DONOVAN W. FRANK, District Judge.
On April 5, 2010, Guidant, LLC
Although Guidant developed, manufactured, and sold numerous medical devices, only two devices are the subject of this criminal proceeding—the Ventak Prizm 2DR ("Prizm") and the Contak Renewal ("Renewal").
The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., governs, in part, the manufacture, processing, packing, labeling, and shipping in interstate commerce of medical devices. The Food and Drug Administration ("FDA") is the agency of the Government that is charged with enforcement of the FDCA. The FDCA and its regulations categorize medical devices into three classes, depending on their risk to the health, safety, or welfare of the patient, and require medical manufacturers to comply with certain reporting requirements. The Prizm and Renewal are Class III devices. Subject to the highest level of regulation, Class III devices include devices that are intended for use in supporting or sustaining life, are of substantial importance in preventing impairment of health, or present a potential unreasonable risk of illness or injury. Once the FDA approves a Class III device for use, a manufacturer may not make any modification to the device that affects the device's safety or effectiveness without receiving prior approval from the FDA. Moreover, in certain circumstances such as when a correction is
On February 25, 2010, the Government charged Guidant with two misdemeanor counts related to the Prizm and Renewal. (Doc. No. 1.) In Count I, Guidant is charged with submitting a false and misleading report to the FDA on August 19, 2003, that concerned a change made to the Prizm on or about November 13, 2002. In Count II, Guidant is charged with failing and refusing to report to the FDA a medical device correction to the Renewal on or about March 2, 2005.
As many as 20,146 patients in the United States may have been implanted with Prizm and Renewal devices between late 2002 and June 2005. (Doc. No. 4 at 3.) Of those 20,146 patients, approximately 2,657 are claimants in the Guidant MDL. (Id. at 4.) On March 1, 2010, the Government filed a Motion for Order for Alternative Victim Notification Procedures pursuant to 18 U.S.C. § 3771(d)(2). In that motion, the Government sought a "reasonable procedure to give effect to the notification provisions of the Crime Victims Rights Act ... due to the large number of individuals who might assert that they are victims of the offenses charged." (Id. at 1.) Because it had "not concluded that any such persons are in fact victims of the offenses charged," the Government submitted the motion "out of an abundance of caution" and recommended that alleged victims be notified in two ways: (1) through the Guidant MDL Lead Counsel Committee and (2) through the United States Attorney and Department of Justice websites. (Id. at 1-2, 4-5.) The Court granted the Government's motion on March 11, 2010, and directed that a notice to alleged victims be posted on the websites of the United States Attorney's Office, the Department of Justice Office of Consumer Litigation, and this Court. (Doc. No. 8 at 2-3.) The Court also directed the Clerk of Court to electronically file a copy of the notice in the Guidant MDL and ordered Mr. Zimmerman to provide a copy of the notice to all Guidant MDL claimants who had been implanted with a Prizm or Renewal device and their counsel. (Id. at 3.)
After asking for and receiving the Court's permission, a memorandum and supplemental memorandum were submitted on behalf of the "victims."
The Plea Agreement provides that Guidant will waive indictment and plead guilty to an Information alleging:
(Doc. No. 9 at 7.) The Plea Agreement further provides that the parties "recommend jointly that the Court impose a sentence requiring Guidant to pay the United States a criminal fine of $253,962,251 pursuant to 18 U.S.C. § 3571(d).
The alleged victims urge the Court to reject the Plea Agreement because it does not contain a provision for restitution. The alleged victims assert that "Guidant device recipients are clearly victims of Guidant's criminal offenses and any Plea Agreement and Sentencing Stipulation that does not include a provision for restitution for said victims is neither fair nor appropriate." (Doc. No. 13 at 16.) The Government and Guidant respond that the Court does not have authority to order restitution because restitution is not available for the charged offenses,
The Court has no inherent authority to impose restitution; rather, "[f]ederal courts cannot order restitution in a criminal case without a statutory basis." United States v. Lachowski, 405 F.3d 696, 698 (8th Cir.2005). The foundational inquiry for determining whether restitution is available is to identify the offense charged, in this case violations of 21 U.S.C. §§ 331(q)(1) and (2). Those portions of the FDCA do not contain a specific restitution provision. There are, however, two other possible statutory bases for ordering restitution in this case: (1) 18 U.S.C. §§ 3663, 3663A and (2) 18 U.S.C. § 3771. The Court will consider each in turn.
