Worthy v. Collagen Corp.

• Decision Date: 13 February 1998
• Docket Number: No. 96-0675,96-0675
• Citation: 967 S.W.2d 360
• Parties: 34 UCC Rep.Serv.2d 865, Prod.Liab.Rep. (CCH) P 15,167 Tempie Fortson WORTHY, Petitioner, v. COLLAGEN CORPORATION, Respondent.
• Court: Texas Supreme Court

Page 360

967 S.W.2d 360

34 UCC Rep.Serv.2d 865, Prod.Liab.Rep. (CCH) P 15,167

Tempie Fortson WORTHY, Petitioner, v. COLLAGEN CORPORATION, Respondent.

No. 96-0675.

Supreme Court of Texas.

Argued Dec. 17, 1996.

Decided Feb. 13, 1998.

Michael M. Essmyere, Houston, Clinard J. Hanby, The Woodlands, John M. O'Quin, Susan A. Allinger, Houston, for Petitioner.

Joe W. Redden, Houston, for Respondent.

HECHT, Justice.

The principal issue before us is whether the Medical Device Amendments of 1976 to the federal Food, Drug and Cosmetic Act preempt this action against a manufacturer brought under the Texas Deceptive Trade Practices--Consumer Protection Act for damages resulting from the injection of a collagen implant material that is a class III medical device under the Act and that has received premarketing approval from the federal Food and Drug Administration. To resolve the issue we must construe and apply the United States Supreme Court's recent opinions in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). We agree with the lower courts, Tempie Worthy v. Collagen Corp., 921 S.W.2d 711 (Tex.App. 1995), that this action is preempted.

Tempie Fortson Worthy sued Collagen Corporation and Dr. James Gilmore, alleging that she was injured when Dr. Gilmore injected her with Zyderm TM and Zyplast TM ("Zyderm"), products manufactured by Collagen for cosmetic use. Zyderm is made from a purified form of bovine dermal collagen, a natural protein that provides structural support for skin, muscles, tendons, and bones. The collagen is processed so that it will be accepted by the human body, and the product is injected into connective tissue to repair soft tissue deformities such as scars, pockmarks, and wrinkles, caused by disease, trauma, surgery, or aging. Worthy alleges that these injections caused her to suffer autoimmune disease and physical deformities.

The federal Food and Drug Administration has determined that Zyderm is a Class III medical device as defined by the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act ("the MDA", "the FDCA", or "the Act")--that is, a device that either is for "use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or [ ]presents a potential unreasonable risk of illness or injury". 21 U.S.C. § 360c(a)(1)(C)(ii). With certain exceptions, a Class III device may not be marketed without FDA approval. Id. §§ 331(a), 351(f); Medtronic, 518 U.S. at 477, 116 S.Ct. at 2246-2247. To obtain approval, a person must provide the FDA with "reasonable assurance" that the device is both safe and effective. 21 U.S.C. § 360e(d)(2); Medtronic, 518 U.S. at 477, 116 S.Ct. at 2246. "[T]he safety and effectiveness of a device are to be determined--(A) with respect to the persons for whose use the device is represented or intended, (B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and (C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." 21 U.S.C. § 360c(a)(2). "[T]he process of establishing this 'reasonable assurance,' which is known as the 'premarket approval,' or 'PMA' process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission." Medtronic, 518 U.S. at 477, 116 S.Ct. at 2246-2247; see 21 U.S.C. § 360e(c); 21 C.F.R. 814.1-.126 (1997).

Specifically, a PMA application must contain:

(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;

(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;

(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device;

(D) ... adequate information to show that [any aspect of the device subject to certain performance standards] fully meets such performance standard or adequate information to justify any deviation from such standard;

(E) such samples of such device and of components thereof as [the FDA] may reasonably require ...;

(F) specimens of the labeling proposed to be used for such device; and

(G) such other information relevant to the subject matter of the application as [the FDA] may require.

