1 Page 1 Pharmacist Defense: A Federal Criminal Charge Robert P. Esgro, R.Ph., Esq. Pharmacy Lawyer This webcast has been supported by PharmCon Pharmacist Defense: A Federal Criminal Charge Accreditation: Pharmacists: L03-P CE Credits: 1.0 contact hour Target Audience: Pharmacists Program Overview: Generally, medical malpractice is litigated as a civil tort. In civil cases, as opposed to criminal suits, the alleged victim brings the lawsuit for the purpose of remedying perceived damages sustained via monetary compensation. In criminal cases, the State is the plaintiff. Criminal prosecution for medical malpractice is extremely rare in the United States, but maybe that's starting to change; more than half of the criminal cases since 1809 have been filed since The frightening thing is that the decision to make a medical malpractice event a criminal case is entirely up to the discretion of the prosecutor. This program will help you to understand the difference between malpractice cases and criminal proceedings, the steps in a criminal case, and standards of proof needed to convict. Objectives: Compare a pharmacy malpractice case versus a criminal proceeding Differentiate when the Federal government will pursue criminal charges as opposed to the state Identify the major steps in a Federal criminal case Identify the different standards of proof in which the government will have to prove throughout the case. PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. This webcast has been supported by PharmCon Pharmacist Defense: A Federal Criminal Charge Speaker: Robert Esgro, Esq is a Pharmacy Law Specialist out of Villanova Pennsylvania. He is also a Medical Editor and Consultant for Edward Newland Associates. Robert is a graduate of Philadelphia College of Pharmacy and Science and Widener University School of Law. He has worked for Merck & Co. as an Industrial Pharmacist as well as in the Merck marketing department. He continues to stay active in the practice of pharmacy and is knowledgeable of the working environment of the front line pharmacist. He belongs to several professional organizations including the American Pharmaceutical Association, American Bar Association, American Health Lawyers Association, The American Association of Nurse Attorneys, American Society of Pharmacy Law, and the Potomac Pharmacist Association where he was a former President. Speaker Disclosure: Mr. Esgro has no actual or potential conflicts of interest in relation to this program This webcast has been supported by PharmCon PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Objectives 1. Identify accusations that may lead to criminal prosecution as opposed to administrative actions or civil claims. 2. Differentiate when the federal government will pursue criminal charges as opposed to the state. 3. Describe the grand jury process. 4. Describe constitutional issues that can provide defenses. Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.
2 Page 2 Brief Review of Three areas of Law Civil Litigation 1. Civil Litigation 2. Criminal Law 3. Administrative Law Malpractice Award Money Damages Time consuming, stressful, and expensive to defend. Criminal Law Administrative Law Government is seeking to take the Defendant s Liberty/Freedom. Government must prove each element of statute allegedly violated or charged. Protect the health and welfare of the Public. License is considered a privilege. Rules are more relaxed in favor of state. Board of Pharmacy decisions can be appealed to the court system. First look to the Federal/state Constitution.
3 Page 3 The Connection When reviewing a case, all three areas of law MUST be considered. When working with a client licensee, there is a strong possibility that all three areas of law will have to be defended. Case Study Pharmacist Misfills - Lethal Dose of a Narcotic Civil Case Malpractice Wrong Death Action Use of Medical Experts Emotional for all Parties Involved Case Study Pharmacist Misfills a Lethal Dose of a Narcotic Criminal Law Manslaughter 18 Pa. C.S. 2504(a) "A person is guilt y of involuntary manslaughter when as a direct result of the doing of an unlawful act in a reckless or grossly negligent manner, or the doing of a lawful act in a reckless or grossly negligent manner, he causes the death of another person. Case Study Pharmacist Misfills a Lethal Dose of a Narcotic Federal Manslaughter Statute: 18 U.S.C. Sec Involuntary manslaughter is when a person is killed during the process of another unlawful act which does not amount to a felony, while acting in an unlawful manner or while acting without due caution or circumspection in a lawful action which might produce death.
