Morris Manning & Martin, LLP

Healthcare

The Healthcare Practice is highly regulated and rapidly changing. Individuals and companies that do business in this arena require legal counsel with a hands-on understanding of the unique issues of the healthcare environment and constructive solutions to their problems. Our Healthcare lawyers practice exclusively in this area and, consequently, have in-depth expertise helping clients properly structure their business relationships and transactions, comply with laws and regulations, and achieve successful resolutions in civil, criminal and administrative proceedings. Our excellent service and skills are evidenced by the practice’s ranking in Chambers USA, a leading legal services ranking publication.

Business Transactions and Regulatory Guidance

Our industry knowledge uniquely positions us to assist clients in structuring transactions and relationships that meet their business goals and comply with state and federal healthcare laws. Our Healthcare lawyers have extensive experience in assisting clients in selecting and forming the appropriate business entity(ies); putting into place effective corporate governance and financial mechanisms; documenting contractual and other legal relationships; implementing tax-efficient business arrangements; and developing, documenting and executing joint ventures, mergers and acquisitions, and other business relationships. We provide our clients with advice and creative solutions to ensure compliance with the myriad of complex healthcare laws and regulations, including the Anti-Kickback Statute, federal and state self-referral laws, Certificate of Need matters, HIPAA’s Privacy and Security Standards, and the Georgia Medical Practice Act.

Healthcare Litigation

Our experienced Healthcare litigators regularly represent clients in litigation in federal and state courts and in administrative proceedings. This representation includes matters ranging from complex business litigation to employment issues to whistleblower actions to provider reimbursement issues to medical staff disputes. Additionally, our attorneys have represented clients in civil and criminal disputes involving allegations of fraud and abuse and false claims. In administrative matters, we regularly represent healthcare providers in Certificate of Need appeals; licensure investigations and disciplinary actions; credentialing matters; Medical staff investigations, adverse actions and hearings; and Medicare/Medicaid audits, investigations, and appeals.

Complete Industry Solutions

Our lawyers' experience in these areas of business transactions, statutory and regulatory guidance, and litigation extends to all components of the healthcare industry, including hospitals and healthcare systems, physician practices (both single and multispecialty), home health agencies, skilled nursing facilities, assisted living facilities, ambulatory surgery centers, and diagnostic imaging centers. This comprehensive knowledge and experience allows us to anticipate and address concerns throughout the healthcare industry.

 

Key Services:

  • Anti-Kickback statute & false claims act 
  • Certificates of Need 
  • HIPAA privacy & security regulations 
  • Medicare & Medicaid audits & appeals 
  • Medicare & Medicaid regulations 
  • Mergers & acquisitions 
  • Staff membership & clinical privileges disputes 
  • Stark II & physician self-referral laws
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Areas of Expertise

Accountable Care Organizations

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The Patient Protection and Affordable Care Act, especially its provisions relating to Accountable Care Organizations (ACOs), presents unique challenges and opportunities for healthcare providers, managed care organizations and insurers. If successful, ACOs could result in a much more efficient healthcare delivery model, reducing utilization and costs while providing the best acute and long term care for patients. Prior to “starting an ACO,” each healthcare provider and supplier must initially evaluate their current status and readiness for the ACO world and determine if establishing or participating in an ACO is to its benefit. ACOs became part of the Medicare system on January 1, 2012.

Morris, Manning & Martin offers a multidisciplinary approach to assist with meeting the challenges of determining provider organizations readiness for ACOs as well as advising on the tasks necessary to forming and managing an ACO. Bringing together experienced attorneys from our Healthcare, Corporate, Insurance, Tax and other practice groups, we can:

  • Evaluate the current state of your organization and its readiness for ACOs
  • Assist in selecting the structure that best meets your needs based on business goals, tax considerations, financing, antitrust and other factors
  • Effectively structure, negotiate and manage participation contracts, acquisitions, joint ventures, capital funding and other transactions necessary to prepare your organization for ACO participation and develop and operate an ACO
  • Establish fair and effective corporate governance and management procedures
  • Negotiate vendor agreements necessary to implement clinical, administrative and healthcare IT systems
  • Ensure compliance with the Stark Law, Anti-Kickback Law, Civil Money Penalty Law and other applicable state and federal regulations
  • Obtain licenses and ensure compliance with state and federal laws governing risk-bearing entities
  • Evaluate, negotiate and implement insurance arrangements, including captive insurance programs, to support ACO operations

