U.S. v. Prigmore

• Decision Date: 09 November 2000
• Docket Number: 00-1230,Nos. 00-1158,00-1229,s. 00-1158
• Parties: (1st Cir. 2001) UNITED STATES, Appellee, v. DAVID W. PRIGMORE, Defendant, Appellant, UNITED STATES, Appellee, v. LEE H. LEICHTER, Defendant, Appellant, UNITED STATES, Appellee, v. JOHN F. CVINAR, Defendant, Appellant. Heard
• Court: U.S. Court of Appeals — First Circuit

Page 1

243 F.3d 1 (1st Cir. 2001)

UNITED STATES, Appellee, v. DAVID W. PRIGMORE, Defendant, Appellant, UNITED STATES, Appellee, v. LEE H. LEICHTER, Defendant, Appellant, UNITED STATES, Appellee, v. JOHN F. CVINAR, Defendant, Appellant.

Nos. 00-1158, 00-1229, 00-1230

United States Court of Appeals For the First Circuit

Heard November 9, 2000

Decided March 16, 2001

Amended August 20, 2001

APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Joseph L. Tauro, U.S. District Judge]

[Copyrighted Material Omitted] Richard G. Taranto, with whom Farr & Taranto, Andrew Good, Harvey A. Silverglate, Silverglate & Good, William H. Kettlewell, Michael B. Galvin, Dwyer & Collora, LLP, Robert D. Keefe, Daniel W. Halston, Jason T. Sherwood, and Hale and Dorr LLP, were on brief, for appellants.

David S. Kris, Attorney, Department of Justice, with whom David S. Mackey, Acting United States Attorney, Stephen A. Higginson, Special Assistant United States Attorney, and Michael K. Loucks, Assistant United States Attorney, were on brief, for appellee.

Before Selya, Circuit Judge, Coffin, Senior Circuit Judge, and Stahl, Circuit Judge.

STAHL, Circuit Judge.

On August 24, 1995, after a twenty-seven day trial, a jury convicted defendants-appellants Lee H. Leichter, John F. Cvinar, and David W. Prigmore of conspiring to defraud and impair the functioning of the United States Food and Drug Administration (FDA) in connection with its oversight and regulation of medical devices. See 18 U.S.C. § 371. The jury simultaneously acquitted George Maloney and Kenneth Thurston of the same charge. The district court thereafter sentenced each convicted defendant to 18 months' imprisonment and two years of supervised release, but stayed execution of the sentences pending appeals. In these appeals, Leichter, Cvinar, and Prigmore ("defendants") raise a host of arguments challenging the legality of their convictions. In addition, Prigmore claims that insufficient evidence supports his conviction and that his sentence is unlawful. We vacate the convictions and remand for further proceedings.

I.

Because we review the trial record primarily to ascertain whether an error in the district court's jury instructions was harmless, see infra Section II, we look at the evidence as a whole and not in the light most favorable to the government, see Arrieta-Agressot v. United States, 3 F.3d 525, 528 (1st Cir. 1993). Thus, although we give a detailed account of the evidence the government relies on to support its case theory and harmless-error argument, we also provide an overview of relevant responsive evidence and arguments. See id. at 528-29. We note too that this case has a complicated procedural history which we describe only insofar as is relevant to these appeals. Readers interested in additional procedural background should consult our previous opinion in this matter. See United States v. Leichter, 160 F.3d 33, 34 (1st Cir. 1998).

A. Statutory and Regulatory Background

In 1976, Congress amended the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 360 et seq., by passing what it denominated the Medical Device Amendments (MDA), 21 U.S.C. § 360c et seq. The amendments made the FDA responsible for ensuring the safety and effectiveness of medical devices distributed to the American public. This prosecution proceeded on the theory that, in testing and marketing medical devices known as "heart catheters," the defendants conspired to violate provisions of these statutes and regulations promulgated thereunder.

