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Medical Devices

Overview

Medical device companies turn to Nutter’s multidisciplinary legal team for strategic legal counsel to help achieve their business objectives throughout all stages of the companies’ lives and their products’ lifecycle – from research through commercialization. We routinely counsel companies in the following sectors:

  • Medical devices
  • Diagnostics
  • Medtech
  • Surgical robotics
  • Health IT and software
  • Remote health
  • Drug-device combination products

Nutter represents a broad array of innovative clients, ranging from emerging startups to mid-market companies to global medical technology corporations to renowned hospitals and research universities.

What We Do
With our fluency in medical technology and innovation, understanding of the health care industries, and business-savvy approach, we develop practical solutions to the issues and obstacles our clients face, including corporate, intellectual property, and product liability defense matters.

We have a proven track record in numerous areas:

Corporate and Transactional Issues
We provide practical advice to clients on how to solve and manage complex business and legal issues, including:

  • Transactional and strategic matters
  • Drafting and negotiating M&A, licensing, partnering, and joint development agreements
  • Financing (equity and debt): public offerings and private placements
  • Governance for boards of directors
  • Employment matters, including equity and bonus plans, employment agreements, and consulting agreements
  • Agreements for sponsored research, clinical trials, and manufacturing
  • Distribution and sales representative issues
  • SEC reporting and communications: 10-Ks, proxy statements, press releases, and investor presentations

Intellectual Property Portfolio Development and Strategy
Nutter attorneys recognize that the medical device space can be quite litigious. Because of this heightened risk, we often recommend an “eyes wide open” approach to avoid third party IP barriers to entry, including engaging in freedom to operate studies that enable clear access to a market. Members of the firm also work closely with clients to develop valuable, highly sought-after patent portfolios in at least the following technologies:

  • Anastomotic and occlusion devices
  • Bioassays and biomarkers correlations
  • Bone plates and adhesives
  • Catheters
  • Dialysis pumps
  • Electrochemical meters and cells (i.e., glucose meters)
  • Gastric bands and bypass procedures
  • Genetic analysis
  • Hydrocephalus valves
  • Ligament repair devices and procedures
  • Microfluidic devices
  • Optical imaging
  • Nerve stimulation
  • Photodynamic therapy
  • Software diagnostics
  • Spinal implants, including spinal rods, cages, and cross connectors
  • Surgical staplers and clip appliers
  • Sutures, suture anchors, and related surgical methods
  • Tenaculums
  • Tissue cutting and sealing devices
  • Trocars, retractors, and seal elements
  • Valves for injecting medication

IP Litigation
Nutter’s IP litigators represent medical devices clients in both plaintiff and defense matters, including:

  • Pre-filing diligence and assessment
  • Cease and desist matters
  • Settlement/license negotiations
  • District court litigation
  • Inter Partes reviews (IPRs)
  • Appeals to the CAFC relating to both district court and PTO proceedings

Products Liability Defense
Nutter is a national leader in medical products liability defense. We manage and resolve “one-off” litigation cases as either national or local counsel, as well as mass tort litigations. We are frequently a member of “virtual” law firm teams that are assembled to manage hundreds or thousands of plaintiffs in venues across the United States and internationally. This experience has allowed us to develop an expansive network of leading medical device expert witnesses in the world. The best way to win a products liability litigation is to avoid it in the first place, so we also assist clients with pre-litigation advice.

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Representative Matters

Representative Matters

  • Representation of a manufacturer of prosthetic knee, hip, and spinal implants in cases around the country

    Nutter is representing a manufacturer of prosthetic knee, hip, and spinal implants in lawsuits around the country, including so-called “mass tort” multi-district litigation (MDL) proceedings and other coordinated national litigation.

  • Representation of major corporations in cases involving diverse pharmaceutical and medical device products

    Nutter is representing major corporations in cases involving diverse pharmaceutical and medical device products, such as contact lenses, contraceptive patches, pediatric painkillers, quinolone antibiotics, and migraine medication in lawsuits in Massachusetts and New Hampshire.  

