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Tony Baish is co-chair of the Litigation and Intellectual Property Litigation Practice Groups in the firm's Milwaukee office.
Tony has handled a wide variety of commercial disputes, concentrating on intellectual property litigation and other complex commercial litigation. Highlights of his litigation work include representing a patent holder in inter partes proceedings before the Patent Trial and Appeal Board, serving as lead patent litigation counsel for an automotive supplier enforcing its patent rights against an alleged infringer from Taiwan and its American distributor, serving as lead patent litigation counsel for California and Arkansas manufacturers in an infringement suit in the Eastern District of Wisconsin, and acting as lead counsel in a copyright infringement suit involving the unauthorized live broadcast of Mexican soccer games via website.
Outside the field of intellectual property litigation, Tony has served various clients in the construction industry, including as lead counsel for a construction management firm in litigation involving a multi-state project for the construction of numerous facilities and as lead counsel for a hospital in a dispute over defects in a major expansion.
Tony has been lead counsel in numerous jury trials, court trials, and arbitrations. He has successfully argued before the Seventh Circuit Court of Appeals and the Federal Circuit Court of Appeals. Representative clients include Kimberly-Clark Corporation, Oshkosh Corporation, the Atlantic Richfield Company, The Sportsman Channel and School Specialty, Inc.
Tony serves on the Seventh Circuit Pattern Civil Jury Instructions Committee, which reviews and proposes revisions to the Circuit’s pattern jury instructions to ensure they are understandable and reflect the current state of the law. He is a member of the patent instructions subcommittee and is the co-chair of the copyright and trademark subcommittees.
Tony is a Past President of the Eastern District of Wisconsin Bar Association, through which he worked closely with the District's judges. He currently chairs the Association’s Court Liaison Committee, which is charged with providing feedback from lawyers to judges in order to improve practice in the District’s courts. Tony received the 2010 Judge John W. Reynolds Community Building award for his efforts to expand and improve pro bono representation in the Eastern District of Wisconsin. As former Co-Chair of the association's Pro Bono Committee, his efforts, together with those of the rest of the committee, earned the 2008 Outstanding Achievement Award by the unanimous vote of the State Bar of Wisconsin's Local Bar Grant Competition Committee.
Tony earned his J.D. from the University of Michigan Law School, in 1998, where he was an associate editor of the Michigan Law Review. From 1998 to 1999, he served as the law clerk to the Honorable Suzanne B. Conlon of the United States District Court for the Northern District of Illinois.
Samson Lift Technologies, LLC v. Oshkosh Corporation and Jerr-Dan Corporation. Tony represented Jerr-Dan Corporation and its parent Oshkosh Corporation in this dispute, which involved alleged violations of a patent license agreement. The dispute ranged across various federal and state courts over several years. Tony helped obtain a complete dismissal of all claims against Oshkosh and many claims against Jerr-Dan through motions to dismiss and motions for summary judgment. The remaining claim against Jerr-Dan culminated in a month-long jury trial in state court in Manhattan, at which Tony was co-lead trial counsel. The trial was a resounding success. Although the jury ruled against Jerr-Dan on liability, the award of approximately $500,000 was several orders of magnitude less than the plaintiff sought.
Kimberly-Clark Corporation. Tony has served as both lead counsel and local counsel for Kimberly-Clark Corporation and its affiliates in various patent infringement and other patent- related matters in jurisdictions throughout the United States.
Asyst Technologies LLC et al. v. Eagle Eyes Traffic Ind. Co. Ltd, et al. As lead litigation counsel for the plaintiffs in this patent infringement suit in the automotive industry, Tony saw the case through to a successful settlement at the close of discovery.
M-B-W, Inc., et al. v. Multiquip, Inc., et al. This patent infringement case involved motorized power trowels used in the construction industry. Tony served with Howard Pollack as lead counsel. After Tony obtained summary judgment of infringement in favor of his clients, the case was settled prior to trial.
Seat Sack, Inc. v. Childcraft Education Corp., et al. Tony was lead counsel for Childcraft Education and its parent company, School Specialty, Inc., in this case, pending in the Southern District of New York, involving claims of trademark and patent infringement. Tony prevailed on summary judgment and on appeal to the Federal Circuit.
Ori v. Fifth Third Bank and Fiserv, Inc. Tony served as lead counsel for the defendants in this class action asserting violations of the Fair Credit Reporting Act and related common law claims. Tony obtained dismissal of the initial complaint. The case ultimately was settled after the named plaintiff filed an amended complaint.
TV Azteca SA de CV, et al. v. Durden, et al. Tony served as lead litigation counsel for TV Azteca in this copyright infringement case involving the unauthorized live broadcast of Mexican soccer games owned by TV Azteca. After locating the infringer, who used a fictitious name to operate the website, Tony helped negotiate a consent judgment involving a permanent injunction against the infringer and other relief.
Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., et al. In this case involving claims of false advertising under the Lanham Act and FDA regulations for product labeling, Schwarz Pharma was represented by Hyman, Phelps & McNamara P.C., with Tony leading the local counsel team. After briefing on the plaintiff's motion for partial summary judgment and Schwarz Pharma's motion to dismiss, the complaint was dismissed in its entirety.
Wolters v. The Sportsman Channel, Inc., et al., and Demi & Cooper, Inc. v. The Sportsman Channel, Inc. These two related cases, one in the Western District of Michigan and one in an Illinois state court, centered around alleged copyright infringement in the use of a photograph in marketing materials. Tony served as lead counsel for The Sportsman Channel. Both matters were settled.
5560, LLC v. Clutch and Transmission Service, Inc. This case involved substantial claims and counterclaims for breach of a commercial lease. Tony served as lead counsel for the landlord, 5560, LLC. After a four-day trial, the jury awarded 5560, LLC damages in excess of what was initially requested.
UMB Fund Services, Inc. v. Mount Yale Opportunity Fund, LLC. Tony served as lead counsel for UMB Fund Services in this dispute over complex administrative services to a hedge fund. The matter was settled after extensive discovery.
Orren Pickell Development, LLC v. Delavan Resort Development, Inc. et al. In this Illinois state court case, Delavan Resort Development and its affiliates were accused of breaching agreements related to Orren Pickell's attempt to purchase certain resort property and assets in Wisconsin. Tony served as Delavan Resort Development's lead counsel, and prevailed on a motion to dismiss the complaint.
Aquent Partners Inc. v. Catalyst International, Inc. As lead counsel for Catalyst International in this Milwaukee County suit, Tony obtained a complete victory on all claims after a jury trial.
Wisconsin Patients Compensation Fund v. Physicians Insurance Company of Wisconsin, Inc. In this first-of-its-kind bad faith insurance dispute, Tony represented the Wisconsin Patients Compensation Fund as second chair in a lengthy jury trial. The Fund prevailed on its claims and was awarded a substantial judgment.
United States v. Peterson. In this appeal to the Seventh Circuit Court of Appeals, Tony was one of two attorneys who represented, pro bono, two individuals convicted in the Northern District of Indiana of violations of the Hobbs Act. After oral argument, the Seventh Circuit reversed both convictions for insufficient evidence.
Anthony Baish and Timothy Nixon were featured in the May 2010 issue of Wisconsin Lawyer "Awards, Degrees, Honors.

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Write my essay on Case Studies – Miller v. Alabama and Jackson v. Arkansas (2012).
Case Studies – Miller v. Alabama and Jackson v. Arkansas (2012).
For this assignment, read the cases of Miller v. Alabama and Jackson v. Arkansas (2012). These cases deal with the topic of juveniles tried and sentenced as adults.
1.Analyze whether either of these cases addresses the utilitarian view of ethical treatment of convicted murderers.
2.Differentiate between the peacemaking philosophy and deontological philosophy in the context of murder sentencing for juveniles. Do these philosophies differ when the defendant is an adult?
3.Considering these two cases, determine whether either should have been handled differently under the utilitarian or the deontological philosophies.
4.In general terms, consider a judge who must determine whether a 16-year-old who committed a violent crime should be tried as an adult. Identify the ethical dilemma(s) the judge faces and describe how he or she might arrive at an ethical decision.
Cite sources in APA format on a separate page.
Case Studies – Miller v. Alabama and Jackson v. Arkansas (2012). appeared first on WriteDen.

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UNITED STATES OF AMERICA, Plaintiff - Appellee, v. ERIC G. ACOSTA, Defendant - Appellant.
Because he believed the temporary license on the rear window of Acosta's car was improperly displayed and because he could not read the license from his police vehicle, a Las Cruces police officer stopped a car containing Acosta and a passenger. When the officer asked Acosta for his license, registration, and insurance, Acosta gave his name and date of birth, but admitted that he had no driver's license. When the officer did a records check on Acosta, he learned that his license had been revoked for a DUI conviction. The officer arrested Acosta, performed an inventory search of the car, and found and seized a handgun and glass pipe under the front seat and a large quantity of methamphetamine in the trunk.
The government charged Acosta with three felonies: (1) conspiracy to possess with intent to distribute 500 grams or more of a mixture and substance containing methamphetamine, in violation of 21 U.S.C. §§ 846, 841(a), (b)(1)(A); (2) possession with intent to distribute 500 grams or more of a mixture and substance containing methamphetamine, in violation of 21 U.S.C. §§ 841(a)(1), (b)(1)(A); and (3) possession of a firearm and ammunition after a felony conviction, in violation of 18 U.S.C. § 922(g)(1).
Acosta filed a motion to suppress evidence of the methamphetamine and firearm, arguing that the officer lacked reasonable suspicion to stop his car. The officer, Acosta argued, had relied on an objectively unreasonable understanding of New Mexico law governing the required display of temporary licenses. After holding a suppression hearing, the district court agreed that the officer had indeed misinterpreted the statute as requiring the temporary tag to be posted on the lower, left-hand corner of the rear window, when the statute simply required it be anywhere on the left side of the rear window. But the district court still denied the motion after concluding that the officer had reasonable suspicion to make a stop because the officer could not read the temporary tag from his police vehicle.
In a puzzling decision, Acosta then decided to plead guilty to all three counts without a written plea agreement, despite the government's having offered a written plea agreement giving him a better deal.4 Acosta's presentence report set an adjusted offense level of thirty-three and a Criminal History Category of III, resulting in an advisory guideline range of 168 to 210 months. The district court varied downward and sentenced Acosta to 120 months in prison, the mandatory minimum required by each methamphetamine conviction.