Our attorneys have the deep expertise and experience necessary to help you plan, finance and implement a successful ACO. The areas of expertise we draw upon include the following:

Healthcare

Our Healthcare lawyers possess the experience and in-depth expertise to help clients properly structure their business relationships and transactions, comply with laws and regulations and achieve successful resolutions of any disputes and administrative proceedings that may result in this intensely regulated environment. Our team has extensive experience in assisting clients in selecting and forming the appropriate business entity(ies); adopting effective corporate governance and financial mechanisms; documenting contractual and other legal relationships; and developing and documenting joint ventures, mergers and acquisitions and other business relationships.

Corporate

With over 35 years of service to businesses throughout the U.S. and abroad, we have developed operations and best practices to efficiently and comprehensively provide counsel for virtually every corporate need such as corporate finance, governance, funding, complex partnerships and joint ventures, mergers and acquisitions, private equity transactions, restructuring and securities.

Insurance

Morris, Manning & Martin is well-known for its exceptional practice serving the insurance industry. Our practice spans the full gamut of corporate, regulatory, dispute resolution and securities matters faced by insurers, reinsurers, brokers, alternative risk programs and affiliated service providers. Our attorneys possess in-depth industry knowledge and experience navigating the complex legal environment in which insurance is transacted.

Tax

Healthcare organizations, especially those utilizing tax-exempt entities, are subject to complex tax laws, especially on the federal level. Our lawyers have extensive experience forming and organizing tax-exempt organizations and obtaining federal and state tax-exempt status. We also provide continuing advice on maintaining and protecting tax-exempt status, including the tax consequences of an entity’s operations and activities ranging from sophisticated investment activities to participation in ancillary for-profit subsidiaries, joint ventures, technology transfers and other activities.

Data Security, Privacy & Breach

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Data privacy and security is pivotal. Data – client data, customer data, vendor data, patient data, personnel data – is core to operating a business, as such it must be properly protected and maintained. The number of data breach incidents has increased sharply over the past few years. Given the potential costs associated with a data breach or cyber-attack, companies need a law firm with significant regulatory, risk management and litigation experience. Morris, Manning & Martin’s Data Security, Privacy & Breach practice offers a wealth of experience guiding clients through such situations, managing them in the most effective way possible to optimize compliance, limit risk and minimize damages.

We provide a broad spectrum of specialized services which pull from several key practices including regulatory, litigation, insurance, financial services, healthcare, and technology. We recognize that the flow of information between businesses, consumers, and third-party vendors is becoming increasingly faster and more difficult to protect. While the vast array of data presents numerous opportunities and advantages, it also presents tremendous risks and exposure to potential cyber-liabilities.

Cross-Industry Experience

Our specialized industry experience ensures we have the right lawyers in place to address regulatory compliance and breaches in a myriad of industries. We represent a diverse group of clients with respect to data security breaches, including financial institutions, payment processing vendors, retailers, health care providers, hospitality, travel & leisure, high-tech companies, and insurance issuers.

Practice Overview

The means by which we communicate information has exploded in the past few decades and as each channel becomes available, the rules for protecting them must be created and the exposures they reveal must be examined. Clients need experienced, responsive counsel to help make sense of the opportunities and issues these channels present, as well as provide an understanding of the different rules associated with each, developing appropriate policies, and handling potential data breaches.

