This blog article presents an overview of the potential application of the Wisconsin Right to Try Law in light of the contemporaneous passage of the Federal Right to Try Act. This article should not be construed as legal advice. Contact an attorney to determine how these laws may affect you.
Last month in Part I of this article, we discussed the Wisconsin Right to Try (“WRTT”) law and the Federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right to Try Act”). In Part I, we discussed how these laws could apply to a patient, provider, or manufacturer when a patient seeks access to an investigational drug. In this Part II, we will try to answer the questions “Why are there so many laws about this? How do I comply with all of them?” with a discussion on the interaction of the WRTT law with federal law and how the federal Right to Try Act impacts the “Expanded Access” program under the Federal Food, Drug, and Cosmetic Act (“FDCA”).
To recap from Part I, the WRTT law permits eligible patients to gain access to investigational drugs, devices, or biological products under certain circumstances.[i] The Right to Try Act amends the FDCA to authorize eligible patients to access investigational drugs directly from the manufacturer or sponsor of eligible investigational drugs without prior permission from the U.S. Food and Drug Administration (“FDA”).[ii] The “Expanded Access” program, commonly referred to as the “Compassionate Use” program, gives eligible patients a way to access investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no adequate therapy options available outside of clinical trials.[iii] Under the Expanded Access program, eligible patients could apply to the FDA for approval to access to investigational drugs, biologics, and medical devices. The key difference between the Expanded Access program and the Right to Try Act is that the Right to Try Act excludes the FDA from the process. In other words, eligible patients do not need to apply for review and approval from the FDA to obtain access to certain investigational products under the new law.[iv] They can now obtain investigational drugs directly from drug manufacturers or sponsors.
So what’s the deal with all of these laws? Congress enacted the federal law in large part to ensure the state right to try laws would not be preempted. Under the Supremacy Clause of the U.S. Constitution, the U.S. Constitution and the laws of the U.S. are the “supreme Law of the Land,” and they prevail over any conflicting or inconsistent state exercise of power.[v] Congress can expressly preempt state action, but it can also do so impliedly. This means that if Congress expressly preempts state action or if Congress comprehensively regulates or demonstrates intent to regulate a particular field, then the U.S. Constitution and federal law is the law of the Land where state law is inconsistent.
State right to try laws would have likely been preempted in their entirety if Congress did not enact the Right to Try Act because Congress has historically given the FDA comprehensive authority to regulate drugs and investigational products under the FDCA. The FDCA’s legislative history indicates that Congress intended to protect patients with terminal illness from fraudulent cures and to regulate unapproved drugs because of the comprehensive system under the FDCA.[vi] Moreover, certain provisions of the state right to try laws would have made it impossible to comply with both state and federal law.[vii] Therefore, if state right to try laws were challenged before passage of the Right to Try Act, a court would have likely found that the FDCA preempted state right to try laws. This is largely why we now have two right to try laws.
The federal and state laws contain three main provisions. First, they permit eligible patients to access investigational products, as applicable, that have not been approved or licensed for use by the FDA. Second, they limit liability for any manufacturer, distributor, pharmacist, practitioner, or other person who makes applicable investigational products available under the conditions specified in the law. Third, they require the manufacturers or sponsors of the investigational products to submit an annual summary to the FDA regarding the use of the investigational product by eligible patients.
The WRTT law is consistent with federal law in that both cover investigational drugs as defined by the FDCA. However, the state and federal laws differ in an important way. One main difference between the state and federal law is that the WRTT law covers investigational drugs, devices, and biological products. Whereas, the federal Right to Try Act does not expressly cover investigational devices, nor does it expressly cover certain biological products not included in the FDCA’s definition of “investigational drugs.”[viii] This is an important distinction because of federal preemption. Since the WRTT law covers investigational devices and biological products, and the Right to Try Act does not, these provisions risk federal preemption under the Supremacy Clause of the U.S. Constitution because they are inconsistent with federal law.
