Feldt v. Mentor Corp.

• Decision Date: 21 August 1995
• Docket Number: No. 94-20592,94-20592
• Citation: 61 F.3d 431
• Parties: Prod.Liab.Rep. (CCH) P 14,318 Sam FELDT, Plaintiff-Appellant, v. MENTOR CORPORATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Fifth Circuit

Page 431

61 F.3d 431

Prod.Liab.Rep. (CCH) P 14,318

Sam FELDT, Plaintiff-Appellant, v. MENTOR CORPORATION, Defendant-Appellee.

No. 94-20592.

United States Court of Appeals Fifth Circuit.

Aug. 21, 1995.

Jeffrey P. Hintermeister, Houston, TX, for appellant.

Brian Wolfman, Public Citizen Liti. Grp., and Arthur Bryant, Washington, DC, for amicus, Public Citizens & Trial Lawyers.

Earnest W. Wotring and Michael Connelly, Mayor, Day, Caldwell & Keeton, L.L.P., Houston, TX, for appellee.

Richard A. Samp, Washington, DC, for amicus, Washington Legal Foundation.

Appeal from the United States District Court for the Southern District of Texas.

Before WISDOM, GARWOOD and DAVIS, Circuit Judges.

GARWOOD, Circuit Judge:

In this products liability suit, plaintiff-appellant Sam Feldt (Feldt) appeals the district court's award of summary judgment, on the basis of preemption, for defendant-appellee Mentor Corporation (Mentor). We affirm in part, reverse in part, and remand.

Facts and Proceedings Below

On October 19, 1988, in an effort to cure erectile impotency, Feldt, then 68 years old, had implanted a pump-activated, Mentor GFS inflatable penile prosthesis (the prosthesis or the GFS), which had been approved by the Food and Drug Administration (the FDA) for marketing because of its substantial equivalence to prior devices. Feldt's prosthesis worked until June 1991 when, because of a flaw in the connection between the penile cylinders and the scrotal pump reservoir, it would no longer inflate and had to be removed and replaced. Feldt claims that, as a result of this defect, he suffered from embarrassment, trauma, and decreased sexual desire. He also claims that the defect contributed to the end of his relationship with his fiancee.

Seeking recovery for these and other injuries, Feldt filed suit against Mentor, the product manufacturer, in Texas state court on June 17, 1993, alleging negligence, strict products liability, breach of express and implied warranties, and violations of the Texas Deceptive Trade Practices Act (DTPA). In its answer, Mentor raised eighteen affirmative defenses, among them the complete preemption of Feldt's state law claims. Asserting diversity and federal question jurisdiction, Mentor removed the suit to federal court, where on May 20, 1994, it filed a motion for summary judgment based only on the preemption defense. Feldt opposed the motion but dropped his negligence and strict liability claims with regard to the GFS's manufacture. On July 11, 1994, the district court awarded Mentor summary judgment, from which Feldt now appeals.

Discussion

The only issue in this appeal is whether 21 U.S.C. Sec. 360k(a), part of the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug and Cosmetic Act, expressly preempts Feldt's remaining state law claims. ¹ When the field alleged to be preempted by federal law has been traditionally occupied by the states, there is a presumption against preemption that can be rebutted only by a "clear and manifest" congressional purpose, be it express or implied. Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977). When Congress explicitly displaces state law, however, as it has here, congressional intent is determined with reference only to the express language of the statute; preemption will not be implied. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516-18, 112 S.Ct. 2608, 2618, 120 L.Ed.2d 407 (1992); Stamps v. Collagen Corp., 984 F.2d 1416, 1420 (5th Cir.) (rejecting the argument that the language of the MDA permits a finding of implied preemption), cert. denied, --- U.S. ----, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993). The federal statute at issue, section 360k(a) of the MDA, provides as follows:

"[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 other matter included in a requirement applicable to the device under this chapter." 21 U.S.C. Sec. 360k(a).

The parties dispute whether Texas law establishes, with respect to the GFS, "any requirement different from, or in addition to, any requirement applicable under this chapter to the device." ² Id.

Since the enactment of the MDA in 1976, the FDA has had authority to regulate the entry of medical devices into the market. Pursuant to this authority, the FDA groups medical devices into three classes (Classes I-III) according to the amount of regulation necessary to ensure their safety and effectiveness. Although all classes of medical devices are subject to general controls, including labeling requirements and so-called good manufacturing practices (GMPs), Class II and Class III devices are subject to additional regulations. Moreover, because Class III devices are deemed to pose the greatest threat of illness or injury, they are subject to the most stringent regulation of the three classes. The GFS is a Class III device. 21 C.F.R. Sec. 876.3350(b).

