Practice Areas & Industries: Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Practice/Industry Group Overview

Medical device companies, durable medical equipment (DME) and supply companies, pharmaceutical companies and bioscience companies constitute one of the largest segments of the health care industry. We know that each type of business has its own unique health law concerns, and offer our clients an integrated approach, using multidisciplinary teams across our offices for representation.

Services Available

Business, Regulatory and Transactional Practice

By utilizing a team of attorneys with specific knowledge in various legal areas, we stay abreast of the constantly changing regulatory and business environments affecting medical supply, equipment and pharmaceutical companies. The ever-changing face of the health care industry requires up-to-date knowledge and legal experience in areas including, finance, mergers and acquisitions, business structures and planning, tax, real estate, labor and employment, governmental compliance and intellectual property.

Representative Matters:

• Worked with National Clearinghouse and each regional DMERC to facilitate successful enrollment in the Medicare program, including assistance in completing 855S forms, preparing for on-site reviews and assistance in complying with Medicare's supplier standards.
• Reviewed, developed and implemented compliance programs for medical supply, pharmaceutical and DME companies.
• Advised purchasers on health care regulatory risks associated with proposed acquisitions of medical supply and DME companies.
• Reviewed compliance with Medicare's coverage standards and medical record reviews to ensure documentation to support claims billed to Medicare and secondary payers.
• Advised participants in proposed joint ventures in fraud and abuse issues associated with DME joint venture arrangements.
• Assisted regional group purchasing organization in restructuring its operations to comply with anti-kickback statute developments.
• Assisted clients in developing regulatory training programs for sales and marketing staffs.
• Assisted pharmaceutical company in self-reporting potential overpayments involving average wholesale price issues to CMS and the OIG.
• Assisted clients in obtaining FDA pre-market approval of pharmaceuticals and medical devices.
• Organized biotechnology/life sciences fund among a major academic medical center and a NYSE company.
• Served as outside patent counsel for a leading medical device company.

Product Liability and Commercial Litigation Practice

Product liability cases present complicated legal issues for manufacturers, distributors and retailers in this industry and often carry the risk of substantial financial exposure. Baker Donelson trial attorneys have extensive experience defending these cases, many of which involve class action claims with far-reaching implications. The Firm's experience includes defending companies in lawsuits alleging the defective design and manufacture of products such as dialysis equipment, orthopedic devices, cardiac defibrillators, spinal screws, intravenous equipment, patient controlled anesthesia pumps, blood products, breast implants, acne medications and anti-nausea medications, among many other medical devices and pharmaceuticals. In addition to handling significant single plaintiff cases, Baker Donelson attorneys have served as national and regional coordinating counsel in products liability cases and are experienced in managing the defense of large class action and multiple-suit or mass tort litigation in these areas, including various consolidated multi-district litigation proceedings.

We understand that pharmaceutical, medical device and bioscience companies also confront the same types of commercial disputes that arise in the context of running any business. Yet our litigators' deep knowledge of these industries, gained through our business, regulatory and products liability experience, gives us a unique perspective to fully appreciate our clients' specific dispute resolution goals and concerns. Our attorneys have experience resolving disputes through both the litigation process and other forms of alternative dispute resolution, such as mediation and arbitration. Baker Donelson's multi-discipline teams provide a full spectrum of services to the Firm's clients, including commercial and contract disputes, antitrust disputes and regulatory and governmental counseling.

Baker Donelson's depth of litigation defense experience allows us to proactively identify the "dangerous" cases and conclude them on terms most advantageous for our clients. Our team of trial lawyers includes attorneys who are actively involved in organizations that monitor the most recent developments in litigation targeting the industry, including the Products Liability Advisory Council and the Defense Research Institute. Moreover, because of the significant health care legal work the Firm does in all areas, Baker Donelson has established and cultivated longstanding relationships with professionals in various medical communities throughout the country who can be called upon to assist in evaluating products liability and tort cases and provide expert witness testimony when needed.

We were ranked by The Best Lawyers in America® 2008 as number one in the nation for product liability litigation, with 10 attorneys and our drug, device and bioscience team includes attorneys recognized for their work in product liability defense by such publications as The Best Lawyers in America®, Chambers USA and Super Lawyers.

Representative Matters:

• Represented large pharmaceutical and medical device manufacturer across the country in multiple products liability lawsuits involving various medical products including IV administration equipment, dialysis equipment and anti-nausea medications.
• Obtained 25 summary judgments, seven affirmances on appeal, ultimate dismissal of all claims and no judgment against spinal screw manufacturer in mass tort litigation (over 1,600 plaintiffs in 35 state and federal cases) involving claims of manufacturing defects and multiple FDA violations.
• Resolved successfully, with no judgments, more than 200 cases alleging manufacturing defects for breast implant manufacturer.
• Obtained dismissal against drug manufacturer in case alleging use of defective preservative.
• National counsel for manufacturer of acne medication alleged to cause inflammatory bowel disease.
• Obtained dismissal of class action suit brought against pharmacy chain for dispensing drug recalled by the FDA.
• Arbitrated disputes between pharmaceutical manufacturers and customers.
• Resolved over 125 suits/claims worldwide in lead defense counsel role for manufacturer of dialysis product withdrawn from market.
• Acted as deputy regional defense counsel in California-based multi-district litigation involving hepatitis C infection from blood derivative withdrawn from worldwide market.
• Acted as deputy national counsel in defense of cases relating to mechanical heart valve withdrawn from worldwide market.
• Defended manufacturer of anti-malaria drug as lead counsel with success for client.
• Defended physician practice management company in common law fraud and misrepresentation, state and federal securities law fraud and breach of contract claim brought by 18 orthopedic surgeons and their clinic with successful outcome for client. Negotiated dissolution of practice management relationship, termination of management contract and payment of management fees of $3.5 million.
• Represented HMOs administering TennCare (Medicaid) benefits to Tennessee Medicaid beneficiaries in class action brought by class of beneficiaries alleging due process and other violations. Baker Donelson's clients allowed to intervene to challenge consent decree entered by plaintiffs and state defendants.
• Represent various pharmaceutical manufacturers in average wholesale pricing litigation.