4 Page 4 Case Study Pharmacist Administers a Lethal Dose of a Narcotic Administrative Law Board of Pharmacy will investigate because there was a death involved. Employer/facility will likely report. Licensee will likely have to report upon license renewal. Board of Pharmacy Report HHS The OIG, under Congressional mandate, established a program to exclude individuals and entities affected by these various legal authorities, contained in sections 1128 and 1156 of the Social Security Act. Maintains a list of all currently excluded parties. List of Excluded Individuals/Entities. Board of Pharmacy Report NPDB-HIPDB National Practitioner Data Bank Healthcare Integrity and Protection Data Bank State Licensing Agencies have specific reporting requirements to the National Practitioner Data Bank under Section 1921, and the Healthcare Integrity and Protection Data Bank. Client Case Pharmacist was plead guilty to a misdemeanor involving a controlled substance. Board of Pharmacy suspended license for 1 year. Pharmacy License was then reinstated. Pharmacist could not find employment regardless of discipline and criminal record. Why Not?
5 Page 5 Who Investigates State or Federal Pharmacist created fraudulent prescriptions for Tussinex and Ultram Pharmacist Get s an Unexpected Break There have been no criminal charges filed. Used the same physician s name and DEA for all Rxs Upon discovery, the physician reported this to the DEA Was this the correct agency to call? Client Question: How did this start? Search Warrant Traffic Stop Drug Bust Health Care Professional Report to Police/BNI FBI DEA HHS IRS
6 Page 6 Federal Search Warrant Confidential Informant Offer a consent agreement Initial suspect may become a Confidential Informant 1. Identify other participants 2. Wear a wire 3. Execute marked documents to help prosecution. Grand Jury The Fifth Amendment of the U.S. Constitution "No person shall be held to answer for a capital, or otherwise infamous crime, unless on a presentment or indictment of a grand jury Grand Jury Primary function of a grand jury is to review the evidence presented by the prosecutor and determine whether there is probable cause to return an indictment. No Judge, Prosecutor runs the proceeding. Consists of 16 to 23 members. Rule 6(a)(1) Recording of Grand Jury allowed but not required.
7 Page 7 Indictment Contains: 1. Criminal Charges 2. Forfeiture Indictment Charges: Conspiracy to distribute mixtures and substances containing oxycodone, a schedule II controlled substance, in violation of 21 U.S.C. 841(a)(1), 841 (b)(1)(c) & 846 Distribution of a mixture or substance containing a Schedule II controlled substance in violation of 21 U.S.C. 841(a)(1) & (b)(1)(c), and 18 U.S.C. 2 Forfeiture: Indictment Proffer Meeting Meeting with the Government for client to confess. Sum Of $220,000 As Total Drug Proceeds (Forfeiture Money Judgment) and/or facilitating property Gross proceeds forfeitable in drug case; United States v. Keeling, 235 F.3d 533, 537 (10th Cir. 2000) Some say: Ask for immunity from further charges State what will be discussed Discuss Plea agreement
8 Page 8 Proffer Agreement Proffer Agreement Proffer Meeting Lying, telling half truths or less than forth coming can bring on perjury charges or at least make the defendant appear to be hiding material information. Can expose client to additional involvement and greater drug quantity. Government can ask questions about other conspirators. Drug Quantity Hearing Government alleged the pharmacist defendant was responsible for all prescriptions filled. Even the prescriptions filled by other pharmacists. Even when the pharmacist was not working.
