Court Opinion

ID: 9668229
Source: CourtListenerOpinion
Date Created: 2023-08-24 02:06:45.330558+00
Date Added: 2024-06-11T18:15:43.851709
License: Public Domain

DEVANY, Justice,
concurring.
Tempie Fortson Worthy appeals the trial court’s granting of Collagen Corporation’s motion for summary judgment. The trial court ruled that all claims and causes of action asserted by Worthy, including those asserted in her second amended petition, are preempted by federal law. In two points of error, Worthy contends that the trial court erred in granting Collagen Corporation’s motion for summary judgment and in holding that the federal Medical Devices Act preempted her State law claims.
Worthy has brought her appeal with less than a full record of the proceedings in the trial court. An appellant bears the burden to present the appellate court with a sufficient record showing reversible error. Tex. R.App.P. 50(d); DeSantis v. Wackenhut Corp., 793 S.W.2d 670, 689 (Tex.1990); Christiansen v. Prezelski, 782 S.W.2d 842, 843 (Tex.1990); Sunwest Reliance Acquisitions Group v. Provident Nat’l Assurance, 875 S.W.2d 385, 388 (Tex.App.—Dallas 1993, no writ); Bayoud v. Bayoud, 797 S.W.2d 304, 313 (Tex.App.—Dallas 1990, writ denied). Without a record sufficient to show reversible error, an appellant waives any right to complain of the alleged error on appeal. See Sunwest, 875 S.W.2d at 388. Even where an appellant properly requests that all necessary items be included in the record, the appellant still has the duty to be certain that all requested items are actually received by the appellate court. Bayoud, 797 S.W.2d at 313. The failure to present a sufficient record requires the appellate court to presume that the omitted portions of the record support the trial court’s ruling. DeSantis, 793 S.W.2d at 689; AAA Rapid Concrete Serv. v. Woods, 818 S.W.2d 178, 180 (Tex.App.—Houston [14th Dist.] 1991, no writ); Bayoud, 797 S.W.2d at 313.
*718The incomplete record becomes apparent in this case because the trial court’s final order granted the motion for summary judgment holding that federal law preempted all claims asserted by Worthy, including those asserted in her second amended petition, implying that other claims were asserted in prior pleadings not in the record before us. An examination of the record reveals that Worthy’s only pleading in the record before this Court, her second amended petition, alleges only a elaim under the Texas Deceptive Trade Practices Act (DTPA).
Therefore, we cannot determine what Worthy refers to when she claims the court erred in denying all of her tort actions. If she pled other tort actions in her operative pleading, she would have waived those other actions by filing her second amended petition containing only a DTPA complaint. By failing to provide this Court with her original pleadings, upon which the trial court based its judgment, Worthy has waived any error by the trial court on appeal as to other tort claims. Yet, Worthy has asked this Court to decide that the federal Medical Devices Act does not preempt any Texas tort law claim or that it preempts all Texas tort law claims. We cannot render such a decision because it would constitute an advisory opinion. Neither the Texas Constitution nor the Texas Legislature has vested this Court with the authority to render an advisory opinion. See Tex. Const, art. II, § 1; Camarena v. Texas Employment Comm’n, 754 S.W.2d 149, 151 (Tex.1988).
Therefore, Worthy’s failure to present this Court with a sufficient record to show reversible error waives any right to complain of any alleged error with regard to all tort actions except the one action she has preserved on appeal, to-wit: the DTPA claim. See Sunwest, 875 S.W.2d at 388. In the absence of a sufficient record as to those other tort claims, a presumption exists in favor of the trial court’s judgment, hence, such judgment will not be disturbed as to those other tort claims. See Woods, 818 S.W.2d at 180.
As to Worthy’s DTPA claim, I conclude that federal law operates in this instance to establish that Collagen did not misrepresent its product by deception since Collagen’s motion for summary judgment is supported by summary judgment evidence that it followed the mandates of the Medical Device Act in the advertising and labeling of the complained-of product. Therefore, I would specifically overrule Worthy’s two points of error as to her DTPA claim, and affirm the judgment.
