Practice Areas & Industries: Duane Morris LLP


Healthcare Industry Litigation Return to Practice Areas & Industries

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Practice/Industry Group Overview

Our considerable knowledge of the healthcare industry is the cornerstone of Duane Morris' healthcare industry litigation practice. Our lawyers support their clients in courts, arbitration, mediation and administrative proceedings by combining in-depth experience in healthcare matters with litigation skills developed in trials and hearings, as well as responding to government investigations and negotiating settlements. We provide comprehensive litigation services for any disputed matter, and strive to achieve the results for our clients that make sense in the context of the industry and the client's role in the healthcare environment.

Our healthcare litigation teams serve two distinct aspects of the healthcare industry. The first is healthcare providers, including doctors, hospitals and health systems, long-term care facilities, home health agencies, ancillary service providers, laboratories, pharmacies, free-standing ancillary and surgery facilities, information technology and other medical suppliers, healthcare consultants, medical and industry associations, and non-profit foundations. The other is pharmaceutical and medical device companies, including manufacturers, distributors, purchasing cooperatives, biotechnology companies and other vendors.

Range of Litigation Services for Healthcare Providers

Healthcare Fraud and Abuse. We defend healthcare providers across the nation in government or qui tam actions brought under the federal anti-kickback statute, Stark self-referral regulations, False Claims Act and similar state laws. On occasion, these types of claims also encompass RICO and SEC allegations to be defended. These engagements may begin with an internal compliance audit, a governmental audit or investigation, a third party payor audit or investigation, the filing of a lawsuit or upon receipt of subpoena from the Office of Inspector General, Department of Justice or state Attorney General. In defense of these matters, we understand the potentially devastating impact these claims can have on a provider and make use of our strong industry knowledge as well as our past experience with the government regulators who may be pursuing the claims.

Healthcare Fraud and Abuse Representative Matters

Professional Arrangements. Our lawyers represent physicians, nurses and other healthcare professionals and hospitals in disputes regarding staff privileges, misconduct, credentialing (including economic credentialing), employment, contractual arrangements, compensation and problems arising from partnerships and joint ventures. These matters typically involve complex ongoing relationships requiring firm but sophisticated handling of the issue in dispute to seek a creative solution. Our healthcare litigation team also includes employment and benefits litigators experienced in addressing claims of discrimination, ERISA violations and wrongful termination.

Professional Arrangements Representative Matters

Reimbursement and Managed Care. Healthcare providers denied reimbursement by federal healthcare programs or private payers turn to our lawyers to assist them in enforcing their rights. Managed care disputes often involve nonmonetary challenges to medical necessity, site of service, and other complex factors involved in payment for healthcare services, making this type of litigation much more than a contract or collection matter. We represent clients pursuing these issues not only in courts, arbitration and mediation proceedings, but in administrative hearings, before the Provider Reimbursement Review Board, in carrier or intermediary fair hearings, and through managed care grievance processes.

Reimbursement and Managed Care Representative Matters

Antitrust and Competition. Antitrust and unfair competition lawsuits often arise between dominant payers or hospitals and physicians or competing systems vying with them for patients and managed care positioning. These cases can also involve contract breaches in business relationships and attempts to enforce non-competition covenants. Because these cases are heavily dependent on market analysis, our healthcare experience gives our lawyers a head start in analyzing and litigating antitrust and competition lawsuits in the heavily-regulated healthcare industry.

Antitrust and Competition Representative Matters

Business Reorganizations and Financial Restructuring. Our industry knowledge is fundamental to the representation of failing hospitals in bankruptcy matters. Healthcare bankruptcies also involve adversary proceedings in which bankruptcy trustees seek to increase the assets in the estate by gaining control of the assets of other healthcare entities who were contractors to, or venturers with, the debtor. Relations with government payers and continuing exposure to professional liability are also significant factors. We have represented a number of parties needing defense in such proceedings and others, such as creditors' committees, interested in resolving these specialized litigation disputes.

Business Reorganizations and Financial Restructuring Representative Matters

Patient Care and Research. Informed consent, right to treat, medical records and confidentiality, data breach response, professional liability for negligent patient care, human subject research protection, research misconduct, FDA warning letters and conflict of interest infractions are all healthcare litigation issues which our lawyers have handled. Unlike firms that handle only malpractice claims, our industry focus often enables our lawyers to develop creative lines of defense that might not otherwise be pursued and to handle matters that involve complex combinations of patient care or information issues.

