Ethicon, Inc. v. Food and Drug Admin., Civ. A. No. 90-1797 (JHG).

• Decision Date: 11 April 1991
• Docket Number: Civ. A. No. 90-1797 (JHG).
• Citation: 762 F. Supp. 382
• Parties: ETHICON, INC., Plaintiff, v. FOOD AND DRUG ADMINISTRATION and Louis W. Sullivan, M.D., Secretary, Department of Health and Human Services, Defendants, and United States Surgical Corporation, Defendant-Intervenor.
• Court: U.S. District Court — District of Columbia

762 F. Supp. 382

ETHICON, INC., Plaintiff, v. FOOD AND DRUG ADMINISTRATION and Louis W. Sullivan, M.D., Secretary, Department of Health and Human Services, Defendants, and United States Surgical Corporation, Defendant-Intervenor.

Civ. A. No. 90-1797 (JHG).

United States District Court, District of Columbia.

April 11, 1991.

Max O. Truitt, Daniel Marcus, Randolph P. Moss, Wilmer, Cutler & Pickering, Washington, D.C., for plaintiff.

Michael T. Ambrosino, Asst. U.S. Atty., Mark Heller and Lucy Russell, Attys., FDA, Rockville, Md., for defendants.

Sanford M. Litvack, Anthony J. Viola, Dewey, Ballantine, Bushby, Palmer & Wood, New York City, for defendant-intervenor.

AMENDED MEMORANDUM OPINION AND ORDER

JOYCE HENS GREEN, District Judge.

Pending before the Court are the cross-motions of the parties for summary judgment. On consideration of the pleadings, the administrative record, and the oral hearing held on this matter, and for the reasons set forth below, defendants' and defendant-intervenor's motions are granted and plaintiff's motion is denied.

I. BACKGROUND

Plaintiff Ethicon, Inc. manufactures VICRYL poly(glycolide/L-lactide) absorbable surgical sutures ("poly (g/l) sutures"). Ethicon challenges the decision by defendants Food and Drug Administration ("FDA") and Secretary of Health and Human Services Dr. Louis W. Sullivan ("Secretary") to reclassify a generic class of poly (g/l) sutures from Class III to Class II under the Medical Device Amendments ("Amendments") to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392 (1988) ("the Act").¹ Ethicon seeks a judgment declaring the reclassification decision null and void for FDA's alleged failure to fulfill both substantive and procedural statutory requirements for the reclassification of medical devices. Ethicon further requests an injunction preventing FDA from implementing or enforcing its decision and an order directing FDA to rescind all actions taken pursuant to the decision.

A. The Regulatory Scheme

In 1976, Congress passed the Medical Device Amendments, establishing a three-tiered scheme of regulating medical devices. Class I devices are those deemed in need of the least regulatory oversight, with the general controls of the Act considered sufficient to ensure safety and effectiveness. 21 U.S.C. § 360c(a)(1)(A). Class II devices are those for which the general controls in the Act are deemed insufficient by themselves to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish performance standards that assure their safety and effectiveness. Id. § 360c(a)(1)(B). Class III devices are those that do not meet the criteria of the first two classes. They are defined as devices that are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" or that present "a potential unreasonable risk of illness or injury." Id. § 360c(a)(1)(C). Manufacturers of such devices must obtain premarket approval from FDA to market the devices pursuant to the requirements and procedures set forth in § 360e ("PMA").²

Outside of but related to the above classification scheme, medical devices are categorized as within three types: "pre-amendment" devices, those in distribution prior to the enactment date of the Amendments; "transitional devices," products within the definition of "devices" and regulated, before the Amendments, as drugs; and "post-amendment devices," those first introduced after the Amendments and not substantially equivalent to pre-amendment devices. Initially, all transitional devices were automatically classified into Class III, with the potential for reclassification. See id. § 360j(l)(1). The statute further provides that if a new device were substantially equivalent to a transitional device, that device would be placed in the same class as the transitional device and subject to the same regulatory controls. Id. § 360j(l)(1)(D).

Devices that are introduced into interstate commerce after the effective date of the Amendments are also automatically classified as Class III unless they are shown to be of a non-class III type of device and to be "substantially equivalent" to a particular device already so classified. Id. § 360c(f)(1)(A). FDA may reclassify any device deemed to be overclassified, but only upon a proffer of "valid scientific evidence" of safety and effectiveness. 21 C.F.R. §§ 860.7, .123(a)(6). See generally Contact Lens Manufacturers Association v. Food & Drug Administration, 766 F.2d 592, 593-94 (D.C.Cir.1985), cert. denied, 474 U.S. 1062, 106 S.Ct. 810, 88 L.Ed.2d 784 (1986) ("Contact Lens"). Section 360j(l)(2) outlines the procedures for reclassification of transitional devices.³