FACTS
In February, 1991, a medical doctor injected Worthy with Collagen Corporation’s cosmetic medical device, Zyderm. Zyderm is a processed bovine product marketed for “soft tissue augmentation” for facial defects. Worthy complains that, thereafter, she developed a severe reaction to the injected material, which required reconstructive plastic surgery on her face and immune-suppressant drugs to control the reaction systemically. Zyderm was approved for marketing in 1981 by the FDA pursuant to Pre-Marketing Application procedures of the Medical Device Amendments of 1976.
Congress enacted the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301, et seq., granting the FDA comprehensive regulatory authority over medical devices. By its terms, the MDA applies solely to medical devices; it does not regulate drugs, cosmetics, foods or other products. Section 360k(a) of the MDA expressly provides as follows:
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 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 other matter included in a requirement applicable to the device under this chapter.
The MDA requires that the FDA classify each medical device intended for human use into Class I, II, or III. 21 U.S.C. § 360c(b)(1). Only class III devices require premarket approval. 21 U.S.C. § 360e. The *719stated purpose of premarket approval is to enable the PDA to determine whether a proposed Class III device provides reasonable assurance of safety and effectiveness in its use. There is a rigorous approval process provided for in the federal law. 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 PMA approval order for the device.” 21 C.F.R. § 814.80. The FDA classified Zyderm as a Class III medical device and, consequently, required Collagen Corporation to obtain FDA approval of Zyderm’s safety and effectiveness before marketing the product. The summary judgment proof establishes that Collagen’s product, Zyderm, has met all the requirements of the applicable federal law.
APPELLANT’S ARGUMENTS UNDER DTPA
Worthy’s brief presents arguments that conclude that her “state tort law claims are not preempted by the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug and Cosmetic Act.” Thus, her brief, for the main part, fails to specifically address her claims under the DTPA. However, she does provide some guidance in her appeal as to her DTPA claim by stating in one paragraph of her brief that the DTPA is an unfair trade practices law of general applicability and is explicitly not preempted by the federal MDA of 1976. Worthy cites Bollier v. Medtronic, Inc., No. H-92-2439, 1993 WL 734843 (S.D.Tex.1993), as a case that the appellee might cite as one where a local federal judge has preempted DTPA claims under the Medical Devices Act (MDA). Having cited that case, Worthy immediately distinguishes Bol-lier because the plaintiff in that case failed to raise the exclusions contained in 21 C.F.R. 808.1(d)(1). Worthy then draws the conclusion that FDA regulations hold that Worthy’s DTPA claims are not preempted. The law that Worthy cites is as follows:
Section [360k(a) ] does not preempt 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 electrical codes and the Uniform Commercial Code (warrant of fitness)), or to unfair trade practices in which the requirements are not limited to devices.
21 C.F.R. § 808.1(d)(1).
STATE STATUTES OF GENERAL APPLICABILITY
It appears that federal regulations under the MDA provide that the MDA preempts state statutes which would alter explicit requirements of the MDA, but do not preempt such statutes of general applicability. The federal plan gleaned from Congressional intent as to medical devices is to carefully regulate the testing, sale, and distribution of medical devices.
Once a product is determined to be subject to the control of the MDA, it is subjected to vigorous tests and labeling as prescribed by the MDA. Any further specific requirements of any state are preempted in order to maintain uniformity in the testing, sale, and distribution of medical devices throughout the nation.
However, while a state may not impose further restrictions on the testing, advertising, and labeling of particular products, which would be by statutes of specific applicability, the regulations do allow states to pass laws of general applicability.
For example, if the federal government were to require wiring for homes to be of a certain composition for the safety of people and their homes throughout the nation, the states presumably would not be permitted to change such specifications. The reasoning would simply be to enable standardization of home wiring for all purposes. However, I see no prohibition against a state passing a law of general applicability that would require that all home-wiring had to be run through PVC tubing to protect the wire from accidental damage. Such a state statute would appear to be one of general applicability that would not change the federal mandate on the composition of wiring.