Patient Care and Research Representative Matters

Administrative Practice. Because the healthcare industry is heavily regulated, healthcare matters often involve appearing before administrative agencies or taking their decisions to court. On the federal level, such proceedings often involve reimbursement issues, but also challenge regulatory changes and provider status decisions. Our lawyers also have experience in appeals of state certificate of need (CON) decisions, challenges to state regulations and adversarial presentations to state planning boards and administrative review panels.

Administrative Practice Representative Matters

Nonprofit Institution and Tax Issues. Hospitals and health systems face many challenges in maintaining and taking advantage of their nonprofit status, under both federal and state taxation systems. Our healthcare and tax litigators have broad experience in litigating property tax exemptions, community benefit demonstrations, private inurement and excess benefit issues, and in gaining approval for transactions with for-profit entities. Through our representation of charitable healthcare foundations, we have considerable experience in litigating their entitlement to distributions and defending them against creditors of prior entities. Our hospital clients have also found it productive to engage us to defend their right to contested testamentary bequests.

Nonprofit Institution and Tax Issues Representative Matters

Environmental, Energy and Construction Litigation. Our environmental and energy attorneys represent clients in litigation matters involving regulatory compliance and enforcement concerns. Environmental issues affect hospitals and other healthcare facilities in unique ways and we have litigated these complex regulatory issues before government agencies and state and federal courts. Energy litigation to oppose electricity and gas rate increases also makes use of our industry experience.

Duane Morris' national and regional construction practice involving virtually all real estate, construction and development matters has extensive experience in matters relating to healthcare facilities. We are experienced in the full range of litigation confronting hospitals, nursing, surgery and other facilities related to the purchase, sale, leasing, development, financing, condemnation, eminent domain, valuation and tax issues, and construction disputes associated with real estate development for healthcare purposes.

Environmental, Energy and Construction Litigation Representative Matters

Range of Litigation Services for Pharmaceutical and Medical Device Companies

Intellectual Property. Companies in the pharmaceutical and medical device sector of healthcare rely on intellectual property rights to define their business expectations. Our patent litigators are adept at explaining complex technical issues in a straightforward manner while communicating the healthcare significance of the issue. We handle patent litigation for companies of all sizes as well as individual physician inventors and start-up enterprises. We also are experienced in conducting interference proceedings before the U.S. Patent and Trademark Office.

Our attorneys handle multi-billion dollar, market-defining pharmaceutical patent litigations for global pharmaceutical manufacturers. Duane Morris' intellectual property litigation practice is distinct in that our attorneys have decades of experience in trying cases to verdict, including those in the chemical/pharmaceutical arts. Our clients benefit from this perspective and insight, which can only be gained from years of "on-the-ground" patent trial experience in virtually every major jurisdiction in the United States.

Intellectual Property Representative Matters

Sales and Distribution Issues. Current government scrutiny of referral relationships has made manufacturers' sales and distribution arrangements with hospitals and physicians the focus of more traditional anti-kickback and False Claims Act litigation. As with our defense of healthcare providers, we are aggressive in defending pharmaceutical and medical device clients from claims of kickbacks and improper financial relationships in the distribution chain. Our industry knowledge facilitates a comprehensive defense of allegations involving the provider-manufacturer relationship, including improper research support, off-label marketing, unlawful promotion, improper consultant agreements and intellectual property development ventures and royalty arrangements.

Sales and Distribution Issues Representative Matters

Products Liability. Manufacturers of pharmaceuticals and medical devices are exposed to claims that their product has injured groups of people for whom the product was prescribed, resulting in a single case to thousands of cases in multi-district litigation or class actions. Our lawyers have experience handling these cases on a national or local basis, whether trying cases to juries or achieving resolution through arbitration or mediated settlements.

Products Liability Representative Matters

Environmental. The manufacturing process may involve releases of chemical agents that prompt administrative investigations and lawsuits. Duane Morris attorneys defend these cases in courts and before the EPA, and respond to DOJ requests and subpoenas for information.

Environmental Representative Matters

Construction. The design and construction of complex research and manufacturing facilities for pharmaceutical and medical device companies often leads to construction litigation. Our construction litigators have the experience and skill to handle these matters.

Construction Representative Matters

Commercial and Contract Matters. Our litigators are aggressive in pursuing and defending claims between competing pharmaceutical and medical device companies or involving other business matters, such as distributor termination disputes, breach of contract actions, trade secret violations, and enforcement of non-compete restrictions.