Unlike state regulation of investigational drugs,[ix] Congress has expressly preempted state regulation of medical devices under the Medical Device Amendments of 1976 (“MDA”).[x] MDA established a comprehensive system for federal regulation of the premarket approval of medical devices and explicitly restricted states’ authority over their regulation.[xi] Moreover, access to investigational devices are regulated under the Expanded Access program, and the requirements for access to investigational devices directly conflict with WRTT law.[xii] For example, because the WRTT law permits manufacturers to provide access to investigational devices to eligible patients in contravention of the FDCA’s requirement not to introduce certain new devices into interstate commerce without prior FDA approval, a court could nullify those WRTT provisions inconsistent with federal law.[xiii] Thus, the manufacturer of an investigational device risks operating in contravention of federal law if it supplies a patient with a device without prior FDA approval pursuant to the Expanded Access program.
Finally, although Congress has not expressly preempted state regulation of biological products,[xiv] there are strong arguments for implied preemption. Therefore, if a manufacturer were to provide an eligible patient with a biological product (not covered by the Right to Try Act)[xv] pursuant to the WRTT law, the manufacturer risks violating federal law.
However, because of potential federal preemption, it is uncertain how the federal government will treat access to investigational devices and biological products pursuant to WRTT law. As a result, the constitutionality of the WRTT law could be legally challenged as it applies to the aforementioned inconsistencies.
If the FDA disagreed with the WRTT’s inconsistent provisions, it could seek an injunction to prevent a patient’s access to an unapproved investigational device or biological product and to prevent future patient access to such investigational products. An enforcement action could bring rise to a lawsuit, and a litigant with standing, such as a drug manufacturer, could seek declaratory relief in court as to the validity of the inconsistent WRTT provisions.[xvi] If the legally inconsistent provisions were nullified by a court, “the FDA could impose penalties on doctors and manufacturers for marketing or distributing unapproved [devices]. More practically, however, the FDA could impose penalties first with the intent to raise the preemption issue in court.”[xvii] This means that manufacturers and physicians could risk facing FDA enforcement for distributing unapproved investigational devices and certain biological products in contravention of the federal law.
To avoid the risk of operating in contravention with federal law, eligible Wisconsin patients and physicians could apply for FDA approval through the Expanded Use program to access investigational devices and those investigational biological products not covered by the Right to Try Act.[xviii] Also to avoid this risk, manufacturers or sponsors of investigational devices and biological products not covered by the Right to Try Act could require patients and physicians to seek FDA approval from the Expanded Access program before permitting access to such products. Any person or entity who determines not to provide access to such investigational products is exempt from liability for such determination.
The application of the WRTT law and the Federal Right to Try Act is yet to be determined. Because of the discrepancies between these laws, it is possible that we will see further action by the states, by the FDA or in the courts to settle these discrepancies in the months and years to come. Consult with McCarty Law if you have questions about how you can access investigational drugs, devices, and biological products or how you can provide these products to eligible patients.
Please note that this blog article does not discuss access to investigational drugs pursuant to the WRTT law, it only focuses on the potential federal preemption issues concerning access to investigational devices and certain biological products not covered by the Right to Try Act. Although the WRTT law covers investigational drugs, devices, and biological products, the federal Right to Try Act does not expressly cover investigational devices or certain investigational biological products. For a discussion on access to investigational drugs under the WRTT law and the Right to Try Act, please see Part I of this blog article.
[i] Wis. Stat. § 450.137.
[ii] Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115-176, 132 Stat. 1374 (May 30, 2018) (codified at 21 U.S.C. § 360bbb-0a).
[iii] Food & Drug Administration Modernization Act of 1997 (“FDAMA”), Pub. L. No. 105–115; Food & Drug Administration Amendments Act of 2007 (“FDAAA”), Pub. L. No. 110–85 (codified at 21 U.S.C. § 360bbb et seq.).
