Goldberg Segalla LLP

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Life Sciences

Life sciences companies conquer new frontiers daily — which means each day brings new regulatory, commercial, and legal challenges.

While Goldberg Segalla’s Life Sciences practice encompasses the traditional spheres of biotechnology, pharmaceuticals, and medical devices, we understand that these do not represent discrete subspecialties. As a team of attorneys equipped with advanced degrees across the spectrum of biology, chemistry, and biomedical and chemical engineering — as well as real-world experience working in the high-tech and health sciences sectors — we know from experience that drug discovery often involves biotechnological tools, diagnostics combine materials with assay systems, and medical devices often carry drug or biological actives.

That provides a distinct advantage for clients as they develop new technologies that cross scientific disciplines. Our Life Sciences lawyers have the technical and legal experience to assist at any stage — from offering comprehensive regulatory compliance counsel to handling product liability lawsuits or Hatch-Waxman litigation, launching new products, providing risk management analysis, and navigating enforcement actions and crises.

Our team has dozens of years of combined experience counseling and representing U.S. and international companies of all sizes involved with the manufacturing and distribution of medical devices, over-the-counter drugs, prescription pharmaceuticals, nutraceuticals, and other health-related products or services. We help our clients comply with all applicable regulations and structure commercial relationships with an emphasis on avoiding business-disrupting enforcement actions or disputes. When necessary, we put our extensive and highly regarded trial experience to work to protect our clients’ interests efficiently and effectively, so they may remain focused on what’s most important — their medical, scientific, and business innovations.

With You at Every Stage
Our Life Sciences team partners with other Goldberg Segalla practice groups to offer clients a full array of legal services tailored to each client’s specific business as well as the rapidly evolving medical, scientific, and legal issues affecting their industries.

  • Regulatory compliance — We help clients develop sound regulatory strategies and advise on the full range of applicable regulations, including those of the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and other federal and state agencies.
  • Litigation — When litigation becomes inevitable, we work tirelessly to protect our clients’ interests in disputes regarding product liability, contracts, commercial agreements, intellectual property rights, and other critical areas. We have defended our clients in jurisdictions across the United States, including in some of the most dangerous venues, in single-plaintiff cases, consolidated mass actions and multi-district litigations (MDLs), and class actions. We have a deep understanding of the technical and scientific issues unique to each litigation and are adept at building successful defense strategies that integrate this knowledge. In our experience, most cases settle or are otherwise resolved before a trial, but Goldberg Segalla’s trusted and vast trial experience provides clients with a distinct advantage because our opponents know that we’re not afraid to try cases when necessary — and that we know how to win. We also understand that, at times, alternative dispute resolution is preferable to trial, and we have extensive experience with various forms of arbitration and mediation.
  • Drug approval and Hatch-Waxman litigation — Our attorneys are experienced in handling matters involving the federal Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman Act. Goldberg Segalla’s dedicated Hatch-Waxman litigation team, a part of the Intellectual Property group, fully understands the drug approval process. Our litigators have represented both branded and generic pharmaceutical companies and, therefore, are able to craft an appropriate strategy based on each client’s specific goals and needs. We use our experience and technical knowledge to counsel clients on all aspects of Abbreviated New Drug Applications (ANDAs) filed under the Hatch-Waxman Amendments. Our litigators routinely represent and advise pharmaceutical companies on pre-litigation strategies, FDA approval, prior art analysis and opinions, Paragraph IV certifications, trials, and appeals.
  • Business planning and growth — We can assist with the establishment of U.S. entities and foreign subsidiaries; strategic planning, risk management, and general corporate counseling; mergers, acquisitions, and all types of financing arrangements; licensing, joint venture, and other agreements; and other areas critical to company or product line expansion.
  • Product development, launch, marketing, and distribution — Our team can assist with new drug applications, clinical trials, monographs, 510(k) filings, and premarket approval applications. We counsel on testing protocols and outcomes, product safety concerns, and the full array of complex packaging, labeling, instruction, and warning requirements. We also advise on advertising and promotional campaigns involving all types of traditional and social media.
  • Manufacturing and distribution — We have extensive experience drafting and negotiating manufacturing and distribution agreements, and we can advise on a broad range of import and export concerns. We also assist with workplace safety issues, including evaluation of compliance with Occupational Safety and Health Administration (OSHA) standards.
  • Enforcement actions and crisis management — We utilize our extensive experience negotiating with the FDA to help clients respond to warning letters, notices of inspectional observations, and other enforcement actions. Our team is also experienced in handling enforced or voluntary product recalls, and we can advise clients on effective responses to adverse publicity resulting from recalls or safety concerns.
  • Foreign considerations — Our ability to assist does not end at the U.S. border. Our team also has experience counseling clients on litigation risks and regulatory compliance in Canada, Europe, and Asia.
Industry Perspective and Trusted Experience
At Goldberg Segalla, we pride ourselves on understanding each client’s business and the science behind their products so we are better positioned to advise them on how to achieve their unique goals. Our Life Sciences team members have collectively spent dozens of years representing the pharmaceutical, medical device, and health products industries. They are also current or past bar leaders in life sciences law, not only serving as members of the Product Liability Advisory Council and every national bar organization for this area, but also taking active leadership roles in those organizations.