Commercial and Contract Matters Representative Matters

Employment Issues. Our employment and benefits attorneys are familiar with all aspects of defending discrimination and ERISA claims in state and federal courts and before administrative panels.

Employment Issues Representative Matters

Industry-Wide Litigation

Because we represent professional and trade associations within the healthcare industry, our litigation often raises issues, pursues claims or advocates for legal or regulatory changes on behalf of entire segments of the industry.

Industry-Wide Litigation Representative Matters

Group Presentations
  Duane Morris Special Counsel Michael E. Clark to Present at the 2015 Physicians Legal Issues Conference, Chicago, IL, June 10, 2015
Duane Morris Partner Greg Brodek to Speak at Texas Unencumbered #bizPT Conference, Irving, Texas, May 29, 2015
Duane Morris Partner Mark Silberman to Present at AHLA's Long Term Care and the Law Conference, New Orleans, February 24, 2015
Duane Morris Attorney Michael Clark to Speak on "Expert Testimony in Health Care Trials" at the National CLE Conference, Vail, Colorado, January 7, 2015
Past Seminar Materials
  Duane Morris Partner William Weiner to Speak at the National Business Institute's Health Law 2014 Seminar, Holiday Inn Cherry Hill, Cherry Hill, NJ , March 21, 2014
Articles Authored by Lawyers at this office:

CMS Updates 5 Star Ratings System for Nursing Homes with New Measures
Ari J. Markenson, April 07, 2015
As of February 20, 2015, the Centers for Medicare & Medicaid Services (CMS) has revised its 5 Star Rating System for nursing homes. The changes to the system involve adding two new nursing home quality measures for antipsychotic use into the Quality Measure Rating, Increasing the number of...

Lawyer in Vietnam Oliver Massmann Pharmaceutical Market
Oliver Massmann, March 30, 2015
Vietnam’s healthcare system is currently in general on the move due to the economic growth and the rapid development.

OIG - Medicare Hospices Have Financial Incentives to Provide Care in Assisted Living Facilities
Ari J. Markenson, March 30, 2015
On January 14, 2015, the U.S. DHHS Inspector General’s Office (the “OIG”) released a report (OEI-02-14-00070) entitled “Medicare Hospices Have Financial Incentives to Provide Care in Assisted Living Facilities.”

CMS Advises That Payment Codes on Home Health Claims Will Be Matched Against OASIS
Ari J. Markenson, March 25, 2015
CMS recently issued Transmittal SE1504 entitled “Payment Codes on Home Health Claims Will Be Matched Against Patient Assessments”.

Civil RICO Actions on the Rise to Combat Healthcare Insurance Fraud
James J. Ferrelli, March 25, 2015
Over the past several years, insurance carriers have aggressively pursued civil suits against doctors and other medical providers in an effort to fight healthcare insurance fraud. Besides theories of liability based upon common law claims such as fraud and unjust enrichment, insurers have more...

Consultants’ Communications Privileged from Discovery
Philip H. Lebowitz, March 25, 2015
In healthcare, companies often hire consultants to review billing and coding, privacy and security and a host of other technical issues that regular staff does not have the time or expertise to pursue. A recent discovery ruling in federal court in the Eastern District of Pennsylvania holds that...

HHS Moves to Limit In-Office Ancillary Services Exception
Matthew C. Jones, March 19, 2015
The Department of Health and Human Services (“HHS”) is once again targeting the In-Office Ancillary Services Exception (“IOASE”) to the federal Stark Law, in an attempt to produce cost savings in the U.S. healthcare system. The IOASE provides a limited exception to the Stark...

Health System Integration and Antitrust Laws on Collision Course
Philip H. Lebowitz, March 18, 2015
Health systems attempting to fulfill the mandate of integrating hospitals and physicians may find themselves accused of going too far. Although the Affordable Care Act, shared savings, gainsharing and other alternative payment methodologies have made integration of physicians, hospitals and other...

New Jersey State Bar Committee to Review RPC 1.2(d) and Issues Pertaining to Medical Marijuana
James J. Ferrelli, March 18, 2015
The New Jersey State Bar Association (“NJSBA”) has established an ad hoc committee to review the ethical issues raised under New Jersey Rule of Professional Conduct 1.2(d) (which prohibits a lawyer from counseling or assisting a client in conduct that the lawyer knows is illegal or...

Virtual Credit Card Payments
Patricia S. Hofstra, March 18, 2015
On January 30, 2015, several healthcare organizations sent a group letter to CMS protesting the use of virtual credit cards by health plans to pay providers. In a virtual credit card payment (a nonstandard type of electronic funds transfer EFT), a health plan or its payment vendor issues single-use...