The Government and Guidant assert that there is no statutory basis for restitution under the discretionary Victim and Witness Protection Act of 1982 ("VWPA"), 18 U.S.C. § 3663, or the Mandatory Victims Restitution Act of 1996 ("MVRA"), 18 U.S.C. § 3663A, because violations of 21 U.S.C. §§ 331(q)(1) and (2) are not enumerated in the statutes. The Court agrees, noting that the alleged victims have offered no authority to support their assertion that restitution is available under either the VWPA or the MVRA. The VWPA provides, in relevant part:
18 U.S.C. § 3663(a)(1)(A). The MVRA provides, in relevant part:
18 U.S.C. § 3663A(a)(1), (c)(1). Therefore, because neither statute mentions the violations at issue in this case, there is no statutory basis for restitution under either the VWPA or the MVRA.
The alleged victims cite in passing the Crime Victim's Right Act ("CVRA"), 18 U.S.C. § 3771, as a statutory source for restitution in this case. A "crime victim" is defined under the CVRA as a person "directly and proximately harmed as a result of the commission of a Federal offense." 18 U.S.C. § 3771(e). The CVRA gives crime victims "[t]he right to full and timely restitution as provided in law." 18 U.S.C. § 3771(a)(6). In their memoranda, neither the Government nor Guidant directly address whether the CVRA provides an avenue for restitution. At the plea hearing, however, citing a conclusory footnote in In re Doe, 264 Fed.Appx. 260 (4th Cir.2007), the Government asserted that the CVRA does not provide any substantive rights with regard to restitution but rather simply refers back to the restitution at law provided by the VWPA and MVRA. Guidant agreed at the plea hearing with the Government that the CVRA does not provide the Court with more jurisdiction than is otherwise provided in the VWPA and MVRA.
Because the United States Court of Appeals for the Eighth Circuit has not directly addressed the issue of whether § 3771 provides an independent basis for restitution, the Court looks to other courts for guidance. The Court finds a recent case from the United States Court of Appeals for the Sixth Circuit instructive because, unlike the footnote relied upon by the Government, this case provides an in-depth discussion of the precise issue before the Court.
In In re McNulty, 597 F.3d 344 (6th Cir.2010), an alleged victim of a corporate defendant's antitrust conspiracy sought restitution under the CVRA. The Sixth Circuit affirmed the district court's decision that McNulty was not a victim for the purposes of the CVRA because the
The Court's inquiry, however, does not end here, because a person can only be a "crime victim" under the CVRA if that person is "directly and proximately harmed as a result of the commission of a Federal offense." 18 U.S.C. § 3771(e). The requirement that the victim be "directly and proximately harmed" encompasses the traditional "but for" and proximate cause analyses and is therefore necessarily fact-specific. In re McNulty, 597 F.3d at 350. A district court must "look at the offense itself only to determine the harmful effects the offense has on parties. Under the plain language of the statute, a party may qualify as a victim, even though it may not have been the target of the crime, as long as it suffers harm as a result of the crime's commission." In re Stewart, 552 F.3d 1285, 1289 (11th Cir.2008) (court held that mortgage borrowers were CVRA victims of conspiracy to deprive bank of honest services, where defendants were bank officer and co-conspirator whose offense caused borrowers to pay excess fees that defendants pocketed). Therefore, in order to determine whether there are any crime victims, as defined by § 3771(e), that were directly and proximately harmed by Guidant's criminal conduct, the Court must (1) look to the offense of conviction, based solely on facts admitted by Guidant and then (2) determine, based on those facts, whether any person or persons were directly and proximately harmed as a result of the commission of that offense. In re McNulty, 597 F.3d at 351 (internal citations omitted).