In his pro se response to his counsel's brief, Acosta argues that his guilty plea was not knowing and voluntary because his appointed counsel at the time “did not explain the significance of the appellant waiver contained in the plea agreement.”5 Appellant Response at 2. The record of Acosta's plea hearing undercuts this claim. At the hearing, the magistrate judge asked Acosta's counsel at the time, Leon Schydlower, “is this reasonable for your client to plead straight up? I'd like to know if a plea agreement was offered, if so, why you—it was rejected. It's a lot of time.” R. vol. 4 at 10. In response, Acosta's counsel identified an earlier proposed plea agreement that would have allowed Acosta “to appeal the denial of his motion to suppress.” Id. at 11. But his counsel stated that Acosta “is highly intelligent and well-versed in the law” and had “made a calculated decision ․ to forego the opportunity to appeal the denial of the motion to suppress” out of an apparent belief that such a decision would help bring positive aspects of Acosta's life to the attention of the sentencing judge. Id. at 11-12. Counsel stated that “I will put on the record I do not necessarily agree with that. I would like the opportunity to appeal the denial of the motion to suppress, but Mr. Acosta's decision does make ․ factual sense to me and he's the boss ․ So here we are pleading straight up.”6 Id. at 12.
After those statements by counsel, the magistrate judge asked Acosta if he agreed with everything his counsel had said. He replied, “Yes, ma'am.” Id. at 13. Then the magistrate judge asked Acosta if “this was your decision to reject the plea agreement and your decision to plead straight up ․?” Id. Acosta answered, “Yes.” Id. The magistrate judge also asked other questions to satisfy herself that Acosta's plea was knowing and voluntary, and Acosta's answers persuaded the magistrate judge that Acosta was indeed pleading guilty knowingly and voluntarily. Then the magistrate judge asked again whether Acosta was satisfied with pleading guilty straight up “knowing what the risks might be for you,” and Acosta said he was. Id. at 15. So Acosta chose to proceed without a written plea agreement reserving a right to appeal the suppression order. Having examined the existing record, we see no reason that Acosta's plea was not fully knowing and voluntary.
Acosta also argues that the district court erred in denying his motion to suppress the evidence found when police inventoried his car. Though Acosta's counsel believes that the suppression argument has merit, he concedes that Acosta waived almost all non-jurisdictional defenses by voluntarily and unconditionally pleading guilty to the charges.7 United States v. De Vaughn, 694 F.3d 1141, 1145 (10th Cir. 2012). A guilty plea keeps a defendant from “rais[ing] independent claims relating to the deprivation of constitutional rights that occurred prior to the entry of the guilty plea.” United States v. Salazar, 323 F.3d 852, 856 (10th Cir. 2003) (quoting Tollett v. Henderson, 411 U.S. 258, 267 (1973)). That rule applies to post-plea attempts, such as Acosta's here, to appeal denials of motions to suppress. United States v. Banuelos-Barraza, 639 F.3d 1262, 1263 (10th Cir. 2011). As mentioned above, the plea-hearing colloquy demonstrates that, if fully attentive and attuned, Acosta had a basis to know that he was waiving this avenue of appeal when he decided to plead guilty unconditionally.
We agree with Acosta's counsel that Acosta has no non-frivolous sentencing issues for appeal. The sentencing floor created by the mandatory minimum would have prevented any procedural or substantive error by the court from having an actual effect, making any such sentencing error harmless. See Williams v. United States, 503 U.S. 193, 203 (1992) (noting that harmless error is an error that does not affect a district court's sentencing decision). And with four criminal-history points, Acosta could not qualify for the safety valve provided for in 18 U.S.C. 3553(f), USSG § 5C1.2(a)(1).
Finally, construing Acosta's response liberally because he is proceeding pro se, Yang v. Archuleta, 525 F.3d 925, 927 n.1 (10th Cir. 2008), we acknowledge that Acosta may well have a meritorious ineffective-assistance-of-counsel claim based on his allegation that his counsel did not explain how a plea without a written plea agreement affected his appellate rights, and based on his having a real basis to appeal the district court's suppression decision.
Because of Acosta's waiver, we cannot resolve the merits of his suppression issue, but we would point to United States v. McSwain, 29 F.3d 558, 561-62 (10th Cir. 1994) and later cases on the same point—unaddressed by Mr. Schydlower or the district court—that might undermine the suppression decision. Time will tell whether the failure of Acosta's counsel to raise McSwain in support of the motion to suppress, combined with the alleged failure to advise Acosta of the impact of a plea without a written plea agreement on his appellate rights, might raise a compelling ineffective-assistance claim for Acosta. If the contents of Acosta's March 19, 2015 letter about his counsel to the district court are accurate, the claim might be more compelling still. See Letter, USA v. Acosta, et al, No. 2:14-cr-03528-KG-1 (D. N.M. Mar. 20, 2015), ECF No. 65. But absent special circumstances, such as the presence of a developed record, ineffective-assistance claims should be addressed during a collateral proceeding, not on a direct appeal. United States v. Brooks, 438 F.3d 1231, 1242 (10th Cir. 2006). We see no special circumstances present here and so defer consideration of these issues to a possible later proceeding.
Finding that Acosta's direct appeal is frivolous, we grant counsel's motion to withdraw as counsel under Anders v. California, and we dismiss the appeal.
1. Anders permits an attorney who believes an appeal to be “wholly frivolous, after a conscientious examination of it” to advise the court of such and to ask to withdraw from the case, so long as he also submits a brief that discusses potentially appealable issues and their possible support in the record. 386 U.S. at 744. The court then conducts a full examination of the proceedings to determine if the appeal is indeed frivolous. Id.
2. Our mention of this issue obviously does not foreclose its being raised in subsequent proceedings.
3. Acosta has already been granted in forma pauperis status for this proceeding.
4. The government had been willing to have Acosta sign a plea agreement that would have allowed him to appeal the denial of his motion to suppress. R. vol. 4 at 11. We are doubtful that Acosta understood how this works.
5. Acosta apparently is referring to his not knowing that a plea without a written plea agreement would deprive him of an ability to appeal his highly appealable suppression issue.
6. Contrary to counsel's statement, we see nothing in the record explaining how this decision to unilaterally disarm makes “factual sense.” R. vol. 4 at 12. But whether Acosta's decision was a fit of pique, or an attempt to ingratiate himself with the district court, or just plain neglect from his counsel, the record appears to show that Acosta, if hanging on every word, had the chance to hear at his sentencing hearing that his course would keep him from appealing the suppression decision.
7. A narrow exception covers due-process claims for vindictive prosecution and double-jeopardy claims that are evident from the face of the indictment. De Vaughn, 694 F.3d at 1145-46.


A BILL to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section, designated §33-6-38; to amend said code by adding thereto a new section, designated §33-15-4l; to amend said code by adding thereto a new section, designated §33-16-3x; and to amend said code by adding thereto a new section, designated §33-25A-8l, all relating to requiring health insurance providers to provide coverage for long-term antibiotic therapy for a patient with Lyme disease.
§33-6-38. Lyme disease to be covered by all health insurance policies.
All individual and group health insurance policies providing coverage on an expense-incurred basis and individual and group service or indemnity type contracts issued by a nonprofit corporation shall provide coverage for long-term antibiotic therapy for a patient with Lyme disease when determined to be medically necessary and ordered by a licensed physician after making a thorough evaluation of the patient’s symptoms, diagnostic test results, or response to treatment.
§33-16-3zz. Lyme disease to be covered by all health insurance policies.
Any insurer who, on or after January 1, 2019, delivers or issues a policy of group accident and sickness insurance in this state under the provisions of this article shall make available as benefits to all subscribers and members coverage on an expense-incurred basis and individual and group service or indemnity type contracts issued by a nonprofit corporation shall provide coverage for long-term antibiotic therapy for a patient with Lyme disease when determined to be medically necessary and ordered by a licensed physician after making a thorough evaluation of the patient’s symptoms, diagnostic test results, or response to treatment.
§33-25A-8p. Lyme disease to be covered by all health insurance policies.
A health maintenance organization issuing coverage in this state pursuant to the provisions of this article shall make available as benefits to all subscribers and members coverage on an expense-incurred basis and individual and group service or indemnity type contracts issued by a nonprofit corporation shall provide coverage for long-term antibiotic therapy for a patient with Lyme disease when determined to be medically necessary and ordered by a licensed physician after making a thorough evaluation of the patient’s symptoms, diagnostic test results, or response to treatment.


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An improved device and process for the oral inhalation of medicaments in finely divided form is disclosed. The device has a hollow elongate housing having one end adapted for insertion into the oral or nasal cavity of a user, this end having at least one air passageway therein. There is at least one other air passageway near the other end of the housing. A propeller attached to a medicament container is rotatably mounted in the housing. Piercing members are provided for perforating the medicament container. There is also a self-contained power source for rotating the propeller and the medicament container to dispense the medicament in a positive pressure airstream. Optionally, the device contains an atomizer rotatably mounted in the housing intermediate the medicament container and the medicament dispensing end of the device.
 References Cited UNITED STATES PATENTS 1,272,283 7/1918 Madden 222/193 1,526,096 2/1925 Sims 128/266 1,864,188 6/1932 Deutsch 128/173 R 2,147,435 2/1939 Gehrcke 128/266 2,163,185 6/1939 Belstrup 46/68 2,483,148 9/1949 Nicolle 222/193 2,693,805 11/1954 Taplin et a1 128/266 3,378,005 4/1968 Smith, Jr 128/188 3,535,707 10/1970 Greenlee l28/143.3 3,696,973 10/1972 Cottell 222/193 FOREIGN PATENTS OR APPLICATIONS 2,023,891 ll/l970 Germany 128/266 Primary Examiner-Richard A. Gaudet Assistant Examiner-.1. C. McGowan Attorney, Agent, or Firm-Thomas E. Ciotti; Edward L. Mandell; Paul L. Sabatine ABSTRACT An improved device and process for the oral inhalation of medicaments in finely divided form is disclosed. The device has a hollow elongate housing having one end adapted for insertion into the oral or nasal cavity of a user, this end having at least one air passageway therein. There is at least one other air passageway near the other end of the housing. A propeller attached to a medicament container is rotatably mounted in the housing. Piercing members are provided for perforating the medicament container. There is also a self-contained power source for rotating the propeller and the medicament container to dispense the medicament in a positive pressure airstream. Optionally, the device contains an atomizer rotatably mounted in the housing intermediate the medicament container and the medicament dispensing end of the device.
