Mears v. Marshall

• Decision Date: 25 October 1995
• Citation: 905 P.2d 1154,137 Or.App. 390
• Parties: , 28 UCC Rep.Serv.2d 107, Prod.Liab.Rep. (CCH) P 14,445 Janice M. MEARS, Appellant, v. William R. MARSHALL, M.D., and Collagen Corporation, Respondents. 9307-04839; CA A85078.
• Court: Oregon Court of Appeals

Page 1154

905 P.2d 1154

137 Or.App. 390, 28 UCC Rep.Serv.2d 107,

Prod.Liab.Rep. (CCH) P 14,445

Janice M. MEARS, Appellant, v. William R. MARSHALL, M.D., and Collagen Corporation, Respondents.

9307-04839; CA A85078.

Court of Appeals of Oregon.

Argued and Submitted July 10, 1995.

Decided Oct. 25, 1995.

[137 Or.App. 391-D] Susan A. Allinger, Houston, Texas, argued the cause for appellant. On the opening brief were Michael M. Essmyer, Essmyer & Tritico, L.L.P., Houston, Texas, and Clinard J. Hanby, The Woodlands, Texas, and Jeffrey S. Merrick and Williams & Troutwine, P.C. On the reply briefs were Michael M. Essmyer, Essmyer & Tritico, L.L.P., Houston, Texas, and Clinard J. Hanby, The Woodlands, Texas.

Janet Schroer, Portland, argued the cause for respondent William R. Marshall, M.D. With her on the brief were Gordon J. Evans and Hoffman, Hart & Wagner.

Joe W. Redden, Jr., Houston, TX, argued the cause for respondent Collagen Corporation. With him on the brief were Curt Webb and Beck, Redden & Secrest, Houston, TX, and Eric J. Neiman, John D. Ostrander and Tooze Shenker Duden Creamer Frank & Hutchinson, Portland.

Alfredo Wheelock, Portland, filed an amicus curiae brief for Oregon Trial Lawyers Association.

Before RIGGS, P.J., and LANDAU and LEESON, JJ.

LEESON, Judge.

Plaintiff brought this action for damages for personal injuries she sustained after receiving medical treatments to remove facial wrinkles. Defendant Marshall, her physician, administered four injections of Zyderm and Zyderm FL, products designed, manufactured and marketed by defendant Collagen Corporation (Collagen). Plaintiff appeals from the trial court's grant of summary judgment for defendants on the ground that all of plaintiff's claims are preempted by the Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetics Act, 21 USC § 301 et seq. We affirm with respect to all claims against Collagen, but reverse and remand, in part, with respect to the claims against Marshall.

Zyderm is a medical implant composed of purified bovine collagen, a protein extracted from calf hide that is similar to the human collagen that provides texture and suppleness to the skin. Zyderm is injected into the skin to smooth out facial contours such as smile and frown lines that result as the naturally occurring collagen in the skin breaks down as part of the aging process. Treatment consists of a skin test to determine whether the prospective patient has any untoward sensitivity to the material, followed by a series of injections at intervals of at least two weeks. Because the cosmetic effects are not permanent, most patients choose to receive touch-up treatments within 6 to 24 months. Plaintiff received injections of Zyderm in April, May and June 1991 and of Zyderm FL in August 1991. Zyderm FL contains the same collagen material as Zyderm, but it is injected with a smaller gauge needle to correct fine lines that develop around the eyes.

Under the MDA, medical devices intended for human use are classified by the federal Food and Drug Administration (FDA) into one of three categories, depending on the level of regulation needed to provide reasonable assurances of safety and effectiveness. See 21 USC § 360c (establishing classifications). Class I devices pose little or no threat to health and safety and are subject to only general controls over manufacturing processes. Id. at § 360c(a)(1)(A). Tongue depressors, elastic bandages, ice bags and bed pans are common examples of Class I devices. Robert S. Adler and Richard A. Mann, Preemption and Medical Devices: The Courts Run Amok, 59 MoLRev 895, 913 (1994). Class II devices are more complex, requiring special controls such as performance standards, postmarket surveillance, patient registries, guidelines and recommendations deemed necessary to assure safety and effectiveness. 21 USC § 360c(a)(1)(B). Examples of Class II devices are syringes, hearing aids, bone plates, and condoms. Adler and Mann, 59 MoLRev at 913. Class III devices are those that cannot be classified into Classes I or II because of insufficient information to determine whether general controls will "provide reasonable assurances of [their] safety or effectiveness," and are either purported to be "for a use in supporting or sustaining human life or * * * of substantial importance in preventing impairment of human health" or "present a potential unreasonable risk of illness or injury." 21 USC § 360c(a)(1)(C). Class III devices include pacemakers, IUDs and replacement heart valves. Adler and Mann, 59 MoLRev at 914. The Zyderm collagen implants in this case are Class III devices.

