3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly. 3D printing, or “additive manufacturing,” has been around since the 1980s. In the past few years, however, the technology has developed at an unprecedented rate, resulting in 3D printing becoming a significant industry with tremendous innovative potential for many applications - from dental and medical, to automotive, aerospace, military, fashion, food, eyewear, and construction.

Forecasters predict that 3D printing will democratize manufacturing, allowing every individual with the means to buy a printer to become a manufacturer and market his or her products to others. As such, 3D printing presents myriad of legal challenges, and our 3D printing focused lawyers are poised to assist.

One of the most powerful tools used by the federal and state governments to identify fraud and recover overpayments in government programs is the federal False Claims Act, 31 U.S.C. section 3729 et seq. (“FCA”), and corollary state false claims acts. We are experienced in responding to Inspector General (“IG”), Assistant United States Attorney (“AUSA”) and Department of Justice (“DOJ”) Civil Investigative Demands; subpoenas; successfully resolving FCA investigations; and defending clients in FCA actions and qui tam litigation filed by FCA relators and the DOJ. Our FCA and qui tam experience includes:

• Providing compliance and related guidance to minimize potential exposure
• Negotiating Corporate Integrity Agreements/Certification of Compliance Agreements
• Conducting internal investigations of potential compliance issues and preparing voluntary or mandatory disclosures
• Utilizing extensive in-house document collection and production capabilities to economically respond to subpoenas and document requests

Clients turn to Reed Smith’s highly regarded FDA attorneys for help in achieving and maintaining compliant operations as they seek to develop and commercialize products and services in a business environment that is evolving on a real-time basis. Our team can counsel clients on traditional FDA-related challenges, such as inspections and investigations, as well as on developing areas, such as personalized medicine and gene therapy, software as a medical device (SaMD), artificial intelligence (AI), and machine learning (ML).

Innovative, future-focused life sciences and health care companies require strategic insights on a wide array of FDA and related regulatory matters to assess opportunities and risks, advocate for solutions that benefit patients or customers, and develop tailored risk mitigation strategies. We are proud to be the trusted advisors of numerous companies in the pharmaceutical, biologic, compounding, medical device, digital health, telehealth, pharmacy, laboratory, animal health, dietary supplement, food, and cosmetic spaces. We also counsel companies providing technology and services targeted to these regulated sectors.

Additionally, we regularly provide tailored regulatory due diligence advice and counseling to life sciences and health companies seeking strategic growth – whether through a range of collaboration agreements, mergers, acquisitions, divestitures, or financing opportunities – as well as to investors and investment banks and financial services companies that are active in the life sciences and health care sectors.

In addition to our knowledge of and focus on these issues at the federal level, we also assist life sciences and health care clients with related matters at the state level, typically involving state boards of pharmacy and health departments.

Our team includes a partner who was formerly a registered nurse; lawyers with advanced degrees in public health, global health, pharmacy, and business administration; and lawyers with backgrounds in science and computer science, giving us a unique perspective into our life sciences and health care clients and their needs.

Additionally and importantly, our team works seamlessly with colleagues around the world to provide our clients with comprehensive services and counseling. For example, we draft specialized manufacturing and quality agreements with our corporate colleagues, collaborate with our international trade colleagues to assist clients with import and export issues, and work with colleagues in Europe and Asia to provide strategic cross border regulatory counsel for clients whose needs require interactions with or advice on FDA’s equivalent organizations around the world.

Reed Smith’s international arbitration practice spans the globe. With offices in the world’s leading arbitral seats, including London, Paris, New York, Singapore, Hong Kong, Dubai, Miami, and Houston, we are strongly positioned to represent clients in international business disputes.

For the sixth consecutive year, leading international arbitration publication Global Arbitration Review has included Reed Smith in its elite list of the world’s top 30 international arbitration law firms, the GAR 30.

Our clients, whether privately or publicly owned, benefit from the invaluable insights, in-depth knowledge, award-winning talent and cross-border collaboration of our global team of international arbitration lawyers, many embedded in our core industry practice areas.

We act as trusted advisers, advocates and arbitrators across a broad spectrum of complex and often multi-million/billion-dollar commercial, investor-state, and sector-specific arbitrations. Our dynamic and forward-looking practice has a strong track record of achieving results based on our clients’ needs, their commercial objectives and the characteristics of the dispute.