4 Claims, 3 Drawing Figures PATENTED 35831 @606 INVENTOR NALINKANT C. DAMANI AUTO INHALER This is a continuation; of application Ser. No. 117,015, filed Feb. 19, 1971, now abandoned.
BACKGROUND OF THE INVENTION This invention relates to the administration of drugs to a patient via inhalation through the oral and/or nasal passages, and more especially to a device which propels a uniform dosage of finely divided medicament into the lungs through the aforementioned passages.
In the past, administration of medicaments for the alleviation of ailments of the lungs has been carried out using plastic squeeze bottles or aerosol cans to deliver drugs through the oral and/or nasal cavities. Devices of this type have not been entirely satisfactory because they do not allow the user to properly control the medicament concentration or dosage. Furthermore, significant problems arise as a result of the variation in particle size of the medicament spray delivered from these devices. Thus, it is not always possible with these devices to dispense a medicament in the form of very fine and uniform particle size or mist which can be readily inhaled by the user. Sonic generators have proven to be the only truly effective devices for accomplishing complete control of both medicament dosage and particle size; however, these are extremely large and can be used only in a hospital, doctors office, clinic, etc. There have also been attempts to provide smaller, pocket-sized inhalation devices which may be used in any location to supply the necessary medication. Many of these personal sized devices are based upon aerosol principles (see for example, U.S. Pat. Nos. 3,183,907, 3,456,645, and 3,456,646 and of necessity suffer from the aforementioned disadvantages associated with aerosolized atomizers. Most recent endeavors in the area of pocket size atomizers are exemplified by U.S. Pat. Nos. 3,507,277 and 3,518,992 wherein the medicament is placed in the inhaler in capsulized form, made of gelatin or other material, and thereafter the capsule is perforated in situ to render the medicament available immediately prior to its contemplated use. The user then inhales through the device which causes an internally contained propeller, well as the punctured capsule, to rotate thereby dispensing the medicament from the device and into the oral or nasal passages ofthe user. While these latter type of devices may solve the heretofore mentioned medicament dosage and particle size problems, they too are rendered not wholly effective because typically those people having ailments necessitating the subject medication, as for example asthmatic patients, cannot efficiently draw air through their oral or nasal passages, and, as a result, they often cannot administer to themselves the entire medicament dosage. In fact, those persons most in need of the drug are those who are least able to draw air, and hence medicament. through the device.
SUMMARY OF THE INVENTION Accordingly, it is a primary object of this invention to provide an inhalation device which is capable of dispensing a precise quantity of medicament in extremely uniform particle size to any patient regardless of his ability to inhale.
Another object of this invention is to provide an improved inhalation device which can deliver in uniform particle size a medicament in either liquid, microencapsulated, or dry power form without the use of Freon or similar aerosolizing material.
In attaining the objects of this invention, one feature resides in a device for the oral inhalation of medicaments in finely divided form which comprises a hollow elongate housing having one end adapted for insertion into the oral or nasal cavity of a user. The end soadapted is provided with at least one air passageway therein, and there is provided at least one other air passageway near the other end of the housing. Inside the housing there is rotatably mounted a propeller means, and attached thereto is a mounting means for receiving a container of medicament. The device also contains one or more piercing members for perforating the container while it is contained in the aforementioned mounting means, such piercing members typically being spring-biased or loaded. The device is particu- Iarly characterized by a self-contained power source for operating the propeller means via external manual manipulation by the user. One such power source comprises an electric motor, battery and external switch combination, while an alternative embodiment includes a threaded plunger arrangement. In a further embodiment the device contains an atomizing means rotatably mounted inside the housing intermediate the medicament container mounting means and the housing end adapted for insertion into the oral or nasal cavity of a user. This atomizer is employed when the medicament is present in other than dry particulate form. In a typical embodiment, the spring-loaded piercing members include exteriorly located push button means attached thereto allowing the user to press the piercing members into the medicament container.
FIG. 3 is a view along the line 3-3 in FIG. 2 illustrating an atomizer disc which may optionally be included in the devices of this invention.
DETAILED DESCRIPTION OF THE INVENTION In one embodiment in accordance with this invention, as illustrated in FIG. 1, an oral inhalation device 10 is comprised of a rigid, hollow cylindrical housing 12 having its upper end adapted for insertion into the oral or nasal cavity of a user. Located in the upper end wall are a plurality of passageways 14 communicating with the inside of the housing and allowing free passage of air and medicament therethrough. Near the lower endof the housing 12 are located another series of similar passageways 16 providing for the ingress of air into the inhalation device. Propeller 18 is rotatably mounted on shaft 19 inside of housing 12. Immediately above propeller l8 and likewise connected to shaft 19 is a cup-like mounting means 20 for receiving a con-. tainer of medicament such as capsule 22. This entire assembly comprised of mounting means 20, propeller l8 and shaft 19 is driven by a small battery powered electric motor 24 secured to housing 12 immediately beneath the indicated assembly. A battery 26, typically size N or smaller, is also contained within housing 12 and is connected to motor 24 through conductors 28 and 29. Selective operation of motor 24 is achieved through operation of push button 30 located on the ex terior of housing 12 adjacent to battery 26.
In the sidewall portions of housing 12 immediately adjacent medicament container mounting means are located two spring-loaded piercing members 31 and 32 by means of which the user may pierce the medicament container 22, while in its supporting member 20. immediately prior to desired use of the device. The piercing members are conveniently actuated by the push button members 33 and 34 connected thereto on the external side of housing 12; however, other actuating means may also be employed for this purpose. For purposes of illustration, one assembly is shown in the non-piercing posit-ion whereas the other assembly is shown with the tip of piercing member 31 having pierced capsule 22. Preferably, the perforating ends of piercing members 31 and 32 are sharpened with a plane face at an acute angle, and furthermore, the acute angled plane face desirably faces away from propeller 18. Actuation of the piercing members advantageously provides one or more holes, suitably of about 0.6 to 0.65 mm. in diameter, in the capsule wall. It will of course be appreciated that any other suitable medicament container piercing assembly may be employed in the device of this invention, for example, one such as that disclosed in U.S. Pat. No. 3,518,992.
Medicament containing capsule 22 can be a standard capsule of gelatin or other material having'the medicament contained therein in either dry powder, microencapsulated, or liquid form. After piercing of the capsule walls has taken place, medicament will be forced out of the capsule into the positive pressure air stream created by propeller 18 as a result of the forces created by the rotational movement of the capsule itself.
When the medicament in capsule 22 is in liquid form, and in certain other instances, it is desired to further employ an atomizing disc 36 between the medicament container mounting means 20 and the medicament dispensing end of the device. The atomizing disc 36 is secured to shaft 17 and the resultant assembly is likewise secured to inverted cup-like member 21 which may be removably engaged over cup-like mounting member 20 which receives and holes the medicament capsule 22. Thus, inverted cup-like member 21 rotates together with mounting means 20, and as a result, atomizing disc 36 is likewise caused to rotate. For support and stabilization, shaft 17 loosely engages with bearing member 15 contained in housing 12. Inverted cup-like member 21 advantageously is of a cage-like configuration having only a few relatively narrow support members (preferably having no two support members lying on any one diameter across member 21) thereby providing openings 23 around substantially the entire circumference of member 21 to facilitate easy entrance by piercing members 31 and 32.
A planar view of atomizer disc 36 is illustrated in FIG. 3. The disc contains a plurality of apertures 37 uniformly distributed thereover, the same being for the purpose of assuring substantially uniform medicament particle size when capsule 22 contains medicament in the form of a liquid or any other form which is likely to agglomerate.
Referring now to FIG. 2, there is illustrated an alternative embodiment of the oral inhalation device of the invention. The portion of the device extending from propeller 18 to the medicament dispensing end of the device is essentially identical to the corresponding portion of the device illustrated in FIG. 1. In FIG. 2, a spring-loaded plunger assembly is employed as the power source in lieu of the battery operated electric motor illustrated in FIG. 1. The plunger assembly consists of plunger 40 slidably mounted in sleeve 42 at the lower end wall of housing 12. Plunger 40 is biased downwardly by spring 43 and retained in the device by cooperation of flange 44 with sleeve 42. Near the upper end of plunger 40 are located a plurality of ball bearings 45 which are freely rotatable and cooperate with threads 46 contained on the lower portion of shaft 19. Thus, when plunger 40 is depressed into housing 12, ball bearings 45 travel upwardly in threads 46 causing rotation of shaft 19 and hence propeller 18, medicament container support 20 and optionally atomizing disc 36. It will be appreciated that suitable gearing linkages may be incorporated into the plunger assembly to selectively vary the amount of rotation generated by each depression of plunger 40.
In operation, the two sections of housing 12 are separated and a container of medicament, such as a capsule, is placed into support 20. At this time, the atomizer disc assembly may be inserted or removed as desired. The housing is again closed, and the device may now be carried by the user for an indefinite period of time without deterioration or loss of medicament. When the administration of medicament is required, the user depresses push-buttons 33 and 34 to puncture the capsule in situ, and thereafter places the dispensing end of the device into his oral or nasal cavity, whereupon medicament may then be dispensed by either activation of electric motor 24 via push button 30 or depression of plunger 40.
The drug present in capsule 22 may be either a single or multiple dosage. For a single dosage, the device is constructed so that all of the medicament is delivered with a single push of the plunger 40 or depression of switch 30. In the case of a multiple dosage containing capsule, the device may be designed to administer only a single dose on each push of plunger 40 or timed depression of button 30. Repetition of this action similarly delivers the second and subsequent doses of the medicament. The embodiment illustrated in FIG. 2 is especially suited for such a modification.