A heart catheter is a tiny instrument consisting primarily of a thin metal wire with a small inflatable balloon at or near one end. The device is used in a surgical procedure called angioplasty, which seeks to treat heart disease by opening clogged coronary arteries. During angioplasty, a physician inserts a heart catheter into a patient's body, typically through an artery in the leg or groin area. The physician then steers the device through the patient's circulatory system to the site of the blockage and inflates the balloon with fluid. As it is inflated, the balloon breaks the "plaque" that is clogging the artery and pushes it against the artery wall. The physician subsequently withdraws the liquid, deflates the balloon, and removes it and the catheter, thereby allowing blood to flow freely through the artery.

Regulations promulgated pursuant to the FDCA and MDA designate heart catheters as Class III medical devices. Seegenerally 21 C.F.R. Part 870. Class III medical devices are the most heavily regulated medical devices in the country. See 21 U.S.C. § 360c(a). Before a manufacturer may market a new Class III medical device, the manufacturer must apply for and receive "premarket approval" (PMA) from the FDA. 21 U.S.C. § 360c(a)(C). In connection with its PMA application, the manufacturer must submit information sufficient to provide the FDA with "reasonable assurance" that, inter alia, the device is both "safe" and "effective." 21 U.S.C. § 360e(d)(2).

Under the MDA,

[T]he safety and effectiveness of a [Class III] 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 use of the device against any probable risk of injury or illness from such use.

21 U.S.C. § 360c(a)(2). Regulations promulgated pursuant to this statute (and others) elaborate:

In determining the safety and effectiveness of a device for purposes of [deciding whether to grant] . . . premarket approval of class III devices, the Commissioner . . . will consider the following among other relevant factors: (1) The persons for whose use the device is represented or intended; (2) The conditions of use for the device, including conditions of use prescribed, recommended, or suggested in the labeling or advertising of the device, and other intended conditions of use; (3) The probable benefit to health from the use of the device weighed against any probable injury or illness from such use; and (4) The reliability of the device.

21 C.F.R. § 860.7(b).

There is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.

Id. § 860.7(d)(1).

There is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the targeted population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.

Id. § 860.7(e)(1).

Two additional sets of regulations governing Class III surgical devices are of particular importance to this case, so we describe them in some detail. The first requires, insofar as is relevant, that a manufacturer of a previously approved Class III surgical device "submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device . . . ." 21 C.F.R. § 814.39(a). As with an application for initial PMA, the so-called "PMA supplement" must contain scientific information that provides a basis for approval of the modified device. See id. § 814.39(c). The regulation lists eight "types of changes" for which a PMA supplement must be filed "if [the changes] affect the safety or effectiveness of the device," id. § 814.39(a), including the following: "[n]ew indications for use of the device," id. § 814.39(a)(1); "[t]he use of a different facility or establishment to manufacture, process, or package the device," id. § 814.39(a)(3); and "[c]hanges in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device," id. § 814.39(a)(7). By operation of § 814.39(c) ("All procedures and actions that apply to [a PMA] application under § 814.20 also apply to PMA supplements . . ."), the manufacturer also must "periodically update [a] pending [PMA] application with new safety and effectiveness information learned about the device from on-going or completed studies that may reasonably affect an evaluation of the safety or effectiveness of the device . . . ." Id. § 814.20(e).

As implied by the regulations just quoted, a manufacturer need not submit a PMA supplement "if the change does not affect the device's safety and effectiveness . . ., e.g., an editorial change in labeling which does not affect the safety or effectiveness of the device." Id. § 814.39(b). But where the FDA has required periodic reports as a condition of approval of the device, the manufacturer must report any changes to the FDA "in [its] postapproval periodic reports . . . ." Id. The PMAs of the heart catheters at issue in this case explicitly required postapproval reports documenting any and all changes to the catheters.

The second set of regulations underlying this prosecution arise from the background fact that, prior to submitting a PMA application or PMA supplement, the manufacturer of a new or modified Class III medical device may desire to test the device in humans. To do so lawfully, the manufacturer must apply to the FDA for an "investigational device exemption" (IDE). An IDE "permits a device that otherwise would be required . . . to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device." 21 C.F.R. § 812.1(a). An IDE thus permits limited use of an unapproved device for the purpose of collecting human test data. See id. But the testing regulations themselves specify a number of situations in which an IDE is...