B. Factual Background

In May 1987, defendant-intervenor United States Surgical Corporation ("USSC") petitioned FDA to reclassify a generic class of poly (g/l) sutures from Class III to Class II.⁴ Administrative Record ("AR") at 1-1041. FDA referred the petition to its Administrative Panel on General and Plastic Surgery Devices ("Panel"),⁵id. at 1049-51, and a notice of the Panel's meeting was duly announced. See 52 Fed.Reg. 23,081, 23,082 (June 17, 1987). The Panel received written testimony and held a hearing on August 28, 1987. Transcript of General and Plastic Surgery Devices Panel Meeting, Aug. 28, 1987 ("Panel Tr."), AR at 6353-6584Q. At the close of the hearing, the Panel unanimously recommended that poly (g/l) sutures be reclassified from Class III to Class II. Panel Tr. at 235, AR at 6584F. On June 15, 1988, plaintiff Ethicon,⁶ which had participated in these proceedings, e.g., Panel Tr. at 164-79 (oral testimony), AR at 6518-33; AR at 3031-78 (written submissions),⁷ submitted further arguments to the effect that FDA wrongly applied the § 360j(l)(2) provisions and should have examined the petition under § 360c(e). AR at 3188, 3204.

After further study, on September 14, 1989, FDA issued a letter ruling ("1989 Letter Ruling") granting USSC's petition and reclassifying the generic class of poly (g/l) sutures. 1989 Letter Ruling, AR at 3221-36. FDA found that sufficient publicly available scientific evidence existed to enable development of a performance standard for poly (g/l) sutures, the generic class of poly (g/l) sutures was well-characterized, and reclassification was warranted. Id. It specifically commented that "a class III designation for absorbable poly (g/l) surgical suture constitutes overregulation." 1989 Letter Ruling at 4, AR at 3224. FDA defined the generic class as including any "absorbable sterile, flexible strand as prepared and synthesized from homopolymers and copolymers made from glycolide and/or L-lactide." 1989 Letter Ruling at 1, AR at 3221. It thus determined that the generic class encompasses VICRYL and DEXON and any other poly (g/l) sutures that in the future could be shown to be substantially equivalent to either of them. Id.

On November 2, 1989, Ethicon petitioned FDA to reconsider the reclassification decision and asked for a stay pending the decision on its petition. AR at 6601-6726. On July 5, 1990, FDA issued a letter ruling ("1990 Letter Ruling") denying Ethicon's motion for a stay and petition for reconsideration. 1990 Letter Ruling, AR at 6898-6911. In the 1990 Letter Ruling, FDA also modified the definition of the generic class set forth in the 1989 Letter Ruling by narrowing it to include only poly (g/l) sutures made from 100% glycolide or from 90% glycolide and 10% L-lactide, which ratios correspond to the structures of VICRYL and DEXON. 1990 Letter Ruling at 8, AR at 6905.

In August 1990, Ethicon initiated this lawsuit. The instant cross-motions for summary judgment followed. A hearing on the motions was held on February 15, 1991. Four days later, Ethicon filed a motion for a temporary restraining order and preliminary injunction. After a hearing on February 20, the Court denied the motion. See Order, Feb. 20, 1991.

II. DISCUSSION

Ethicon argues that FDA reached its reclassification decision improperly by failing to satisfy both the substantive and procedural statutory requirements for reclassification. It thus asserts that FDA's decision was arbitrary and capricious and therefore violated the Administrative Procedure Act, 5 U.S.C. § 706(2)(A) ("APA"). Defendants urge the Court to reject these arguments and find instead that it carefully considered the relevant factors for reclassifying poly (g/l) sutures, as set forth in the Act, the Amendments, and the agency's regulations, and formulated a reasoned order based on the administrative record.

A. Standard of Review

Section 706 of the APA provides that a court may set aside an agency action only where it finds the action "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A). Under this standard, there is a presumption in favor of the validity of administrative action. A court cannot substitute its judgment for that of the agency. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 823, 28 L.Ed.2d 136 (1971). Ethicon asserts that FDA abandoned its established policies, and therefore its action is subject to a rigorous standard of review. See Greater Boston Television Corp. v. FCC, 444 F.2d 841, 852 (D.C.Cir.1970), cert. denied, 403 U.S. 923, 91 S.Ct. 2229, 29 L.Ed.2d 701 (1971) (agency must provide "reasoned analysis indicating that prior policies and standards are being deliberately changed, not casually ignored"). In particular, Ethicon avers that FDA departed from the standards it employed in the reclassification proceedings of another medical device, in the Contact Lens case. Defendants argue that Ethicon is demanding an incorrect standard of review as well as a misinterpretation of the controlling standard. Defendants are correct. As explained infra, Contact Lens does not set forth a universal...