Before being marketed and sold, Class III devices must undergo the rigors of Pre-Market Approval (PMA), a lengthy, comprehensive process, at the end of which the FDA determines whether there is "reasonable assurance" that the device under consideration is safe and effective. See 21 U.S.C. Sec. 360d(c)(1), (d); see also Reeves v. AcroMed Corp., 44 F.3d 300, 303 (5th Cir.), cert. denied, --- U.S. ----, 115 S.Ct. 2251, 132 L.Ed.2d 258 (1995). As this Court recently summarized "The FDA's [PMA] application requires manufacturers to submit extensive animal and human data to establish their devices' safety and effectiveness. 21 C.F.R. Sec. 814.20.... FDA regulations also require [PMA] applicants to submit '[c]opies of all proposed labeling for the device.' 21 C.F.R. Sec. 814.20(b)(10). The FDA approves a [PMA] application only after extensive review by the agency and an advisory committee composed of outside experts." Id.

Although as a general rule a Class III device must obtain PMA before it can be marketed to the public, 21 U.S.C. Sec. 360e(c)(2), there are two exceptions. First, Class III devices found by the FDA to be "substantially equivalent" to devices on the market before May 28, 1976, the MDA's effective date, are entitled to bypass the PMA process. Id. Sec. 360e(b)(1). Second, Class III devices that obtain an investigational device exemption (IDE) from the FDA, id. Sec. 360j(g), may be clinically tested on humans without first obtaining PMA. Id. Sec. 360e(a). At any time, however, the FDA may issue a regulation requiring an exempted device to undergo the formal PMA process, see id. Sec. 351(f)(2), but to date has not done so for inflatable penile prostheses.

It is undisputed that Mentor never obtained PMA for the GFS. The prosthesis was instead found by the FDA to be substantially equivalent to devices marketed before the MDA's effective date. A finding of substantial equivalence is based on a section 510(k) statement submitted as part of a pre-market notification application, a process significantly more abbreviated and less involved than PMA. ³ Reeves, 44 F.3d at 303. Applicants for pre-market notification must submit device descriptions and other information sufficient for the FDA to determine whether the device in question is substantially equivalent to pre-MDA marketed devices. As with the application for PMA, applicants must also submit their proposed labeling, 21 C.F.R. Sec. 807.87, for the FDA to determine compliance with general labeling regulations. See 21 C.F.R. Sec. 801 et seq.; Reeves, 44 F.3d at 305. In this case, Mentor filed a 510k notification for the GFS on June 9, 1987, and included a variety of information relating to the design of the product as well as a summary of a nine-month clinical evaluation performed pursuant to a previously approved IDE. See English v. Mentor Corp., 1994 WL 263353 at 4-5 (E.D.Pa. June 13, 1994) (unpublished) (describing the content of Mentor's 510k statement). The FDA approved the pre-market notification application on August 26, 1987, thereby allowing the GFS to enter the market subject only to general controls, at least until the FDA requires by regulation that the prosthesis undergo PMA.

Whether the pre-market notification procedures and general controls, like the PMA process, constitute "any requirement[s] applicable ... to the device" so as to displace any additional or different state requirements (relating to the product's safety or effectiveness), 21 U.S.C. Sec. 360k(a), is the central question in this case. The test for section 360k preemption in this Circuit tracks the statutory language:

"A state tort cause of action will be preempted if, in the context of the particular case, it (1) constitutes a requirement different from, or in addition to, any requirement the MDA makes applicable to the device at issue and (2) relates either to (a) the safety or effectiveness of the device or (b) any other matter included in a requirement made applicable to the device by the MDA." Stamps, 984 F.2d at 1421.

There is no question that the state law duties in question are requirements relating to safety and effectiveness. The only issue, then, is whether there is "any requirement the MDA makes applicable to the device at issue."

Below and on appeal, Feldt has argued that, although state law imposes duties on manufacturers of medical devices, these duties are not "in addition to" any federal requirements because no such requirements exist until the FDA requires PMA for penile prostheses. Rejecting this contention, the district court determined that the FDA's regulations relating to pre-market notification were requirements to which all Mentor's state law duties were "in addition" and therefore preempted. On appeal, Feldt argues mainly that the regulations now applicable to the GFS are for...