*720DECEPTIVE TRADE PRACTICES ACT (DTPA)
Texas adopted the DTPA statute a number of years ago for the protection of consumers generally. That statute is nothing more than a restatement of certain existing common law that allows a consumer to bring an action against a vendor who violates a specific common law tort, such as deceptive or misleading advertising or false labeling that lures consumers by misrepresentation; the DTPA further embodies an existing common law contract remedy for breach of warranty. The DTPA specifies its own special measure of damages for a violation of specific “DTPA” violations. Therefore, I would hold that the Texas DTPA statute is one of general applicability.
However, where a DTPA claim is based upon false advertising and labeling, that specific claim must fail if the complained-of advertising or labeling was prescribed by the federal government under the MDA because the vendor has no control over the advertising and labeling. This would be so because of the vendor’s compliance with a federal statute.
In Worthy’s second amended petition, she specifically complained that Collagen made representations that were false and misleading, yet the summary judgment evidence establishes that the representations were mandated under the federal law.
Collagen’s Motion for Summary Judgment provided summary judgment proof that it manufactured, labeled, and distributed Zy-derm in accordance with the mandates of the MDA. Collagen cannot be held responsible for compliance with those mandates. Collagen provided adequate summary judgment proof to support its compliance with the federal law.
Therefore, because Collagen complied with federal law in its labeling and advertising, it cannot be guilty of misleading Worthy since Collagen had no control over the representations made. My concern is that the order of the court, held that the DTPA claim of Worthy was preempted by federal law. As a general statement, I would disagree and hold that the DTPA is a statute of general applicability and is not preempted by the applicable federal law. For example, a DTPA claim of breach of warranty that is based upon a guarantee of performance might very well be the basis of a State action unless the complained of warranty was specifically part of the MDA mandated advertising, which is doubtful since the federal law is designed to protect consumers, not suggest guaranteed results.
My examination of the federal law applicable in this case, when read in context with other sections, makes it clear that State law that would alter the general requirements of a product that comes under the jurisdiction of the MDA will be preempted when such requirements have the effect of establishing a different or additional requirement applicable to a specific device. The following regulation is on point:
Generally, section [360k(a) ] does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition mil be preempted if the requirement is different from, or in addition to, a Federal requirement established under the act.
21 C.F.R. § 808.1(d)(6)(ii). (Emphasis added.)
Worthy’s lawsuit brought under the DTPA, a statute of general applicability, is not preempted per se, but her specific complaint about the statements made by Collagen as being misrepresentations must fail since Collagen has followed the mandated requirements of the federal law. Since Collagen had no authority to use different language, Worthy’s complaint is preempted by the federal mandate. The word preempted has developed several meanings in law since its first use in English International law, but the word pertains to a first or prior right, or to take precedence. See Black’s Law Dictionary 1177 (6th Ed.1990). In the instant case, the representations made by Collagen met the requirements of federal law and *721must take precedence over any State test that would find such representations false.
Worthy’s claim is that Zyderm’s label should have contained specific additional warnings, which would have altered the federal requirements about the product, and, therefore, such additional warnings are preempted by the federally prescribed label. Worthy charges that Zyderm should have been designed, manufactured or marketed in a different manner and that it should not have been marketed at all. Hence, Worthy’s complaint seeks to impose additional or different requirements applicable to a device within the meaning of § 360k(a) and 21 C.P.R. § 808.1(d).
Collagen cites a number of eases from across the nation which have specifically held that similar state law causes of action involving Zyderm are preempted by the federal law. Those eases include: Mitchell v. Collagen Corporation, 870 P.Supp. 885 (N.D.Ind.1994), aff'd, 67 F.3d 1268 (7th Cir.1995), which involves the Indiana Deceptive Consumer Sales Act, which held that said act was preempted by the MDA; and Tucker v. Collagen Corporation, No. 93 C 2375, 1994 WL 87367 (N.D.Ill. March 16, 1994), which involves a strict liability law of Illinois, which held that said law was preempted by the MDA. Similar holdings in other states cover this area. See, e.g., Anguiano v. E.I. Du Pont De Nemours & Co., 44 F.3d 806 (9th Cir.1995).
I am not in full accord with those cases insofar as they hold that a statute such as the DTPA statute of Texas is per se preempted by the federal law. I would limit our holding to the facts of this case as I have stated.
Therefore, I would overrule Worthy’s two points of error in accordance with this opinion.
I agree that the judgment of the trial court should be affirmed.