• “The ‘committed and specialised’ Reed Smith LLP international arbitration practice ‘epitomises excellence’.” The Legal 500 Latin America 2023
• “Reed Smith's distinguished dispute resolution team has deep experience in commercial arbitrations.” Chambers USA 2023
• “Reed Smith is particularly noted for its expertise in construction, energy and transportation arbitration cases… It is a wonderful team." Chambers Europe – France 2023
• “Reed Smith has an excellent team of lawyers who have a wealth of experience of international arbitration.” The Legal 500 EMEA – UAE 2023
• “One of the best arbitration teams around.” The Legal 500 UK 2024
• “A formidable opponent in commercial disputes.” The Legal 500 APAC 2023

For pharmaceutical, medical device, and other life sciences companies, commercial disputes can arise from contracts and agreements governing all stages of the product life-cycle, including product development, clinical trials, collaboration, supply, manufacturing, distribution, licensing, joint-ventures, profit-sharing, and royalty agreements. We have the experience to assist you regardless of when a dispute occurs in this cycle or where it occurs in the world.

We can also help you prevent disputes from arising in the first place. Our litigators frequently work directly with life sciences companies at the contract drafting table, putting our deep subject and industry experience to work for you at the start to discover potential issues, address them, and prevent them from creating litigation down the road.

Our team has also defended and prosecuted matters for life sciences companies involving allegations of unfair competition or anti-consumer business practices. And, because commercial disputes never arise in a vacuum, our litigators have gained cross-disciplinary knowledge of the transactional, regulatory and intellectual property issues that are typically involved in disputes in today’s dynamic life sciences marketplace – that we can leverage for you.

This vast industry knowledge, coupled with litigation savvy team members, allows us to quickly assess litigation risk and provide an early assessment of a dispute, offering you better resolution opportunities. Unsurprisingly, whether it’s through a creative dispute-resolution strategy or a trial anywhere in the United States, the United Kingdom or around the world, we can offer you an enviable record of success.

Global life sciences companies like yours increasingly encounter parallel regulatory enforcement regimes and proceedings with cross-border impact, necessitating experienced investigations counsel to guide you through enforcement actions, litigation and, often, settlement.

Our team includes many former senior prosecutors and lawyers from various regulatory authorities.  We have conducted compliance program reviews and internal investigations, as well as defense in enforcement agency or criminal investigations in more than 45 countries worldwide, and we most often assist life sciences companies with investigations related to the False Claim Act (FCA), anti-corruption and anti-trust issues.

The pharmaceutical and medical device industries increasingly face FCA and qui tam investigations and subsequent litigation. We have extensive experience helping businesses like yours reduce potential FCA exposure through compliance and related guidance, conducting internal investigations of potential issues, and defending and litigating FCA actions against the government and qui tam relators. We also routinely respond to government subpoenas, and draw on our long-standing relationships with government regulators to help us successfully negotiate with the Department of Justice (DOJ), Office of Inspector General (OIG), and other agency counsel to resolve investigations and litigation.

Our multi-jurisdictional anti-corruption team can advise you, as a life sciences company, on regulatory compliance with bribery and anti-corruption regulations, including the Foreign Corrupt Practices Act (FCPA) and UK Bribery Act, and we can defend you and your senior executives in all phases of criminal investigations and prosecutions. Our coordinated team has seamlessly handled global investigations and negotiated landmark settlements with regulatory bodies around the world on behalf of many pharmaceutical and medical device clients, just as we can do for you.

Enforcement authorities around the world are increasingly coordinating their antitrust and competition, activities, especially in the United States, the EU, and Asia. It is therefore critical for you, as a global life sciences company, that your antitrust/competition counsel be able to operate on an international scale. We offer advice and counseling support for you in dealing with multi-jurisdictional and national competition issues, including handling allegations of price-fixing, bid-rigging, boycott, and customer allocation cartels; as well as allegations of anticompetitive agreements or investigations by competition enforcement authorities; or where customers or competitors are challenging your conduct.

We can even counsel you on internal investigations, state lawyers general matters, and general compliance issues to avoid litigation altogether.