MMM’s Data Security, Privacy & Breach Practice assists businesses of all sizes and types with:

  • Comprehending relevant privacy and data security issues
  • Assisting with regulatory examinations and audits
  • Developing policies and procedures to comply with state and federal consumer privacy and data security laws
  • Drafting and negotiating privacy and data security provisions in service provider contracts and other such agreements
  • Evaluating new products and programs to ensure compliance with consumer privacy and data security laws
  • Performing regulatory due diligence for mergers and acquisitions
  • Responding to security incidents involving personal information
  • Reviewing the use of consumer information for marketing purposes for compliance with applicable law
  • Addressing privacy and data security obligations and liabilities in contracts with third-party vendors
  • Appropriately utilizing social media and other web and telecommunications-based marketing channels
  • Implementing compliant document management and data retention plans
  • Handling data breaches, privacy complaints, and litigation
  • Responding to government subpoenas and wiretap requests
  • Defending regulatory enforcement actions by the Federal Trade Commission (FTC), Federal Communications Commission (FCC), and various state Attorneys General

Regulatory Guidance

Our lawyers have a thorough knowledge of the state, federal and international data privacy and security laws which apply to data breaches. For instance, our team regularly analyzes and applies the following laws to data breaches across various industries and circumstances:

  • Bank Secrecy Act
  • California Database Protection Act
  • CAN-SPAM Act
  • Children’s Online Privacy Protection Act
  • Drivers Privacy and Protection Act
  • Electronic Fund Transfer Act (Reg E)
  • Fair & Accurate Credit Transactions Act (FACTA)
  • Fair Credit Reporting Act
  • FCC Truth in Billing Regulations
  • FTC “Red Flag Rule”
  • Genetic Information Nondiscrimination Act
  • Gramm-Leach-Bliley Act
  • Health Information Technology for Economic & Clinical Health Act (HITECH)
  • Health Insurance Portability & Accountability Act (HIPAA)
  • Telephone Consumer Protection Act

We also advise clients with regard to state security breach notification laws and other state laws dealing with the privacy and security of personal information.

Post-Breach Counseling

In the event of a breach, our integrated approach ensures that the best privacy, internal investigations and securities legal counseling is provided in a coordinated manner at a time when companies feel the most vulnerable. We have extensive experience working on cyber security matters with federal officials, investigators, the FTC and other government agencies. In addition, our corporate and securities lawyers have counseled the leaders of many top companies and their boards of directors in disclosure requirements arising from data security breaches.

Areas in which MMM provides specific advice pertaining to data breaches & security include:

Privacy of Consumer Information

Businesses must be hyper-cognizant of regulations concerning the protection of consumers’ personally identifiable information (PII), particularly those within the healthcare and insurance industries. Those that collect, use, and store PII – such as names, addresses, phone numbers, account numbers, credit information, and social security numbers – are subject to an increasing number of state and federal laws and regulations that require privacy notices to consumers, patients, employees, and the rigorous protection of PII. Noncompliance with these requirements, as well as data breaches resulting in sensitive information being released to unauthorized persons, can result in substantial fines, penalties and other legal liability, as well as public relations concerns.

Businesses are also subject to a plethora of regulations concerning marketing practices. We regularly counsel clients on the CAN-SPAM Act, Do Not Call and Telemarketing Sales laws among others, analyzing whether existing and prospective advertising campaigns and promotions are fully compliant. MMM’s lawyers are also experienced with the unique issues presented by new media outlets such as social networking sites, blogs, and mobile advertising, and we advise businesses on how to protect themselves while taking advantage of powerful, new communication tools.

Privacy of Healthcare Information

We regularly counsel clients on healthcare-related privacy regulations, such as those mandated by the Health Insurance Portability and Accountability Act (HIPAA) and the HITECH provisions of the American Reinvestment and Recovery Act of 2009, which imposes civil and criminal penalties for mishandling medical records upon healthcare providers and the many businesses that support them.

Privacy of Financial Information

MMM counsels clients regarding the rapidly evolving body of regulations aimed at protecting financial information. Under FTC regulations adopted pursuant to the Gramm-Leach-Bliley Act, companies that offer financial products or services to individuals (consumer lending, tax preparation, financial advice or credit counseling, residential real estate settlement, and consumer debt collection) must comply with the Financial Privacy Rule, Safeguards Rule, and antipretexting provisions. The FTC’s “Red Flags Rule” requires virtually every business that extends credit to consumers to develop and implement written identity theft prevention programs. We are experienced in helping businesses understand their obligations and developing practical compliance methods.