[iv] Jarrow, Lurie, Crowley, et al., Overview of FDA’s Expanded Access Program for Investigational Drugs, 51(2) Therapeutic Innovation & Regulatory Science 177 (Feb. 26, 2017) (available at https://doi.org/10.1177/2168479017694850).
[v] U.S. CONST. art. VI.
[vii] See Black, supra note vi, at 740 (concluding “the right to try acts are contrary to the FDA’s approval process, which requires a minimum of three phases of testing, and are also contrary to the FDA’s compassionate use program, which requires permission from the FDA for a terminally ill patient to receive access to investigational drugs.”).
[viii] Under the Right to Try Act, “eligible investigational drug” means an investigational drug (as such term is used in section 561 of the FDCA): 1.) for which a Phase 1 clinical trial has been completed; 2.) that has not been approved or licensed by the FDA; 3.) either a.) for which an application has been filed for FDA license or approval, or b.) that is under investigation in a clinical trial that i.) is intended to form the primary basis of a claim of effectiveness in support of approval or ii.) licensure or is the subject of an active investigational new drug application; and 4.) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold. The FDCA regulations define an investigational new drug as “a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.” “Investigational drug” and “investigational new drug” are deemed to be synonymous under the law and regulations. See 21 U.S.C. § 360bbb; see also 21 C.F.R. §312.3(b).
[ix] See Martin, supra note vi, at 181 (pointing out that the “Kefauver Harris Amendments to the FDCA added a savings clause to the Act, noting that ‘[n]othing in the amendments made by this Act to the [FDCA] shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.’” Drug Amendments of 1962, Pub. L. No. 87-781, § 202, 76 Stat. 780, 793 (1962).).
[x] See Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified as amended at 21 U.S.C. §§ 360c-360k, 379, 379a; 42 U.S.C. § 3512 (2012)); 21 U.S.C. § 360k(a) (“Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement 1.) which is different from, or in addition to, any requirement applicable under this chapter to the device, and 2.) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”); see also Martin, supra note vi, footnote 142 (“When Congress included this express preemption provision within the MDA of 1976, it could have easily added a parallel provision for prescription drugs, yet declined to do so [in Riegel v. Medtronic, Inc].”); Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17 (2008) (holding that § 521 of the FDCA expressly preempts personal injury lawsuits at common law that challenge the safety or effectiveness of medical devices if the devices enters interstate commerce under the a Premarket Approval application; See also Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996) (holding that § 521 preemption does not apply if the device enters interstate commerce under the “premarket notification” process of § 510(k) of FDCA).
[xi] See Martin, supra note vi, at 167–68.
[xii] See 21 U.S.C. § 360bbb; 21 U.S.C. § 360bbb-0a (Note the absence of the words “investigational device,” “eligible investigational device,” and reference to investigational devices from the statute).
[xiii] Jan Murraya & Lindsey E. Gabrielsena, Right-to-Try Laws: Safe and Effective or Placebo Legislation?, 9 J. Health & Life Sci. L. 54, 67 (June 2016); Certain devices must also receive premarket approval by the FDA. See 21 U.S.C. §§ 360e & 360j.
[xiv] See Abbott v. American Cyanamid Co., 844 F.2d 1108, 1111 (4th Cir. 1988) (finding no express preemption provision applicable to biologics).
[xv] The definition of investigational drugs under the FDCA includes investigational biological products used in vitro for diagnostic purposes. Therefore, access to investigational drugs and those investigational biological products included in the FDCA’s definition of investigational drugs would likely be covered under the WRTT law and the Right to Try Act.
[xvi] See Martin, supra note vi, at 190.
[xvii] See generally Murrarya & Gabrielsena, supra note xiii.
[xviii] U.S. Dept. of Health & Human Servs, U.S. Food & Drug Admin., Expanded Access (last updated Nov. 8, 2018).
Lindsey focuses her practice on regulatory compliance and corporate transactions in health care as she assists her clients in understanding and navigating health care policies.


Document-Id: 108500, Please cite as: "https://www.trans-lex.org/108500"
This document is included in TransLex by kind permission of Grotius Publications/Cambridge University Press.
