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MedTech, Tools, and Devices

Transactional

  • Represented Blue Belt Holdings, Inc. in its $275M merger with Smith & Nephew.
  • Represented Beacon Endoscopic in its merger with Covidien LP.
  • Represented Lotus Tissue Repair in its merger with Shire.
  • Represented Endotronix, Inc. in its $32M Series C financing led by BioVentures Investors; SV Life Sciences; Lumira Capital; Aperture Venture Partners; and OSF Ventures.
  • Represented MedCPU Inc. in its $35M Series C financing led by UPMC; Merck Global Health Innovation Fund, LLC; and New Richmond Ventures, LLC.
  • Represented AdvanDx, Inc., a medical device company, in its merger with OpGen, Inc. (NASDAQ:OPGN).

Intellectual Property

  • Provide strategic guidance and opinions to a company focused on developing and selling surgical tools. We continually help the company maintain its position in the market, producing, in one instance, 12 opinions related to 3 different product lines in a compressed timeframe.
  • Represented Alphatec Holdings, Inc. as the defendant in a patent infringement lawsuit relating to intervertebral implants. Resulted in a favorable settlement for the client.
  • Successfully represented Petitioners Adlens USA, Inc., and Adlens, Ltd., in two inter partes review proceedings challenging the validity of patents covering fluid filled, adjustable eyeglass lenses. The PTAB invalidated all challenged claims in the patents. IPR2015-01821, IPR2015-01824
  • Conducted a broad scope due diligence for a medical device manufacturer as it considered investing in a company operating in the electrical nerve stimulation space. This effort involved understanding the technology and the details of future, to-be-developed products. It was necessary to assess the potential for the company to have freedom to market these future products. In doing so, detailed evaluations of some patents were necessary. Our study also assessed the quality of the patent protection in place at the investee, with the goal of determining the effectiveness of the portfolio to prevent third parties from successfully marketing competing technology. We ultimately advised our client that the target company had clearance to operate and the client made the investment.
  • Provided strategic guidance to a medical device manufacturer in relation to a new product launch. This involved a detailed evaluation of more than 50 patents, assessing them for invalidity and/or non-infringement, to ensure our client's new product would not be impacted by any of the patents. The company is planning a large surgical tool product launch and this freedom to operate project provided the clearance needed to comfortably go to market.
  • We are trusted by a high-profile San Diego-based vision-focused medical device incubator with helping to assess and develop the patent strategies of its portfolio companies, and have been key legal counsel in recent successes of its portfolio companies. In 2016 and 2017, two of the incubator's companies were acquired by global corporations.
  • Represented NxStage Medical in successfully challenging the domain name filing in Chile of nxstage.cl.
  • Handle all manner of patent services for a publicly-traded company with market capitalization of more than $1 billion, which manufactures standard and custom engineered products and systems for a wide variety of cryogenic and gas processing applications. The firm has filed dozens of US and non-US patent applications and handled a European patent opposition as well.
  • Conducted a freedom to operate assessment for a client which produces a clinical diagnostic product, essentially a lab-on-a-chip which provides for point of care testing for a wide range of infections. Most such tests have to be conducted at a central laboratory, which increases expense and causes a significant wait for results. The company's product allows treatment professionals to carry out testing on-site. We reviewed numerous third-party patents to advise the company that it had freedom to operate.
  • Conducted complex due diligence in the course of a significant planned acquisition for an orthopedics client assessing the value of the target company from an intellectual property perspective. This included a freedom-to-operate assessment of more than 300 third party patents, and evaluation of the target company’s portfolio to determine the extent to which it provided sufficient protection to prevent competitors from marketing products that can effectively compete with the proposed next generation of products.
  • Mintz served as M&A and IP counsel for an acquisition by HealthpointCapital portfolio company CrossRoads Extremity Systems. The Mintz team represented CrossRoads as it acquired from Surgical Frontiers LLC several FDA-cleared products covered by dozens of patents and patent applications. Technologies involved include soft tissue-to-bone reattachment, precision cutting guides for bone alignment in small-bone procedures, anatomic ligament reattachment, and reproducible restoration of anatomic bone alignment and ligament function.
  • Mintz handled the IP due diligence for Johnson & Johnson in its acquisition of TARIS Biomedical LLC, a privately owned biotech company, in December 2019. Through the acquisition, J&J division Janssen Pharmaceuticals adds to its portfolio “a first-in-class clinical stage platform to evaluate novel, locally-delivered therapeutics for patients with localized bladder cancer.” TARIS’ lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder.
  • Philips Medical Systems (Cleveland), Inc. v. GL Leading, Inc., 1:19-cv-02648 (N.D. Ill.) – Lead counsel to several divisions of Philips Healthcare in a case brought against competitors and a former employee, inter alia, alleging misappropriation of trade secrets relating to the design and manufacture of X-ray tubes used in commuted tomography.

