Medical device companies, durable medical equipment (DME) and supply companies, pharmaceutical companies and life science companies constitute one of the largest segments of the health care industry. We know that each type of business has its own unique legal issues, and offer our clients an integrated approach, drawing on over 100 attorneys experienced in the industry to create multidisciplinary teams across our offices for representation.
We were ranked by Best Lawyers in America® 2011 as No. 1 in the nation for product liability litigation; No. 3 in the nation for health care law; and our drug, device and life sciences team includes attorneys who have been recognized in Best Lawyers in America® (since 1991), Chambers USA (since 2007) and Super Lawyers (since 2006).
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 biotech medical device, equipment and pharmaceutical companies. The ever-changing face of the health care industry requires up-to-date knowledge and legal experience in federal regulatory agencies such as Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), Federal Trade Commission (FTC), Patent and Trademark Office (PTO) and Drug Enforcement Administration (DEA). In addition, our experience extends to traditional areas including, finance, mergers and acquisitions, business structures and planning, tax, real estate, labor and employment, governmental compliance and intellectual property.
Representative Matters:
- Assisted public pharmaceuticals company, in raising approximately $8 million in a private placement offering to 36 institutional and accredited investors. In connection with the closing, the company issued approximately 10 million shares of 8% convertible preferred stock and warrants to purchase approximately 5 million shares of common stock of the company. Complete victory on behalf of pharmaceutical distributor, winning ownership of disputed non-patented intellectual property that was created in the process of formulating 26 generic pharmaceuticals and four medical devices for our client.
- 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.
- Served as outside patent counsel for cancer therapeutic biotech company.
- Served as outside patent counsel for a leading medical diagnostic company.
- Assisted clients in obtaining patent term extension for patent covering FDA approved product.
- Represented pharmaceutical company at the International Trade Commission in complaint regarding patent infringement by imported products involving patented drug delivery system.
- Handled facility and product licensing for pharmaceutical manufacturer acquisition of manufacturing site and individual drug products.
- Performed due diligence review and site visits for potential acquisitions and strategic partnerships.
- Assisted clients in preparation of responses to FDA warning letters and deficiency notices including the determination of corrective actions.
- Advised clients on the carrying out of drug, device and food product recalls and the communication and handling of adverse events.
- Reviewed marketing, promotional materials and product labeling to assure compliance with FDA regulations and guidance.
- 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 device, 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 Office of Inspector General (OIG).
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 life science 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.
Representative Matters:
- Currently serve as lead counsel for distributor of anesthesia medication in more than 200 cases in Las Vegas, Nevada.
- Represent large pharmaceutical and medical device manufacturer as national counsel in multiple products liability lawsuits involving various medical products including IV administration equipment, dialysis equipment, pain pumps and pharmaceuticals.
- Currently serve as national counsel for pharmaceutical company in isotretinoin litigation.
- Served as national coordinating counsel for manufacturer in children's vaccine, fen-phen, hormone replacement therapy (HRT) and average wholesale price (AWP) litigation.
- 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 of class action suit brought against pharmacy chain for dispensing drug recalled by the FDA.
- 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.
- Co-lead counsel for pharmaceutical company in all Mississippi diet drug litigation in state court, federal court and multi-district proceeding.
- Mississippi counsel team for pharmaceutical company in birth control device litigation.
- Mississippi counsel team for pharmaceutical company in hormone replacement therapy litigation.
- Represented world's largest manufacturer of store-brand over-the-counter drugs in all phenylpropanolamine (PPA) litigation in Tennessee.
- Established the learned intermediary doctrine in Alabama.
- Obtained summary judgment for major manufacturer of knee prostheses even though plaintiff had had both components for both knees replaced by separate subsequent operations and plaintiff's product liability claim was supported by a metallurgical expert.
- Defended manufacturer of anti-malaria drug as lead counsel with success for client.
- Represent various pharmaceutical manufacturers in average wholesale pricing litigation.
- Lead counsel for pharmaceutical company in multi-million dollar commercial arbitration arising from dispute involving aseptic manufacturing of biopharmaceutical product.
- Arbitrated disputes between pharmaceutical manufacturers and customers.