US v. AN ART. OF DEVICE, 1,217 CARDBOARD BOXES

• Decision Date: 02 April 1985
• Docket Number: No. K 84-502.,K 84-502.
• Citation: 607 F. Supp. 990
• Parties: UNITED STATES of America, Plaintiff, v. AN ARTICLE OF DEVICE CONSISTING OF 1,217 CARDBOARD BOXES, more or less, each containing an individually packaged unit in a tube packaged in a blister-pack with an insert labeled in part as follows: (box) "*** stryker *** A0931660404261C *** B311001c ***", (tube) "stryker Shoulder 130-10 Dacron * Ligament Prosthesis ***", Defendant.
• Court: U.S. District Court — Western District of Michigan

607 F. Supp. 990

UNITED STATES of America, Plaintiff,

v.

AN ARTICLE OF DEVICE CONSISTING OF 1,217 CARDBOARD BOXES, more or less, each containing an individually packaged unit in a tube packaged in a blister-pack with an insert labeled in part as follows:

(box)

"*** stryker *** A0931660404261C *** B311001c ***",

(tube)

"stryker Shoulder 130-10 Dacron * Ligament Prosthesis ***", Defendant.

No. K 84-502.

United States District Court, W.D. Michigan, S.D.

April 2, 1985.

Thomas Martin, Asst. U.S. Atty., Grand Rapids, Mich., Mark A. Heller, Assoc. Chief Counsel for Enforcement, Food & Drug Admin., Rockville, Md., for plaintiff.

Grant Gruel, Grand Rapids, Mich., for defendant.

OPINION

ENSLEN, District Judge.

This action was filed on November 20, 1984 against a prosthetic shoulder ligament device, manufactured by Meadox Medicals, Inc., and distributed by Stryker Corporation. The device is used in the surgical repair of third-degree, and sometimes second-degree, acromioclavicular separation, a severe dislocation of the joint which stabilizes the clavical (collarbone) and scapula (shoulder blade). See, 1A Gordy & Gray, Attorneys' Textbook of Medicine ¶ 5.40-5.49 (1984). Such injuries often result from a fall with an outstretched arm, a force from above striking the shoulder, or a sudden or severe pull on the arm. Id. The Stryker device is used to pull and hold together the separated bones in the proper alignment.

The US filed the Complaint in this action pursuant to the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 301 et seq.) alleging that the Stryker device is misbranded and adulterated. On November 28, 1984, the United States Marshal seized 1,217 boxes, each containing one Stryker device, pursuant to a warrant for arrest. On December 3, 1984, Stryker filed its claim as owner of the seized articles. The Complaint requests the Court to condemn the seized devices, order their disposal pursuant to the Act, and grant Plaintiff costs. This Opinion is rendered after a hearing held March 22, 1985, upon claimant Stryker's Motion for Summary Judgment filed December 5, 1984, and the government's cross-Motion for Summary Judgment filed March 20, 1985.

Standard of Review

To warrant the grant of summary judgment, the moving party bears the burden of establishing the non-existence of any genuine issue of fact that is material to a judgment in his favor. Adickes v. S.H. Kress & Company, 398 U.S. 144, 147, 90 S.Ct. 1598, 1603, 26 L.Ed.2d 142 (1970); United States v. Articles of Device ... Diapulse, 527 F.2d 1008, 1011 (CA 6 1976); Nunez v. Superior Oil Company, 572 F.2d 1119 (CA 6 1978); Tee-Pak, Inc. v. St. Regis Paper Company, 491 F.2d 1193 (CA 6 1974). If no genuine issue as to any material fact is established, the moving party is entitled to judgment as a matter of law. Chavez v. Noble Drilling Company, 567 F.2d 287 (CA 5 1978); Irwin v. US, 558 F.2d 249 (CA 6 1977).

In determining whether or not there are issues of fact requiring a trial, "the inferences to be drawn from the underlying facts contained in the (affidavits, attached exhibits, and depositions) must be viewed in the light most favorable to the party opposing the motion." United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 994, 8 L.Ed.2d 176 (1962); Bohn Aluminum & Brass Corporation v. Storm King Corporation, 303 F.2d 425 (CA 6 1962). Even if the basic facts are not disputed, summary judgment may be inappropriate when contradictory inferences may be drawn from them. United States v. Diebold, supra; EEOC v. United Association of Journeymen & Apprentices of the Plumbing & Pipefitting Industry, Local 189, 427 F.2d 1091, 1093 (CA 6 1970). In making this determination, the Court must make reference to the entire record and all well pleaded allegations are to be accepted as true. Dayco Corporation v. Goodyear Tire and Rubber Company, 523 F.2d 389 (CA 6 1975); Holmes v. Insurance Company of North America, 288 F.Supp. 325 (DC Mich.1968); Mahlar v. U.S., 196 F.Supp. 362 (DC Pa 1961). These guidelines will be adhered to as substantive issues of the motion are examined.

