, that “any requirement” different from, or in addition to, a federal requirement is preempted when it “relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to a device under this chapter.” 21 U.S.C.A. § 360k(a) (emphasis added). The term “relates to” sweeps broadly and encompasses all state requirements that affect medical devices. Accord Mitchell v. Collagen Corp., 870 F.Supp. 885, 892 (N.D.Ind.1994), aff'd, 67 F.3d 1268 (7th Cir.1995).

The United States Supreme Court has addressed the scope of the term “relates to” in connection with other preemption provisions. In each case the Supreme Court has found state law preempted where it has a connection with or reference to a preemptive plan. See Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 139, 111 S.Ct. 478, 482-83, 112 L.Ed.2d 474 (1990) (ERISA); see also Morales v. Trans World Airlines, Inc., 504 U.S. 374, 386, 112 S.Ct. 2031, 2038, 119 L.Ed.2d 157 (1992) (Airline Deregulation Act of 1978). Indeed, a law may “relate to” a preemptive plan, and therefore be preempted, “even if the law is not specifically designed to affect such plans, or the effect is only indirect.” Ingersoll-Rand, 498 U.S. at 139, 111 S.Ct. at 483.

In her second amended petition, Worthy alleges causes of action under the DTPA, claiming that Collagen misrepresented Zy-derm as safe when, in fact, the product is defective and not fit for the ordinary purpose for which it is to be used. Worthy’s claims go to the safety and effectiveness of Zyderm. Although the DTPA is not specifically directed at medical devices, if Worthy’s claims were successful, Collagen would be forced either to meet requirements different from or in addition to the premarket approval requirements or be subjected to DTPA liability. In this case, the DTPA claims clearly “relate to” the safety and effectiveness of the medical device. Guided by United States Supreme Court decisions addressing the scope of the term “relates to,” which is the language used in section 360k(a), we conclude the FDA’s interpretation of section 360k(a) is not a reasonable interpretation because it is inconsistent with expressed congressional intent. That expressed intent encompasses a broader scope for the MDA than interpreted by the FDA. Accordingly, the regulation is not controlling. Section 360k(a), therefore, preempts Worthy’s DTPA claims. To conclude otherwise would negate the purpose of section 360k(a) and allow states to regulate class III medical devices freely through laws of “general applicability.”³

In her response to Collagen’s second motion for summary judgment, Worthy characterizes her DTPA claims as state tort law claims. She contends that this Court should follow the guidance of the Texas Supreme Court in Moore v. Brunswick Bowling & Billiards Corp., 889 S.W.2d 246 (Tex.), cert. denied, — U.S. -, 115 S.Ct. 664, 130 L.Ed.2d 599 (1994), and hold that section 360k(a) does not apply to state tort law. In Moore, the court concluded that the preemption provision of the Federal Boat Safety Act did not preempt state common-law tort claims. In doing so, the court recognized that “jury awards can have an effect akin to regulation” and “[t]he obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy.” Id. at 249. The court held, however, that Congress’s intent to preempt state common law was not “clear and manifest” in the Federal Boat Safety Act. This was due, at least in part, to the fact that the Federal Boat Safety Act itself contains a savings clause expressly preserving state common-law claims. See id. at 250.

The Moore decision is distinguishable when applied to this case. First, and perhaps most importantly, the MDA, unlike the Federal Boat Safety Act, does not contain a savings provision.⁴ Second, the preemption provision addressed by the court in Moore does not contain the “relates to” language found in section 360k(a).⁵ As discussed above, this phrase indicates that Congress intended the MDA preemption provision to be broad in seope. Third, the court in Moore addressed the preemption of state common law and not a state statutory remedy such as the DTPA. The court noted specifically that the regulatory effect of the common law is not as direct as that of positive enactments. Id.

