Harris Beach has defended numerous Fortune 500 pharmaceutical and technology companies in a wide range of issues, such as patent enforcement, unfair competition, unfair importation, antitrust and breach of contract litigation.
Class Action, Multi-District and Multi-Party Liability
Our experienced trial lawyers regularly coordinate the defense of a wide range of complex litigation, defending companies in class action suits, multi-district litigation, as well as multi-party products liability actions.
Communications
Protecting the image of a medical and life sciences company is critical, especially during a crisis or highly controversial situation. Harris Beach has extensive industry experience crafting effective communication strategies to maximize positive public exposure and lessen the negative impact to organizations during controversial situations.
Harris Beach attorneys have assisted medical device, biological and life sciences organizations with their broad corporate needs. Our corporate legal services include financing, capital, U.S. Securities and Exchange Commission issues, initial public offerings, tax issues, licensing agreements, export applications, and equity and technology exchange agreements. We also advise Boards of Directors on state and federal regulatory compliance; corporate governance and structure; and merger, acquisition and divestiture activities.
Cutting-Edge Litigation Techniques
Harris Beach routinely utilizes cutting-edge litigation management techniques for clients such as proprietary databases, and document imaging and coding software in electronic environments.
To protect your data, your business interests and your reputation, you need robust protection that extends beyond firewalls. Our cybersecurity team provides a full range of data privacy and cybersecurity services: compliance counseling and legal risk assessments, defense in litigation and investigations, advisement on state and federal regulations and rapid response should a breach occur. Our attorneys, information security and communications management professionals partner with you to reduce risk and give you data the defense it deserves.
Database of Expert Witnesses
Our expert witness database consists of the nations’ leading authorities on epidemiology, teratology, toxicology, pharmacology, industrial hygiene, dysmorphology, oncology, genetics, pathology, biomedical engineering, cardiology, obstetrics, gynecology and economics.
Defense of a Broad Range of MLS Claims
Harris Beach attorneys defend innovator and generic pharmaceutical manufacturers and distributors and medical device manufacturers and distributors that make or sell prescription and OTC drugs, medical devices, professional dental products, nutritional supplements and products impacting women’s health. Our extensive defense experience ranges from urology imaging systems and other sophisticated products, to contact lenses and personal care items, to cough and cold remedies and other OTC products such as dietary and sports nutritional supplements. When it comes to helping pharmaceutical, OTC medication, personal care/cosmetic, medical device, biologic, nutritional supplement and other life sciences clients resolve complex business disputes, our Medical and Life Sciences attorneys have extensive experience litigating commercial disputes that may arise at each phase of the product’s life-cycle. Representative matters have included breach of contracts and agreements governing product development and manufacturing, clinical trial liability, disputes in joint ventures, and commercial litigation involving the supply, manufacture, distribution, licensing, profit-sharing, intellectual property, and royalty agreements for FDA regulated products.
The attorneys in the e-info Practice Group are leaders in the areas of applying dataset analysis and computer assisted predictive coding to the challenges of complex litigation and investigations. This benefits our clients with substantial improvement in the analysis of their documents while lowering the total cost through increased efficiencies. Our e-discovery predictive-coding solutions are powered by software which acts as an efficiency engine to leverage attorneys’ analytical skills and Technology-Assisted Review (TAR) to increase accuracy in review by up to 70%, dramatically reduce review timeframes by up to 50% and cut client costs by up to 50%.
As a law firm with state-of-the-art technology, Harris Beach is well positioned to meet the defensibility and cost challenges associated with e-discovery. We leverage predictive-coding to make e-discovery reasonable for any litigation, regardless of size or industry, and we provide these services to a wide range of organizations, including national law firms. We have routinely been named as a Go-To Law Firm® for the Top 500 Companies for litigation e-discovery in the In-House Law Departments at the Top 500 Companies as published by Corporate Counsel. The e-info Practice Group leader, Alan M. Winchester, is recognized by the Courts as a thought leader in this area and has been appointed to chair the Operations e-Discovery Working Group. This group has drafted legislation and participates in the training for judges to improve the practice of electronic discovery.