Workplace Privacy

Our Data Security, Privacy & Breach Practice is experienced with analyzing the internal practices of large and small employers, and the steps taken to maintain privacy compliance in the workplace. We advise employers on the development of systematic and consistent data protection policies across various company functions, such as the implementation of effective staff training to increase sensitivity to data privacy concerns and the maintenance of physical and technological safeguards for sensitive data, such as passwords, encryption, and data retention/destruction policies. Equally important, we advise employers regarding workplace monitoring and searches, the handling of medical records, employees’ personal use of office technology (e-mail, computers, phones), and social media.

Breach Management and Litigation

The evolution of privacy regulations has been paralleled by a significant increase in the penalties associated with breaches of privacy. The price of a compromise of confidential information is steep – it can result in fines reaching millions of dollars along with significant public relations and customer service challenges. The lawyers in our Data Security & Breach Practice offer a wealth of experience guiding clients through such situations, managing them in the most effective way possible to minimize damages, and correcting mistakes to ensure future compliance.

Representative Matters

MMM lawyers have advised clients on a wide variety of data security and privacy matters, including the following:

  • Advised employers with respect to the effect of HIPAA privacy rules on their health plans, including drafting notices, policies, procedures, and plan amendments and reviewing and negotiating business associate contracts
  • Prepared privacy policies, website terms of use, blog terms of use, and customer terms and conditions for multiple website operators
  • Advised multiple clients regarding compliance with the FTC’s “Red Flags Rule”
  • Counseled numerous clients on changes to telemarketing campaigns (telephone and text messaging) to comply with federal telemarketing laws, including the Do Not Call, Telemarketing Sales and “robocalls” rules
  • Drafted employment policies regarding workplace monitoring and searches, medical records, data protection, technology (e-mail, computers, phones), and social media
  • Drafted and litigated disputes arising under confidentiality and nondisclosure agreements
  • Advised regarding employment-related rights and obligations under the Fair Credit Reporting Act
  • Advised multiple Internet service providers regarding behavioral advertising and FTC consumer privacy rules
  • Served as regulatory counsel for privacy and data security issues to well-known broadband providers
  • Developed and reviewed Customer Proprietary Network Information (CPNI)-compliant privacy policies and procedures for multiple regulated telephone and VoIP providers, including preparing call center scripts, customer notices, and annual compliance certifications
  • Developed CALEA SSI (Communications Assistance for Law Enforcement Act) manuals addressing federal wiretap requests and counseled on subpoena compliance for numerous telecommunications, Internet, and VoIP providers
  • Advised on federal and state call monitoring/recording requirements for client call centers and telemarketing
  • Counseled clients on federal and state privacy law compliance in responding to government requests for consumer documents and information
  • Defended clients in Do Not Call investigations by state and federal government agencies
  • Advised telecommunications companies on the use of Automatic Number Identification (ANI), Calling Party Number (CPN), Calling Party Name, and Billing Name and Address (BNA) in compliance with federal regulations

Healthcare Fraud & Abuse

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Today’s healthcare, pharmaceutical, life sciences and medical device companies face ever expanding state and federal regulations, and are often targeted in parallel civil, criminal and administrative proceedings at the federal and state level. Additional collateral proceedings such as product liability suits, third-party payor suits and employment issues are frequent by products of civil and criminal investigations. Morris, Manning & Martin’s deep expertise in the healthcare sector, along with its collaborative approach of teaming with appropriate substantive and regulatory experts, provides clients with full-service, multidisciplinary representation when confronted with such issues. In addition, the firm utilizes a broad array of mobile resources and technology to respond quickly and efficiently to pressing client needs.

A Diverse Team of Specialists

Attorneys in the Healthcare Fraud and Abuse Practice have extensive training and experience in the healthcare industry and with various federal healthcare compliance and regulatory matters. Two of the Healthcare Fraud and Abuse Practice’s members have served as in-house counsel at large Georgia hospitals, providing unique insight into the challenges faced by many of our clients. Additionally, one of our practice members is a former Assistant United States Attorney who served as the federal Criminal Healthcare Coordinator, in which capacity she oversaw all healthcare investigations and prosecutions in her office’s district, including investigations into and prosecutions of federal providers and pharmaceutical companies. These combined prior experiences provide a unique understanding of the investigative and prosecutorial process, as well as an appreciation for the consequences of the findings that may arise from such inquiries.