Can a State corporation rely on its separate personality to plead that an act of State constitutes force majeure, freeing the corporation from a contract with a third party? The third party may sometimes have good reason to think that the State may have acted jure impeii in order to escape from a commitment contracted jure gestionis by its alter ego. Böckstiegel258 recognizes that the other party to the contract may have great difficulty in proving such a connivance. He would therefore place the burden on the corporation to prove that the act of force majeure had been taken for the benefit of the general public good and not only for the benefit of the corporation.
Two recent Arbitral Awards rendered under the rules of the International Chamber of Commerce263 indicate a readiness to deny a State-owned enterprise the right to rely on force majeure in such circumstances. Both awards approve a decision by the French Supreme Court264 which held that Air France could not rely on force majeure where its guardian authority, the State, had tried to prevent it from carrying out its obligations. The awards, however, could avoid the issue. In one case the event relied on was held to have been foreseeable. In the other case the State itself was made a party to the arbitration, thus rendering moot the force majeure issue.
German Democratic Republic270 does give a definition of force majeure, but does not indicate clearly whether State interventions come under this definition. Sosniak271 has recently stated that the rules embodied in these two Protocols were special mutual concessions which have not been granted to the other Council partners, let alone to third States.
Enderlein272 explains this attitude by pointing out that in relations between socialist States each enterprise binds itself under international law to furnish and to accept the goods concerned. Non-recognition of a force majeure plea constitutes a sanction for a default concerning these duties.
In the Barcelona Traction case the International Court declared that the corporate veil may be lifted in appropriate cases,568 which the court did not deem to exist in the case concerned.
As far as diplomatic protection of common inter-State enterprises is concerned, no problem arises as long as such enterprises are established under the law of one of the partner States. They are thus nationals of that State, which will be entitled to grant them diplomatic protection.
If one were to tie the right to protect a Corporation to a genuine link with the State exercising such protection, this condition would be fulfilled in the present case.569 The seat State of the enterprise, as partner of that enterprise, will have a considerable interest in it.
Things become more difficult in the case of enterprises established under international law. According to the will of the partner States they should be cut loose frorn any national ties. These enterprises would be in a position similar to that of stateless persons. None of the partner States could therefore grant them the diplomatic protection it may grant to its nationals.
This undesirable result could be overcome by assuming that this right belongs to those parts of the law of the host State which apply residuarily. However this solution would be incompatible with the desires of the partner States.
However, the partner States would certainly not be willing to leave without any protection enterprises belonging to them and established by them for the promotion of their common good.571 The only way of obtaining such protection would be to lift the corporate veil. Each partner State would then be able to exercise diplomatic protection on behalf of its share in the enterprise. All the partners could jointly exercise diplomatic protection on behalf of the enterprise.
The Barcelona Traction572 judgment also refers to piercing the corporate veil in the interest of creditors.
Shihata577 refuses to deduce the existence of a rule of unlimited liability merely from the absence of a rule of limited liability in international law. "All relevant provisions and circumstances must be studied to ascertain what was intended by the parties in this respect and the extent to which their intention was made known to third parties." These intentions will be closer to limiting the responsibility of the partners.
As far as common inter-State enterprises are concerned, the partner States here too come to their rescue. The partners assumed the financial consequences of their bad judgment when establishing the International Institute for the Management of Technology in Milan.582 It should have been evident to them that there was no market for a school of this type, in addition to the well-established schools already in existence in this field.
The responsibility of the partner States was even more directly engaged in the case of Eurochemic. They had ordered Eurochemic 121 to continue its activities for political reasons when the management of Eurochemic saw no other possibility than winding up.583 After protracted negotiations the partners furnished funds to Eurochemic in excess of their share in Eurochemic's capital in order to avoid its bankruptcy.
However, may the member States hide behind this veil at all in order to escape liability for debts incurred by their common inter-State enterprise? The above precedents are not devoid of legal significance. The States appear to have acted on the assumption that they had more than a moral responsibility. Such responsibility as there is would be borne by the partner States jointly and severally.