Whether providing stand-alone document counsel, or document and legal counsel, our e-info team can help you control costs, ensure compliance, avoid sanctions, foster collaboration, and increase efficiency. Working with the Harris Beach e-info team also ensures attorney-client privilege is maintained throughout the litigation process.
Electronic Records Management Solutions for Risk Management and Operational Efficiency
Our team of attorneys and IT professionals understand the legal and IT issues associated with electronic records management systems. Their extensive experience in records management coupled with decades of litigation experience can provide unique insights into efficient and cost-effective records management solutions.
Effective Case Management
Harris Beach offers effective case management experience with large, high-risk cases and has established a track record for developing successful defense strategies for federal and state court cases.
Electronically Stored Information Risk Analysis and Management
Our risk analysis services also include ESI. By reviewing electronic files and electronic information infrastructure and recommending record retention policies, we can help clients eliminate up to 80% of e-discovery costs should litigation arise in the future.
Environmental Law and Sustainability
Our environmental and toxic tort team has years of experience dealing with the elimination of toxic and hazardous wastes and by-products from the manufacture of pharmaceutical and medical devices.
Harris Beach attorneys help pharmaceutical and medical device companies, as well as manufacturers of nutritional and dietary supplements, vitamins and OTC products, stay abreast of changing regulatory requirements and develop effective programs for ensuring compliance. We also assist companies subject to government, regulatory agency, or enforcement actions, as well as those dealing with government procurement rules and issues.
We have protected numerous patents of leading pharmaceutical and life sciences companies. Our intellectual property (IP) attorneys have a wide range of technical backgrounds in science and technology, as well as the medical and life sciences, which help our clients identify and protect proprietary formulas and trade secrets. We also assist clients with the analysis, purchase, sale and licensing of their IP domestically and worldwide, as well as managing and assessing the scope and value of their IP portfolios. Our IP attorneys focus on U.S. and foreign patent and trademark procurement for clients in all areas of advanced technology, including mechanical and electrical engineering, biotechnology, pharmaceuticals, nanotechnology, medical devices, materials science, environmental chemistry and agriscience. We have procured, enforced and defended patents for leading medical device manufacturers, pharmaceutical and life sciences companies in administrative proceedings, alternative dispute resolution processes and federal district court litigation. Harris Beach attorneys are also experienced in developing, designing and implementing strategies to combat illicit trade on a global basis.
In the highly competitive medical and life sciences field, where “first-to-market” status and technological advances can increase the value of a company’s stock, Harris Beach attorneys can help protect companies from harmful employee actions by safeguarding patents, enforcing noncompete and confidentiality agreements, and taking other protective measures. Our attorneys also handle National Labor Relations Board and Equal Opportunity Commission regulations for their clients.
Our trial lawyers regularly coordinate the defense of medical and life sciences industry related mass torts. We have developed effective mass tort defense strategies for Food and Drug Administration (FDA) regulated products such as infusion pain pumps, methylprednisolone acetate, contraceptives, metoclopramide, dental anesthetics, Neurontin, latex products, silicone breast implants, ephedra, Diethylstilbestrol, Hormone Replacement Therapies, Phenylpropanolamine-containing pharmaceuticals and phentermine diet drugs.
National, Regional and Local Counsel
Harris Beach attorneys serve as national, regional, and local counsel for some of the largest names in pharmaceuticals, biologics, medical devices, cosmetics, nutritional supplements and products impacting women’s health.
Pre-Product Launch Risk Analysis and Management
Our industry team provides legal counseling concerning prelitigation risk assessments and submissions to the FDA, including package inserts, marketing materials, brochures, warnings, patient labeling, pharmacovigilance as well as development and use of Risk Minimization Action Plans. To help our clients avoid potentially damaging legal actions, our attorneys also examine pre- and post-market liability issues relating to clinical trials, marketing and product recalls.
We defend claims of birth defects, cancer, cardiac injuries, autoimmune disease, neurologic injuries, learning disabilities and others by challenging “junk science” and through motions directed at causation under Daubert (federal) and Frye (state) standards.