Litigation

  • Served for more than two decades as national products liability and lead trial counsel for national medical device manufacturer with responsibility for handling, supervising, managing and/or directing the defense of their significant products liability matters and providing general advice regarding risk management, CAPA, recalls, pre-litigation strategy, litigation prevention and regulatory issues relating to their various divisions and product lines. Also supervised local counsel throughout the country and participated in trials in multiple venues.
  • Represented a medical device company in a potentially bet-the-company class action with all types of claims that involved their then major product which included Racketeer Influenced and Corrupt Organizations (RICO), breach of fiduciary duty, and Ohio Product Liability Act (OPLA). Successfully obtained a dismissal on a 12(b)(6) motion to dismiss with prejudice.
  • Represented a medical device manufacturer in a matter concerning a supposed fraudulent scheme whereby our client was accused of reaping significant profits by 1) using patients as research subjects without their knowledge, 2) charging the patients and their insurers for implants that were not used in compliance with the FDA approval process and which uses were not disclosed to the patients as necessary to obtain informed consent, and 3) knowingly concealing the charges for the implants, not reporting to the patient or insurer that the devices were not approved for such use, not obtaining precertification for such use, and not obtaining informed consent for experimental use. The court granted a motion to dismiss the claims in their entirety.
  • Represented several manufacturers and sellers of silicone implant devices as national coordinating counsel and trial attorney. Successfully reversed the initial trend of verdicts favoring claimants [claiming autoimmune disease and other injuries from the silicone], and obtained defense verdicts for multiple clients in various jurisdictions across the US. The litigation of nearly 40,000 claimants was resolved via national settlement saving clients from long- lasting financial burden.
  • Provide product risk assessment and pre-litigation counseling to several foreign and domestic medical device companies.
  • Represented a medical device company in securities actions as a result of improper disclosures and derivatives actions for corporate waste.
Case Study
Mintz conducted a comprehensive analysis of a portfolio held by a competitor in relation to our client's products. The team identified a number of weaknesses in the portfolio, ultimately advising the client that based on multiple issues associated with each patent they could maintain production and distribution of their products.
Case Study
Mintz and Mergermarket produced a comprehensive report on recent M&A activity in the life sciences sector. We asked 100 US-based executives to share what motivated their latest transaction and their post-closing integration experiences.
Case Study
Mintz is helping a client that manufactures medical technologies for facility and home-based care design and implement corrective actions in response to an FDA follow-up inspection. Although the client has two open FDA inspections, Mintz attorneys have helped the company avoid a warning letter.
Case Study
Mintz serves as national trial and coordinating counsel in two mass tort litigations against a surgeon involved in the design of two implantable orthopedic devices. An early trial result facilitated a national settlement that resolved most of the individual cases in one mass tort.
Case Study
Mintz helped two in-house Johnson & Johnson attorneys conduct due diligence for J&J’s $4.325 billion acquisition of Abbott Medical Optics (AMO). Mintz attorneys assessed AMO’s patent portfolio, license and settlement agreements, and patent litigations and made freedom-to-operate assessments.
Case Study
Mintz served as national coordinating and lead trial counsel for a Fortune 500 medical device company in products liability mass torts. Mintz used a national settlement program in one litigation. Several published appellate decisions in another led to dismissals and favorable settlements.
Case Study
Mintz has handled all of NxStage's trademark needs, from its founding as a small start-up to achieving $400 million in annual revenue, including its first NxStage logo in the US, Canada, and Japan, and all of its subsequent brand registrations in South America, Mexico, Latin America, Europe, Oceania, Asia, and the Middle East.
Case Study
Mintz successfully mediated a dispute relating to medical device company Invivo Corp.’s retention of an $850,000 holdback reserve in its acquisition of Hologic, Inc.’s Sentinelle, an MRI coil product line. Mintz argued that Invivo suffered monetary losses due to Hologic’s breaches and inaccuracies.
Case Study
Mintz is helping a manufacturer and distributor of device systems used in wound treatment pursue Medicare and Medicaid coverage options throughout the country, including negotiating coding. Mintz attorneys met with the Centers for Medicare & Medicaid Services (CMS) regarding scope of coverage.
Case Study
Mintz steered precision health company Quanterix Corporation through a $73.7 million initial public offering (IPO). The firm’s Securities & Capital Markets Practice advised Quanterix on the Securities and Exchange Commission review process as well as pricing and timing of the offering.