Guidant pled guilty to violating 21 U.S.C. § 331(q)(2), as charged in Count One of the Information. That statute provides, in relevant part, "[t]he following acts and the causing thereof are prohibited:. . . [w]ith respect to any device . . ., the submission of any report that is required by or under this chapter that is false or misleading in any material respect." 21 U.S.C. § 331(q)(2). Under the FDCA, an FDA-approved medical device cannot be lawfully modified in any manner that affects the device's safety and effectiveness, unless and until the manufacturer submits a supplemental premarket approval application regarding the change and receives approval from the FDA to market the modified device. 21 C.F.R. § 814.39(a). Only changes that do not affect a device's safety and efficacy can be made to devices without prior FDA approval; however such changes must be reported to the
At the plea hearing, Guidant admitted that it manufactured the Prizm, which was approved for sale and marketing by the FDA in August 2000. Guidant admitted that it discovered in 2002 that the Prizm had a potential for "arcing" or electrical short-circuiting failures that cause the Prizm to fail to deliver life-saving therapies in certain circumstances. After that discovery, Guidant admitted that it made changes to the Prizm in April and November of 2002 that affected the device's safety and efficacy.
Specifically, Guidant admitted that on November 13, 2002, it implemented a manufacturing change to the Prizm that applied an insulated sleeve to the backfill tube of the pulse generator in an effort to prevent arcing. Guidant was required by the FDA to submit an annual report related to the Prizm and its family of devices. When it reported the November 2002 change in its August 2003 annual report for June 2002-June 2003, Guidant stated that the November 2002 change was a minor alteration that did not affect safety and efficacy of the Prizm 2: "Device performance is unaffected by this change and the devices continue to meet physical and functional requirements." (Doc. No. 14 at 3.) At the plea hearing, Guidant admitted that the November 2002 change indeed affected the safety and efficacy of the Prizm, and that as a result, its submission in August 2003 concerning the November 2002 change was false and misleading as charged in Count One of the Information.
Guidant pled guilty to violating 21 U.S.C. § 331(q)(1), as charged in Count Two of the Information. That statute provides, in relevant part, "[t]he following acts and the causing thereof are prohibited . . . [t]he failure or refusal to . . . (B) furnish any notification or other material or information required by or under section 360i. . . of this title." 21 U.S.C. § 331(q)(1). Section 360i, entitled "Records and reports on devices," requires manufacturers to, among other things, submit to the FDA written reports within ten working days for any "corrections" made to medical devices undertaken to reduce a risk to health posed by the device. See 21 U.S.C. 360(i)(g); 21 C.F.R. § 806.10. "Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location." 21 C.F.R. § 806.2(d) (emphasis in original). "Risk to health means (1) a reasonable probability that use of, or exposure to the product will cause serious adverse health consequences or death; or (2) that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious health consequences is remote." 21 C.F.R. 806.2(j) (emphasis in original).
At the plea hearing, Guidant admitted that it manufactured and sold the Renewal, which is both an ICD and a pacemaker, after it received FDA approval at the end of 2002 through approximately 2005. Guidant admitted that at some point it learned that the Renewal had a short-circuit flaw because a high-voltage wire was routed along the bottom of the header and therefore in contact with the pulse generator.
Guidant further admitted that in July 2004, it learned that a doctor in Spain had tested a patient's Renewal device; received the "shorted shock lead" warning screen; conducted a test to evaluate the device's leads; and upon finding no problem with the leads, sent the patient home. Guidant admitted that the patient died approximately one week later when his Renewal device failed to deliver therapy after the patient suffered a cardiac event. Guidant admitted that the patient's death was its first report of a death from the Renewal's short-circuit flaw and its fourth report of an arcing incident. Guidant admitted that on August 26, 2004, it stopped shipment of all Renewal devices, although it continued to market the Renewal devices already in the field at that time. By March 2005, Guidant admitted that it knew of twelve Renewal arcing incidents.