Should the need arise, we provide clients with a creative, hardworking litigation team equipped to deal efficiently, effectively and responsively with the most sensitive and challenging legal issues. Each case is engaged with our aggressive, hands-on approach and, always conscious of the cost of litigation, we strive to formulate a strategy to obtain the best possible result, carried out in a practical, cost-effective manner that best applies our resources to meet each client’s objectives.

Representative Matters:

  • Represented pharmaceutical company in complex internal investigation relating to government allegations of off-label marketing, Anti-Kickback violations and potential manipulation of the AWP.
  • Coordinated criminal investigation into pharmaceutical manufacturer and distributor for misbranding and cGMP violations.
  • Represented several clients in EMTALA investigations and appeals.
  • Represented owner of pharmacy in federal investigation and related Board of Pharmacy proceedings relating to Internet pharmacy prescriptions.
  • Represented clients in federal investigation of Medicare billing compliance issues.
  • Represented clients in self-disclosure and negotiation of resolution for governmental payer program enforcement activities.
  • Represented clients in Qui Tam actions involving physician and hospital regulatory compliance issues.
  • Representing clients in regulatory audits and billing compliance reviews on state and federal levels.
  • Represented major pharmaceutical company in connection with investigation and resolution of investigation into certain prescribing practices.
  • Represented large physician practice in investigation of certain off-label prescriptions.
  • Assisted in representation of clinical laboratory testing company with respect to certain unbundling practices.
  • Assisted in representation of president of generic drug company in criminal and civil market allocation investigation.
  • Co-trial counsel for executive of managed care company who brought suit for violation of retaliatory discharge provisions of False Claims Act resulting in substantial jury verdict for executive.
  • Advise on compliance structuring of various arrangements for hospital systems, academic medical center and physician groups.

Healthcare Information Technology

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Our Healthcare Information Technology Practice provides legal and compliance services to information technology companies and healthcare providers by providing regulatory advice, drafting and negotiating contracts, counseling, and litigation defense in all aspects of the data security, privacy, and use and transmission of data on both a state and federal level.  Our lawyers work collaboratively with our clients to address regulatory compliance with software or product modifications, enhancements and upgrades.  We continually provide information technology companies with regulatory analysis of strategic business plans, products and offerings and daily operational activities.  In addition to regulatory compliance, our lawyers have specific expertise in intellectual property rights and assist clients in proactively protecting intellectual property assets.

Key Services

  • HIPAA/HITECH Privacy and Security Regulations
  • Anti-Kickback Statute and False Claims Act
  • Compliance Programs
  • Stark II Physician Self-Referral Laws
  • Data Privacy and Security Regulations
  • Medicare and Medicaid Regulations
  • Standards for Electronic Medical Records and Personal Health Records 

Experience

Our firm has significant experience in data privacy and security, both on state and federal levels.  Our lawyers have unique experience and expertise in not only healthcare regulations, including HIPAA, but also the impact and application of healthcare regulations to information technology organizations.

Our lawyers have counseled numerous clients on issues related to electronic exchange of health information, personal health records, pay for performance and payer programs, discovery, document preservation issues, document retention policies, and data breach issues.  We advise our clients regarding the electronic exchange of health information and when security breaches, theft, or loss of electronic storage media or health records occurs, including how to prevent such breaches and thefts in the future.  We also work with our clients to address regulatory compliance and best practices in the changing electronic medical record industry. 

Our industry knowledge and experience uniquely positions us to assist clients in structuring compliant transactions, addressing the regulations to establish relationships that meet their business goals and comply with the state and federal healthcare laws.