Moreover, numerous courts addressing the issue of the MDA’s preemption of state tort liability have concluded that tort liability constitutes a “requirement” as contemplated in section 360k(a). See, e.g., Mendes v. Medtronic, Inc., 18 F.3d 13, 18 (1st Cir.1994); Stamps v. Collagen Corp., 984 F.2d 1416, 1421 (5th Cir.), cert. denied, 510 U.S. 824, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993); Slater v. Optical Radiation Corp., 961 F.2d 1330, 1332-33 (7th Cir.), cert. denied, 506 U.S. 917, 113 S.Ct. 327, 121 L.Ed.2d 246 (1992). In Stamps, the Fifth Circuit concluded that Texas tort liability would constitute a requirement different from, or in addition to, the premarket approval requirements applicable to Zyderm. Stamps, 984 F.2d at 1421. We agree. This conclusion is supported by the fact that the FDA, whose guidance Worthy previously urged us to follow, has concluded that the scope of preemption under section 360k(a) includes statutes, ordinances, regulations, and court decisions. See 21 C.F.R. § 808.1(b). Nothing in Moore dictates a contrary conclusion.

We hold that section 360k(a) preempts Worthy’s DTPA claims. We overrule Worthy’s first and second points of error. We affirm the trial court’s judgment.

1 . The only grounds for and against summary judgment this Court will consider are those that were first presented to the trial court in Collagen’s "supplemental” motion for summary judgment and Worthy’s response thereto. See Hall v. Harris County Water Control & Improvement Dist. No. 50, 683 S.W.2d 863, 867 (Tex.App.—Houston [14th Dist.] 1984, no writ) (the appellate court may address on appeal only those grounds for summary judgment which were expressly presented to the trial court); see also McConnell v. Southside Indep. Sch. Dist., 858 S.W.2d 337, 341 (Tex.1993). Although Collagen's motion for summary judgment addressing Worthy’s second amended petition is labeled a "supplemental" motion, and therefore ostensibly incorporates the grounds for judgment and arguments made in its earlier motion, we conclude that Collagen’s "supplemental” motion is a separate and independent motion. See Llast v. Emmett, 526 S.W.2d 288, 290 (Tex.Civ.App.—Tyler 1975, no writ) (in determining the nature of an instrument, we look at its substance and not its caption). At the time Collagen filed its "supplemental” motion for summary judgment, its previous motion for summary judgment had been ruled on. Therefore, there was no pending motion to supplement. See Inman’s Corp. v. Transamerica Commercial Fin. Corp., 825 S.W.2d 473, 478-79 (Tex.App.—Dallas 1992, no writ).

2 . The FDCA authorizes the creation of regulations for the "efficient enforcement” of the Act. Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 371 (West 1972).

3 . There is a split of authority regarding the reasonableness of the FDA's interpretation of section 360k(a) as set forth in section 808.1(d)(1). See, e.g., King v. Collagen Corp., 983 F.2d 1130, 1139 (1st Cir.), cert. denied, - U.S. -, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993) (when statute is clear, agency interpretation must give way); Talbott v. C.R. Bard, Inc., 865 F.Supp. 37, 49 (D.Mass.1994), aff'd, 63 F.3d 25 (1st Cir.1995) (808.1(d)(1) conflicts with clear intent of congress); Mitchell v. Collagen Corp., 870 F.Supp. 885, 892-93 (N.D.Ind.1994), aff'd, 67 F.3d 1268 (7th Cir.) (808.1(d)(1) is contrary to Congress's intent); see contra Ministry of Health v. Shiley, 858 F.Supp. 1426, 1435-36 (C.D.Cal.1994) (citing 808.1(d)(1) as authority); Mulligan v. Pfizer, Inc., 850 F.Supp. 633, 635 (S.D.Ohio 1994) (FDA’s interpretation in 808.1(d)(1) is reasonable); Oliver v. Johnson & Johnson, Inc., 863 F.Supp. 251, 255 (W.D.Pa.1994) (claims under Pennsylvania's Uniform Commercial Code not preempted pursuant to 808.1(d)(1)). We consider the cases concluding section 808.1(d)(1) is inconsistent with congressional intent to be more persuasive.

4 . Although Worthy argues that section 360h(d) of the MDA constitutes a savings provision, this argument was not presented to the trial court. Therefore, we do not address it here. Hall, 683 S.W.2d at 867.

5 . The relevant portions of the Federal Boat Safety Act preemption provision read as follows:

... [A] State or political subdivision of a State, may not establish, continue in effect, or enforce a law or regulation establishing a recreational vessel or associated equipment performance or other safety standard or imposing a requirement for associated equipment ... that is not identical to a regulation prescribed under section 4302 of this title.

Moore, 889 S.W.2d at 248.