Guidant admitted that the March 2005 product update was designed to reduce a risk to health and that it was a correction to the labeling
The alleged victims assert that they were directly and proximately harmed by Guidant's conduct, at least with respect to Guidant's purported overall scheme underlying the actions for which it has admitted guilt. The alleged victims' definition of "victim" has evolved through these proceedings. Their most recent position is that a crime victim is "any individual who purchased a medical device or drug that did not comply with the [FDA] Regulations" (Doc. No. 13 at 1), namely, "all patients implanted with a pre-corrective [Prizm or Renewal device]." (Doc. No. 18 at 3.)
At the plea hearing, the Government noted that it was mindful of the injuries suffered by Prizm and Renewal device recipients, but it asserted that Congress did
Guidant agrees with the Government and summarizes the alleged victims' argument as follows: "They argue that patients made decisions to purchase devices based upon statements made by Guidant well after the purchase relating to different devices, that is, they made a purchase of a pre-change device in 2002 in reliance upon a statement that was later to be made about post-change devices in 2003." (Doc. No. 14 at 5.) Guidant further points out that the alleged victims "have not attempted to identify any Plaintiff that purchased a pre-changed device after the publication of the 2003 Annual Report to the FDA setting forth the November 13, 2002 change to the Prizm 2. Nor have they attempted to identify any plaintiff that purchased a Renewal 1 device that is subject to Count 2." (Doc. No. 20 at 1-2.)
The Court agrees with the Government and Guidant that the alleged victims are not victims for the purposes of restitution in this case. Because Count One relates solely to Guidant's filing of a false and misleading report in August 2003, only persons directly and proximately harmed by Guidant's August 2003 filing would be victims of Count One. There is nothing in the record to suggest that any person was harmed in any manner as a result of Guidant's statement in August 2003 that the November 2002 change—which, by all accounts, made the device safer—did not affect the safety and efficacy of the Prizm. In this way, the alleged victims' reliance of the chain of events that happened prior to the August 2003 filing is irrelevant for the purposes of defining "victim" as it applies to Count One because this count only involves how Guidant described the November 2002 change in its August 2003 report. Much to the alleged victims' and public's frustration, Guidant's motivation for when and how it described the November 2002 change, and for that matter the April 2002 change, makes no difference in the Court's analysis of Count One, given the elements of the crime as charged in Count One.
Count Two relates to the March 2005 product update that Guidant failed to disclose to the FDA within 10 days of its issuance. The update itself properly went to the doctors for whom it was intended. There is nothing in the record to suggest that any person was harmed in any manner as a result of Guidant's failure to provide the FDA with a copy of that product update. In this way, the alleged victims' reliance on Guidant's failure to include certain facts about the Renewal failures in March 2005 is irrelevant for the purposes of defining "victim" as it applies to Count Two. Given the elements of 21 U.S.C. § 331(q)(1), the crime charged in Count Two relates only to Guidant's failure not to disclose the update to the FDA and not to the contents of the update itself.
In sum, contrary to the Government's and Guidant's position, the Court concludes that it has the authority under the VCRA to order restitution for victims of crimes. It also concludes, however, that there are no persons who were directly and proximately harmed by Guidant's
"Whether to approve or reject a plea agreement is a matter confided to the sound discretion of the trial court." United States v. Nicholson, 231 F.3d 445, 451 (8th Cir.2000); see also In re United States, 503 F.3d 638, 641 (7th Cir.2007) (explaining that a court can reject a plea bargain if the agreed sentence would be one the judge deems inappropriate); Government of the Virgin Islands v. Walker, 261 F.3d 370, 375 (3rd Cir.2001) (stating that "[a] sentencing court can, of course, reject the results of a plea negotiation if it concludes that the resulting agreement is not in the best interest of justice"). Therefore, at this stage, the Court must determine whether to accept and be bound to the specific provisions of the Plea Agreement.