With Goldberg Segalla on your side, you receive the combination of legal prowess and industry perspective necessary to help you reach your goals, protect your assets, and gain an advantage in this highly regulated and competitive market.

For an inside look at the latest legal developments involving medical devices, pharmaceuticals, and more, visit our Life Science Matters blog.

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  • 5.0/5.0 Review for John M. Allen by a Associate on 05/04/16 in General Liability

    John is an excellent civil defense attorney. Most importantly, he seeks resolutions that are fair to the parties. This is a trait not often found in litigation matters. Given that John and I were on opposite sides of the fence in a recent case, my... Read more

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    John is an excellent civil defense attorney. Most importantly, he seeks resolutions that are fair to the parties. This is a trait not often found in litigation matters. Given that John and I were on opposite sides of the fence in a recent case, my comments stem from personal knowledge of this gentleman. Read less

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Both within our own firm and across the wider business and legal communities, Goldberg Segalla’s commitment to diversity is strong, sincere, and a critical component of our firm’s mission and culture. Our philosophy has always been that we hire people who are excellent at what they do, and even better human beings. Period. We feel we would be doing a disservice to our firm and to our clients if we didn’t include contributions from every available resource.

We are extremely proud that our commitment has received regional and national recognition for the innovative programs we have developed and the results we have been able to achieve. The following is a sampling of the firm-wide or individual honors we have received for implementing initiatives that make a difference:

  • George B. Vashon Innovator Award, Minority Corporate Counsel Association
  • MCCA Firm Affiliate Network
  • Vault/MCCA Commitment to Diversity
  • Community Service Award, Defense Research Institute
  • Good Works Award, American Bar Association Section of Litigation
  • Outstanding Committee Chair, ABA Section of Litigation
  • Diversity Trailblazer Award, New York State Bar Association
  • Legal Service Award, Minority Bar Association of Western New York
  • Lawyer of the Year, Bar Association of Erie County
  • Legal Community Leader Award, National Federation for Just Communities of Western New York
  • Diversity Excellence Award, Buffalo Niagara Human Resource Association
  • Value Award for Diversity, Leadership Buffalo
  • Western New York Game Changers, Buffalo Spree magazine

What we are most proud of, though, is that our efforts have shown significant results and continue to make a lasting impact on the lives of many.

Leadership and Action

To put our philosophy and commitment into practice, we have a Diversity Task Force, which includes our managing partner, in place to conceptualize and implement diversity-focused programs as well as give diversity a voice in our decision-making at the highest level. The individuals on this task force share the firm’s strong commitment to increasing diversity, and they use their unique experiences and backgrounds to support and advance that goal. The team meets regularly to create programs, schedule events, establish diversity initiatives both inside and outside of the firm, set long-term goals, and develop the strategy to recruit and retain people from diverse backgrounds.

The chair of our Diversity Task Force, Joseph M. Hanna, has spearheaded numerous diversity initiatives in various organizations and outreach programs, serves on several diversity-related committees, and is a frequent author and speaker on diversity. Among other positions, he is co-chair of the American Bar Association (ABA) Young Lawyer Leadership Program, former chair of the association’s Minority Trial Lawyer Committee and its Special Committee on Human Rights, and former editor-in-chief of the ABA’s Minority Trial Lawyer; a 2014 fellow of the Leadership Council on Legal Diversity (LCLD); a past president of the Minority Bar Association of Western New York (MBAWNY) and the MBAWNY Foundation; and the Diversity Liaison for several committees at the 22,000-member DRI.

For more than a decade, Goldberg Segalla has proudly supported the ABA’s Judicial Internship Opportunity Program, which provides racial and ethnic minority law students, along with members of other groups underrepresented in the legal profession, opportunities to serve as an intern with a judge during the summer after their first or second year of law school. Joe Hanna — an alumni of the program himself — acts as a mentor and leader in the program, through which he has conducted more than 100 interviews for students across the country.

In 2017, Goldberg Segalla participated in the Thurgood Marshall Summer Law Internship Program, the New York City Bar Association’s flagship pipeline program for high school students. As a participating legal employer, we hosted high-achieving inner-city students for the summer and collaborate with the NYC Bar to provide them with additional programming before, during, and after the summer designed to help them prepare for a legal career.

Each summer, Goldberg Segalla proudly welcomes interns through a formal Diversity Clerkship Program that was conceived by Joe while he served as president of the MBAWNY. The program was developed in collaboration with the MBAWNY and the SUNY Buffalo Law School to provide opportunities for minority UB Law students to gain firsthand experience in the legal system. Since it was launched in 2011, the program has placed more than 100 students in clerkships in area courts as well as in several area law firms, with more judges and law firms asking to participate every day. It provides participants with an in-depth look at the legal process and the interaction between the bench and the bar that they would not otherwise get. At our firm, a dedicated team of partners monitors the work of these law clerks and ensures they obtain valuable experience to help develop important legal research, writing, case management, and client service skills critical to their long-term success. Our program earned the firm the Minority Corporate Counsel Association’s 2012 George B. Vashon Innovator Award.

