The attorneys in Baker Donelson's Health Law Department have extensive experience helping clients in the pharmaceutical, medical device and biomedical industries resolve disputes through both the litigation process and alternative dispute resolution methods, such as mediation and arbitration. We handle a wide array of cases, including product liability suits, commercial disputes, antitrust cases, labor and employment problems, and regulatory and governmental matters. Our trial lawyers participate in industry trade groups and actively monitor developments in litigation targeting the drug, device and life science industry. Our litigation defense experience allows us to proactively identify the most dangerous cases and conclude them on terms most advantageous to our clients.
Baker Donelson's trial attorneys have defended numerous medical product liability cases for manufacturers, distributors and retailers, including lawsuits with plaintiffs from around the world and class action lawsuits with hundreds of millions of dollars at stake. We have defended companies in suits alleging the defective design and manufacture of products such as dialysis equipment, orthopedic devices, cardiac defibrillators, spinal screws, birth control devices, hormone replacement therapy, intravenous equipment, anesthesia pumps, blood products, mechanical heart valves, breast implants, acne drugs and anti-nausea medications, among many others.
In addition to handling single plaintiff cases, we have served as national and regional coordinating counsel in product liability cases. We have also managed the defense of large class action, multiple-suit and mass tort litigation, including consolidated multi-district proceedings. Some have involved hundreds or even thousands of plaintiffs, with products marketed and distributed worldwide.
Pharmaceutical, medical device and life science companies confront the same types of commercial disputes as other businesses. Our litigators’ deep knowledge of these industries, gained through our business, regulatory and product liability experience, enables us to fully appreciate our clients’ specific dispute resolution goals and concerns. Our teams provide a full spectrum of services, including work on commercial, intellectual property and contract disputes, antitrust actions, regulatory counseling and assistance with government investigations.
Baker Donelson's attorneys have served as outside patent counsel for a number of pharmaceutical, medical device and life science companies, handling patent infringement cases both in the U.S. and internationally in venues such as the International Trade Commission. We have represented pharmaceutical manufacturers in average wholesale price (AWP) litigation and facility and product licensing. Our appellate attorneys were even responsible for establishing the learned intermediary doctrine in Alabama.
Regulatory Matters and Government Investigations
Baker Donelson’s attorneys have extensive experience handling the myriad, complex regulatory issues that drug, device and life science companies confront on a daily basis. Our services include:
- Assisting with coverage, payment and coding issues for new product launches.
- Reviewing, developing and implementing compliance programs.
- Helping clients respond to FDA warning letters and deficiency notices, including the determination of corrective actions.
- Self-reporting potential overpayments involving average wholesale price issues to CMS and the Office of Inspector General (OIG).
- Advising clients on product recalls and handling of adverse events.
- Restructuring operations to comply with developments in the Anti-Kickback Statute.
- Working with the National Clearinghouse and each regional Durable Medical Equipment Regional Carrier (DMERC) to facilitate Medicare enrollment.
- Reviewing compliance with Medicare coverage standards and medical record reviews to support claims billed to Medicare and secondary payers.