Medical and Life Sciences

Industry Team

Our Medical and Life Sciences Industry Team attorneys, capitalizing on insights resulting from their combination of medical and legal credentials, have earned a national reputation for providing integrated solutions and successfully defending some of the largest entities in the strictly FDA-regulated pharmaceuticals and medical devices industries. Harris Beach has the expertise, relationships, and resources to help industry stakeholders compete and succeed in this constantly evolving marketplace.

The Medical and Life Sciences (MLS) industry’s dynamic growth over recent years has been driven by a demographic shift in the U.S. population. As the “Baby Boom” generation continues to age, there is an increasing demand for prescription and Over the Counter (OTC) pharmaceuticals, medical devices, dietary and nutritional supplements, and products enhancing overall health.

Integrated Solutions

Due to their complex nature, MLS industry matters often demand integrated solutions which involve other Harris Beach industry teams and/or practice areas. To provide the greatest efficiency and value for our clients, we strategically leverage our broad knowledge base to build interdisciplinary, problem-solving teams of complementary disciplines. This team approach has proven beneficial in defending mass torts, and addressing other legal issues such as intellectual property, corporate and securities law, fraud and abuse, business and commercial litigation, labor and employment law, risk management, R&D, strategic alliances, and licensing.

Industry Leadership

Harris Beach attorneys frequently address and chair national industry conferences as MLS thought leaders. In a constantly changing industry, our attorneys stay on the cutting edge through membership and leadership of such medical and legal professional organizations as the American Bar Association, American Society for Pharmacy Law, and the Defense Research Institute. Our attorney team continuously monitors and explores new medical and scientific developments, such as nanotechnology, which will impact the industry’s future.

Legal Experience Combined with Medical Knowledge

Since some of our attorneys began their careers as nurses, pharmacists, or other health care professionals, they routinely leverage their sophisticated industry insight to benefit clients. Our attorneys’ combination of legal acumen and first-hand MLS industry knowledge helps them reach client solutions quicker and more cost-effectively.

Our Complex Litigations services include:

Our Integrated Legal Services include:

COMPLEX LITIGATION

National, Regional, Local Counsel

Harris Beach MLS 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.

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.

Defense of a Broad Range of MLS Claims

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.

MLS Product Defense

The Harris Beach MLS attorneys defend innovator and generic pharmaceutical manufacturers and distributors and medical device manufacturers and distributors, who 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.

Mass Torts Defense

Our trial lawyers regularly coordinate the defense of MLS industry related mass torts. We have developed effective mass tort defense strategies for Food and Drug Administration (FDA) regulated products such as contraceptives, latex products, silicone breast implants, ephedra, Diethylstilbestrol, Hormone Replacement Therapies, Phenylpropanolamine-containing pharmaceuticals, and diet drugs.

Pre-Product Launch Risk Analysis and Management

Our MLS industry team provides legal counseling concerning pre-litigation risk assessments, submissions to the FDA including package inserts, marketing materials, brochures, warnings, patient labeling, pharmacovigilance and the 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.

ESI Risk Analysis and Management

Our risk analysis services also include Electronically Stored Information (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.

e-Discovery

Harris Beach was named as a Go To® law firm for litigation e-discovery in the In House Law Departments at the Top 500 Companies 2010 7th annual edition, from the publishers of Corporate Counsel. When the stakes are high, Fortune 500 corporations and top ranking law firms trust our e-info℠ attorneys and IT consultants to provide customized and comprehensive solutions to the new reality of complex litigation challenges.

The Harris Beach e-info℠ team offers a full range of integrated solutions to meet our clients' needs including e-discovery solutions for litigation support and electronic records management solutions.

e-Discovery Solutions for Litigation Support in the Electronic Age
The Harris Beach e-info℠ Electronic Information Counseling and Management Practice Group has been involved in complex litigation for decades. As a result, we have developed a proprietary approach to large case management and have extensive experience in all phases of e-discovery. We offer integrated solutions ranging from technical assistance associated with back end document and electronic information collection and processing, to service as separate document counsel where our attorneys and IT consultants collaborate to provide a complete solution to your electronic and paper document needs. In any scenario, Harris Beach e-info team attorneys and IT consultants deliver cost-effective counseling and management.

There are a number of unique advantages to working with the Harris Beach law firm for e-discovery. First and foremost, our e-info team is led by attorneys and IT professionals who understand the legal and technological issues associated with electronic document preservation, collection, and production. With our law firm roots, we know what the legal requirements are, and work closely with you to meet your specific needs. Our experience working with many of the nation’s leading law firms ensures that we bring the most current “best practices” for preserving, reviewing, and producing documents to your organization. We will help guide you around the pitfalls of electronic discovery.

Electronic Records Management Solutions for Risk Management and Operational Efficiency
Our e-info team is led by attorneys and professionals who 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.

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.

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.

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.

INTEGRATED LEGAL SERVICES

Corporate Law

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, merger, acquisition, and divestiture activities.

Intellectual Property

We have protected numerous patents of leading pharmaceutical and life sciences companies. Our 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 purchase, sale, and licensing of their intellectual property domestically and worldwide.

Our intellectual property attorneys focus on domestic and foreign patent and trademark procurement, for clients in all areas of high 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, ADR and federal district court litigation. Our IP attorneys have a wide range of technical backgrounds in science and technology, as well as in the medical and life sciences, which help our clients identify and protect proprietary formulas and trade secrets.

Harris Beach attorneys are also experienced in developing, designing and implementing strategies to combat illicit trade both on a domestic and worldwide basis. We also assist clients with the analysis, purchase, sale, and licensing of their intellectual property domestically and worldwide and as well as managing and assessing the scope and value of their intellectual property portfolios.

Business and Commercial Litigation

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.

Labor and Employment

In the highly competitive MLS 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 non-compete and confidentiality agreements, and taking other protective measures. Our attorneys also handle National Labor Relations Board and Equal Opportunity Commission regulations for their clients.

Government Compliance and Investigations

The Harris Beach MLS team helps pharmaceutical and medical device companies, and 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.

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. Our Energy practice helps organizations meet their sustainability challenges by taking advantage of the wealth of opportunities, technologies, and resources available to support green business practices.

Communications

Protecting the image of a medical or life sciences company is critical, especially during a crisis or highly controversial situation. Harris Beach has extensive MLS industry experience crafting effective communication strategies to maximize positive public exposure and lessen negative impact to organizations during controversial situations.