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 pharmaceutical and medical device industries strictly regulated by the FDA. 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 US population. As the “Baby Boomer” 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.
Due to their complex nature, MLS industry matters often demand integrated solutions which involve many of our areas of practice. 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.
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 services include:
INTEGRATED LEGAL SERVICES
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.
Harris Beach routinely utilizes cutting-edge litigation management techniques for clients such as proprietary databases, and document imaging and coding software in electronic environments.
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.
The Harris Beach MLS 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.
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%.
E-Discovery has become a significant cost component of litigation and government or regulatory investigations. It is also an area fraught with risk since sanctions and claims of spoliation are now common in large litigation cases. 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 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 Winchester, is recognized by the Courts as an expert 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.
Our e-info services include counseling or representation at Federal Rule 26 conferences regarding Electronically Stored Information (ESI), implementing legally sufficient litigation holds to reduce risk of spoliation and infrastructure burden, developing “best practices” management and retention policies to reduce the amount of extraneous or redundant ESI, creating consistent ESI document sweeps and production processes, utilizing the safe harbor exception of Rule 37 to help avoid sanctions, preparing custodial and IT witnesses for Federal Rule 30 (b)(6) depositions, and assisting trial counsel by identifying case-winning documents. We also offer computer forensic services through in-house Certified Computer Examiners.
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.
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.
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.
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.
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.
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.
Our MLS industry team provides legal counseling concerning pre-litigation risk assessments and submissions to the FDA, including package inserts, marketing materials, brochures, warnings, patient labeling and 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.
INTEGRATED LEGAL SERVICES
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.
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 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.
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.
The Harris Beach MLS team helps 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 US 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 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.
May 23, 2013 / Authored Article
December 12, 2012 / Authored Article
October 1, 2012 / Authored Article
August 3, 2012 / Legal Alert
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