  • Strategic counseling for successful exit

    Nutter developed a strategic patent portfolio for an early stage emerging medical device company focused on minimally invasive wound closure. We defended the company in a due diligence evaluation by prospective investors and asserted patents against a large medical device company, resulting in a successful exit for investors through the sale of company assets to the competitor.

  • Represented a manufacturer of prosthetic spine implants in multi-district product liability litigation involving over 250 plaintiffs

    Nutter represented a medical device manufacturer in a multi-district product liability litigation involving over 250 plaintiffs. We managed a team of associates in the review and production of over four million pages of documents contained in an Electronic Reading Room.

  • Representation of a manufacturer of prosthetic hip implants in multi-district product liability litigation

    Nutter conducted expert witness preparation in this litigation.

  • Patent prosecution and portfolio development (medical)

    Nutter provided strategic advice on the development and management of robust patent portfolios to help medical device companies present a significant entry barrier to competitors. These companies include DePuy Spine, Ethicon Endo-Surgery, and DePuy Mitek, all Johnson & Johnson companies.

  • Market clearance

    Nutter analyzed the claims of third party patents and provided strategic counseling and advice to major medical device companies in connection with planned commercial launches. Products include a broad range of surgical devices in various fields, including bariatrics, spinal surgery, soft tissue fixation, neurosurgery, nutritional products, contact lenses, and pharmaceuticals.

  • Represented a medical device manufacturer that became aware of adverse medical incidents (failures of a small number of their products during usage) shortly before closing a deal to divest this product line

    Nutter represented a medical device manufacturer that became aware of adverse medical incidents (failures of a small number of their products during usage) shortly before closing a deal to divest the product line. Following FDA notification and the development of a product recall plan, the entire deal had to be restructured to provide for a partial closing and a supply and distribution agreement under which the client would complete the product recall and supply the buyer with products in the interim. The sale was successfully completed. Throughout the process, Nutter attorneys also advised the client, a publicly traded company, on its obligations under the Securities Exchange Act to report the transaction as it developed to the regulators and the investment community.

  • Served as trial counsel for a medical device company that was sued for patent infringement by two separate competitors

    Nutter served as trial counsel for a medical device company that was sued for patent infringement by two separate competitors. In one case, Nutter attorneys worked with the company’s engineers to develop product modifications that were clearly outside the scope of the patent-in-suit and then negotiated a settlement on favorable terms that allowed the client to sell off existing inventory at a modest royalty rate. In the other suit, Nutter attorneys successfully terminated the litigation by winning a summary judgment of patent invalidity in court.

  • Advised several Fortune 500 companies on patent and trademark prosecution, counseling, opinion work, and patent litigation on portfolio of pharmaceutical, medical, and biotechnology products

    Nutter advised several Fortune 500 companies on patent and trademark prosecution, counseling, opinion work, and patent litigation on portfolio of pharmaceutical, medical, and biotechnology products.

  • Represented pharmaceutical, surgical, and health care companies in employment litigation, including discrimination and wrongful termination claims

    Nutter represented a family of national corporations devoted to pharmaceutical, surgical, and health care services, handling litigation of discrimination and wrongful termination claims, litigation of non-competition agreements, non-solicitation agreements, and trade secrets, and preventive training on disability law, internal corporate investigations, and layoffs and reductions in force. We successfully avoided any material liability claims while adhering to budget constraints.

  • Represent a company in multi-district product liability litigation

    Nutter represented a medical device company in a multi-district product liability litigation involving a recalled device. The team was responsible for analysis of the science, retention of expert witnesses, analysis of company documents, and development of narrative themes for company witnesses.

  • National representation of medical device manufacturer in real estate matters

    Nutter represented a medical device manufacturer on a national basis on real estate leasing, acquisition, disposition, financing, permitting, and environmental and other land use related activities, including negotiation of letters of intent, purchase and sale agreements, leases, lease amendments, architects and construction contracts, brokerage agreements, and other consulting arrangements.

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