Representative Healthcare IT Client List

Carecentric National

Coalition America

Compliance360

Dialog Medical

Greenway Medical

HealthOne

Ingenious Med

inquickER

McKesson

MDdatacor

Navicure

North Star Health

Novo Innovations

nuBridges

Premier Research Group

Quintiles

RevenueMed

simplifyMD

Surgical Information Systems

Transcend

Velocity Medical Solutions, LLC

Vendormate

WebOps

Representative Healthcare IT Transactions

  • C.R. Bard agreements for international development, distribution and marketing of medical devices.
  • McKesson agreements for development and marketing of healthcare software.
  • Agreement between McKesson and VanderbiltMedicalCenter for software and computer services and medical expertise.
  • Agreement with Children's HealthCare of Atlanta and Epic Systems for the license of an outpatient clinical system. 
  • Many license, hosting and computer acquisition agreements for medical practices and hospitals purchasing healthcare information technology and EMR information system and related hardware purchases.
  • Many BPO agreements to provide third-party claims processing for the healthcare industry, including call centers and technology development located in both the U.S. and India.
  • Agreements with BPO business unit of Siemens for processing healthcare claims.
  • Agreements with BPO company for invoicing and collecting healthcare payments. 
  • License and hosting agreements with multiple hospital groups in the licensing and hosting of a HIS system.
  • License and equipment acquisition agreements for medical groups licensing a clinic information system and related hardware purchases.
  • Negotiated acquisition of IT BPO business unit from Siemens for processing healthcare claims.
  • Represented BPO company that invoiced and collected amounts for covered healthcare entities. 

Healthcare Litigation

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The Healthcare Practice is highly regulated and rapidly changing. Individuals and companies that do business in this arena require legal counsel with a hands-on understanding of the unique issues of the healthcare environment and constructive solutions to their problems. Our Healthcare litigators practice exclusively in this area and, consequently, have in-depth expertise helping clients achieve successful resolutions in civil, criminal and administrative proceedings. Our excellent service and skills are evidenced by the practice’s ranking in Chambers USA, a leading legal services ranking publication. 

Comprehensive Representation

Our experienced Healthcare litigators offer deep healthcare expertise and significant experience with sensitive and high-pressure matters. Our clients span the healthcare industry, including for-profit and nonprofit healthcare providers, rural and community hospitals, pharmaceutical companies, managed care organizations and physician practice groups. We regularly represent these clients in litigation in federal and state courts and in administrative proceedings, ranging from complex business litigation to employment issues to whistleblower actions to provider reimbursement issues to medical staff disputes. Our team represents clients in civil and criminal disputes involving allegations of fraud and abuse and false claims. We also represents healthcare providers in administrative matters such as Certificate of Need appeals; licensure investigations and disciplinary actions; credentialing matters; Medical staff investigations, adverse actions and hearings; and Medicare/Medicaid audits, investigations, and appeals.

Representative Matters

  • Co-trial counsel for executive of managed care company who brought suit for violation of retaliatory discharge provisions of False Claims Act resulting in substantial jury verdict for executive.
  • Advise on compliance structuring of various arrangements for hospital systems, academic medical center and physician groups.
  • Successfully represented a physicians practice group in connection with its application for a Certificate of Need over the opposition of various existing providers.
  • Successfully represented three physicians in connection with a multimillion-dollar dispute over equity interests in a radiation oncology company.
  • Successfully represented a national behavioral health company in obtaining a Certificate of Need and defending on appeal a unique senior psychiatric program to be operated as a hospital within a hospital.
  • Successfully represented an Oregon community hospital in obtaining a pre-litigation settlement of managed care claims in excess of $1 million against a publicly traded health insurer.
  • Obtained a multimillion-dollar settlement in an arbitration proceeding brought by a Chicago not-for-profit health system against a publicly traded managed care company.
  • Successfully represented a large not-for-profit healthcare system in defending on appeal a Certificate of Need to develop a radiation therapy service.
  • Obtained dismissal with prejudice of a Medicare Secondary Payor lawsuit brought by a whistleblower in Arkansas Federal District Court.
  • Successfully represented the founding shareholder in a radiation oncology practice in a dispute in Georgia over the value of a multimillion-dollar equity interest.
  • Obtained a favorable settlement for the pharmacy operations of a publicly traded company for investigation of billing practices in Georgia.
  • Represented pharmaceutical company in complex internal investigation relating to government allegations of off-label marketing, Anti-Kickback violations and potential manipulation of the AWP.
  • Represented several clients in EMTALA investigations and appeals.
  • Represented clients in federal investigation of Medicare billing compliance issues.
  • Represented clients in Qui Tam actions involving physician and hospital regulatory compliance issues.
  • Representing clients in regulatory audits and billing compliance reviews on state and federal levels.