Just as a State cannot escape its responsibility under international law by entrusting to another legal person the fulfilment of its international obligations,584 the partner States of a common inter-State enterprise are jointly and severally responsible in international law for the acts of the enterprise.
Agreements establishing a common inter-State enterprise often include as an annex a statute containing rules for its own amendment. However, as long as the partner States act in common, they may disregard these rules. This will be so even if the enterprise has been established under the law of one of its member States,585 unless the rules in the statute form part of the imperative law of that State.
At least such would be the result if one were to examine the problem exclusively from the international law angle. The rules of 122 domestic constitutional law on the transformation or incorporation of international law into domestic law may be more formalistic. Even in international law, though, there may be limits to the "masters of the treaty" doctrine. Article 84 and Annex 29 of the Treaty between France and the Federal Republic of Germany on the Saarland of 27 October 1956587 established Saarlor S.A. for a period of 25 years. This period expired in 1981. The State partners of Saarlor S.A. continued this common inter-State enterprise beyond this term. Rolshoven and Jehne588 believe that the statute of Saarlor S. A. enables the organs of Saarlor to take this decision, provided it is approved by the two governments. Nevertheless, in view of the specific terms of the Treaty this decision may have been ultra vires. It would have been preferable to modify the relevant provisions of the Treaty.
258 Der Staat als Vertragspartner ausländischer Privatunternehmen (1971), pp.73-4, contra Enderlein, "Juristische Selbständigkeit sozialistischer Aussenhandelsbetriebe contra 'Durchgriff'," Staat und Recht 33 (1984), p.401.
259 Domke, "The Israeli-Soviet Oil Arbitration," A.J.I.L. 53 (1959), pp.787-800, Berman, "Le cadre juridique des relations commerciales entre pays d'économie planifié et pays d'économie libre: L'exemple americano-soviétique" in David (ed.), Aspects juridiques du commerce avec les pays d'économie planifiée (1961), pp.27-8.
260 Jordan Investments Limited v. Sojuzneft Export, A.J.I.L. 53 (1959), p.800, I.L.R. 27, p.631.
261 Seidl-Hohenveldern, "Völkerrechtsfragen der Wirtschaftsbeziehungen mit zentralwirtschaftlichen Handelspartnern," Osteuropa-Recht 1974, p.198, id., Rev.Eg. 21 (1965), p.129.
262 Czarnikow Ltd. v. Rolimpex  A.C. 351,  3 W.L.R. 274.
263 Award of 30 May 1979, Case Nos. 3099 and 3100, Yearbook Commercial Arbitration VII (1982), p.87 , Award of 11 March 1983, Case No. 3493 S.P.P. (Middle East) Limited, Southern Pacific Properties Limited v. Arab Rebublic of Egypt and the Egyptian General Organization for Tourism and Hotels (E.G.O.T.H.), I.L.M. 22 (1983), p.753, at p.780, annulled by Paris Court of Appeals 12 July 1984, I.L.M. 23 (1984), p.1048.
264 Decision of 15 April 1970, Recueil Dalloz 1971, Jurisprudence, p.107 as quoted in Yearbook Commercial Arbitration VII (1982), p.90.
265 Award of 11 December 1958 quoted by Jakubowski, "The Settlement of Foreign Trade Disputes in Poland," I.C.L.Q. 11 (1963), p.815.
266 Art.68 of ALB/RGW of 1968/1975 as modified in 1979, Uschakow, Integration im RGW (COMECON) (1983), p.546 and Fink, "Einheitliches COMECON Handelsrecht," Recht der Internationalen Wirtschaft 1974, p.19.