The manufacturer of a Class III device must obtain premarket approval (PMA) from the FDA by submitting an application that presents all available scientific knowledge concerning investigations of the device's safety and effectiveness; detailed information regarding its design, components, ingredients, properties, and principles of its operation; a full description of manufacturing methods and facilities; any applicable performance standards; samples of the device; specimens of proposed labeling; and other information deemed relevant by the FDA. ¹ 21 USC § 360e(c)(1); 21 CFR § 814.20. PMA applications are reviewed by a panel of experts, which makes recommendations to the FDA. 21 USC § 360e(c)(2). The FDA may approve a device for sale or return the application for additional information or testing of the device. Id. at § 360e(d)(1). The FDA must inform the applicant of the measures needed to correct a deficient application. Id. at § 360e(d)(2).

Even after a PMA application has been approved, a device remains subject to post-approval regulation. Id. at § 360e(e); 21 CFR § 814.82(a). The manufacturer must maintain certain records and make reports to the FDA, 21 USC § 360i; 21 CFR § 814.82, and must not manufacture, package, store, label, distribute or advertise the device "in a manner inconsistent with any conditions to approval specified in the PMA approval order for the device." 21 CFR § 814.80. With only minor exceptions, the manufacturer must also submit a PMA supplement for FDA review and approval before making changes that affect the safety or effectiveness of an approved device. 21 CFR § 814.39. The FDA retains the power to withdraw approval of a device on the basis of new information, or if it discovers that the manufacturer submitted false or misleading information in its PMA application or otherwise fails to comply with the MDA or conditions of PMA approval. 21 USC § 360e(e). The FDA has limited remedial power to require the manufacturer to notify the public of newly discovered risks; to order repair, replacement, or refund of the purchase price of a device; and to order recall of a device. Id. at § 360h. Additionally, a device manufacturer is subject to criminal penalties for certain prohibited acts and may be assessed civil penalties by the FDA. Id. at §§ 331, 333. It is generally understood, and the parties in this case do not disagree, that there is no private right of action under the Food, Drug and Cosmetics Act. See Talbott v. C.R. Bard, Inc., 865 F.Supp. 37, 45 (D.Mass.1994), aff'd 63 F.3d 25 (1st Cir.1995) (citing four federal circuit court cases and four federal district court cases so holding); see also King v. Collagen Corp., 983 F.2d 1130, 1140 (1st Cir.), cert. den. 510 U.S. 824, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993) (no implied right of action).

The FDA, upon recommendation of its Surgical and Rehabilitation Devices Panel, approved Collagen's PMA application for Zyderm by letter on July 22, 1981, and by order published on September 18, 1991. 46 FedReg 46,394 (1981). PMA approval was made subject to a set of conditions including an extension of the post-approval immunological study; distribution with the device of a patient information brochure; submission in final printed form of labeling and informational package inserts; prior submission of PMA supplements before making changes involving indications for use, labeling, manufacturing, packaging or ingredients; and required reports. Between initial PMA approval and the time plaintiff began treatment, Collagen had submitted 16 PMA supplements seeking approval for changes in ingredients, manufacturing processes, labeling and physician's package inserts. Changes were approved only after Collagen complied with FDA requests to submit additional data or to include specified language on labels or physician's package inserts.

Plaintiff alleges that the injections administered by Marshall triggered immune and autoimmune reactions that caused "numbness, swelling and soreness in her face; dizziness; vertigo; and visual disturbances[,]" some of which "more likely than not, will be permanent." She brought this action against Collagen and Marshall on claims of strict products liability, breach of express warranties and breach of implied warranties of merchantability and fitness; against Collagen on a claim of negligence; and against Marshall on a claim of medical negligence, including counts of breach of the duty of care and failure to obtain informed consent. The trial court granted Marshall's motion for summary judgment on the claims against him for strict products liability, breach of implied warranties and breach of express warranty with respect to the device itself, but denied the motion "as to the alleged warranty of the services" and the medical negligence claims. While that motion was pending, plaintiff filed a second amended complaint reiterating the claims against both defendants, but further alleging as part of each claim that Zyderm FL had not been approved by the FDA at the time of plaintiff's injection with that product. Subsequently, each defendant moved for summary judgment on the grounds that plaintiff's claims are preempted by the MDA and are also barred by the Statute of Limitations. The trial court entered judgment on its orders granting summary judgment to both defendants ...