Polsinelli’s attorneys in the area of medical technology have decades of deep involvement with clients integral to the field of medical devices, including companies in the Fortune 500 and with annual revenue into the billions of dollars. They have executed hundreds of patent applications for medical device companies, and defended companies in the industry against product liability claims by individuals and certified classes. Polsinelli attorneys also have significant experience representing medical device companies in mergers, acquisitions, and other transactional corporate matters.
The firm’s health care attorneys provide strategic guidance to medical device companies on a broad range of issues, including clinical trials, sales and marketing operations (including direct-to-consumer marketing compliance), digital and telehealth counseling, coverage and reimbursement, and HIPAA and state privacy laws.
We also assist in the development and implementation of corporate compliance programs that address key compliance areas, including the development of policies and procedures, conducting risk assessments, and performing internal reviews, audits and investigations. Should inquiry or audit occur, we also have deep experience representing medical device manufacturers and suppliers in connection with criminal and civil litigation on matters involving the False Claims Act, the Foreign Corrupt Practices Act, federal and state fraud waste and abuse laws, enforcement actions by the DOJ, HHS-OIG, FDA and CMS, and other disputes.
In the universe of patents, those involving medical devices require extensive experience and cross-disciplined teams to protect and enforce the valuable inventions they cover. Polsinelli’s medical device patent prosecution attorneys understand the technology behind these inventions, and have decades of deep involvement with clients integral to the field of medical devices, including representation of companies in the Fortune 500 with annual revenue into the billions of dollars.
Clients have engaged Polsinelli in all aspects of protecting medical devices. We have written and prosecuted patent applications, drafted opinions, negotiated licensing deals, assisted with asset sales and purchases, and litigated infringement lawsuits. We have represented companies offering a broad diversity of device types, ranging from radiation therapy devices, bone repair devices, cardiovascular implants, trocars, stints, catheters, wound closure devices, mesh implants, devices having a drug coating, wearable physiological monitoring devices, spinal implants, lab-on-a-chip, microfluidics, and a variety of other devices.
For over half a century, our attorneys have been committed to defending manufacturers in complex and high exposure cases, and on behalf of clients we have successfully managed class actions, multi-party litigation and insurance coverage disputes with impact to our clients into the hundreds of millions of dollars. The Polsinelli Products Liability practice handles medical device disputes in federal and state courts across the country. Our work in this area includes defense in claims arising out of alleged product defect or contamination, exposure during clinical trials, breach of warranty, failure to warn, allegations of professional negligence, and personal injury.
Food and Drug Administration
A robust knowledge of the FDA regulatory regime, a deep understanding of the policies and objectives that FDA laws are intended to achieve, and a grasp of the nuances involved in medical device manufacturing and distribution allow the attorneys in our FDA practice to provide counselling and advocacy on a diversity of issues involving most types of medical devices. Additionally, we have significant recent experience counselling various clients regarding the scope of FDA scrutiny and the parameters of FDA’s enforcement discretion regarding mobile medical applications and similar software-based mobile health products.
We are also very well-versed with FDA’s 510K clearance and PMA approval processes, typically working closely with our clients’ internal technical/scientific experienced professionals (or similar outside consultants) who are likely to prepare the technical submission documents for FDA’s review division personnel. This approach has proven to maximize efficiency and places Polsinelli in a good position to address legal concerns that may arise as issues shift from a technical regulatory focus to more legal regulatory matters after a 510K clearance or PMA has been obtained.
Representative medical technologies include:
- Cardiac ablation
- Cardiac stents and associated deliver tools
- Implantable pulse generators, leads and associated delivery tools for cardiac and pain management applications
- Pain management applications
- Programmers for programming implanted pulse generators
- Cardiac patient management
- Aneurysm treatment
- Blood clot removal
- Joint replacement implants
- Spine implants
- Surgical planning and simulation
- Robotic surgery
- Medical imaging, including MRI, CT and echocardiography
- Ophthalmological examination, surgery and implants
- Endoscopic and laparoscopic surgeries
- Carpal and cubital tunnel surgeries
- Oral health products
- Dental tools and implants
- Surgical filters
- Wound healing
- Medicament administration including via injection and infusion
- Laboratory processing
- Surgical tables
- Patient transporting
- Medical fluid pathway connectors and valves
- Bone substitute materials
- Stem cell harvesting
- Breast health monitoring and tumor detection
- Physical therapy
- Diabetic neuropathy treatment
- Medical data mining
- Medical facility communication systems