We also have sponsored Success in the City, an annual diversity networking and mentoring event developed by Joe that brought together students, legal and business professionals, educators, nonprofits, and political leaders to make lasting partnerships. Many employment, business, and mentoring relationships resulted from this event. Past events have drawn more than 500 political and business leaders, legal professionals, and students. Success in the City has influenced the development of similar programs in Baltimore, Cleveland, Birmingham, Dallas, and elsewhere.

Our firm is committed to spreading the message throughout the broad legal and business communities that embracing diversity contributes to greater overall success. We conduct training sessions for in-house counsel at Fortune 500 corporations on increasing and promoting diversity. Our attorneys have authored articles and delivered presentations on diversity for various legal organizations, including DRI and the ABA, and our efforts and accomplishments in this area have been profiled in publications such as Law360, the New York State Bar Association’s State Bar News, Business First of Buffalo, the Buffalo Law Journal, and others.

In one example of our work to provide inspiration and raise awareness of diversity and women’s issues in the legal community, Caroline Berdzik, chair of our Employer and Labor Practice Group, spoke to Law360 for the publication’s “Female Powerbrokers” series. In the interview, Caroline discussed her career, the challenges of being a woman at a senior level at a law firm, the work-family life balance, and the importance of taking risks. She also offered guidance to female attorneys on moving their careers forward and advice to law firms on both increasing the number of women partners and retaining top female talent. Her longtime advocacy for women (at her previous firm, she served on the Women’s Business Development Committee and was a member of what became the national Women’s Presidents Organization) helped earn her a spot on the 2015 NJBIZ list of New Jersey’s Best 50 Women in Business.

Joe Hanna also was featured by Law360 in its “Minority Powerbrokers” series, in which he shared his perspective on breaking the glass ceiling in the legal industry, the challenges of being a lawyer of color at a senior level, how law firms can increase diversity in their partner ranks, and Goldberg Segalla’s core commitment to diversity.


Goldberg Segalla is proud to be a member of the Minority Corporate Counsel Association Firm Affiliate Network, which was created by the MCCA to assist and acknowledge law firms that are committed to advancing diversity and inclusion in the legal profession.

We are also a member of the Leadership Council on Legal Diversity (LCLD), a national organization of leaders in law firms and corporate legal departments dedicated to creating a truly diverse legal profession. As noted earlier, Joe Hanna was a fellow of the LCLD in 2014. In this position, he played a critical role in organizing the first-ever New York City LCLD Fellows Roundtable event, and he was instrumental in establishing a mentorship program in Hartford for local diverse first-year law students.

We support the diversity efforts of numerous organizations, including:

  • American Bar Association
  • Asian American Bar Association of New York
  • Columbian Lawyers Association
  • Defense Research Institute
  • Federal Bar Association
  • Korean American Association of Greater New York
  • League of First Nations
  • Minority Bar Association of Western New York
  • National Bar Association
  • Native American Rights Fund
  • National Association of Asian American Professionals
  • National Congress of American Indians
  • New York State Bar Association
  • Seneca Free Trade Association
  • SUNY Buffalo Law School
  • Women’s Bar Association of the State of New York

Our outreach efforts led to the creation of a comprehensive database of more than 500 minority law organizations throughout the United States. Contact between these organizations takes place in anticipation of bringing CLE and legal programs together. This group of minority bar associations includes both local and national organizations, such as:

  • National Association of Women Lawyers
  • National Association of Muslim Lawyers
  • Hispanic National Bar Association
  • National Asian Pacific American Bar
  • Black Women Lawyers Association of Los Angeles
  • South Asian Bar Association of Philadelphia
  • Vietnamese American Bar Association of North Carolina

A Talented and Diverse Team

Diversity is further evident within our firm through the many languages and dialects spoken by members of our team, including Albanian, Arabic, Croatian, French, German, Greek, Hebrew, Hindi, Italian, Korean, Malayalam, Mandarin, Marathi, Norwegian, Portuguese, Punjabi, Russian, Spanish, Swedish, Tagalog, Tamil, Thai, and Urdu.

Goldberg Segalla’s culture is one that values team-spiritedness, collegiality, and interpersonal harmony within our working community. We are a firm that believes in diversity in the workplace, and we are proud to offer a professional and positive work environment for each and every member of our team.

On these values, and on our commitment to diversity, we will never waver. We are proud of what we have accomplished thus far, but we also realize that this is a long-term mission. We will continue to innovate and to improve diversity in law and business — both within Goldberg Segalla and across the communities in which we live and work.

Diversity Matters — Join the Conversation

If you have questions regarding any of the firm’s diversity initiatives or would like to discuss ideas regarding increasing diversity in the legal profession, please contact Joe Hanna (716.566.5447; [email protected]) or another member of our Diversity Task Force:

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