Life Sciences Product Liability

Home Capabilities Life Sciences Life Sciences Product Liability

As a medical device or pharmaceutical manufacturer, you are often in the crosshairs of plaintiffs’ lawyers who file product liability lawsuits – sometimes regardless of the underlying merit. For more than 40 years, Companies facing these challenges have relied on Reed Smith to defend them in product liability litigation, both large and small. We have a longstanding history of partnering with life sciences companies, enabling businesses like yours to continue driving important, life-saving progress for patients.

Proactive Risk Management

For many clients, our work begins even before a lawsuit filed. We offer fixed-fee product liability risk assessments designed to identify vulnerabilities, legal issues, and potential defense themes. Forewarned is forearmed.

Comprehensive Litigation Experience

While we are always ready to defend individual cases or serve as local or regional counsel, our national reputation is built on successfully representing life sciences manufacturers like you in high-profile, complex, and mass tort product liability litigation. Our experience extends to related class actions, third-party payor lawsuits, and False Claims Act cases.

We are trial lawyers at heart, but we recognize that the earlier we can eliminate a case — or help you avoid it altogether — the better it is for your business. If litigation does arise, we deploy lean teams with deep experience who hit the ground running. We know the plaintiffs’ lawyers’ playbook and are committed to staying ahead of evolving legal theories and tactics. Our team continually refines and advances defense strategies through rigorous case analysis, creative motion practice, and the development of innovative legal arguments. We leverage our deep industry knowledge and experience to anticipate challenges and proactively shape the direction of each case. In addition, our active participation in thought leadership platforms – such as the influential Drug and Device Law blog – ensures we remain at the forefront of emerging trends and legal developments, benefiting our clients with the most current and effective defense approaches.

Efficient Discovery and Trial Readiness

In discovery, we fight against disproportionate and asymmetrical burdens. Our in-house Records & E-Discovery team efficiently and cost-effectively manage electronic discovery and document review. When heading to trial, we can deploy multiple experienced trial lawyers across the United States. In recent years, our lawyers have secured more than 35 defense verdicts at trial, including in some of the most challenging jurisdictions. Our appellate lawyers not only win on appeal, but also proactively ensure the creation of favorable records from the outset.

Strategic Settlements and Global Resolution

When settlement is the right course, we strategically position cases for advantageous resolution to meet or exceed your settlement and alternative dispute resolution goals. For mass torts requiring parallel litigation and settlement tracks, we have a dedicated team of authorities who negotiate global resolution strategies.

International Reach and Forthcoming EU Product Liability Directive

The depth of our sector knowledge extends beyond the United States. We have assisted product liability clients in Canada, the UK, the EU, South America, Asia, and Australia with litigation, preventive risk management, crisis procedures, and arbitration under both national and international rules. Most recently, we have been advising multinational pharmaceutical and medical device clients on the EU’s forthcoming Product Liability Directive (PLD). The PLD marks a fundamental shift in the product liability landscape for all companies placing products on the EU market. It expands the definition of “product” to include all software, including AI systems, digital health applications, and connected devices, expands the range of parties who can be held strictly liable, drastically lowers the evidentiary burden for claimants, and introduces new categories of damages. The PLD sits alongside the EU’s new class action regime, further increasing the potential exposure for companies operating in the EU. Thanks to our product liability lawyers in the EU and UK, our team is well equipped to advise on product liability issues wherever they arise.

Broad Industry Experience and Recognition

Our work spans a wide range of medical products, including contraceptives and hormone therapies, surgical mesh, diabetes medications, defibrillators, antidepressants, orthopedic implants, diet drugs, vaccines, over-the-counter medicines, heart valves, bone screws, latex gloves, biologics, and many others. Our dedication has consistently earned us recognition as one of the top life sciences product liability practices in the United States by publications such as Chambers, The Legal 500, and The American Lawyer. While we appreciate these honors, our greatest satisfaction comes from representing clients like you in this vital industry.

Areas Of Focus

Civil Justice Reform

For many years, we have worked to craft helpful tort reform measures and ward off initiatives pushed by the plaintiffs’ bar. This work spans the country and includes efforts regarding the availability of protective orders in discovery, the use of confidential settlement agreements, punitive damages liability, class actions, and federal removal jurisdiction.

In addition to partnering with businesses like yours to affect change for companies in the industry, our product liability team keeps abreast of potentially precedent-setting cases and works to both educate concerned parties about them and advocate for outcomes that advance civil justice reform. Several of our lawyers contribute to the award-winning Drug and Device Law blog, where we provide easy-to-understand analysis and commentary on current, important pharmaceutical and medical device product liability cases.

We then often takes things a step further, playing an active role in advocating for verdicts and rulings in these key cases that would promote civil justice reform. Our lawyers have served as a resource for life sciences clients like you on civil justice reform issues, providing legal analysis and data from our various subject matter experts to support the work of businesses like yours, and we can also connect with legislative contacts whenever necessity dictates.

Finally, we actively partner with or are members of important industry organizations involved in civil justice reform, including Lawyers for Civil Justice, Civil Justice Reform Group, Product Liability Advisory Counsel, The Sedona Conference, E-Discovery Institute, EDRM, and ARMA, so we can better be in the know and advocate on your behalf.

Preemption

Federal preemption ranks among the most important doctrines available to medical device and pharmaceutical manufacturers in product liability litigation, and our team has long helped lead the charge.

We have won dozens of preemption motions for companies like yours across the country - in state and federal trial and appellate courts - in cases involving express and implied preemption for PMA medical devices, implied preemption for generics and branded drugs, and express and implied preemption for OTC drugs. We are uniquely familiar with plaintiff lawyers’ preemption-avoidance tactics, and we are proud of our continual efforts to push the law forward on this important issue.

Product Risk Assessments

There are numerous reasons why a risk assessment could be valuable for your company. Risk assessments create a strategic blueprint for handling existing litigation, and can be used to build a strong "good company” story and defense for any product liability or other lawsuits that may be filed in the future. Even if litigation has already commenced, assessing the risk of additional individual and/or class action lawsuits is beneficial to see whether such potential actions can be foreclosed before any further cases are filed as well as what the response should be if further lawsuits are filed.

Due diligence investigations can also mitigate future risk if conducted before litigation has started – or before the product is even introduced to the market. And product liability risk assessments are also useful tools when evaluating costs in connection to mergers and acquisitions.

Women's Health Products

Our team has particularly extensive experience handling a wide range of individual, class, and mass tort product liability litigation for a broad spectrum of women’s health products and reproductive-system injuries. This unique body of experience and scientific knowledge led to the creation of our Women’s Health Product Liability team.

Our team has defended, or is currently defending, product liability litigation involving hormone contraceptives, pelvic mesh, hormone replacement therapy, diet drugs, breast implants, and age and bone loss drugs, among others. In addition this team is exceptionally diverse, featuring numerous women trial lawyers and mass tort litigators with an unparalleled history working in this arena.

Learn More About Our Women's Health Products Capability

Meet the Women's Health Products Team

Christine Morgan named a California Leader in Tech Law

Industries

Services

Business Teams

PitchBook lists Reed Smith in 22 Global League Tables for deal volume

Areas Of Focus