For more than 20 years, Katy Koski has represented companies in the heavily regulated life science space, including manufacturers, distributors, and sellers in the pharmaceutical and medical device industries. She is a partner in the firm’s Business Litigation & Dispute Resolution Practice and a member of the Health Care & Life Sciences Sector.
Katy has represented life science companies in jury and bench trials in state and federal courts throughout the United States addressing complex claims involving fraud, unfair competition, product liability, intellectual property, mass torts, and false claims. In addition to representing client interests at trial, Katy counsels clients in developing and executing strategies to address and exit high-profile and “bet the company” litigation, including in multi-district litigation (MDLs) and other coordinated proceedings involving thousands of plaintiffs.
Foley’s pharmaceutical practice includes representing clients in some of the largest MDLs threatening the industry. Most recently, Katy served with other Foley lawyers as national coordinating counsel representing a pharmaceutical distributor, Anda, Inc. as well as generic pharmaceutical manufacturers in defense of claims asserted in the national opioid litigation. The opioid litigation includes claims brought by state, county, and local governments, third-party payers, and private individuals in state and federal courts throughout the 50 states. Katy works with clients to conduct early assessment of the claims, the relative pressures on each company’s business interests, as well as the role each company has among the many defendants named in each suit to devise appropriate litigation and settlement strategies.
In addition to the large-scale attacks on the pharmaceutical and device industries generally, Katy also counsels and represents individual companies facing product liability claims targeting key products in a client portfolio. From ADHD medication to heart valves and blood processing devices, Katy’s depth of knowledge of and experience with the regulations and controls in the life science industry make her a trusted advisor to clients as they consider options in protecting their product line.
- National and trial counsel for a pharmaceutical wholesale distributor, in nationwide litigation relating to the distribution of prescription opioid medications, including more than 1,000 cases brought by states, cities, counties, tribes, and private parties seeking recovery in connection with the opioid abuse crisis.
- National counsel for generic pharmaceutical manufacturers in national opioid litigation; federal MDL currently pending in the Northern District of Ohio.
- Served as national coordinating and trial counsel for generic pharmaceutical manufacturers in nationwide Average Wholesale Price litigation brought on behalf of individual States and the United States in state and federal courts around the country. The claims challenged drug pricing practices under state and federal tort law as well as state and federal false claims act provisions.
- Counsel for generic pharmaceutical manufacturers in claims brought by the Attorneys General of Mississippi and Louisiana, as well as a federal qui tam action, regarding federal Medicaid regulations.
- National counsel for LivaNova USA, Inc. and affiliated entities in product liability litigation alleging personal injuries caused by the use by surgeons of the legacy Mitroflow Aortic Pericardial Heart Valve in patients with congenital heart defects and other valve disorders. Obtained summary judgment on all claims pursuant to federal preemption under the Medical Device Amendments to the FDCA.
- Represent various pharmaceutical manufacturers and distributors, as regional counsel, in defense of product liability claims including failure to warn, design and manufacturing defects. Successfully defeated multiple claims on federal preemption grounds.
Awards and Recognition
- Selected for inclusion in the Massachusetts Super Lawyers – Rising Stars® (2005 – 2008, 2010 – 2011, 2013 – 2016).
- The Legal 500 recognized Katy for her work in life sciences (2016).
- Elected to membership in the International Association of Defense Counsel (IADC). This invitation-only membership is comprised of the world’s leading corporate and insurance lawyers and insurance executives
- Boston Bar Association
- American Bar Association
- Women in Products Liability Subcommittee
- Defense Research Institute
- Drug and Medical Device Section
- Frequent writer and speaker on topics affecting FDA regulated business and products, and issues concerning litigation prevention, assessment, and management, among other topics