ACOs are More Important Than Ever for LTC Facilities
Amy E. McCracken, March 13, 2015
On January 26, 2015, the United States Department of Health & Human Services (HHS) announced its timeline for shifting Medicare reimbursements from volume-based criteria to value-based criteria. HHS has adopted a framework that categorizes health care payments according to how providers receive...

Antipsychotic Drug Use Can Lower Nursing Home's Five-Star Rating
Amy E. McCracken, March 13, 2015
The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to reduce the national prevalence of antipsychotic drug use in long-stay nursing home residents. Its initial goal of a 15.1% reduction in antipsychotic drug use was met, so CMS now seeks to reduce antipsychotic drugs...

Fees and Costs Awarded to False Claims Act Defendant
Seth A. Goldberg, March 13, 2015
A recent decision in the U.S. District Court for the Southern District of New York provides fair warning to qui tam relators who assert erroneous claims under the False Claims Act ("FCA") that they could be hit with legal fees and expenses pursuant to 31 U.S.C. § 3730, which permits...

Health Care Workers May Think Twice Before Becoming a Relator
Amy E. McCracken, March 13, 2015
The Federal False Claims Act (and many similar state false claims acts) allow an individual-called a "relator"-to file a lawsuit on behalf of the United States Government. If successful, the relator stands to collect a portion of the amount collected. Since the False Claims Act provides...

Mayo Lawsuit Against Former Exec Raises Numerous Health Care and Business Litigation Issues
Elinor H. Murarova, March 13, 2015
A recent settlement between Mayo Collaborative Services d/b/a Mayo Medical Laboratories ("MML") and Mayo Clinic (together with MML, "Mayo") and a former Mayo executive, Dr. Franklin Cockerill, reveals the potential legal issues that may arise when health care executives seek new...

New CMS Payment Policy Will Negatively impact Healthcare Investors
C. Mitchell Goldman, March 13, 2015
I have been concerned about the difficulty of projecting revenue and determining valuations for new and existing healthcare companies based on risk based reimbursement models. My fears have not been allayed. Rather, they have been confirmed.

Real Estate Tax Exemption Issue Muddied Again
Philip H. Lebowitz, March 13, 2015
On December 23, 2014, the Commonwealth Court of Pennsylvania logged another frustrating mile down the confused and confusing road of property tax exemption for purely public charities. In Fayette Resources, Inc. v. Fayette County Board of Assessment Appeals, the Court overturned a lower court...

Top Three Problems with Text Messaging in Health Care Settings
Amy E. McCracken, March 13, 2015
1. Since most text messaging is not a secure form of communication, it raises HIPAA concerns if any protected health information is included in the text message. There is the possibility of a data breach in the transmission of the text message, as well as in the event of a lost or stolen phone.

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
, February 26, 2015
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

7th Circuit Clarifies FCA Fraud Standard
Philip H. Lebowitz, January 23, 2015
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, nadyor v. Ukrainian Village Pharmacy,...

CMS Bringing Star Ratings to Home Health
Ari J. Markenson, January 23, 2015
The Centers for Medicare and Medicaid Services (“CMS”) issued a fact sheet on December 11th, 2014, discussing its intention to issue star ratings for Medicare certified home health agencies. The star ratings would be live in 2015.

Clinical Trial Sponsors Can Be Liable For Inadequate Consent Forms
Philip H. Lebowitz, January 23, 2015
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...

The IMPACT ACT of 2014 - New Enforcement and Oversight for Hospice Providers
Ari J. Markenson, January 23, 2015
The IMPACT Act of 2014 (“IMPACT”) was signed into law on October 6, 2014. It includes two significant enforcement and oversight changes for Medicare hospice providers among other post-acute care policy changes.

OIG 2015 Work Plan - Hospice
Ari J. Markenson, January 22, 2015
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

OIG 2015 Work Plan - Home Health
Ari J. Markenson, January 02, 2015
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

Responding to Subpoena for Medical Records May Create Liability for Healthcare Providers Under State Law Negligence Claims
Seth A. Goldberg,Philip H. Lebowitz, December 10, 2014
Healthcare providers receiving a subpoena for patient medical records may want to think twice before complying with the subpoena and producing the records. A recent Connecticut case, Byrne v. Avery Center for Obstetrics and Gynecology, P.C. ("Byrne"), arose when the defendant gynecology...