9 Page 9 Drug Quantity At the hearing, Defendant s counsel stipulated that 2,600 Convicted Doctor s prescriptions were filled by Convicted Dealer during this period at Pharmacy 1 and 2. Of those 2,600 prescriptions, 331 were for schedule II narcotic controlled substances containing oxycodone. These 331 prescriptions contained a total of 160 grams of oxycodone. These are the only prescriptions affecting the sentencing guideline level. See U.S.S.G. 2D1.1 - Judge s Opinion: Drug Quantity 1. Defendant aided and abetted Drug Dealer s use of sham prescriptions to illegally obtain drugs at Pharmacy 1 and Pharmacy 2 in the period from 2004 until Defendant is criminally responsible for the distribution of 160 grams of oxycodone, a Schedule II controlled substance. This is the amount of oxycodone Defendant aided, abetted, counseled, commanded, induced, procured, or willfully caused to be distributed and, in the case of jointly undertaken criminal activity, is the amount distributed by others in furtherance of Defendant s jointly undertaken criminal activity, which was reasonably foreseeable to Defendant. Sentencing Hearing The Fine Government request a fine within the middle of the $15,000 to $3,000,000 range Listing $2,500,00 in assets and a net worth of over a million dollars Clearly the defendant had the ability to pay. Defense $250,000 equity in real estate Judge s Ruling - $18,000 Sentencing Hearing Forfeiture Government Request Defense 1. $220,000 determined by Drug Quantity Hearing (DQH) 2. Pharmacy s DEA License 1. Uncontested after the DQH 2. DEA License was property of the pharmacy LLC and not the Defendant s Judge s Ruling 1. $220, Denied DEA license request
10 Page 10 Government s Sentencing Memorandum Base offense level distribution of controlled substances, 21 U.S.C. 841, under USSG 2D1.1(c)(4) (at least 1,000 kilograms but less than 3,000kilograms marijuana) 32 Specific offense characteristic for abuse of position of public or private trust, or use of a special skill under USSG 3B Adjustment for acceptance of responsibility, under USSG 3E1.1(a) -2 Adjustment for timely acceptance of responsibility, under USSG 3E1.1(b) -1 TOTAL OFFENSE LEVEL 31 Defense Objection to Sentencing Memorandum Specific offense characteristic for abuse of position of public or private trust, or use of a special skill under USSG 3B Base offense level 32 contains the necessary skill and private trust. Therefore, Judge should deny the additional 2 point increase. Judge relied on U.S. v. Sherman 3rd Circuit No , Sentencing Guideline Chart Criminal History Category I Offense Level to 135 Months Range The Sentence Even though the Judge ruled 108 to 135 months was an appropriate sentence he considered other factors. Judge ordered a 7 level downward departure to a offense level of 24 Sentence was 60 months
11 Page 11 Why Would the Judge Do That? Prison Defendant, now felon, played a substantial role, but was not a significant participant in the overall conspiracy. The pharmacist was the last conspirator to be sentence. The Judge relied on the fact that the other defendants had received the lower leave and felt compelled to comply with that standard here. Upon sentencing the now Prisoner, is either referred directly to the Bureau of Prisons or sent home on an electronic monitoring. Pick a Prison Defendant is allowed to request a specific prison. Correct Statement? I m not worried about costs. That s why I malpractice insurance. Judge will consider the request and reasons for the it.
12 Page 12 Client Question How Much is this Going to Cost? Top Criminal Defense Lawyers in Phila. Area: $600 per hour $75,000 retainer Total Costs to Defend a Federal Case can Exceed: $300,000 Fundamental Problem for Pharmacists Pharmacists were brought into the criminal action last. Meaning the pharmacist could not cooperate in a way that would incriminate others in the conspiracy. Collateral Costs: Family in shock Business destroyed Career destroyed Fundamental Problem for Pharmacists In addition: The drug quantity looked at the amount dispensed over time not just what was on the person at time of arrest or search warrant. Brief Introduction to Internet Pharmacies The Players: Web Hosts Set up websites, patients, coordinate the doctors and pharmacists. In addition collect and pay fees, setup the computer network and hide. Physicians Pharmacists
13 Page 13 Internet Pharmacies Dispense extremely high prescription counts per day. Prescriptions and Prescription labels are received via closed computer network. Mailing labels are also provided by Web Host. Two Philosophies: Internet Pharmacies 1. Dispense Controlled Substances 2. Dispense anything but Controlled Substances. Internet Pharmacies Federal Charges are centered around The Pharmacist knew or should have known there was no physician patient relationship. 1. Violations of the Controlled Substance Act 2. Violations of the FDA misbranding 3. State regulations concerning the practice of pharmacy. 4. Many states require a license for prescriptions to be mailed into state. Internet Pharmacies Federal investigation will involve visiting recipients addresses of the mailed medication. The recipients will gladly testify against the pharmacy after seeing the badge of the federal agent on their doorstep.
14 Page 14 Who Makes the Money? Who Assumes the Risk? Web Host Questions?? Physician Pharmacist Notes Notes
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