Thus, the invention provides an oral inhalation device suitable for the administration of exact dosages of medicaments in finely divided form for the alleviation of ailments of the bronchial tract and of the lungs. The device may also be used for the administration of medicaments having systemic action, for example, it may be used for the administration of an antidote to poisonous substances. The device provides a simple method of carrying medicaments which require rapid or emergency usage, and moreover the device assures that a uniform dosage of such a medicament is administered regardless of the users ability to properly inhale.
While the invention has been described and illustrated with reference to certain preferred embodiments thereof, those skilled in the art will appreciate that various modifications, changes, omissions and substitutions can be made without departing from the spirit of the invention. It is intended, therefore, that the invention be limited only by the scope of the following claims.
l. A device for the dispensing of medicament in finely divided form for oral or nasal inhalation which comprises a rigid hollow elongate cylindrical housing having one end adapted for insertion into the oral or nasal cavity of a user, said one end having at least one air outlet passageway therein and there being at least one air inlet passageway near the other end of said housing; shaft means rotatably mounted axially within said housing; airstream generator means in the form of a propeller attached to said shaft; mounting means for receiving a container of medicament attached to said shaft downstream of said propeller; means for perforating holes in said container while said container is in said mounting means; power rotating means contained within said housing and attached to said shaft means for rotating said shaft means, for rotating said propeller means to direct an airstream around said container to said air outlet passageway, and for rotating said mounting means and container to rotationally force medicament out of said container through said holes into said airstream; and atomizing means mounted on said shaft for rotation at a fixed longitudinal position in said housing intermediate the medicament container mounting means and the housing end adapted for insertion into the oral or nasal cavity of a user.
2. A process of dispensing medicament in finely divided form for oral or nasal inhalation which comprises: providing a rigid hollow elongate cylindrical housing having one end adapted for insertion into the oral or nasal cavity of a user; forming at least one air outlet passageway in said end of said housing; forming at least one air inlet passageway near the other end of said housing; rotatably mounting a shaft axially within said housing; attaching a propeller to said shaft; mounting a medicament container in said housing attached to said shaft; mounting an atomizing means on said shaft in said housing intermediate the medicament container and the housing end adapted for insertion into the oral or nasal cavity of a user; perforating said container while the same is mounted in said housing; and power rotating said shaft to drive said propeller such that a positive pressure airstream is created from said air inlet passageway to said air outlet passageway, said powered rotation of said shaft further rotating said container to rotationally force medicament out of said container through said holes into said airstream whereby a dosage of medicament is dispensed for inhalation.
3. The process of claim 2 wherein said power rotating step comprises driving said shaft with a self-contained, batterypowered electric motor.
4-. The process of claim 2 wherein said power rotating step comprises driving said shaft by movement of a plunger assembly.
1. A device for the dispensing of medicament in finely divided form for oral or nasal inhalation which comprises a rigid hollow elongate cylindrical housing having one end adapted for insertion into the oral or nasal cavity of a user, said one end having at least one air outlet passageway therein and there being at least one air inlet passageway near the other end of said housing; shaft means rotatably mounted axially within said housing; airstream generator means in the form of a propeller attached to said shaft; mounting means for receivinG a container of medicament attached to said shaft downstream of said propeller; means for perforating holes in said container while said container is in said mounting means; power rotating means contained within said housing and attached to said shaft means for rotating said shaft means, for rotating said propeller means to direct an airstream around said container to said air outlet passageway, and for rotating said mounting means and container to rotationally force medicament out of said container through said holes into said airstream; and atomizing means mounted on said shaft for rotation at a fixed longitudinal position in said housing intermediate the medicament container mounting means and the housing end adapted for insertion into the oral or nasal cavity of a user.
4. The process of claim 2 wherein said power rotating step comprises driving said shaft by movement of a plunger assembly.
US1272283A (en) * 1918-02-07 1918-07-09 Jeremiah M Madden Insect-destroyer.
DK114218B (en) * 1966-12-08 1969-06-09 Fisons Pharmaceuticals Ltd Inhaler for medicaments in finely divided form.

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UNITED STATES of America v. Thomas REYES, Appellant.
Keith M. Donoghue, Esq., Sarah S. Gannett, Esq., Federal Community Defender Office, West Philadelphia, PA, for Appellant. Joseph J. Khan, Esq., Bernadette A. McKeon, Esq., Office of United States Attorney, Philadelphia, PA, for Appellee.
Before: McKEE, Chief Judge, CHAGARES, and NYGAARD, Circuit Judges.
The District Court denied Appellant Thomas Reyes' SHOE petition for a writ of habeas corpus, which he had filed pursuant to 28 U.S.C. § 2255. But, the court granted Reyes a certificate of appealability on the following question: whether the decision of the United States Supreme Court in Alleyne v. United States, ––– U.S. ––––, 133 S.Ct. 2151, 186 L.Ed.2d 314 (2013) applies retroactively to cases on collateral review? While briefing was pending in this appeal, we issued an opinion and order in United States v. Winkelman, et al., 746 F.3d 134 (3d Cir.2014), which answered that question in the negative. In light of our holding in Winkelman, we will affirm the District Court's order denying Reyes' petition for a writ of habeas corpus.
The Gomez Grocery store in Philadelphia, Pennsylvania was robbed and some of its employees assaulted in July of 2006. Appellant Reyes was convicted by a jury of Hobbs Act robbery of that store, a violation of 18 U.S.C. § 1951(a) ; using a firearm in relation to a crime of violence, a violation of 18 U.S.C. § 924(c); and of being a felon in possession of a firearm, a violation of 18 U.S.C. § 922(g)(1). Reyes was subsequently sentenced to 180 months' imprisonment, five years of supervised release, a $1,000 fine, and a special assessment of $300. He appealed, challenging only his conviction for Hobbs Act robbery. We rejected his challenge and affirmed his conviction. See United States v. Reyes, 2010 WL 299222 (3d Cir. Jan. 27, 2010).
In relevant part, the Hobbs Act criminalizes activity that “obstructs, delays, or affects commerce or the movement of any article or commodity in commerce, by robbery or extortion or attempts or conspires so to do....” 18 U.S.C. § 6 & 1951(a).
After unsuccessfully petitioning the Supreme Court for a Writ of Certiorari, Reyes filed a pro se habeas petition in October of 2011. The District Court appointed counsel for Reyes and conducted a thorough evidentiary hearing. Before the District Court ruled, however, Reyes sought permission to amend his petition, to add claims under the Supreme Court's Alleyne decision. The District Court denied Reyes' petition, and also denied Reyes' request to amend his petition to include the Alleyne claims. The District Court concluded that Alleyne did not retroactively apply to cases that were on collateral review, but did issue Reyes a certificate of appealability on the question.
Expounding on our decision in Winkelman, we reiterate here that the rule of criminal procedure announced by the Supreme Court in Alleyne does not apply retroactively to cases on collateral review. In Alleyne, the Supreme Court overruled its prior precedent, Harris v. United States, 536 U.S. 545, 122 S.Ct. 2406, 153 L.Ed.2d 524 (2002), and clarified that, under the Sixth Amendment, “ ‘any facts that increase the prescribed range of penalties to which a criminal defendant is exposed’ are elements of the crime” and must be found beyond a reasonable doubt. Alleyne, 133 S.Ct. at 2160 (quoting Apprendi v. New Jersey, 530 U.S. 466, 490, 120 S.Ct. 2348, 147 L.Ed.2d 435 (2000)).
The District Court had jurisdiction under 28 U.S.C. §§ 2241(a) and 2254(a). We have jurisdiction under 28 U.S.C. §§ 1291 and 2253(a). We exercise plenary review over the District Court's legal conclusions. See Coombs v. Diguglielmo, 616 F.3d 255, 260 (3d Cir.2010).
At the outset, we note that we did not make a definitive pronouncement in Winkelman as to whether Alleyne announced a new rule, so today we clarify that Alleyne did indeed announce a new rule. See also, In re Payne, 733 F.3d 1027, 1029 (10th Cir.2013) (internal quotation marks omitted); Simpson v. United States, 721 F.3d 875, 876 (7th Cir.2013). However, while Alleyne set out a new rule of law, it is not retroactively applicable to cases on collateral review, like Reyes'.
When the Supreme Court announces a new rule of law, it generally applies to cases still on direct review. See Schriro v. Summerlin, 542 U.S. 348, 351–52, 124 S.Ct. 2519, 159 L.Ed.2d 442 (2004). A new rule will only apply “in limited circumstances” to cases in which the conviction is already finalized, however. Id.; see also Teague v. Lane, 489 U.S. 288, 303–11, 109 S.Ct. 1060, 103 L.Ed.2d 334 (1989). Those limited circumstances arise with new rules “that place particular conduct or persons covered by the statute beyond the State's power to punish,” or where the rule announces new “watershed rules of criminal procedure implicating the fundamental fairness and accuracy of the criminal proceeding.” Schriro at 352, 124 S.Ct. 2519 (citations and internal quotation marks omitted); Teague, 489 U.S. at 307, 109 S.Ct. 1060; United States v. Swinton, 333 F.3d 481, 490 (3d Cir.2003). The new rule announced in Alleyne falls under neither circumstance. First, Alleyne announced a procedural, rather than substantive rule. See Alleyne, 133 S.Ct. at 2164 (Sotomayor, J., concurring) (explaining that in Alleyne “procedural rules are at issue”); id. at 2173 n. * (Alito, J., dissenting) (agreeing that Alleyne involves a procedural rule).
Second, Alleyne announced no “watershed rule” of criminal procedure. The Supreme Court has noted that “[t]his class of rules is extremely narrow, and it is unlikely that any has yet to emerge.” Schriro, 542 U.S. at 352, 124 S.Ct. 2519 (internal quotation marks and alterations omitted). Further, every court to consider the issue has concluded that Alleyne provides only a limited modification to the Sixth Amendment rule announced in Apprendi v. New Jersey, 530 U.S. 466, 120 S.Ct. 2348, 147 L.Ed.2d 435 (2000). See United States v. Redd, 735 F.3d 88, 91–92 (2d Cir.2013); In re Payne, 733 F.3d at 1029–30; In re Kemper, 735 F.3d 211, 212 (5th Cir.2013); Simpson v. United States, 721 F.3d at 876. We agree with the Court of Appeals for the Seventh Circuit, which recently explained that Apprendi itself and the subsequent rulings applying and extending that decision have not been applied retroactively: “ Alleyne is an extension of Apprendi. The Justices have decided that other rules based on Apprendi do not apply retroactively on collateral review. This implies that the Court will not declare Alleyne to be retroactive.” Simpson, 721 F.3d at 876 (citations omitted).
