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 Partner Matthew Jones to Speak at the 20th Annual Health Law Institute, Pennsylvania Convention Center, Philadelphia , March 13, 2014
Duane Morris Special Counsel Michael Swit to Present an "Update on FDA Development for Biosimilars", Sheraton Philadelphia Downtown Hotel, Philadelphia, February 12, 2014
Duane Morris Attorneys Erin Duffy and Michael Mustokoff to Present at the "'Wait, Is This Money Mine?' Overpayments Under the Affordable Care and Flase Claims Act" Webinar, January 14, 2014
 
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:

FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
, December 11, 2013
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, the new...

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do
, November 15, 2013
On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated New Drug Applications (ANDAs) to add warnings, precautions, adverse...

Mobile Medical Apps Guidance
, October 08, 2013
Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its long-awaited final guidance on mobile medical...

Refill Reminder Exception to the Privacy Rule Created by the HITECH Act
, September 30, 2013
The passing of the Health Information Technology for Economic and Clinical Health Act (HITECH) resulted in multiple changes regarding existing protection of protected health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA). Part of this was to limit the use of...