Our experts can help you navigate this intricate and often confusing world of medical sector litigation and opportunity. Representative areas of specialty for our medical experts include:
Medical Devices: The medical device industry is nearly $200 billion in the United States, which represents about 40% of the world medical device market. Medical device innovations have led to innumerable improvements in quality of life for millions of people, ranging from pacemakers to artificial joints to Left Ventricular Assist Devices (LVADs). But bringing truly innovative new medical devices to market usually requires a premarket approval from the FDA, which is expensive and costly, and missteps are easy and can make it more costly. It’s no surprise that when an important new medical device area emerges, such as minimally invasive surgeries performed by interventionalists, it gives rise to a wide array of tools to enable these procedures, such as robotic surgery machines, stents and cardiac ablation catheters. New tools in a huge emerging new market means patent litigation is almost a foregone conclusion. Click here to learn more about Rubin Anders’ robust medical device expert witness practice. To view our medical device expert case studies, click here.
Pharmaceuticals: Pharmaceutical experts span a wide range of disciplines, including pharmacological research and development, drug design and manufacturing, pharmaceutical chemistry, clinical trials, drug effects, and mechanisms (pharmacodynamics), movement and metabolism of drugs (pharmacokinetics), patent validity and infringement and the substantial Food and Drug Administration (FDA) regulations and requirements. In high-stakes situations — such as patent litigation or bringing a new drug molecule into clinical practice — having the perfect scientific or clinical expert on your team can make a world of difference. Click here to learn more about our pharmaceutical experts who can provide the niche expertise you need.
Physicians and Other Medical Practitioners: Doctors (including numerous specialists such as cardiologists, oncologists, orthopedists, and many others), physicians’ assistants, nurses (which includes RNs, Nurse Practitioners, Home Healthcare nurses, and other specialized nurses), dentists, ophthalmologists, and other medical practitioners undoubtedly strive to work on behalf of their patients. But if a patient does not obtain the desired result, the question arises as to where the responsibility lies. What is clear is that if a medical professional fails to meet a recognized standard of care and the patient suffers injury, the medical professional can be held legally responsible. Our experts can opine on medical malpractice and other such issues around medical care in any part of medical practice, including major specialties, from anesthesiology to oncology to ophthalmology, and much rarer specialties such as pediatric cardiology, physiatry or gerontology. Our recent expert placements have included a general practitioner and a home healthcare nurse to testify on the standard of care in a wrongful death case involving respiratory distress of a quadriplegic adolescent, and a rehabilitation therapy expert who opined on the standard of care, and the impact of delayed rehabilitation, on full recovery of a patient’s injured leg.
Medical Research and Development: Patient care is improved by medical research and development. Through the careful study of medicines and other treatment approaches, researchers can determine whether new or adapted medical devices, pharmaceuticals and treatment processes are safe and effective. Yet due to the technical nature of this study, it is rife with legal issues. Does a refurbished medical device infringe a patent? Did a generic pharmaceutical manufacturer “actually induce” infringement of method-of-use patent claims under the Hatch-Waxman Act? Our experts can opine on these and many other issues related to medical research and development. We can also provide consultants with experience in the drug development and commercialization process to guide our clients in the review and negotiation of licenses, distribution agreements, and contract manufacturing.
Medical Standards and Practices: Many regulatory bodies have developed rules and regulations governing the development and provision of medical products and services. The FDA has the broad mandate to ensure the safety and efficacy of drugs, medical devices, and food. The Centers for Medicare and Medicaid Services sets the requirements for Medicare and Medicaid coverage and reimbursement. The Federal Trade Commission sets advertising standards for non-prescription drugs and devices. If these prescribed medical standards are alleged to have been breached, companies may be subject not only to private party litigation, but also to regulatory investigations. As an example, the FDA might allege that a drug developer failed to follow FDA’s Institutional Review Board (IRB) regulations, which are designed to protect the rights and welfare of research participants, or CMS may seek to bring a case around a violation of the Stark Amendment. The Department of Justice might allege telemedicine fraud where medical providers knowingly prescribed unnecessary durable medical equipment and diagnostic testing otherwise reimbursable by Medicare.
Industry associations also set voluntary industry standards and practices. For example, the American Medical Association administers the process of creating new Current Procedural Terminology (CPT) billing codes, and requires doctors to comply with a variety of ethical standards governing the behavior and communication between doctors and patients. Similarly, the National Association for Home Care and Hospice sets ethical standards to provide for the highest quality of care of the aged and infirm. Whether your client needs an expert involving a private dispute or a governmental investigation, we have the perfect expert to meet your needs.