And, of course, the decision to make Alleyne retroactive rests exclusively with the Supreme Court, which has not chosen to do so. See Winkelman, 746 F.3d at 136; see also Simpson, 721 F.3d at 876 (“Unless the Justices themselves decide that Alleyne applies retroactively on collateral review,” lower courts may not do so.); United States v. Redd, 735 F.3d 88, 91 (2d Cir.2013). Therefore, Alleyne does not provide Reyes with any basis for relief because the Supreme Court has not chosen to apply Alleyne's new rule retroactively to cases on collateral review.
Reyes raises several well-trod and meritless arguments in an attempt to persuade us that we should apply Alleyne 's new rule to his habeas case. For example, he argues that Teague does not apply to habeas actions in federal criminal cases because concerns of federalism and comity are not implicated. Instead, he posits that the correct test for retroactivity remains the Supreme Court's decision in Linkletter v. Walker, 381 U.S. 618, 85 S.Ct. 1731, 14 L.Ed.2d 601 (1965). We disagree. We have long held that Teague applies to petitions filed pursuant to 28 U.S.C. § 2255. See Lloyd v. United States, 407 F.3d 608, 611 (3d Cir.2005); United States v. Jenkins, 333 F.3d 151, 154 (3d Cir.2003). And, the Linkletter decision was itself rejected by the Supreme Court in Teague. See Teague, 489 U.S. at 302–04, 109 S.Ct. 1060; Banks v. Horn, 316 F.3d 228, 248 (3d Cir.2003) (recognizing the “reformulation” of Linkletter ).
For the foregoing reasons, we will affirm the District Court decision denying Reyes' petition for a writ of habeas corpus.


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Last week we put In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation (Doria), 2009 WL 2600517 (M.D. Ga. Aug. 24, 2009) (slip op. here), on the device preemption scorecard. Only a couple of pages long, Doria held that punitive damages were unavailable the New Jersey Product Liability Act (“PLA”) because the fraud on the FDA exception in the PLA was preempted by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
No great shock there. Doria certainly wasn’t the first case to so hold. An appellate court in New Jersey did that last year. See McDarby v. Merck & Co., 949 A.2d 223, 271-76 (N.J. Super. A.D. 2008).
But Doria is the latest case to hold that preemption of fraud on the FDA allegations under the Buckman rationale applied to allegations that amounted to less than a full-blown, independent cause of action. In so doing, Doria came down firmly on what we consider to be the correct side of what we’ll call the Garcia/Desiano divide.
Both Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), and Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 128 S. Ct. 1168 (2008), involved a Michigan tort reform statute that was more thoroughgoing than the PLA. Michigan essentially bars all tort claims against FDA approved drugs and devices, except where the plaintiff proves fraud on the FDA (or bribery, but frankly we’ve never seen a plaintiff seriously allege that).
The United States Supreme Court has expressly considered the question of a state common law fraud-on-the-FDA tort claim and found that it was impliedly preempted. . . . This case, however, presents a somewhat different legal regime from the one invalidated in Buckman. The Michigan legislature has provided a general immunity for drug manufacturers with a specific exception for circumstances involving, inter alia, fraud on the FDA rather than a specific cause of action for fraud on the FDA. This difference, however, is immaterial in light of Buckman. . . . Buckman teaches that state tort remedies requiring proof of fraud committed against the FDA are foreclosed since federal law preempts such claims. . . .
Doubtless, Buckman prohibits a plaintiff from invoking the exceptions on the basis of state court findings of fraud on the FDA. Such a state court proceeding would raise the same inter-branch-meddling concerns that animated Buckman. But the same concerns do not arise when the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process. Thus, in this setting, it makes abundant sense to allow a State that chooses to incorporate a federal standard into its law of torts to allow that standard to apply when the federal agency itself determines that fraud marred the regulatory-approval process.
385 F.3d at 965-66 (a bunch of Buckman citations omitted) (emphasis added).
The Second Circuit in Desiano did not agree. It held that the very same Michigan fraud-on-the-FDA exception wasn’t preempted because the effect of the exception was not to create liability for fraud upon an agency. Rather, the exception only provided a route for assertion of “traditional” – and thus unpreempted – tort claims.
Appellants here are not pressing “fraud-on-the-FDA” claims, as the plaintiffs in Buckman were understood by the Supreme Court to be doing. They are, rather, asserting claims that sound in traditional state tort law. In Buckman, the Supreme Court mentioned two characteristics of preempted “fraud-on-the-FDA” claims that distinguish them from claims sounding in preexisting common law. . . .
[A]ll of the claims advanced by Appellants in this case are premised on traditional duties between a product manufacturer and Michigan consumers. None of them derives from, or is based on, a newly-concocted duty between a manufacturer and a federal agency. . . .
The second difference between common law actions and “fraud-on-the-FDA” claims, suggested in Buckman, is that in FDA-fraud cases, proof of fraud against the FDA is alone sufficient to impose liability. In Buckman, there were no freestanding allegations of wrongdoing apart from the defendant’s purported failure to comply with FDA disclosure requirements.
467 F.3d at 94-95 (more Buckman citations omitted). Desiano thus exempted “traditional” state law duties from preemption and limited the scope of Buckman to “independent” actions for fraud on the FDA.
Naturally, as defense lawyers. we thought Desiano was wrongheaded and result oriented. We’ve said so a number of times, most thoroughly here. We view Desiano as an attempt to gut Buckman, since any plaintiff’s lawyer worthy of the name is able to plead fraud on the FDA as an element of some other, more “traditional” cause of action rather than as a cause of action in its own right. We had hoped the Supreme Court would clear things up when it accepted certiorari in Desiano (now called Kent), but that didn’t happen either.
Anyway, what we say hardly matters – except to us and (we hope) to our readers. What matters is what courts say. It’s now been a good two years since Desiano was decided, and we wondered whether the Second Circuit’s rationale has made much on an inroad into preemption of fraud on the FDA claims.
We can happily report that we haven’t seen much.
First, to be fair, we have to exclude decisions from district courts in either the Sixth or Second Circuits. Those courts aren’t independent actors any more, because their circuits have ruled and they’re bound to follow the law thus mandated . That means that we have to set aside these Sixth Circuit district court cases: Cupek v. Medtronic, Inc., 405 F.3d 421, 423-24 (6th Cir. 2005) (preempting “disguised fraud on the FDA claim”); In re Aredia & Zometa Products Liability Litigation, 2009 WL 2497229, at *2 (M.D. Tenn. Aug. 13, 2009) (Florida statute); White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1028-29 (W.D. Mich. 2008) (Michigan statute); In re Aredia & Zometa Products Liability Litigation, 2008 WL 2944910, at *3-5 (M.D. Tenn. July 25, 2008) (Texas statute); In re Aredia & Zometa Products Liability Litigation, 2008 WL 913087, at *2 (M.D. Tenn. Apr. 2, 2008) (Michigan statute); Alfred v. Mentor Corp., 2007 WL 708631, at *7 (W.D. Ky. March 5, 2007) (fraud “construed” as fraud on the FDA); In re Aredia & Zometa Products Liability Litigation, 2007 WL 649266, at *8-10 (M.D. Tenn. Feb. 27, 2007) (New Jersey statute); Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp.2d 666, 674-75 (E.D. Ky. 2006) (all “failure-to-warn claims based on conduct that occurred prior to and during the labeling approval process would be preempted”); and Zammit v. Shire US, Inc., 415 F. Supp.2d 760, 767-68 (E.D. Mich. 2006) (Michigan statute).
And while we would have to do the same for decisions from district courts in the Second Circuit, there aren’t any. While In re Zyprexa Products Liability Litigation, 489 F.Supp.2d 230, 273-75 (E.D.N.Y. 2007), cited Desiano a lot, that was for things like a presumption against preemption. Zyprexa wasn’t a fraud on the FDA case. When you think about it, the absence of fraud on the FDA cases in the Second Circuit following Desiano isn’t all that surprising, since none of the states in that circuit (New York, Connecticut, Vermont) have statutes with fraud on the FDA exceptions in them.
So we’re being fair about this, and setting to one side a lot more pro-defense decisions than pro-plaintiff ones. We can afford to be “fair,” since the other side’s getting clobbered anyway.
That’s because, throughout the country most courts have continued to apply Buckman broadly, to all fraud on the FDA allegations, even when they’re embedded in other, common-law causes of action. A lot of these decisions have to do with statutes that have fraud-on-the-FDA exceptions like Michigan’s.
Federal Vaccine Act: Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 305 n.16 (E.D. Pa. 2007).
Arizona: Kobar v. Novartis Corp., 378 F. Supp.2d 1166, 1172-74 (D. Ariz. 2005).
Florida: None except for the bound Aredia-Zometa decision out of a Sixth Circuit district court, cited above.
Michigan: Henderson v. Merck & Co., 2005 WL 2600220, at *10-11 (E.D. Pa. Oct. 11, 2005), reconsideration denied, 2005 WL 2864752, at *1 (E.D. Pa. Oct. 31, 2005); Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 139 (Mich. 2003); Duronio v. Merck & Co., 2006 WL 1628516, at *5 (Mich. App. June 13, 2006) (unpublished). There’s also a bound Aredia-Zometa decision.
New Jersey: Doria, 2009 WL 2600517, at *1; McDarby, 949 A.2d at 271-76. And a bound Aredia-Zometa decision.
Texas: Ledbetter v. Merck & Co., 2007 WL 1181991 (Tex. Dist. Apr. 20, 2007) (“Whether it is an element of plaintiffs’ cause of action, or a way to defeat an affirmative defense, the proof is the same. All of the federalism concerns expressed in Buckman still apply.”), appeal dismissed, 2008 WL 2066580 (Tex. App. May 15, 2008) (unpublished). TAnd a bound Aredia-Zometa decision.
Utah: Grange v. Mylan Laboratories, Inc., 2008 WL 4813311, at *6-7 (D. Utah Oct. 31, 2008). On the other hand, there’s Lake-Allen v. Johnson & Johnson, L.P., 2009 WL 2252198, at *3-4 (D. Utah July 27, 2009), but that one’s just weird. Lake-Allen didn’t preempt the Utah statute’s exception, but only because it incorrectly treated Buckman as if were an express preemption case under the MDAs. There’s nothing in it supporting the Desiano position.