Key Services:

  • Alternative dispute resolution proceedings such as arbitration and mediation
  • Anti-Kickback statute & false claims act
  • Certificate of Need hearings and appeals
  • Class actions
  • Government civil proceedings, including whistleblower suits brought under the Federal False Claims Act
  • Internal Compliance Investigations
  • Licensure disputes and proceedings
  • Licensure investigations
  • Managed care network disputes
  • Management or services contract disputes
  • Medical staff and credentialing
  • Medicare & Medicaid audits & appeals
  • Stark II & physician self-referral laws

Medical Devices

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Morris, Manning & Martin’s Medical Device Practice enables successful development of new medical device and life science technologies by providing legal and business guidance on formation, financing and operation of leading medical device companies.

Client Focus

The Medical Device Practice of Morris, Manning & Martin has built its reputation by assisting medical device entrepreneurs grow their businesses. We have consistently focused on representing companies that are developing and commercializing new technologies and engaged in fundamental scientific research. From our inception over 30 years ago, we have grown into one of the leading law firms in the Southeast and, in the words of the Atlanta Business Chronicle, are “generally regarded as having the city’s top technology group.” We understand the promise of medical device and life sciences technology, and we bring the full scope of our expertise to help our clients succeed.

Legal Leaders

From emerging companies to large public enterprises, Morris, Manning & Martin has become a leader in technology related venture capital deals, M&A transactions and IPOs for medical device companies. We have also developed leading practices in the intellectual property and regulatory areas related to the medical device industry. As such, our lawyers have the industry experience and business acumen to work with companies in all stages of development, from idea generation and initial patent filings, to clinical trials and venture financings, through to an M&A transaction or an IPO and beyond. We maintain extensive ties with venture capital firms and other investors who are active in the medical device field. We were leaders in the formation and operation of the Southeastern Medical Device Association (SEMDA), a networking community that helps inventors and entrepreneurs locate sources of financing, navigate complex licensing and regulatory issues and grow their medical device businesses. Through SEMDA and other organizations, our Medical Device Practice has an extended reach into resources and contacts and has established crucial business relationships within the medical device community.

Raising Capital

Medical device and related life science companies need capital to grow. We have been recognized as the Southeast’s leading law firm in representing companies in venture capital transactions. In the recent past, we have acted as counsel in well over 200 venture capital transactions that have raised approximately $2 billion. Due to our active practice in this area, we have strong relationships with many venture capitalists throughout the country. We assist our clients in identifying funding sources, creating the appropriate investment structure and negotiating both the term sheet and final investment documents. More importantly, our experience helps our clients avoid strategic errors that may hinder further growth or complicate exit strategies. We understand that as our clients succeed, we succeed. Therefore, our philosophy is to add value, not expense.

As our clients grow, we assist them in raising capital in the public securities markets, where we have been ranked among the top firms in the nation in initial public offerings. In the recent past, our clients have raised approximately $6 billion from sales of equity in initial public offerings. As company counsel, we help our clients through every stage of the offering process, from identifying and selecting the underwriters to preparing the prospectus and closing the transaction.

For companies with an interest in debt financing, we are very active in the public and private debt markets. In addition to acting as counsel with respect to offerings of debt securities, such as senior subordinated notes and convertible subordinated notes, we are regularly involved in asset-based financings, acquisition financings, mezzanine financings, syndicated financings and sale/leaseback transactions.

Achieving Corporate Goals

Many of our clients engage in joint ventures or mergers and acquisitions as an integral part of their corporate strategies. Due to our reputation for providing creative, efficient and effective solutions to our clients’ business and legal challenges, we have one of the leading merger, acquisition and joint venture practice groups in the Southeast. In the recent past, we have acted as counsel in more than $15 billion of merger, acquisition and joint venture transactions. We represent companies at all stages of their growth. We are able to efficiently staff transactions from small private company acquisitions to multibillion-dollar public company acquisitions and joint ventures.