267 Protocol of 19 December 1968, Uschakow, Der Ostmarkt im COMECON (1972), p.231.
268 Protocol of 13 December 1968, Uschakow (1972), p.235.
269 Seidl-Hohenveldern, "Innerstaatliche Rechtsregeln der Bundesrepublik Deutschland, die für die wirtschaftliche Zusammenarbeit zwischen ihr und Polen von Bedeutung sind," in Kokot, Skubiszewski (ed.), Staatsangehörigkeit, Soziale Grundrechte, Wirtschaftliche Zusammenarbeit (1976), p.275.
270 Law of 5 February 1976, Gesetzblatt der D.D.R., I, 1976, No.5, p.61. The relevant articles are translated into English in Strohbach, "Force Majeure and Hardship Clauses in International Commercial Contracts and Arbitration. The East German Approach," Journal of International Arbitration 1 (1984), pp.41 and 47. Strohbach, however, omits to discuss there the problem discussed in the text.
271 Sosniak, "Staatsakt und höhere Gewalt im internationalen Handelsverkehr der R.G.W. Länder," R.I.W. 1984, p.106.
272 Enderlein, loc. cit., p. 403.
273 Sovtorgflot v. The "King Edgar ", Recueil des décisions de la Commission d'arbitrage maritime (of the U.S.S.R.) (Editions du commerce extérieur 1934, p.13) as quoted by Riad, "L'entreprise Publique et Semi-Publique en Droit International Privé," RdC 108 (1963-I), p.647.
274 Swedish Supreme Court, 29 July 1952, Fischler, "Das internationale Privatrecht Schwedens 1949-1951," RabelsZ 22 (1957), p.29. Seidl-Hohenveldern, Rev.Eg. 21 (1965), p.130.
568 See supra text at note 33.
569 Contra the I.C.J. in the Barcelona Traction case, I.C J. Reports 1970, p.50, para.100.
570 But see Goldman's proposal for granting such a right of diplomatic protection to the U.N. in respect of multinational enterprises, supra text at note 103.
571 See supra text after note 530.
572 See supra text at note 568.
573 Adam, Les organismes internationaux spécialisés (1965), Vol. l, pp.129-30.
574 Cf. supra text at notes 472-3.
575 Cf. supra text at note 492.
576 R. David and Drobnig in S. Bastid, R. David, op.cit., pp. 12-13 and 46-8 respectively.
577 Shihata, "Role of Law in Economic Development. The Legal Problem of International Public Ventures," Rev.Eg. 25 (1969), p.125.
578 But see text at note 576.
579 Cf. supra text at notes 412-20.
580 Keesing's Archiv der Gegenwart (1975), p.19.162.
581 Blanpain, "The Badger Case and O.E.C.D. Guidelines for Multinational Enterprises" (1977), Seidl-Hohenveldern, RdC 163 (1979-II), pp.209-11.
582 See supra text at note 559.
583 Von Busekist, loc.cit., p.264.
584 The Attilio Regolo Award of 1945, Ann.Dig. 14 (1947), p.319, at p.323.
585 According to the German Federal Court, the partners of a contract could modify this contract merely by their unanimous behaviour over a certain period of time although according to the text of the contract all amendments thereto should have had to be made in writing. German Federal Court, 17 January 1966, Lindenmaier-Möhring, Nachschlagewerk des Bundesgerichtshofes, No.22 to H.G.B., Art.105.
586 Cf. supra text at notes 351 and following.
587 French J.O., 10 January 1957, p.460.
588 Rolshoven and Jehne, "Saarlor, Eine europäische Gesellschaft besonderen Rechtes" in Liber Amicorum B.C.H. Aubin (1979), p.191.


text:
Can. 1717 §1. Whenever an ordinary has knowledge, which at least seems true, of a delict, he is carefully to inquire personally or through another suitable person about the facts, circumstances, and imputability, unless such an inquiry seems entirely superfluous.
§2. Care must be taken so that the good name of anyone is not endangered from this investigation.
§3. The person who conducts the investigation has the same powers and obligations as an auditor in the process; the same person cannot act as a judge in the matter if a judicial process is initiated later.
3/ whether a judicial process must be used or, unless the law forbids it, whether the matter must proceed by way of extrajudicial decree.