Insurance is an important piece of the portfolio of assets of any life sciences company, but as you know, the variety of policies — product liability, directors and officers, cyber, clinical trials, property, crime and fidelity — may seem endless and overwhelming.

Our insurance recovery lawyers have the breadth and depth of experience to provide the answers you need.  We represent clients like you in all facets of the life sciences industry on everything from policy review, formation and renewal questions to contract review, analysis of insurance assets in M&A due diligence and presenting and resolving claims including advocating for coverage, and negotiating disputes. When necessary, our team will litigate and arbitrate on behalf of your company to work towards your desired outcome.

Given the global nature of the life sciences business, we are uniquely situated to address insurance issues wherever they arise.

In your industry, perhaps no asset matters more than your intellectual property. For decades, our lawyers have played critical roles in obtaining, defending and enforcing intellectual property rights in the most technologically-advanced countries in the world. We are available to assist in every aspect of your IP needs, from strategic counseling to obtaining and licensing IP rights, to their defense and enforcement.  We, at Reed Smith, have an unparalleled skill-set at evaluating IP portfolios for companies that are considering sale or acquisition of IP rights.  We file and prosecute patent and trademark applications, clear products for commercialization, and defend and enforce claims of infringement involving drug, medical device, diagnostic and biologic technology, including ANDA litigation under the Hatch-Waxman Act.

You steward your patients’ most sensitive information as you create devices and diagnostic tools that transmit patient information, manage clinical studies and trials, track individuals’ reactions to drugs and devices, and research needs for new or improved products.

With the explosive growth of electronic medical records and ever-changing medical privacy laws, we advise clients across the life sciences and health industries on existing and emerging global data security issues.

We can help you build policies and procedures to protect this sensitive information; advise you on the development and launch of mobile and cloud-based monitoring and other new technology development; guide you through major incidents of data theft, loss, and unauthorized access; and defend you in bet-the-company litigation and investigations over privacy issues. Our privacy litigators have defended more than 80 putative class actions arising from the theft or loss of information, or allegations of improper collection or use of it, including cases for life sciences companies.

We have represented companies with medical privacy issues in response to government investigations by the Federal Trade Commission (FTC) and the Department  of Health & Human Services Office for Civil Rights (OCR). Our national privacy litigation team has obtained outright dismissals of privacy suits and has even compelled such actions to individual arbitration.

In the United States, we can provide regular advice on a wide range of data privacy issues under the Health Insurance Portability and Accountability Act (HIPAA)/ Health Information Technology for Economic and Clinical Health (HITECH) Act and related state authorities, including  business associate agreements, marketing considerations and de-identification of data.

Internationally, we can advise you on data protection issues under the EU General Data Protection Regulation (GDPR) and similar national legislation worldwide on a range of issues covering the full life cycle of data collection, use, handling, storage, disclosure, destruction, and security.

As a medical device or pharmaceutical manufacturer, you are in the cross-hairs of plaintiffs’ lawyers who file product liability lawsuits—sometimes regardless of potential merit.

Companies facing these challenges have relied on us at Reed Smith in product liability litigations, both large and small, for more than 40 years. We partner with life sciences companies in the defense of these cases, so businesses like yours can continue to drive important, life-saving progress for your patients.

For many clients, our work has started before a lawsuit even has been filed, with fixed fee product liability risk assessments designed to give your company a quick handle on potential defense themes, legal issues, and vulnerabilities. Forewarned is forearmed.

As a life sciences company, you are faced with the daily challenges associated with operating in a highly-regulated industry, where the laws and guidelines are constantly shifting, and, in our  increasingly global marketplace, are sometimes even at odds with one another.

Advising companies on transactions in the life sciences industry requires in-depth knowledge of the industry to be able to identify and resolve potential issues that may arise or regulations that surround these industry transactions. You need a team with both industry and corporate-specific competency, and we are that team.

Our global team includes lawyers who have served as in-house counsel at life science companies; have had careers in the life science industry prior to practicing law; or have degrees in the science, such as chemical engineering, biochemistry, biology, chemistry and other disciplines.

We, at Reed Smith provide the entire range of life sciences transactions services. We will advise you with respect to acquisitions, divestitures, licensing, joint ventures, strategic alliances, collaborations, co-promotion and other operational transactions.