As mentioned previously, the Government and Guidant jointly agreed to a Plea Agreement that contains no provision requiring probation, and the Plea Agreement itself specifically states that a presentence investigation report is not necessary because the plea and sentencing hearings, together with the record, will provide the Court with sufficient information. When asked at the plea hearing why the Government was not seeking probation, Mr. Goldstein on behalf of the Government replied:
(Doc. No. 24 at 101-102.) The Court then asked the Government why it would not serve the public interest to, as a condition of probation, require good faith compliance on the part of Guidant or Boston Scientific. The Government responded that it did not believe the Court had jurisdiction over Boston Scientific, although it conceded that the parent company could agree to it. The Government explained that it is already supervising Boston Scientific through a recent unidentified civil settlement, that "there are other vehicles in play," (id. at 103), and that the Office of Inspector General of the Department of Health and Human Services
Interestingly, these statements seem to contradict the tone of the Government's press release on the day of the plea hearing:
(Press Release, The United States Department of Justice, Medical Device Manufacturer Guidant Pleads Guilty for Not Reporting Defibrillator Safety Problems to FDA (April 5, 2010)).
At the plea hearing, the alleged victims urged the Court to reject the Plea Agreement because it did not require the Court to place Guidant on probation, presumably because the alleged victims recognize that the Court can, as a part of probation, order restitution.
In addition to the alleged victims, Drs. Hauser and Maron
(Doc. No. 21 at 2.)
There is no dispute concerning the validity, in general, of placing a corporation on probation. See, e.g., U.S. v. Missouri Valley Const. Co., 741 F.2d 1542, 1550 (8th Cir.1984) (citing cases for the validity of (1) imposing community service as a condition of corporate probation and (2) requiring corporate defendants or their employees (including employees of parent or subsidiary corporations) to conduct activities to educate the public or to receive instruction on compliance with the law). The Court respectfully disagrees with the Government's view that probation would be a waste of the taxpayers' money, especially given that Guidant could be required, as a condition of probation, to reimburse the Government for any costs associated with its probation. The Court also disagrees with the Government's position that Guidant's current corporate structure renders any probation meaningless, especially given the fact that Boston Scientific itself recently entered into a $22 million settlement and corporate integrity agreement based on certain pre-acquisition actions by Guidant. Guidant Corporation became Guidant LLC less than two weeks before the Government filed the Information. The interests of justice are not served by allowing a company to avoid probation simply by changing their corporate form. At a minimum, the public's interest in accountability would be served by Guidant and Boston Scientific being placed on probation, regardless of the fact that Boston Scientific acquired Guidant after the events in question. And, the Court believes that a period of probation would likely benefit, rather than harm, Guidant's and Boston Scientific's public image.
U.S. Sentencing Guidelines Manual § 8D1.1(3), (6), (8). As a condition of probation, a court "may impose other conditions that . . . are reasonably related to the nature and circumstances of the offense or the history and characteristics of the organization." Id. § 8D1.3(c). A court also may order an organization to establish a program to eliminate the risk that the instant actions would occur in the future; to perform community service if it is designed to repair the harm caused by the offense; and to establish an effective compliance and ethics program, which often includes an outside compliance officer paid by the organization. Id. §§ 8B1.2, 1.3, 8B2.1. In so doing, "a court should consider the views of any governmental regulatory body that oversees the conduct of the organization relating to the instant offense." Id., Application Note 1 to § 8D1.4.
The sentencing guidelines further instruct, among other things, that:
U.S. Sentencing Guidelines Manual § 8D1.4(a), (c) (emphasis added).
The Court believes that a term of probation would be appropriate in this case and could be fashioned in a manner to serve
Guidant, through Boston Scientific, could also be required to establish a compliance and ethics program, or if one is already established, to dedicate additional resources to that program to address the specific crimes in this case. Such a program could be overseen by a compliance officer skilled in the regulatory area and who perhaps could work in coordination with either the FDA or the Heart Rhythm Society,
As part of the plea, Guidant agreed to forfeit $42,079,675 as a result of the crime as charged in Count Two. Because the Renewal devices, which are the subject of the forfeiture, cannot be located or have been sold, the Government is seeking the value of the forfeited property directly from Guidant pursuant to 21 U.S.C. § 853(p) and 28 U.S.C. 2461(c). The record is not entirely clear as to how the forfeited amount was calculated. According to Guidant, it agreed to let the Government decide which portion of the monetary penalty should be directed toward a fine
Under Department of Justice regulations, the United States Attorney General may return forfeited property (including money) to a victim of the crime underlying the forfeiture, provided that certain eligibility requirements are met. See 28 C.F.R. § 9.4 (describing what information an individual should submit in support of a petition for remission, where the information should be submitted, and who reviews the petition). For the purposes of forfeiture, a victim is defined as "a person who has incurred a pecuniary loss as a direct result of the commission of the offense underlying a forfeiture." 28 C.F.R. § 9.2(v). The Government states that it "specifically contemplated the crime victim remission provisions in negotiating the forfeiture provisions of the plea agreement in this case notwithstanding the fact that the restitution statutes do not apply at sentences to the offense of conviction." (Doc. No. 15 at 9.) Yet, the Government also argues that there are no victims in this case. By arguing so, the Government places a very high burden on the very individuals it claims it considered when drafting the Plea Agreement.