Aside from the statutory fraud-on-the-FDA exception cases, there are also a large number of cases that dismiss as preempted fraud-on-the-FDA allegations that are incorporated/embedded into some other, ostensibly, common-law claims, usually denominated as “fraud,” but sometimes as negligence per se or failure to warn. See Miller v. DePuy Spine, Inc., ___ F. Supp.2d ___, 2009 WL 1767555, at *4 (D. Nev. May 1, 2009) (“any claim by [plaintiff] based on a contention that [defendant] provided inaccurate or incomplete information to the FDA would be preempted”); McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917, 923 (N.D. Ill. 2008) (off-label promotion asserted as “parallel” claim in PMA device case is preempted); Demahy v. Wyeth, Inc., 586 F. Supp.2d 642, 662 (E.D. La. 2008) (any and all claims “constitut[ing]” fraud on the FDA preempted); Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 1094 (D. Minn. 2008) (preemption bars alleged “conceal[ment of] known defects from the FDA asserted as “parallel” claim in PMA device case); Mason v. Smithkline Beecham Corp., 546 F. Supp.2d 618, 627 n.5 (C.D. Ill. 2008) (any allegations “suggest[ing] that [defendant] withheld facts or studies from the FDA” are preempted); Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768, 785 (W.D.N.C. 2008) (wantonness, fraud, misrepresentation); Aubrey v. Sanders, 2008 WL 4443826, at *5 n.9 (W.D. Pa. Sept. 26, 2008) (fraud-on-the-FDA allegation in securities fraud claim preempted); In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, 2006 WL 2374742, at *10 (N.D. Cal. Aug. 16, 2006) (preempting fraud on the FDA allegations in failure to warn claim); Dusek v. Pfizer Inc., 2004 WL 2191804, at *7 & n.24 (S.D. Tex. Feb. 20, 2004) (“contentions [that] amount to allegations of ‘fraud-on-the-agency’” preempted; Texas prior to the statute); Webster v. Pacesetter, Inc., 259 F. Supp.2d 27, 36 (D.D.C. 2003) (fraud on the FDA allegations embedded in warning claim preempted; “plaintiffs cannot bootstrap their arguments regarding defendant’s alleged failure to report and to investigate adverse incidents to the FDA”); Andrx Pharmaceuticals v. Biovail Corp., 175 F. Supp.2d 1362, 1369-70 (S.D. Fla. 2001) (preempting fraud on the FDA allegations embedded in deceptive trade practices, tortious interference and negligence per se claims), vacated on other grounds, 276 F.3d 1368 (Fed. Cir. 2002); Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127, 138-39 (Tex. App. 2005) (“appellants’ fraud claim is really a fraud-on-the-FDA claim” and therefore preempted); Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008) (fraud on the FDA allegations in supposed alleged “parallel” claim in PMA device case preempted); McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008) (same); O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008) (same).
Notably, three different New York state courts, not bound by Desiano, have not followed it. Instead, these courts all hold embedded fraud-on-the-FDA allegations preempted. Lake v. Kardjian, 874 N.Y.S.2d 751, 964 (N.Y. Sup. Dec. 17, 2008) (failure to report to FDA is not a defense to preemption); Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *4 (N.Y. Sup. April 9, 2009) (“intentional misrepresentation and fraud” claims that “are premised on false representations to the FDA. . .are clearly preempted”); Rosner v. Mira, Inc., 2004 WL 5519541 (N.Y. Sup. Oct. 18, 2004) (fraud on the FDA could not be asserted as a basis for punitive damages), aff’d, 792 N.Y.S.2d 41 (N.Y. A.D. 2005).
There are also cases (like Lake) holding that fraud on the FDA is preempted when asserted as a defense to express preemption in medical device cases. See Riley v. Cordis Corp., 625 F. Supp.2d 769, 2009 WL 1606650, at *6 (D. Minn. 2009); Covert v. Stryker Corp., ___ F. Supp.2d ___, 2009 WL 2424559, at *11 (M.D.N.C. Aug. 5, 2009); Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174, 1179 (N.D. Ill. 2008).
Finally, totally apart from formal assertions of fraud on the FDA, there is a body of case law holding that evidence tending to suggest fraud on the FDA to a jury is barred by preemption. In re Baycol Products Litigation, 532 F. Supp.2d 1029, 1052-53 (D. Minn. 2007) (expert testimony about fraud on the FDA); In re Prempro Products Liability Litigation, 2006 WL 3806391, at *6 (E.D. Ark. Dec. 27, 2006); Swank v. Zimmer, Inc., 2004 WL 5254312, at *2 (D. Wyo. Apr. 20, 2004); Skibniewski v. American Home Products Corp., 2004 WL 5628157, at *13 (W.D. Mo. April 1, 2004); Bouchard v. American Home Products Corp., 213 F. Supp.2d 802, 811-12 (N.D. Ohio 2002).
On the other side of the ledger, what’s actually followed Desiano? Not a whole lot, actually.
There’s In re Medtronic, Inc., Implantable Defibrillators Litigation, 465 F. Supp.2d 886, 896-98 (D. Minn. 2006), which used a Desiano-type argument (before Desiano was decided) to allow fraud on the FDA to defeat preemption in a pre-Riegel PMA device case. That’s contrary to unanimous PMA precedent post-Riegel. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289, at *10-11 (D. Minn. June 12, 2007), more or less blindly followed Medtronic Defibrillators in another pre-Riegel case. Given Riegel and its progeny, both of these are probably dead letters, unless the Eighth Circuit does something unusual. Compare In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), reconsideration denied, 2009 WL 294353 (D. Minn. Feb. 5, 2009) (finding much broader preemption after Riegel).
One Massachusetts trial court has adopted a Desiano “independent” claim rationale. Brown v. DePuy Spine, Inc., 2007 WL 1089337, at *13. (Mass. Super. Apr. 9, 2007). Also, in Ackermann v. Wyeth Pharmaceuticals, 471 F.Supp.2d 739, 749-50 (E.D. Tex. 2006), the court more or less followed Desiano in dictum after granting summary judgment for the defendant on other, non-preemption grounds. Those other grounds – but not the court’s preemption rationale – were later affirmed. Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008).
Stretching the limits, Knipe v. SmithKline Beecham, 583 F. Supp.2d 553 (E.D. Pa. 2008), seemed to be adopting a Desiano-type rationale, id. at 583 n.31, but on reconsideration, it redirected its analysis of the plaintiff’s claims towards a pure fraud on the public rationale. Id. at 597-98 (pointing out that plaintiffs “do not allege fraud on the FDA).
As mentioned, we had hoped that the Supreme Court would overturn Desiano in Kent, insteag the Court divided evenly. Still, with the missing member of the Court being Justice Roberts (a dissenting pro-preemption vote in Levine), we can be pretty confident that there’s a majority for the strong view of Buckman on the Court.
The current weight of precedent – massively in support of the Garcia view that Buckman preempts any form of state-law liability grounded in fraud on the FDA – seems to indicate that most courts share our assessment of the situation.

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So it looks like there are several aspects to the allegations in Operation Varsity Blues 1) a college entrance exam cheating scheme; 2) a college recruitment scheme; and 3) a tax fraud conspiracy.
Some of the individuals (4) are charged by Information - a clear indication that they have reached an agreement with the government. We see two cooperating witnesses mentioned in the documents. The crimes alleged in the Information include charges of racketeering conspiracy, money laundering conspiracy, conspiracy to defraud the US, mail and wire fraud and obstruction of justice. Twelve others face indictment on a charge of racketeering conspiracy. The remaining individuals have criminal complaints against them of either conspiracy to commit mail fraud and honest services mail fraud or conspiracy to commit mail and wire fraud. The affidavit for one of the criminal complaints is over 200 pages long (see here). There are also forfeiture allegations for some of the accused individuals. It will be interesting to see how many of the criminal complaints turn into Informations (requires waivers by the defense) as opposed to Indictments in the next for weeks.
The prosecutorial power of using conspiracy and picking one's venue is emphasized here as the cases are being brought in the District of Massachusetts, although the majority of those accused of criminal activity are not from that jurisdiction. The ACT is headquartered in Iowa City and the Educational Testing Service for the SAT is in New York and New Jersey.
Likewise the prosecutorial power of granting cooperation status appears likely as some of the cases have references to CW-1 and CW-2. Prosecutors get to decide who gets the cooperation status and who gets the cooperator's testimony against them.
The alleged fraud appears to be massive, and one has to wonder how this could have occurred- but compromised college related entrance exams are not something new. Just today the Central District of California filed a 26-count Indictment with charges of conspiracy of false passport, and aggravated identity theft, against defendants for allegedly "using false passports" to take TOEFL (English proficiency) exams for others. (see here). It may be tougher to detect some issues of fraud outside the United States, but internally this should not be happening. Will the verification processes used with college entrance exams be re-evaluated? Or were they the ones who detected fraud?
As an educator, I am wondering how the students fared in college. Were the alleged improper scores an accurate prediction of their college abilities? Could the value of these tests become an issue should someone go to trial?
How many students were improperly admitted to a college, taking a seat of a student who might have had this opportunity? And if the admitted students were not aware of what their parents had done, one can only imagine the hurt they are feeling right now. So you have issues related to both the admitted students and those who may have been borderline but denied at these institutions.
Likewise, the parents who are accused of this activity were attempting to assist their children, and it is likely that the damage caused is even greater right now. As is so often the case, especially in white collar cases, the collateral consequences can be significant.
And should the collateral consequences to the families who may have committed these acts be considered if determining the plea offers and later sentences that might occur here.
Many of those accused are probably trying to decide how best to handle these charges - plead not guilty and go to trial, or reach a quick agreement with the government. With tapes and other supporting evidence the decisions will likely be examined against possible cross-examination against cooperating witnesses who were involved in multiple cases. How much sympathy will a parent trying to assist their children receive, and will it surpass criticism against privilege. And there are also legal questions to examine here - is this the intended use of mail and wire fraud, is conspiracy too broad a crime here, and was this a "wheel-and-spoke' conspiracy? But what is the risk of making such challenges?