We have particular experience in complicated domestic and international licensing, distribution and joint venture transactions. These types of transactions often require expertise in many legal disciplines, such as tax, securities, intellectual property, litigation, employee benefits, environmental and real estate. To address the complexities of these transactions, we create multidisciplinary client teams that work together seamlessly and efficiently to complete the transactions.

Protecting and Managing Intellectual Property

Most of our clients create and depend upon intellectual property as their core asset. Our practice group that deals with protecting, developing, selling, licensing and granting rights in intellectual property is among the most prominent in the Southeast. Patent filings and transactions involving critical technologies require not only solid legal drafting and negotiation skills, but also comprehensive technical knowledge and business acumen. Patens and technology contracts are as diverse as the technologies they address, and the law governing patenting and licensing intellectual property evolves almost daily. Accordingly, we actively focus our practice on understanding and applying the most recent industry and legal developments for the benefit of our clients.

Regulatory Guidance

We provide guidance on key regulatory issues faced by a medical device concern. Clients count on our thorough understanding of HIPAA privacy and security rules to keep them in compliance with the evolving nuances of this recent law. Operational hurdles are surmounted, from FDA compliance issues through clinical trials to product approval. We also focus on reimbursement issues, fraud and abuse laws and product liability concerns, allowing our clients to keep their attention fixed on creating innovative medical products. Together with Morris, Manning & Martin’s Healthcare Regulatory lawyers, we provide the sound advice our clients need to successfully navigate the many laws and regulations imposed upon them, both in the U.S. and internationally.

Interdisciplinary Approach

Practicing a team approach to legal service, we work closely with other relevant practices, such as our Licensing, Intellectual Property and Healthcare Regulatory Practices, to assist medical device and related life science companies in all stages of their lifecycles. Our Medical Device lawyers also draw upon the experience of our corporate and technology practices, who have built their reputations on helping entrepreneurs grow their businesses and by representing companies that are developing and commercializing new technologies, particularly in scientific research. We advise and assist our Medical Device clients on matters involving equity and debt financings, mergers and acquisitions, intellectual property, technology licensing and protection, strategic joint ventures and general corporate governance. For a sound legal approach with sophisticated deal-making experience, Medical Device clients rely on Morris, Manning & Martin.

Representative Clients and Transactions

Morris, Manning & Martin’s Medical Device lawyers represent clients and organizations of all types across the medical device industry, including clients engaged in the development of products in the cardiovascular, orthopedic, endoscopic, bioinformatics, nanotechnology and related fields, as well as other biotechnology and healthcare companies, including therapeutics companies, clinical research organizations, pharmaceutical manufacturers, pharmaceutical distributors, healthcare IT companies and venture capital and private equity investors. Several recent representations include:

  • Representation of medical device company developing a product combining radiation therapy with MRI technology in a $25M venture capital transaction.
  • Patent filings for medical device company involved in the research and development of products for use in minimally invasive cardiothoracic surgery.
  • Formation and initial licensing transaction for company developing innovative products for neuropsychological assessments.
  • Representation of several leading research universities in licensing and technology transfer transactions to commercialize new medical devices.
  • Representation of a leading clinical research organization based in the U.K. in its U.S. acquisitions.
  • Representation of specialty pharmaceutical company in it initial Series A financing.
  • Representation of venture capital fund in its Series A investment in a leading provider of endoscopy products.
  • Representation of a technology-based, healthcare cost containment company in its $25M acquisition of a competing provider and several PPO networks and in its $35M senior secured credit facility.
  • Representation of a development stage company involved in the research and development of bifocal and progressive contact lenses for treatment of presbyopia in its Series B financing.

Key Services:

  • Corporate
  • Venture capital
  • Regulatory and compliance
  • Intellectual property
  • Licensing & distribution
  • Mergers & acquisitions
  • Employment
  • Securities
  • Product Liability
  • Public offerings
  • Privacy and security
  • Joint ventures/Strategic alliances