The forfeiture remission process can be, to say the least, cumbersome, and for this reason, the Court believes that the interests of justice would be served only if clear guidelines were established by the Government that directed individuals as to how they can petition for the remission of any forfeited funds in this case. The Government would also need to have a contact person to answer individuals' questions concerning this process. The Court has no role is the remission of forfeited funds. 28 C.F.R. § 9.1(2) ("[r]emission and mitigation functions in judicial cases are performed by the Criminal Division of the Department of Justice. Within the Criminal Division, authority to grant remission and mitigation is delegated to the Chief, Asset Forfeiture and Money Laundering Section, Criminal Division."). Nevertheless, the Court reminds individuals that forfeited funds are available only to individuals who suffered pecuniary losses as a direct result of Guidant's commission of the offense as charged in Count Two relating to Renewal devices. In this way, the remission process necessarily involves an analysis similar to the one the Court performed above when it determined that there were no victims for the purposes of restitution. The Court expects that any remission proceeding would reach the same result.
Given the unlikelihood of recovery of any forfeited funds by alleged victims, the question of where the forfeited funds are to go if they are not returned to any
Given this, the Court asks the Government to consider the following. In the Guidant MDL, approximately 75% of the claimants were Medicare recipients who had received Guidant devices at issue in the Guidant MDL, including the Prizm and Renewal devices. Through a global lien resolution program ably led by The Garretson Firm Resolution Group, Inc., Medicare reclaimed a portion of the money it paid for Guidant MDL claimants' medical expenses. It is possible that at least 15,000 of the devices at issue in this case went to Medicare recipients and that, as a result, Medicare likely incurred significant expenses related to the Prizm and Renewal devices. As the alleged victims stated at the plea hearing, "one of the major losers in this whole fiasco with the ICD's was the Medicare Program and the Medicaid Program." (Doc. No. 24 at 91.) For this reason, the Court urges the Government to consider directing that a significant portion of the forfeited funds be paid to Medicare. See 18 U.S.C. § 981(e)(1) (allowing the Attorney General to transfer property forfeited on terms and conditions as he may determine to any other Federal agency). The Court respectfully encourages the Government and Guidant to work with The Garretson Firm Resolution Group, Inc., which, it assumes, would be able to employ a mathematical model to assist the Government in determining an appropriate sum that should be directed to Medicare.
The Plea Agreement was entered into pursuant to Rule 11(c)(1)(C) of the Federal Rules of Criminal Procedure. Rule 11(c)(1)(C) provides that a "plea agreement may specify that an attorney for the government will . . . (C) agree that a specific sentence or sentencing range is the appropriate disposition of the case." Fed.R.Crim.P. 11(c)(1)(C). It further declares that "such a recommendation or request binds the court once the court accepts the plea agreement." Id. Therefore, "[a] plea agreement under Rule 11(c)(1)(C), like all plea agreements, is binding on both the government and the defendant, but Rule 11(c)(1)(C) plea agreements are unique in that they are also binding on the court after the court accepts the agreement." United States v. Kling, 516 F.3d 702, 704 (8th Cir.2008) (emphasis in the original).
As discussed above, the Court has exercised its discretion and declined to accept—and be bound to—the Plea Agreement. Therefore, because the Plea Agreement is a Rule 11(c)(1)(C) agreement, the Court hereby advises Guidant that it now has an opportunity to withdraw its guilty plea but that if it chooses not to withdraw its guilty plea, the Court may then dispose of this case less favorably than the Plea Agreement contemplated.