In 1976, Congress passed the Medical Device Amendments to the Act, PL 94-295, erecting a system for medical device classification and premarket approval. The amendments became effective May 28, 1976. These statutory provisions and their enforcing regulations are complicated. They will be dissected as each issue contained in the Motions for Summary Judgment is reviewed.

MISBRANDING

Section 502(o) of the Act, 21 U.S.C. § 352(o) provides in pertinent part that a device is misbranded if no premarket notification has been filed when required by § 510(k) of the Act, 21 U.S.C. § 360(k), or if it is not listed as required by § 510(j) of the Act, 21 U.S.C. § 360(j). The Government asserts in its Complaint, and argues in its motion, that both requirements are applicable to the Stryker device which complies with neither.

1. Premarket Notification

Section 510(k) of the Act, 21 U.S.C. 360(k), provides that each person required to register and who proposes to introduce a medical device into interstate commerce shall report to the Secretary of Health and Human Services at least 90 days before making such an introduction. (The Secretary has delegated this authority to the Commissioner of the Food and Drug Administration, 21 C.F.R. § 5.10(a)(1)). 21 C.F.R. Part 807, Subpart E implements this premarket notification requirement. The premarket notification requirement applicable to Stryker is contained in 21 C.F.R. § 807.81(a)(2). It provides that a person required to register, who introduces a device for the first time, must provide premarket notification. Stryker has admitted that it first commercially distributed the device itself after June of 1982, well after the effective date of the amendments. (See, Govt. Exhibit C, Response 4). Stryker does not dispute that it is a person registered or required to register. It must therefore comply with this premarket notification requirement unless exempt.

21 C.F.R. § 807.85 details the exemptions from premarket notification. 21 C.F.R. § 807.85(b) provides that a distributor who places a device into commercial distribution for the first time under his own name, as Stryker did in June of 1982, is exempt from the premarket notification requirement if the device was in commercial distribution before May 28, 1976. The Government asserts that this exemption does not apply to Stryker because the device, as it is now in distribution, is so changed from that in distribution prior to the effective date, that it is an entirely new device. Though Stryker hotly disputes that the device is "new", it does not invoke this exemption, but argues instead that 21 C.F.R. § 807.81(a)(3) provides an exemption applicable to it. This provision states that a device which a person currently has in commercial distribution that is about to be significantly changed or modified requires a premarket notification. It defines a significant change or modification as one that could either significantly affect the safety or effectiveness of the device, or one that constitutes a major change or modification in the intended use of the device. Stryker asserts that because the changes which have occurred in the device since 1976 do not rise to this significance, the device is exempt from premarket notification.

I find that Stryker's argument misinterprets these applicable regulations. 21 C.F.R. § 807.81(a)(3) applies only to those persons who have a device in commercial distribution at the time that the modification is about to be made. Stryker, by its own admission, did not begin distributing the device until June 1982. Numerous exhibits and affidavits submitted by both parties indicate that the modifications which occurred to this device occurred not later than 1979. Accordingly, this provision is inapplicable to Stryker. Only the premarket notification requirement contained in 21 C.F.R. § 807.81(a)(2) applies to Stryker. Therefore, the sole exemption available to Stryker is contained in 21 C.F.R. § 807.85(b). Only if the device were in commercial distribution before May 28, 1976, would it be exempt from the premarket notification requirement. Though Stryker has not specifically invoked this exception, because of Stryker's assertion that the device is not "new", and its admission that it first commercially distributed the device itself after June of 1982, the Court will consider the applicability of this exemption to the device in question. Because the Act concerns the public health, the exemption will be strictly construed and Stryker must prove each of its elements. U.S. v. Articles of Drug: 5,906 boxes, 745 F.2d 105, 113 (CA 1 1984); US v. An Article of Drug "Bentex Ulcerine", 469 F.2d 875, 878 (CA 5 1972).

Compliance Policy Guide 7124.26 is the current expression of the Food and Drug Administration's (FDA's) interpretation of "commercial distribution". (Govt. Exhibit H.) This policy guide states:

If a manufacturer can meet all of the following conditions, we consider a device to presently be in commercial distribution and also to have been in commercial distribution before May 28, 1976, even though no units of the device had been delivered to purchasers or consignees before that date:

(1) The device was displayed, advertised, or otherwise offered for sale before May 28, 1976, for a specific intended purpose or purposes, with no limitations (e.g. no limitation to research or investigational use).

(2) The manufacturer had, before May 28, 1976, accepted, or been prepared to accept, at least one order to purchase the device that resulted, or would have resulted, in a contract of sale for the device in the United States, generally with delivery to occur immediately or at a promised future date;

(3) The device was not being offered or accepted only for research or investigational use;

(4) The manufacturer of the device can provide adequate documentation establishing (1) through

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