The colleges and universities also need to reflect on the allegations here. What kind of compliance programs did they have in place to root out such conduct from individuals involved in sports activities on campus, and what now needs to be done to make certain that this doesn't occur in the future. Perhaps there is nothing they can do, but if the allegations prove true, it should be examined.
There will be much to learn from what happened today. It was a sad day for many people.
Yes, The Supreme Court's opinion here looks at whether RICO has extraterritorial application in the civil context. And in that regard it limits its extraterritorial application. But there is some important language in this opinion for both civil and criminal practitioners, especially since much of RICO is premised on a criminal statute, and all of RICO is located in Title 18, the Criminal Code.
There has been much confusion as to whether one should look at the predicate acts or the enterprise in determining extraterritoriality and the Court provides significant guidance here.
In deciding RICO's extraterritorial application, the Court divides it into two issues: a) "do RICO's substantive prohibitions, contained in sec. 1962, apply to conduct, that occurs in foreign countries;" b) "does RICO's private cause of action, contained in sec 1964(c) apply to injuries that are suffered in foreign countries?" It is this first issue that one needs to examine for criminal cases.
The Court reaffirms in statutory construction the premise that there is "presumption against extraterritoriality."
The Court describes the two-step process - "Morrison and Kiobel reflect a two-step framework for analyzing extraterritoriality issues. At the first step, we ask whether the presumption against extraterritoriality has been rebutted—that is, whether the statute gives a clear, affirmative indication that it applies extraterritorially. We must ask this question regardless of whether the statute in question regulates conduct, affords relief, or merely confers jurisdiction. If the statute is not extraterritorial, then at the second step we determine whether the case involves a domestic application of the statute, and we do this by looking to the statute’s 'focus.' If the conduct relevant to the statute’s focus occurred in the United States, then the case involves a permissible domestic application even if other conduct occurred abroad; but if the conduct relevant to the focus occurred in a foreign country, then the case involves an impermissible extraterritorial application regardless of any other conduct that occurred in U. S. territory."
With respect to 1962 (b) and (c) the Court states, "[w]e therefore conclude that RICO applies to some foreign racketeering activity. A violation of sec. 1962 may be based on a pattern of racketeering that includes predicate offenses committed abroad, provided that each of those offenses violates a predicate statute that is itself extraterritorial."
With respect to 1962(a) the Court states, "arguably sec 1962(a) extends only to domestic uses of the income."
In dicta, with respect to 1962(d), the conspiracy section, the Court states, "[w]e therefore decline to reach this issue, and assume without deciding that sec 1962(d)'s extraterritoriality tracks that of the provision underlying the alleged conspiracy."
The Court is less focused on whether the enterprise element is domestically based. But it does note that "[e]nterprises whose activities lack that anchor to U.S. commerce cannot sustain a RICO conviction."
The language in this case provides important guidance for criminal practitioners on the extraterritoriality of RICO, and clearly it provides strong arguments that not all of RICO applies abroad.
In a major blow to the government, the U.S. Court of Appeals for the Sixth Circuit has reversed the convictions of each and every defendant in U.S. v. Douglas C. Adams, et al. This was a high-profile RICO public corruption prosecution (premised on an alleged vote-buying scheme) brought by the U.S. Attorney's Office for the Eastern District of Kentucky. The Sixth Circuit vacated and remanded based on the following evidentiary errors: 1) admitting testimony from three cooperators regarding their drug-dealing activities with some of the defendants, which activities occurred 10 years prior to the alleged vote-buying scheme; 2) admitting an Inside Edition video that also discussed drug-dealing activities in the community; 3) admitting evidence of witness intimidation that could not be tied to any of the defendants; 4) the trial court's making of unprompted, substantive changes to the government's tape transcripts; 5) permitting use before the jury of the inaccurate transcripts that resulted from the unprompted changes; 6) admitting un-redacted, and highly prejudicial, versions of state election records which contained statements implicating the defendants in vote-buying schemes. This appears to be a case of government overkill in the presentation of its evidence, as the Sixth Circuit had no problem affirming the sufficiency of the evidence. The unanimous panel opinion was written by Judge Karen Nelson Moore. John Kline, Trevor Wells, and Jason Barclay argued the case for Appellants. With them on the various briefs were: Larry Mackey, Marty Pinales, Candace Crouse, Kent Westberry, Elizabeth Hughes, Jerry Gilbert, Robert Abell, Scott White, and Russ Baldani. Congratulations to all.
The Third Circuit Court of Appeals reversed and remanded a district court's dismissal of a RICO indictment against an attorney and others. (See Opinion - U.S. v. Bergrin here) RICO is clearly a complicated statute and the court's decision presents an extremely thorough review of many aspects of the law in this area. Typically, RICO is one of the few topics that need a few days of classes in order to truly understand its depth and breadth. The Supreme Court's continually allowance for RICO to be read broadly, brings it to an even higher level. Areas that continually plague readers/students is what constitutes a sufficient "enterprise" and when do you have a "pattern of racketeering activity." Justice Scalia in HJ Inc. criticizes the test of "continuity plus relationship" as set forth by the Court, as he says that this is "as helpful to the conduct of their affairs as 'life is a fountain.'"
This Third Circuit decision to reinstate the indictment comes on the heels of the Supreme Court's 2009 decision in Boyle (see here), where the Court held that RICO association-in-fact enterprises require an "ascertainable structure beyond that inherent in the pattern of racketeering activity in which it engages, but no - "an instruction framed in this precise language is not necessary."The Court held that an association-in-fact enterprise needs to have "three structural features: a purpose, relationships among those associated with the enterprise, and longevity sufficient to permit these associates to pursue the enterprise's purpose." At the time the Boyle decision came down, I blogged that the decision would be "very helpful for government prosecutions in that it allows RICO cases to be brought with the jury being told a minimal amount of what is required for a RICO enterprise."
This Third Circuit decision confirms that the government will have an easier time in presenting RICO cases. Whether the defendant and others will be convicted in this case remains to be seen, but for now it is clear that the breadth of RICO will allow this matter to move forward.
"I wanted to begin by reaching out to law professors who might be interested in signing on to a amicus brief in support of a petition for writ of certiorari. Max Huffman(Indiana) and I are writing an amicus brief in the case British American Tobacco v. United States. The cert. petition is part of a massive case brought by the U.S. against the tobacco companies. Various cert. petitions have been filed, including a government petition seeking recovery of a $280 billion disgorgement award. Details about the underlying case can be found on SCOTUSblog.
"The amicus brief that we are writing is on a narrow issue focused on how a court should interpret the geographic reach of federal law (the extraterritoriality question). The brief is being submitted to encourage the Court to grant certiorari and review the decision of the D.C. Circuit. The brief clarifies the history and application of the effects test and shows how that history bears upon the proper interpretation of whether Congress intended a statute to reach extraterritorial conduct. The brief does not take a position on the underlying merits: the federal government's use of RICO to prevent and restrain an alleged scheme to deceive American consumers about the health risks of smoking.
"If you are a law professor who would consider signing on to the amicus brief, please email me at aparrish@swlaw.edu, and I can send you a draft. A draft will be completed Monday, and we hope to finalize within the next week or so (it's on a tight filing deadline). Because the effects test applies in a number of contexts (antitrust, securities, trademark, labor law, environmental law, criminal law etc.), the D.C. Circuit's decision, if left to stand, could have far-reaching implications. Legal commentators have also lamented the doctrinal incoherence in how courts approach legislative jurisdiction. This would be a good opportunity for the Court to clarify what is now a confused area of law. More information about the case and the amicus brief is included below.
"The petitioner's cert petition implicates the question of whether RICO applies to the overseas conduct of foreign corporations. The D.C. Circuit did not directly address whether Congress intended RICO to apply extraterritorially -- an issue on which the lower courts are divided. Instead, it found: (1) that when domestic effects are felt in the United States, regulation of foreign conduct of a foreign corporation does not implicate extraterritorial jurisdiction; and (2) that it need not decide whether RICO applies extraterritorially so long as the foreign conduct has substantial effects in the United States. Because the D.C. Circuit found a domestic effect, it presumed that Congress intended RICO to regulate abroad. The case raises interesting questions about the role of the presumption against extraterritoriality and the effects test. It implicates at least a three-way circuit split on how the courts determine legislative (prescriptive jurisdiction).
"The amicus brief attempts to show how the D.C. Circuit's opinion has added confusion to the existing circuit split. It also suggests that the D.C. Circuit erred by disregarding the presumption against extraterritoriality. The brief argues that the effects test sets the outer limits, under international law, of Congress's legislative jurisdiction, but does not serve as a canon of construction that overrides the presumption against extraterritoriality. The brief highlights how assuming legislation applies extraterritoriality can cause harm and undermine the meaningful development of international law.
"Max Huffman and I have previously written about these issues. Max's excellent article on the Foreign Trade Antitrust Improvements Act can be found here. I have written two pieces on international law, the effects test, and extraterritoriality. They can be found here and here."
In a 7-2 decision, the Supreme Court held that yes - RICO association-in-fact enterprises require an "ascertainable structure beyond that inherent in the pattern of racketeering activity in which it engages, but no - "an instruction framed in this precise language is not necessary." (Boyle v. United States). In the first part of the decision, the Court looks are three questions - "First, must an association-in-fact enterprise have a 'structure'? Second, must the structure be 'ascertainable'? Third, must the 'structure' go 'beyond that inherent in the pattern of racketeering activity' in which its members engage?" The decision relies heavily on Turkette.
The Court held that an association-in-fact enterprise needs to have "three structural features: a purpose, relationships among those associated with the enterprise, and longevity sufficient to permit these associates to pursue the enterprise's purpose." But despite the Court stating that these three features are needed, it does not require that the jury be told many specifics. The Court found that the instruction given "properly conveyed the point [ ] made in Turkette, that proof of a pattern of racketeering activity may be sufficient in a particular case to permit a jury to infer the existence of an association-in-fact enterprise.
Such a group need not have a hierarchical structure or a "chain of command"; decisions may be made on an ad hoc basis and by any number of methods—by majority vote, consensus, a show of strength, etc. Members of the group need not have fixed roles; different members may perform different roles at different times. The group need not have a name, regular meetings, dues, established rules and regulations, disciplinary procedures, or induction or initiation ceremonies. While the group must function as a continuing unit and remain in existence long enough to pursue a course of conduct, nothing in RICO exempts an enterprise whose associates engage in spurts of activity punctuated by periods of quiescence.