The Government and Guidant are, of course, free to submit a modified Plea
As Guidant alluded to at the plea hearing, sophisticated medical devices, such as the ones at issue in this case, generally have a very high rate of reliability and provide life-saving benefits to many people. Advances in medical technology have, unfortunately, inflated the public's expectations so much so that when any device fails, many assume that there must have been a crime committed or that someone is at fault. This is not necessarily always the case.
The Court reminds the parties, Guidant device recipients, and the public that in any criminal case, the prosecution—not a court—determines what crimes are charged against a defendant. The prosecution has wide discretion in determining what charges to bring. It must make such decisions after carefully considering the facts known at the time, the elements of a particular crime, and the uncertainty of results in any criminal proceeding. A court's responsibility is to apply the law, and a court cannot reject a plea agreement simply because the prosecution could have possibly charged a defendant with additional or different crimes. See United States v. Miller, 722 F.2d 562, 564 (9th Cir.1983) ("When a prosecutor selects a charge, he has made an executive choice. When a judge sentences a defendant, he has made a judicial choice. When a plea bargain is placed before a court, the necessary interplay between charging and sentencing decisions becomes manifest."); see also Standards for Criminal Justice § 14-3.3 (commentary discussion concerning difference between discretion afforded to prosecutor and to a court).
The Court recognizes the frustration that device recipients and the public may have for this criminal proceeding, and the Court is well-aware of the physical and emotional trauma caused by the Guidant recalls. But, as the Court repeatedly stated at the plea hearing, the only matter currently before the Court concerns the criminal case against Guidant and the conduct admitted to, specifically, on the Government's charges concerning reports Guidant made to the FDA about the Prizm and Renewal devices. Although the Guidant MDL claimants and the public may be frustrated with the results of the Guidant MDL, this is not the proper forum in which to address those complaints.
Throughout the Guidant MDL, the Court saw how the MDL process sometimes gave claimants unjustifiable expectations of recovery and therefore caused many claimants to experience anxiety throughout the entire litigation process. Nothing in this Order is intended to give any person who considers herself or himself to be a victim of Guidant's criminal conduct any expectation of future recovery through this proceeding. While such recovery is not entirely foreclosed through a possible remission petition, the Court believes
Based on the files, records, and proceedings herein, and for the reasons set forth above,
1. The Court declines to accept the Plea Agreement (Doc. No. 9).
The Court also received documents from James F. Allen of Lancaster, New York. Mr. Allen described himself as a "criminal victim," marked his document as "Confidential Document Not for the Public Copy," and submitted a timeline related to certain events involving Guidant and the FDA. The Court received a letter dated April 12, 2010, from Robert G. Hauser, M.D., and Barry J. Maron, M.D. Dr. Hauser and Dr. Maron treated Joshua Okrup, a 21-year-old college student who died in 2005 when his Prizm short-circuited. In the 1980s, Dr. Hauser was the president of Cardiac Pacemakers, Inc., which was once a part of Eli Lilly & Company. After Dr. Hauser left Cardiac Pacemakers, Inc., Eli Lilly & Company spun off that company and four other subsidiaries to form the company that became Guidant Corporation. Dr. Hauser and Dr. Maron urge the Court not to accept the guilty plea because it "does not hold the guilty parties fully accountable and inevitably undermines patient safety." (Doc. No. 21.) Heather S. Sorensen, an MDL claimant who had a Prizm explanted and other related surgeries, submitted a letter urging the Court to reject the Plea Agreement because it does not provide restitution to victims. (Doc. No. 22.) Lisa Salberg, Chief Executive Officer for Hypertrophic Cardiomyopathy Association, submitted an e-mail to the Court, urging it to hold corporations accountable for their actions. (Doc. No. 25.) Finally, Robert O. Harker, Esq., wrote a letter to the Court, expressing his agreement with the views expressed in Drs. Hauser and Maron's letter. (Doc. No. 26.)