§2. The ordinary is to revoke or change the decree mentioned in §1 whenever new evidence indicates to him that another decision is necessary.
§3. In issuing the decrees mentioned in §§1 and 2, the ordinary is to hear two judges or other experts of the law if he considers it prudent.
§4. Before he makes a decision according to the norm of §1 and in order to avoid useless trials, the ordinary is to examine carefully whether it is expedient for him or the investigator, with the consent of the parties, to resolve equitably the question of damages.
Can. 1719 The acts of the investigation, the decrees of the ordinary which initiated and concluded the investigation, and everything which preceded the investigation are to be kept in the secret archive of the curia if they are not necessary for the penal process.

matches: §1 §2 §3 §2 §1 §3 §4 §1


PETER K. CHO, et al., Defendants.
Marsha J. Pechman United States District Judge.
THIS MATTER comes before the Court on Plaintiff's Response to the Court's Order to Show Cause (Dkt. No. 22) and Plaintiff's Motion to Appoint Counsel (Dkt. No. 18.) The Court's Order to Show Cause directed Plaintiff to show cause why this case should not be dismissed without prejudice for failure to prosecute. (See Dkt. No. 21.) Having considered Plaintiff's Response, the Court hereby ORDERS that this action be DISMISSED without prejudice for failure to prosecute. The Court DENIES Plaintiff's Motion to Appoint Counsel.
Generally, a person has no right to counsel in civil actions. See Campbell v. Burt, 141 F.3d 927, 931 (9th Cir. 1998). A court has discretion to appoint counsel for indigent civil litigants pursuant to 28 U.S.C. § 1915(e)(1), but an appointment of counsel should only be granted under “exceptional circumstances.” Agyeman v. Corrections Corp. of Am., 390 F.3d 1101, 1103 (9th Cir. 2004). When determining whether “exceptional circumstances” exist, the Court considers “the likelihood of success on the merits as well as the ability of the [plaintiff] to articulate his claims pro se in light of the complexity of the legal issues involved.” Weygandt v. Look, 718 F.2d 952, 954 (9th Cir. 1983).
Because Plaintiff failed to establish either that the search of his person and property was more extensive or intensive than necessary or that it was unreasonably prolonged, the Court finds that Plaintiff is not likely to succeed on the merits of his claims. Therefore, the Court DENIES the Motion to Appoint Counsel.
In determining whether to dismiss a claim for failure to prosecute or comply with a Court order, the Court must assess the following factors: (1) the public's interest in expeditious resolution of litigation; (2) the Court's need to manage its docket; (3) the risk of prejudice to defendants/respondents; (4) the availability of less drastic alternatives; and (5) the public policy favoring disposition of cases on their merits. Pagtalunun v. Galaza, 291 F.3d 639, 642 (9th Cir. 2002).
“The public's interest in expeditious resolution of litigation always favors dismissal.” Id. (quoting Yourish v. California Amplifier, 191 F.3d 983, 990 (9th Cir. 1999)). Plaintiff has failed to serve Defendants for more than five months. Thus, this factor weighs in favor of dismissal.


§ 171-5 Preapplication discussion; classification of subdivisions; sketch layout.
§ 171-6 Preliminary layout; submission of application.
§ 171-7 Subdivision plat application.
§ 171-8 Subdivision plat; action by Planning Board.
§ 171-9 Required improvements; performance bond.
§ 171-10 Acceptance of streets.
§ 171-11 Reservation of recreation areas or moneys in lieu thereof.
§ 171-13 Modifications in procedure and standards.
§ 171-15 Character of land.
§ 171-16 Conformance to Master Plan and Official Village Map.
§ 171-17 Streets and blocks.
§ 171-18 Street design and improvements.
§ 171-22 Construction details sheet.
§ 171-23 Reimbursement for Village services.
§ 171-24 Approval by Planning Board required.
§ 171-26 Penalties for offenses.
Electrical inspections — See Ch. 78.