It is easy to envision situations in which proof that individuals engaged in a pattern of racketeering activity would not establish the existence of an enterprise. For example, suppose that several individuals, independently and without coordination, engaged in a pattern of crimes listed as RICO predicates—for example, bribery or extortion.Proof of these patterns would not be enough to show that the individuals were members of an enterprise.
A two-person dissent (Stevens and Breyer) offers a more limited and structured view of what should be included within the word "enterprise." They state that "Congress intended the term 'enterprise' as it is used in [RICO] to refer only to business-like entities that have an existence apart from the predicate acts committed by their employees or associates."
"This Court should reverse and hold definitively that a RICO enterprise requires structure apart from a random association of individuals to commit crime. RICO did not and could not create a federal felony for “a pattern of racketeering activity.” If an alleged RICO enterprise need not have structure, then the statute’s explicit enterprise requirement is meaningless."
For background and commentary on this issue, see the prior post here.
Brian Leiter on his blog links to the May 28, 2008 appointment of Alan Michaels as Interim Dean at Ohio State. Michael's appointment results from Dean Nancy Rogers stepping down as dean to serve as the Interim Ohio Attorney General. It reminded me that Dean Michaels, who teaches white collar crime, has a link to a thoughtful podcast on his webpage that discusses the RICO decision - Wilkie, Charles, et al. v. Robbins, Harvey. Check it out here.
Although the Racketeer Influenced and Corrupt Organization Act (RICO), enacted in 1970, was focused on organized crime, its use in the white collar sphere is common. One finds RICO charges in many corruption and fraud prosecutions. The United States Supreme Court recently accepted on certiorari a RICO case that will hopefully resolve one of the nagging issues that pervades this area of the law. The Court, in the case of Boyle v. United States, will look at the issue: "does proof of an association-in-fact enterprise under the Racketeer Influenced and Corrupt Organization Act, 18 U.S.C. §§ 1962 (c) - (d), require at least some showing of an ascertainable structure beyond that inherent in the pattern of racketeering activity in which it engages?"
The federal circuits have been all across the board on what is required for a 1961(4) enterprise. If it is a legal structure, person, or corporation, the process is easy. In this regard prosecutors have used an Office of a Governor, Prosecutor’s Office and other entities as the enterprise for a RICO prosecution.
Less clear is when the prosecution is premised upon "any union or group of individuals associated in fact although not a legal entity."
The Second Circuit has permitted prosecutions that have an "association-in-fact" form of enterprise that merely uses the predicate acts. Other circuits have required some "ascertainable structure." In some cases they require that the ascertainable structure be "distinct from the pattern of racketeering," with other cases looking at whether it is "an on-going structure."
Hopefully, the Supreme Court will offer some guidance on how to interpret this aspect of the RICO statute.
Since its passage in 1970, the Court has been reluctant to restrict the reach of the RICO Act. And although the statute has long left its initial roots as a tool to combat organized crime to become a statute that is regularly used by both prosecutors and civil litigants in common cases of fraud, the Court has reigned it in.
Even when interstate commerce was restricted in Lopez, the Court came back in the Robertson decision and held that RICO had an alternative way of proceeding - either "engaged in" or "substantially affect" interstate commence.
The two key cases that restricted RICO, H.J. Inc. v. Northwestern Bell Telephone Co. and Reves v. Earnst & Young, both were interpreting the statutory language.
The Court has ruled in several cases to restrict the constantly expanding mail fraud statute. Mail fraud is a commonly used predicate offense in RICO.
Although the Court often refers to common law concepts when discussing fraud statutes, it won't help the party being subjected to a RICO claim as the Court firmly notes that "Congress chose to make mail fraud, not common-law fraud, the predicate act for a RICO violation."
The Court sends a clear message to Congress that if you don't like this decision, then its up to you to correct it. And Congress may want to consider this challenge as this decision opens the door to increased civil litigation using RICO.
U.S. District Court Judge Amy St. Eve. narrowed the jury pool to twenty, from which a twelve-person jury with six alternates will be chosen to hear opening arguments on March 19 in the conspiracy, securities fraud, and RICO prosecution of Lord Conrad Black and three former senior executives of Hollinger International (now Sun-Times Media Group). The jury will have a blue-collar tint, according to an article in Canadian Business (here). Black's three co-defendants are John Boultbee, Hollinger's former CFO, former executive vice president Peter Atkinson, and former general counsel Mark Kipnis, and they have been largely ignored in the media's focus on Black. It will be interesting to see if they will present a united front at trial, and whether any (or all) will testify. While Black is reputed to have a rather imperial manner, little is known about the other three defendants, who may be able to connect with the jury better than the former CEO.
While Patrick J. Fitzgerald is busy prosecuting I. Lewis "Scooter" Libby, his office back home in Chicago filed its brief in the case U.S. v Ryan. Former Governor Ryan had been convicted of fraud and other charges (see here). The brief responds to defense claims including arguments that "[t]he district court properly dismissed two jurors and replaced them with alternates," the mail fraud "honest services" provision was not vague, and that the RICO charge was proper. In the last argument, the government claims that the State of Illinois can be a proper RICO Enterprise. Although this last point has been held acceptable by other courts, it raises interesting federalism concerns that may at some point be addressed by higher courts.
Former Illinois Governor George Ryan was sentenced to serve 6 and one-half years in federal prison for his convictions on corruption and RICO charges following a seven-month trial. The charges related to conduct when Ryan was the Illinois Secretary of State and involved gifts related to the issuance of drivers licenses and other government contracts. A number of former aides have been convicted, and Ryan received the same sentence as his top aide. The government sought a sentence within the Guidelines range of 8-10 years, and the defense argued for a 30-month sentence due to Ryan's poor health. Although U.S. District Judge Rebecca Pallmeyer did not impose the sentence called for by the Sentencing Guidelines, the term of imprisonment is significant and means that Ryan will not be released until he is at least 78 years old, assuming the conviction is upheld on appeal. A Chicago Tribune story (here) discusses the sentencing.
A judge of the Ontario Superior Court of Justice issued an order freezing the Canadian assets of Lord Conrad Black, former CEO of Hollinger International and a defendant (along with three other former Hollinger executives) in a federal court indictment charging fraud, conspiracy, and RICO related to transactions with the company. Black is out on a $20 million bond secured by a home in Florida and, more recently, $1 million in cash because of certain disclosure "problems" in his orignial bail application (see earlier post here). The order in the Ontario court arises from a civil suit in which Hollinger seeks repayment of approximately $700 million that it accuses Black of looting from the company, involving many of the same issues charged in the U.S. prosecution.
U.S. District Judge Gladys Kessler ruled in favor of the federal government in its massive RICO case against the tobacco companies alleging that they engaged in misleading conduct for decades as part of a broad conspiracy (U.S. v. Philip Morris USA, et al. here). The opinion may be nearly as dangerous to the environment as smoking, coming in at 1,653 pages, not counting the appendices, so that's a whole lot of trees. The table of contents alone is 29 pages, although there are only 58 footnotes.
[T]he Court is enjoining Defendants from further use of deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full flavor cigarettes, including the popular descriptors “low tar,” “light,” “ultra light,” “mild,” and “natural.” The Court is also ordering Defendants to issue corrective statements in major newspapers, on the three leading television networks, on cigarette “onserts,” and in retail displays, regarding (1) the adverse health effects of smoking; (2) the addictiveness of smoking and nicotine; (3) the lack of any significant health benefit from smoking “low tar,” “light,” “ultra light,” “mild,” and “natural” cigarettes; (4) Defendants’ manipulation of cigarette design and composition to ensure optimum nicotine delivery; and (5) the adverse health effects of exposure to secondhand smoke.
The Supreme Court reemphasized that private RICO claims must meet a fairly high standard of proximate causation if they will survive a motion to dismiss in its decision in Anza v. Ideal Steel (here). The civil cause of action granted under RICO is unique in federal law by providing private parties a means to recover treble damages plus attorney's fees for a claim based on conduct by defendants that can be shown to violate a variety of federal criminal laws, most importantly the mail and wire fraud statutes. The "catch-all" provision of RICO, Sec. 1962(c), arguably allows almost every business dispute to be turned into a RICO claim because the plaintiff only needs to show that the defendants conducted or participated in the conduct of the enterprise through a pattern of racketeering activity. Because the pattern requirement is fairly minimal -- only two illegal acts, one of which is within the past ten years -- a creative lawyer can make most contractual claims into possible RICO actions because there will be mailings, faxes, e-mails, and the like in most of them that can support a complaint.
The proper referent of the proximate-cause analysis is an alleged practice of conducting National’s business through a pattern of defrauding the State. To be sure, Ideal asserts it suffered its own harms when the Anzas failed to charge customers for the applicable sales tax. The cause of Ideal’s asserted harms, however, is a set of actions (offering lower prices) entirely distinct from the alleged RICO violation (defrauding the State).
Ideal accuses the Anzas of defrauding the State of New York out of a substantial amount of money. If the allegations are true, the State can be expected to pursue appropriate remedies. The adjudication of the State’s claims, moreover, would be relatively straightforward; while it may be difficult to determine facts such as the number of sales Ideal lost due to National’s tax practices, it is considerably easier to make the initial calculation of how much tax revenue the Anzas withheld from the State. There is no need to broaden the universe of actionable harms to permit RICO suits by parties who have been injured only indirectly.
The Court did not consider the application of the proximate cause analysis to a Sec. 1962(a) claim, which requires proof of different elements than Sec. 1962(c), and remanded the case to the Second Circuit to consider that claim.
In my view, the “antitrust” nature of the treble-damage provision’s source, taken together with both RICO’s basic objectives and important administrative concerns, implies that a cause is “indirect,” i.e., it is not a “proximate cause,” if the causal chain from forbidden act to the injury caused a competitor proceeds through a legitimate business’s ordinary competitive activity. To use a physical metaphor, ordinary competitive actions undertaken by the defendant competitor cut the direct causal link between the plaintiff competitor’s injuries and the forbidden acts.

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