Life Sciences

The Life Sciences arena continues to expand with advances in biotechnology, nutraceuticals and emerging medical techniques in pharmaceuticals, medical devices, over the counter (OTC) products, durable goods, therapies and delivery and monitoring technology. Lewis Brisbois’ nationwide Life Sciences team has impressive depth of experience successfully defending mass tort/pattern litigation and catastrophic injury cases. As masters of scientific and medical knowledge, we have excellent relationships with the most qualified experts, using our network to help clients at all stages of product development, regulatory and compliance and litigation. Trusted advisors and zealous advocates, our attorneys stand ready to address the unique issues that impact all businesses operating in the Life Sciences space across the country. 

With one of the strongest trial benches in the nation and largest geographical reach, Lewis Brisbois provides a client-focused, results-oriented and cost-effective approach creating favorable results. Our demonstrated prowess includes: 

• National Coordinating Counsel in state-coordinated litigation and Multidistrict Litigation (MDL);
• Lead counsel in mass tort/pattern litigation in state and federal court;
• Class action defense for medical devices and pharmaceuticals;
• Catastrophic injury defense as both national and local counsel;
• Representing branded drug manufacturers, generic drug manufacturers and over-the-counter (OTC) product manufacturers of dietary supplements, cosmetics and other regulated consumer products (DSHEA);
• Defending 510k cleared and PMA approved medical devices;
• Counseling clients on product recalls and adverse event reporting;
• FDA Emergency Use Authorization (EUA) requests;
• Covid-19 vaccine and compliance related risk assessment, advice and defense of claims;
• Advising on “Dear Doctor” letters, labeling and marketing efforts within FDA’s sophisticated regulatory framework;
• Retaining and working with renowned experts; 
• Performing risk assessments for manufacturers, distributors and insurers;
• Deploying current preemption and innovator liability arguments and defenses; 
• Expertise in electronic discovery, electronically-stored information (ESI) protocols and management and management and review of mass quantities of documents through linear and/or technology assisted review (TAR); and
• Clinical trials and Investigative Device Exemptions (IDE) advice and defense.

Our clients are diverse and include brand and generic prescription and OTC pharmaceutical manufacturers, retailers, repackagers as well as medical device manufacturers and distributors. Our Life Sciences Practice is as broad as the growing industry and includes representation of nutraceuticals, cosmetics, durable medical equipment, vaccines, biologics and a wide range of other products. Biotechnology companies, Clinical Research Organizations (CRO), sales representatives, combination products companies and insurers regularly retain our team. Our Life Sciences attorneys have handled the following representative matters and products:

• MDLs involving Metformin, Zantac, Valsartan, diet drugs, hormone replacement therapy and more;
• Defense of Class III devices including ventricular assist devices and cardio defibrillators (WCD and ICD);
• Orthopedic bone screw (pedicle) litigation;
• Pediatric dental lawsuits;
• Inferior vena cava filter litigation; 
• Generic pharmaceutical MDL involving allegations of NDMA impurities/contamination;
• Compounding pharmacy litigation arising from spread of fungal meningitis; 
• Catastrophic injury suits involving the following medical procedures, devices and issues:
  • Ischemic strokes resulting from cerebral artery dissections;
  • Neurological injuries attributed to chiropractic manipulative therapy;
  • Intraoperative neurophysiologic monitoring during spinal surgery;
  • Mechanical ventilation;
  • Cardiopulmonary bypass equipment;
  • Electronic fetal monitoring;
  • Treatment planning and delivery of intensity modulated radiation therapy for primary cancers;
  • Tampon-induced toxic shock syndrome;
  • Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN);
  • Idiosyncratic and allergic drug reactions;
  • Elastomeric infusion pumps;
  • Venous access devices, airway management, fluid delivery/warming devices;
  • Cosmetic radiofrequency (RF) and Collagen Induction Therapy (CIT);
  • Pacemakers and implantable cardioverter defibrillators (ICD);
  • Injectibles and dermatology procedures;
  • Heater-Cooler Devices;
  • Lazarus syndrome (auto-resuscitation after failed cardiopulmonary resuscitation);
  • Traumatic cervical spine fractures;
  • Kyphoplasty; 
  • Vertebroplasty;
  • Spinal disc replacement and spinal hardware failures;
  • Knee, hip and shoulder joint replacement; 
  • Pedicle screw spinal fusion surgery; and
  • Burn cases from medical lasers. 

Our skilled FDA regulatory lawyers have years of experience navigating the regulatory framework governing food products and food safety, and routinely defend manufacturers and distributors of food products in class actions, pattern litigation and individual cases involving human, veterinary and livestock food products contamination cases involving Salmonella, Listeria and E.coli as well as defending heavily regulated food labeling matters.

Chairs

• Michelle Gilboe (Managing Partner) - Michelle.Gilboe@lewisbrisbois.com, 612.428.5002
• John Salvucci (Managing Partner) - John.Salvucci@lewisbrisbois.com, 215.977.4057

Vice Chairs

• Pamela Ferguson (Partner) - Pamela.Ferguson@lewisbrisbois.com, 415.438.6638