Health Law – Page 15 – Duane Morris Health Law

December 22, 2014December 22, 2014 by Seth A. Goldberg

False Claims and Anti-Kickback Defendants Should Insist on Discovery from the Whistleblower/Relator

One arrow in the quiver for healthcare providers sued for violations of false claims and anti-kickback statutes is pressing for discovery from the whistleblower/relator, including a deposition of the relator. The failure of the whistleblower to comply with the discovery obligations could result in meaningful sanctions, including dismissal.

In Guthrie v. A Plus Home Health Care, Inc. et al, 0:12-cv-60629-WPD (S.D. FL), the relator, William Guthrie, sued a home health care provider, its seven doctors, and their spouses, alleging that the doctors and their spouses implemented a fraudulent scheme of compensation and referral payments resulting in violations of the False Claims Act, the Stark Act, and the federal Anti-Kickback Statute. Continue reading “False Claims and Anti-Kickback Defendants Should Insist on Discovery from the Whistleblower/Relator”

December 12, 2014 by Philip H. Lebowitz

Clinical trial sponsors can be liable for inadequate consent forms

Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal law imposes several specific items to be included in the consent form. Where all pertinent risks, benefits and alternatives have been disclosed, and the patient signs the form, the patient is said to have given “informed consent.”

A patient injured in a clinical trial studying a new therapy for Parkinson’s Disease sued the manufacturer of the equipment used in the procedure. In addition to a claim of negligent design and manufacture of the equipment itself, the patient asserted that the manufacturer, as the sponsor of the clinical trial, was negligent in drafting and approving the informed consent documents that the patient signed to participate in the clinical trial. Can a manufacturer be liable for an improperly drafted consent form? Continue reading “Clinical trial sponsors can be liable for inadequate consent forms”

December 10, 2014June 14, 2017 by Philip H. Lebowitz

Medical Marijuana article

My partner Seth Goldberg and I just published an article in the Legal Intelligencer describing the ethical dilemmas faced by lawyers who have clients who may embark on business ventures that involve medical marijuana in Pennsylvania and other jurisdictions where the law and the norms are still being formulated. You can read the full text here.

December 5, 2014 by Philip H. Lebowitz

7th Circuit Clarifies FCA Fraud Standard

In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy. The principal claims in the case, Grenadyor v. Ukrainian Village Pharmacy, Inc., were that the pharmacy’s practice of soliciting and keeping its base of mostly Ukrainian customers by providing gifts of caviar and Russian language TV Guides, as well as waiving co-pays, amounted to kickbacks in violation of the federal (and several state) anti-kickback statutes.

Judge Richard A. Posner, the author of the court’s opinion, revealed his distaste for the relator early in the opinion by describing him as a “bounty hunter”. The court rejected most of the relator’s claims because he had failed to identify a single patient who received gift bags worth more than the de minimis $50, even though the relator had amended his complaint ostensibly to correct this deficiency, and had not alleged that the pharmacy intended to offer kickbacks when it certified to the government that it would abide by Medicare and other federal laws. Continue reading “7th Circuit Clarifies FCA Fraud Standard”

October 27, 2014 by Duane Morris

Duane Morris Special Counsel Michael E. Clark to Moderate Tweet Chat: Ebola and Legal Issues Raised by Reactions

Duane Morris special counsel Michael E. Clark will moderate a free Tweet Chat that is being hosted by the ABA Health Law Section on Wednesday, November 5, 2014 at 12:00 noon EST/11:00 a.m. CST.

About the Program

The Health Law Section’s second Tweet Chat will be held on Wednesday, November 5, 2014 at 12:00 noon EST / 11:00 am CST. The hashtag for the Tweet Chat will be #HLSChat. The Section’s Twitter account is @abahealthlaw. Follow the account for more information. The moderator for the chat will be the Section’s Chair, Michael Clark (@MichaelEClark). Also participating will be Kirk Nahra, @KirkJNahrawork an expert on privacy issues, and Melissa Markey, an expert on pandemics.

The topic is Ebola and legal issues raised by reactions. This is a popular topic in light of many fears about an outbreak in the United States and wanting to learn about treatment of individuals who have come back with the virus. Please join us to discuss these issues and share your ideas, thoughts and insights.

May 8, 2014September 10, 2014 by Duane Morris

Duane Morris Special Counsel Michael E. Clark to Present on “The Physician and Attorney Relationship in a Fraud Audit”

Duane Morris special counsel Michael E. Clark will be speaking on “The Physician and Attorney Relationship in a Fraud Audit: Working Through Related Ethical Issues,” during the Physicians Legal Issues Conference presented by the American Bar Association Health Law Section in conjunction with the Chicago Medical Society and the American College of Physician Executives. Mr. Clark’s presentation will be on Friday, June 13, 2014 from 8:00 a.m. until 9:15 a.m. at the Palmer House Hilton in Chicago.

Continue reading “Duane Morris Special Counsel Michael E. Clark to Present on “The Physician and Attorney Relationship in a Fraud Audit””

April 16, 2014September 10, 2014 by Duane Morris

Duane Morris’ Michael E. Clark Quoted in Modern Healthcare

Duane Morris special counsel Michael E. Clark of the firm’s Houston office, is quoted in “AHA Lawsuit over ‘Two-Midnight’ Rule Called Uphill Battle,” which appeared in Modern Healthcare on April 15, 2014.

No matter how strong their legal arguments, hospitals will have a tough time convincing judges to overturn Medicare’s controversial new rules on classifying inpatients, some legal experts say.

Continue reading “Duane Morris’ Michael E. Clark Quoted in Modern Healthcare”

November 4, 2013September 10, 2014 by Duane Morris

Duane Morris Attorneys Frederick Ball and Erin Duffy to Present “Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation”

Duane Morris partner Frederick Ball and associate Erin Duffy will present at the “Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation” program on Thursday, November 7, 2013 at the Hyatt Regency New Brunswick in New Brunswick, New Jersey.

This introductory program provides a comprehensive overview of the laws and Food and Drug Administration regulations affecting the drug industry, and will help you and your organization get products approved and navigate regulatory problems. Experts will review the essential elements of FDA drug regulation in a systematic and comprehensive way. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, speakers walk you through key regulations and policies and will help you determine how those regulations and policies are applied.

For more information please visit the Food and Drug Law Institute website.

October 7, 2013September 10, 2014 by Duane Morris

Mobile Medical Apps Guidance

Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. It is vital for any app developer to understand whether the guidance applies to their product from the initial design stage. Those who are already marketing software and apps that involve healthcare should also review the guidance with care to try to determine how FDA’s new regime impacts both business plans and continuing operations.

Continue reading “Mobile Medical Apps Guidance”

July 17, 2013September 10, 2014 by Duane Morris

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

The U.S. Food and Drug Administration (FDA) on July 15, 2013, released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA’s new authority to protect the integrity of the drug supply chain—specifically, Section 709 of the FDASIA [amending section 304(g) of the Food, Drug, and Cosmetic Act (FDCA)]. The proposed rules provide the FDA with the administrative authority to detain drugs the FDA believes are either adulterated or misbranded. The FDA will detain the drugs until it considers what action it should take concerning the drugs, whether legal or otherwise. The goal of this detention authority has been stated by the FDA as follows: “to protect the public by preventing distribution or subsequent of use of drugs … that are believed to be adulterated or misbranded … .” Comments on the proposed rule are due no later than September 13, 2013.

Click here to read the full Alert.