21 U.S.C. § 360e(c)(1). The PMA application must also include: "[a] general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended", 21 C.F.R. § 814.20(b)(3)(i); "[a]n explanation of how the device functions, the basic scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device", id. § 814.20(b)(3)(ii); "[a] description of existing alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended", id. § 814.20(b)(3)(iii); "[a] discussion demonstrating that the data and information in the application constitute valid scientific evidence ... and provide reasonable assurance that the device is safe and effective for its intended use", id. § 814.20(b)(3)(vi); and a discussion of the "benefit and risk considerations related to the device including a discussion of any adverse effects of the device on health and any proposed additional studies or surveillance the applicant intends to conduct following approval of the PMA", id. These are but a few of the requirements for a PMA application. See 21 C.F.R. § 814.20.

A PMA application is ordinarily referred to a panel of experts for study. 21 U.S.C. §§ 360e(c)(2), 360c(b). When the study is completed, the panel gives the FDA "a report and recommendation respecting approval of the application, together with all underlying data and the reasons or basis for the recommendation." Id. § 360e(c). The FDA grants premarketing approval only if it finds reasonable assurance that the device is safe and effective with respect to the conditions of use prescribed, recommended, or suggested in the labeling, that the manufacturing and processing methods and facilities are satisfactory, and that the proposed labeling is not false or misleading in any manner. 21 U.S.C. § 360e(d)(2); see also 21 C.F.R. § 814.44. A device approved for marketing cannot be "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.

A device manufacturer must promptly report to the FDA any malfunctions of a device or any deaths or serious injuries caused by it. 21 C.F.R. § 803.1 (1997). The FDA is authorized to notify the public of risks presented by medical devices, 21 U.S.C. § 360h(a); to require manufacturers to repair or replace defective devices, id. § 360h(b); to institute recall campaigns, id. § 360h(e); to require that records and reports be made of adverse reactions, serious injuries, and death associated with devices, id. § 360i; to require postmarketing surveillance of devices, id. § 360l ; and to withdraw marketing approval if it finds that an approved device is not safe and effective, id. § 360e(e).

There are three exceptions to the PMA requirement. One is for devices marketed prior to May 28, 1976. They can continue to be marketed pending the FDA's completion of the PMA process. 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1) (1997). A second is for devices "substantially equivalent" to devices marketed before May 28, 1976. 21 U.S.C. § 360e(b)(1)(b). They also can be marketed pending completion of the PMA process, but they are subject to a premarket notification process, referred to as a " § 510(k) process" (after the relevant provision of the statute before codification). 21 U.S.C. §§ 360e(b)(2), 360(k); 21 C.F.R. § 814.1(c)(1) (1997); Medtronic, 518 U.S. at 478, 116 S.Ct. at 2247. A third exception is for devices being investigated for human use. They cannot be used without FDA approval obtained through a process different from the PMA process but involving comparably rigorous review. 21 U.S.C. 360j(g); 21 C.F.R. 812.1-.150 (1997).

None of these exceptions applied to Zyderm. Collagen applied for premarketing approval of its product in May 1980. The initial application consisted of eight volumes containing safety and effectiveness data, in vitro data, animal data, clinical data from tests with more than five thousand patients, a statement of ingredients, a reference to performance standards, labeling, a bibliography, significant articles, manufacturing methods, product samples, and patient report forms. While the application was pending, Collagen amended it to correct deficiencies noted by the FDA. In July 1981 the FDA approved Zyderm subject to several conditions. The FDA restricted Zyderm to prescription use and required that it be distributed with FDA-approved labeling and with a patient manual. The FDA also required that "[n]o advertisement for this device shall recommend or imply that the device may be used for any use that is not mentioned in the approved labeling for the device. All written promotional material shall state the indications, contraindications, warnings, precautions and adverse effects of the device." The FDA required that patient studies continue under specified guidelines and that patients be monitored for adverse reactions to the product. Finally, the FDA required Collagen to submit a supplemental PMA before making any changes "that may...